# Patent

## Title
Paravalvular leak sealing mechanism

## Abstract

A prosthetic heart valve includes a stent body with a generally tubular annulus section, which may include one or more circumferential rows of cells. One or more prosthetic valve elements mounted to the stent body operate to allow blood flow in an antegrade direction but to substantially block flow in a retrograde direction. A cuff is attached to the stent body and positioned on a luminal surface of the stent body. At least one sealing member is attached to the cuff. The sealing member may be patch with an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction. Flow of blood in the second axial direction will tend to force blood into the sealing member and cause the sealing member to billow outwardly relative to the stent body.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application claims the benefit of the filing date of U.S. Provisional Patent Application No. 61/900,475 filed Nov. 6, 2013, the disclosure of which is hereby incorporated herein by reference.


BACKGROUND
The present disclosure relates to heart valve replacement and, in particular, to collapsible prosthetic heart valves. More particularly, the present disclosure relates to collapsible prosthetic heart valves having improved mechanisms to seal against paravalvular leak.
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 types of stents on which the valve structures are ordinarily mounted: a self-expanding stent and 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 valve, assuring its proper location, 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.
Clinical success of a self-expanding valve may be at least partially dependent on accurate deployment and sealing. For example, inaccurate deployment and anchoring may result in the leakage of blood between the implanted heart valve and the native valve annulus, commonly referred to as perivalvular or paravalvular leakage (“PV leak”). 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. Additionally, in certain procedures, collapsible valves may be implanted in a native valve annulus without first resecting the native valve leaflets.
BRIEF SUMMARY
One aspect of the present disclosure relates to mechanisms and features for prosthetic valves to facilitate sealing against paravalvular leaks. These mechanisms may include, for example, patches or other types of material that expand or billow open upon PV-leak to create a better seal between the prosthetic valve and the native tissue in which the prosthetic valve is implanted.
In one embodiment of the disclosure, a prosthetic heart valve includes a stent body including a generally tubular annulus section defining a first circumferential row of cells. The prosthetic heart valve may include one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section. The prosthetic heart valve may further include a cuff attached to the stent body and positioned on a luminal surface of the stent body. At least one sealing member may be attached to the cuff, the at least one sealing member having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the at least one sealing member and cause the sealing member to billow outwardly relative to the stent body. The at least one sealing member may have a shape chosen from the group consisting of generally triangular, generally trapezoidal, and generally semicircular.
In another embodiment of the disclosure, a prosthetic heart valve includes a stent body including a generally tubular annulus section defining a first circumferential row of cells and a second circumferential row of cells distal to the first circumferential row of cells. The prosthetic heart valve may also include one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section. The prosthetic heart valve my further include a cuff attached to the stent body and positioned on a luminal surface of the stent body. At least one proximal sealing member may be attached to the cuff and positioned substantially within a cell in the first circumferential row of cells, the proximal sealing member having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the proximal sealing member and cause the proximal sealing member to billow outwardly relative to the stent body. At least one distal sealing member may be attached to the cuff and positioned substantially within a cell in the second circumferential row of cells, the distal sealing member having an open side facing in the first axial direction and a closed side facing in the second axial direction so that the flow of blood in the second axial direction will tend to force blood into the distal sealing member and cause the distal sealing member to billow outwardly relative to the stent body.
In yet a further embodiment of the disclosure, a prosthetic heart valve includes a stent body including a generally tubular annulus section and one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section. A cuff may be attached to the stent body and positioned on a luminal surface of the stent body. A sealing member may be attached to the cuff, the sealing member being generally rectangular and having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the sealing member and cause the sealing member to billow outwardly relative to the stent body. The sealing member may be wrapped around an entire circumference of the stent body and define a pocket divided into a plurality of regions, each of the regions being in fluid communication with adjacent ones of the regions.
In still a further embodiment of the invention, a prosthetic heart valve includes a stent body including a generally tubular annulus section, and one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section. A cuff may be attached to the stent body and positioned on a luminal surface of the stent body. At least one strut may form a finger at a proximal end thereof. The finger may be configured to lie substantially parallel to the stent body when the stent body is in a collapsed condition and may be configured to curve radially outwardly and distally when the stent body is in an expanded condition, the cuff being attached to the finger.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of a conventional prosthetic heart valve.
FIG. 2 is a highly schematic cross-sectional view taken along line A-A of FIG. 1 and showing the prosthetic heart valve disposed within a native valve annulus.
FIG. 3A is an enlarged partial schematic view of a sealing member attached to a stent according to an embodiment of the disclosure.
FIG. 3B is a schematic view of an isolated individual sealing member.
FIG. 3C is a schematic view of an isolated series of sealing members.
FIGS. 3D-E are enlarged views showing portions of sealing members having different fiber orientations.
FIGS. 3F-G are highly schematic longitudinal cross-sections showing a sealing member of a valve billowing open to different extents.
FIGS. 3H-I are schematic views of isolated individual sealing members with different shapes.
FIG. 4A is an enlarged partial schematic view of a sealing member attached to a stent according to another embodiment of the disclosure.
FIG. 4B is an enlarged partial schematic view of a sealing member attached to a stent according to a further embodiment of the disclosure.
FIG. 4C is a schematic view of isolated sealing members arranged in a staggered pattern.
FIG. 5 is an enlarged partial schematic view of a sealing member attached to a stent according to still another embodiment of the disclosure.
FIG. 6A is a highly schematic partial longitudinal cross-section of a sealing member attached to a stent, with the stent in an expanded configuration, according to yet another embodiment of the disclosure.
FIG. 6B is a highly schematic partial longitudinal cross-section of the sealing member and stent of FIG. 6A in a collapsed configuration.



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 heart valve according to the descriptions herein and are therefore not to be considered limiting of the scope of the present disclosure.
DETAILED DESCRIPTION
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. The term “circumferential,” when used in connection with a prosthetic heart valve, refers to the direction around the perimeter of the valve. Also, when used herein, the words “generally” and “substantially” are intended to mean that slight variations from absolute are included within the scope of the structure or process recited.
FIG. 1 shows a collapsible stent-supported prosthetic heart valve 100 known in the art. The prosthetic heart valve 100 is designed to replace the function of a native tricuspid, bicuspid or unicuspid valve of a patient, such as a native aortic valve. It should be noted that while the present disclosure is described predominantly in connection with prosthetic aortic valves and a stent having a shape as illustrated in FIG. 1, the concepts described herein may also be used with prosthetic bicuspid valves, such as prosthetic mitral valves, and with stents having different shapes, such as those having a flared or conical annulus section, a less-bulbous aortic section, and the like, and a differently shaped transition section. Examples of collapsible prosthetic heart valves are described in International Patent Application Publication No. WO/2009/042196; U.S. Pat. No. 7,018,406; and U.S. Pat. No. 7,329,278, the disclosures of all of which are hereby incorporated herein by reference.
Prosthetic heart valve 100 will be described in more detail with reference to FIG. 1. Prosthetic heart valve 100 includes expandable stent 102, which may be formed from biocompatible materials that are capable of self-expansion, such as, for example, shape memory alloys such as nitinol. Stent 102 extends from proximal or annulus end 130 to distal or aortic end 132, and includes tubular annulus section 140 adjacent the proximal end and aortic section 142 adjacent the distal end. Annulus section 140 has a relatively small cross-section in the expanded condition, while aortic section 142 has a relatively large cross-section in the expanded condition. Preferably, annulus section 140 is in the form of a cylinder having a substantially round cross-section and a substantially constant diameter along its length. Transition section 141 may taper outwardly from annulus section 140 to aortic section 142. Each of the sections of stent 102 includes a plurality of cells 112 connected to one another in one or more annular rows around the stent. For example, as shown in FIG. 1, annulus section 140 may have two annular rows of cells 112 and aortic section 142 and transition section 141 may each have one or more annular rows of cells. Cells 112 in aortic section 142 may be larger than the cells in annulus section 140. The larger cells in aortic section 142 better enable prosthetic valve 100 to be positioned in the native valve annulus without the stent structure interfering with blood flow to the coronary arteries.
Stent 102 may include one or more retaining elements 118 at distal end 132 thereof, the retaining elements being sized and shaped to cooperate with retaining structures provided on the deployment device (not shown). The engagement of retaining elements 118 with retaining structures on the deployment device helps maintain prosthetic heart valve 100 in 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. In some variations, retaining elements 118 may be disposed near proximal end 130 of heart valve 100.
Prosthetic heart valve 100 includes one or more prosthetic valve elements, such as valve assembly 104, preferably positioned in the annulus section 140 of stent 102 and secured to the stent. Valve assembly 104 includes cuff 106 and a plurality of leaflets 108, which collectively function as a one-way valve by coapting with one another, generally allowing blood to flow in an antegrade direction while substantially blocking blood from flowing in a retrograde direction. As a prosthetic aortic valve, valve 100 has three leaflets 108. However, it will be appreciated that other prosthetic heart valves with which the active sealing mechanisms of the present disclosure may be used may have a greater or lesser number of leaflets.
Although cuff 106 is shown in FIG. 1 as being disposed on the luminal or inner surface of annulus section 140, it is contemplated that the cuff may be disposed on the abluminal or outer surface of the annulus section or may cover all or part of either or both of the luminal and abluminal surfaces. Both cuff 106 and leaflets 108 may be wholly or partly formed of any suitable biological material or polymer such as, for example, polytetrafluoroethylene (PTFE), ultra high molecular weight polyethylene (UHMWPE), polyethylene terephthalate (PET), silicone, urethane, and combinations of the preceding materials.
Leaflets 108 may be attached along their belly portions to cells 112 of stent 102, with the commissure between adjacent leaflets attached to commissure attachment features (“CAFs”) 116. The particular size and shape of CAFs 116 may vary in different valves, for example valves with larger or smaller diameters may include CAFs that are sized or shaped different than the illustrated CAFs. As can be seen in FIG. 1, each CAF 116 may lie at the intersection of four cells 112 of stent 102, 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, CAFs 116 are positioned entirely within the annulus section 140 of stent 102 or at the juncture of annulus section 140 and transition section 141. CAFs 116 may include one or more eyelets which facilitate the suturing of the leaflet commissure to the stent.
Prosthetic heart valve 100 may be used to replace, for example, a native aortic valve, a surgical heart valve, a repair device or a heart valve that has undergone a surgical procedure. The prosthetic heart valve may be delivered to the desired site (e.g., near the native aortic annulus) using any suitable delivery device. During delivery, the prosthetic heart valve is disposed inside the delivery device in the collapsed condition. The delivery device may be introduced into a patient using a transfemoral, transapical, transseptal, transaortic, subclavian or any other percutaneous approach. Once the delivery device has reached the target site, the user may deploy prosthetic heart valve 100. Upon deployment, prosthetic heart valve 100 expands so that annulus section 140 is in secure engagement within the native aortic annulus. When the prosthetic heart valve is properly positioned inside the heart, it works as a one-way valve, allowing blood to flow from the left ventricle of the heart to the aorta, and preventing blood from flowing in the opposite direction. However, as described in greater detail below, some amount of blood may unintentionally flow in the opposite direction around the outside of the prosthetic heart valve due to PV leak.
FIG. 2 is a highly schematic cross-sectional illustration of prosthetic heart valve 100 disposed within native valve annulus 250. As seen in the figure, annulus section 140 of stent 102 has a substantially circular cross-section which is disposed within non-circular native valve annulus 250. It should be understood that the depiction of native valve annulus 250 in FIG. 2, represented as diagonal lines, is not intended to represent the anatomical shape of the native valve annulus. At certain locations around the perimeter of heart valve 100, crescent-shaped gaps 200 form between the heart valve and native valve annulus 250. Blood flowing through these gaps and past valve assembly 104 of prosthetic heart valve 100 can cause regurgitation and other inefficiencies which reduce cardiac performance. Such improper fitment may be due to bending of stent 102 upon application of force, or due to suboptimal native valve annulus geometry due, for example, to calcification of native valve annulus 250 or to unresected native leaflets. Embodiments of prosthetic heart valves disclosed herein address PV leak that may occur through gaps 200.
FIG. 3A illustrates a portion of prosthetic heart valve 300 according to an embodiment of the disclosure. In particular, prosthetic heart valve 300 includes an active sealing mechanism for sealing against PV leak in the form of one or more sealing members 320. In this example, sealing members 320 take the form of parachute-like elements that billow open when blood flows in a retrograde direction DR into the parachute-like elements. If retrograde flow occurs on the abluminal side of valve 300, the blood may enter one or more sealing members 320, causing the sealing members to billow open and facilitating the sealing of gap spaces between the patient's anatomy and the valve. It should also be noted, for this and other embodiments described herein, sealing members 320 may help seal a gap space between prosthetic valve 300 and the native anatomy, even if there is little or no PV leak to cause the sealing members to billow open. This may be due to, for example, the additional material of sealing members 320 filling gap spaces by virtue of the material being positioned in those gap spaces.
In the illustrated embodiment, prosthetic heart valve 300 includes an expandable stent 302 with a plurality of CAFs 316 (only one illustrated in FIG. 3A), which may be similar in many or all respects to stent 102 and CAFs 116 of FIG. 1. Stent 302 extends from proximal or annulus end 330 to a distal or aortic end (not shown), and includes annulus section 340 adjacent the proximal end and an aortic section (not shown) adjacent the distal end. Each of the sections of stent 302 includes a plurality of cells 312 connected to one another in one or more annular rows around the stent. For example, as shown in FIG. 3A, annulus section 340 may have two annular rows of cells 312, including a first proximalmost circumferential row of cells 312a and a second circumferential row of cells 312b distal to the first row. Valve 300 may also include cuff 306, which may be substantially similar to cuff 106 of FIG. 1. Preferably, cuff 306 has a relatively straight proximal end. In the illustrated embodiment, cuff 306 is positioned on the luminal side of stent 302 and attached to the stent, for example, by sutures (not illustrated).
Sealing members 320 may take the form of generally triangular patches of material, although other shapes may be suitable. The triangular patches may be attached to cuff 306 during valve assembly, or after valve assembly is otherwise complete. Any suitable attachment method, such as sewing, may be used. Preferably, a distal or open side 321 of each sealing member 320, in this case the distal side of the triangular patch, is left partially or completely unconnected to cuff 306. For example, if sewing the triangular patch to cuff 306, two proximal sides 322, 323 of the triangle, meeting at a proximalmost point, are sewn to the cuff, but the open side 321 of the triangle is not. With this configuration, the open side 321 of sealing member 320 remains capable of opening upon retrograde blood flow, with the open side facing the distal end of valve 300. Further, the closed proximal sides 322, 323 that are connected to cuff 306 restrict blood from exiting through the proximal sides of sealing member 320. Proximal sides 322, 323 may be sewn such that open side 321 is loose or floppy, and not taught, thereby enabling blood to flow into sealing member 320. As described above, if retrograde blood flow does occur on the abluminal side of valve 300, the parachuting or billowing action of sealing members 320 upon blood flowing into the sealing members facilitates active sealing between the prosthetic heart valve and the native tissue surrounding the valve.
When taking the form of triangular patches, sealing members 320 may be individual elements, as illustrated in FIG. 3B, or a continuous series of elements, as illustrated in FIG. 3C. With sealing members 320 that are individual elements, a user may individually attach any desired number of the sealing members to corresponding portions of valve 300 in any desired pattern or location. Generally, the more sealing members 320 that are used, the greater the profile and general bulkiness of valve 300. If certain areas of valve 300 are particularly prone to PV leak, it may be desirable to strategically attach individual sealing members 320 to the valve only in those prone areas. For example, an area of valve 300 proximal to each CAF 316 may be particularly prone to PV leak. During operation, when valve 300 is closed and the pressure distal to the valve is greater than the pressure proximal to the valve, a proximally directed force may cause portions of stent 302, such as CAFs 316, to pull radially inward, exposing areas of the valve to potential PV leak. By using individual sealing members 320 only in those areas, sealing against PV leak may be maximized while minimizing the profile and/or bulkiness of valve 300.
Alternatively, sealing members 320 may take the form of a plurality of triangular patches in series. Although FIG. 3C illustrates three sealing members 320 in series, more or less may be acceptable. For example, if the first row 312a of cells 312 includes nine cells spanning the circumference of annulus section 340, it may be preferable to use nine sealing members 320 connected together as a single element. This configuration may be particularly convenient, enabling the user to handle only a single piece of material. In this configuration, sealing members 320 may be attached to cuff 306 such that, for each cell 312 in a particular row of cells, one sealing member is positioned substantially within each cell. However, this may also be achieved by attaching nine individual sealing members 320 to cuff 306, or by using a combination of individual sealing members and sealing members attached to one another in series. The term “substantially within” refers to the fact that, although each sealing member 320 is preferably positioned mostly within a particular cell 312 such that it may billow open through the cell with relatively little resistance, some minimal amount of the cell structure may overlap a portion of the sealing member.
Each sealing member 320 may be attached to cuff 306, or to both the cuff and stent body 302. Preferably, each sealing member 320 is attached only to cuff 306 and is capable of parachuting or billowing open through a cell 312 of stent body 302 upon blood entering the sealing member. By attaching sealing members 320 to cuff 306 only, rather than to both the cuff and stent body 302, the overall bulkiness and/or profile of valve 300 may be reduced.
For this and other embodiments described herein, it should also be noted that sealing members 320, when valve 300 is implanted in a patient, may be situated sub-annularly, intra-annularly, and/or supra-annularly. The particular position of sealing members 320 with respect to the native annulus may be affected by, for example, the particular position of the sealing members on stent body 302. There may be particular advantages and disadvantages of each position. For example, if the sealing members are positioned supra-annularly, they may be less likely to be distorted by the shape of the native annulus. However, this positioning may be more likely to result in coronary blockage, a larger profile in a relatively bulky area of the valve, and the positioning may be coincident with the most calcified areas of the native anatomy. If the sealing members are positioned intra-annularly, they may provide for sealing above and below the annulus without causing other physiological issues. However, this positioning may lead to interference with anchoring features of a prosthetic valve, which may lead to a higher likelihood of valve migration or a larger profile in a relatively bulky area of the valve. Finally, if the sealing members are positioned sub-annularly, the valve may have a relatively small profile and the sealing members may be coincident with the least calcified portions of the native anatomy. However, this positioning may increase the likelihood of mitral valve or conduction interference, and may require a longer delivery device and may result in a decreased tracking ability of the valve.
A number of variables may be manipulated to change the way in which, and how much, each sealing member 320 billows open during retrograde blood flow. For example, the type of material forming sealing member 320 may influence how it billows open. In particular, forming sealing member 320 from a material with high compliance, such as tissue, including bovine or porcine tissue, may cause the sealing member to open to a greater extent upon retrograde blood flow in comparison to a lower compliance material. Similarly, forming sealing member 320 from a thin material may lead the sealing member to open to a greater extent upon retrograde blood flow in comparison to a thicker material. The method of attaching sealing members 320 to valve 300 may also affect how the sealing members open. For example, loosely sewing sealing members 320 to cuff 306, such that the sealing members have a relatively large amount of slack, may lead the sealing members to open to a greater extent upon retrograde blood flow in comparison to a method in which the sealing members have relatively little slack from being sewn tightly to the cuff.
Still further, features such as orientation of fibers in the material used to form sealing members 320 may affect performance. For example, if sealing member 320 is formed from tissue and is attached to valve 300 with the fibers of the tissue oriented predominantly circumferentially, the fibers may have a spring-like effect and resist opening. This may result in relatively little billowing of sealing member 320 upon retrograde blood flow in comparison to a sealing member attached to the valve with tissue fibers oriented predominantly longitudinally. Regarding the fiber orientation, FIG. 3D illustrates tissue portion Tc in which tissue fibers Fc are oriented predominantly in a direction that is substantially circumferential. That is, when sealing member 320 is attached to valve 300, tissue fibers Fc would predominantly align along the circumferential direction of the valve. FIG. 3E illustrates tissue portion TL in which tissue fibers FL are oriented predominantly in a direction that is substantially longitudinal, i.e., a direction that, when sealing member 320 is assembled to valve 300, is substantially parallel to the longitudinal axis of the valve. Sealing members 320 may also be formed so that the predominant fiber orientation of the tissue is between circumferential and longitudinal, and may provide for intermediate extents of billowing of the sealing members. Various methods, such as polarized light microscopy, deflection testing and/or tensioning, may be used to determine the dominant tissue fiber orientation. The above description regarding fiber orientation may also apply to other materials. For example, a sealing member made from fabric may also function differently depending on the orientation of the fibers in the fabric. However, the difference in opening of tissue with longitudinal versus circumferential fiber orientation may be exaggerated in comparison to the difference in opening of fabric with longitudinal versus circumferential fiber orientation.
FIGS. 3F-G illustrate a schematic cross-section of a portion of valve 300 with sealing member 320′ (or 320′′) attached to cuff 306 and billowed open through an open portion of stent body 302. In FIG. 3F, sealing member 320′ may, for example, be thin, with longitudinally oriented fibers, and may be loosely sewn to cuff 306 so that the sealing member has a relatively large amount of slack. In FIG. 3G, sealing member 320′′ may, for example, be thick, with circumferentially oriented fibers, and may be tightly sewn to cuff 306 so that the sealing member has a relatively small amount of slack. All else being equal, a given amount of retrograde blood flow may cause sealing member 320′ of FIG. 3F to billow open to a greater extent than sealing member 320′′ of FIG. 3G. These variables may be manipulated such that sealing member 320 opens a desired amount upon exposure to retrograde blood flow. In fact, it may be desirable to pre-shape sealing members such that they have an open configuration but which still may be crimped along with the prosthetic valve during delivery, such that, upon delivery into a final expanded configuration, the sealing member returns to an original open shape that tends to maximize the ability to capture retrograde blood flow therein.
Sealing member 320 may also take shapes other than generally triangular. For example, FIG. 3H shows a sealing member 325 that has a generally semicircular shape, while FIG. 3I shows a sealing member 326 that has a generally trapezoidal shape. However, it should be understood that shapes other than those specifically disclosed herein may be suitable for use as a sealing member. Considerations that may be relevant to the suitability of such an alternate shape include the extent to which the alternate shape matches the shape of the cell 312 through which it billows open. For example, when attaching a sealing member with an alternate shape to cuff 306 and inside stent body 302, the shape preferably allows the sealing member to open through the open portion of the particular cell 312. A sealing member with a shape similar to that of the cell 312 through which it opens may be able to open relatively easily upon retrograde blood flow, while the matching shape may maximize the volume of blood capable of entering the sealing member. Further, a sealing member with a straight, curved, or otherwise non-pointed proximal side, such as the curved proximal side of sealing member 325 or the straight proximal side of sealing member 326, may provide benefits over sealing members with pointed proximal sides, such as generally triangular sealing member 320. In particular, a pointed proximal side may tend to cause blood trapped therein to stagnate, while a non-pointed proximal side may reduce the tendency for blood to stagnate, thereby reducing the likelihood of the formation of a thrombus, for example. Further, the pointed proximal side of such a sealing member may not provide an adequate volume into which blood may flow compared to a similar shape with a non-pointed proximal side.
The width of the open sides of sealing members, such as open side 321 of sealing member 320, may also be varied. For example, sealing members may have wider openings than those illustrated to maximize the likelihood of capturing retrograde blood flow. The wide openings, or any other sealing member openings described herein, may also alternately be punctuated by frequent stitches or other mechanisms to close portions of the open side. The effect of frequently spaced sutures, for example, may create a number of smaller openings that still allow blood flow to enter the particular sealing member. However, if a thrombus forms within the sealing member, the reduced sized openings may make it less likely that the thrombus may exit the sealing member into the blood flow.
FIG. 4A illustrates a portion of prosthetic heart valve 400 according to another embodiment of the disclosure. Prosthetic heart valve 400 may be similar or identical to prosthetic heart valve 300 in all respects other than the active sealing mechanism. For example, prosthetic heart valve 400 includes an expandable stent 402 with a plurality of CAFs 416 (only one illustrated in FIG. 4A). Stent 402 extends from proximal or annulus end 430 to a distal or aortic end (not shown), and includes annulus section 440 adjacent the proximal end and an aortic section (not shown) adjacent the distal end. Each of the sections of stent 402 includes a plurality of cells 412 connected to one another in one or more annular rows around the stent. For example, as shown in FIG. 4A, annulus section 440 may have two annular rows of cells 412, including a first proximalmost row of cells 412a and a second row of cells 412b distal to the first row. Valve 400 may also include cuff 406, which may be substantially similar to cuff 306 of FIG. 3A. In the illustrated embodiment, cuff 406 is positioned on the luminal side of stent 402 and attached to the stent, for example, by sutures (not illustrated).
Prosthetic heart valve 400 includes sealing members 420 that provide an active sealing mechanism for sealing against PV leak. Similar to valve 300, the sealing members 420 take the form of generally triangular patches or parachute-like members that billow open when blood flows into them. However, valve 400 includes proximal sealing members 420a positioned along the first row of cells 412a as well as distal sealing members 420b positioned along the second row of cells 412b. All of the considerations discussed above with respect to sealing members 320 of FIG. 3A apply with equal force to sealing members 420a and 420b of FIG. 4A. Sealing members 420b on the second row of cells 412b may provide for additional sealing against PV leak. For example, points at which open sides 421a of two adjacent sealing members 420a meet may be less likely to catch retrograde blood flow. In the illustrated embodiment, a second row of sealing members 420b is positioned such that center portions of the open sides 421b of sealing members 420b generally align longitudinally with points at which open sides 421a of two adjacent sealing members 420a meet. In other words, the position of the center of open sides 421a of the first row of sealing members 420a is circumferentially staggered or offset from the position of the center of open sides 421b of the second row of sealing members 420b. This configuration may decrease the likelihood that retrograde blood flow will travel proximally between two adjacent sealing members 420a without being caught in any sealing member.
As described with respect to sealing members 320, sealing members 420a, 420b may be individually attached to cuff 406, or multiple sealing members may first be connected to one another in a series for convenience. For example, in one embodiment, sealing members 420a, 420b may be attached to cuff 406 at each cell 412 in the first and second rows of cells 412a, 412b, respectively. Also as described with respect to sealing members 320, sealing members 420a, 420b may be placed strategically on valve 400 to maximize sealing against PV-leak while minimizing the number of the sealing members, and therefore minimizing the bulk of the valve. One embodiment that may be particularly effective, illustrated in FIG. 4B, includes only a single sealing member 420b on the cells 412 in the second row of cells 412b that are directly proximal to each CAF 416. For each sealing member 420b on the second row of cells 412b, two sealing members 420a are positioned on the first row of cells 412a below the sealing member 420b, such that the center portion of the open side 421b of the sealing member 420b generally aligns longitudinally with the point at which the open sides 421a of the adjacent sealing members 420a meet.
A number of alternate configurations of sealing members may be utilized. As described above, sealing members, such as sealing members 420a and 420b, may be positioned on the inner diameter of stent body 402, that is, between the stent body and cuff 406. However, they may alternately be placed on the outer diameter of stent body 402. If positioned on the outer diameter, more shapes and configurations may be used since the sealing members no longer need to be capable of billowing open through the open cells of stent body 402. Rather, if on the outer diameter of stent body 402, the position of open cells of stent body 402 do not limit the shape or configuration of the sealing members at all. For example, FIG. 4C illustrates a schematic view of sealing members 420a, 420b arranged in a staggered pattern, with the remainder of prosthetic valve 400 not illustrated. In this configuration, a first row of sealing members 420a is positioned in a staggered relationship with a second row of sealing members 420b. Open sides 421a of sealing members 420a are positioned proximally relative to open sides 421b of sealing members 420b. However, there is some overlap between sealing members 420a, 420b. In particular, open sides 421a of sealing members 420a are positioned approximately at a midline of sealing members 420b. In other words, the proximal-to-distal distance between open sides 421b and 421a is approximately equal to the proximal-to-distal distance between open sides 421a of sealing members 420a and the proximalmost points of sealing members 420b. These distances may be varied, however, to increase or decrease the level of staggering and overlap between sealing members 420a and 420b. It should further be noted that, in this particular embodiment, it may be preferable for sealing members 420a, 420b to be attached to the outer diameter of stent body 402, rather than between the stent body 402 and cuff 406. This may be preferable if the shape and position of sealing members 420a, 420b does not match with the shape and position open cells of stent body 402 such that the sealing members may easily billow open through the open cells. By staggering sealing members 420a, 420b, the profile of valve 400 may be reduced in comparison to a configuration in which sealing members 420a, 420b were aligned in a single non-staggered row. Still further, it should be noted that in the embodiments described herein, one row, two rows, or more rows of sealing members may be suitable for use with a prosthetic heart valve.
FIG. 5 illustrates a portion of prosthetic heart valve 500 according to a further embodiment of the disclosure. Prosthetic heart valve 500 may be similar or identical to prosthetic heart valves 300 and 400 in all respects other than the active sealing mechanism. For example, prosthetic heart valve 500 includes an expandable stent 502 with a plurality of CAFs 516 (only one illustrated in FIG. 5). Stent 502 extends from proximal or annulus end 530 to a distal or aortic end (not shown), and includes annulus section 540 adjacent the proximal end and an aortic section (not shown) adjacent the distal end. Each of the sections of stent 502 includes a plurality of cells 512 connected to one another in one or more annular rows around the stent. For example, as shown in FIG. 5, annulus section 540 may have two annular rows of cells 512, including a first proximalmost row of cells 512a and a second row of cells 512b distal to the first row. Valve 500 may also include a cuff 506, which may be substantially similar to cuffs 306 and 406 of FIGS. 3A and 4A, respectively. In the illustrated embodiment, cuff 506 is positioned on the luminal side of stent 502 and attached to the stent, for example, by sutures (not illustrated).
Prosthetic heart valve 500 includes a sealing member 520 that provides an active sealing mechanism for sealing against PV leak. Sealing member 520 may take the form a rectangular patch that functions as a parachute-like member that billows open when blood flows into it. In the illustrated embodiment, sealing member 520 includes an open distal side 521 and a closed proximal side 522. The proximal side 522 of sealing member 520 may be attached, for example by sewing, to cuff 506. The attachment is preferably such that blood entering sealing member 520 cannot exit through the closed proximal side 522 of the sealing member. In this configuration, sealing member 520 defines a pocket. The pocket may include regions defined by the points at which sealing member 520 near the open side 521 is attached to cuff 506, as described below. Each region of the pocket may be in fluid communication with adjacent regions. The rectangular patch may be wrapped around the entire circumference of stent 502 with ends of the patch attached to one another to secure the patch in a desired position. In this embodiment, sealing member 520 is a separate entity from cuff 506. Further, in this embodiment, sealing member 520 is preferably attached over the outside of both cuff 506 and stent 502 to allow the sealing member to billow open. This is in contrast to other embodiments, such as generally triangular sealing members 320, which preferably are attached between cuff 306 and stent 302 and which are capable of billowing open through cells 312 of the stent.
One or more individual rectangular patches may be individually attached to stent 502 such that the collective patches are wrapped partially, or entirely, around the circumference of the stent. Portions of sealing member 520 near the open side 521 are also preferably attached to cuff 506, for example using sutures S. As illustrated, a small number of stitches, such as two or three, connect distal portions of sealing member 520 to cuff 506 at spaced locations around the circumference of the sealing member. While the sutures S are shown as attaching sealing member 520 to cuff 506 along portions of the struts where adjacent cells 512a meet, the connections may be made at any point on the cuff. The distal attachments preferably are few enough to leave a substantial portion of open side 521 free such that retrograde blood flow may freely flow into sealing member 520, while still providing enough support to maintain the position of the distal end of the sealing member relative to cuff 506. Similar to embodiments described above, if blood flows in the retrograde direction, represented by arrows DR, on the abluminal side of the valve 500, the blood may flow into sealing member 520 between the points at which the sealing member is attached to cuff 506. The blood may enter and fill sealing member 520, causing it to expand similar to an inner tube, facilitating the creation of a seal against PV-leak between valve 500 and the native tissue in which the valve is positioned.
Sealing member 520 may alternately be formed as an extension of cuff 506, rather than one or more separate rectangular patches. For example, cuff 506, which is positioned on the luminal side of valve 500, may include a portion which extends beyond the proximal end of stent 502. This extending portion may be folded or wrapped around the proximal end of stent 502 such that the extending portion is on the abluminal side of valve 500. The extending portion would form sealing member 520 and would otherwise act similarly to separate rectangular patches attached to cuff 506. In this embodiment, in which sealing member 520 is an extension of cuff 506, it may not be necessary to suture or otherwise attach the proximal end of the sealing member to the cuff, since the sealing member is an extension of the cuff. However, it still may be preferable to form a seam, for example with a suture, between sealing member 520 and cuff 506 adjacent the proximal ends thereof. This may, for example, provide structural support to sealing member 520.
FIG. 6A illustrates a sealing member 620 according to another embodiment of the disclosure. FIG. 6A is a highly schematic sectional view of a proximal portion of a stent body 602 for use in a prosthetic heart valve. As illustrated, a strut of stent body 602 extends proximally from CAF 616 to a proximal end of the stent, at which point the strut transitions into a finger 650 that curves radially outwardly and distally in a general “J” shape. In other words, the strut forms finger 650 at a proximal end of the strut. Cuff 606 may be attached on the luminal side of stent 602 and extend toward the proximal end of the stent, and then curve back up radially outwardly and distally, following the contour of finger 650. In this embodiment, cuff 606 may extend partially or completely around the circumference of stent 602, attached to a discrete number of fingers 650. This embodiment functions similarly to the embodiment described above in which sealing member 520 forms an extension of cuff 506 that is folded or wrapped over the proximal end of stent 502. However, the use of fingers 650 may be beneficial, as the arms may be set to curve outwardly only after stent 602 is deployed and transitions from a collapsed condition to an expanded condition. For example, FIG. 6B illustrates stent 602 and finger 650, along with cuff 606 and sealing member 620, prior to deployment when it is in a collapsed condition, for example within a delivery device. In this configuration, finger 650 lies substantially flat with respect to stent body 602. This configuration allows for the collapsed profile to remain relatively small, since finger 650 and sealing member 620 do not curve outwardly until stent 602 is released from a delivery device and transitions into the expanded condition illustrated in FIG. 6A. Once in the expanded condition, retrograde blood flowing into the sealing member 620 may cause the sealing member to expand further or fill up like an inner tube, helping to create a seal between the valve and the native tissue in which the valve is implanted.
Although the prosthetic valves herein have been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
It will be appreciated that the various dependent claims and the features set forth therein can be combined in different ways than presented in the initial claims. It will also be appreciated that the features described in connection with individual embodiments may be shared with others of the described embodiments.
The following Paragraphs summarize certain aspects of the disclosure.
Paragraph A: A prosthetic heart valve, comprising: a stent body including a generally tubular annulus section defining a first circumferential row of cells; one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section; a cuff attached to the stent body and positioned on a luminal surface of the stent body; and at least one sealing member attached to the cuff, the at least one sealing member having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the at least one sealing member and cause the sealing member to billow outwardly relative to the stent body, wherein the at least one sealing member has a shape chosen from the group consisting of generally triangular, generally trapezoidal, and generally semicircular.
Paragraph B: The prosthetic heart valve of Paragraph A, wherein the at least one sealing member is not directly attached to the stent body.
Paragraph C: The prosthetic heart valve of Paragraph A, wherein the at least one sealing member is attached to both the cuff and the stent body.
Paragraph D: The prosthetic heart valve of Paragraph A, wherein a plurality of sealing members are attached to the cuff.
Paragraph E: The prosthetic heart valve of Paragraph D, wherein each of the plurality of sealing members is individually attached to the cuff.
Paragraph F: The prosthetic heart valve of Paragraph D, wherein the plurality of sealing members form a continuous series of sealing members attached to one another.
Paragraph G: The prosthetic heart valve of Paragraph D, wherein the plurality of sealing members is attached to the cuff such that one sealing member is positioned substantially within each cell in the first circumferential row of cells.
Paragraph H: A prosthetic heart valve, comprising: a stent body including a generally tubular annulus section defining a first circumferential row of cells and a second circumferential row of cells distal to the first circumferential row of cells; one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section; a cuff attached to the stent body and positioned on a luminal surface of the stent body; at least one proximal sealing member attached to the cuff and positioned substantially within a cell in the first circumferential row of cells, the proximal sealing member having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the proximal sealing member and cause the proximal sealing member to billow outwardly relative to the stent body; and at least one distal sealing member attached to the cuff and positioned substantially within a cell in the second circumferential row of cells, the distal sealing member having an open side facing in the first axial direction and a closed side facing in the second axial direction so that the flow of blood in the second axial direction will tend to force blood into the distal sealing member and cause the distal sealing member to billow outwardly relative to the stent body.
Paragraph I: The prosthetic heart valve of Paragraph H, wherein a plurality of distal sealing members and a plurality of proximal sealing members are attached to the cuff.
Paragraph J: The prosthetic heart valve of Paragraph I, wherein the plurality of distal sealing members is circumferentially staggered with respect to the plurality of proximal sealing members such that a center portion of the open side of each distal sealing member aligns generally longitudinally with a point at which the open sides of two adjacent proximal sealing members meet.
Paragraph K: The prosthetic heart valve of Paragraph H, wherein one proximal sealing member is attached to the cuff and positioned substantially within each cell in the first circumferential row of cells and one distal sealing member is attached to the cuff and positioned substantially within each cell in the second circumferential row of cells.
Paragraph L: The prosthetic heart valve of Paragraph H, further comprising at least one commissure attachment feature defined by the stent body, wherein exactly one distal sealing member is attached to the cuff and positioned substantially within a cell in the second circumferential row of cells directly proximal to the commissure attachment feature, and no distal sealing members are attached to the cuff and positioned substantially within any other cell in the second circumferential row of cells.
Paragraph M: The prosthetic heart valve of Paragraph L, further comprising exactly two proximal sealing members for each distal sealing member, the two proximal sealing members being attached to the cuff at two adjacent cells in the first circumferential row of cells such that a center portion of the open side of each distal sealing member aligns generally longitudinally with a point at which the open sides of two adjacent proximal sealing members meet.
Paragraph N: A prosthetic heart valve, comprising: a stent body including a generally tubular annulus section; one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section; a cuff attached to the stent body and positioned on a luminal surface of the stent body; and a sealing member attached to the cuff, the sealing member being generally rectangular and having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite to the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the sealing member and cause the sealing member to billow outwardly relative to the stent body, wherein the sealing member is wrapped around an entire circumference of the stent body and defines a pocket divided into a plurality of regions, each of the regions being in fluid communication with adjacent ones of the regions.
Paragraph O: The prosthetic heart valve of Paragraph N, wherein the open side of the sealing member is attached to the cuff at spaced locations around the circumference of the stent body.
Paragraph P: The prosthetic heart valve of Paragraph O, wherein the sealing member comprises an extension of the cuff, the extension being wrapped around a proximal end of the stent body such that the extension is positioned on an abluminal surface of the stent body.
Paragraph Q: The prosthetic heart valve of Paragraph P, wherein a proximal portion of the extension on the abluminal surface of the stent body is connected to a proximal portion of the cuff on the luminal surface of the stent body with a seam.
Paragraph R: The prosthetic heart valve of Paragraph O, wherein the sealing member is formed from a separate piece of material than the cuff.
Paragraph S: A prosthetic heart valve, comprising: a stent body including a generally tubular annulus section; one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section; a cuff attached to the stent body and positioned on a luminal surface of the stent body; and at least one strut forming a finger at a proximal end thereof; wherein the finger is configured to lie substantially parallel to the stent body when the stent body is in a collapsed condition and is configured to curve radially outwardly and distally when the stent body is in an expanded condition, the cuff being attached to the finger.

## Claims

1. A prosthetic heart valve, comprising:
a stent body including a generally tubular annulus section defining a first circumferential row of cells and a second circumferential row of cells distal to the first circumferential row of cells;
one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section;
a cuff attached to the stent body and positioned on a luminal surface of the stent body;
a plurality of proximal sealing members each attached to the cuff and positioned substantially within a corresponding cell in the first circumferential row of cells, the proximal sealing members having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the proximal sealing members and cause the proximal sealing members to billow outwardly relative to the stent body; and
a plurality of distal sealing members each attached to the cuff and positioned substantially within a corresponding cell in the second circumferential row of cells, the distal sealing members having an open side facing in the first axial direction and a closed side facing in the second axial direction so that the flow of blood in the second axial direction will tend to force blood into the distal sealing members and cause the distal sealing members to billow outwardly relative to the stent body;
wherein the plurality of distal sealing members is circumferentially staggered with respect to the plurality of proximal sealing members such that a center portion of the open side of each distal sealing member aligns generally axially with a point at which the open sides of two adjacent proximal sealing members meet.

2. The prosthetic heart valve of claim 1, wherein each cell in the first circumferential row of cells includes one of the proximal sealing members positioned substantially therein and each cell in the second circumferential row of cells includes one of the distal sealing members positioned substantially therein.

3. The prosthetic heart valve of claim 1, further comprising a plurality of commissure attachment features defined by the stent body, wherein each of the distal sealing members is attached to the cuff and positioned substantially within a cell in the second circumferential row of cells directly proximal to a corresponding one of the commissure attachment features.

4. The prosthetic heart valve of claim 3, further comprising exactly two of the proximal sealing members for each of the distal sealing members, the two proximal sealing members being attached to the cuff at two adjacent cells in the first circumferential row of cells such that a center portion of the open side of each of the distal sealing member aligns generally axially with a point at which the open sides of the two adjacent proximal sealing members meet.

5. A prosthetic heart valve, comprising:
a stent body including a generally tubular annulus section defining a first circumferential row of cells and a second circumferential row of cells distal to the first circumferential row of cells;
one or more prosthetic valve elements mounted to the stent body and operative to allow flow in an antegrade direction but to substantially block flow in a retrograde direction through the annulus section;
a cuff attached to the stent body and positioned on a luminal surface of the stent body;
a plurality of proximal sealing members each attached to the cuff and positioned substantially within a corresponding cell in the first circumferential row of cells, the proximal sealing members having an open side facing in a first axial direction and a closed side facing in a second axial direction opposite the first axial direction so that a flow of blood in the second axial direction will tend to force blood into the proximal sealing members and cause the proximal sealing members to billow outwardly relative to the stent body;
a plurality of distal sealing members each attached to the cuff and positioned substantially within a corresponding cell in the second circumferential row of cells, the distal sealing members having an open side facing in the first axial direction and a closed side facing in the second axial direction so that the flow of blood in the second axial direction will tend to force blood into the distal sealing members and cause the distal sealing members to billow outwardly relative to the stent body; and
a plurality of commissure attachment features defined by the stent body, wherein each of the distal sealing members is attached to the cuff and positioned substantially within a cell in the second circumferential row of cells directly proximal to a corresponding one of the commissure attachment features;
wherein exactly two of the proximal sealing members are included for each of the distal sealing members, the two proximal sealing members being attached to the cuff at two adjacent cells in the first circumferential row of cells such that a center portion of the open side of each of the distal sealing member aligns generally axially with a point at which the open sides of the two adjacent proximal sealing members meet.