EP0388421A1 - Artificial cardiac valve - Google Patents

Artificial cardiac valve

Info

Publication number
EP0388421A1
EP0388421A1 EP88910047A EP88910047A EP0388421A1 EP 0388421 A1 EP0388421 A1 EP 0388421A1 EP 88910047 A EP88910047 A EP 88910047A EP 88910047 A EP88910047 A EP 88910047A EP 0388421 A1 EP0388421 A1 EP 0388421A1
Authority
EP
European Patent Office
Prior art keywords
valve
axis
heart valve
side wall
valve according
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
EP88910047A
Other languages
German (de)
French (fr)
Inventor
Jean-Paul Couetil
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Eracc Etudes Recherches Et Applications En Chirurgie Cardiaque
Original Assignee
Eracc Etudes Recherches Et Applications En Chirurgie Cardiaque
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 Eracc Etudes Recherches Et Applications En Chirurgie Cardiaque filed Critical Eracc Etudes Recherches Et Applications En Chirurgie Cardiaque
Publication of EP0388421A1 publication Critical patent/EP0388421A1/en
Pending legal-status Critical Current

Links

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
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • 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
    • A61F2/2403—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 pivoting rigid closure members
    • A61F2/2406—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 pivoting rigid closure members without fixed axis

Definitions

  • the present invention relates to an artificial heart valve.
  • valves of the type comprising a pivoting single disc valve.
  • the disc in question pivots by means of articulations in the form of protuberances arranged on the internal wall of the valve body and which, by virtue of their configurations and their arrangements are capable of causing thrombosis phenomena.
  • valves are in the fully open position only when the valve has pivoted by a certain angle which is always less than 90 ° around an axis of rotation which coincides with its diameter. Indeed, the limit angle of 90 ° does not allow passive closure of the valve. Consequently, in the open position, half of the disc constituting the valve is engaged in the aorta, which can cause problems of flow and / or bulk.
  • an artificial heart valve made of biocompatible material of the type comprising:
  • valve pivotally housed inside said body and having connecting elements intended to cooperate with storage and retaining means provided on the internal lateral wall of the annular body, characterized in that said valve consists of a disc curved along an axis XX 'parallel to one of its diameters with an angle ⁇ between 0 and 30 ° and preferably about 10 °, so that the opening of the valve takes place in two consecutive phases, the first phase corresponding to a rotation of the valve around the point of contact and articulation A of the part posterior disc with the lower edge of the side wall of said body until said connecting elements are hued in the guide and retaining means, the second phase corresponding to a rotation about an axis ZZ 'parallel to the 'axis XX' until the posterior part of the disc is parallel to the axis YY 'of the body.
  • the heart valve of the invention is also characterized in that said guiding and retaining means consist of two symmetrical lateral slides produced in the mass of the coros and. in which the connecting elements of the valve are movably engaged. These slides may consist of an arc of the circle with center A and a radius equal to the rear part of the valve or else excavations comprising, on at least part of their periphery, straight sides forming stops.
  • the connecting elements are provided laterally and symmetrically on the axis ZZ 'of the valve and preferably consist of two pivots or two ears.
  • the heart valve of the invention therefore has in the open position a so-called posterior part parallel to the axis of the body, which is not achieved with the disc valves of the prior art.
  • the two orifices existing during the opening between the valve and the internal wall of the coros and constituting the passageways for the sanquin flow are of substantially equal dimensions.
  • the lateral internal wall of the valve coros has no hooking element for blood flow, this yes reduces the risk of thrombosis.
  • the opening in two phases (proto opening and full opening) by transfer of the axis of rotation of the valve makes it possible advantageously to obtain a progressive increase in the blood flow.
  • the invention also provides the possibility of producing the curved disc of the valve with a concave-convex morphology.
  • Figure 1 is a perspective view of the valve of the invention.
  • Figure 2 is a top view of the valve of the invention in the open position (upper half-view) and closed (lower half-view).
  • Figures 3, 4 and 5 are sectional views of the va l ve of the invention respectively in three different positions of the valve.
  • Figure fi is a partial top view of another embodiment of the valve of the invention.
  • FIG. 7 is a sectional view of an embodiment inspired by that of FIG. 6.
  • FIGS. 1 and 2 show the valve of the invention in perspective and in top view, respectively, with the body 1 and valve 2 consisting of a curved valve.
  • the body 1 has a shape which substantially follows the profile of the valve 2.
  • the lower half-view of FIG. 2 shows the valve 2 in the open position while the upper half-view shows it in the closed position.
  • the disc is bent along an axis XX 'parallel to one of its diameters.
  • the axis XX ' preferably passes very close to the center of the disoue but can also be confused with a diameter.
  • the bending of the disc corresponds to an anal ⁇ this aui means that it there is an angle of (180 ° - ⁇ ) between a so-called posterior part 3 and a so-called anterior part 5 of the disc.
  • the angle ⁇ is between 0 and 30 ° and is preferably 10 °.
  • the axis ZZ 'constituting the axis of rotation for the second phase of the opening is coincident with the axis XX'
  • the rotation for the second phase of the opening can take place around an axis ZZ 'parallel but distinct from the bending axis XX'.
  • the front and rear parts of the valve 2 are defined relative to the axis ZZ 'In this case the rear part is located between the axis ZZ 'and point A and the front part beyond the axis ZZ'; the axis XX 'can be located either on one side or the other of the axis ZZ'.
  • Figure 3 shows the valve in section in the closed position, Oans the closed position, the rear part 3 of the valve 2 is in contact at the point. A with the lower edge of the side wall 4 of the body 1.
  • the contact point A acts as an articulation during the first phase of the opening.
  • the side wall 4 while having a profile matching that of the valve 2 nevertheless has a partial cutout 10 from its lower edge, forming a stop at the point of contact and articulation A with the rear part 3 of the valve 2.
  • the front part 5 of the valve 2 rests on a seat 6 formed on the upper edge of the internal side wall of the body 1.
  • the connecting elements of the valve 2 with the body 1 consist of two symmetrical lateral pivots (7,7 ') provided on the axis ZZ' merged here with the axis XX 'and on each side of the valve 2
  • These pivots (7 , 7 ') cooperate with guide and retaining formed on the internal side wall of the body 1 and which preferably consist of two symmetrical lateral slides (8,8 ') made in the mass of the body and corresponding to an arc of the circle with center A and of radius equal to the part posterior.
  • the pivots (7,7 ') can freely slide and turn in the slides (8,8') during the opening phases of valve 2.
  • the body 1 also has on its internal side wall at the upper end of the slides (8,8 ') two stops (9,9') intended to limit and direct the rotation of the valve 2 during the opening.
  • Figure 4 shows the valve in section during the first phase of the opening also called proto-opening.
  • This phase corresponds to a rotation of the valve 2 by a few degrees around the point of contact and articulation A of the rear part 3 of the valve 2 with the lower edge of the side wall 4 until the pivots (7,7 ') are in abutment in the upper part of the slides (8,8').
  • the length of the arc of the rails (7.7 ') determines the angle of the rotation.
  • the rear part 3 of the valve 2 is in pivoting contact around the point A. This first phase therefore corresponds to a true rotation and not to a translation.
  • the front part 5 of the valve 2 is raised relative to its seat 6, leaving a free passage for the blood flow.
  • Figure 5 shows the valve in section in the fully open position.
  • the pivots (7,7 ') are in abutment in the slides (8,8') and the rear part 3 comes to bear against the lower faces of the stop stops (9 , 9 ') located at the upper end of the slides (8,8').
  • the valve still has degrees of freedom, there is a transfer from the center of rotation of point A to the axis ZZ 'here confused with XX'.
  • the valve 2 pivots around the axis ZZ '(here XX') until the rear part 3 is parallel to the axis YY 'of the body 1, which corresponds for an angle ⁇ of approximately 10 ° to a rotation of approximately 60 °.
  • the valve 2 comes to bear against the lateral faces of the stop stops (9, 9 '). These faces are inclined at an angle ⁇ relative to the axis YY 'In the final position the front part 5 therefore makes an angle of about 10 ° with the axis YY'.
  • the rear part 3 is slightly smaller (shorter) than the front part 5.
  • the two consecutive phases are very short and in any case shorter than the opening phases of the valves of the prior art since the angular travel is smaller.
  • FIG. 6 is a partial top view of another embodiment of the invention in leguel the connecting elements of the valve 2 are constituted by ears or beads (17,17 ') forming ball joints and made in the mass of valve 2 intended to cooperate with guide and retaining means constituted by two symmetrical slides (18, 18 ′) formed in the internal lateral wall of the body 1.
  • This embodiment therefore has more rounded contours than the previous embodiment, which further reduces the risk of thrombosis and improves blood flow.
  • the establishment of the valve 2 in the valve body is facilitated.
  • FIG. 7 represents a cross-section view of an embodiment of the valve of the invention in the ⁇ uel the connecting elements of the valve 2 are identical to those described with reference to FIG. 6.
  • These connecting elements cooperate with guide and retaining means consisting of two symmetrical lateral slides in the form of an excavation (28,28 ') made in the mass of the internal lateral wall of the body 1.
  • These excavations (28,28' ) have on at least part of their periphery straight flanks (19a, 19b - 19'a, 19 'b) forming stops and whose role is also to limit and orient the stroke of the valve 2 during opening.
  • the combination of the excavations (28,28 ') and the ears (17,17') corresponds to a joint of the ball type.
  • the orientations of the straight flanks (19a, 19b) relative to the axis YY ', are chosen so that the rotation of the valve 2 takes place in accordance with what has been described previously; that is to say that the fully open position is obtained when the rear part 3 of the valve 2 is parallel to the axis YY '.
  • the valve of the invention can be made of any biocompatible material and for example carbon pyrolite or ceramic.
  • the curved flat disc can be replaced by a curved disc with concave-convex morphology or else with any combination between planar, concave and convex surfaces.

Landscapes

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

Abstract

PCT No. PCT/FR88/00558 Sec. 371 Date Jul. 12, 1990 Sec. 102(e) Date Jul. 12, 1990 PCT Filed Nov. 14, 1988 PCT Pub. No. WO89/04154 PCT Pub. Date May 18, 1989.An artificial cardiac valve made of biocompatible material comprises an annular valve body and a flap pivotally lodged inside the valve body and possessing linking elements for cooperating with guiding and restraining means provided on an internal side wall of the annular valve body. The flap consists of a disc folded along an axis XX' parallel to one of its diameters through an angle between 0 and 30 degrees in such a way that opening of the valve is effected in two consecutive phases. The first phase corresponds to a rotation of the flap about the contact and hinging point A between a rear part of the flap and a lower edge of the side wall of the valve body until said linking elements abut against the guiding and restraining means. The second phase corresponds to a rotation of about an axis ZZ' parallel to the axis XX' until the rear part of the flap is parallel to the axis YY' of the annular body.

Description

Valve cardiaque artificielle. Artificial heart valve.
La présente invention concerne une valve cardiaque artificielle. II existe déjà de nombreuses valves cardiaques artificielles utilisant des dispositifs à clapet du type bille, disque ou volets en forme d'hémidisque.The present invention relates to an artificial heart valve. There are already many artificial heart valves using valve devices of the ball, disc or hemidisk-shaped flaps.
C'est le cas par exemple des valves décrites dans les demandes de brevets EP 0 176 337 (CARBOMEDICS INC.), EP 0023 797 (HEMEX INC.), EP 0 039 217 (MITRAL MEDICAL INTERNATIONAL, INC. et EP 0 050 971 (HEMEX INC.).This is the case, for example, for the valves described in patent applications EP 0 176 337 (CARBOMEDICS INC.), EP 0023 797 (HEMEX INC.), EP 0 039 217 (MITRAL MEDICAL INTERNATIONAL, INC. And EP 0 050 971 (HEMEX INC.).
Dans ces documents sont décrites notamment des valves du type comprenant un clapet à disque unique pivotant. Le disque en question pivote au moyen d'articulations en forme de protubérances disposées sur la paroi interne du corps de la valve et qui, de part leurs configurations et leurs dispositions sont susceptibles de provoquer des phénomènes de thrombose.In these documents are described in particular valves of the type comprising a pivoting single disc valve. The disc in question pivots by means of articulations in the form of protuberances arranged on the internal wall of the valve body and which, by virtue of their configurations and their arrangements are capable of causing thrombosis phenomena.
Par ailleurs, ces valves ne sont en position de pleine ouverture que lorsque le clapet a pivoté d'un certain angle qui est toujours inférieur à 90° autour d'un axe de rotation qui est confondu avec son diamètre. En effet, l'angle limite de 90° ne permet pas la fermeture passive de la valve. Par conséquent, dans la position d'ouverture, la moitié du disque constituant le clapet est engagée dans l'aorte, ce qui peut poser des problèmes d'écoulement et/ou d'encombrement.Furthermore, these valves are in the fully open position only when the valve has pivoted by a certain angle which is always less than 90 ° around an axis of rotation which coincides with its diameter. Indeed, the limit angle of 90 ° does not allow passive closure of the valve. Consequently, in the open position, half of the disc constituting the valve is engaged in the aorta, which can cause problems of flow and / or bulk.
De plus, on constate que ces valves ont une tendance à osciller en raison de la grande distance entre l'axe de rotation et l'extrémité la plus éloignée du clapet.In addition, it is found that these valves have a tendency to oscillate due to the large distance between the axis of rotation and the most distant end of the valve.
La présente invention permet de remédier à ces inconvénients pour la première fois et de manière satisfaisante en proposant une valve cardiaque artificielle en matériau biocompatible du type comprenant :The present invention overcomes these drawbacks for the first time and in a satisfactory manner by proposing an artificial heart valve made of biocompatible material of the type comprising:
- un corps annulaire,- an annular body,
- un clapet logé de façon pivotante à l'intérieur dudit corps et possédant des éléments de liaison destinés à coopérer avec des moyens de quidage et de retenue prévus sur la paroi latérale interne du corps annulaire, caractérisée en ce que ledit clapet est constitué d'un disque cintré suivant un axe XX' parallèle à l'un de ses diamètres avec un angle α compris entre 0 et 30° et de préférence d'environ 10°, de telle sorte que l ouverture de la valve s ' effectue en deux phases consécutives, la première phase correspondant à une rotation du clapet autour du point de contact et d'articulation A de la partie postérieure du disque avec le bord inférieur de la paroi latérale dudit corps jusqu'à ce que lesdits éléments deliaison soient en hutée dans les moyens de guidage et de retenue, la deuxième phase correspondant à une rotation autour d'un axe ZZ' parallèle à l'axe XX' jusqu'à ce que la partie postérieure du disque soit parallèle à l'axe YY' du corps. La valve cardiaque de l'invention est également caractérisée en ce que lesdits moyens de guidage et de retenue sont constitués de deux glissières latérales symétriques réalisées dans la masse du coros et. dans lesquelles les éléments de liaison du clapet sont engagés de façon mobile . Ces glissières peuvent être constituées d'un arc du cercle de centre A et de rayon éqal à la partie postérieure du clapet ou bien d'excavations comportant, sur au moins une partie de leur pourtour, des flancs droits formant butées.- a valve pivotally housed inside said body and having connecting elements intended to cooperate with storage and retaining means provided on the internal lateral wall of the annular body, characterized in that said valve consists of a disc curved along an axis XX 'parallel to one of its diameters with an angle α between 0 and 30 ° and preferably about 10 °, so that the opening of the valve takes place in two consecutive phases, the first phase corresponding to a rotation of the valve around the point of contact and articulation A of the part posterior disc with the lower edge of the side wall of said body until said connecting elements are hued in the guide and retaining means, the second phase corresponding to a rotation about an axis ZZ 'parallel to the 'axis XX' until the posterior part of the disc is parallel to the axis YY 'of the body. The heart valve of the invention is also characterized in that said guiding and retaining means consist of two symmetrical lateral slides produced in the mass of the coros and. in which the connecting elements of the valve are movably engaged. These slides may consist of an arc of the circle with center A and a radius equal to the rear part of the valve or else excavations comprising, on at least part of their periphery, straight sides forming stops.
Les éléments de liaison sont prévus de façon latérale et symétrique sur l'axe ZZ' du clapet et sont constitués de préférence par deux pivots ou deux oreilles.The connecting elements are provided laterally and symmetrically on the axis ZZ 'of the valve and preferably consist of two pivots or two ears.
La valve cardiaque de l'invention présente donc en position d'ouverture une partie dite postérieure parallèle à l'axe du corps ce qui n'est pas réalisé avec les valves à disque de l'art antérieur.The heart valve of the invention therefore has in the open position a so-called posterior part parallel to the axis of the body, which is not achieved with the disc valves of the prior art.
D,autre part, les deux orifices existant lors de l'ouverture entre le clapet et la paroi interne du coros et constituant les voies de passage du flux sanquin sont de dimensions sensiblement égales. En outre., la paroi interne latérale DU coros de la valve ne présente aucun élément d'accrochage pour le flux sanguin, ce oui diminue les risques de thrombose.D , on the other hand, the two orifices existing during the opening between the valve and the internal wall of the coros and constituting the passageways for the sanquin flow are of substantially equal dimensions. In addition, the lateral internal wall of the valve coros has no hooking element for blood flow, this yes reduces the risk of thrombosis.
L'ouverture en deux phases (proto ouverture et ouverture totale) par transfert de l ' axe de rotation du clapet permet d'obtenir avantageusement une augmentation progressive du débit sanguin.The opening in two phases (proto opening and full opening) by transfer of the axis of rotation of the valve makes it possible advantageously to obtain a progressive increase in the blood flow.
Afin d'obtenir un flux encore plus laminaire, l'invention prévoit également la possibilité de réaliser le disque cintré du clapet avec une morphologie concave-convexe. L'invention sera mieux comprise à la lecture de la description qui va suivre accompagnée des dessins annexés sur lesquels :In order to obtain an even more laminar flow, the invention also provides the possibility of producing the curved disc of the valve with a concave-convex morphology. The invention will be better understood on reading the description which follows, accompanied by the appended drawings in which:
La figure 1 est une vue en perspective de la valve de l'invention. La figure 2 est une vue de dessus de la valve de l'invention en position ouverte (demi-vue supérieure) et fermée (demi-vue inférieure).Figure 1 is a perspective view of the valve of the invention. Figure 2 is a top view of the valve of the invention in the open position (upper half-view) and closed (lower half-view).
Les figures 3, 4 et 5 sont des vues en coupe de la va l ve de l'invention respectivement dans trois positions différentes du clapet.Figures 3, 4 and 5 are sectional views of the va l ve of the invention respectively in three different positions of the valve.
La figure fi est une vue partielle de dessus d ' un autre mode de réalisation de la valve de l'invention.Figure fi is a partial top view of another embodiment of the valve of the invention.
La figure 7 est une vue en coupe d'un mode de réalisation s'inspirant de celui de la figure 6. Les figures 1 et 2 représentent la valve de l'invention respectivement en perspective et en vue de dessus, avec le corps 1 et le clapet 2 constitué d'un disgue cintré. Le corps 1 a une forme qui suit sensiblement le profil du clapet 2. La demi-vue inférieure de la figure 2 montre le clapet 2 en position d'ouverture tandis que la demi-vue supérieure le montre en position de fermeture.FIG. 7 is a sectional view of an embodiment inspired by that of FIG. 6. FIGS. 1 and 2 show the valve of the invention in perspective and in top view, respectively, with the body 1 and valve 2 consisting of a curved valve. The body 1 has a shape which substantially follows the profile of the valve 2. The lower half-view of FIG. 2 shows the valve 2 in the open position while the upper half-view shows it in the closed position.
Le disque est cintré suivant un axe XX' parallèle à un de ses diamètres. L'axe XX' passe, de préférence, très près du centre du disoue mais peut être également, confondu avec un diamètre. Le cintrage du disque correspond à un anale α ce aui signifie qu'il existe un angle de (180° - α ) entre une partie 3 dite postérieure et une partie 5 dite antérieure du disque. L'angle α est compris entre 0 et 30° et est de préférence de 10°.The disc is bent along an axis XX 'parallel to one of its diameters. The axis XX 'preferably passes very close to the center of the disoue but can also be confused with a diameter. The bending of the disc corresponds to an anal α this aui means that it there is an angle of (180 ° - α) between a so-called posterior part 3 and a so-called anterior part 5 of the disc. The angle α is between 0 and 30 ° and is preferably 10 °.
Dans le mode de réalisation préféré de l'invention tel qu'il est illustré par les figures, l'axe ZZ' constituant l'axe de rotation pour la deuxième phase de l ' ouverture est confondu avec l'axe XX' Cependant, dans un autre mode de réalisation de l'invention, la rotation pour la deuxième phase de l'ouverture peut s ' effectuer autour d'un axe ZZ' parallèle mais distinct de l'axe de cintrage XX'.In the preferred embodiment of the invention as illustrated by the figures, the axis ZZ 'constituting the axis of rotation for the second phase of the opening is coincident with the axis XX' However, in Another embodiment of the invention, the rotation for the second phase of the opening can take place around an axis ZZ 'parallel but distinct from the bending axis XX'.
Dans le cas le plus général où les axes XX' et ZZ' sont parallèles sans être confondus, les parties antérieures et postérieures du clapet 2 sont définies par rapport à l'axe ZZ' Dans ce cas la partie postérieure se trouve entre l'axe ZZ' et le point A et la partie antérieure au-delà de l'axe ZZ' ; l'axe XX' pouvant être situé indifféremment d'un côté ou de l'autre de l'axe ZZ'.In the most general case where the axes XX 'and ZZ' are parallel without being confused, the front and rear parts of the valve 2 are defined relative to the axis ZZ 'In this case the rear part is located between the axis ZZ 'and point A and the front part beyond the axis ZZ'; the axis XX 'can be located either on one side or the other of the axis ZZ'.
La figure 3 représente la valve en coupe dans la position de fermeture, Oans la position de fermeture, la partie postérieure 3 du clapet 2 est en contact au point. A avec le bord inférieur de la paroi latérale 4 du corps 1.Figure 3 shows the valve in section in the closed position, Oans the closed position, the rear part 3 of the valve 2 is in contact at the point. A with the lower edge of the side wall 4 of the body 1.
Le point de contact A joue le rôle d'articulation pendant la première phase de l'ouverture. La paroi latérale 4 tout en ayant un profil épousant celui du clapet 2 présente néanmoins une découpe partielle 10 de son bord inférieur, Formant butée au niveau du point de contact et d ' articulation A avec la partie postérieure 3 du clapet 2 .The contact point A acts as an articulation during the first phase of the opening. The side wall 4 while having a profile matching that of the valve 2 nevertheless has a partial cutout 10 from its lower edge, forming a stop at the point of contact and articulation A with the rear part 3 of the valve 2.
Toujours en position de fermeture, la partie antérieure 5 du clapet 2 repose sur un siège 6 ménagé sur le bord supérieur de la paroi latérale interne du corps 1.Still in the closed position, the front part 5 of the valve 2 rests on a seat 6 formed on the upper edge of the internal side wall of the body 1.
Les éléments de liaison du clapet 2 avec le corps 1 sont constitués de deux pivots latéraux symétriques (7,7') prévus sur l'axe ZZ' confondu ici avec l'axe XX' et de chaαue côté du clapet 2 Ces pivots (7,7') coopèrent avec des movens de guidage et de retenue ménagés sur la paroi latérale interne du corps 1 et qui sont de préférence constitués de deux glissières latérales symétriques (8,8') réalisées dans la masse du corps et correspondant à un arc du cercle de centre A et de rayon égal à la partie postérieure. Les pivots (7,7') peuvent librement coulisser et tourner dans les glissières (8,8') pendant les phases d'ouverture du clapet 2.The connecting elements of the valve 2 with the body 1 consist of two symmetrical lateral pivots (7,7 ') provided on the axis ZZ' merged here with the axis XX 'and on each side of the valve 2 These pivots (7 , 7 ') cooperate with guide and retaining formed on the internal side wall of the body 1 and which preferably consist of two symmetrical lateral slides (8,8 ') made in the mass of the body and corresponding to an arc of the circle with center A and of radius equal to the part posterior. The pivots (7,7 ') can freely slide and turn in the slides (8,8') during the opening phases of valve 2.
Le corps 1 possède éqalement sur sa paroi latérale interne au niveau de l'extrémité supérieure des glissières (8,8') deux butées d'arrêt (9,9') destinées à limiter et à orienter la rotation du clapet 2 pendant l'ouverture.The body 1 also has on its internal side wall at the upper end of the slides (8,8 ') two stops (9,9') intended to limit and direct the rotation of the valve 2 during the opening.
La figure 4 représente la valve en coupe pendant la première phase de l'ouverture appelée aussi proto-ouverture.Figure 4 shows the valve in section during the first phase of the opening also called proto-opening.
Cette phase correspond à une rotation du clapet 2 de quelques degrés autour du point de contact et d'articulation A de la partie postérieure 3 du clapet 2 avec le bord inférieur de la paroi latérale 4 jusqu'à ce que les pivots (7,7') soient en butée dans la partie supérieure des glissières (8,8'). La longueur de l'arc des qlissières (7,7') détermine l'angle de la rotation. Pendant toute la première phase la partie postérieure 3 du clapet 2 est en contact de pivotement autour du point A. Cette première phase correspond donc bien à une véritable rotation et non à une translation.This phase corresponds to a rotation of the valve 2 by a few degrees around the point of contact and articulation A of the rear part 3 of the valve 2 with the lower edge of the side wall 4 until the pivots (7,7 ') are in abutment in the upper part of the slides (8,8'). The length of the arc of the rails (7.7 ') determines the angle of the rotation. During the entire first phase the rear part 3 of the valve 2 is in pivoting contact around the point A. This first phase therefore corresponds to a true rotation and not to a translation.
A la fin de cette première phase, la partie frontale 5 du clapet 2 se trouve soulevée par rapport à son siège 6 en laissant libre un passage pour le flux sanguin.At the end of this first phase, the front part 5 of the valve 2 is raised relative to its seat 6, leaving a free passage for the blood flow.
La figure 5 représente la valve en coupe dans la position de pleine ouverture.Figure 5 shows the valve in section in the fully open position.
A la fin de la première phase d'ouverture, les pivots (7,7') sont en butée dans les glissières (8,8') et la partie postérieure 3 vient en appui contre les faces inférieures des butées d'arrêt (9,9') situées au niveau de l'extrémité supérieure des glissières (8,8'). Comme le clapet a encore des degrés de liberté, il se produit un transfert du centre de la rotation du point A à l'axe ZZ' confondu ici avec XX'. A ce moment là, le clapet 2 pivote autour de l'axe ZZ' (ici XX') jusqu'à ce que la partie postérieure 3 soit parallèle à l'axe YY' du corps 1, ce qui correspond pour un angle α d'environ 10° à une rotation d'environ 60°. A la fin de cette rotation, le clapet 2 vient se bloquer en appui sur les faces latérales des butées d'arrêt (9, 9'). Ces faces sont inclinées d'un angle α par rapport à l'axe YY' Dans la position finale la partie antérieure 5 fait donc un angle d'environ 10° avec l'axe YY'. Dans ce mode de réalisation, comme l'axe XX' ne passe pas par le centre du disque, la partie postérieure 3 est légèrement plus petite (plus courte) que la partie frontale 5.At the end of the first opening phase, the pivots (7,7 ') are in abutment in the slides (8,8') and the rear part 3 comes to bear against the lower faces of the stop stops (9 , 9 ') located at the upper end of the slides (8,8'). As the valve still has degrees of freedom, there is a transfer from the center of rotation of point A to the axis ZZ 'here confused with XX'. At that time, the valve 2 pivots around the axis ZZ '(here XX') until the rear part 3 is parallel to the axis YY 'of the body 1, which corresponds for an angle α of approximately 10 ° to a rotation of approximately 60 °. At the end of this rotation, the valve 2 comes to bear against the lateral faces of the stop stops (9, 9 '). These faces are inclined at an angle α relative to the axis YY 'In the final position the front part 5 therefore makes an angle of about 10 ° with the axis YY'. In this embodiment, since the axis XX ′ does not pass through the center of the disc, the rear part 3 is slightly smaller (shorter) than the front part 5.
Bien entendu, comme l'ouverture est assez rapide, les deux phases consécutives sont très courtes et de toutes façons plus courtes que les phases d'ouverture des valves de l'art antérieur puisque la course angulaire est plus faible.Of course, as the opening is fairly rapid, the two consecutive phases are very short and in any case shorter than the opening phases of the valves of the prior art since the angular travel is smaller.
Le corps 1 possède sur sa paroi latérale externe des moyens de solidarisation, par exemple de suture (non représentés) avec les organes naturels du patient. La figure 6 est une vue partielle de dessus d'un autre mode de réalisation de l'invention dans leguel les éléments de liaison du clapet 2 sont constitués par des oreilles ou bourrelets (17,17') formant rotules et réalisés dans la masse du clapet 2 destinés à coopérer avec des moyens de guidage et de retenue constitués de deux glissières symétriques (18,18') ménagées dans la paroi latérale interne du corps 1.The body 1 has on its external side wall means for securing, for example suturing (not shown) with the patient's natural organs. Figure 6 is a partial top view of another embodiment of the invention in leguel the connecting elements of the valve 2 are constituted by ears or beads (17,17 ') forming ball joints and made in the mass of valve 2 intended to cooperate with guide and retaining means constituted by two symmetrical slides (18, 18 ′) formed in the internal lateral wall of the body 1.
Ce mode de réalisation présente donc des contours plus arrondis que le mode de réalisation précédent, ce qui diminue encore plus les risques de thrombose et améliore l ' écoulement sanguin. De plus la mise en place du clapet 2 dans le corps de la valve s'en trouve facilité.This embodiment therefore has more rounded contours than the previous embodiment, which further reduces the risk of thrombosis and improves blood flow. In addition the establishment of the valve 2 in the valve body is facilitated.
La figure 7 représente une vue en coupe d'un mode de réalisation de la valve de l'invention dans leαuel les éléments de liaison du clapet 2 sont identiques à ceux décrits en référence à la fiqure 6. Ces éléments de liaison coopèrent avec des moyens de guidage et de retenue constitués de deux glissières latérales symétriques en forme d'excavation (28,28') réalisées dans la masse de la paroi latérale interne du corps 1. Ces excavations (28,28') comportent sur au moins une partie de leur pourtour des flancs droits (19a, 19b - 19'a, 19 'b) formant butées et dont le rôle est également de limiter et d'orienter la course du clapet 2 pendant l'ouverture.FIG. 7 represents a cross-section view of an embodiment of the valve of the invention in the ααuel the connecting elements of the valve 2 are identical to those described with reference to FIG. 6. These connecting elements cooperate with guide and retaining means consisting of two symmetrical lateral slides in the form of an excavation (28,28 ') made in the mass of the internal lateral wall of the body 1. These excavations (28,28' ) have on at least part of their periphery straight flanks (19a, 19b - 19'a, 19 'b) forming stops and whose role is also to limit and orient the stroke of the valve 2 during opening.
La combinaison des excavations (28,28') et des oreilles (17,17') correspond à une articulation du type rotule.The combination of the excavations (28,28 ') and the ears (17,17') corresponds to a joint of the ball type.
Dans ce mode de réalisation, avec les flancs droits (19a, 19b), les butées d'arrêt deviennent inutiles et sont donc supprimées.In this embodiment, with the straight flanks (19a, 19b), the stops become unnecessary and are therefore eliminated.
Sur la figure 7, les trois positions du clapet 2 sont représentées.In Figure 7, the three positions of the valve 2 are shown.
Les orientations des flancs droits (19a, 19b) par rapport à l'axe YY' , sont choisies de telle sorte que la rotation du clapet 2 s'effectue conformément à ce qui a été décrit précédemment ; c'est-à-dire que la position de pleine ouverture est obtenue lorsque la partie postérieure 3 du clapet 2 est parallèle à l'axe YY'.The orientations of the straight flanks (19a, 19b) relative to the axis YY ', are chosen so that the rotation of the valve 2 takes place in accordance with what has been described previously; that is to say that the fully open position is obtained when the rear part 3 of the valve 2 is parallel to the axis YY '.
La valve de l'invention peut être réalisée en tout matériau biocompatible et par exemple en pyrolite de carbone ou en céramique. En outre, le disque cintrée plan peut être remplacé par un disque cintré à morphologie concave-convexe ou bien avec toute combinaison entre des surfaces plane, concave et convexe. The valve of the invention can be made of any biocompatible material and for example carbon pyrolite or ceramic. In addition, the curved flat disc can be replaced by a curved disc with concave-convex morphology or else with any combination between planar, concave and convex surfaces.

Claims

REVENDICATIONS 1. Valve cardiaque artificielle en matériau biocompatible du type comprenant : - un corps annulaire (1), - un clapet (2) logé de façon pivotante à l'intérieur dudit corps (1) et possédant des éléments de liaison destinés à coopérer avec des moyens de guidage et de retenue prévus sur la paroi latérale interne (4) du corps annulaire (1), caractérisée en ce que ledit clapet (2) est constitué d'un disque cintré suivant un axe XX' parallèle à l'un de ses diamètres avec un angle α compris entre 0 et 30°, de telle sorte que l'ouverture de la valve s'effectue en deux phases consécutives, la première phase correspondant à une rotation du clapet (2) autour du point de contact et d'articulation A de la partie postérieure (3) du clapet (2) avec le bord inférieur de la paroi latérale dudit corps jusqu'à ce que lesdits éléments de liaison soient en butée dans les moyens de guidage et de retenue, la deuxième phase correspondant à une rotation autour d'un axe ZZ' parallèle à l'axe XX' jusqu'à ce que la partie postérieure (3) du clapet (2) soit parallèle à l'axe YY' du corps (1). CLAIMS 1. Artificial heart valve made of biocompatible material of the type comprising: - an annular body (1), - a valve (2) pivotally housed inside said body (1) and having connecting elements intended to cooperate with guide and retaining means provided on the internal side wall (4) of the annular body (1), characterized in that said valve (2) consists of a disc curved along an axis XX 'parallel to one of its diameters with an angle α between 0 and 30 °, so that the opening of the valve takes place in two consecutive phases, the first phase corresponding to a rotation of the valve (2) around the point of contact and d hinge A of the rear part (3) of the valve (2) with the lower edge of the side wall of said body until said connecting elements are in abutment in the guide and retaining means, the second phase corresponding to a rotation around an axis ZZ 'parallel to the axis XX' until the rear part (3) of the valve (2) is parallel to the axis YY 'of the body (1).
2. Valve cardiaque selon la revendication 1, caractérisée en ce que ledit angle α est d ' environ 10° .2. Heart valve according to claim 1, characterized in that said angle α is about 10 °.
3. Valve cardiaque selon l'une des revendications précédentes,caractérisée en ce que lesdits moyens de guidage et de retenue sont constitués de deux glissières latérales symétriques réalisées dans la masse du corps et dans lesquelles les éléments de liaison du clapet sont engagés de façon mobile.3. Heart valve according to one of the preceding claims, characterized in that said guiding and retaining means consist of two symmetrical lateral slides produced in the body mass and in which the connecting elements of the valve are movably engaged .
4. Valve cardiaque selon la revendication 3, caractérisée en ce que lesdites glissières latérales symétriques correspondent à un arc du cercle de centre A et de rayon égal à la partie postérieure (3) du clapet (2).4. Heart valve according to claim 3, characterized in that said symmetrical lateral slides correspond to an arc of the circle of center A and of radius equal to the rear part (3) of the valve (2).
5. Valve cardiaque selon l'une des revendications5. Heart valve according to one of claims
1 à 4, caractérisée en ce que lesdits éléments de liaison du clapet sont constitués de deux pivots latéraux symétriαues (7,7') prévus sur L'axe ZZ'. 1 to 4, characterized in that said connecting elements of the valve consist of two symmetrical lateral pivots (7,7 ') provided on the axis ZZ'.
6. Valve cardiaque selon l'une des revendications précédentes, caractérisée en ce que ledit corps (1) possède deux butées d'arrêt (9,9') destinées à limiter et à orienter les deux phases de la rotation du clapet (2) et réalisées sur sa paroi latérale interne (4) au niveau de l'extrémité supérieure desdites glissières latérales symétriques.6. Heart valve according to one of the preceding claims, characterized in that said body (1) has two stops (9,9 ') intended to limit and orient the two phases of rotation of the valve (2) and produced on its internal side wall (4) at the upper end of said symmetrical side rails.
7. Valve cardiaque selon la revendication 3, caractérisée en ce que lesdites glissières latérales symétriques correspondent à des excavations (28,28') comportant, sur au moins une partie de leur pourtour, des flancs droits (19a, 19b - 19'a, 19' b) formant butées.7. Heart valve according to claim 3, characterized in that said symmetrical lateral slides correspond to excavations (28, 28 ′) comprising, on at least part of their periphery, straight sides (19a, 19b - 19'a, 19 'b) forming stops.
8. Valve cardiaque selon l'une des revendications 4 ou 7, caractérisée en ce que lesdits éléments de liaison du clapet (2) sont constitués de deux oreilles latérales (17,17') formant rotules, prévues sur l'axe ZZ' et réalisées dans la masse du clapet (2).8. Heart valve according to one of claims 4 or 7, characterized in that said valve connecting elements (2) consist of two lateral ears (17,17 ') forming ball joints, provided on the axis ZZ' and made in the mass of the valve (2).
9. Valve cardiaque selon l'une des revendications précédentes, caractérisée en ce que la paroi latérale dudit corps (1) annulaire a une forme qui suit sensiblement le profil du clapet (2) et présente une découpe partielle (10) de son bord inférieur formant butée au niveau du point de contact et d'articulation A avec la partie postérieure (3) du clapet (2).9. Heart valve according to one of the preceding claims, characterized in that the side wall of said annular body (1) has a shape which substantially follows the profile of the valve (2) and has a partial cutout (10) from its lower edge. forming a stop at the point of contact and articulation A with the rear part (3) of the valve (2).
10. Valve cardiaque selon l'une des revendications précédentes, caractérisée en ce que ledit corps possède un siège (6) ménagé sur le bord supérieur de sa paroi latérale interne (4) et destiné à faire reposer en position de fermeture le bord de la partie antérieure (5) du clapet (2).10. Heart valve according to one of the preceding claims, characterized in that said body has a seat (6) formed on the upper edge of its internal side wall (4) and intended to rest the closed edge of the anterior part (5) of the valve (2).
11. Valve cardiaque selon l'une des revendications précédentes, caractérisée en ce que le clapet est un disque cintré à morphologie plane, concave ou convexe. 11. Heart valve according to one of the preceding claims, characterized in that the valve is a curved disc with a flat, concave or convex morphology.
EP88910047A 1987-11-13 1988-11-14 Artificial cardiac valve Pending EP0388421A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8715728 1987-11-13
FR8715728A FR2623084B1 (en) 1987-11-13 1987-11-13 ARTIFICIAL HEART VALVE

Publications (1)

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EP0388421A1 true EP0388421A1 (en) 1990-09-26

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EP88402844A Expired - Lifetime EP0318351B1 (en) 1987-11-13 1988-11-14 Artificial heart valve
EP88910047A Pending EP0388421A1 (en) 1987-11-13 1988-11-14 Artificial cardiac valve

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EP88402844A Expired - Lifetime EP0318351B1 (en) 1987-11-13 1988-11-14 Artificial heart valve

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US (1) US5078738A (en)
EP (2) EP0318351B1 (en)
JP (1) JPH0753166B2 (en)
AT (1) ATE81272T1 (en)
BR (1) BR8807797A (en)
CA (1) CA1293343C (en)
DE (1) DE3875224T2 (en)
ES (1) ES2035344T3 (en)
FR (1) FR2623084B1 (en)
WO (1) WO1989004154A1 (en)

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Publication number Publication date
DE3875224T2 (en) 1993-03-18
ES2035344T3 (en) 1993-04-16
FR2623084B1 (en) 1990-04-13
BR8807797A (en) 1990-08-07
CA1293343C (en) 1991-12-24
EP0318351B1 (en) 1992-10-07
WO1989004154A1 (en) 1989-05-18
ATE81272T1 (en) 1992-10-15
JPH0753166B2 (en) 1995-06-07
DE3875224D1 (en) 1992-11-12
JPH03503489A (en) 1991-08-08
FR2623084A1 (en) 1989-05-19
EP0318351A1 (en) 1989-05-31
US5078738A (en) 1992-01-07

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