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
branches
valve according
carrier frame
pocket
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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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WL Gore and Associates Inc
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Laboratoires Perouse SAS
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Priority to FR0214986A priority Critical patent/FR2847800B1/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart 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; Valves implantable in the body
    • A61F2/2412—Heart 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; Valves implantable in the body with soft flexible valve members, e.g. tissue valves shaped like natural valves
    • A61F2/2418—Scaffolds therefor, e.g. support stents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063—Three-dimensional shapes
    • A61F2230/0073—Quadric-shaped
    • A61F2230/008—Quadric-shaped paraboloidal
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional 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

ii

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. 10 Le coeur comporte deux oreillettes et deux ventricules qui sont séparés par des valves. Des valves sont en outre présentes en sortie du ventricule droit (valve pulmonaire) et du ventricule gauche (valve aortique).  The present invention relates to an interchangeable prosthetic valve, of the type comprising, on the one hand, a carrier frame deformable radially elastically with respect to a main axis between an extended position of implantation and a folded position of establishment, la5 which carrier frame is biased elastically towards its deployed position and, secondly, a flexible shutter connected to the carrier frame and deformable between an obstruction position in which it is extended transversely and a release position in which it is contracted transversely under the action of the flow flowing through the carrier frame. The heart has two atria and two ventricles that are separated by valves. Valves are also present at the outlet of the right ventricle (pulmonary valve) and the 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 provide unambiguous flow of blood, avoiding blood reflux after ventricular contraction.

Des maladies affectent les 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.  Diseases affect the valves. In particular, they may suffer from poor opening, thus reducing blood flow, or being only partially sealed, thus allowing reflux or regurgitation to the ventricle having expelled blood flow.

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 dilation of the ventricle which ultimately produces heart failure.

Il est connu de traiter ce type de maladie de manière chirurgicale, en remplaçant la valve malade. 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.  It is known to treat this type of disease surgically, replacing the sick valve. The diseased valves, and in particular the pulmonary valve at the outlet of the right ventricle, are replaced by a valve taken from a deceased subject, or by a bioprosthesis constituted by a metal armature and a shutter made from a tissue of animal origin.

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

Des valves prothétiques sont également connues. Celles-ci sont constituées d'une armature métallique supportant un obturateur en polymère. De telles valves sont décrites, notamment dans les documents WO30 01/54625 et WO-01/28459.  Prosthetic valves are also known. These consist of a metal frame supporting a polymer shutter. Such valves are described, in particular in the 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. L'armature élastiquement déformable s'applique contre la paroi intérieure d'un conduit organique, notamment l'artère pulmonaire issue du ventricule gauche.  In these prostheses, the armature is elastically little deformable and the shutter consists of a pocket. The elastically deformable frame is applied against the inner wall of an organic duct, in particular the left ventricular pulmonary artery.

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. Une nouvelle prothèse doit alors être mise en place.  After several years of implantation of such a prosthesis, it is found that the prosthesis is degraded and no longer functions effectively. A new prosthesis must then be put 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 removal of the old prosthesis can not be carried out endoluminally, in particular because the carrying frame of the prosthesis is fixed with the cardiac wall, prohibiting their disengagement without heavy surgery providing for valvular replacement.

L'invention a pour but de proposer une valve prothétique pouvant être remplacée sans difficulté excessive, et sans nécessiter une intervention chirurgicale lourde.  The object of the invention is to propose a prosthetic valve that can be replaced without undue difficulty and without requiring a heavy surgical procedure.

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.  For this purpose, the subject of the invention is an interchangeable prosthetic valve, of the aforementioned type, characterized in that it comprises integrated means of centripetal compression of said carrying frame towards its folded position against the elastic action. .

Suivant des modes particuliers de réalisation, la valve prothétique comporte l'une ou plusieurs des caractéristiques suivantes 20 - ledit obturateur comporte une poche; - la poche comporte un orifice d'évacuation ménagé dans son fond - le fond de la poche est généralement hémisphérique; - 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; - 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; l'armature porteus comporte deux branches; - l'armature porteuse comporte trois branches; - elle comporte des brins reliant le fond de la poche à chaque branche; 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.  According to particular embodiments, the prosthetic valve comprises one or more of the following features: said closure comprises a pocket; - the pocket has a discharge hole in its bottom - the bottom of the pocket is generally hemispherical; - The centripetal compression means comprise a clamp comprising at least two branches connected together in a com25 mune region, each branch being connected to said shutter along a bonding range, the branches each having a specific operating range to cooperate with a complementary member clamping device for centripetal compression of the carrier frame to its folded position; - 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 connecting ranges of branches to the shutter being located the same side of the weld; the porteus armature has two branches; the carrying frame comprises three branches; - It has strands connecting the bottom of the pocket to each branch; and the carrier frame comprises an elastic metal mesh and said centripetal compression means comprise a constriction strand engaged around said elastic metal 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 stent 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. intérieure de celle-ci.  It finally relates to a prosthesis implanted in a tubular conduit and having a stent disposed against the inner surface of an organic conduit and a prosthetic valve disposed in the stent and applied against the surface. inside of it.

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; - 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; - 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.  The invention will be better understood on reading the description which will follow, given solely by way of example and with reference to the drawings, in which: FIG. 1 is a longitudinal sectional view of a prosthesis; implanted in an organic conduit having a prosthetic valve in its closed state; FIG. 2 is a sectional view of the prosthesis of FIG. 1 taken along the line III-1; FIGS. 3 and 4 are views identical to FIGS. 1 and 2, the prosthetic valve being in its conducting state; FIGS. 5 and 6 are views identical to that of FIG. 1 illustrating the successive stages of removal of a prosthetic valve according to the invention and FIG. 7 is a view identical to that of FIG. variant 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.  FIG. 8 is a view identical to that of FIG. 1 of another embodiment 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.  FIG. 1 shows a prosthesis according to the invention assumed to be implanted in a pulmonary artery 12 connected at its end 12A to the outlet of the right ventricle of the heart, in particular from 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 inside 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. Le treillis 14A est constitué d'acier inoxydable ayant des propriétés de ressort, de sorte que l'endoprothèse 14 est auto-expansible. Une telle 10 endoprothèse est couramment désignée par le terme anglais "stent".  The stent 14 consists, for example, of a tubular lattice 14A embedded in an expandable and liquid-tight 14B film such as an elastomer. The lattice 14A is made of stainless steel having spring properties, so that the stent 14 is self-expanding. Such an endoprosthesis is commonly referred to as "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 deforming a compressed state, in which it has a small diameter in an expanded state, in which it has a larger diameter, this expanded state constituting its state of rest.

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 illustrated in the figures, the endoprosthesis 14 is applied, because of its elasticity, against the inner surface of the conduit 12 thus constituting an inner sheath of 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. La valve est généralement d'axe X-X.  The interchangeable prosthetic valve 16 comprises a carrier frame 22 and a deformable shutter 24 supported by the frame 22 and solid of it. The valve is usually X-X axis.

L'armature porteuse comporte des moyens intégrés pour sa compression centripète. 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 X-X et une position repliée dans laquelle les deux branches sont rapprochées de l'axe médian X-X.  The carrying frame has integrated means for its centripetal compression. More specifically, the armature 22 consists of two branches 26A, 26B connected to one another at a first end 28 to form an elastically deformable clamp between an extended position 25 in which the two branches are spaced from the axis median XX and a folded position in which the two branches are close to the median axis XX.

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

La longueur des branches mesurée suivant l'axe X-X est comprise entre 2 et 4 cm et est de préférence égale à 3 cm.  The length of the branches measured along the X-X axis 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 branch 26A, 26B includes a support section 30A, 30B on the stent 14. Each support section consists of a rectilinear segment extending generally along a generatrix of the stent 14, when the frame 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 support sections is 1 to 3 cm and preferably about 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 X-X. 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. Ainsi, les tronçons 32A, 32B sont bombés vers l'intérieur de la pince.  These bearing sections 30A, 30B are extended by maneuvering sections 32A, 32B converging towards each other as far as the point of connection 28. The sections are generally inclined with respect to the median axis X-X. The maneuvering sections 32A, 32B are generally curved and have a center of curvature disposed outside the space delimited between the two branches. Thus, the sections 32A, 32B are bulged towards the inside of the clamp.

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

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

La poche 34 est réalisée par exemple en polyuréthanne ou en matériel biologique (péricarde bovin).  The pocket 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 bearing sections 30A, 30B by gluing or any other means adapted to 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 the two half-skirts delimited on either side 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 wires 42 to the operating sections 32A, 32B of the two branches of the carrier frame in order to prevent a reversal of the pocket by invagination.

Une telle valve prothétique implantée fonctionne de la manière suivante. 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. 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.  Such an implanted prosthetic valve functions as follows. At the end of an expulsion of the right ventricle, when it increases in volume, the blood flow is drawn into the conduit 12 of the end 12B to the end 12A. The blood then fills the pocket 34, which is applied to the stent 14, as illustrated in FIGS. 1 and 2, thus sealing the organic pipe 12 in a substantially watertight manner.

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. En revanche, lors d'une contraction du ventricule droit, le sang circule 10 de l'extrémité 12A vers l'extrémité 12B. Comme illustré aux figures 3 et 4, la poche 34 est sollicitée extérieurement depuis le fond 38 provoquant un aplatissement de cette poche. Ainsi, le flux sanguin est libre de circuler dans le conduit de part et d'autre de la poche.  During the blood circulation, the orifice 40 allows a constant flow of a weak blood flow through the pocket 34, avoiding the formation of a clot at the bottom of the pocket 34 due to possible stagnation of blood . On the other hand, upon contraction of the right ventricle, blood flows from end 12A to end 12B. As illustrated in Figures 3 and 4, the pocket 34 is biased externally from the bottom 38 causing a flattening of this pocket. Thus, the blood flow is free to flow in the conduit on both sides 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 parts of the skirt arranged on either side of the two arms prevents that, in the position of FIGS. 3 and 4, the two half-skirts are applied against each other and come together to flatten themselves 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. Ainsi, le retrait de la valve prothétique est possible.  After implantation of such a prosthesis, the wall of the organic duct gradually adheres with the stent 14. In contrast, the endoprosthesis 14 constitutes a screen sheath between the prosthetic valve 16 and the wall of the organic duct 12 thus avoiding agglomeration organic duct and prosthetic valve. 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, since the prosthetic valve is equipped with centripetal compression means, it can be brought back into its compressed state and evacuated in a 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 FIG. 5, for the removal of the prosthetic valve, a catheter 60 is introduced through the right atrium and the right ventricle and is arranged facing 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. 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.  A pulling tool 62 is conveyed through the catheter 60. This tool comprises, at its end, a jaw 64 for grasping the end 28 of the clamp. While the open end, denoted 66, of the catheter is in contact with the operating sections 32A, 32B, the carrying frame is progressively pulled inside the conduit 60. By camming, the two arms 26A, 26B are tightened towards each other and the prosthetic valve is gradually brought into its tightened state and introduced into the catheter 60, as illustrated in Figure 6. The catheter 60 enclosing 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. 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.  A new catheter containing a new prosthetic valve is then introduced into the human body and the valve is released by carrying out the above-mentioned operations in the opposite direction. In particular, the prosthetic valve is progressively extracted from the catheter 60 by being pushed from its end 28. Under the elastic action of the clamp constituting the carrying frame 22, the prosthetic valve unfolds and rests 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 pro-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. Ces bras sont régulièrement répartis autour de l'axe longitudinal X-X de la prothèse.  In this embodiment, the carrier frame denoted 122 consists of a clamp comprising three arms 126A, 126B, 126C each having the shape of an arm 26A, 26B. These arms are regularly distributed around the longitudinal axis X-X 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 yet another variant illustrated in FIG. 8, the prosthetic valve 216 comprises an elastic tubular metal mesh 222 and a pouch 224 forming a shutter identical to that of the pocket 34. The pouch 224 is bonded following on an open periphery in two or three points on the tubular lattice.

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. Le brin est refermé 30 en boucle. Il est suffisamment long pour permettre l'expansion de la valve.  The prosthetic valve further comprises a constriction strand 226 permanently engaged in the various loops delimited by the stent 216 along a circumference thereof. The strand is closed in a loop. It is long enough to allow expansion of the valve.

Ce brin forme des moyens de compression centripète. 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.  This strand forms centripetal compression means. Traction on this strand, for example, using a clamp, causes a constriction of the carrier frame 222 allowing removal of the prosthetic valve after engagement thereof in 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 (X-X) 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, on the one hand, a carrier frame (22; 122; 222) deformable radially elastically with respect to a main axis (XX) between an extended position of im5 planting and a folded positioning position, which carrier frame (22; 122; 222) is biased elastically towards its deployed position and, secondly, a flexible shutter (24; 124; 224) related to the carrying frame (22; 122; 222) and deformable between an obstruction position in which it is extended transversely and a release position in which it is contracted transversely under the action of the flow flowing through the carrier frame (22; 122, 222), characterized in that it comprises integrated means (26A, 26B, 122, 126A, 126B, 126C; 226) of centripetal compression of said carrier (22; 122; 222) towards its folded position 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.- prosthetic valve according to any one of the preceding claims, characterized in that said shutter - comprises 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. The prosthetic valve according to claim 2, characterized in that the pocket (24; 124; 224) has an outlet (40) in its bottom (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.- 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.- prosthetic valve according to any one of the preceding claims, 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 connecting range (30A, 30B), the legs (26A, 26B; 126A, 126B, 126C) each having an actuating range (32A , 32B) adapted to cooperate with a complementary clamping member for the centripetal compression of the carrier to 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.- prosthetic valve according to claim 5, characterized in that the branches (26A, 26B; 126A, 126B, 126C) are welded by a weld in their common region (28, 128) and the carrier frame (22, 122). ) has a fork shape, each branch being elastically deformable, the actuating areas (32A, 32B) and the ranges of connection (30A, 30B) 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.- 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.- 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. The prosthetic valve according to any one of claims 2 to 4 and any one of claims 5 to 8, characterized in that it comprises strands (42) connecting the bottom (40) of the pocket to 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.- prosthetic valve according to any one of claims 1 to 4, characterized in that the carrier frame (222) comprises an elastic 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 one of the preceding claims adapted to be implanted in said tubular stent (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 in said tubular stent (14).
FR0214986A 2002-11-28 2002-11-28 INTERCHANGEABLE PROTHETIC VALVE Expired - Lifetime FR2847800B1 (en)

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