(19)
(11)EP 1 667 614 B2

(12)NEW EUROPEAN PATENT SPECIFICATION
After opposition procedure

(45)Date of publication and mention of the opposition decision:
08.04.2020 Bulletin 2020/15

(45)Mention of the grant of the patent:
07.12.2016 Bulletin 2016/49

(21)Application number: 04785349.4

(22)Date of filing:  01.10.2004
(51)Int. Cl.: 
A61F 2/24  (2006.01)
(86)International application number:
PCT/US2004/032388
(87)International publication number:
WO 2005/034812 (21.04.2005 Gazette  2005/16)

(54)

IMPLANTABLE PROSTHETIC VALVE WITH NON-LAMINAR FLOW

IMPLANTIERBARE KLAPPENPROTHESE MIT NICHTLAMINAREM FLUSS

VALVE PROTHETIQUE IMPLANTABLE À ÉCOULEMENT NON LAMINAIRE


(84)Designated Contracting States:
AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HU IE IT LI LU MC NL PL PT RO SE SI SK TR

(30)Priority: 02.10.2003 US 677947

(43)Date of publication of application:
14.06.2006 Bulletin 2006/24

(60)Divisional application:
16191929.5 / 3156007

(73)Proprietor: Edwards Lifesciences Corporation
Irvine, CA 92614 (US)

(72)Inventor:
  • ROWE, Stanton
    Newport Beach, CA 92660 (US)

(74)Representative: Dolleymores 
9 Rickmansworth Road
Watford, Hertfordshire WD18 0JU
Watford, Hertfordshire WD18 0JU (GB)


(56)References cited: : 
EP-A- 1 264 582
WO-A1-00/44313
WO-A1-03/047468
WO-A2-01/76510
WO-A2-03/003949
NL-C2- 1 017 275
US-B1- 6 454 799
WO-A-01/54625
WO-A1-02/36048
WO-A1-2005/034812
WO-A2-03/003943
FR-A- 2 788 217
US-A1- 2003 153 974
  
      


    Description

    FIELD OF INVENTION



    [0001] The present invention relates to implantable prosthetic valves. More particularly, the invention relates to a valve prosthesis for cardiac implantation or for implantation in other body ducts where the prosthesis has improved flow characteristics.

    BACKGROUND OF INVENTION



    [0002] Several prosthetic valves are known. See, for example, U.S. Patent No. 5,411,552 (Andersen et al.), entitled VALVE PROSTHESIS FOR IMPLANTATION IN THE BODY AND CATHETER FOR IMPLANTING SUCH VALVE PROSTHESIS, which discloses a valve prosthesis comprising a stent made from an expendable cylinder-shaped thread structure comprising several spaced apices. See, also, U.S. Patent No. 6,168,614 (Andersen et al.), entitled VALVE PROSTHESIS FOR IMPLANTATION IN THE BODY, U.S. Patent No. 5,840,081 (Andersen et al.), entitled SYSTEM AND METHOD FOR IMPLANTING CARDIAC VALVES, and PCT Application No. PCT/EP97/07337 (Letac, Cribier et al.), published as WO 98/29057, entitled VALVE PROSTHESIS FOR IMPLANTATION IN BODY CHANNELS.

    [0003] U.S. Patent No. 6,454,799 discloses an expandable pre-assembled heart valve which includes a plastically-expandable annular base having a plurality of upstanding commissure posts. A tubular flexible member including a prosthetic section and a fabric section is provided, with the prosthetic section being connected to the commissure posts and defining leaflets therebetween, and the fabric section being attached to the annular base. Further prior art arrangements are known from WO 03/003949 and WO 03/003943.

    [0004] In the development of stented valves, a highly desirable and often preferred design utilises a cylindrical stent platform of either balloon expandable or self-expanding metal designs. Usually these stents follow the cellular designs which tend to have higher radial strength and less foreshortening than wire-wound platforms.

    [0005] Such cylindrical stents offer a stable and reproducible expansion platform for attaching valves and may be manufactured from a variety of biocompatible metals including stainless steels, titanium alloys, platinum-iridium, nickel-titanium alloys, chromium alloys, or tantalum.

    [0006] Polymeric, bovine venous, pericardial, and porcine valve constructs have lead the early development efforts of stent-valve designs. All of the early designs have utilized either bicuspid or tricuspid valve designs.

    [0007] One of the key factors that determines the long term functionality of stented valves is the retrograde flow characteristics. The retrograde flow characteristics, along with the stiffness characteristics of the valve material, will determine leakage and closing pressure requirements. The retrograde flow characteristics are most important in low flow/low pressure systems where the valve leaflets may thrombose in the presence of poor retrograde laminar flow.

    [0008] Stented valves are passive devices. The valves function as a result of changes in pressure and flow. An aortic stented valve opens passively when the pressure in the left ventricle exceeds the pressure in the aorta (plus any resistance required to open the valve). The valve closes when the pressure in the left ventricle is less than the pressure in the aorta. However, the flow characteristics are critical to effect the closing of the aortic valve, otherwise regurgitation will ensue.

    [0009] Laminar flow is the normal condition found in most of the circulatory system. It is characterized by concentric layers of blood moving in parallel down the length of the blood vessel. The highest velocity is found in the middle of the blood vessel while the lowest is found along the wall. The flow is parabolic in a long straight vessel under steady flow conditions.

    [0010] Non-laminar, or turbulent, flow is useful to the circulatory system. For example, the aortic valve opens into the sinus of Valsalva at the inferior aspect of the ascending aorta. This sinus has two key functions: First, it maximises the flow characteristics so that the aortic valve closes during diastole. And second, it optimises coronary sinus flow and perfusion.

    [0011] Laminar flow makes the retrograde flow characteristics of valves mounted in cylindrical stents problematic as the flow along the wall is least, which is central to the closing of a valve. Such laminar flow with its attendant drawbacks is a characteristic of known stented valves. There is a need to have stented valves where the retrograde flow characteristics will be non-laminar, which will be advantageous with regard to valve closing.

    SUMMARY OF THE INVENTION



    [0012] The present invention provides a valve prosthesis device as recited by Claim 1.

    [0013] A preferred embodiment provides a valve prosthesis, wherein the support stent comprises a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location.

    [0014] A preferred embodiment provides a valve prosthesis, wherein the device is configured so that an artificial sinus is formed adjacent to the valve assembly.

    [0015] A preferred embodiment provides a valve prosthesis, wherein the valve assembly is attached to the support beams providing collapsible slack portions of the conduit at the outlet.

    [0016] A preferred embodiment provides a valve prosthesis, wherein said valve assembly has a tricuspid configuration.

    [0017] A preferred embodiment provides a valve prosthesis, wherein the valve assembly is made from pericardial tissue, or other biological tissue.

    [0018] A preferred embodiment provides a valve prosthesis, wherein said valve assembly leaflets are longer than needed to exactly close the outlet, thus when they are in the collapsed state substantial portions of the leaflets fall on each other creating better sealing.

    [0019] A preferred embodiment provides a valve prosthesis, wherein the support stent is provided with heavy metal markers so as to enable tracking and determining the valve device position and orientation.

    [0020] A preferred embodiment provides a valve prosthesis, wherein the support stent at the outlet is wider in diameter than the pliant material forming the outlet.

    [0021] A preferred embodiment provides a valve prosthesis, wherein the device is incorporated with an expandable balloon.

    [0022] A preferred embodiment provides a valve prosthesis, wherein the balloon has a central longitudinal axis that runs along a flow path through the device, and a perimeter, the balloon comprising four inflatable portions, one portion located along a central axis and the other three located on the perimeter, the pliant material in the form of leaflets is distributed about the perimeter.

    [0023] A preferred embodiment provides a valve prosthesis, wherein the support stent when deployed has a diameter in the range of about 19 mm to about 26 mm.

    [0024] A preferred embodiment provides a valve prosthesis, wherein the support stent comprises nickel titanium.

    BRIEF DESCRIPTION OF THE DRAWINGS



    [0025] To better understand the invention and appreciate its practical applications, the following Figures are provided and referenced hereafter. It should be noted that the figures are given as examples only and in no way limit the scope of the invention as defined in the appended claims.

    Figure 1 represents an oblique view of an embodiment of the invention;

    Figure 2 represents a cross-sectional view across line 2-2 of the embodiment shown in Figure 1;

    Figure 3 represents an oblique, partly cross-sectional view of an example not forming an embodiment of the invention; and

    Figure 4 represents a cross-sectional view across line 4-4 of the example shown in Figure 3.


    DETAILED DESCRIPTION OF THE INVENTION



    [0026] A main aspect of the present invention is the introduction of several novel designs for an implantable prosthetic valve. Another aspect is the disclosure of several manufacturing methods for implantable prosthetic valves in accordance with the present invention. A further aspect of the present invention is the provision of novel deployment and positioning techniques suitable for the valve of the present invention.

    [0027] Basically the implantable prosthetic valve of the present invention comprises a leaflet-valve assembly, preferably tricuspid but not limited to tricuspid valves only, consisting of a conduit having an inlet end and an outlet, made of pliant material arranged so as to present collapsible walls at the outlet. The valve assembly is mounted on a support structure or frame such as a stent adapted to be positioned at a target location within the body duct and deploy the valve assembly by the use of deploying means, such as a balloon catheter or similar devices. In embodiments suitable for safe and convenient percutaneous positioning and deployment the annular frame is able to be posed in two positions, a crimped position where the conduit passage cross-section presented is small so as to permit advancing the device towards its target location, and a deployed position where the frame is radial extended by forces exerted from within (by deploying means) so as to provide support against the body duct wall, secure the valve in position and open itself so as to allow flow through the conduit.

    [0028] The valve assembly can be made from biological matter, such as a natural tissue, pericardial tissue or other biological tissue. Alternatively, the valve assembly may be made form biocompatible polymers or similar materials. Homograph biological valves need occasional replacement (usually within 5 to 14 years), and this is a consideration the surgeon must take into account when selecting the proper valve implant according to the patient type. Mechanical valves, which have better durability qualities, carry the associated risk of long-term anticoagulation treatment.

    [0029] The frame can be made from shape memory alloys such as nickel titanium (nickel titanium shape memory alloys, or NiTi, as marketed, for example, under the brand name Nitinol), or other biocompatible metals. The percutaneously implantable embodiment of the implantable valve of the present invention has to be suitable for crimping into a narrow configuration for positioning and expandable to a wider, deployed configuration so as to anchor in position in the desired target location.

    [0030] The support stent is preferably annular, but may be provided in other shapes too, depending on the cross-section shape of the desired target location passage.

    [0031] Manufacturing of the implantable prosthetic valve of the present invention can be done in various methods, by using pericardium or, for example, by using artificial materials made by dipping, injection, electrospinning, rotation, ironing, or pressing.

    [0032] The attachment of the valve assembly to the support stent can be accomplished by sewing it to several anchoring points on the support frame or stent.

    [0033] To prevent leakage from the inlet it is optionally possible to roll up some slack wall of the inlet over the edge of the frame so as to present rolled-up sleeve-like portion at the inlet.

    [0034] Furthermore, floating supports may be added to enhance the stability of the device and prevent it from turning inside out.

    [0035] An important aspect of the present invention is the provision of rigid support beams incorporated with the support stent that retains its longitudinal dimension while the entire support stent may be longitudinally or laterally extended.

    [0036] The aforementioned embodiments as well as other embodiments, manufacturing methods, different designs and different types of devices are discussed and explained below with reference to the accompanying drawings. Note that the drawings are only given for the purpose of understanding the present invention and presenting some preferred embodiments of the present invention, but this does in no way limit the scope of the present invention as defined in the appended claims.

    [0037] Figures 1 and 2 illustrate a general tricuspid implantable prosthetic valve 10 in accordance with a preferred embodiment of the present invention, suitable for percutaneous deployment using an expandable stent or similar deploying means, shown in its deployed position. Valve 10 comprises a valve assembly 20 having an inlet 22 and an outlet 24, the outlet walls consisting of collapsible pliant leaflet material 26 that is arranged to collapse in a tricuspid arrangement. Valve assembly 20 is attached to an annular support stent 32, which is a net-like frame designed to be adapted to crimp evenly so as to present a narrow configuration and be radially deployable so as to extend to occupy the passage at the target location for implantation in a body duct. Support beams 34 are provided on annular support stent 32 to provide anchorage to valve assembly 20. Support beam 34 are optionally provided with bores 36 to allow stitching of valve assembly 20 to support beams 34 by thread, wire, or other attachment means.

    [0038] The proximal portion 38 of support stent 32 is snuggly fit or fastened to the proximal portion of valve assembly 20 so that any flow is only into inlet 22. Optionally the radial sections of each leaflet 26 is closed by stitching, gluing or other means to narrow outlet 24. The distal portion 42 of support stent 32 is narrower than proximal portion 38. The combination of the effect on flow characteristics due to the narrowing of support stent 32 and the narrowing of outlet 24 is sufficient to engender the desired effect or flow characteristics, namely, non-laminar retrograde flow that will assist in the closing of leaflets 26.

    [0039] An example is shown in Figures 3 and 4. A prosthetic valve 50 comprises a valve assembly 52 positioned within a support stent 54. The proximal 56 and distal 58 portions of support stent 54 are narrow as compared to the mid-portion 60 of support stent 54, where valve assembly 52 is positioned. Within support stent mid-portion 60 valve assembly 52 is preferably positioned co-axially and at a small distance, for example, from 0.5 to 3 cm, from the interior surface 64 of support stent 54. Valve assembly 52 is attached by connecting membrane 66 to stent supports 68, which optimally have holes or projections 70 to anchor said membranes 66. Any annular space between interior surface 64 and valve assembly 52 is filled with appropriate material to prevent flow around valve assembly 52. Valve leaflets are shown in closed 72 and open 74 positions.

    [0040] The effective cross-sectional area of valve assembly 52 will preferably be from about 40 to 80% of the cross-sectional area across support stent midsection 60.

    [0041] The preferred embodiments representing an implantable prosthetic valve in accordance with the present invention are relatively easy to manufacture as they are generally flat throughout most of the production process and only at the final stage of mounting the other elements of the valve assembly on the support frame, a three dimensional form is established.

    [0042] A typical size of an aortic prosthetic valve is from about 19 to about 26 mm in diameter. A maximal size of a catheter inserted into the femoral artery should be no more than 9 mm in diameter. The present invention introduces a device, which has the ability to change its diameter from about 4 mm to about 26 mm. Artificial valves are not new; however, artificial valves in accordance with the present invention posses the ability to change shape and size for the purpose of delivery and as such are novel. These newly designed valves require new manufacturing methods and technical inventions and improvements, some of which were described herein.

    [0043] As mentioned earlier, the material of which the valve is made from can be either biological or artificial. In any case new technologies are needed to create such a valve.

    [0044] To attach the valve to the body, the blood vessels determine the size during delivery, and the requirements for it to work efficiently, there is a need to mount it on a collapsible construction which can be crimped to a small size, be expanded to a larger size, and be strong enough to act as a support for the valve function. This construction, which is in somewhat similar to a large "stent", can be made of different materials such as Nitinol, biocompatible stainless steel, polymeric material or a combination of all. Special requirement for the stent are a subject of some of the embodiments discussed herein.

    [0045] The mounting of the valve onto a collapsible stent is a new field of problems. New solutions to this problem are described herein.

    [0046] Another major aspect of the design of the valve of the present invention is the attachment to the body.

    [0047] In the traditional procedure the valve is sutured in place by a complicated suturing procedure. In the case of the percutaneous procedure there is no direct access to the implantation site therefore different attachment techniques are needed.

    [0048] Another new problem that is dealt herein is the delivery procedure, which is new and unique. Positioning of the device in the body in an accurate location and orientation requires special marking and measuring methods of the device and surgical site.

    [0049] Artificial polymer valves require special treatment and special conditions when kept on a shelf, as well as a special sterilization procedure. One of the consequences of the shelf treatment is the need to crimp the valve during the implantation procedure.

    [0050] It should be clear that the description of the embodiments and attached Figures set forth in this specification serves only for a better understanding of the invention, without limiting its scope as covered by the following claims.

    [0051] It should also be clear that a person skilled in the art, after reading the present specification could make adjustments or amendments to the attached Figures and above described embodiments that would still be covered by the following claims.


    Claims

    1. A valve prosthesis device suitable for cardiac implantation in corporeal ducts, the device comprising:

    a support stent (32) being a net-like annular frame comprising a proximal portion (38) and a distal portion (42), wherein the support stent is adapted to be crimped in a first narrow configuration and be radially deployable so as to extend to a second expanded configuration to occupy a passage at the target location for implantation in the corporeal duct, and a valve assembly (20) comprising a flexible conduit formed from pliant material and having an inlet (22) and an outlet (24), wherein the outlet is tapered with respect to the inlet, and the proximal portion (38) is snuggly fit or fastened to a proximal portion of the valve assembly (20),

    characterised in that the support stent is provided with a plurality of longitudinally rigid support beams (34) of fixed length, and the conduit is sutured to the support beams to provide collapsible slack portions at the outlet arranged to open to permit fluid flow from the inlet to the outlet and to collapse to prevent fluid flow from the outlet to the inlet,

    wherein when flow is allowed to pass through the valve prosthesis device from the inlet to the outlet, the valve assembly is kept in an open position; wherein a reverse flow is prevented as the collapsible slack portions of the valve assembly collapse inwardly providing blockage to the reverse flow, and

    in the second expanded configuration, the distal portion is narrower than the proximal portion, such that the device is configured so that retrograde flow will be altered from laminar flow and directed towards the collapsible slack portions to effect closing.


     
    2. The valve prosthesis device of claim 1, wherein the support stent (32) comprises a deployable construction adapted to be initially crimped in a narrow configuration suitable for catheterization through the body duct to a target location and adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location.
     
    3. The valve prosthesis of claim 1, wherein the device is configured so that an artificial sinus is formed adjacent to the valve assembly.
     
    4. The valve prosthesis of claim 1, wherein the valve assembly is attached to the support beams providing collapsible slack portions of the conduit at the outlet.
     
    5. The valve prosthesis device of any preceding claim, wherein said valve assembly has a tricuspid configuration.
     
    6. The valve prosthesis device of any preceding claim, wherein the valve assembly is made from pericardial tissue, or other biological tissue.
     
    7. The valve prosthesis device of any preceding claim, wherein said valve assembly leaflets (26) are longer than needed to exactly close the outlet, thus when they are in the collapsed state substantial portions of the leaflets fall on each other creating better sealing.
     
    8. The valve prosthesis device of any preceding claim, wherein the support stent is provided with heavy metal markers so as to enable tracking and determining the valve device position and orientation.
     
    9. The valve prosthetic device of any preceding claim, wherein the support stent (32) is adapted to be deployed by exerting substantially radial forces from within by means of a deployment device to a deployed state in the target location.
     
    10. The valve prosthetic device of any preceding claim, wherein the support stent (32) at the outlet is wider in diameter than the pliant material forming the outlet.
     
    11. The valve prosthetic device of any preceding claim, wherein the device is configured to be deployed with an expandable balloon.
     
    12. The valve prosthetic device of claim 11, wherein the balloon has a central longitudinal axis that runs along a flow path through the device, and a perimeter, the balloon comprising four inflatable portions, one portion located along a central axis and the other three located on the perimeter, the pliant material in the form of leaflets is distributed about the perimeter.
     
    13. The valve prosthetic device of any preceding claim, wherein the support stent when deployed has a diameter in the range of about 19 mm to about 26 mm.
     
    14. The valve prosthetic device of any preceding claim, wherein the support stent is made from nickel titanium.
     


    Ansprüche

    1. Klappenprothesevorrichtung, die zur kardialen Implantation in Körperkanälen geeignet ist, wobei die Vorrichtung Folgendes umfasst:

    einen Stütz-Stent (32), der ein netzartiger ringförmiger Rahmen ist, der einen proximalen Abschnitt (38) und einen distalen Abschnitt (42) umfasst, wobei der Stütz-Stent angepasst ist, um zu einer ersten schmalen Konfiguration zusammengedrückt zu werden und radial einsetzbar zu sein, sodass er sich zu einer zweiten erweiterten Konfiguration ausdehnt, um einen Durchgang am Zielort für die Implantation in dem Körperkanal einzunehmen, und eine Klappenanordnung (20), die einen flexiblen Conduit umfasst, der aus einem biegsamen Material ausgebildet ist, und einen Einlass (22) und einen Auslass (24) aufweist, wobei sich der Auslass in Bezug auf den Einlass verjüngt, und wobei der proximale Abschnitt (38) genau an einen proximalen Abschnitt der Klappenanordnung (20) angepasst oder daran befestigt ist,

    dadurch gekennzeichnet, dass der Stütz-Stent mit einer Vielzahl von in Längsrichtung steifen Stützträgern (34) einer festgelegten Länge bereitgestellt ist und der Conduit an die Stützträger angenäht ist, um faltbare lockere Abschnitte an dem Auslass bereitzustellen, die zur Öffnung, um einen Flüssigkeitsfluss von dem Einlass zum Auslass zu erlauben, und zum Zusammenfalten, um einen Flüssigkeitsfluss von dem Auslass zum Einlass zu verhindern, angeordnet sind,

    wobei, wenn der Durchgang eines Flusses durch die Klappenprothesevorrichtung von dem Einlass zum Auslass ermöglicht wird, die Klappenanordnung in einer geöffneten Position gehalten wird; wobei ein Rückfluss verhindert wird, da sich die faltbaren lockeren Abschnitte der Klappenanordnung nach innen zusammenfalten, was eine Blockierung des Rückflusses bereitstellt, und

    in der zweiten erweiterten Konfiguration der distale Abschnitt schmaler ist als der proximale Abschnitt, sodass die Vorrichtung derart konfiguriert ist, dass retrograder Fluss von laminarem Fluss geändert und in Richtung der faltbaren lockeren Abschnitte geleitet werden wird, um ein Verschließen zu bewirken.


     
    2. Klappenprothesevorrichtung nach Anspruch 1, wobei der Stütz-Stent (32) eine einsetzbare Konstruktion umfasst, die angepasst ist, um am Anfang zu einer schmalen Konfiguration zusammengedrückt zu werden, die zur Katheterisierung durch den Körperkanal zu einem Zielort geeignet ist, und angepasst ist, um durch Ausüben von im Wesentlichen Radialkräften von innen mittels einer Einsatzvorrichtung auf einen eingesetzten Zustand an dem Zielort eingesetzt zu werden.
     
    3. Klappenprothese nach Anspruch 1, wobei die Vorrichtung derart konfiguriert ist, dass ein künstlicher Sinus benachbart zur Klappenanordnung gebildet wird.
     
    4. Klappenprothese nach Anspruch 1, wobei die Klappenanordnung an den Stützträgern angebracht ist, was faltbare lockere Abschnitte des Conduit an dem Auslass bereitstellt.
     
    5. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei die Klappenanordnung eine Trikuspidalkonfiguration aufweist.
     
    6. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei die Klappenanordnung aus Perikardgewebe oder anderem biologischem Gewebe hergestellt ist.
     
    7. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei die Segel der Klappenanordnung (26) länger als benötigt sind, um den Auslass genau zu verschließen, sodass, wenn sie sich in dem gefalteten Zustand befinden, wesentliche Abschnitte der Segel aufeinanderfallen, was eine bessere Abdichtung bewirkt.
     
    8. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei der Stütz-Stent mit Schwermetallmarkern bereitgestellt ist, um die Verfolgung und Bestimmung der Position und Ausrichtung der Klappenvorrichtung zu ermöglichen.
     
    9. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei der Stütz-Stent (32) angepasst ist, um durch Ausüben von im Wesentlichen Radialkräften von innen mittels einer Einsatzvorrichtung auf einen eingesetzten Zustand an dem Zielort eingesetzt zu werden.
     
    10. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei der Stütz-Stent (32) an dem Auslass breiter im Durchmesser ist als das biegsame Material, das den Auslass bildet.
     
    11. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei die Vorrichtung konfiguriert ist, um mit einem expandierbaren Ballon eingesetzt zu werden.
     
    12. Klappenprothesevorrichtung nach Anspruch 11, wobei der Ballon eine zentrale Längsachse, die entlang eines Flusswegs durch die Vorrichtung läuft, und einen Umfang aufweist, wobei der Ballon vier aufblasbare Abschnitte umfasst, einen Abschnitt, der sich entlang einer zentralen Achse befindet, und die anderen drei, die sich am Umfang befinden, wobei das biegsame Material in Form der Segel um den Umfang verteilt ist.
     
    13. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei der Stütz-Stent, wenn er eingesetzt ist, einen Durchmesser im Bereich von etwa 19 mm bis etwa 26 mm aufweist.
     
    14. Klappenprothesevorrichtung nach einem vorstehenden Anspruch, wobei der Stütz-Stent aus Nickel-Titan hergestellt ist.
     


    Revendications

    1. Dispositif de prothèse valvulaire conçu pour une implantation cardiaque dans des canaux corporels, le dispositif comprenant :

    une endoprothèse vasculaire de support (32) qui est un cadre annulaire semblable à un reseau comprenant une partie proximale (38) et une partie distale (42), dans lequel l'endoprothèse vasculaire de support est conçue pour être ramassée dans une première configuration étroite et pour être déployable radialement de manière à s'étendre dans une deuxième configuration développée pour occuper un passage au niveau de l'emplacement cible pour une implantation dans le canal corporel, et un assemblage formant valvule (20) comprenant un conduit flexible formé à partir d'un matériau pliant et ayant une admission (22) et une évacuation (24), dans lequel l'évacuation est rétrécie par rapport à l'admission et dans lequel la partie proximale (38) est bien ajustée ou rattachée à une partie proximale de l'assemblage formant valvule (20),

    caractérisé en ce que l'endoprothèse vasculaire est pourvue d'une pluralité de montants de support rigides longitudinalement (34) de longueur fixe, et le conduit est suturé aux montants de support pour fournir des parties lâches repliables au niveau de l'évacuation arrangées pour s'ouvrir pour permettre l'écoulement de fluide de l'admission vers l'évacuation et pour se replier pour empêcher l'écoulement de fluide de l'évacuation à l'admission,

    dans lequel quand l'écoulement peut traverser le dispositif de prothèse valvulaire de l'admission vers l'évacuation, l'assemblage formant valvule est maintenu en position ouverte ; dans lequel un écoulement inverse est empêché quand les parties lâches repliables de l'assemblage formant valvule se replient vers l'intérieur fournissant le blocage de l'écoulement inverse, et

    dans la deuxième configuration développée, la partie distale est plus étroite que la partie proximale, d'une manière telle que le dispositif est configuré de sorte qu'un écoulement rétrograde sera modifié à partir de l'écoulement laminaire et dirigé vers les parties lâches repliables pour effectuer une fermeture.


     
    2. Dispositif de prothèse valvulaire de la revendication 1, dans lequel l'endoprothèse vasculaire de support (32) se compose d'une construction déployable conçue pour être ramassée au départ dans une configuration étroite conçue pour un cathétérisme à travers le canal corporel vers un emplacement cible et conçue pour être déployée par l'application de forces sensiblement radiales de l'intérieur au moyen d'un dispositif de déploiement en un état déployé au niveau de l'emplacement cible.
     
    3. Prothèse valvulaire de la revendication 1, dans laquelle le dispositif est configuré de sorte qu'un sinus artificiel est formé adjacent à l'assemblage formant valvule.
     
    4. Prothèse valvulaire de la revendication 1, dans laquelle l'assemblage formant valvule est attaché aux montants de support fournissant les parties lâches repliables du conduit au niveau de l'évacuation.
     
    5. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel l'assemblage formant valvule a une configuration tricuspide.
     
    6. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel ledit assemblage formant valvule est fait de tissu péricardique ou autre tissu biologique.
     
    7. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel lesdits feuillets d'assemblage formant valvule (26) sont plus longs que nécessaire pour fermer exactement l'évacuation, ainsi quand ils sont à l'état replié des parties importantes des feuillets retombent les unes sur les autres créant une meilleure étanchéité.
     
    8. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel l'endoprothèse vasculaire de support est pourvue de marqueurs de métaux lourds de manière à permettre le suivi et la détermination de la position et de l'orientation du dispositif de valvule.
     
    9. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel l'endoprothèse vasculaire de support (32) est conçue pour être déployée par l'application de forces sensiblement radiales de l'intérieur au moyen d'un dispositif de déploiement en un état déployé au niveau de l'emplacement cible.
     
    10. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel l'endoprothèse vasculaire de support (32) au niveau de l'évacuation a un diamètre plus grand que le matériau pliant formant l'évacuation.
     
    11. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, le dispositif étant configuré pour être déployé avec un ballonnet expansible.
     
    12. Dispositif de prothèse valvulaire de la revendication 11, dans lequel le ballonnet a un axe longitudinal central qui s'étend le long d'une trajectoire d'écoulement à travers le dispositif, et un périmètre, le ballonnet comprenant quatre parties gonflables, une partie située le long d'un axe central et les trois autres situées sur le périmètre, le matériau pliant sous la forme de feuillets est réparti autour du périmètre.
     
    13. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel l'endoprothèse vasculaire de support quand elle est déployée a un diamètre compris dans l'intervalle d'environ 19 mm à environ 26 mm.
     
    14. Dispositif de prothèse valvulaire de l'une quelconque des revendications précédentes, dans lequel l'endoprothèse vasculaire de support est fabriquée en nickel-titane.
     




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    REFERENCES CITED IN THE DESCRIPTION



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    Patent documents cited in the description