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WO2000041652A1 - Valvule prothetique implantable par catheterisme, ou chirurgicalement - Google Patents

Valvule prothetique implantable par catheterisme, ou chirurgicalement Download PDF

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Publication number
WO2000041652A1
WO2000041652A1 PCT/FR2000/000051 FR0000051W WO0041652A1 WO 2000041652 A1 WO2000041652 A1 WO 2000041652A1 FR 0000051 W FR0000051 W FR 0000051W WO 0041652 A1 WO0041652 A1 WO 0041652A1
Authority
WO
WIPO (PCT)
Prior art keywords
prosthetic valve
expandable structure
valve
valve according
stiffeners
Prior art date
Application number
PCT/FR2000/000051
Other languages
English (en)
Inventor
Brice Letac
Original Assignee
Brice Letac
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Brice Letac filed Critical Brice Letac
Priority to AU30529/00A priority Critical patent/AU3052900A/en
Publication of WO2000041652A1 publication Critical patent/WO2000041652A1/fr

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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
    • 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
    • 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
    • A61F2/2427—Devices for manipulating or deploying heart valves during implantation
    • A61F2/243—Deployment by mechanical expansion
    • A61F2/2433—Deployment by mechanical expansion using balloon catheter

Definitions

  • the present invention relates to a prosthetic valve implantable by catheter i sme, or chi rurg i cal ement.
  • a stenosis that is to say the narrowing of an organic orifice
  • Aortic stenosis is known in particular, which can result from fibrosis and calcification of the sigmoid valves, and which requires an excision of the aortic valve apparatus and its replacement by a prosthetic valve.
  • a prosthetic valve is currently implanted surgically. However, some patients cannot be operated, particularly because of their advanced age, knowing that aortic stenosis mainly affects the elderly.
  • a prosthetic valve implantable by catheter is described in document EP 0 850 607, it comprises an expandable structure and a vul val ai re structure.
  • the expandable structure consists of a lattice of metallic wires, preferably of steel, having a tubular shape whose expansion, in the radial direction under the action of a pressure, allows it to reach a predetermined diameter, which moreover corresponds to an optimal rigidity of said trellis.
  • the expandable structure is intended to be positioned at the location of the stenosed valve, and there be blocked by its expansion.
  • the valve structure is frusto-hyperbolic and made of a flexible and resistant fabric. It is secured by its end of larger diameter to the internal wall of the expandable structure, substantially in the middle region of the latter, or near one end of the latter to extend inside. More specifically, the valve structure is integral with a tubular envelope which covers the internal wall of the expandable structure and which ensures the sealing thereof.
  • valve structure can be deformed to pass al ernati ement from a closed state to an open state in the expandable structure, that is to say that its end of smaller diameter can be flared or tightened, alternately , open and let a flow pass and close the orifice to avoid regurgitation.
  • the valve structure has preformed longitudinal reinforcements.
  • the prosthetic valve In practice, after a widening of the stenosis by means of a balloon routed by arterial route, the prosthetic valve is brought by the same way to the said stenosis, then the expansion of the expandable structure is carried out by the powerful swelling d '' a balloon placed inside it. The expandable structure is thus firmly anchored, in its most rigid configuration, and the valve structure is functional 1 e.
  • this prosthetic valve has a drawback. In fact, during the inflation of the balloon, knowing that the pressure necessary for the expansion of the expandable structure is of the order of 4 bars, the valve structure is highly susceptible to being damaged by being pressed against said expandable structure, this which can result in piercing or tearing the tissue .
  • this soil i dar i sa ti one is not reliable over time, there may occur a separation due to the movement of said valve structure relative to said envelope .
  • the object of the present invention is to propose a prosthetic valve making it possible to remedy these various drawbacks, and more particularly an improvement to the prosthetic valve previously described.
  • the prosthetic valve object of the present invention comprises a rigid expandable structure and a valve structure secured to said expandable structure and capable of being deformed to change alternately from an open socket to a closed state, and it is characterized in that said valve structure is secured to one end of said expandable structure, and extends outside thereof.
  • the expandable structure comprises a lattice of metal wires having a tubular shape.
  • the expandable structure in its deployed configuration has in its median region a diameter less than that of the extreme edges.
  • the valve structure consists of a piece of frusto-hyperbolic shape, made of a flexible and resistant fabric, and is secured to the expandable structure by its end of larger diameter .
  • the expandable structure comprises an envelope which covers it internally, made of a flexible and resistant fabric, and at one end of which is secured the valve structure.
  • the valve structure has preformed stiffeners to remind el ast i quernent said green valve structure - its closed state.
  • the stiffeners of the valve structure are such that they tend to approach each other until they come into contact with each other.
  • the valve structure comprises two diametrically opposite stiffeners which tend to move away from one another.
  • the valve structure comprises stiffeners which tend to approach each other until contact.
  • FIG. 1a, 1b and 1c each show a perspective view of a first embodiment of a prosthetic valve according to the invention, during three stages of its operation.
  • Figures 2a, 2b and 2c show schematic sectional views of Figures 1a, 1b and 1c respectively, along a median longitudinal plane.
  • FIG. 3 shows a perspective view schematic of a part I the same prosthetic valve according to a first variant.
  • FIG. 4 shows a schematic perspective view of part of the prosthetic valve inertia according to a second variant.
  • FIG. 5a, 5b and 5c show perspective views of a second embodiment of a prosthetic valve according to the invention, during three stages of its operation.
  • FIGS 6a, 6b and 6c show partial views from above of Figures 5a, 5b and 5c respectively.
  • FIG. 7a and 7b show perspective views in different representations of a prosthetic valve according to the invention during its implantation.
  • FIGS. 1a, 1b, 1c, 2a, 2b and 2c show perspective views in different representations of the same prosthetic valve during its installation. If one refers to FIGS. 1a, 1b, 1c, 2a, 2b and 2c, one can see a first embodiment of a prosthetic valve 1 according to the invention, which comprises a rigid expandable structure 2 and a valve structure 3.
  • the expandable structure 2 as can only be seen in FIGS. 1a, 1b and 1c, comprises a trellis 20 of metal wires 21, shaped into a tube capable of being irreversibly deformed in the radial direction, while retaining its tubular shape ire.
  • the expandable structure 2 is in its deployed configuration, which corresponds to an optimal rigidity.
  • the metal wires 21 are crisscrossed in an arrangement making it possible to go from a compressed state to a developed state.
  • the diameter of the expandable structure 2 in the folded state is of the order of 4 to 8 mm, while in the developed state i is 20 to 23 mm depending on the size of the patient.
  • the internal wall of the expandable structure 2 here is covered with a tubular envelope 4 which is secured to it and which carries out the sealing.
  • the envelope 4 is able to follow the expansion movement of the expandable structure 2, it can for this purpose be for example pleated when the expandable structure is in its folded state.
  • the valve structure 3 consists of a tissue
  • the fabric 30 can be made of plastic material such as polyurethane treated to avoid calcification, or pericardium also treated against calcification, or any other equivalent material.
  • valve structure 3 is made of polyurethane, it can advantageously be made in one piece with the casing 4.
  • the fabric 30 is armed with stiffeners 33 which extend from the base 31 to the end 32. They are arranged, as shown, according to curved generatrices of the truncated cone, but they can however be arranged hel i coidally.
  • the stiffeners 33 may consist of beads of material from which the valve structure is made, or of metal wires such as steel, and are preferably 3 or 4 in this configuration.
  • the stiffeners 33 are originally formed to force the valve structure 3 to close as shown in Figures 1c and 2c, that is to say that they are curved in the direction of the main e of the prosthetic valve 1, and tend to approach each other. Their riyidity is however limited to allow the opening of the valve structure 3 by a flow as is shown in Figures 1a and 2a, Figures 1b and 2b representing an intermediate step.
  • the stiffeners 33 may be integral with the expandable structure 2 and come into external support against the valve structure ⁇ to which they are sol idarized by suture when the latter is performed by means of pericardium. In the case of a valve structure made of polyurethane, the stiffeners 33 can advantageously be embedded therein.
  • valve structure 3 is disposed on the side of the aorta, so that during the ventricular systole the high pressure of the systolic blood flow generated by the contraction ven tr i cul ai re opens the valve structure 3, while during the diastole the stiffeners 33 and the inversion of the blood pressure close it.
  • valve structure 3 allows the obturation to be achieved not only at its end 32, but, because the ends of stiffeners 33 come into tangent contact, on a portion representing substantially a third of its height, so as to obtain a perfect seal thus avoiding regurgitation.
  • the expandable structure 3 can, during its expansion, take a concave forine so as to make appear in its median region a narrowing 34 capable of favoring fate centering at the place of its establishment.
  • FIG. 4 it can be seen that in another variant, the centering of the expandable structure 3 is facilitated by the presence of a constriction
  • This prosthetic valve 1 ′ also comprises an expandable structure 2 covered internally with an envelope 4 and a valve structure 3 of frustoconical shape.
  • the valve structure 3 is equipped with six regularly spaced stiffeners, two diametrically opposed stiffeners 36, and four stiffeners 37.
  • the stiffeners 36 are shaped to move away from one another, while the stiffeners 37 are shaped to get closer to each other. From the production point of view, for example, the stiffeners 36 are arranged inside the valve structure 3 while the aiders 37 are placed outside.
  • valve structure 3 opens under the thrust F of the blood flow.
  • FIGS. 5c and 6c which represent a diastole
  • the valve structure 3 closes like two sheets placed side by side, in the sense that the stiffeners 36 pull the tissue 30 outwards while the stiffeners 37 join two by two, which causes, in association with the aortic blood pressure P, the flattening of the valve structure 3.
  • valve structure 3 flattened, stretched by ⁇ the stiffeners 36 and attached to itself over a large area, does not have a pis likely to create leaks engeridrant regurgitation as in the first embodiment. It will be noted that according to a variant, not shown, the valve structure 3 may only comprise the two stiffeners 36. In this cr, during a diastole, the stiffeners. 36 moving away from each other tighten the valve structure 2, and the aortic blood pressure P which completes the flattening and closing. Referring now to Figures 7a and 7b, we can see a prosthetic valve 1 during implantation, knowing that the implantation of a prosthetic valve 1 'is performed in the same way.
  • the expandable structure 2 is folded, and is mounted on a set of elements intended to achieve its expansion.
  • This assembly comprises a probe 5 on which is threaded a rod 50 comprising not far from its end a balloon 51 which takes place inside the expandable structure 2, against the envelope 4, and so that it does not overflow above the 1 igneous junction of the valve structure 3 to the envelope 4.
  • the rod 50 has two conduits, not visible, in one of which passes the probe 5, while the other opens into the balloon 51 to allow it to swell.
  • FIGS. 8a and 8b it can be seen that the inflation of the balloon 51 allows the expansion of the expandable structure 2.
  • the balloon 51 is in contact only with the envelope 4 so that the valve structure 3 does not risk being damaged by the swelling.
  • the prosthetic valve 1 has many advantages compared to existing prosthetic valves and in particular that described in document EP 0 850 607.
  • the prosthetic valve according to the invention is intended to be implanted by catheterization as has been seen previously, it can however be implanted chi rurgi calmly with an open heart having advantages compared to the usual prosthetic valves.
  • the metallic expandable structure 2 of the prosthetic valve according to the invention can, after its positioning in the valve orifice, optionally by means of an expansion balloon, be sutured around the periphery of the valve ring.
  • the prosthetic valve according to the invention does not include the large teflon-coated ring of the usual prosthetic valves, which is intended to allow suturing, so that the opening caliber is much greater.
  • a prosthetic valve according to the invention has an opening of between 3.1 and 4.1 cm 2 , while that of a conventional prosthetic valve is of the order of 2 cm 2 .

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

Valvule prothétique implantable par cathétérisme, ou chirurgicalement, comportant une structure rigide expansible (2) et une structure valvulaire (3) solidarisée à la structure expansible (2) et apte à être déformée pour passer alternativement d'un état ouvert à un état fermé. La structure valvulaire (3) est solidarisée à une extrémité de la structure expansible (2), et s'étend extérieurement à celle-ci.

Description

VALVULE PR0THE7I0UE IMPLANTABLE PAR CATHETERISME, OU CHIRURGICALEMENT.
La présente invention a pour objet une valvule prothétique implantable par cathéter i sme , ou chi rurg i cal ement .
Dans le cas d'une sténose, c'est-à-dire le rétrécissement d'un orifice organique, il est nécessaire d'intervenir pour supprimer ce rétrécissement, et lorsque la sténose intervient au niveau d'une valvule, celle-ci doit être remplacée ch i rurg i cal ement par une valvule prothétique.
On connaît notarnmenl la sténose aortique, laquelle peut résulter d'une fibrose et d'une calcification des valves sigmoïdes, et qui nécessite une exérèse de l'appareil valvulaire aortique et son remplacement par une valvule prothétique.
Une valvule prothétique est actuellement implantée chi rurg i cal ement . Toutefois certains patients ne peuvent pas être opérés, particulièrement en raison de leur âge avancé, en sachant que la sténose aortique atteint principa ement les personnes âgées.
Pour pallier cet inconvénient il a été proposé d'implanter la valvule prothétique par cathéter i sme , c'est- à-dire de l'amener jusqu'au coeur par la voie artérielle, en passant par l'artère fémorale jusqu'à l'aorte sans ouvrir le thorax.
Une valvule prothétique implantable par cathéter i sme est décrite dans le document EP 0 850 607, elle comprend une structure expansible et une structure val vul ai re . La structure expansible consiste en un treillis de fils métalliques, de préférence en acier, présentant une forme tubulaire dont l'expansion, dans le sens radial sous l'action d'une pression, lui permet d'atteindre un diamètre prédéterminé, qui de plus correspond à une rigidité optimale dudit treillis. La structure expansible est destinée à être positionnée à l'emplacement de la valvule sténosée, et à y être bloquée par son expansion.
La structure valvulaire est de forme tronco- hyperbol i que et est réalisée en un tissu souple et résistant. Elle est solidarisée par son extrémité de plus grand diamètre à la paroi interne de la structure expansible, sensiblement dans la région médiane de cette dernière, ou à proximité d'une extrémité de celle-ci pour s'étendre à l'intérieur. Plus précisément, la structure valvulaire est solidaire d'un enveloppe tubulaire qui recouvre la paroi interne de la structure expansible et qui assure l'étanchéité de cel e-ci.
Ainsi, la structure valvulaire peut être déformée pour passer al ernati ement d'un état fermé à un état ouvert dans la structure expansible, c'est-à-dire que son extrémité de plus petit diamètre peut être évasée ou resserrée, pour alternati ement, s'ouvrir et laisser passer un flux et obturer l'orifice pour éviter une régurgitation.
En outre, pour guider- son mouvement lors du passage de l'état ouvert à l'état fermé, la structure valvulaire présente des renforts longitudinaux préformés.
En pratique, après un élargissement de la sténose au moyen d'un ballonnet acheminé par voie artérielle, la valvule prothétique est amenée par la même voie jusqu'à ladite sténose, puis on réalise l'expansion de la structure expansible par le gonflement puissant d'un ballonnet placé à l'intérieur de celle-ci. La structure expansible est ainsi solidement ancrée, dans sa configuration la plus rigide, et la structure valvulaire est foncti onnel 1 e . Or cette valvule prothétique présente un inconvénient. En effet, lors du gonflement du ballonnet, sachant que la pression nécessaire à l'expansion de la structure expansible est de l'ordre de 4 bars, la structure valvulaire est fortement susceptible d'être endommagée en étant plaquée contre ladite structure expansible, ce qui peut se traduire par le percement ou le déchirement du t i ssu .
D'autre part, la structure valvulaire étant rapportée sur l'enveloppe, cette sol i dar i sa ti on n'est pas fiable dans le temps, il peut survenir une séparation du fait du mouvement de ladite structure valvulaire par rapport à ladite enveloppe.
La présente invention a pour but de proposer une valvule prothétique permettant de remédier à ces divers inconvénients, et plus particulièrement un perfectionnement à la valvule prothétique précédemment décrite.
La valvule prothétique objet de la présente invention comporte une structure rigide expansible et une structure valvulaire solidarisée à ladite structure expansible et apte à être déformée pour passer alternativement d'un étot ouvert à un état fermé, et elle se caractérise en ce que ladite structure valvulaire est solidarisée à une extrémité de ladite structure expansible, et s'étend extérieurement à celle-ci.
Selon na caractéristique additi nnelle de la valvule prothétique selon l'invention, la st ucture expansible comporte un treillis de fils métalliques présentant une forme tubulaire.
Selon une autre caractéristique additionnelle de la valvule prothétique selon l'invention, la structure expansible dans sa configuration déployée présente dans sa région médiane un diamètre inférieur à ceux des bords extrêmes .
Selon une autre caractéristique additionnelle de la valvule prothétique selon l'invention, la structure valvulaire consiste en une pièce de forme tronco- hyperbol ique , réalisée en un tissu souple et résistant, et est solidarisée à la structure expansible par son extrémité de plus grand diamètre.
Selon une autre caractéristique additionnelle de la valvule prothétique selon l'invention, la structure expansible comporte une enveloppe qui la recouvre intérieurement, faite d'un tissu souple et résistant, et à une extrémité de laquelle lui est solidarisée la structure valvulaire.
Selon une autre caractér istique additionnelle de la valvule prothétique selon l'inven ion, la structure valvulaire présente des raidisseurs préformés pour rappeler él ast i quernent ladite structure valvulaire vert- son état fermé .
Selon un premier mode de réalisation de la valvule prothétique selon l'invention, les raidisseurs de la structure valvulaire sont tels qu'ils tendent à se rapprocher les uns des autres jusqu'à venir au contact les uns des autres.
Selon un second mode de réalisation de la valvule prothétique selon l'invention, la structure valvulaire comporte deux raidisseurs opposés diamét alement qui tendent à s'éloigner l'un de l'autre.
Selon une caractéristique additionnelle du second mode de réalisation de la valvule prothétique selon l'i vention, la structure valvulaire comporte des raidisseurs qui tendent à se rapprocher les uns des autres jusqu'au contact.
Les avantages et les caractéristiques de la présente invention ressorti ront plus clairement de la description qui suit et qui se rapporte au dessin annexé, lequel en représente plusieurs modes de réalisation non
1 ïmi tati fs .
Dans le dessin annexé :
- les figures 1a, 1b et 1c représentent chacune une vue en perspective d'un premier mode de réalisation d'une valvule prothétique selon l'invention, lors de trois étapes de son fonctionnement.
- les figures 2a, 2b et 2c représentent des vues schématiques en coupe des figures respectivement 1a, 1 b et 1c, selon un plan longitudinal médian.
- la figure 3 représente une vue en perspective schématique d'une partie Je la même valvule prothétique selon une première variante.
- la figure 4 représente une vue en perspective schématique d'une partie de la inertie valvule prothétique selon une seconde variante.
- les figures 5a, 5b et 5c représentent des vues en perspective d'un second mode de réalisation d'une valvule prothétique selon l'invention, lors de trois étapes de son foncti onnement . - les figures 6a, 6b et 6c représentent des vues partielles de dessus respectivement des figures 5a, 5b et 5c.
- les figure;-- 7a et 7b représentent des vues en perspective dans des rep ésentations différentes d'une valvule prothétique selon l'invention lors de son impl antat i on .
- les figures 8a et 8b représentent des vues en perspective dans des représentations différentes de Ici même valvule prothétique lors de sa mise en place. Si on se réfère aux figures 1a, 1b, 1c, 2a, 2b et 2c on peut voir un premier mode de réalisation d'une valvule prothétique 1 selon l'invention, qui comprend une structure rigide expansible 2 et une structure valvulaire 3.
La structure expansible 2, comme cela est visible uniquement sur les figures 1a, 1b et 1c, comporte un treillis 20 de fils métalliques 21, conformé en un tube apte à être déformé de manière irréversible dans le sens radial, tout en conservant sa forme tubu ire.
On notera que sur ces figures la structure expansible 2 est dans sa configuration déployée, laquelle correspond à une rigidité optimale.
Les fils métalliques 21 sont entrecroisés selon une disposition permettant de passer d'un état comprimé à un état développé. Dans le cas d'une valvule prothétique 1 destinée à remplacer les valves sigmoïdes, le diamètre de la structure expansible 2 à l'état replié est de l'ordre de 4 à 8 mm, tandis qu'à l'état développé i est de 20 à 23 mm selon la taille du patient.
La paroi interne de Ici structure expansible 2 est recouverte d'une enveloppe tubuldire 4 qui lui est solidarisée et qui réalise 1 ' étctnchéi té . L'enveloppe 4 est apte à suivre le mouvement d'expansion de la structure expansible 2, elle pourra à cet effet être par exemple plissée lorsque la structure expansible est dans son état repl ié . La structure valvulaire 3 consiste en un tissu
30 conformé en un tronc de cône hyperbolique, c'est-à-dire que sa paroi est concave, dont la base 31, qui correspond au diamètre le plus grand du tronc de cône est solidaire d'un bord extrême de 1 ' envel oppe 4, tandis que l'extrémité 32, correspondant au diamètre le plus petit, s'étend vers 1 ' extér i eur .
Le tissu 30 peut être réalisé en matière plastique tel que du polyuréthanne traité pour éviter une calcification, ou du péricarde également traité contre la calcification, ou tout autre matériau équivalent.
On notera que lorsque la structure valvulaire 3 est réalisée en polyuréthanne, elle peut avantageusement ne faire qu'une seule pièce avec l'enveloppe 4.
Le tissu 30 est armé de raidisseurs 33 qui s'étendent de la base 31 jusqu'à l'extrémité 32. Ils sont disposés, comme cela est représenté, selon des génératrices courbes du tronc de cône, mais ils peuvent toutefois être disposés hél i coïdalement .
Les raidisseurs 33 peuvent consister en des bourrelets de matière dont est faite la structure valvulaire, ou en des fils de métal tel que de l'acier, et sont de préférence au nombre de 3 ou 4 dans cette con i guration .
Les raidisseurs 33 sont formés d'origine pour contraindre la structure valvulaire 3 à la fermeture comme cela est représenté sur les figures 1c et 2c, c'est-à-dire qu'ils sont incurvés en direction de l'a e principal de la valvule prothétique 1, et tendent à se rapprocher les uns des autres. Leur riyidité est toutefois limitée pour permettre l'ouverture de la structure valvulaire 3 par un flux comme cela est ep ésenté sur les figures 1a et 2a, les figures 1b et 2b représentant une étape intermédiaire.
Les raidisseurs 33 peuvent être solidaires de la structure expansible 2 et venir en appui extérieur contre la structure valvulaire Ξ à laquelle ils sont sol idarisés par suture lorsque celle-ci est réalisée au moyen de péricarde. Dans le cas d'une structure valvulaire réalisée en polyuréthanne, les raidisseurs 33 peuvent avantageusement y être noyés.
Dans le cas d'une valvule prothétique 1 destinée à remplacer les valves sigmoïdes, la structure valvulaire 3 est disposée du côté de l'aorte, en sorte que lors de la systole vent r i cul ai re la forte pression du flux sanguin systolique généré par la contraction ven tr i cul ai re fait s'ouvrir la structure valvulaire 3, tandis que lors de la diastole les raidisseurs 33 et l' inversion de la pression sanguine la ferment.
La forme tr onco-hyper bol i que de la structure valvulaire 3 permet que l'obturation soit réalisée non pas uniquement au niveau son extrémité 32, mais, du fait que les extrémités de raidisseurs 33 viennent en contact tangent, sur une portion représentant sensiblement un tiers de sa hauteur, en sorte d'obtenir une parfaite étanchéité évitant ainsi une régurgitation.
Si on se réfère à la figure 3, on peut voir que dans une variante, la structure expansible 3 peut, lors de son expansion, prendre une forine concave de manière à faire apparaître dans sa région médiane un rét écissement 34 apte à favoriser sort centrage sur le lieu de son implantation.
En référence à la figure 4, on peut voir que dans une autre variante, le centrage de la structure expansible 3 est facilité par la présence un étranglement Si on se ré fè re maintenant aux figures 5a, 5b, 5c, 6a, 6b et 6c, on peut voir un second mode de réalisation d'une valvule prothétique 1' selon l'invention. Cette valvule prothétique 1' comprend également une structure expansible 2 couverte inté ieuremen d'une enveloppe 4 et une structure valvulaire 3 de forme tronconique.
La structure valvulaire 3 est équipée de six raidisseurs régulièrement espacés, deux raidisseurs 36, opposés diamé ralement, et quatre raidisseurs 37.
Comme on peut le voir sur les figures 6a, 6b et 6 c, les raidisseurs 36 sont conformés pour s'éloigner l'un de l'autre, tandis que les raidisseurs 37 sont conformés pour se rapprocher les uns des autres. Du point de vue réalisation, par exemple, les raidisseurs 36 sonl disposés à l'intérieur de la structure valvulaire 3 tandis que les i aidisseurs 37 sont placés à 1 ' extér leur .
Sur les figures 5a et 6a, qui représentent une systole ventr cul i r e . structure valvul ire 3 s'ouvr sous la poussée F du flux sanguin. Ptr contre sur les figures 5c et 6c, qui représentent une diastole, après une étape in er édiaire représentée sur les figures 5b et 6b, la structure valvulaire 3 se ferme comme deux feuillets accolés l'un à l'autre, en ce sens que les raidisseurs 36 tirent le tissu 30 vers l'extérieur tandis que les-, raidisseurs 37 se rejoignent deux à deux, ce qui entraîne, en association avec la pression sanguine aortique P, l'aplatissement de la structure valvulaire 3. La structure valvulaire 3 aplatie, tendue par¬ les raidisseurs 36 et accolée à elle-même sur une grande surface, nt présente pas de p is susceptibles de créer des fuites engeridrant une régurgitation comme dans le premier mode de réalisation. On notera que selon une variante, non représentée, la structure valvulaire 3 peut ne comporter que les deux raidisseurs 36. Dans ce cr , lors d'une diastole, les raidisseurs-. 36 en s'élcignant l'un de l'autre tendent la structure valvulaire 2, et la pression sanguine aortique P qui complète l'aplatissement et la fermeture. Si on se réfère maintenant aux figures 7a et 7b, on peut voir une valvule prothétique 1 en cours d'implantation, sachant que l'impl ntation d'une valvule prothétique 1' est réalisée de la même manière.
La structure expansible 2 est repliée, et est montée sur un ensemble d'éléments destiné à réaliser son expansion. Cet ensemble comprend une sonde 5 sur laquelle est enfilée une tige 50 comportant non loin de son extrémité un ballonnet 51 qui prend place à l'intérieur de la structure expansible 2, contre l'enveloppe 4, et de manière qu'il ne déborde pas au-dessus de la 1 igné de jonction de la structure valvulaire 3 à l'enveloppe 4.
La tige 50 comporte deux conduits, non visibles, dans l'un desquels passe la sonde 5, tandis que l'autre débouche dans le ballonnet 51 pour permettre le gonflement de celui-ci .
Si on se réfère maintenant aux figures 8a et 8b, on peut voir que le gonflement du ballonnet 51 permet l'expansion de la structure expansible 2.
Le ballonnet 51 n'est en contact qu'avec l'enveloppe 4 en sorte que la structure valvulaire 3 ne risque pas d'être endommagée par le gonflement.
D'autre part, la position du ballonnet. 51 en dessous de la ligne de jonction de la structure valvulaire 3 avec l'enveloppe 4 évite un risque d ' endommagement au niveau de cette jonction et d'évasement de la structure valvulaire
3.
Outre que, comme vue précédemment, la structure valvulaire 3 ne peut pas être endommagée lors de sa mise en place, la valvule prothétique 1, selon l'invention présente de nombreux avantages par rapport aux valvules prothetiques existantes et notamment celle décrite dans le document EP 0 850 607 .
Ainsi, la prolongation de l'enveloppe 4 par la structure valvulaire 3 et la sol î dar i sati on de cette dernière à la structure expansible 2 conduit à une fabrication plus aisée et à une plus grande fiabilité dans le temps.
D'autre part, le passage de l'état ouvert à l'état fermé, et inversement, est plus facile, du fait d'une plus grande liberté de débattement de la structure valvulaire 3 sur l'enveloppe 4.
La valvule prothétique selon l'invention est prévue pour être implantée par cathétérisme comme cela a été vu précédemment, elle peut toutefois être implantée chi rurgi calement à coeur ouvert en présentant des avantages par rapport aux valvules prothétique usuelles.
Ainsi, la structure expansible métallique 2 de valvule prothétique selon l'invention peut, après sa mise en place dans l'orifice valvulaire, éventuellement au moyen d'un ballon de dilatation, être suturée sur le pourtour de l'anneau valvulaire.
Avantageusement, la valvule prothétique selon l'invention ne comporte pas le gros anneau téfloné des valvules prothetiques usuelles, qui est destiné à permettre la suture, en sorte que le calibre d'ouverture est bien supérieur. A titre d'exemple, une valvule prothétique selon l'invention présente une ouverture comprise entre 3,1 et 4,1 cm2, tandis que celle d'une valvule prothétique usuelle est de 1 'ordre de 2 cm2.

Claims

REVENDICATIONS
1) Valvule prothétique implantable par cathétérisme, ou chi rurgi calement . comportant une structure rigide expansible (2) et une structure valvulaire (3) solidarisée à ladite structure expansible (2) et apte à être déformée pour passer al ter nati veinent d'un état ouvert à un état fermé, caractérisée en ce que ladite structure valvulaire (3) est solidarisée à une extrémité de ladite structure expansible (2), et s'étend extérieurement à celle- ci . 2) Valvule prothétique selon la revendication 1, caractérisée en ce que la structure expansible (2) comporte un treillis (20) de fils métalliques (21) présentant une forme tubulaire.
3) Valvule prothétique selon la revendication 2, caractérisée en ce que la structure expansible (2) dans sa configuration déployée présente dans sa région médiane un diamètre inférieur à ceux des bords extrêmes.
4) Valvule prothétique selon la revendication 3, caractérisée en ce que la paroi de la structure expansible (2) est concave de manière que ladi e structure expansible présente un rétrécissement (34) dans sa région médiane.
5) Valvule prothétique selon la revendication 3, caractérisée en ce que la structure expansible (2) présente un étranglement (35) dans sa région médiane. 6) Valvule prothétique selon l'une quelconque des revendications précédentes, caractérisée en ce que la structure valvulaire (3) consiste en une pièce de forme tronco-hyperbol i que , réalisée en un tissu (30) souple et résistant, et est solidarisée à la structure expansible (2) par son extrémité (31) de plus grand diamètre.
7) Valvule prothétique selon l'une quelconque des revendications précédentes, caractérisée en ce que la structure expansible (2) comporte une enveloppe (4) qui la ι : recouvre i térieurement, faite d'un tissu souple et résistant, à une extrémité de laquelle lui est solidarisée la structure val ulaire (3).
S) Valvule prothétique selon l'une quelconque des revendications précédentes, caractérisée en ce que la structure valvulaire (3) présente des raidisseurs (33, 36,
37) préformés pour rappeler él s i quemen L ladite structure valvulaire (3) vers son état fermé.
9) Valvule prothétique selon la revendication 8, caractérisée en ce que les raidisseurs (33) de la structure valvulaire (3) sont tels qu'ils tendent à se rapprocher les uns des autres.
10) Valvule prothétique selon la revendication 8, caractérisée en ce que la structure valvulaire (3) comporte deux raidisseurs (36) opposés diamétralement qui tendent à s'éloigner l'un de l'autre.
11) Valvule prothétique selon la revendi ation 10, caractérisée en ce que la structure valvulaire (3) comporte des raidisseurs (37) qui tendent à se rapprocher les uns des autres.
12) Valvule prothétique selon l'une quelconque des revendications de 8 à 11, caractérisée en ce que les raidisseurs (33; 36, 37) consistent en des bourrelets de matière dont est faite la structure valvulaire (3), ou en des fils de métal.
12) Valvule prothétique selon la revendication 12, caractérisée en ce que les raidisseurs (33; 36, 37) sont des fils métalliques solidaires de la structure expansible (2).
PCT/FR2000/000051 1999-01-12 2000-01-12 Valvule prothetique implantable par catheterisme, ou chirurgicalement WO2000041652A1 (fr)

Priority Applications (1)

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AU30529/00A AU3052900A (en) 1999-01-12 2000-01-12 Prosthetic heart valve implantable by catheter insertion or surgically

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FR9900416A FR2788217A1 (fr) 1999-01-12 1999-01-12 Valvule prothetique implantable par catheterisme, ou chirurgicalement
FR99/00416 1999-01-12

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FR2788217A1 (fr) 2000-07-13
AU3052900A (en) 2000-08-01

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