# Patent

## Title
Expandable valve prosthesis with sealing mechanism

## Abstract

A prosthetic heart valve includes at least one sealing member. The sealing member is adapted to conform to any surface irregularities found on the inner surface of the valve annulus, including any calcium deposits formed on the valve leaflets. The sealing member can be self-expanding or non-expanding. When deployed, the sealing member is adapted to create a blood tight seal between the prosthetic heart valve and the inner surface of the valve annulus thereby minimizing and/or eliminating perivalvular leakage at the implantation site.

## Background
TECHNICAL FIELD
The present invention relates to instruments for the in situ positioning of implantable devices. In particular, the invention relates to a sealing mechanism for expandable prosthetic heart valves to prevent perivalvular leakage.
BACKGROUND
Natural heart valves, such as aortic valves, mitral valves, pulmonary valves, and tricuspid valves, often become damaged by disease in such a manner that they fail to maintain bodily fluid flow in a single direction. A malfunctioning heart valve may be stenotic (i.e., calcification of the valve leaflets) or regurgitant (i.e., heart leaflets are wide open). Maintenance of blood flow in a single direction through the heart valve is important for proper flow, pressure, and perfusion of blood through the body. Hence, a heart valve that does not function properly may noticeably impair the function of the heart. Left untreated, coronary valve disease can lead to death.
Recently, there has been increasing consideration given to the possibility of using, as an alternative to traditional cardiac-valve prostheses, valves designed to be implanted using minimally-invasive surgical techniques or endovascular delivery (so-called “percutaneous valves”). Implantation of a percutaneous valve (or implantation using thoracic-microsurgery techniques) is a far less invasive act than the surgical operation required for implanting traditional cardiac-valve prostheses. Upon implantation of a heart valve prosthesis, it is important to ensure that a blood-tight seal is created between the prosthesis and the valve annulus in order to minimize or eliminate perivalvular leakage.
SUMMARY
According to one embodiment of the present invention, an expandable valve prosthesis includes: at least one sealing member, the sealing member adapted to provide a seal between the expandable prosthesis and an inner surface of a valve annulus, the sealing member adapted to conform to the inner surface of the annulus upon deployment of the prosthesis.
According to another embodiment, the present invention is a method of replacing a diseased native heart valve and includes placing at least a portion of an expandable heart valve prosthesis over a calcification on a native valve leaflet, and conforming the portion to the contours of the calcification.
According to another embodiment, the present invention can be a kit for replacement of a diseased heart valve. The kit includes an expandable heart valve prosthesis, a seal sized and dimensioned to restrict the flow of blood between the heart valve prosthesis and an inner surface of the valve annulus, and a delivery system for deployment of the expandable heart valve prosthesis.
According to yet another embodiment of the present invention, an expandable heart valve prosthesis can include one or more portions configured to create a seal between the prosthesis and at least two heart valve leaflets upon deployment of the heart valve prosthesis.
According to another embodiment the present invention is a method of replacing a diseased native heart valve. According to this embodiment, the method includes creating a non-naturally occurring aperture in a heart valve by excising one or more heart valve leaflets or portions thereof, deploying an expandable heart valve prosthesis, and sealing any remaining portion between at least two heart valve leaflets and the valve annulus to prevent an undesirable flow of blood past the prosthesis. At least a portion of the prosthesis is located in the aperture.
According to another embodiment, the present invention is an expandable heart valve prosthesis comprising one or more portions thereof configured to create a seal between the prosthesis and at least two heart valve leaflets when the prosthesis is deployed, the seal being formed in a manner that does not require the seal to increase in volume.
While multiple embodiments are disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a sectional view of a human heart showing the pulmonary, aortic, and mitral valves.
FIGS. 2A-2C are perspective views of an expandable prosthetic heart valve including one or more sealing members according to various embodiments of the present invention.
FIG. 3 is a sectional view of a sealing member according to an embodiment of the present invention.
FIGS. 4A and 4B are schematic views showing deployment and delivery of an expandable prosthetic heart valve including a sealing member according to an embodiment of the present invention.
FIG. 5 is a schematic view showing an expandable prosthetic valve at an implantation site according to an embodiment of the present invention.



While the invention is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the invention to the particular embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION
FIG. 1 is a sectional view of a human heart 6 with an expandable prosthetic heart valve 10 implanted within or adjacent an aortic valve 16. The natural flow path of blood through the heart 6 starts from superior and inferior vena cavas 20 to a right atrium 24 and through a tricuspid valve 28 to facilitate blood flow from the right atrium 24 to a right ventricle 32. A pulmonary valve 36 facilitates blood flow from the right ventricle 32 to the pulmonary arteries 40. The blood is then oxygenated by the lungs and returned back to the heart via pulmonary veins 44. A mitral valve 48 then facilitates blood flow from a left atrium 52 to a left ventricle 56. The aortic valve 16 facilitates blood flow from the left ventricle 56 to an aorta 60 for perfusion of oxygenated blood through the peripheral body, as shown by the implanted heart valve 10. The sinuses of Valsalva 58 are also shown. As will be appreciated by those skilled in the art, the sinuses of Valsalva 58 are, in a normal heart, three in number, and are distributed in an approximately angularly uniform way around the root of the artery distal to the semilunar valve (i.e., the aortic or pulmonary valve).
The expandable prosthetic heart valve 10 is suitable for placement within or adjacent a valved intraluminal site. The valved intraluminal site includes the aortic valve 16, tricuspid valve 28, the pulmonary valve 36, and the mitral valve 48 annuluses of the heart 6. It will be appreciated however that the present invention may be applied to valved intraluminal sites other than in the heart. For example, the present invention may be applied to venous valves as well. The intraluminal site typically includes surface irregularities on the inner surface of the valve annulus. For example, calcium deposits may be present on the valve leaflets (e.g., stenotic valve leaflets). Another example includes a valve leaflet that was not fully excised leaving behind a stump. These surface irregularities, whatever their underlying cause, can make it difficult for conventional prosthetic valves to form a blood tight seal between the prosthetic valve and the inner surface of the valve annulus, causing undesirable leakage at the implantation site.
Typically the valve annulus includes two or more valve leaflets. Occasionally, it may be desirable or necessary to use a valve excisor or similar tool to create an artificial aperture in the valve annulus by removing all or a portion of one or more valve leaflets. Thus, the term “valve annulus” includes the inner surface of the valve (natural or artificial) and, if appropriate, includes the valve leaflets and any deposits formed on the valve annulus including the leaflets.
According to one embodiment of the present invention, the expandable valve prosthesis 10 is self-expanding, and can be either a stented or stentless valve, as are known to those of skill in the art. Upon expansion, the self-expanding valve prosthesis 10 is radially constrained by the inner geometry of the intraluminal site. The expandable prosthesis 10 places sufficient radial expansion force on the inner surface of the valve annulus so as to secure and stabilize the prosthesis at the intraluminal site. The self-expanding valve prosthesis may be delivered to the intraluminal site by placing valve prosthesis 10 within a delivery catheter or sheath and removing the sheath at the valved intraluminal site. According to an alternative embodiment of the present invention, the prosthetic heart valve 10 can be balloon expandable.
FIGS. 2A-2C are perspective views of an expandable prosthetic heart valve 10 according to various exemplary embodiments of the present invention. FIG. 3 is a top cross-sectional view of an expandable prosthetic heart valve 10 implanted within the aortic valve 16. Exemplary expandable prosthetic heart valves are shown and described in U.S. Publication 2006/0178740 and U.S. Publication 2005/0197695, both of which are incorporated herein by reference.
As shown in FIGS. 2A and 2B, the expandable prosthetic valves 10 typically include an armature 64, which is able to support and fix the valve prosthesis 10 in the implantation position. According to one embodiment, as shown in FIG. 2A, the armature 64 includes an annular structure 66 and anchoring members 68a and 68b. The annular structure 66 of the armature 64 is designed to be located upstream of the sinuses of Valsalva and prosthetic valve. The anchoring members 68a and 68b are generally arched, projecting towards the outside of the prosthesis 10. When expanded at an intraluminal site, the anchoring members 68a and 68b expand so as to ensure firm anchorage in the sinuses of Valsalva. Alternatively, the prosthetic valve includes a stent-like armature 64, as shown in FIG. 2B. According to yet another embodiment of the present invention, the prosthetic valve 10 can be a stentless, self-expanding valve, as shown in FIG. 2C.
The prosthetic valve 10 also includes elements 69a, 69b, and 69c, generally in the form of leaflets or flaps, which are stably connected to the anchoring structure and are able to regulate blood flow.
As shown in FIGS. 2A-2C, the prosthetic heart valve 10 includes at least one sealing member 70. The sealing member(s) 70 is attached by an adhesive or other attachment means to the exterior of the anchoring structure 64, as shown in FIGS. 2A and 2B. Alternatively, the sealing means may be attached to the base of the prosthetic valve 10, as shown in FIG. 2C. The sealing member(s) 70 is configured to conform to the internal geometry of the inner surface of the valve annulus in which the prosthetic valve 10 is implanted. More particularly, the sealing member(s) 70 is configured to conform to any surface irregularities present on the inner surface of the valve annulus or the valve leaflets. According to one embodiment of the present invention, shown in FIG. 2C, the prosthetic heart valve 10 includes two sealing members 70. When the prosthetic heart valve 10 is deployed at a target intraluminal site, the sealing member can be located at the valve annulus, slightly above the valve annulus, or slightly below the valve annulus (or some combination thereof). When two or more sealing members 70 are provided, the sealing members 70 can be located in the same or different locations.
As best shown in FIG. 3, the sealing member(s) 70 provides a seal between the expandable prosthesis 10 and the inner surface of a valve annulus 71. More particularly, the sealing member(s) 70 provides a seal between the expandable prosthesis 10 and one or move of the native valve leaflets or a calcium deposit 72. The seal minimizes and/or eliminates any perivalvular (also commonly referred to as “paravalvular”) leakage at the implantation site. In other words, the sealing member is sizes and dimensioned to minimize and/or eliminates the flow of blood between the prosthesis 10 and the inner surface of the valve annulus 71. The appropriate size and dimensions of the sealing member 70 can be readily determined by one of skill in the art, depending on the desired implantation site and its particular dimensions. As is generally known in the art, the size and dimensions of a native valve annulus will vary widely from one patient to another, thus the size and dimensions of the sealing member 70 may vary accordingly. According to yet another embodiment, the sealing member 70 is sized and dimensioned in a custom manner, such that the sealing member 70 is configured or optimized to fit the native valve annulus 71 anatomy of a particular patient.
According to one embodiment of the present invention, the sealing member(s) 70 is self-expanding. Upon implantation of the prosthetic valve 10 in a valve annulus the sealing member 70 automatically expands such that it engages and conforms to the inner surface of the valve annulus including any surface irregularities that may be present. The sealing member 70 is made from an elastic, deformable material that is sufficiently resilient to withstand the forces of the beating heart and deformable enough to conform over any calcium deposits or other surface irregularities in or near the valve annulus. Exemplary materials include foams, gels, biocompatible polymers, and the like.
According to a further exemplary embodiment of the present invention, the sealing member 70 is made from a viscoelastic material. Viscous materials resist shear flow and strain linearly with time when a stress is applied. Elastic materials strain instantaneously when stretched and return to their original state once the stress is removed. Viscoelastic materials have elements of both viscous and elastic properties and, as such, exhibit time-dependent strain. Exemplary viscoelastic materials include, but are not limited to, silicone and latex rubbers and bioglue.
According to one such embodiment, the sealing member 70 may be sufficiently compressed to allow for minimally invasive delivery of the prosthetic valve 10 through a catheter or cannula. Upon deployment at the target site (e.g., the aortic valve annulus), the sealing member elastically returns to its original configuration, except as otherwise constrained by the native valve annulus, leaflets, calcium deposits, and the like. In this embodiment, the sealing member 70 does not expand in volume from its original state, but instead only attempts to return to its original configuration upon deployment at the target site. According to a further aspect of this embodiment, the sealing member 70 may also experience a decrease in volume, as the prosthetic valve 10 expands from a compressed delivery configuration to an expanded implantation configuration. In other words, the expansion of the prosthetic valve may compress the sealing member 70 between the armature 64 and the valve annulus 71.
According to an embodiment of the present invention, the sealing member(s) 70 is configured to be inflated with an inflation medium. According to this embodiment, as shown in FIG. 2C, the sealing member(s) 70 includes an inflation manifold 74 for delivery of the inflation medium into the sealing member 70. Once the sealing member(s) 70 has been sufficiently inflated such that a satisfactory seal has been created between the prosthetic valve 10 and the inner surface of the valve annulus, the inflation manifold 74 can be sealed off to maintain constant pressure within the sealing member 70. The inflation medium can include a variety of materials. Exemplary materials include, gels, biocompatible polymers including curable polymers, gases, saline, and the like.
According to yet another embodiment of the present invention, the sealing member(s) 70 includes one or more internal chambers 78. The chambers 78 are adapted to be inflated with an inflation medium such as described above. According to a further embodiment, the chambers 78 are configured to be selectively inflated as desired or necessary. Imaging techniques known to those of skill in the art can be used to locate the prosthetic valve in the valve annulus and to determine whether or not a sufficient seal exists between the prosthetic valve and the valve annulus. If leakage is present, the sealing member (s) 70 or chamber 78 at or near the site of the leakage can be selectively inflated until a seal has been created.
According to yet another embodiment of the present invention, the sealing member(s) 70 includes an intracellular matrix, (e.g. memory foam) within its interior. The intracellular matrix gives the sealing member 70 the ability to deform about the surface irregularities found on the inner surface of the valve annulus.
According to a further embodiment of the present invention, the sealing member(s) 70 includes an extracellular matrix on its exterior surface. The extracellular matrix promotes tissue ingrowth at the site of implantation. An exemplary extracellular matrix includes collagen. Stem cells can be added to the collagen matrix to further promote and direct tissue ingrowth at the site of implantation. Stem cells can differentiate into a wide variety of cell types and their presence may lend to more specialized applications and/or procedures at the site of implantation.
In yet another embodiment, the present invention is a kit for implanting an expandable prosthetic heart valve at a valved intraluminal site. The kit includes an expandable prosthetic heart valve and a delivery tool such as a catheter or a sheath. Additionally, the kit can include a leaflet excision tool for removal or excision of the valve leaflets prior to deployment of the prosthetic valve. The leaflet excision tool also includes a device for capturing the excised leaflet for external removal of the valve leaflet.
FIGS. 4A and 4B show schematic views of an expandable prosthetic heart valve 10 including at least one sealing member according to an embodiment of the present invention, being delivered and deployed within the aortic valve 16. As shown in FIG. 4A, an expandable prosthetic valve 10 according to various embodiments of the present invention can be collapsed and inserted within a delivery catheter or sheath 84. The prosthesis is then endovascularly delivered to the targeted valved intraluminal site, for example the annulus of the aortic valve 16. The delivery of the prosthetic valve 10 can be accompanied by a variety of visualization techniques known to those of skill in the art. If necessary, a leaflet excision tool is used to remove all or a portion of one or more leaflets within the valve needing repair and/or replacement. In this embodiment, a leaflet capture device 88 is provided along with the leaflet excision tool to capture the excised leaflet portion such that it can be removed from the patient's body. Once a suitable position has been determined for valve placement, the delivery catheter sheath 84 is removed allowing the prosthetic valve 10 to expand, as shown in FIG. 4B. At least a portion of the expandable prosthetic valve is placed over a calcium deposit on the inner surface of the valve annulus.
According to one exemplary embodiment of the present invention as shown in FIG. 4B, the expandable prosthetic valve 10 includes at least one sealing member 70. According to one embodiment of the present invention, the sealing member is self-expanding. According to another embodiment, the sealing member is inflatable. In either embodiment, the sealing member conforms to the inner surface geometry of the valve annulus including any surface irregularities, such as calcium deposits, that are present. As shown in FIG. 4B, the sealing member 70 is positioned on the prosthesis such that it creates and maintains a seal slightly above the annulus of the aortic valve 16. As further shown in FIG. 4B, an inflow portion of the prosthetic valve 10 is formed of a material capable of exerting a sufficient radial force to maintain a steady state, expanded orifice in relation to calcified native valve leaflets, after ballooning of the native valve leaflets.
FIG. 5 illustrates another embodiment of the invention featuring a prosthetic valve 10 having a sealing skirt 100, which is located above the annulus and above a lower skirt 110. The lower skirt 110 is sutured to the prosthesis, while the sealing skirt 100 is only sutured at a hinge 120 so that a flap 130 is free to be pushed down by blood back flow coming from above the annulus with is seen during diastole during 2⁄3 of the cardiac cycle. The lower skirt 110 provides sealing at the annulus. The sealing skirt 100 provides a minimized perivalvular leakage at the annular and infrannular region. The hinge 120 is located at the junction of the inflow ring of the prosthesis and the sinus of Valsalva in one embodiment of the invention. The sealing skirt 100 is free to conform to anatomical structure of the native annulus, and it is appreciated that over time fibrosis creates a permanent seal. The sealing skirt 100 is free floating at insertion. When the prosthesis is delivered antegrade from the apex of the heart, it is possible to position the prosthesis further up from its final desired location, partially deploy it so that the sealing skirt 100 does not form a tunnel structures but rather lies flat in the aortic aspect of the annulus. If the prosthesis is delivered through the aorta, the sealing skirt may naturally be juxtaposed upon insertion into its desired location. The sealing skirt 100 is dimensioned or of an appropriate height so as not to impede blood flow into the coronary ostia.
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. For example, while the embodiments described above refer to particular features, the scope of this invention also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.

## Claims

1. An expandable heart valve prosthesis comprising:
an anchoring structure configured to support and fix the valve prosthesis at an implantation position, the implantation position having an annulus, a Valsalva sinus, and an aortic tunica intima, the anchoring structure including a generally cylindrical portion having a principal axis and adapted to engage an annulus at the implantation position, wherein the generally cylindrical portion includes an outflow portion adapted to engage the vessel wall at a location distal to the Valsalva sinus, an inflow portion that is tapered and sized and shaped to be positioned within and secured adjacent the annulus, and connecting members extending between the outflow portion and the inflow portion and angularly spaced from one another about the principal axis, and;
a plurality of leaflets connected to the anchoring structure and configured to regulate blood flow; and
at least one sealing member coupled to the inflow portion, the sealing member sized and dimensioned to provide a seal between the annulus and the prosthesis to prevent paravalvular leakage;
wherein the at least one sealing member comprises a lower skirt adapted to be located below the annulus, an upper skirt having a free end and adapted to be located above the annulus, and a hinge that comprises a suture coupling the upper skirt to the anchoring structure, wherein the suture constitutes the hinge, such that the blood flow may push the free end of the upper skirt down against the annulus, wherein the lower and upper skirts are configured to minimize paravalvular leakage.

2. The prosthesis of claim 1, wherein the sealing member is selected from the group consisting of a viscoelastic material and pericardium.

3. The prosthesis of claim 1, wherein the sealing member comprises silicone rubber or latex rubber.

4. The prosthesis of claim 1, wherein the expandable valve prosthesis is selected from the group consisting of a self-expanding heart valve prosthesis and a balloon expandable heart valve prosthesis.

5. The prosthesis of claim 1, wherein the sealing member does not need to expand in volume to provide the seal.

6. The prosthesis of claim 1, wherein the sealing member decreases in volume upon expansion of the prosthesis, from an undeployed state to a deployed state.

7. The prosthesis of claim 1, wherein the sealing member comprises a gel.

8. The prosthesis of claim 1, wherein the seal formed between the prosthesis and the inner surface of the valve annulus is an annular seal.

9. The prosthesis of claim 1, wherein the inflow portion is formed of a material capable of exerting a sufficient radial force to maintain a steady state, expanded orifice in relation to ballooned, calcified, native valve leaflets.

10. An expandable heart valve prosthesis comprising:
an anchoring structure configured to support and fix the valve prosthesis at an implantation position, the implantation position having an annulus, a Valsalva sinus, and an aortic tunica intima, the anchoring structure including a generally cylindrical portion having a principal axis and adapted to engage an annulus at the implantation position, wherein the generally cylindrical portion includes an outflow portion adapted to engage the vessel wall at a location distal to the Valsalva sinus, an inflow portion that is tapered and sized and shaped to be positioned within and secured adjacent the annulus, and connecting members extending between the outflow portion and the inflow portion and angularly spaced from one another about the principal axis;
a plurality of leaflets connected to the anchoring structure and configured to regulate blood flow; and
at least one sealing member coupled to the inflow portion, the sealing member sized and dimensioned to provide a seal between the annulus and the prosthesis to prevent paravalvular leakage;
wherein the at least one sealing member comprises a lower skirt adapted to be located below the annulus and longitudinally extend further into a ventricle below the annulus and configured to minimize paravalvular leakage, an upper skirt having a free end and adapted to be located above the annulus, and a hinge coupling the upper skirt to the anchoring structure such that the free end of the upper skirt is free to be moved by blood flow and may be pushed down against the annulus by the blood flow in order to minimize paravalvular leakage.

11. The prosthesis of claim 10, wherein the hinge comprises a suture coupling the upper skirt to the anchoring structure.

12. The prosthesis of claim 10, wherein the sealing member is selected from the group consisting of a viscoelastic material and pericardium.

13. The prosthesis of claim 10, wherein the sealing member comprises silicone rubber or latex rubber.

14. The prosthesis of claim 10, wherein the expandable valve prosthesis is selected from the group consisting of a self-expanding heart valve prosthesis and a balloon expandable heart valve prosthesis.

15. The prosthesis of claim 10, wherein the sealing member does not need to expand in volume to provide the seal.

16. The prosthesis of claim 10, wherein the sealing member decreases in volume upon expansion of the prosthesis, from an undeployed state to a deployed state.

17. The prosthesis of claim 10, wherein the sealing member comprises a gel.

18. The prosthesis of claim 10, wherein the seal formed between the prosthesis and the inner surface of the valve annulus is an annular seal.

19. An expandable heart valve prosthesis comprising:
an anchoring structure configured to support and fix the valve prosthesis at an implantation position, the implantation position having an annulus, a Valsalva sinus, and an aortic tunica intima, the anchoring structure including a generally cylindrical portion having a principal axis and adapted to engage an annulus at the implantation position, wherein the generally cylindrical portion includes an outflow portion adapted to engage the vessel wall at a location distal to the Valsalva sinus, an inflow portion that is tapered and sized and shaped to be positioned within and secured adjacent the annulus, and connecting members extending between the outflow portion and the inflow portion and angularly spaced from one another about the principal axis, and;
a plurality of leaflets connected to the anchoring structure and configured to regulate blood flow; and
at least one sealing member coupled to the inflow portion, the sealing member sized and dimensioned to provide a seal between the annulus and the prosthesis to prevent paravalvular leakage, wherein the entirety of the at least one sealing member includes pericardium; and
wherein the at least one sealing member comprises a lower skirt adapted to be located below the annulus, an upper skirt having a free end and adapted to be located above the annulus, and a hinge coupling the upper skirt to the anchoring structure such that the blood flow may push the free end of the upper skirt down against the annulus, wherein the lower and upper skirts are configured to minimize paravalvular leakage.