# Patent

## Title
Minimally-invasive cardiac-valve prosthesis

## Abstract

A cardiac-valve prosthesis is adapted for percutaneous implantation. The prosthesis includes an armature adapted for deployment in a radially expanded implantation position, the armature including a support portion and an anchor portion, which are substantially axially coextensive with respect to one another. A set of leaflets is coupled to the support portion. The leaflets can be deployed with the armature in the implantation position. The leaflets define, in the implantation position, a flow duct that is selectably obstructable. The anchor portion can be deployed to enable anchorage of the cardiac-valve prosthesis at an implantation site.

## Background
CROSS REFERENCE TO RELATED APPLICATION
This application is a continuation of U.S. application Ser. No. 11/066,346, now U.S. Pat. No. 8,109,996, filed Feb. 25, 2005, entitled “Minimally-Invasive Cardiac-Valve Prosthesis,” which claims priority under 35 U.S.C §119 from Italian patent application number TO2004/A000135, filed on Mar. 3, 2004, both of which are hereby incorporated by reference.


TECHNICAL FIELD
The present invention relates to cardiac-valve prostheses. More specifically, the present invention is directed to a prosthesis that is amenable to minimally-invasive implantation.
BACKGROUND
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 (the 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. Further details of exemplary percutaneous implantation techniques are provided in U.S. Publication 2002/0042651, U.S. Pat. No. 3,671,979, and U.S. Pat. No. 5,954,766, which are hereby incorporated by reference.
These prosthetic valves typically include an anchoring structure, which is able to support and fix the valve prosthesis in the implantation position, and prosthetic valve elements, generally in the form of leaflets or flaps, which are stably connected to the anchoring structure and are able to regulate blood flow.
Furthermore, the methods of implantation of valves via a percutaneous route or by means of thoracic microsurgery are very frequently irrespective of the effective removal of the natural valve leaflets. Instead, the cardiac valve may be introduced in a position corresponding to the natural annulus and deployed in situ by simply divaricating definitively the natural valve leaflets.
There is a need for a percutaneous valve that does not run the risk of being displaced (dislodged) with respect to the implantation position, as a result of the hydraulic thrust exerted by the blood flow. There is a further need for a percutaneous valve that secures tightly to the flow duct generally defined by the natural valve annulus, such that it resists blood flow around the outside of the percutaneous valve structure.
SUMMARY
In an exemplary embodiment, the invention described herein is based on the concept of separating, in the framework of the supporting armature of the valve, the function of anchorage of the valve in the implantation site (including the possible function of sealing the valve with respect to the blood-flow duct natural to the region in which the valve is implanted) and the valve function proper. In a preferred way, this purpose is achieved by providing, within the armature of the valve, two structures (which are functionally distinct, but which in effect may be structurally integrated with one another), which are delegated separately to the accomplishment of these two functions. These two structures or portions comprise an external portion which can be spread out to enable anchorage of the cardiac-valve prosthesis at the implantation site, and an internal portion, which is substantially axially coextensive with the external portion, for supporting the prosthetic valve leaflets. The valve thus obtained is adapted in a particularly advantageous way to be implanted in a position corresponding to the so-called Valsalva's sinuses.
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. As will be realized, the invention is capable of modifications in various obvious aspects, all without departing from the spirit and scope of the present 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 general perspective view of a prosthetic valve according to the invention.
FIG. 2 illustrates the corresponding armature of the valve without the leaflets.
FIGS. 3 and 4 illustrate a second exemplary embodiment of a prosthetic valve according to the 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
In the figures, the reference number 1 designates as a whole a cardiac valve, which can be implanted via percutaneous route or resorting to thoracic-microsurgery techniques. These percutaneous implantation techniques are generally known in the art, and include those techniques described in the documents referenced above.
The valve 1 represented in FIGS. 1 and 2 is basically made up of two elements, namely an armature 2, having the characteristics that emerge more clearly from the representation of FIG. 2, and a set of leaflets 3, coupled to the armature 2. The characteristics of the leaflets 3 may be appreciated more fully from the view of FIG. 1.
As shown in FIG. 2, the armature 2 of the valve has a general cage-like structure comprising a set of ribs that extend with a general symmetry of a cylindrical type about a principal axis X4. In percutaneous valves, the axis X4 usually corresponds to the principal axis of the distal part of the catheter used for implantation of the valve 1. For the present purposes, the axis X4 can be viewed basically as an entity of a purely geometrical nature, even though it can in effect be identified either with elements of the implantation catheter or with elements of the armature 2 of the valve 1.
The armature 2 includes a distinguishable first and a second series of ribs designated, respectively, by the reference numbers 5 and 6. These ribs are usually made of metal material that is able to present characteristics of radial expandability, both as a result of a positive action of a dilatation or divarication force exerted by, for example, a balloon catheter and as a result of characteristics proper to the material constituting the ribs 5 (and possibly 6). In particular, the ribs may be made of a superelastic material and/or a material with shape-memory characteristics. A material that is well known in biomedical applications and that presents these characteristics is the material known as Nitinol.
Structures that may substantially be likened to cages, which can be introduced into a vessel of the human body and in particular into a venous site and can then be dilated in loco via dilatation of a distal part of the introducing catheter or, in the case of materials with shape-memory characteristics or the like, as a result of the retraction of a sheath that maintains the structure in a compressed position, are well known in the art. For example, these structures are well known in stent technology and, in particular, the technology of stents for angioplasty.
Due to the possibility of providing cage-like structures with ribs extending with a profile more or less shaped in diametral planes with reference to a principal axis, such as for example the axis X4, further reference may be made to technologies adopted for the fabrication of devices for the mapping or passivation of endocardial sites, such as, typically, endocavitary sites, used for localization and/or treatment of the so-called ectopic sites characteristic of the pathological conditions of a fibrillative type.
The distinction made between the ribs 5 and 6 is based on the fact that, within the armature 2, these different sets of ribs are designed to perform different functions, regardless of whether the ribs constitute physically distinct parts or are different portions of a unitary structure within the armature 2. In particular, the ribs 5 form an external part or anchor portion of the armature 2 designed (see FIG. 1) to enable the location and anchorage of the valve 1 at the implantation site. The ribs 6 are designed to constitute a more internal part or support portion of the armature 2, specifically the part that is to support the valve leaflets 30 of the prosthesis. Essentially, the ribs 5 and 6 are designed to define, within the armature 2, an external portion (ribs 5), which can be spread out or radially expanded to enable anchorage of the prosthesis 1 in the implantation site and an internal portion (ribs 6), which supports the prosthetic valve leaflets 30 provided in the set of leaflets 3.
An important characteristic of the solution described herein is provided by the fact that the two portions of the armature 2 are “substantially axially coextensive” with respect to one another. This definition is understood to indicate synthetically the fact that the two portions occupy, in the direction of the axis X4, axial stretches that are substantially coincident with one another. This is in direct contrast with solutions such as the one described, for example, in the U.S. Pat. No. 6,482,228, which illustrates a valve comprising two homologous portions that are totally staggered with respect to one another in an axial direction so that they can be located, one in a proximal position and the other in a distal position with respect to the coronary ostia.
The ribs 5, which in what follows are designated also as “external” ribs, are preferably arranged in sets of ribs, said sets being typically arranged in threes or multiples of three so as to be more readily adaptable, in a complementary way, to the anatomy of the Valsalva's sinuses, which is the site of choice for implantation of the valve 1.
In an exemplary embodiment, within the ribs 5 there is distinguishable a top part or top branch 50 and a bottom part or bottom branch 51. In the implantation position, the top parts or branches 50 are able, when they are in the deployed or expanded position, to extend within the so-called Valsalva's sinuses. The Valsalva's sinuses are the dilatations, from the overall lobed profile, which are present at the root of the aorta, hence in a physiologically distal position with respect to the aortic valve annulus. The bottom portions or branches 51 (see FIG. 1) are instead designed to extend in a proximal position with respect to the valve annulus so as to extend for a certain stretch within the ventricular chamber.
As a whole, the top parts 50 of the ribs 5, when brought into the extended position, jointly define a tripodal structure, which, by expanding within the Valsalva's sinuses, enables attainment of a condition of firm anchorage of the valve 1. This avoids the possibility of the valve 1, once implanted, being dislodged or even just displaced with respect to the implantation position, as a result of the hydraulic stresses applied thereto during operation by the blood flow.
The anchorage of the valve 1 in the implantation site is further reinforced by the fact that the area of radiusing between the top branches 50 and the bottom branches 51 of the ribs 5 has, precisely on account of the general divaricated or flared pattern of the bottom branches 51, an area of convexity that is thus positioned astride of the valve annulus, reinforcing the condition of shape fit between the armature of the valve and the implantation site. In the schematic representation of the figures, the natural valve leaflets of the valve that is to be replaced with the prosthetic valve 1 are not specifically illustrated.
The valve 1 described herein can be located in situ regardless of whether the natural valve leaflets have previously been removed or (and in a way that is from certain points of view preferred), without proceeding to the removal of said natural valve leaflets, by simply introducing the valve within the valve orifice and thus bringing about, as a result of the divarication of the valve 1 structure, the corresponding definitive divarication of the natural valve leaflets that are brought into, and maintained in, a position of substantial adherence to the surrounding portion of the valve annulus.
The particular conformation of the ribs 5, and in particular of the parts 50 and 51 just described, corresponds to the solution envisaged for the implantation of the valve 1 in the aortic site. Similar structures can be adopted for implantations, for example, in the mitral site.
The top and bottom branches 50 and 51 may in actual fact present conformations that are altogether different from the ones illustrated. For example, the top branches 50 may possibly present a conformation that is approximately symmetrical to the conformation represented herein with reference to the bottom branches 51, thus conferring on the external part of the armature of the valve 2 an overall hourglass conformation. Moreover, the presence of both of the branches 50 and 51 is altogether optional.
Again, in the exemplary embodiment illustrated herein, the terminal top ends of the branches 50 and the bottom ends of the branches 51 are connected to collar parts 52, which are designed to be fitted around, and usually to slide along the principal axis X4 during divarication of the armature 2. This solution proves advantageous as regards to the simplicity and the structural congruence of the armature 2. Recourse thereto should, however, be reconciled with the need to prevent the collar parts 52 from possibly ending up playing an excessive role of obstruction in regard to the blood flow that is to pass (from below upwards, with reference to the configuration of implantation as represented in FIG. 1) through the central orifice of the valve 1 defined between the valve leaflets 30 in a divaricated position. For example, it is conceivable to use just one of the collars 52, for example the one illustrated in the bottom portion in FIG. 2.
The structure and the configuration of the ribs 6 is, as a whole, akin to that of the ribs 5. In the case of the ribs 6, which form the internal part of the armature 2 of the valve 1, there is, however, usually the presence of just three elements that support, in a position corresponding to homologous lines of commissure (which take material form as sutures 31 passing through openings 61 provided on the elements 6), the valve leaflets 30. Essentially, the complex of ribs 6 and valve leaflets 30 is designed to form the normal structure of a biological valve prosthesis. This is a valve prosthesis which (in the form that is to be implanted with a surgical operation of a traditional type, hence of an invasive nature) has met with a wide popularity in the art.
The structural details of biological valve prostheses, consisting of a tubular structure made of biological material (for example, the pericardium or meningeal tissue of animal origin) subjected to treatments of passivation (with gluteraldehyde or similar compounds) or alternatively a biocompatible synthetic material, after prior possible shaping of the cusp-like areas that are to constitute the prosthetic valve leaflets 30, are well known in the art. For further details of the structure of such a valve, reference can be made to EP-B-0 155 245, which is hereby incorporated by reference. For further details of the technology of fabrication and/or treatment of the material of the prosthetic valve leaflets, useful reference can be made to EP-B-0 133 420, which is hereby incorporated by reference.
In addition to the more strictly “valve” part comprising the prosthetic valve leaflets 30 supported in a commissural position by the ribs 6 of the armature 2, the leaflet part of the prosthesis illustrated also has an apron-like part 32, which extends according to a general chimney-like or flared configuration and is supported by the bottom parts 51 of the external ribs 5 of the armature 2. For this purpose, the bottom parts 51 have an overall V-shaped structure, hence comprising two branches that are to enclose within them the chimney-like portion 32 of the set of leaflets 3 of the valve armature 2, so causing this to be divaricated at the moment of spreading out of the valve and maintained in said divaricated position in the intraventricular site in a proximal position with respect to the valve annulus.
Albeit conserving an extreme structural simplicity, from which there derives a corresponding reliability during implantation, the valve structure described manages to meet in an excellent way various needs that in themselves contrast with one another. This is obtained basically by separating the two parts of the armature 2, which are functionally distinct, even though they may be integrated in a single structure, and hence delegating to them two different functions.
In particular, the external ribs 5 (and more specifically when these are present in the two branches 50 and 51, which can be positioned astride of the valve annulus) provide the firm anchorage of the valve in situ, so preventing it from possibly being removed or even just displaced from the implantation site chosen by the person carrying out the implantation operation. This is obtained with a structure that is able to adapt to the natural anatomical conformation without exerting thereon stresses of a traumatic nature.
As shown in the Figures, the ribs 5 can present a rather thin or light structure. This allows them to adhere to the walls of the root of the aorta, to the surrounding portion of the valve annulus, and to the walls of the endocardial chamber, without exerting particularly marked stresses on those walls, which—in extreme cases—could even be at the basis of phenomena of lesions and, even more, of onset of reactions of the organism in regard to said lesions. The action of anchorage is in fact achieved, more than for any other reason, on account of the presence of numerous ribs 5 and their conformation, which is complementary with respect to that of the implantation site (in particular, when this is represented by the Valsalva's sinuses).
The internal part of the armature 2, represented by the ribs 6, enables, spreading out and support of the prosthetic valve leaflets 30 in the implantation position. This is achieved by recourse to a structure and a conformation which, precisely because they reproduce very closely those of traditional prosthetic valves of a biological type, prove particularly suitable and efficient for performing substitution of a defective natural valve. In particular, it is well known that valve prostheses of a biological type, precisely because they are able to reproduce closely the fluid-dynamic characteristics and the characteristics of behaviour of the leaflets of natural cardiac valves, can be used to benefit patients affected by forms of rather marked cardiac insufficiency. This possibility is achieved in an optimal way in the solution described herein precisely because the valve function is rendered altogether independent of the function of anchorage in situ of the prosthesis.
The presence of the branches 51 in the armature 2 of the prosthesis and, conversely, of the apron-like or chimney-like portion 32 in the set of leaflets 3 (in addition to contributing further to the shape fit and hence to the anchorage in the implantation site of the valve 1) likewise enables very efficient channeling of the blood flow coming from the heart, channeling it in a practically complete way, precisely on account of the divaricated or flared configuration of the chimney-like portion 32 within the flow duct defined within the valve leaflets 30. There is thus minimized (and in effect cancelled out) shortly following implantation, the possibility of there being created lines of blood flow that pass on the outside of the cardiac-valve prosthesis.
The foregoing likewise envisages that the two parts or portions of armature 2 are substantially axially coextensive with respect to one another, occupying, if viewed in their development in the direction of the axis X4, axial stretches substantially coinciding with one another. This characteristic enables a precise positioning of the prosthetic valve leaflets in a “physiological” location (i.e., in a location basically corresponding to the location of the natural valve leaflets), likewise benefiting, for the purposes of the anchorage of the prosthesis in situ, from a shape fit with the Valsalva's sinuses.
FIGS. 3 and 4 illustrate a second exemplary embodiment of a cardiac valve, according to the present invention. From a general structural standpoint, the valve of FIGS. 3 and 4 derives basically from the structure of the valve shown in FIGS. 1 and 2. The valve according to FIGS. 3 and 4 is obtained by recourse, as regards the armature, to a single element of tubular shape and reticular structure. In particular, FIG. 3 illustrates this tubular element in an “extroverted” or “extended” configuration, whereas in FIG. 4 the same element is illustrated in an “introverted” configuration, corresponding to the final conformation of implantation of the valve.
In this particular embodiment, the two parts or portions of the armature 2 (the external portion 5 for anchorage of the valve 1 in the implantation site and the internal portion 6 with the function of supporting the valve leaflets) are integrated in a single structure consisting precisely of the tubular element referred to previously. This element, designated as a whole by reference numeral 2, has a substantially cylindrical structure that develops about a principal axis X4 and consists of ribs having a general helical conformation and presenting joints in pairs 53 and 63 at the two ends. The armature 2 is without any discontinuity between the external portion 5 and the internal portion 6 of the ribs. The ribs that form the armature 2 in this embodiment are basically made of a superelastic material and/or shape-memory material.
The valve 1 passes from the extroverted configuration (FIG. 3) to the introverted or final configuration (FIG. 4) through a mechanism of deformation that may be obtained at the implantation site. This can occur, in the case of percutaneous valves, via remote manipulation devices associated to the catheter for introduction of the valve. Said devices are in themselves known in so far as they are used in association with catheters of various types, for example to obtain actions of selective spreading out of implantation devices, such as stents, stent-grafts or the like.
The mechanism of deployment (i.e., introversion) in question involves passing from the extended conformation of FIG. 3 to the final conformation of FIG. 4, thereby causing the joints 63, to which the set of leaflets 3 are fixed (internally with respect to the original cylindrical tubular element), to converge within the tubular structure and then advance therein until the joints 63 arrive in the proximity of the joints 53, which, at the start of the movement of introversion described, were exactly at the opposite end of the original cylindrical tubular element.
Basically, this movement causes the tubular element 2 to pass between an extroverted configuration (FIG. 3), in which said tubular element has a substantially cylindrical shape, with the external portion 5 and internal portion 6 of the armature axially juxtaposed with respect to one another, and a final introverted configuration (FIG. 4), in which the external portion 5 and internal portion 6 are substantially axially coextensive with respect to one another.
This overall movement is usually accompanied by at least a slight divarication of the joints 53 and of the areas of the armature of the valve (external part 5) adjacent thereto. This divarication of the joints 53 and of the areas of the armature adjacent thereto is clearly perceptible in FIG. 4. In the same figure there is moreover perceptible the action of “pinching” of the apron-like part of the leaflet, which may be achieved with a positive action of deformation of the armature and/or by exploiting the shape-memory characteristics of the constituent material. Also in this case, a final configuration is reached, in which the external portion 5 and internal portion 6 of the armature 2 of the valve 1 are substantially axially coextensive with respect to one another, finding themselves occupying axial stretches that substantially coincide with respect to the axis X4.
In the introverted configuration (see FIG. 4), it is possible to distinguish top branches 50 and bottom branches 51 of the ribs 5, in a conformation suitable for being implanted in the Valsalva's sinuses. The top branches 50 extend in a generally cage-like form, which is complementary with the lobed anatomy of the Valsalva's sinuses and co-operate with the bottom branches 51, which are to extend in a proximal position with respect to the valve annulus so as to be introduced within the ventricular chamber, ensuring a firm anchorage of the valve 1 at the implantation site. The set of leaflets 3 comprises the prosthetic valve leaflets 30 supported by the internal ribs 6 and an apron-like part 32 supported by and fixed to the bottom branches 51 of the external ribs 5.
Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the present invention. 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. A cardiac valve prosthesis capable of being located in a Valsalva sinus region of a subject including a plurality of Valsalva sinuses, the prosthesis comprising:
a plurality of coapting valve leaflets; and
an expandable frame having an inflow portion, an outflow portion, a principal axis extending through the inflow and outflow portions, and a plurality of leaflet supports and a plurality of flexible anchoring supports extending from the inflow portion to the outflow portion, the leaflet supports being sized and dimensioned to anchor the leaflets to the frame while not conforming to the Valsalva sinus and each positioned to support a respective commissural location of the plurality of coapting valve leaflets, the leaflet supports and the anchoring supports angularly spaced from one another about the principal axis, wherein each of the anchoring supports includes a set of ribs sized and dimensioned to anchor the frame in the Valsalva sinus, wherein each of the anchoring supports arches radially outwardly with respect to the principal axis between the inflow and outflow portions.

2. The cardiac valve prosthesis of claim 1 in which the leaflet supports each include a substantially straight portion.

3. The cardiac valve prosthesis of claim 1 in which the anchoring supports are dimensioned to conform to the Valsalva sinus.

4. The cardiac valve prosthesis of claim 1 in which the frame is self expandable.

5. The cardiac valve prosthesis of claim 1 in which the anchoring supports are spaced about 120 degrees apart from one another.

6. The cardiac valve prosthesis of claim 1 in which the leaflet supports are spaced about 120 degrees apart from one another.

7. The cardiac valve prosthesis of claim 6 in which at least one of the leaflet supports and at least one of the anchoring supports are spaced about 60 degrees apart from one another.

8. A cardiac valve prosthesis capable of being located in a Valsalva sinus region of a subject comprising:
a plurality of coapting valve leaflets defining a plurality of commissural locations; and
an expandable frame having a principal axis, the frame comprising a plurality of leaflet supports angularly spaced about the principal axis each including a portion extending generally parallel to the principal axis, and a plurality of flexible Valsalva sinus anchoring supports angularly spaced about the principal axis and each located between two of the leaflet supports, wherein each of the Valsalva sinus anchoring supports is configured and positioned so as to extend into and engage a respective Valsalva sinus when implanted and includes a set of ribs having an upper portion, a lower portion, and an intermediate portion, the intermediate portion arching outwardly with respect to the principal axis, and wherein the plurality of coapting valve leaflets are coupled to the leaflet supports with a respective commissural location coupled to a respective one of the leaflet supports.

9. The cardiac valve prosthesis of claim 8 in which the leaflet supports and the anchoring supports are spaced apart so as to avoid interference with coronary ostia.

10. The cardiac valve prosthesis of claim 8 in which a portion of at least one of the leaflet supports is perpendicular to at least one other portion of the frame.

11. A cardiac valve prosthesis capable of being located in a Valsalva sinus region of a subject, the prosthesis defining a lumen for passage of blood flow and comprising:
an expandable frame having a principal axis, the frame comprising a plurality of leaflet supports angularly spaced about the principal axis each including a portion extending generally parallel to the principal axis, and a plurality of flexible Valsalva sinus anchoring supports angularly spaced about the principal axis and each located between two of the leaflet supports, wherein each of the Valsalva sinus anchoring supports is configured and positioned so as to extend into and engage a respective Valsalva sinus when implanted and includes a set of ribs having an upper portion, a lower portion, and an intermediate portion, the intermediate portion arching outwardly with respect to the principal axis, and wherein the leaflet supports and the Valsalva sinus anchoring supports are substantially axially coextensive with respect to one another; and
a valve having a plurality of leaflets, the valve coupled to the expandable frame and configured to permit blood flow through the lumen in a first direction and substantially prevent blood flow through the lumen in a second direction opposite the first direction.

12. The cardiac valve prosthesis of claim 11 wherein the plurality of leaflet supports includes three leaflet supports each positioned about the principal axis so as to support a commissural location of the valve.

13. The cardiac valve prosthesis of claim 12 wherein each of the Valsalva sinus anchoring supports is adaptable to a shape of a respective Valsalva sinus when implanted.