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EP1858449A1 - Intraparietal reinforcing device for biological cardiac prosthesis and reinforced biological heart valve prosthesis - Google Patents

Intraparietal reinforcing device for biological cardiac prosthesis and reinforced biological heart valve prosthesis

Info

Publication number
EP1858449A1
EP1858449A1 EP05708678A EP05708678A EP1858449A1 EP 1858449 A1 EP1858449 A1 EP 1858449A1 EP 05708678 A EP05708678 A EP 05708678A EP 05708678 A EP05708678 A EP 05708678A EP 1858449 A1 EP1858449 A1 EP 1858449A1
Authority
EP
European Patent Office
Prior art keywords
heart valve
biological
intraparietal
valve
base
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.)
Withdrawn
Application number
EP05708678A
Other languages
German (de)
French (fr)
Inventor
Raymond Andrieu
Afksendiyos Kalangos
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.)
Leman Cardiovascular SA
Original Assignee
Leman Cardiovascular SA
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 Leman Cardiovascular SA filed Critical Leman Cardiovascular SA
Publication of EP1858449A1 publication Critical patent/EP1858449A1/en
Withdrawn legal-status Critical Current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
    • A61F2/2412—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

Definitions

  • the present invention relates to an intraparietal reinforcement device intended to be integrated in a biological valve prosthesis comprising a biological heart valve whose valvular plane is formed by sheets attached laterally to a tubular outer wall by commissures.
  • the device is adapted to be placed within the organic tissue of this heart valve and has a base and a stabilizer portion mounted on the base and adapted to be inserted into the tubular outer wall of the heart valve and to strengthen the structure of the latter so as to maintain the shape of the heart valve after implantation.
  • the invention also relates to a biological valve prosthesis provided with such a device.
  • the present inventors have proposed a new principle for strengthening the biological part of the prosthesis, that is to say normally the animal heart valve, this principle of inserting a reinforcement device to the prosthesis. inside the heart valve tissue instead of using the animal valve without reinforcement in the case of non-stented prostheses or stenting on the valve surface in the case of stented prostheses.
  • the device for producing a biological prosthesis of this new kind essentially comprises a short leg on which is fixed a rod intended to be inserted inside the outer wall. tubular biological valve along a line of intersection of this wall with the commissures of the valve.
  • This reinforcement device allows the realization of reinforced biological valvular prostheses bringing together the advantages of both conventional non-stented and stented biological prostheses. Indeed, it allows, on the one hand, to produce biological prostheses with a maximum of the surface or even the volume available for their primary heart valve function, as for non-stented prostheses, because space is not occupied by a bulky device like a traditional stent.
  • the area around the point of intersection of the line of intersection of the tubular outer wall with the commissures of the heart valve and the valvular plane of the heart valve of the prosthetic valve is distinguished by a particular structure of the fibers that constitute it, this structure making the area fragile.
  • the insertion of a rod in this zone can cause dissections of the fibers and consequently damage in the organic tissue in this zone, which can adversely affect the stability and the quality of the prosthesis thus obtained and which can notably constitute primers of rupture of the commissures of the heart valve.
  • the object of the present invention is to obviate the aforementioned drawbacks and to create a reinforcement device for biological valvular prostheses which does not cause damage to the biological tissue of the biological valve and which allows a simple and rapid implantation of the cardiac prosthesis. thus obtained.
  • the present invention relates to an intraparietal reinforcement device for biological cardiac prostheses comprising the features set forth in claim 1, the stabilizing portion of the device including in particular at least two intraparietal stems adapted to be inserted into the organic tissue of the heart valve, these intraparietal stems being positioned on the base so as to be, once the device is in place on the heart valve, laterally offset from the point of intersection of the line of intersection of the tubular outer wall with the commissures of the heart valve and the valvular plane of the heart valve of the prosthetic valve, as well as biological valvular prostheses provided with at least one such device, as set forth in claim 8 and following.
  • the device may comprise a base consisting of a ring or a quasi-ring having an open portion around its periphery.
  • the base and / or a fastener attached to the second end of the stems of the reinforcing devices may be covered by a biological material such as pericardium.
  • a device is obtained that is suitable for rendering a biological heart prosthesis sufficiently stable and rigid to maintain it in its desired shape after implantation, without damaging the biological tissue of the biological heart valve and without resorting to a bulky conventional stent.
  • the device can be implanted, particularly in the case of a circular base, by a relatively simple and fast implantation technique, the biological prosthesis exposing in the embodiment with the metal parts covered by a biological material mainly than biological tissue to the human body after implantation.
  • Figures 1a and 1b schematically illustrate the principle and two different embodiments of an intraparietal reinforcement device for biological valvular prostheses.
  • Figure 2 shows a perspective view of a third embodiment of an intraparietal reinforcement device for biological valvular prostheses.
  • Figure 3 is a schematic perspective view of a biological valve prosthesis provided with an intraparietal reinforcement device of a fourth embodiment and placed, for example, between the aortic root and the ascending aorta.
  • the invention relates to a biological valvular prosthesis reinforced and adapted for the replacement of a heart valve.
  • a cardiac prosthesis can be implanted in the sigmoid (aortic), mitral or tricuspid position respecting the direction of the blood flow.
  • the invention relates first of all to the intraparietal reinforcement devices necessary for producing such cardiac prostheses. Before proceeding to the description of the intraparietal reinforcement devices and the cardiac prostheses thus obtained, it is nevertheless useful to briefly describe the natural structure of the human heart valve corresponding to that of the biological valve to be equipped with a view to replacing it, in order to of understand the arrangement of the intraparietal reinforcement device and its location in the reinforced biological valvular prosthesis.
  • Such a valve for example an animal aortic valve, or even the corresponding biological cardiac prosthesis is shown schematically in Figure 3, placed in the aorta 20 between the aortic root 21 and the ascending aorta 22.
  • the heart valve 10 comprises essentially three leaflets 11a, 11b and 11c forming the valvular plane and a tubular outer wall 12 originally forming part of the tubular wall of the animal aorta and surrounding the plane formed by the leaflets, the latter being at their outer end integral to this tubular outer wall 12. It further comprises, for each of the sheets 11a, 11b and 11c, substantially triangular vertical walls called commissures 13 which extend towards the center of the valve or the heart chamber for the mitral or tricuspid positions.
  • commissures 13 are integral, on the one hand, with the two ends of the sheets 11a, 11b and 11c oriented inside the valve or the cardiac cavity for the mitral or tricuspid positions and, on the other hand, of the tubular outer wall 12.
  • blood flow can propagate in the direction of the aortic root 21 to the ascending aorta 22, or from the atrium to the corresponding ventricular cavity, as indicated by the arrows in the figure. 3, while this is not possible in the opposite direction.
  • the valve serving as a biological part of the reinforced biological valvular prosthesis is often removed from the animal aorta and, in the case of a replacement of the aortic valve described here by way of example, the end of the tubular outer wall 12 oriented in the direction of blood flow and carrying the commissures 13 is normally cut in a sinusoidal form.
  • This allows, on the one hand, to integrate the sino-tubular junctions 14 corresponding to the highest points of contact, with respect to the valve plane, between the tubular outer wall 12 and the commissures 13 and, on the other hand, to provide space for the right coronary artery 23a respectively the left coronary artery 23b opening at the level of the right Valsalva sinus 24a respectively of the Valsalva sinus left 24b.
  • the portion of this wall 12 facing the non-coronal Valsalva sinus 24c may also include a sinusoidal shape.
  • FIGS. a and 1b Given this natural configuration of the aortic valve and, in general, biological heart valves used in biological cardiac prostheses, the structure of an intraparietal reinforcement device according to the present invention, as shown by way of example in FIGS. a and 1b, can be better understood.
  • Figure 1a shows a first embodiment of an intraparietal reinforcement device 1 according to the present invention which is intended to be integrated in a biological valve prosthesis comprising a biological heart valve 10 having a structure as described above.
  • This intraparietal reinforcement device 1 is adapted to be placed, at least partially, inside the organic tissue of this heart valve 10 because it comprises a base 3 and a stabilizing portion 2 mounted on the base 3
  • the stabilizing portion 2 is adapted to be inserted within the tubular outer wall 12 of the heart valve 10 and to strengthen the structure of the heart valve 10 so as to maintain the shape of the heart valve 10 after implantation.
  • the stabilizing portion 2 comprises at least two intraparietal stems 2a, 2b adapted to be inserted into the organic tissue of the heart valve 10, these intraparietal rods 2a, 2b being positioned on the base 3 so that, once the device is placed on the heart valve 10, laterally offset from the intersection point of the intersection line of the tubular outer wall 12 with the commissures 13 of the heart valve 10 and the valvular plane of the heart valve 10 of the valve prosthesis.
  • the fiber structure of this zone is not affected, resulting in a better stability and quality of the biological valve prosthesis. strengthened.
  • the order of magnitude of the lateral offset from the point of intersection is at least 2 mm. and may be up to about half the height between the sino-tubular junctions 14 and the minima in the sinusoidal shape of the tubular outer wall 12 between these junctions 14.
  • the tubular outer wall 12 shows a fairly constant stiffness and the exact location of the intraparietal rods 2a, 2b outside this sensitive zone is chosen so as to place the reinforcement device 1 sufficiently far from this zone while guaranteeing the desired stability of the cardiac prosthesis.
  • the intraparietal rods 2a, 2b forming the stabilizing portion 2 are preferably positioned on the base 3 with an identical lateral offset on either side of the point on this base 3 corresponding to the point of intersection once.
  • the device 1 being placed on the heart valve 10.
  • Figure 1a and in Figure 1b which shows a second embodiment of a reinforcing device 1 according to the present invention comprising more of two, in the set illustrated six intraparietal stems 2a-2f.
  • the number of rods 2 and their lateral offset from the intersection point can obviously be chosen differently from the illustrated configurations, including having an irregular lateral shift.
  • the location of the stems 2 can also go above the half-height quoted above between the sino-tubular junctions 14 and the minima in the sinusoidal form of the tubular outer wall 12 between these junctions 14.
  • the intraparietal rods 2 form a right angle relative to the base 3.
  • the rods 2 are laterally and parallel to each other line of intersection of the tubular outer wall 12 with the commissures 13 of the heart valve 10 of the valve prosthesis, once the device 1 is placed on the heart valve 10 to form a prosthesis reinforced valve.
  • this perpendicular arrangement between the rods 2 and the base 3, in which the rods 2 are also parallel to the axis of the heart valve 10 simplifies the placement of the device 1 on the heart valve 10.
  • the intraparietal stems 2 of an intraparietal reinforcement device 1 are preferably straight. They may also have a helical shape, so as to form a "miniature corkscrew” or they may include on their surface a helical portion, to stabilize the device 1 in the position in which it was introduced into the fabric of
  • the intraparietal stems 2 may comprise, at the second end not fixed to the base 3 and opposite the first end which serves as a point of attachment on the base 3, a pointed part adapted to pierce and to penetrate, without causing damage, the organic tissue of the heart valve.
  • the base 3 of such an intraparietal reinforcement device 1 may consist of a curved bar 3a, as shown in FIGS. 1a and 1b, or possibly straight, if the lateral offset of the stems 2 n is not important.
  • the base 3 may also preferably consist of a ring 3b, see FIG. 3, or a quasi-ring 3c having an open portion around its periphery, which makes it possible to have a positioning game on the cardiac valve 10, as shown in FIG. 2.
  • a circular base 3 in the form of a ring 3b or a quasi-ring 3c the placement of the reinforced valve prosthesis is amply simplified and accelerated for the surgeon practicing implantation due to the rigidity of the basic structure of the cardiac prosthesis.
  • An intraparietal reinforcement device 1 may also comprise at least one end portion in the form of a fastener 4 adapted to be fixed on the second end of the rods 2 in order to better secure them on the tubular outer wall 12.
  • this fastener plays, especially in the case where the second end of a rod 2 comprises a pointed part, the role of a cap to cover this pointed part and to guarantee the stability of the device 1 in the position in which it was introduced into the organic tissue of the heart valve 10.
  • the clip 4 may be straight or curved, the curvature corresponding to the curvature of the outer circumference of the heart valve 10 at the plane where the clip must be placed.
  • the fastener 4 can be placed substantially parallel to the base 3 or inclined so as to follow the sinusoidal shape of the wall tubular outer 12 on its end oriented in the direction of the flow of blood. It can be fixed on one or possibly several intraparietal rods 2, as shown in Figure 1b.
  • An intraparietal reinforcement device 1 is made of a material adapted to guarantee sufficient stability while having a certain flexibility, such as a flexible and / or semi-rigid and / or rigid polymer, or a flexible metal such as titanium. . It is produced in different sizes in order to have a set of reinforcing devices 1 for equipping biological valves 10 of corresponding sizes to provide all the sizes of cardiac prostheses required for surgical practice.
  • the embodiment comprising a base 3 in quasi-ring 3c has an additional clearance for the positioning of the device 1 on the heart valve 10. It remains now, after describing the reinforcing device 1 according to the present invention. as such, to describe in detail all of such a device 1 and a biological heart valve 10 forming a reinforced biological valvular prosthesis according to the present invention.
  • FIG. 3 shows, as indicated above, a schematic view of a biological valve prosthesis for the replacement, by way of example, of the aortic valve 10, provided with an intraparietal reinforcement device 1 according to the present invention and placed in the aorta 20, between the aortic root 21 and the ascending aorta 22.
  • This biological valvular prosthesis comprises a biological heart valve 10 whose valvular plane is, according to the general description above, formed by leaflets 11 attached laterally to a tubular outer wall 12 by commissures 13.
  • the heart valve 10 is provided with at least one intraparietal reinforcement device 1 of an embodiment described above.
  • the intraparietal stems 2 of the intraparietal reinforcement devices 1 are normally inserted inside the tubular outer wall 12 of the valve biological heartbeat 10 so as to be positioned parallel to the lines of intersection of this wall 12 with the commissures 13 of the heart valve 10, once the device 1 is put in place on the heart valve 10.
  • the base 3 of a device 1 is located in the lower part of the biological prosthesis at the level of the valve plane, this level also serving as the insertion point of the device 1 see rods 2 in the tissue of the heart valve 10.
  • the fasteners 4 are, if necessary, placed on the second end of the rods 2.
  • the length of a rod 2 of the device 1 depends on the size of the aortic valve, mitral or tricuspid to equip and the location of the rod along the tubular outer wall 12 of sinusoidal shape, the length normally being between 3 mm and 30 mm.
  • the thickness of the elements of the device is generally a few tenths of a millimeter.
  • the base 3 and / or, if appropriate, the fastener 4 of the intraparietal reinforcement devices 1 are covered by a biological material such as pericardium.
  • the biological prosthesis does not expose, due to the coverage of artificial parts by pericardium or any other suitable biological material, mainly biological tissue to the blood circuit and human tissue after implantation.
  • the base 3 and / or the fastener 4 of the intraparietal reinforcement devices may be covered by a fabric made of a synthetic material such as Teflon, Dacron, Goretex, etc.
  • An intraparietal reinforcement device and a reinforced biological valvular prosthesis thus obtained can be used for the replacement of the sigmoid valve of the aorta, mitral or tricuspid, the space occupied by the means of reinforcement of the cardiac prosthesis being minimized as it does not require a large conventional stent. As a result, the space reserved for the blood circulation is less obstructed, which is an important factor for the implanted patient.
  • such a device makes it possible to make a biological heart prosthesis sufficiently stable and rigid to maintain it in its desired shape after implantation without damaging the biological tissue of the biological heart valve, in particular the area around the point of inking of the commissures. .
  • a biological valvular prosthesis reinforced with the intraparietal reinforcement devices according to the present invention allows, by design, to be implanted in a relatively simple and rapid manner, in particular in the case of a circular base, the that the latter and the rods of the reinforcing device serve simultaneously as a means of reinforcement and locating means for the surgeon who must perform the implantation, with a precise orientation, in a place yet difficult to access within the body. natural orifice.
  • covering the metallic parts of the cardiac prosthesis with a biological material such as pericardium may allow mainly biological tissue to be exposed to the blood circuit and the human tissue only after the reinforced biological valve prosthesis has been implanted.

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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

The invention concerns an intraparietal reinforcing device (1) designed to incorporated in a biological valve replacement comprising a biological heart valve (10) whereof the valvular plane is formed by leaflets (11a, b, c) laterally attached to an outer tubular wall (12) by the commissures (13), as well as a biological prosthesis provided with such a device. The device is adapted to be set inside the organic tissue of the heart valve (10) by comprising a base (3) and a stabilizing part (2) mounted on the base (3) and adapted to be inserted inside the outer tubular wall (12) of the heart valve (10) and to reinforce the structure thereof so as to maintain the shape of the heart valve (10) after implantation. The stabilizing part (2) comprises at least two intraparietal rods (2a, 2b) adapted to be inserted in the organic tissue of the heart valve (10), said intraparietal rods (2) being positioned on the base (3) so as to be, once the device set on the heart valve (10), laterally offset relative to the point of intersection of the outer tubular wall (12) with the commissures (13) of the heart valve (10) and the valvular plane of the heart valve (10) of the valve replacement.

Description

Dispositif de renfort intraparîétal pour prothèse cardiaque biologique et prothèse cardiaque biologique renforcée Intraparetal reinforcement device for biological cardiac prosthesis and reinforced biological heart prosthesis
La présente invention concerne un dispositif de renfort intrapariétal destiné à être intégré dans une prothèse valvulaire biologique comportant une valvule cardiaque biologique dont le plan valvulaire est formé par des feuillets rattachés latéralement à une paroi externe tubulaire par des commissures. Le dispositif est adapté à être placé à l'intérieur du tissu organique de cette valvule cardiaque et comporte une base et une partie stabilisatrice montée sur la base et adaptée à être insérée à l'intérieur de la paroi externe tubulaire de la valvule cardiaque et à renforcer la structure de cette dernière de manière à maintenir la forme de la valvule cardiaque après implantation. L'invention concerne également une prothèse valvulaire biologique munie d'un tel dispositif.The present invention relates to an intraparietal reinforcement device intended to be integrated in a biological valve prosthesis comprising a biological heart valve whose valvular plane is formed by sheets attached laterally to a tubular outer wall by commissures. The device is adapted to be placed within the organic tissue of this heart valve and has a base and a stabilizer portion mounted on the base and adapted to be inserted into the tubular outer wall of the heart valve and to strengthen the structure of the latter so as to maintain the shape of the heart valve after implantation. The invention also relates to a biological valve prosthesis provided with such a device.
Dans le domaine de la chirurgie cardiaque concernant le remplacement de la valvule du cœur on connaît actuellement essentiellement des prothèses valvulaires artificielles, constituées normalement d'une valve métallique couverte de tissu synthétique, et des prothèses valvulaires biologiques, comportant normalement une valvule d'origine animale préparée en vue de son implantation dans le corps humain. Ces prothèses biologiques sont classées en prothèses stentées d'une part et prothèses non-stentées d'autre part.In the field of cardiac surgery concerning the replacement of the heart valve, artificial valvular prostheses, normally consisting of a metal valve covered with synthetic tissue, and biological valvular prostheses, normally comprising a valve of animal origin, are nowadays mainly known. prepared for implantation in the human body. These biological prostheses are classified into prostheses stented on the one hand and non-stented prostheses on the other hand.
Par rapport à la catégorie de prothèses biologiques, les présents inventeurs ont proposé un nouveau principe pour renforcer la partie biologique de la prothèse, c'est-à-dire normalement la valvule cardiaque animale, ce principe consistant à insérer un dispositif de renfort à l'intérieur du tissu de la valvule cardiaque au lieu d'utiliser la valvule animale sans renforcement dans le cas des prothèses non-stentées ou de fixer un stent à la surface de la valvule dans le cas des prothèses stentées. Le dispositif permettant la réalisation d'une prothèse biologique de ce nouveau genre comprend essentiellement une courte jambe sur laquelle est fixée une tige destinée à être insérée à l'intérieur de la paroi externe tubulaire de la valvule biologique le long d'une ligne d'intersection de cette paroi avec les commissures de la valvule. Ce dispositif de renfort permet la réalisation des prothèses valvulaires biologiques renforcées réunissant les avantages à la fois des prothèses biologiques conventionnelles non-stentées et stentées. En effet, il permet, d'une part, de réaliser des prothèses biologiques disposant d'un maximum de la surface voire du volume disponible pour leur fonction primaire de valvule cardiaque, comme pour les prothèses non-stentées, du fait que l'espace n'est pas occupé par un dispositif volumineux comme un stent traditionnel. D'autre part, il permet simultanément, sans recours à un stent conventionnel, de rigidifier et maintenir les prothèses dans leur forme voulue permettant ainsi d'appliquer la technique d'implantation relativement simple et rapide des prothèses biologiques stentées actuelles à ce nouveau type de prothèses biologiques renforcées, du fait que le renforcement de la valvule cardiaque biologique ne nécessite qu'une suture autour du plan valvulaire au lieu de deux dans le cas des prothèses non-stentées. Dans ce contexte, il s'est pourtant avéré que l'insertion de ce dispositif de renfort dans la paroi externe de la valvule biologique peut, dans certains cas, causer des inconvénients. En effet, il s'est avéré que la zone autour du point d'intersection de la ligne d'intersection de la paroi externe tubulaire avec les commissures de la valvule cardiaque et du plan valvulaire de la valvule cardiaque de la prothèse valvulaire, ce point étant nommé dans la suite du document le « point d'encrage des commissures » ou le « point d'intersection », se distingue par une structure particulière des fibres qui la constituent, cette structure rendant la zone fragile. L'insertion d'une tige dans cette zone peut causer des dissections des fibres et par conséquent des dommages dans le tissu organique ce cette zone qui peuvent nuire à la stabilité et la qualité de la prothèse ainsi obtenue et qui peuvent notamment constituer des amorces de rupture des commissures de la valvule cardiaque.Compared to the category of biological prostheses, the present inventors have proposed a new principle for strengthening the biological part of the prosthesis, that is to say normally the animal heart valve, this principle of inserting a reinforcement device to the prosthesis. inside the heart valve tissue instead of using the animal valve without reinforcement in the case of non-stented prostheses or stenting on the valve surface in the case of stented prostheses. The device for producing a biological prosthesis of this new kind essentially comprises a short leg on which is fixed a rod intended to be inserted inside the outer wall. tubular biological valve along a line of intersection of this wall with the commissures of the valve. This reinforcement device allows the realization of reinforced biological valvular prostheses bringing together the advantages of both conventional non-stented and stented biological prostheses. Indeed, it allows, on the one hand, to produce biological prostheses with a maximum of the surface or even the volume available for their primary heart valve function, as for non-stented prostheses, because space is not occupied by a bulky device like a traditional stent. On the other hand, it allows simultaneously, without recourse to a conventional stent, to stiffen and maintain the prostheses in their desired form thus allowing to apply the relatively simple and fast implantation technique of the current stented prostheses biological this new type of Reinforced biologic prostheses, because the strengthening of the biological heart valve requires only a suture around the valve plane instead of two in the case of non-stented prostheses. In this context, however, it has been found that the insertion of this reinforcement device into the outer wall of the biological valve can, in some cases, cause inconvenience. Indeed, it turned out that the area around the point of intersection of the line of intersection of the tubular outer wall with the commissures of the heart valve and the valvular plane of the heart valve of the prosthetic valve, this point being named in the rest of the document the "point of inking commissures" or the "point of intersection", is distinguished by a particular structure of the fibers that constitute it, this structure making the area fragile. The insertion of a rod in this zone can cause dissections of the fibers and consequently damage in the organic tissue in this zone, which can adversely affect the stability and the quality of the prosthesis thus obtained and which can notably constitute primers of rupture of the commissures of the heart valve.
De plus, du fait que la tige d'un tel dispositif de renfort est fixée sur une jambe relativement courte, l'implantation d'une prothèse munie de tels dispositifs est relativement plus difficile, par conséquent le chirurgien pratiquant cette implantation doit être expérimenté.In addition, because the stem of such a reinforcing device is fixed on a relatively short leg, the implantation of a prosthesis provided with such devices is relatively more difficult, therefore the surgeon practicing this implantation must be experienced.
Le but de la présente invention est d'obvier aux inconvénients précités et de créer un dispositif de renfort pour des prothèses valvulaires biologiques qui ne provoque pas de dommages au tissu organique de la valvule biologique et qui permette une implantation simple et rapide de la prothèse cardiaque ainsi obtenue.The object of the present invention is to obviate the aforementioned drawbacks and to create a reinforcement device for biological valvular prostheses which does not cause damage to the biological tissue of the biological valve and which allows a simple and rapid implantation of the cardiac prosthesis. thus obtained.
La présente invention a pour objet un dispositif de renfort intrapariétal pour prothèses cardiaques biologiques comprenant les caractéristiques énoncées à la revendication 1 , la partie stabilisatrice du dispositif comportant notamment au moins deux tiges intrapariétales adaptées à être insérées dans le tissu organique de la valvule cardiaque, ces tiges intrapariétales étant positionnées sur la base de manière à être, une fois le dispositif étant mis en place sur la valvule cardiaque, latéralement décalées par rapport au point d'intersection de la ligne d'intersection de la paroi externe tubulaire avec les commissures de la valvule cardiaque et du plan valvulaire de la valvule cardiaque de la prothèse valvulaire, ainsi que des prothèses valvulaires biologiques munies d'au moins un tel dispositif, comme énoncé à la revendication 8 et suivantes.The present invention relates to an intraparietal reinforcement device for biological cardiac prostheses comprising the features set forth in claim 1, the stabilizing portion of the device including in particular at least two intraparietal stems adapted to be inserted into the organic tissue of the heart valve, these intraparietal stems being positioned on the base so as to be, once the device is in place on the heart valve, laterally offset from the point of intersection of the line of intersection of the tubular outer wall with the commissures of the heart valve and the valvular plane of the heart valve of the prosthetic valve, as well as biological valvular prostheses provided with at least one such device, as set forth in claim 8 and following.
De plus, le dispositif peut comprendre une base constituée d'un anneau ou d'un quasi-anneau ayant une partie ouverte sur son pourtour.In addition, the device may comprise a base consisting of a ring or a quasi-ring having an open portion around its periphery.
La base et/ou une attache fixée à la deuxième extrémité des tiges des dispositifs de renfort peuvent être couvertes par un matériau biologique comme du péricarde.The base and / or a fastener attached to the second end of the stems of the reinforcing devices may be covered by a biological material such as pericardium.
Par ces mesures, on obtient un dispositif adapté à rendre une prothèse cardiaque biologique suffisamment stable et rigide pour la maintenir dans sa forme souhaitée après l'implantation, ceci sans endommager le tissu organique de la valvule cardiaque biologique et sans recours à un stent conventionnel volumineux. En même temps, le dispositif peut être implanté, notamment dans le cas d'une base circulaire, par une technique d'implantation relativement simple et rapide, la prothèse biologique n'exposant dans la forme d'exécution avec couverture des parties métalliques par un matériau biologique principalement que du tissu biologique au corps humain après l'implantation.By these measures, a device is obtained that is suitable for rendering a biological heart prosthesis sufficiently stable and rigid to maintain it in its desired shape after implantation, without damaging the biological tissue of the biological heart valve and without resorting to a bulky conventional stent. . At the same time, the device can be implanted, particularly in the case of a circular base, by a relatively simple and fast implantation technique, the biological prosthesis exposing in the embodiment with the metal parts covered by a biological material mainly than biological tissue to the human body after implantation.
D'autres avantages ressortent des caractéristiques exprimées dans les revendications dépendantes et de la description exposant ci-après l'invention plus en détail à l'aide de dessins.Other advantages emerge from the features expressed in the dependent claims and from the description which sets forth the invention in more detail with the aid of drawings.
Les dessins annexés illustrent schématiquement et à titre d'exemple, plusieurs formes d'exécution de l'invention.The accompanying drawings illustrate schematically and by way of example, several embodiments of the invention.
Les figures 1a et 1 b illustrent schématiquement le principe et deux formes d'exécution différentes d'un dispositif de renfort intrapariétal pour prothèses valvulaires biologiques.Figures 1a and 1b schematically illustrate the principle and two different embodiments of an intraparietal reinforcement device for biological valvular prostheses.
La figure 2 montre une vue en perspective d'une troisième forme d'exécution d'un dispositif de renfort intrapariétal pour prothèses valvulaires biologiques. La figure 3 est une vue schématique en perspective d'une prothèse valvulaire biologique munie d'un dispositif de renfort intrapariétal d'une quatrième forme d'exécution et placée, à titre d'exemple, entre la racine aortique et l'aorte ascendante.Figure 2 shows a perspective view of a third embodiment of an intraparietal reinforcement device for biological valvular prostheses. Figure 3 is a schematic perspective view of a biological valve prosthesis provided with an intraparietal reinforcement device of a fourth embodiment and placed, for example, between the aortic root and the ascending aorta.
L'invention va maintenant être décrite en détail en référence aux dessins annexés. Elle concerne une prothèse valvulaire biologique renforcée et adaptée pour le remplacement d'une valvule du cœur. Une telle prothèse cardiaque peut être implantée en position sigmoïde (aortique), mitrale ou tricuspide en respectant la direction du flux sanguin. L'invention concerne d'abord les dispositifs de renfort intrapariétal nécessaire pour réaliser des telles prothèses cardiaques. Avant de procéder à la description des dispositifs de renfort intrapariétal et des prothèses cardiaques ainsi obtenues, il est pourtant utile de décrire brièvement la structure naturelle de la valvule cardiaque humaine correspondant à celle de la valvule biologique à équiper en vue de la remplacer, ceci afin de comprendre l'agencement du dispositif de renfort intrapariétal et son emplacement dans la prothèse valvulaire biologique renforcée.The invention will now be described in detail with reference to the accompanying drawings. It relates to a biological valvular prosthesis reinforced and adapted for the replacement of a heart valve. Such a cardiac prosthesis can be implanted in the sigmoid (aortic), mitral or tricuspid position respecting the direction of the blood flow. The invention relates first of all to the intraparietal reinforcement devices necessary for producing such cardiac prostheses. Before proceeding to the description of the intraparietal reinforcement devices and the cardiac prostheses thus obtained, it is nevertheless useful to briefly describe the natural structure of the human heart valve corresponding to that of the biological valve to be equipped with a view to replacing it, in order to of understand the arrangement of the intraparietal reinforcement device and its location in the reinforced biological valvular prosthesis.
Une telle valvule, à titre d'exemple une valvule aortique animale, voire la prothèse cardiaque biologique correspondante est représentée schématiquement à la figure 3, placée dans l'aorte 20 entre la racine aortique 21 et l'aorte ascendante 22. La valvule cardiaque 10 comprend essentiellement trois feuillets 11 a, 11 b et 11 c formant le plan valvulaire et une paroi externe tubulaire 12 faisant originalement partie de la paroi tubulaire de l'aorte animale et entourant le plan formé par les feuillets, ces derniers étant à leur extrémité extérieure solidaires de cette paroi externe tubulaire 12. Elle comprend encore, pour chacun des feuillets 11 a, 11 b et 11 c, des parois verticales sensiblement triangulaires appelées commissures 13 qui s'étendent vers le centre de la valve ou de la cavité cardiaque pour les positions mitrale ou tricuspide. Ces commissures 13 sont solidaires, d'une part, des deux extrémités des feuillets 11 a, 11 b et 11 c orientées à l'intérieur de la valve ou de la cavité cardiaque pour les positions mitrale ou tricuspide et, d'autre part, de la paroi externe tubulaire 12. Ainsi, le flux du sang peut se propager dans le sens de la racine aortique 21 vers l'aorte ascendante 22, ou de l'oreillette vers la cavité ventriculaire correspondante, comme indiqué par les flèches dans la figure 3, tandis que ceci n'est pas possible dans le sens inverse. La valvule servant comme partie biologique de la prothèse valvulaire biologique renforcée est souvent prélevée de l'aorte animale et, dans le cas d'un remplacement de la valve aortique décrit ici à titre d'exemple, l'extrémité de la paroi externe tubulaire 12 orientée dans le sens du flux du sang et portant les commissures 13 est normalement coupée suivant une forme sinusoïdale. Ceci permet, d'une part, d'intégrer les jonctions sino-tubulaires 14 correspondants aux points de contact les plus élevés, par rapport au plan valvulaire, entre la paroi externe tubulaire 12 et les commissures 13 et, d'autre part, de ménager de l'espace pour l'artère coronaire droite 23a respectivement l'artère coronaire gauche 23b débouchant au niveau du sinus de Valsalva droit 24a respectivement du sinus de Valsalva gauche 24b. La partie de cette paroi 12 en face du sinus de Valsalva non- coronaire 24c peut également comporter une forme sinusoïdale.Such a valve, for example an animal aortic valve, or even the corresponding biological cardiac prosthesis is shown schematically in Figure 3, placed in the aorta 20 between the aortic root 21 and the ascending aorta 22. The heart valve 10 comprises essentially three leaflets 11a, 11b and 11c forming the valvular plane and a tubular outer wall 12 originally forming part of the tubular wall of the animal aorta and surrounding the plane formed by the leaflets, the latter being at their outer end integral to this tubular outer wall 12. It further comprises, for each of the sheets 11a, 11b and 11c, substantially triangular vertical walls called commissures 13 which extend towards the center of the valve or the heart chamber for the mitral or tricuspid positions. These commissures 13 are integral, on the one hand, with the two ends of the sheets 11a, 11b and 11c oriented inside the valve or the cardiac cavity for the mitral or tricuspid positions and, on the other hand, of the tubular outer wall 12. Thus, blood flow can propagate in the direction of the aortic root 21 to the ascending aorta 22, or from the atrium to the corresponding ventricular cavity, as indicated by the arrows in the figure. 3, while this is not possible in the opposite direction. The valve serving as a biological part of the reinforced biological valvular prosthesis is often removed from the animal aorta and, in the case of a replacement of the aortic valve described here by way of example, the end of the tubular outer wall 12 oriented in the direction of blood flow and carrying the commissures 13 is normally cut in a sinusoidal form. This allows, on the one hand, to integrate the sino-tubular junctions 14 corresponding to the highest points of contact, with respect to the valve plane, between the tubular outer wall 12 and the commissures 13 and, on the other hand, to provide space for the right coronary artery 23a respectively the left coronary artery 23b opening at the level of the right Valsalva sinus 24a respectively of the Valsalva sinus left 24b. The portion of this wall 12 facing the non-coronal Valsalva sinus 24c may also include a sinusoidal shape.
Etant donné cette configuration naturelle de la valvule aortique et, en général, des valvules cardiaques biologiques 10 utilisés dans les prothèses cardiaques biologiques, la structure d'un dispositif de renfort intrapariétal selon la présente invention, comme représenté à titre d'exemple aux figures 1 a et 1 b, peut être mieux comprise.Given this natural configuration of the aortic valve and, in general, biological heart valves used in biological cardiac prostheses, the structure of an intraparietal reinforcement device according to the present invention, as shown by way of example in FIGS. a and 1b, can be better understood.
En effet, la figure 1a montre une première forme d'exécution d'un dispositif de renfort intrapariétal 1 selon la présente invention qui est destiné à être intégré dans une prothèse valvulaire biologique comportant une valvule cardiaque biologique 10 ayant une structure comme décrit ci-dessus. Ce dispositif de renfort intrapariétal 1 est adapté à être placé, tout au moins partiellement, à l'intérieur du tissu organique de cette valvule cardiaque 10 du fait qu'il comporte une base 3 ainsi qu'une partie stabilisatrice 2 montée sur la base 3. La partie stabilisatrice 2 est adaptée à être insérée à l'intérieur de la paroi externe tubulaire 12 de la valvule cardiaque 10 et à renforcer la structure de cette dernière de manière à maintenir la forme de la valvule cardiaque 10 après implantation.Indeed, Figure 1a shows a first embodiment of an intraparietal reinforcement device 1 according to the present invention which is intended to be integrated in a biological valve prosthesis comprising a biological heart valve 10 having a structure as described above. . This intraparietal reinforcement device 1 is adapted to be placed, at least partially, inside the organic tissue of this heart valve 10 because it comprises a base 3 and a stabilizing portion 2 mounted on the base 3 The stabilizing portion 2 is adapted to be inserted within the tubular outer wall 12 of the heart valve 10 and to strengthen the structure of the heart valve 10 so as to maintain the shape of the heart valve 10 after implantation.
Afin de ne pas endommager la zone fragile située autour du point d'encrage des commissures 13 mentionnée en introduction, la partie stabilisatrice 2 comprend au moins deux tiges intrapariétales 2a, 2b adaptées à être insérées dans le tissu organique de la valvule cardiaque 10, ces tiges intrapariétales 2a, 2b étant positionnées sur la base 3 de manière à ce qu'elles soient, une fois le dispositif étant mis en place sur la valvule cardiaque 10, latéralement décalées par rapport au point d'intersection de la ligne d'intersection de la paroi externe tubulaire 12 avec les commissures 13 de la valvule cardiaque 10 et du plan valvulaire de la valvule cardiaque 10 de la prothèse valvulaire.In order not to damage the fragile zone located around the anchoring point of the commissures 13 mentioned in the introduction, the stabilizing portion 2 comprises at least two intraparietal stems 2a, 2b adapted to be inserted into the organic tissue of the heart valve 10, these intraparietal rods 2a, 2b being positioned on the base 3 so that, once the device is placed on the heart valve 10, laterally offset from the intersection point of the intersection line of the tubular outer wall 12 with the commissures 13 of the heart valve 10 and the valvular plane of the heart valve 10 of the valve prosthesis.
Du fait de ce décalage latéral des tiges intrapariétales 2a, 2b par rapport au point d'intersection, la structure des fibres des cette zone n'est pas touchée, résultant en une meilleure stabilité et qualité de la prothèse valvulaire biologique renforcée. Pour une circonférence d'environ 3 cm à 4 cm de la paroi externe tubulaire 12 pour une valvule cardiaque 10 destiné à une personne adulte, l'ordre de grandeur du décalage latéral par rapport au point d'intersection est d'au moins 2 mm et peut aller jusqu'à environ mi-hauteur entre les jonctions sino-tubulaires 14 et les minimas dans la forme sinusoïdale de la paroi externe tubulaire 12 entre ces jonctions 14. En effet, en dehors de la zone fragile autour du point d'intersection, la paroi externe tubulaire 12 montre une rigidité assez constante et l'emplacement exact des tiges intrapariétales 2a, 2b en dehors de cette zone sensible est choisi de manière à placer le dispositif de renfort 1 suffisamment loin de cette zone tout en garantissant la stabilité souhaitée de la prothèse cardiaque.Due to this lateral shift of the intraparietal stems 2a, 2b with respect to the point of intersection, the fiber structure of this zone is not affected, resulting in a better stability and quality of the biological valve prosthesis. strengthened. For a circumference of about 3 cm to 4 cm from the tubular outer wall 12 for a heart valve 10 for an adult, the order of magnitude of the lateral offset from the point of intersection is at least 2 mm. and may be up to about half the height between the sino-tubular junctions 14 and the minima in the sinusoidal shape of the tubular outer wall 12 between these junctions 14. In fact, outside the fragile zone around the point of intersection , the tubular outer wall 12 shows a fairly constant stiffness and the exact location of the intraparietal rods 2a, 2b outside this sensitive zone is chosen so as to place the reinforcement device 1 sufficiently far from this zone while guaranteeing the desired stability of the cardiac prosthesis.
Les tiges intrapariétales 2a, 2b formant la partie stabilisatrice 2 sont, de préférence, positionnées sur la base 3 avec un décalage latéral identique de l'un et de l'autre coté du point sur cette base 3 correspondant au point d'intersection une fois le dispositif 1 étant mis en place sur la valvule cardiaque 10. Ceci est illustré schématiquement dans la figure 1 a ainsi que dans la figure 1 b qui montre une deuxième forme d'exécution d'un dispositif de renfort 1 selon la présente invention comportant plus de deux, dans l'ensemble illustré six tiges intrapariétales 2a-2f. Par contre, le nombre de tiges 2 ainsi que leur décalage latéral par rapport au point d'intersection peut évidemment être choisi de façon différente des configurations illustrées, notamment en ayant un décalage latéral irrégulier. Pour le cas de plus de deux tiges intrapariétales 2, notamment, l'emplacement des tiges 2 peut aussi aller au-dessus de la mi-hauteur citée ci-dessus entre les jonctions sino-tubulaires 14 et les minimas dans la forme sinusoïdale de la paroi externe tubulaire 12 entre ces jonctions 14. De préférence, les tiges intrapariétales 2 forment un angle droit par rapport à la base 3. Ainsi, les tiges 2 sont latéralement et parallèlement décalées par rapport à chaque ligne d'intersection de la paroi externe tubulaire 12 avec les commissures 13 de la valvule cardiaque 10 de la prothèse valvulaire, une fois le dispositif 1 mis en place sur la valvule cardiaque 10 pour former une prothèse valvulaire renforcée. En effet, cet agencement perpendiculaire entre les tiges 2 et la base 3, dans lequel les tiges 2 sont également parallèles à l'axe de la valvule cardiaque 10, simplifie la mise en place du dispositif 1 sur la valvule cardiaque 10.The intraparietal rods 2a, 2b forming the stabilizing portion 2 are preferably positioned on the base 3 with an identical lateral offset on either side of the point on this base 3 corresponding to the point of intersection once. the device 1 being placed on the heart valve 10. This is illustrated schematically in Figure 1a and in Figure 1b which shows a second embodiment of a reinforcing device 1 according to the present invention comprising more of two, in the set illustrated six intraparietal stems 2a-2f. By cons, the number of rods 2 and their lateral offset from the intersection point can obviously be chosen differently from the illustrated configurations, including having an irregular lateral shift. For the case of more than two intraparietal stems 2, in particular, the location of the stems 2 can also go above the half-height quoted above between the sino-tubular junctions 14 and the minima in the sinusoidal form of the tubular outer wall 12 between these junctions 14. Preferably, the intraparietal rods 2 form a right angle relative to the base 3. Thus, the rods 2 are laterally and parallel to each other line of intersection of the tubular outer wall 12 with the commissures 13 of the heart valve 10 of the valve prosthesis, once the device 1 is placed on the heart valve 10 to form a prosthesis reinforced valve. Indeed, this perpendicular arrangement between the rods 2 and the base 3, in which the rods 2 are also parallel to the axis of the heart valve 10, simplifies the placement of the device 1 on the heart valve 10.
Les tiges intrapariétales 2 d'un dispositif de renfort intrapariétal 1 selon la présente invention sont, de préférence, droites. Ils pourront également avoir une forme hélicoïdale, de manière à former un « tire-bouchon en miniature » ou ils pourront comprendre sur leur surface une partie hélicoïdale, afin de stabiliser le dispositif 1 dans la position dans laquelle il a été introduit dans le tissu de la valvule cardiaque 10. De plus, les tiges intrapariétales 2 peuvent comporter, à la deuxième extrémité non-fixée à la base 3 et opposée à la première extrémité qui sert de point de fixation sur la base 3, une partie pointue adaptée à percer et à pénétrer, sans causer de dommages, le tissu organique de la valvule cardiaque.The intraparietal stems 2 of an intraparietal reinforcement device 1 according to the present invention are preferably straight. They may also have a helical shape, so as to form a "miniature corkscrew" or they may include on their surface a helical portion, to stabilize the device 1 in the position in which it was introduced into the fabric of In addition, the intraparietal stems 2 may comprise, at the second end not fixed to the base 3 and opposite the first end which serves as a point of attachment on the base 3, a pointed part adapted to pierce and to penetrate, without causing damage, the organic tissue of the heart valve.
En ce qui concerne la base 3 d'un tel dispositif de renfort intrapariétal 1 , elle peut être constituée d'une barre 3a courbée, comme illustré aux figures 1 a et 1 b, ou éventuellement droite, si le décalage latéral des tiges 2 n'est pas important.As regards the base 3 of such an intraparietal reinforcement device 1, it may consist of a curved bar 3a, as shown in FIGS. 1a and 1b, or possibly straight, if the lateral offset of the stems 2 n is not important.
La base 3 peut également être constituée, de préférence, d'un anneau 3b, voir la figure 3, ou d'un quasi-anneau 3c ayant une partie ouverte sur son pourtour, ce qui permet de disposer d'un jeu de positionnement sur la valvule cardiaque 10, comme illustré à la figure 2. Dans le cas d'une base circulaire 3 en forme d'anneau 3b ou de quasi-anneau 3c, la mise en place de la prothèse valvulaire renforcée se trouve amplement simplifiée et accélérée pour le chirurgien pratiquant l'implantation du fait de la rigidité de la structure de base de la prothèse cardiaque.The base 3 may also preferably consist of a ring 3b, see FIG. 3, or a quasi-ring 3c having an open portion around its periphery, which makes it possible to have a positioning game on the cardiac valve 10, as shown in FIG. 2. In the case of a circular base 3 in the form of a ring 3b or a quasi-ring 3c, the placement of the reinforced valve prosthesis is amply simplified and accelerated for the surgeon practicing implantation due to the rigidity of the basic structure of the cardiac prosthesis.
Un dispositif de renfort intrapariétal 1 selon la présente invention peut aussi comprendre au moins une partie terminale sous forme d'une attache 4 adaptée à être fixée sur la deuxième extrémité des tiges 2 en vue de mieux les sécuriser sur la paroi externe tubulaire 12. Ainsi, cette attache joue, notamment dans le cas où la deuxième extrémité d'une tige 2 comprend une partie pointue, le rôle d'un capuchon afin de recouvrir cette partie pointue et de garantir la stabilité du dispositif 1 dans la position dans laquelle il a été introduit dans le tissu organique de la valvule cardiaque 10. L'attache 4 peut être droite ou courbée, la courbure correspondant à la courbure de la circonférence extérieure de la valvule cardiaque 10 au niveau du plan où l'attache doit être placée. En ce qui concerne le positionnement d'une telle attache sur un dispositif de renfort 1 selon la présente invention, l'attache 4 peut être placée de manière sensiblement parallèle à la base 3 ou de façon inclinée afin de suivre la forme sinusoïdale de la paroi externe tubulaire 12 sur son extrémité orientée dans le sens du flux du sang. Elle peut être fixée sur une seule ou éventuellement plusieurs tiges intrapariétales 2, comme illustré à la figure 1 b.An intraparietal reinforcement device 1 according to the present invention may also comprise at least one end portion in the form of a fastener 4 adapted to be fixed on the second end of the rods 2 in order to better secure them on the tubular outer wall 12. , this fastener plays, especially in the case where the second end of a rod 2 comprises a pointed part, the role of a cap to cover this pointed part and to guarantee the stability of the device 1 in the position in which it was introduced into the organic tissue of the heart valve 10. The clip 4 may be straight or curved, the curvature corresponding to the curvature of the outer circumference of the heart valve 10 at the plane where the clip must be placed. As regards the positioning of such a fastener on a reinforcing device 1 according to the present invention, the fastener 4 can be placed substantially parallel to the base 3 or inclined so as to follow the sinusoidal shape of the wall tubular outer 12 on its end oriented in the direction of the flow of blood. It can be fixed on one or possibly several intraparietal rods 2, as shown in Figure 1b.
Un dispositif de renfort intrapariétal 1 selon la présente invention est réalisé en un matériau adapté pour garantir une stabilité suffisante tout en ayant une certaine souplesse, comme un polymère souple ou/et semi-rigide et/ou rigide, ou un métal souple comme le Titane. Il est produit en différentes tailles afin de disposer d'un set de dispositifs de renfort 1 permettant d'équiper des valvules biologiques 10 de tailles correspondantes pour mettre à disposition toutes les tailles de prothèses cardiaques que nécessite la pratique chirurgicale. De plus, la forme d'exécution comportant une base 3 en quasi-anneau 3c dispose d'un jeu supplémentaire pour le positionnement du dispositif 1 sur la valvule cardiaque 10. II reste maintenant, après avoir décrit le dispositif de renfort 1 selon la présente invention en tant que tel, de décrire en détail l'ensemble d'un tel dispositif 1 et d'une valvule cardiaque biologique 10 formant une prothèse valvulaire biologique renforcée selon la présente invention.An intraparietal reinforcement device 1 according to the present invention is made of a material adapted to guarantee sufficient stability while having a certain flexibility, such as a flexible and / or semi-rigid and / or rigid polymer, or a flexible metal such as titanium. . It is produced in different sizes in order to have a set of reinforcing devices 1 for equipping biological valves 10 of corresponding sizes to provide all the sizes of cardiac prostheses required for surgical practice. In addition, the embodiment comprising a base 3 in quasi-ring 3c has an additional clearance for the positioning of the device 1 on the heart valve 10. It remains now, after describing the reinforcing device 1 according to the present invention. as such, to describe in detail all of such a device 1 and a biological heart valve 10 forming a reinforced biological valvular prosthesis according to the present invention.
La figure 3 montre, comme indiqué ci-dessus, une vue schématique d'une prothèse valvulaire biologique pour le remplacement, à titre d'exemple, de la valve aortique 10, munie d'un dispositif de renfort intrapariétal 1 selon la présente invention et placée dans l'aorte 20, entre la racine aortique 21 et l'aorte ascendante 22. Cette prothèse valvulaire biologique comporte une valvule cardiaque biologique 10 dont le plan valvulaire est, conformément à la description générale ci-dessus, formé par des feuillets 11 rattachés latéralement à une paroi externe tubulaire 12 par des commissures 13. La valvule cardiaque 10 est munie d'au moins un dispositif de renfort intrapariétal 1 d'une forme d'exécution décrite ci- dessus. Elle peut être équipée de trois dispositifs 1 selon les formes d'exécution illustrées aux figures 1a et 1b ayant une barre 3a comme base 3 ou, dans l'exécution préférée et illustrée à la figure 3, d'un seul dispositif de renfort 1 ayant une base 3 en forme d'anneau 3b (figure 3) ou de quasi-anneau 3c (figure 2). En ce qui concerne la partie biologique de la prothèse, il s'agit dans la plupart des cas d'une valvule cardiaque 10 d'origine animale, en particulier d'une valvule aortique porcine, qui est ensuite équipée, lors d'un traitement préalable avant l'implantation, d'un ou de plusieurs dispositifs de renfort intrapariétal 1. Dans la prothèse valvulaire biologique, les tiges intrapariétales 2 des dispositifs de renfort intrapariétal 1 sont normalement insérées à l'intérieur de la paroi externe tubulaire 12 de la valvule cardiaque biologique 10 de manière à être positionnées parallèlement aux lignes d'intersection de cette paroi 12 avec les commissures 13 de la valvule cardiaque 10, une fois le dispositif 1 étant mis en place sur la valvule cardiaque 10. La base 3 d'un dispositif 1 se trouve dans la partie inférieure de la prothèse biologique au niveau du plan valvulaire, ce niveau servant également comme point d'insertion du dispositif 1 voir des tiges 2 dans le tissu de la valvule cardiaque 10. Les attaches 4 sont, le cas échéant, placée sur la deuxième extrémité des tiges 2. La longueur d'une tige 2 du dispositif 1 dépend de la taille de la valve aortique, mitrale ou tricuspide à équiper et de l'emplacement de la tige le long de la paroi externe tubulaire 12 de forme sinusoïdale, la longueur étant normalement comprise entre 3 mm et 30 mm. L'épaisseur des éléments du dispositif est généralement de quelques dixièmes d'un millimètre. Ainsi, les dispositifs de renfort intrapariétal 1 permettent de rendre la valvule cardiaque biologique 10, notamment la paroi externe tubulaire 12 et la zone autour des commissures 13, suffisamment stables pour maintenir leur forme après l'implantation.FIG. 3 shows, as indicated above, a schematic view of a biological valve prosthesis for the replacement, by way of example, of the aortic valve 10, provided with an intraparietal reinforcement device 1 according to the present invention and placed in the aorta 20, between the aortic root 21 and the ascending aorta 22. This biological valvular prosthesis comprises a biological heart valve 10 whose valvular plane is, according to the general description above, formed by leaflets 11 attached laterally to a tubular outer wall 12 by commissures 13. The heart valve 10 is provided with at least one intraparietal reinforcement device 1 of an embodiment described above. It can be equipped with three devices 1 according to the embodiments illustrated in Figures 1a and 1b having a bar 3a as a base 3 or, in the preferred embodiment and illustrated in Figure 3, a single reinforcing device 1 having a ring-shaped base 3b (FIG. 3) or quasi-ring 3c (FIG. 2). With regard to the biological part of the prosthesis, it is in most cases a cardiac valve 10 of animal origin, in particular a porcine aortic valve, which is then equipped, during a treatment prior to implantation, one or more intraparietal reinforcement devices 1. In the biological valvular prosthesis, the intraparietal stems 2 of the intraparietal reinforcement devices 1 are normally inserted inside the tubular outer wall 12 of the valve biological heartbeat 10 so as to be positioned parallel to the lines of intersection of this wall 12 with the commissures 13 of the heart valve 10, once the device 1 is put in place on the heart valve 10. The base 3 of a device 1 is located in the lower part of the biological prosthesis at the level of the valve plane, this level also serving as the insertion point of the device 1 see rods 2 in the tissue of the heart valve 10. The fasteners 4 are, if necessary, placed on the second end of the rods 2. The length of a rod 2 of the device 1 depends on the size of the aortic valve, mitral or tricuspid to equip and the location of the rod along the tubular outer wall 12 of sinusoidal shape, the length normally being between 3 mm and 30 mm. The thickness of the elements of the device is generally a few tenths of a millimeter. Thus, the intraparietal reinforcement devices 1 make it possible to make the biological heart valve 10, in particular the tubular outer wall 12 and the area around the commissures 13, sufficiently stable to maintain their shape after implantation.
De préférence, la base 3 et/ou le cas échéant l'attache 4 des dispositifs de renfort intrapariétal 1 sont couvertes par un matériau biologique comme du péricarde. Dans ce cas, la prothèse biologique n'expose, due à la couverture des parties artificielles par du péricarde ou par tout autre matériau biologique adapté, principalement que du tissu biologique au circuit sanguin et au tissu humain après l'implantation.Preferably, the base 3 and / or, if appropriate, the fastener 4 of the intraparietal reinforcement devices 1 are covered by a biological material such as pericardium. In this case, the biological prosthesis does not expose, due to the coverage of artificial parts by pericardium or any other suitable biological material, mainly biological tissue to the blood circuit and human tissue after implantation.
Alternativement, la base 3 et/ou l'attache 4 des dispositifs de renfort intrapariétal peuvent être couvertes par un tissu en un matériau synthétique comme du Téflon, Dacron, Goretex, etc..Alternatively, the base 3 and / or the fastener 4 of the intraparietal reinforcement devices may be covered by a fabric made of a synthetic material such as Teflon, Dacron, Goretex, etc.
Un dispositif de renfort intrapariétal selon la présente invention et une prothèse valvulaire biologique renforcée ainsi obtenue peuvent être utilisés pour le remplacement de la valvule sigmoïde de l'aorte, mitrale ou tricuspide, l'espace occupé par les moyens de renfort de la prothèse cardiaque étant réduit le plus possible du fait qu'il ne pas fait recours à un stent conventionnel volumineux. De ce fait l'espace réservé à la circulation sanguine est moins obstruée, ce qui est un facteur important pour le patient implanté.An intraparietal reinforcement device according to the present invention and a reinforced biological valvular prosthesis thus obtained can be used for the replacement of the sigmoid valve of the aorta, mitral or tricuspid, the space occupied by the means of reinforcement of the cardiac prosthesis being minimized as it does not require a large conventional stent. As a result, the space reserved for the blood circulation is less obstructed, which is an important factor for the implanted patient.
En particulier, un tel dispositif permet de rendre une prothèse cardiaque biologique suffisamment stable et rigide pour la maintenir dans sa forme souhaitée après l'implantation sans endommager le tissu organique de la valvule cardiaque biologique, notamment la zone autour du point d'encrage des commissures.In particular, such a device makes it possible to make a biological heart prosthesis sufficiently stable and rigid to maintain it in its desired shape after implantation without damaging the biological tissue of the biological heart valve, in particular the area around the point of inking of the commissures. .
De plus, une prothèse valvulaire biologique renforcée à l'aide des dispositifs de renfort intrapariétal selon la présente invention permet, de par sa conception, d'être implantée de façon relativement simple et rapide, notamment dans le cas d'une base circulaire, du fait que celle-ci ainsi que les tiges du dispositif de renfort servent simultanément comme moyen de renfort et moyen de repérage pour le chirurgien qui doit réaliser l'implantation, avec une orientation précise, dans un endroit pourtant difficilement accessible à l'intérieur de l'orifice naturel. En même temps, la couverture des parties métalliques de la prothèse cardiaque par un matériau biologique comme du péricarde peut permettre de n'exposer principalement que du tissu biologique au circuit sanguin et au tissu humain, une fois la prothèse valvulaire biologique renforcée étant implantée. In addition, a biological valvular prosthesis reinforced with the intraparietal reinforcement devices according to the present invention allows, by design, to be implanted in a relatively simple and rapid manner, in particular in the case of a circular base, the that the latter and the rods of the reinforcing device serve simultaneously as a means of reinforcement and locating means for the surgeon who must perform the implantation, with a precise orientation, in a place yet difficult to access within the body. natural orifice. At the same time, covering the metallic parts of the cardiac prosthesis with a biological material such as pericardium may allow mainly biological tissue to be exposed to the blood circuit and the human tissue only after the reinforced biological valve prosthesis has been implanted.

Claims

Revendications claims
1. Dispositif de renfort intrapariétal (1) destiné à être intégré dans une prothèse valvulaire biologique comportant une valvule cardiaque biologique (10) dont le plan valvulaire est formé par des feuillets (11 a, b, c) rattachés latéralement à une paroi externe tubulaire (12) par des commissures (13), le dispositif étant adapté à être placé à l'intérieur du tissu organique de cette valvule cardiaque (10) et comportant une base (3) et une partie stabilisatrice (2) montée sur la base (3) et adaptée à être insérée à l'intérieur de la paroi externe tubulaire (12) de la valvule cardiaque (10) et à renforcer la structure de cette dernière de manière à maintenir la forme de la valvule cardiaque (10) après implantation, caractérisé par le fait que la partie stabilisatrice (2) comprend au moins deux tiges intrapariétales (2a, 2b) adaptées à être insérées dans le tissu organique de la valvule cardiaque (10), ces tiges intrapariétales (2) étant positionnées sur la base (3) de manière à être, une fois le dispositif mis en place sur la valvule cardiaque (10), décalées latéralement par rapport au point d'intersection de la ligne d'intersection de la paroi externe tubulaire (12) avec les commissures (13) de la valvule cardiaque (10) et du plan valvulaire de la valvule cardiaque (10) de la prothèse valvulaire.1. intraparietal reinforcement device (1) intended to be integrated in a biological valve prosthesis comprising a biological heart valve (10) whose valvular plane is formed by leaflets (11 a, b, c) attached laterally to a tubular outer wall (12) by commissures (13), the device being adapted to be placed inside the organic tissue of this heart valve (10) and having a base (3) and a stabilizer portion (2) mounted on the base ( 3) and adapted to be inserted inside the tubular outer wall (12) of the heart valve (10) and to strengthen the structure of the latter so as to maintain the shape of the heart valve (10) after implantation, characterized in that the stabilizing portion (2) comprises at least two intraparietal stems (2a, 2b) adapted to be inserted into the organic tissue of the heart valve (10), these intraparietal stems (2) being positioned on the base (3) so as to be, after the device is placed on the heart valve (10), laterally offset from the point of intersection of the line of intersection of the tubular outer wall (12) with the commissures (13) of the heart valve (10) and the valvular plane of the heart valve (10) of the prosthetic valve.
2. Dispositif de renfort intrapariétal (1) selon la revendication 1 , caractérisé par le fait que les tiges intrapariétales (2) sont positionnées sur la base (3) avec un décalage identique de part et d'autre du point sur cette base2. intraparietal reinforcement device (1) according to claim 1, characterized in that the intraparietal rods (2) are positioned on the base (3) with an identical offset on either side of the point on this basis
(3) correspondant au point d'intersection une fois le dispositif étant mis en place sur la valvule cardiaque (10). (3) corresponding to the point of intersection once the device is placed on the heart valve (10).
3. Dispositif de renfort intrapariétal (1) selon l'une des revendications précédentes, caractérisé par le fait que les tiges intrapariétales (2) forment un angle droit par rapport à la base (3) de manière à ce que les tiges soient, une fois le dispositif mis en place sur la valvule cardiaque (10), latéralement et parallèlement décalées par rapport à chaque ligne d'intersection de la paroi externe tubulaire (12) avec les commissures (13) de la valvule cardiaque (10) de la prothèse valvulaire.3. intraparietal reinforcement device (1) according to one of the preceding claims, characterized in that the intraparietal rods (2) form a right angle relative to the base (3) so that the rods are, a once the device placed on the heart valve (10), laterally and parallel to each line of intersection of the tubular outer wall (12) with the commissures (13) of the heart valve (10) of the prosthesis valvular.
4. Dispositif de renfort intrapariétal (1) selon l'une des revendications précédentes, caractérisé par le fait que la base est constituée d'une barre courbée ou droite (3a).4. intraparietal reinforcement device (1) according to one of the preceding claims, characterized in that the base consists of a curved or straight bar (3a).
5. Dispositif de renfort intrapariétal (1) selon l'une des revendications 1 à 3, caractérisé par le fait que la base est constituée d'un anneau (3b).5. intraparietal reinforcement device (1) according to one of claims 1 to 3, characterized in that the base consists of a ring (3b).
6. Dispositif de renfort intrapariétal (1) selon l'une des revendications 1 à 3, caractérisé par le fait que la base est constituée d'un quasi-anneau (3c) ayant une partie ouverte sur son pourtour.6. intraparietal reinforcement device (1) according to one of claims 1 to 3, characterized in that the base consists of a quasi-ring (3c) having an open portion on its periphery.
7. Dispositif de renfort intrapariétal (1) selon l'une des revendications précédentes, caractérisé par le fait qu'il comprend au moins une attache (4) adaptée à être fixée sur une deuxième extrémité des tiges (2).7. intraparietal reinforcement device (1) according to one of the preceding claims, characterized in that it comprises at least one fastener (4) adapted to be fixed on a second end of the rods (2).
8. Prothèse valvulaire biologique comportant une valvule cardiaque biologique (10) dont le plan valvulaire est formé par des feuillets (11 ) rattachés latéralement à une paroi externe tubulaire (12) par des commissures (13), caractérisée par le fait qu'elle est munie d'au moins un dispositif de renfort intrapariétal (1) selon l'une des revendications précédentes. 8. Biological valvular prosthesis comprising a biological heart valve (10) whose valvular plane is formed by leaflets (11) attached laterally to a tubular outer wall (12) by commissures (13), characterized in that it is provided with at least one intraparietal reinforcement device (1) according to one of the preceding claims.
9. Prothèse valvuiaire biologique selon la revendication 8, caractérisée par le fait que la valvule cardiaque (10) est une valvule aortique d'origine animale équipée de dispositif (s) de renfort intrapariétal (1).9. biological valvular prosthesis according to claim 8, characterized in that the heart valve (10) is aortic valve of animal origin equipped with intraparietal reinforcement device (s) (1).
10. Prothèse valvuiaire biologique selon l'une des revendications 8 à 9, caractérisée par le fait que les tiges intrapariétales (2) des dispositifs de renfort intrapariétal (1) sont placées à l'intérieur de la paroi externe tubulaire (12) de la valvule cardiaque (10) parallèlement aux lignes d'intersection de cette paroi (12) avec les commissures (13) de la valvule cardiaque (10).10. Biological valve prosthesis according to one of claims 8 to 9, characterized in that the intraparietal rods (2) of the intraparietal reinforcement devices (1) are placed inside the tubular outer wall (12) of the heart valve (10) parallel to the lines of intersection of this wall (12) with the commissures (13) of the heart valve (10).
11. Prothèse valvuiaire biologique selon l'une des revendications 8 à 10, caractérisée par le fait que la base (3) et/ou l'attache (4) des dispositifs de renfort intrapariétal (1) sont/est couvertes par du matériau biologique.11. biological valve prosthesis according to one of claims 8 to 10, characterized in that the base (3) and / or the fastener (4) of the intraparietal reinforcement devices (1) are / is covered by biological material .
12. Prothèse valvuiaire biologique selon l'une des revendications 8 à 10, caractérisée par le fait que la base (3) et/ou l'attache (4) des dispositifs de renfort intrapariétal (1) sont/est couvertes par un tissu en un matériau synthétique. 12. biological valve prosthesis according to one of claims 8 to 10, characterized in that the base (3) and / or the fastener (4) of the intraparietal reinforcement devices (1) are / is covered by a fabric in a synthetic material.
EP05708678A 2005-03-01 2005-03-01 Intraparietal reinforcing device for biological cardiac prosthesis and reinforced biological heart valve prosthesis Withdrawn EP1858449A1 (en)

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CA2598794C (en) 2012-01-03
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AU2005328535A1 (en) 2006-09-08
MX2007010600A (en) 2007-10-10
JP4786668B2 (en) 2011-10-05
US7927369B2 (en) 2011-04-19
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NO20074478L (en) 2007-09-03
US20080133005A1 (en) 2008-06-05

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