FR2847800A1 - Prosthetic valve, has carrier framework with branches for centripetal compression of framework towards its folded position in contrast to elastic action, valve expanded and contracted in respective obstruction and release positions - Google Patents

Prosthetic valve, has carrier framework with branches for centripetal compression of framework towards its folded position in contrast to elastic action, valve expanded and contracted in respective obstruction and release positions Download PDF

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Publication number
FR2847800A1
FR2847800A1 FR0214986A FR0214986A FR2847800A1 FR 2847800 A1 FR2847800 A1 FR 2847800A1 FR 0214986 A FR0214986 A FR 0214986A FR 0214986 A FR0214986 A FR 0214986A FR 2847800 A1 FR2847800 A1 FR 2847800A1
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France
Prior art keywords
prosthetic valve
characterized
branches
valve according
26b
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Granted
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FR0214986A
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French (fr)
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FR2847800B1 (en
Inventor
Rachid Zegdi
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CORMOVE, FR
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PEROUSE LABORATOIRES
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/24Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices
    • A61F2/2412Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418Scaffolds therefor, e.g. support stents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0073Quadric-shaped
    • A61F2230/008Quadric-shaped paraboloidal
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular

Abstract

The valve has a carrier framework (22) deforming elastically between deployed and folded positions. A valve (24) is expanded and contracted in obstruction and release positions, respectively under an action of flow circulating through the framework. The framework has two branches (26A, 26B) for centripetal compression of the framework towards its folded position in contrast to elastic action. An Independent claim is also included for a prosthesis comprising a tubular endo-prosthesis and a prosthetic valve.

Description

i i

La présente invention concerne une valve prothétique interchangeable, du type comportant, d'une part, une armature porteuse déformable radialement de manière élastique par rapport à un axe principal entre une position déployée d'implantation et une position repliée de mise en place, la5 quelle armature porteuse est sollicitée élastiquement vers sa position déployée et, d'autre part, un obturateur souple lié à l'armature porteuse et déformable entre une position d'obstruction dans laquelle il est étendu transversalement et une position de libération dans laquelle il est contracté transversalement sous l'action du flux circulant au travers de l'armature porteuse. The present invention relates to an interchangeable prosthetic valve, of the type comprising on the one hand, a radially deformable support structure in a resilient manner with respect to a main axis between a deployed implantation position and a folded position of installation, which la5 support frame is elastically biased toward its extended position and, secondly, a flexible shutter connected with the carrier frame and deformable between an obstruction position in which it is stretched transversely and a release position in which it is contracted transversely under the action of the flow circulating through the support frame. 10 Le coeur comporte deux oreillettes et deux ventricules qui sont séparés par des valves. The core 10 comprises two atria and two ventricles which are separated by valves. Des valves sont en outre présentes en sortie du ventricule droit (valve pulmonaire) et du ventricule gauche (valve aortique). Valves are further present at the output of the right ventricle (pulmonary valve) and left ventricle (aortic valve).

Ces valves assurent une circulation univoque du flux sanguin, évitant un reflux sanguin à l'issue de la contraction ventriculaire. These valves ensure a univocal circulation of blood flow, avoiding blood reflux after ventricular contraction.

Des maladies affectent les valves. Diseases affecting the valves. En particulier, celles-ci peuvent souffrir d'une mauvaise ouverture, réduisant ainsi le flux sanguin, ou n'être que partiellement étanches, autorisant ainsi un reflux ou une régurgitation vers le ventricule ayant expulsé le flux sanguin. In particular, they can suffer from poor opening, thereby reducing the blood flow, or only partially sealed, allowing regurgitation or reflux to the ventricle having expelled the bloodstream.

Ces problèmes de régurgitation conduisent à une dilatation anormale 20 du ventricule qui produit, à terme, une insuffisance cardiaque. These regurgitation problems lead to abnormal ventricular dilatation 20 which produces eventually heart failure.

Il est connu de traiter ce type de maladie de manière chirurgicale, en remplaçant la valve malade. It is known to treat this type of disease surgically, by replacing the diseased valve. Les valves malades, et notamment la valve pulmonaire en sortie du ventricule droit sont remplacées par une valve prélevée sur un sujet décédé, ou par une bioprothèse constituée d'une arma25 ture métallique et d'un obturateur réalisé dans un tissu d'origine animale. Diseased valves, and in particular the pulmonary valve output of the right ventricle are replaced by a valve removed from a deceased subject, or a bioprosthesis comprised of a metal arma25 ture and a shutter made in animal tissue.

L'obturateur est solidarisé à demeure sur l'armature. The shutter is permanently secured to the frame.

Des valves prothétiques sont également connues. Prosthetic valves are also known. Celles-ci sont constituées d'une armature métallique supportant un obturateur en polymère. These consist of a metal frame supporting a polymer plug. De telles valves sont décrites, notamment dans les documents WO30 01/54625 et WO-01/28459. Such valves are described in particular in documents WO30 01/54625 and WO-01/28459.

Dans ces prothèses, l'armature est élastiquement peu déformable et l'obturateur est constitué d'une poche. In these prostheses, the armature is resiliently slightly deformable and the shutter is constituted by a pocket. L'armature élastiquement déformable s'applique contre la paroi intérieure d'un conduit organique, notamment l'artère pulmonaire issue du ventricule gauche. The elastically deformable armature bears against the inner wall of a conduit organic, in particular pulmonary artery from the left ventricle.

On constate, après plusieurs années d'implantation d'une telle prothèse, que celle-ci se dégrade et qu'elle ne fonctionne plus de manière effi5 cace. There is, after several years of implantation of such a prosthesis, that it degrades and it no longer works so effi5 cient. Une nouvelle prothèse doit alors être mise en place. A new prosthesis must be in place.

Toutefois, le retrait de l'ancienne prothèse ne peut être effectué de manière endoluminale, notamment du fait que l'armature porteuse de la prothèse se trouve fixée avec la paroi cardiaque, interdisant leur désolidarisation sans une intervention chirurgicale lourde prévoyant le remplacement 10 valvulaire. However, the withdrawal of the old prosthesis can be made so endoluminal, including the fact that the prosthesis support structure is attached to the heart wall, prohibiting their separation without major surgery providing a replacement valve 10.

L'invention a pour but de proposer une valve prothétique pouvant être remplacée sans difficulté excessive, et sans nécessiter une intervention chirurgicale lourde. The invention aims to provide a prosthetic valve can be replaced without undue difficulty, and without requiring major surgery.

A cet effet, l'invention a pour objet une valve prothétique interchan15 geable, du type précité, caractérisée en ce qu'elle comporte des moyens intégrés de compression centripète de ladite armature porteuse vers sa position repliée à l'encontre de l'action élastique. To this end, the invention relates to a prosthetic valve interchan15 geable of the aforementioned type, characterized in that it comprises integrated means of centripetal compression of said carrier frame towards its folded position against the resilient action .

Suivant des modes particuliers de réalisation, la valve prothétique comporte l'une ou plusieurs des caractéristiques suivantes 20 - ledit obturateur comporte une poche; According to particular embodiments, the prosthetic valve includes one or more of the following 20 - said shutter comprises a pocket; - la poche comporte un orifice d'évacuation ménagé dans son fond - le fond de la poche est généralement hémisphérique; - the bag comprises a discharge opening in its bottom - the bottom of the ladle is generally hemispherical; - les moyens de compression centripète comportent une pince comprenant au moins deux branches reliées ensemble dans une région com25 mune, chaque branche étant reliée audit obturateur suivant une plage de liaison, les branches présentant chacune une plage d'actionnement propre à coopérer avec un organe complémentaire de serrage pour la compression centripète de l'armature porteuse vers sa position repliée; - the centripetal compression means comprise a clamp comprising at least two branches connected together in a region mune COM25, each branch being connected to said shutter in a bonding pad, the legs each having an own actuation range to cooperate with a complementary member clamping for the centripetal compression of the supporting frame towards its folded position; - les branches sont soudées par une soudure dans leur région com30 mune et l'armature porteuse présente une forme de fourche, chaque branche étant déformable élastiquement, les plages d'actionnement et les plages de liaison des branches à l'obturateur étant situées du même côté de la soudure; - the branches are welded by a weld in their com30 mune region and the carrier frame has a fork shape, each branch being elastically deformable, the actuating ranges and the bonding pads of the legs to the valve being situated on the same side of the weld; l'armature porteus comporte deux branches; Porteus the reinforcement comprises two branches; - l'armature porteuse comporte trois branches; - the supporting frame comprises three parts; - elle comporte des brins reliant le fond de la poche à chaque branche; - it comprises strands connecting the bottom of the pocket in each branch; et - l'armature porteuse comporte un treillis métallique élastique et lesdits moyens de compression centripète comportent un brin de constriction engagé autour dudit treillis métallique élastique. and - the support structure comprises a resilient wire mesh and said centripetal compression means comprise a constriction strand engaged around said elastic wire mesh.

L'invention a en outre pour objet une prothèse comportant une endoprothèse tubulaire et une valve prothétique telle que définie ci- dessus. The invention further relates to a prosthesis comprising a tubular endoprosthesis and a prosthetic valve as defined above.

Elle concerne enfin une prothèse implantée dans un conduit tubulaire et comportant une endoprothèse disposée contre la surface intérieure d'un conduit organique et une valve prothétique disposée dans l'endoprothèse et appliquée contre la surface. It finally relates to a prosthesis implanted in a tubular conduit and comprising a stent disposed against the inner surface of a conduit organic and a prosthetic valve disposed within the stent and applied against the surface. intérieure de celle-ci. interior thereof.

L'invention sera mieux comprise à la lecture de la description qui va 15 suivre, donnée uniquement à titre d'exemple et faite en se référant aux dessins, sur lesquels: - - la figure 1 est une vue en coupe longitudinale d'une prothèse implantée dans un conduit organique comportant une valve prothétique dans son état obturant; The invention will be better understood on reading the description which 15 follows, given solely by way of example and with reference to the drawings, in which: - - Figure 1 is a longitudinal sectional view of a prosthesis implanted in an organic conduit having a prosthetic valve in its closing state; - la figure 2 est une vue en coupe de la prothèse de la figure 1 prise suivant la ligne I1l-l - les figures 3 et 4 sont des vues identiques aux figures 1 et 2, la valve prothétique étant dans son état passant; - Figure 2 is a sectional view of the prosthesis of Figure 1 taken along the line-I1l - Figures 3 and 4 are views identical to Figs 1 and 2, the prosthetic valve being in its conductive state; - les figures 5 et 6 sont des vues identiques à celle de la figure 1 illus25 trant les stades successifs de retrait d'une valve prothétique selon l'invention et - la figure 7 est une vue identique à celle de la figure 1 d'une variante de réalisation d'une valve prothétique selon l'invention. - Figures 5 and 6 are views identical to that of Figure 1 illus25 trating the successive stages of removing a prosthetic valve according to the invention, and - Figure 7 is a view identical to that of Figure 1 of a alternative embodiment of a prosthetic valve according to the invention.

- la figure 8 est une vue identique à celle de la figure 1 d'un autre 30 mode de réalisation d'une prothèse comportant une valve prothétique. - Figure 8 is a view identical to that of Figure 1 of another embodiment 30 of a prosthesis comprising a prosthetic valve.

Sur la figure 1 est représentée une prothèse selon l'invention supposée implantée dans une artère pulmonaire 12 reliée à son extrémité 12A à la sortie du ventricule droit du coeur, notamment d'un être humain et à son extrémité 12B aux poumons. Figure 1 shows a prosthesis according to the supposed invention implanted in a pulmonary artery 12 connected to the end 12A to the output of the right ventricle of the heart, in particular a human being and at its end 12B to the lungs.

Selon l'invention, la prothèse comporte une endoprothèse tubulaire extérieure 14 à l'intérieur de laquelle est disposée une valve prothétique amovible et remplaçable 16. According to the invention, the prosthesis comprises an outer tubular stent 14 within which is disposed a removable and replaceable prosthetic valve 16.

L'endoprothèse 14 est constituée, par exemple, d'un treillis tubulaire 14A noyé dans un film 14B extensible et étanche aux liquides tel qu'un élastomère. The stent 14 is formed, for example, a 14A tubular mesh embedded in a stretchable, waterproof film 14B liquid such as an elastomer. Le treillis 14A est constitué d'acier inoxydable ayant des propriétés de ressort, de sorte que l'endoprothèse 14 est auto-expansible. 14A mesh is made of stainless steel having spring properties, so that the stent 14 is self-expanding. Une telle 10 endoprothèse est couramment désignée par le terme anglais "stent". 10 Such a stent is commonly referred to by the term "stent".

Comme connue en soi, l'endoprothèse 14 est susceptible de se déformer spontanément d'un état comprimé, dans lequel elle présente un petit diamètre à un état dilaté, dans lequel elle présente un diamètre supérieur, cet état dilaté constituant son état de repos. As known per se, the stent 14 is capable of spontaneously deform from a compressed state, wherein it has a small diameter to an expanded condition, wherein it presents a larger diameter, this expanded state being its rest state.

Dans son état implanté, tel qu'illustré sur les figures, l'endoprothèse 14 s'applique, du fait de son élasticité, contre la surface interne du conduit 12 constituant ainsi une gaine intérieure au conduit. In its implanted state, as shown in the Figures, the stent 14 applies, due to its elasticity against the inner surface of conduit 12 and constituting an inner sheath to the conduit.

La valve prothétique interchangeable 16 comporte une armature porteuse 22 et un obturateur déformable 24 supporté par l'armature 22 et soli20 daire de celle-ci. The interchangeable prosthetic valve 16 comprises a support structure 22 and a deformable shutter 24 supported by the frame 22 and soli20 dary thereof. La valve est généralement d'axe XX. The valve is usually of axis XX.

L'armature porteuse comporte des moyens intégrés pour sa compression centripète. The carrier frame has integrated means for the centripetal compression. Plus précisément, l'armature 22 est constituée de deux branches 26A, 26B reliées l'une à l'autre à une première extrémité 28 pour former une pince élastiquement déformable entre une position déployée 25 dans laquelle les deux branches sont écartées de l'axe médian XX et une position repliée dans laquelle les deux branches sont rapprochées de l'axe médian XX. More specifically, the armature 22 consists of two branches 26A, 26B connected to each other at one end 28 to form an elastically deformable clip 25 between an extended position in which the two branches are spaced apart from the axis median XX and a folded position wherein the two branches are closer to the central axis XX.

Les deux branches 26A, 26B sont généralement symétriques par rapport à l'axe médian XX confondu avec l'axe du conduit, après implanta30 tion. The two branches 26A, 26B are generally symmetrical relative to the median axis X coinciding with the axis of the duct, after implanta30 tion.

La longueur des branches mesurée suivant l'axe XX est comprise entre 2 et 4 cm et est de préférence égale à 3 cm. Branch length measured along the axis X is between 2 and 4 cm and is preferably equal to 3 cm.

Chaque branche 26A, 26B comporte un tronçon d'appui 30A, 30B sur l'endoprothèse 14. Chaque tronçon d'appui est constitué d'un segment rectiligne s'étendant généralement suivant une génératrice de l'endoprothèse 14, lorsque l'armature est déployée. Each leg 26A, 26B comprises a supporting portion 30A, 30B on the stent 14. Each bearing portion is constituted by a straight segment extending generally along a generatrix of the stent 14 when the armature is deployed.

La longueur des tronçons d'appui est de 1 à 3 cm et de préférence d'environ 2 cm. The length of the bearing sections is 1 to 3 cm and preferably approximately 2 cm.

Ces tronçons d'appui 30A, 30B sont prolongés par des tronçons de manoeuvre 32A, 32B convergents l'un vers l'autre jusqu'au point de liaison 28. Les tronçons sont généralement inclinés par rapport à l'axe médian XX. These support sections 30A, 30B are extended by actuating sections 32A, 32B converge towards one another to the point of connection 28. The sections are generally inclined with respect to the central axis XX. 10 Les tronçons de manoeuvre 32A, 32B sont généralement courbes et présentent un centre courbure disposé hors de l'espace délimité entre les deux branches. 10 operating sections 32A, 32B are generally curved and have a curvature center positioned outside the space delimited between the two branches. Ainsi, les tronçons 32A, 32B sont bombés vers l'intérieur de la pince. Thus, the sections 32A, 32B are curved inwardly of the clamp.

L'obturateur 24 est constitué d'une poche souple 34 présentant une 15 ouverture 35 généralement circulaire d'axe XX, lorsque la poche est gonflée. The shutter 24 consists of a flexible pouch 34 having a generally circular opening 35 15 of axis XX, when the bag is inflated.

La poche 34 présente une jupe généralement cylindrique 36 prolongée par un fond 38 généralement hémisphérique. The pocket 34 has a generally cylindrical skirt 36 extended by a generally hemispherical bottom 38. Le fond 38 présente un orifice 40 de petit diamètre par rapport à la section de l'ouverture 35. The bottom 38 has a small diameter orifice 40 relative to the section of the opening 35.

La poche 34 est réalisée par exemple en polyuréthanne ou en matériel biologique (péricarde bovin). The pouch 34 is made for example of polyurethane or biological material (bovine pericardium).

La hauteur de la jupe 36 est par exemple égale à 4 ou 5 mm et est de préférence compris entre 2 et 5 mm. The height of the skirt 36 is for example equal to 4 or 5 mm and is preferably between 2 and 5 mm.

La poche 34 est reliée aux tronçons d'appui 30A, 30B par collage ou 25 tout autre moyen adapté suivant la longueur des génératrices de la jupe 36. The pocket 34 is connected to the support sections 30A, 30B by bonding or any other suitable means 25 along the length of the generatrices of the skirt 36.

Avantageusement, la poche 34 est liée aux deux branches 26A, 26B, de sorte que les deux demi-jupes délimitées de part et d'autre soient de longueurs légèrement différentes. Advantageously, the pocket 34 is connected to the two branches 26A, 26B, so that both share delimited half-skirts and the other are of slightly different lengths.

Enfin, le fond 38 est relié par des fils 42 aux tronçons de manoeuvre 30 32A, 32B des deux branches de l'armature de porteuse afin d'éviter un retournement de la poche par invagination. Finally, the bottom 38 is connected by son 42 to the operating sections 30, 32A, 32B of the two limbs of the carrier frame in order to avoid a reversal of the pouch by invagination.

Une telle valve prothétique implantée fonctionne de la manière suivante. Such an implanted prosthetic valve operates in the following manner. A à l'issue d'une expulsion du ventricule droit, lorsque celui-ci augmente de volume, le flux sanguin est aspiré dans le conduit 12 de l'extrémité 12B vers l'extrémité 12A. A at the end of expulsion of the right ventricle, when the latter increases in volume, blood flow is sucked into the duct 12 of the end 12B toward end 12A. Le sang emplit alors la poche 34, laquelle s'applique sur l'endoprothèse 14, comme illustré sur les figures 1 et 2, obturant ainsi de manière sensiblement étanche le conduit organique 12. Blood then fills the bag 34, which is applied to the stent 14, as illustrated in Figures 1 and 2, thereby closing substantially seal the organic conduit 12.

Lors de la circulation du sang, l'orifice 40 permet un écoulement constant d'un faible flux sanguin au travers de la poche 34, évitant la formation d'un caillot au fond de la poche 34 du fait d'une éventuelle stagnation de sang. When the blood flow, the orifice 40 allows a constant flow of low blood flow through the pocket 34, avoiding the formation of a clot at the bottom of the pocket 34 due to a possible stagnation of blood . En revanche, lors d'une contraction du ventricule droit, le sang circule 10 de l'extrémité 12A vers l'extrémité 12B. However, during a contraction of the right ventricle, blood flows 10 from the end 12A to the end 12B. Comme illustré aux figures 3 et 4, la poche 34 est sollicitée extérieurement depuis le fond 38 provoquant un aplatissement de cette poche. As illustrated in Figures 3 and 4, the pocket 34 is biased outwardly from the base 38 causing a flattening of this pocket. Ainsi, le flux sanguin est libre de circuler dans le conduit de part et d'autre de la poche. Thus, blood flow is free to flow in the conduit on either side of the pocket.

La différence de longueur entre les deux parties de la jupe disposées 15 de part et d'autre des deux bras évite que, dans la position des figures 3 et 4, les deux demi-jupes viennent s'appliquer l'une contre l'autre et viennent ensemble se plaquer définitivement contre l'endoprothèse 14. The difference in length between the two portions of the skirt part 15 disposed on the other of the two arms avoids that in the position of Figures 3 and 4, the two half-skirts are applied against one another come together and be pressed permanently against the stent 14.

Après implantation d'une telle prothèse, la paroi du conduit organique adhère progressivement avec l'endoprothèse 14. En revanche, l'endopro20 thèse 14 constitue une gaine formant écran entre la valve prothétique 16 et la paroi du conduit organique 12 évitant ainsi une agglomération du conduit organique et de la valve prothétique. After implantation of such a prosthesis, the wall of the conduit organic progressively adheres the stent 14. However, the endopro20 thesis 14 constitutes a shield sheath between the prosthetic valve 16 and the wall of organic conduit 12 thereby avoiding agglomeration conduit organic and the prosthetic valve. Ainsi, le retrait de la valve prothétique est possible. Thus, removal of the prosthetic valve is possible.

En particulier, la valve prothétique étant équipée de moyens de com25 pression centripète, celle-ci peut être ramenée dans son état comprimé et évacuée de manière transluminale. In particular, the prosthetic valve being equipped with means of COM25 centripetal pressure, it may be reduced in its compressed state and discharged from transluminal manner.

Plus précisément, et comme illustré sur la figure 5, pour le retrait de la valve prothétique, un cathéter 60 est introduit au travers de l'oreillette droite et du ventricule droit et est disposé en regard de l'extrémité 28 de l'armature 30 porteuse en forme de pince. More specifically, and as illustrated in Figure 5, for the removal of the prosthetic valve, a catheter 60 is introduced through the right atrium and the right ventricle and is disposed opposite the end 28 of the armature 30 carrier shaped clamp.

Un outil de traction 62 est acheminé au travers du cathéter 60. Cet outil comporte, à son extrémité, une mâchoire 64 permettant de saisir l'extrémité 28 de la pince. A pulling tool 62 is routed through the catheter 60. This tool comprises, at its end, a jaw 64 for gripping the end 28 of the clamp. Alors que l'extrémité ouverte, notée 66, du cathéter est en contact avec les tronçons de manoeuvre 32A, 32B, l'armature porteuse est progressivement tirée à l'intérieur du conduit 60. Par effet de came, les deux bras 26A, 26B sont resserrés l'un vers l'autre et la valve prothétique est progressivement amenée dans son état resserré et introduite 5 dans le cathéter 60, comme illustré sur la figure 6. Le cathéter 60 renfermant la valve prothétique est alors extrait du corps humain. While the open end, denoted 66, of the catheter is in contact with the operating sections 32A, 32B, the carrier frame is progressively drawn into the conduit 60. camming, the two arms 26A, 26B are tightened towards each other and the prosthetic valve is gradually moved into its collapsed condition and inserted 5 into the catheter 60, as illustrated in Figure 6. the catheter 60 containing the prosthetic valve is then extracted from the human body.

Un nouveau cathéter contenant une nouvelle valve prothétique est alors introduit dans le corps humain et la valve est larguée en procédant aux opérations exposées précédemment, en sens inverse. A new catheter containing a new prosthetic valve is then introduced into the human body and the valve is released by performing the operations explained above, in the opposite direction. En particulier, la 10 valve prothétique est progressivement extraite du cathéter 60 en étant poussée depuis son extrémité 28. Sous l'action élastique de la pince constituant l'armature porteuse 22, la valve prothétique se déploie et s'appuie radialement contre l'endoprothèse tubulaire 14. In particular, the prosthetic valve 10 is gradually extracted from the catheter 60 by being pushed from its end 28. Under the resilient action of the forceps constituting the carrier frame 22, the prosthetic valve is deployed and bears radially against the stent tubular 14.

Sur la figure 7 est illustrée une variante de réalisation d'une valve pro15 thétique selon l'invention. In Figure 7 is illustrated an alternative embodiment of a PRO15 thetic valve according to the invention.

Dans-ce mode de réalisation, l'armature porteuse notée 122 est constituée d'une pince comportant trois bras 126A, 126B, 126C ayant chacun la forme d'un bras 26A, 26B. In this embodiment, the rated carrier frame 122 comprises a clamp having three arms 126A, 126B, 126C each having the form of an arm 26A, 26B. Ces bras sont régulièrement répartis autour de l'axe longitudinal XX de la prothèse. These arms are regularly distributed around the longitudinal axis XX of the prosthesis.

Comme précédemment, ces bras sont propres à s'appliquer sur l'endoprothèse 14 et sont reliés ensemble à une extrémité de liaison 128. As before, these arms are adapted to be applied to the stent 14 and are connected together at a connecting end 128.

Suivant encore une autre variante illustrée sur la figure 8, la valve prothétique 216 comprend un treillis métallique tubulaire élastique 222 et une poche 224 formant obturateur identique à celui de la poche 34. La po25 che 224 est liée suivant sur périphérie ouverte en deux ou trois points sur le treillis tubulaire. According to another variant illustrated in Figure 8, the prosthetic valve 216 comprises a resilient tubular metal mesh 222 and a pocket 224 forming shutter identical to that of the pocket 34. The PO25 che 224 is linked next on periphery open in two or three points on the tubular mesh.

La valve prothétique comporte en outre un brin de constriction 226 engagé à demeure dans les différentes boucles délimitées par l'endoprothèse 216 suivant une circonférence de celle-ci. The prosthetic valve further comprises a constriction of strand 226 engaged permanently in the different loops defined by the stent 216 along a circumference thereof. Le brin est refermé 30 en boucle. The strand 30 is closed in a loop. Il est suffisamment long pour permettre l'expansion de la valve. It is sufficiently long to allow for expansion of the valve.

Ce brin forme des moyens de compression centripète. This stranded form of centripetal compression means. La traction sur ce brin, par exemple, à l'aide d'une pince, provoque une constriction de l'armature porteuse 222 permettant un retrait de la valve prothétique après engagement de celle-ci dans un cathéter. The traction on this strand, e.g., using forceps, causes a constriction of the supporting frame 222 allowing removal of the prosthetic valve after engagement thereof into a catheter.

Claims (12)

REVENDICATIONS
1.- Valve prothétique (16; 116; 216) comportant, d'une part, une armature porteuse (22; 122; 222) déformable radialement de manière élastique par rapport à un axe principal (XX) entre une position déployée d'im5 plantation et une position repliée de mise en place, laquelle armature porteuse (22; 122; 222) est sollicitée élastiquement vers sa position déployée et, d'autre part, un obturateur (24; 124; 224) souple lié à l'armature porteuse (22; 122; 222) et déformable entre une position d'obstruction dans laquelle il est étendu transversalement et une position de libération dans 10 laquelle il est contracté transversalement sous l'action du flux circulant au travers de l'armature porteuse (22; 122; 222), caractérisée en ce qu'elle comporte des moyens intégrés (26A, 26B, 122, 126A, 126B, 126C; 226) de compression centripète de ladite armature porteuse (22; 122; 222) vers sa position repliée à l'encontre de l'action élastique. 1.- prosthetic valve (16; 116; 216) comprising, firstly, a support structure (22; 122; 222) radially elastically deformable with respect to a main axis (XX) between a deployed position IM5 planting and a folded position of installation, which support structure (22; 122; 222) is resiliently biased towards its deployed position and on the other hand, a shutter (24; 124; 224) flexible linked to the supporting frame (22; 122; 222) and deformable between an obstruction position in which it is stretched transversely and a release position in 10 which it is contracted transversely under the action of the flow circulating through the support frame (22; 122; 222), characterized in that it comprises integrated means (26A, 26B, 122, 126A, 126B, 126C; 226) of centripetal compression of said supporting frame (22; 122; 222) towards its folded position to the against the elastic action.
2.- Valve prothétique selon l'une quelconque des revendications précédentes, caractérisée en ce que ledit obturateur--comporte une poche (24 124; 224). 2. A prosthetic valve according to any one of the preceding claims, characterized in that said shutter - has a pocket (24 124; 224).
3.- Valve prothétique selon la revendication 2, caractérisée en ce que la poche (24; 124; 224) comporte un orifice d'évacuation (40) ménagé dans 20 son fond (38). 3. A prosthetic valve according to claim 2, characterized in that the pocket (24; 124; 224) includes a discharge port (40) formed in its bottom 20 (38).
4.- Valve prothétique selon la revendication 2 ou 3, caractérisée en ce que le fond (38) de la poche (24; 124; 224) est généralement hémisphérique. 4. A prosthetic valve according to claim 2 or 3, characterized in that the bottom (38) of the pocket (24; 124; 224) is generally hemispherical.
5.- Valve prothétique selon l'une quelconque des revendications pré25 cédentes, caractérisée en ce que les moyens de compression centripète comportent une pince comprenant au moins deux branches (26A, 26B; 126A, 126B, 126C) reliées ensemble dans une région commune (28; 128), chaque branche étant reliée audit obturateur (24, 124) suivant une plage de liaison (30A, 30B), les branches (26A, 26B; 126A, 126B, 126C) présentant 30 chacune une plage d'actionnement (32A, 32B) propre à coopérer avec un organe complémentaire de serrage pour la compression centripète de l'armature porteuse vers sa position repliée. 5. A prosthetic valve according to any one of claims pré25 cédentes, characterized in that the centripetal compression means comprise a clamp comprising at least two branches (26A, 26B; 126A, 126B, 126C) connected together in a common region ( 28; 128), each branch being connected to said shutter (24, 124) along a bonding pad (30A, 30B), the arms (26A, 26B; 126A, 126B, 126C) having an actuator 30 each pad (32A , 32B) adapted to cooperate with a complementary clamping member for the centripetal compression of the supporting frame towards its folded position.
6.- Valve prothétique selon la revendication 5, caractérisée en ce que les branches (26A, 26B; 126A, 126B, 126C) sont soudées par une soudure dans leur région commune (28, 128) et l'armature porteuse (22, 122) présente une forme de fourche, chaque branche étant déformable élastique5 ment, les plages d'actionnement (32A, 32B) et les plages (30A, 30B) de liaison des branches à l'obturateur étant situées du même côté de la soudure. 6. A prosthetic valve according to claim 5, characterized in that the legs (26A, 26B; 126A, 126B, 126C) are welded by a weld in the joint region (28, 128) and the carrier frame (22, 122 ) has a fork shape, each branch being deformable élastique5 ment, the actuating pads (32A, 32B) and the tracks (30A, 30B) connecting the branches to the shutter being located on the same side of the weld.
7.- Valve prothétique selon l'une quelconque des revendications 5 et 6, caractérisée en ce que l'armature porteuse (22) comporte deux branches (26A, 26B). 7. A prosthetic valve according to any one of claims 5 and 6, characterized in that the carrier frame (22) comprises two branches (26A, 26B).
8.- Valve prothétique selon l'une quelconque des revendications 5 et 6, caractérisée en ce que l'armature porteuse (122) comporte trois branches (126A, 126B, 126C). 8. A prosthetic valve according to any one of claims 5 and 6, characterized in that the carrier frame (122) comprises three branches (126A, 126B, 126C).
9.- Valve prothétique selon l'une quelconque des revendications 2 à 4 et l'une quelconque des revendications 5 à 8, caractérisée en ce qu'elle 15 comporte des brins (42) reliant le fond (40) de la poche à chaque branche (26A, 26B; 126A, 126B, 126C). 9. A prosthetic valve according to any one of claims 2 to 4 and any one of claims 5 to 8, characterized in that it comprises 15 strands (42) connecting the bottom (40) of the pocket each branch (26A, 26B; 126A, 126B, 126C).
10.- Valve prothétique selon l'une quelconque des revendications 1 à 4, caractérisée en ce que l'armature porteuse (222) comporte un treillis métallique élastique (222) et lesdits moyens de compression centripète 20 comportent un brin de constriction (226) engagé autour dudit treillis métallique élastique (222). 10. A prosthetic valve according to any one of claims 1 to 4, characterized in that the carrier frame (222) comprises a resilient wire mesh (222) and said centripetal compression means 20 comprise a constriction strand (226) engaged around said elastic wire mesh (222).
11.- Prothèse comportant une endoprothèse tubulaire (14) et une valve prothétique (16; 116; 216) selon l'une quelconque des revendications précédentes, propre à être implantée dans ladite endoprothèse tubulaire (14). 11. A prosthesis comprising a tubular stent (14) and a prosthetic valve (16; 116; 216) according to any preceding claim, adapted to be implanted in said tubular endoprosthesis (14).
12.- Prothèse comportant une endoprothèse tubulaire (14) et une valve prothétique (16; 116; 216) selon l'une quelconque des revendications 1 à 10 disposée dans ladite endoprothèse tubulaire (14). 12. A prosthesis comprising a tubular stent (14) and a prosthetic valve (16; 116; 216) according to any one of claims 1 to 10 disposed within said tubular stent (14).
FR0214986A 2002-11-28 2002-11-28 interchangeable prosthetic valve Active FR2847800B1 (en)

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