# Patent

## Title
Support device for valve prostheses and corresponding kit

## Abstract

A support device for implanting stentless valve prostheses, such as biological heart valves, includes a hub and a plurality of support portions for supporting the stentless valve prosthesis. The hub defines a manipulation axis for the device and is flexibly connected to the support portions to allow displacing the manipulation axis for the device between the support portions.

## Background
CROSS-REFERENCE TO RELATED APPLICATION
This application claims priority to Italian Application No. TO2010A000425, filed May 21, 2010, and EP Application No. 11166742.4, filed May 19, 2011, each of which are herein incorporated by reference in its entirety.
TECHNICAL FIELD
This disclosure relates to valve prostheses.
BACKGROUND
Valve prostheses, such as e.g. cardiac valve prostheses, can essentially be separated into two basic categories, namely mechanical valve prostheses and biological valve prostheses. Generally, in mechanical valve prostheses, the blood flow through the valve is controlled by one or more obturators including rigid bodies mounted so as to be able to oscillate or “tilt” in a rigid support. In contrast with biological valve prostheses, blood flow is controlled by valve leaflets formed of biological tissue.
The biological valve leaflet material, which is subjected to treatment (stabilization) to render it biologically inert, can be derived from a natural cardiac valve taken from an animal (for example, a natural pig's valve) or can be formed from biological tissue other than valve tissue (for example, bovine pericardium).
Biological valve prostheses may in turn take the form of “stented” valves—where the valve leaflets are mounted on a rigid or slightly flexible stent or armature—and “unstented”, or “stentless”, valves.
Documents EP-A-0 515 324 and U.S. Pat. No. 5,713,953 disclose various embodiments of stentless cardiac valve prostheses, including embodiments where the biological material is replaced (either partially or completely) with an artificial/synthetic material such as a micro-porous and/or composite synthetic material, for example polyurethane.
Stentless valve prostheses exhibit as a whole characteristics of deformability that offer functional advantages due to a great similarity to the anatomy of natural valves.
Implantation of a stentless valve prosthesis, either by conventional thoracic surgery or by minimally-invasive surgical techniques, may involve positioning the prosthesis at the implantation site (e.g. an aortic site) by using a “holder” device.
The holder may, for example, support the prosthesis i) during production of the prosthesis, while the prosthesis is subjected to phases of immersion in treatment liquids, ii) after the valve has been inserted into its package, where it is usually kept immersed in a storage liquid, and/or iii) during implantation to enable the surgeon to implant the prosthesis. Holder devices may include a support or “grip” hub adapted for connection to a manipulation handle. The surgeon can thus locate the prosthesis (fixedly held by the holder) at the implantation site and properly orient it to ensure that the leaflets of the prosthesis are positioned at the same angular locations of the leaflets of the natural valve substituted by the prosthesis. Exemplary of such a holder is the arrangement disclosed in US 2008/0262603 A1, including a grip element from which a plurality of arms extend for supporting a prosthetic heart valve at an intermediate position between the commissures.
In the case of a stentless prosthesis, the deformability of the prosthesis demands a high degree of skill by the intervening surgeon.
SUMMARY
In various exemplary embodiments, the invention includes a support device having the features set forth in the claims that follow. Various embodiments relate to a corresponding kit for implanting stentless valve prostheses.
The claims form an integral part of the disclosure of the invention as provided herein.
Various embodiments relate to a support device for implanting stentless valve prostheses, the device including a hub defining a manipulation axis for the device, and a plurality of support portions for the valve prostheses (e.g. for the commissures thereof), wherein the hub is flexibly connected to the support portions to allow displacing the manipulation axis for the device between the support portions.
Various embodiments are adapted to reduce the possibility that some stitches may inadvertently extend to the valve leaflets thus undesirably affecting their capability of orienting under the action of blood flow.
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
Various embodiments will now be described, by way of non limiting example, by referring to the annexed representations.
FIG. 1 is a schematic representation of a stentless valve prosthesis.
FIG. 2 is a perspective view of an embodiment,
FIGS. 3 to 5 show various details and modes of operation of embodiments,
FIG. 6 is a perspective view of an embodiment, and
FIGS. 7, 8 and 9 are perspective views of embodiments.



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
Illustrated in the following description are various specific details aimed at an in-depth understanding of the various embodiments. The embodiments may be obtained without one or more specific details, or through other methods, components, materials etc. In other cases, known structures, materials or operations are not shown or described in detail to avoid obscuring the various aspects of the embodiments.
Reference to “an embodiment” or “one embodiment” in this description indicates that a particular configuration, structure or characteristic described regarding the embodiment is included in at least one embodiment. Hence, expressions such as “in an embodiment” or “in one embodiment”, possibly present in various parts of this description, do not necessarily refer to the same embodiment. Furthermore, particular configurations, structures or characteristics may be combined in any suitable manner in one or more embodiments, whereby particular configurations, structures or characteristics described in connection with one embodiment may be applied in any suitable manner to other embodiments.
References herein are used for facilitating the reader and thus they do not define the scope of protection or the range of the embodiments.
As used herein, two elements will be considered to be “connected” together when they are connected directly to one another or indirectly to one another, such as when each is directly connected to intermediate elements.
FIG. 1 of the attached representations shows an exemplary valve prosthesis or prosthetic valve (hereinafter, briefly, “valve”) V.
In various embodiments, the valve V may be a stentless cardiac prosthetic valve for e.g. aortic valve replacement and includes an annular base portion B, having an overall circular shape for suturing at the implantation site, and a series of valve leaflets L including a plurality of commissure portions C oriented in a generally axial direction with regard to the base portion B. The distal edges of the valve leaflets L are configured to mate when the prosthetic valve V is in the closed position, thus impeding blood flow through the valve (i.e. from top to bottom, with reference to the viewpoint of FIG. 1) e.g. into the left ventricle of the heart. The mating leaflet surfaces thus define coapting edges of the leaflets in the closed position. When the direction of blood is reversed (i.e. from bottom to top, with reference to the viewpoint of FIG. 1), e.g. due to the pumping action of the left ventricle, the distal edges of the valve leaflets L are spread open under blood pressure, thus permitting blood flow through the valve.
In various embodiments, in order to reproduce the structure of the native valve (e.g. a natural aortic heart valve), the prosthetic valve V may have three commissures C with three leaflets L each one extending between two adjacent commissures C. The commissures C and the leaflets L are thus angularly spaced 120° apart about the valve circumference.
The features of a stentless valve V as exemplified herein are otherwise conventional in the art and are of no specific relevance for the disclosure of embodiments.
A support device for use with a stentless valve is generally designated 10.
In various exemplary embodiments, the device 10 is adapted for connection to a handle H—represented schematically, and to reduced scale, in FIGS. 3 and 5—to permit use by the surgeon in implanting a vascular prosthesis such as the prosthesis V. Connection to the handle H may be with different means, e.g. via spline connection 120 or bayonet-like connection to a hub 12 to be described in the following.
In the exemplary embodiment of FIG. 2, the device 10 includes a hub 12 defining a main (manipulation) axis X12 for the device 10, and a plurality of flexible formations 14 (to the number of three in the exemplary embodiment considered herein) which extend radially from the hub 12 and exhibit respective distal support portions 14a adapted to support the prosthesis V, e.g. at the commissures C of the prosthesis V.
In various embodiments, three flexible formations 14 may be provided spaced regularly (at 120° from one another) around the main axis X12.
In various embodiments, the hub 12 may be a solid or tubular structure and/or include a rigid material such as metal, e.g. steel or titanium, adapted to contact the human body. In various embodiments, similar materials may be used to produce the formations 14.
In various embodiments, the formations 14 extending radially from the hub 12 may exhibit a hook-like shape with a proximal portion connected to the hub 12 (e.g. soldered or mechanically retained into the hub 12, for instance by crimping). In various embodiments, the formations 14 may comprise integral extensions of the hub 12.
As schematically represented in dashed lines in FIG. 2, various embodiments may provide for flexible (and elastic) connection of the hub 12 and the support portions as comprised e.g. of the distal support portions 14a of the formations 14. As detailed in the following with reference to FIGS. 3 and 4, flexible (and elastic) connection of the hub 12 and the distal support portions 14a enable the device 10 and the prosthesis mounted thereon to be radially contracted and subsequently expanded at the implantation site.
In various embodiments, flexible connection of the hub 12 and the distal support portions 14a may be due to the formations 14 being elastically flexible over their entire lengths. In various embodiments, flexible connection of the hub 12 and the distal support portions 14a may be due to the formations 14 being elastically flexible in part, e.g. at the looped portions extending between the hub 12 and the distal distal support portions 14a, these latter being essentially rigid, that is less flexible than the rest of the respective formation 14, or vice versa, e.g. the looped portions being essentially rigid while the distal portions are more flexible than the rest of the respective formation 14.
In various embodiments, as schematically shown in FIG. 7, the formations 14 may extend spoke-like from a central body 140 which is connected to the hub 12 via a ball-and-socket joint 142 (or the like, e.g. a cardan or universal joint), so that flexible connection of the hub 12 and the distal support portions 14a is obtained thanks to presence of the joint 142.
As shown herein, the joint 142 may be covered by an elastic, bellows-like sleeve which renders the flexible connection of the hub 12 and the distal support portions 14a—analogously to the other embodiments considered previously—an elastically flexible connection. That is, while adapted to “pivot” or angulate with respect to the distal support portions 14a (as discussed in the following, especially in connection with FIG. 5), in the various embodiments considered herein the hub 12 is elastically biased towards a central position where the hub 12 is at least approximately located centrally of the distal support portions 14a. 
In various embodiments, as schematically shown in FIG. 8, a substantially similar support action for the valve V may be provided at the distal end of the hub 12 by a wire-like structure including an elastic material. A superelastic material such as Nitinol, established for use in medical devices such as e.g. stents, may be used for that purpose.
As exemplified in FIG. 8, the wire-like structure extending from the hub 12 may include an annular, three-cusped crown portion including three cusps 14b having festoon-like sections extending therebetween, and a pod-like support member 12a extending from the hub 12 in the direction of the axis X12. In the illustrated embodiment, the support member 12a has an L-shape or a hook-like shape overall thus including an end portion extending away from the axis X12 to support the crown portion e.g. at one of the cusps thereof.
The crown portion is adapted to support the prosthesis V at the commissures C (e.g. via the cusps 14b) and/or at near the proximal edges of the leaflets L (e.g. via the festoon-like sections extending between the cusps). Consequently, while various embodiments herein provide for supporting the valve V at its commissures C, such a way of supporting the valve V is not mandatory.
In the embodiment of FIG. 8, the flexible connection of the hub 12 and the distal support portions 14a is due to both the support member 12a and the formations 14 forming the crown portion carried thereby being elastically deformable (i.e. flexible). In various embodiments, a structure as shown in FIG. 8 may provide for one of the support or the crown portion carried thereby being rigid (i.e. essentially non-flexible). In that case, flexible connection of the hub 12 and the support portions is ensured by the other of the support or the crown portion carried thereby being flexible.
As indicated, particular configurations, structures or characteristics to provide support of the valve V and/or flexible connection of the hub 12 and the distal support portions 14a for the valve as illustrated herein may be exchanged between embodiments or variously combined in each single embodiment.
As is the case of the formations 14 of FIGS. 2 and 7, the formations 14 of FIG. 8 may have a concave shape with a concavity directed towards the hub, i.e. towards the portion 120 of the hub 12 to be connected to the handle H. This arrangement causes the distal support portions 14a of the formations 14 to be located generally proximally of the rest of the formations 14.
The exemplary embodiment of FIG. 9 is schematically representative as capable of turning upside-down the formations 14, so that the formations 14 may have a concave shape with a concavity directed away from the hub 12, that is away from the portion 120 of the hub 12 to be connected to the handle H. This arrangement causes the distal support portions 14a of the formations 14 to be located generally distally of the rest of the formations 14.
It is again recalled that particular configurations, structures or characteristics to provide support of the valve V and/or flexible connection of the hub 12 and the distal support portions 14a for the valve as illustrated herein may be exchanged between embodiments or variously combined in each single embodiment.
In various embodiments, the distal support portions 14a may have a wire-like structure. In various embodiments, the distal support portions 14a may have a tape-like shape, with a flattened cross-sectional shape.
In various embodiments, the distal support portions 14a may include apertures (e.g. through holes) or similar passageways 16 for sutures stitches S or other retaining means to retain the prosthesis V onto the support device 10. FIGS. 3 to 6 (further described below) show such stitches S “passed” through the tissue of the valve and extending through the apertures 16 to retain the prosthesis V onto the support device 10. Other embodiments of means for fixing the valve V onto the support device 10, e.g. metal “clips” or the like, are feasible and thus contemplated by this disclosure.
In various embodiments, the valve V is mounted on the support device 10 by slightly spreading apart the leaflets and sliding the device 10 into the prosthesis V (in either direction). For instance, if support at the commissures C is contemplated, the device 10 is slid into the prosthesis V causing each support portion 14a to penetrate between two adjacent leaflets L until the distal support portions 14a are located in correspondence with the commissures C of the prosthesis V. At this point, the prosthesis V can be fixed onto the support device 10 via fixing means such as the stitches S shown in FIGS. 3 to 6.
In various embodiments, the device 10—and possibly the prosthesis (being) mounted thereon—may be radially contracted and maintained in such a contracted condition by constraint means such as loops of surgical wire (shown in FIG. 3 and designated T) extending, e.g. between the hub 12 and the distal support portions 14a. 
To that effect, a collar member 18 may be provided in the hub 12 having e.g. three extensions 18a each facing one of the distal support portions 14a and having apertures e.g. through holes or similar passageways 180 for the wire loops T.
In such a condition as schematically represented in FIG. 3 (i.e. with loops T of suture wire extending between the collar 18—i.e. the hub 12—and the distal support portions 14a—that is the commissures C) the prosthesis V supported by the device is at least slightly radially constrained towards the main axis X12 of the support device 10.
The prosthesis being thus radially contracted (i.e. made somewhat “smaller”) may facilitate advancing, positioning and orientating the prosthesis at the implantation site. Also, the presence of the wires T helps reduce the tendency for the distal support portions 14a to displace away from the hub 12, and thus the possibility for the hub 12 to “pivot” or angulate with respect to the valve V supported by the support device 10, which may further facilitate the surgeon's activity.
Various embodiments of the device 10 lend themselves to be used in combination with conventional holders, with the holder removed once the valve is positioned at the implantation site, while the support device 10 is left in place to assist the surgeon in the suturing process.
Various embodiments of the device 10 may fully replace a conventional holder.
In various embodiments, the stitches S and/or T (and any other corresponding fixing/constraint means) are applied before the prosthesis V is inserted in its sterile package, where it is usually kept immersed in a storage liquid, so that the device 10 may (also) play the role played by conventional holders in supporting the valve in its sterile package.
When proceeding to implantation of such an embodiment, the sterile package is opened and the kit including the support device 10 and valve V mounted thereon may be extracted from the package by coupling the hub 12 to the handle H.
This is subsequently used to advance, position and angularly orient the valve V at its implantation site. If the device 10 and the valve V mounted thereon are in a radially contracted condition as shown in FIG. 3, once the surgeon determines that the valve V is correctly positioned and oriented, the surgeon may then proceed to remove the constrain means (for instance by cutting the wire loops T by means of surgical scissors F as schematically shown in FIG. 4).
The device 10 and the valve V mounted thereon will thus radially expand and adapt to the implantation site. In various embodiments, the device 10 may be realized (e.g. the formations 14 shaped) in such a way that the device is elastically contracted as a result of the prosthesis V being mounted thereon, in that the device will exert a further radial expansion action of the prosthesis at the implantation site. Also, cutting the wire loops T (i.e. defeating their constraint action) will completely restore the capability for the hub 12 to “pivot” or angulate with respect to the prosthesis supported by the distal support portions 14a. At that point, the surgeon will be able to proceed with suturing the valve V at its implantation site without removing the support device 10 while otherwise retaining—due to the capability for the hub 12 to “pivot” or angulate with respect to the valve V—the possibility to freely orient the hub 12 with respect to the overall location/orientation of the valve e.g. of the commissures C. The surgeon will thus be able to retain a certain “control” of the valve V while otherwise being in a position to freely orient the prosthesis V with respect to the hub 12 (and thus with respect to the handle H) to facilitate the suturing process. Even with the handle H removed, the support device 10 will bestow onto the valve V a certain degree of consistency, by avoiding that a stentless prosthesis V may undesirably collapse radially and uncontrollably deform while being sutured at the implantation site.
Additionally, the flexible, elastic structure of the device 10 may permit the surgeon to deform the valve being sutured (e.g. by deflecting radially inwardly one of the valve commissures C to inspect the result of on-going suturing), without running the risk that the valve V may be undesirably displaced with respect to the correct implantation position.
Due to their essentially wire-like structure, the support formations/portions will be unobtrusive (both visually and mechanically) of the suturing process. Once wishing to remove the device 10 (e.g. when the suturing process is held to be sufficiently completed) the surgeon will be in a position simply to cut the stitches S which anchor the valve V to the device 10, which may then be moved away from the implantation site and the patient's body.
It will be otherwise appreciated that radially contracting the device 10 and the valve V as exemplified with reference to FIGS. 3 and 4 in view of implantation is not mandatory. Also, this disclosure is not limited to embodiments related to implantation of a prosthetic cardiac (e.g. aortic) valve, but may also apply to prosthetic valves in general, including e.g. prosthetic venous valves.
The suturing process just described may involve applying festoon-like lines of stitches along the “valleys” between adjacent commissures C, i.e. in correspondence with the arch-like proximal edges of the valve leaflets L. Certain embodiments of a stentless valve V as considered herein may include two concentric “sleeves” of sheet material such as biological material, wherein the inner sleeve forms the valve leaflets L, while the outer sleeve forms a scalloped annular structure to be sutured to the implantation site.
FIG. 6 schematically illustrates the possibility for various embodiments to include protection elements 20 extending between the distal support portions 14a (not visible in FIG. 6 as they are hidden by the leaflets L) to protect the leaflets L from undesired accidental stitching during the suturing process of the valve V at the implantation site.
In various embodiments, the protective elements 20 are in the form of laminar, “petal-like” formations having rounded distal edges 20a and carried by bridge members 22 extending from the hub 12 (e.g. from the collar 18). In various embodiments, three protective elements 20 are provided, evenly spaced 120° from one another, around the main axis X12 of the device.
Each protective element 20 will form a sort of shield covering those portions of the leaflets L adjacent to the locations where the stitches are applied by the surgeon when suturing the valve V to the implantation site. The protective elements 20 will dispense with the risk that suturing stitches may be inadvertently applied to the proximal portions of the valve leaflets L thus undesirably reducing their capability of opening/closing under the action of the blood flow.
In various embodiments, when mounted onto the device 10, the valve V will thus be arranged in such a way that the distal support portions 14a will extend (e.g. internally of the prosthesis V) to support the commissures C, and the distal rounded edges 20a of the protective elements 20 will be inserted between the inner tubular sheet forming the valve leaflets L and the outer, scalloped tubular sheet which forms the outer structure of the prosthesis V to be sutured to the implantation site.
Without prejudice the underlying principles of the invention, the details and embodiments may vary, even significantly, with respect to what has been described and shown by way of non-limiting example, without thereby departing from the scope of the invention as defined in the annexed claims.
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. A delivery system for implanting a stentless valve prosthesis, the system comprising:
the stentless valve prosthesis comprising a plurality of commissure portions, and a plurality of valve leaflets, wherein each valve leaflet extends between two adjacent commissure portions, and;
a support device comprising:
a hub defining a manipulation axis for the device, and
a plurality of support portions for supporting the stentless valve prosthesis that extend radially from the hub, exhibit a shape with a proximal portion connected to the hub and a distal portion that extends back proximally toward the hub, and are configured to extend along and support the commissure portions of the stentless valve prosthesis, wherein the hub is connected to the support portions via an elastically flexible connection to elastically bias the hub centrally of the support portions, and at least a portion of the distal portion of each support portion extends proximal to the elastically flexible connection.

2. The system of claim 1, further including a plurality of formations extending around the hub with respective support portions for supporting the stentless valve prosthesis.

3. The system of claim 2, wherein the formations extending around the hub have a concave shape with a concavity directed towards the hub.

4. The device of claim 2, wherein the support portions have a wire-like or ribbon-like structure.

5. The system of claim 2, wherein the support portions have passageways for fixing means of the prosthesis to the device.

6. The device of claim 2, further including a restraining element to restrain the device to a radially contracted condition.

7. The device of claim 6, wherein the restraining element restrains displacement of the manipulation axis for the device between the support portions.

8. The device of claim 2, further including protective elements for the leaflets of the prosthesis.

9. The device of claim 8, wherein the protective elements are carried by support elements extending from the hub.

10. The system of claim 1, wherein the support portions have a length sufficient to support the commissure portions of the stentless valve prosthesis.

11. The system of claim 1, wherein the stentless valve prosthesis is sutured to the support portions of the support device.

12. A kit for implanting a stentless valve prosthesis, the kit comprising:
the stentless valve prosthesis comprising a plurality of commissure portions, and a plurality of valve leaflets, wherein each valve leaflet extends between two adjacent commissure portions; and
a support device, wherein the stentless valve prosthesis is configured to be mounted on the support device, including:
a hub defining a manipulation axis for the device, and
a plurality of support portions for supporting the stentless valve prosthesis by extending along the commissure portions of the stentless valve prosthesis, wherein the support portions extend radially from the hub, and exhibit a shape with a proximal portion connected to the hub and a distal portion that extends back proximally toward the hub, wherein the hub is connected to the support portions via an elastically flexible connection to elastically bias the hub centrally of the support portions, and at least a portion of the distal portion of each support portion extends proximal to the elastically flexible connection.

13. The kit of claim 12, wherein the support portions have a length sufficient to support the commissure portions of the stentless valve prosthesis.

14. The kit of claim 12, wherein the stentless valve prosthesis is sutured to the support portions of the support device.