System for attaching a heart valve to a heart prosthesis and a heart prosthesis equipped with such an attachment system - Patent Application 20070122997

Abstract

The present invention relates to a system for attaching a heart valve, the function of which is to attach a heart valve to a cardiac prosthesis intended to be implanted in a patient's pericardial cavity and to replace the patient's natural left and right ventricles, the system comprising a male ring with spikes and a cooperating part with openings, the male ring or the cooperating part being intended to be fixed to the cardiac prosthesis, the spikes and the openings being configured such that the spikes pass through a collar of the heart valve and enter the openings at the attachment position.

Description

[Technical Field]

[0001] The present invention relates to a system for attaching a heart valve to a cardiac prosthesis, said cardiac prosthesis being implantable in a patient's pericardial cavity and capable of replacing the patient's natural left and right ventricles after their removal. The present invention also relates to a cardiac prosthesis comprising such an attachment system. [Background technology]

[0002] Totally implantable cardiac prostheses, as described in, for example, French Patent Nos. 2784585 and 2902345, have the function of replacing the patient's ventricles while preserving the atria. To achieve this, the cardiac prosthesis comprises a rigid prosthetic body in which an artificial ventricle is located. To implant this cardiac prosthesis, i.e., an artificial cardiac prosthesis, into the patient's pericardial cavity, it is necessary to create a connection between the patient's vascular network (atria and arteries) and the cardiac prosthesis, taking into account the patient's anatomical structure.

[0003] It is known that the natural heart contains four heart valves that separate the different chambers and ensure good blood circulation between them: two heart valves located between the atria and the ventricles (mitral and tricuspid valves) and two heart valves located between the ventricles and the arteries (aortic and pulmonary valves). Totally implantable cardiac prostheses intended to replace the natural heart must therefore incorporate (artificial) heart valves to reproduce this specific connection with the atria and the arteries.

[0004] To allow for the use of conventional heart valves used in valve replacement surgery for this purpose, a totally implantable cardiac prosthesis must incorporate specific joints. A standard heart valve generally consists of three leaflets that open and close under pressure, three legs to which the leaflets are attached, and a base that allows the surgeon to suture the valve. The base can be flat or wavy (wave-shaped).

[0005] Such heart valves can be used for the inflow or outflow of blood into a cardiac prosthesis.

[0006] Typically, for evacuation, the heart valve is of the flat base type, with the flat base of the heart valve placed in the channel of the cardiac prosthesis and the legs facing outwards from the ventricle. A woven conduit is placed in the channel of the cardiac prosthesis above the heart valve. A locking system secures the assembly to the cardiac prosthesis, and the woven conduit is then sutured by the surgeon to the patient's artery.

[0007] This attachment mode used during ejection is not entirely satisfactory and has the following drawbacks: - The short distance between the highest point of the heart valve and the point where the tissue conduit is sutured to the patient's artery (pulmonary artery or aorta) can hinder the surgeon's ability to perform the suture; The need to compress the annulus of the heart valve and the tissue conduit in the channel of the cardiac prosthesis to ensure a blood-tight connection requires a great deal of insertion effort on the part of the surgeon, which is further complicated by the fact that the cardiac prosthesis has no gripping points and there is a risk of twisting the locking clip. the materials and dimensions of the assembly formed by the heart valve and the tissue conduit placed in the channel of the cardiac prosthesis are not the best in terms of airtightness, and This method of attachment does not allow the use of heart valves with a non-flat base, for example of a wave shape. Summary of the Invention

[0008] The object of the present invention is to overcome at least some of the above-mentioned drawbacks and to simplify and improve the operation of attaching artificial heart valves to cardiac prostheses (intended to be implanted in the pericardial cavity of a patient to replace the patient's natural left and right ventricles), while allowing the use of heart valves of various designs, in particular heart valves with a non-flat base. To this end, the present invention relates to an attachment system intended to attach (artificial) heart valves to cardiac prostheses.

[0009] According to the invention, the attachment system comprises a male ring with spikes and a cooperating part with openings, the male ring or the cooperating part being intended to be fixed to the cardiac prosthesis, the spikes and openings being configured so that the spikes pass through the collar of the cardiac valve and enter the openings in the so-called attachment position.

[0010] Thanks to the invention, the male ring and the cooperating part intended to hold the heart valve at the level of the collar can therefore be adapted to this collar, i.e. to the base of the heart valve, as specified below. The attachment system can therefore be adapted to heart valves with a wavy structure, in particular to heart valves with a non-flat base, and to both heart valves used for evacuation and for inflow.

[0011] As will be noted below, the above mounting system has many other advantages, including: The attachment system does not increase the time spent in the operating room (e.g., no suturing is required with the joining components), The attachment system can be easily applied by the surgeon, The attachment system ensures that there is no leakage of blood from the inside of the ventricle to the outside of the cardiac prosthesis, The attachment system allows the heart valve to be kept in its packaging and opened for implantation only in the operating room; and The attachment system allows the sinuses of Valsalva to be preserved for the inflow part of the cardiac prosthesis.

[0012] Depending on the embodiment envisaged and as will be explained in more detail below, one of the two elements (male ring or cooperating part) is intended to be fixed to the cardiac prosthesis.

[0013] Advantageously, the male ring and the cooperating part each have so-called contact surfaces, which are intended to grip at least the collar of the heart valve in the mounting position, said contact surfaces having a shape adapted to the shape of the collar of the heart valve.

[0014] In a first embodiment, the spike and opening are configured so that the spike is substantially straight in the attachment position.

[0015] Furthermore, in the second embodiment, the spike and aperture are configured such that the spike is bent (or curved) at the attachment location, e.g., angled or curved, which enhances retention of the spike within the aperture and therefore retention between the various components connected together.

[0016] The spike may have a constant diameter, however, in certain embodiments, the spike has a diameter that decreases towards the free end, which makes it easier to retain the spike within the opening.

[0017] In a preferred embodiment, the male ring, comprising at least one annular support and spikes fixed to the annular support, is a one-piece component, which facilitates manufacturing. In an alternative embodiment, the spikes may be attached to the annular support.

[0018] In a first embodiment, the cooperating part is a female ring, and in this first embodiment, it is intended that one of these two rings (male or female) is attached to the cardiac prosthesis, depending on the envisaged embodiment alternative.

[0019] Advantageously, the female ring comprises a surface opposite the contact surface, which has a shape complementary to the shape of the so-called receiving surface of the cardiac prosthesis.

[0020] In a second embodiment, the cooperating part corresponds to a part of a cardiac prosthesis, preferably comprising a tubular element provided on its inner circumference with a rim intended to receive the collar of a heart valve.

[0021] Furthermore, in certain embodiments, in the case of heart valves intended for evacuation, the spikes and openings are configured so that said spikes also pass through the collar of the conduit (intended to be sutured to the artery) at the attachment point.

[0022] Furthermore, in certain embodiments, the mounting system further comprises at least one of the following elements: -O-ring, -Mounting clips, -Retaining ring.

[0023] The present invention also relates to a cardiac prosthesis implantable within a patient's pericardial cavity, said cardiac prosthesis adapted to replace the patient's natural left and right ventricles and comprising at least one cardiac valve.

[0024] According to the invention, the cardiac prosthesis comprises at least one attachment system as described above for attaching a cardiac valve to the cardiac prosthesis.

[0025] In a preferred embodiment, the cardiac prosthesis comprises two, three or (preferably) four cardiac valves, each of which is attached to the cardiac prosthesis by an attachment system as described above. [Brief explanation of the drawings]

[0026] The accompanying drawings, in which identical reference numerals indicate similar elements, illustrate how the invention may be put into practice.

[0027] [Figure 1] FIG. 1 is an exploded perspective view of a first embodiment of a mounting system.

[0028] [Figure 2] FIG. 2 is a perspective view of the mounting system of FIG. 1 in the mounted position.

[0029] [Figure 3] FIG. 2 is a perspective view of the mounting system of FIG. 1 in the mounting position.

[0030] [Figure 4] FIG. 4 is a cross-sectional view of the mounting system in the mounting position of FIG. 3.

[0031] [Figure 5] FIG. 10 is an exploded perspective view of a first variant of the second embodiment of the mounting system.

[0032] [Figure 6] FIG. 6 is a cross-sectional view of the mounting system of FIG. 5 in the mounting position.

[0033] [Figure 7] FIG. 10 is an exploded perspective view of a second variant of the second embodiment of the mounting system. DETAILED DESCRIPTION OF THE INVENTION

[0034] Detailed Description The attachment system 1 illustrating the present invention and represented diagrammatically in various specific embodiments in Figures 1 to 7 serves to attach an artificial heart valve (intended to replace a patient's natural heart valve) to a cardiac prosthesis.

[0035] This cardiac prosthesis 2 (shown very partially and very diagrammatically in Figures 1 and 5-7) can be implanted in the patient's thoracic and pericardial cavities and is suitable for replacing the patient's natural left and right ventricles after their removal. To achieve this, the cardiac prosthesis 2 comprises a rigid prosthesis body (not shown), in which artificial left and right ventricles are positioned to replace the patient's natural left and right ventricles.

[0036] The cardiac prosthesis 2 comprises all the means necessary for its operation, and in particular may include at least some of the characteristics presented in the above-mentioned patents FR 2 784 585 and FR 2 902 345. The cardiac prosthesis 2, and in particular the elements arranged in the prosthesis body, will not be further described in the following description.

[0037] The cardiac prosthesis 2, which is intended to replace the patient's natural heart, has four heart valves, just like the natural heart: two heart valves (mitral and tricuspid) for inflow, located between the atria and the artificial ventricles of the cardiac prosthesis 2, and two heart valves (aortic and pulmonary) for outflow, located between the artificial ventricles of the cardiac prosthesis 2 and the patient's arteries (aorta and pulmonary artery).

[0038] In a preferred embodiment, at least one heart valve 3, preferably all four heart valves 3, each correspond to a conventional heart valve used in valve replacement surgery.

[0039] In a particular embodiment, each (prosthetic) heart valve 3 comprises an annular base 4 provided with three legs 6 on its downstream face 5, as shown in FIG. 1. The heart valve 3 also comprises three leaflets 7. Each leaflet 7 is attached to two adjacent legs 6 and to the base 4. The three leaflets 7 of the heart valve 3 are configured to open and close under the action of pressure in the upstream portion. In this description, the terms upstream and downstream are defined according to the direction of blood flow through the heart valve 3, as indicated by arrow E in FIGS. 1, 2, 5 and 7.

[0040] Additionally, the base 4 has an upstream face 8 opposite the downstream face 5 and includes a collar 9 surrounding the base 4 (around the entire periphery of the base 4). The upstream face 8 (and collar 9) can have a variety of shapes. In a first embodiment (not shown), the upstream face 8 and collar 9 are flat. In a second particular embodiment, as shown in particular in Figures 1 and 5, the upstream face 8 and collar 9 are curved or wavy, for example, in the general shape of a wave.

[0041] The function of the attachment system 1 is to attach such a heart valve 3 to the heart prosthesis 2 regardless of the shape of the base 4 of the attachment system 1 .

[0042] To do this, the mounting system 1 comprises, as shown in particular in Figure 1, an annular male ring 10 provided on one face 10A (longitudinal direction) with spikes 11. The spikes 11 correspond to elongated elements (in particular solid tubes) protruding from face 10A.

[0043] In a preferred embodiment, the male ring 10 (particularly comprising the annular support 20 and the spikes 11 fixed to the annular support 20) is a one-piece part, which facilitates manufacturing. This one-piece part is made, for example, from titanium. In a variant of the embodiment not shown, it is also possible for the spikes to be represented by separate elements fitted (for example welded or glued) to the annular support.

[0044] The mounting system 1 also comprises a cooperating part 12 intended to cooperate with the male ring 10. This cooperating part 12 is provided with openings 13, each of which is intended to receive a spike 11 of the male ring 10 at a mounting position PF (Figures 3, 4 and 6). The cooperating part 12 therefore comprises at least as many openings 13 as the male ring 10 comprises spikes 11, the spikes 11 and the openings 13 being shaped and arranged so that each of the spikes 11 can be inserted into the opening 13.

[0045] For the purposes of the present invention, the attachment point PF is intended to represent the position at which the heart valve 3 is integrated into the cardiac prosthesis 2 and attached to the cardiac prosthesis 2 by the attachment system 1 in its final position.

[0046] One of the following elements is intended to be fixed to the cardiac prosthesis 2: male ring 10, cooperating part 12. This connection can be achieved in several different embodiments, as explained below.

[0047] Furthermore, the spike 11 and the opening 13 are configured such that the spike 11 enters the opening 13 at the attachment position PF after passing through the collar 9 (e.g., formed from a silicone strip and porous PTFE fabric) of the heart valve 3, as also specified below.

[0048] As a result, in the mounting position PF, the male ring 10 and the cooperating part 12 grip the collar 9 of the heart valve 3, as shown in FIGS.

[0049] Furthermore, as will be explained below, the spikes 11 are held in the openings 13 by lateral contact, which allows the male ring 10 to be fixed to the cooperating part 12 and possibly (in one particular embodiment) to hold them together with the help of additional elements (e.g., clips). This connection allows the heart valve 3 to be held in place by the collar 9, which allows the heart valve 3 to be attached to the cooperating part 12 and therefore to the cardiac prosthesis 2 (to which the cooperating part 12 is fixed).

[0050] The male ring 10 and the cooperating part 12 each have so-called contact surfaces 10A, 14A (FIG. 1) intended to grip the collar 9 at the mounting position PF. These contact surfaces 10A, 14A have a shape adapted to the shape of the collar 9 and therefore to the shape of the base 4.

[0051] The attachment system 1 can therefore be adapted to the shape of the collar 9 and base 4 of the heart valve 3. In particular, the attachment system 1 can be adapted to a heart valve 3 with a wavy base 4. In this way, the attachment system 1 can be used to attach any type of conventional heart valve 3, in particular a heart valve 3 with a non-flat base 4, in order to incorporate the heart valve 3 into a heart prosthesis 2.

[0052] Furthermore, the attachment system 1 can be used to attach a cardiac valve 3 intended to drain blood from the cardiac prosthesis 2, as described above, or to attach a cardiac valve 3 intended to allow blood to flow into the cardiac prosthesis 2.

[0053] The attachment system 1 represents an interface that makes it possible to meet the following constraints related to the use of the attachment system 1 in an implantable cardiac prosthesis 2, as will be explained in more detail below: the mounting system 1 is biocompatible, the mounting system 1 can be implanted for a long period of time, the mounting system 1 is washable and suitable for sterilization, the attachment system 1 ensures a seal with the cardiac prosthesis 2, and The attachment system 1 provides an ergonomic and fast attachment mode (which makes it possible to reduce the duration of extracorporeal circulation).

[0054] The attachment system 1 can be manufactured in different ways. In particular, the attachment system 1 can be manufactured in two different ways, depending on how the cooperating part 12 or the male ring 10 is fixed to the cardiac prosthesis 2.

[0055] In a first embodiment shown in Figures 1 to 4, the cooperating part 12 is a female ring 14, i.e. an independent part intended to be connected to the cardiac prosthesis 2. The female ring 14 is in the form of a pair with the male ring 10. In this first embodiment, one of the two rings (male ring 10 or female ring 14) is attached to the cardiac prosthesis 2.

[0056] Thus, in a first (preferred) variant, the female ring 14 is attached to the cardiac prosthesis 2 in the usual way, and in a second variant, the male ring 10 is attached to the cardiac prosthesis 2 in the usual way.

[0057] Furthermore, in the second embodiment, the cooperating parts 12 correspond to the parts 15, 16 of the cardiac prosthesis 2, as represented according to two different variants in Figures 5 to 7, namely the first variant in Figures 5 and 6 for the installation of a cardiac valve 3 intended for evacuation and the second variant in Figure 7 for the installation of a cardiac valve 3 intended for inflow.

[0058] In the first embodiment shown in Figures 1 to 4, the cooperating part 12 is therefore a female ring 14, for example made of titanium, which is initially separate and independent of the cardiac prosthesis 2 and which has an upstream face 14B of a particular shape intended to come into contact with the cardiac prosthesis 2. This particular shape is complementary to the shape of the downstream face 2A of the cardiac prosthesis 2, known as the receiving face (shown very diagrammatically in Figure 1).

[0059] This first embodiment, comprising a female ring 14 shown in Figures 1 to 4, relates to a mounting system 1 for mounting a heart valve 3 intended for evacuation.

[0060] [Figure 1] shows the various elements in an exploded view. In this embodiment (and therefore intended for evacuation), the function of the attachment system 1 is to connect a conduit 17 to the cardiac prosthesis 2, in addition to the cardiac valve 3. This conduit 17 is intended to carry blood evacuation from the cardiac prosthesis 2 (in the direction of arrow E), through the cardiac valve 3 and into an artery (aorta or pulmonary artery) to which the conduit 17 is sutured in the usual way.

[0061] The woven conduit 17 also includes a collar 18 at the upstream end of the conduit 17. This collar 18 is made, for example, of polyester and is similar in shape to the collar 9 on the heart valve 3. In this particular embodiment, the spike 11 of the male ring 10 is also intended to pass through (or penetrate) the collar 18 of the conduit 17.

[0062] In order to be passed through or penetrated by the spike 11, the collar 9 of the heart valve 3 and, where applicable, the collar 18 of the conduit 17 must be provided with holes (of an appropriate size) or (preferably) made of a material that allows the spike 11 to penetrate them.

[0063] 1, 2 and 3 show three successive steps in the attachment of a heart valve 3 and a conduit 17 to a heart prosthesis 2. FIG.

[0064] More precisely, FIG. 1 shows an initial position P1 in which the various elements are not connected (or assembled) to one another. - [Fig. 2] shows an intermediate position P2 during assembly, in which the male ring 10 is assembled to the collar 18 of the conduit 17 and to the collar 9 of the heart valve 3. The spikes 11 of the ring 10 pass through these collars 9 and 18. - [Figure 3] shows the mounting position PF, which is also shown (in cross section) in [Figure 4].

[0065] In this embodiment, the spike 11 of the male ring 10 therefore penetrates the collar 18 of the conduit 17 and the collar 9 of the heart valve 3 and is then inserted into the opening 13 of the female ring 14 .

[0066] In a preferred embodiment, the spikes 11 of the male ring 10 are arranged parallel to the longitudinal axis XX of the heart valve 3 and the conduit 17 when the male ring 10 is arranged coaxially with respect to this longitudinal axis XX, as shown in Figures 1 to 7.

[0067] In a first embodiment, the female ring 14 is cylindrical, i.e., has a linear opening 13, which is inclined with respect to the longitudinal axis XX, i.e., the orientation of the opening 13 forms a non-zero angle with respect to this longitudinal axis XX, as shown in FIG.

[0068] Thus, when subjected to pressure during assembly and constrained by the slope of opening 13, spike 11 is caused to bend (or curve) as shown in FIG. 4. As a result, upon entering opening 13, spike 11 changes direction and exhibits bend 11A (FIG. 4) at attachment position PF of spike 11. In alternative embodiments (not shown), spike 11 may have a different curved shape than this bend.

[0069] This mechanical deformation allows the assembly of four parts (male ring 10, collar 18 of drainage conduit 17, collar 9 of heart valve 3, and female ring 14) to become a unitary assembly.

[0070] The female ring 14 can be adapted to the contents and shape of the cardiac prosthesis 2, thereby facilitating the incorporation of the cardiac valve 3. The male ring 10 and the female ring 14 may be adapted to allow any type of cardiac valve 3 to be attached without the need to change the design of the cardiac prosthesis 2, regardless of the embodiment considered.

[0071] The attachment system 1 can be manufactured in different sizes and / or shapes, particularly to accommodate a variety of surgical heart valves 3 .

[0072] In the first embodiment only the (preferred) embodiment intended for evacuation is shown, it is also possible to provide such an embodiment with cooperating male and female rings for inflow.

[0073] Furthermore, in order to fit as closely as possible to the cardiac prosthesis 2 and minimize the overall dimensions of the mounting system 1, the second embodiment provides for the elimination of the female ring by adapting the shape of a portion of the cardiac prosthesis 2 to the opposite shape of the male ring 10.

[0074] In this second embodiment, the cooperating parts 12 therefore correspond to the parts 15, 16 of the cardiac prosthesis 2. This second embodiment may also be used to mount a cardiac valve 3 intended for evacuation or for mounting a cardiac valve 3 intended for inflow.

[0075] In a first variant of this second embodiment, shown in Figures 5 and 6, which, like the first embodiment of Figures 1 to 4, also contemplates mounting a heart valve 3 used for evacuation, the cooperating part 12 corresponds to a part 15 of the cardiac prosthesis 2. This part 15 of the cardiac prosthesis 2 comprises, in this example, a tubular element (or stretch) 19.

[0076] In this embodiment, the tubular element 19 is provided with a rim 21 around the entire inner circumference 19A of the tubular element 19, the rim 21 having a shape adapted to the shape of the base 4 of the heart valve 3. The wavy shape of the heart valve 3 is thus incorporated into the body of the cardiac prosthesis 2. The upstream face 8 of the base 4 of the heart valve 3 rests on this rim 21 in the attachment position PF, as shown in FIG.

[0077] In this variant of Figures 5 and 6, the function of the spikes 11 of the male ring 10 is still to penetrate the collar 18 of the conduit 17 and the collar 9 of the heart valve 3, and then be housed in cooperating parts 1 pre-machined in the body of the cardiac prosthesis 2.

[0078] In this particular embodiment, the openings 13 are parallel to the longitudinal axis XX of the mounting system 1, so that in the mounting position PF, as can be seen in FIG. 6, the spikes 11 are not curved (or bent), but remain straight and parallel to the longitudinal axis XX.

[0079] In this embodiment, a clip 22 manufactured in the usual way to hold the assembled parts together may be provided to enhance the retention of the male ring 10. For this purpose, a conventional groove 22A (FIG. 6) intended to receive the clip 22 is preferably provided.

[0080] Furthermore, in the example shown in Figures 5 and 6, an O-ring 23 is also provided in the groove 23A (Figure 6) of the male ring 10, intended to seal the assembled parts against blood flow.

[0081] In the context of the present invention, regardless of the embodiment, the spike 11 may have a constant diameter. However, in certain embodiments, the spike 11 has a diameter that decreases towards the free end of the spike 11 (i.e., the end of the spike 11 opposite the end that is connected to the surface 10A of the male ring 10), thereby facilitating loading and enhancing retention when the spike 11 is inserted into the cylindrical (i.e., constant diameter) opening 13.

[0082] This first variant of the second embodiment, with the portion 15 as the inverse of the male ring 10, allows a good fit to the cardiac prosthesis and minimizes the overall dimensions of the attachment system 1.

[0083] This variant requires a change in the design of the cardiac prosthesis 2 if the shape of (for example) the heart valve 3 changes, but nevertheless offers the advantage of reducing the protruding height of the legs of the heart valve 3.

[0084] Furthermore, a second variant of the second embodiment shown in FIG. 7 is intended to mount a heart valve 3 used for inflow, in which the free ends of the leaflets 7 of the heart valve 3 are directed towards the heart prosthesis 2, i.e. in the opposite direction to the embodiment shown in FIGS. 5 and 6.

[0085] In this second variant, the cooperating part 12 corresponds to a section 16 of the cardiac prosthesis 2. This section 16 of the cardiac prosthesis 2 comprises, in this example, a tubular element (or stretch) 24.

[0086] In this embodiment, the tubular element 24 is provided, all around the inner circumference 24A of the tubular element 24, with a rim 25 whose shape is adapted to the shape of the base 4 of the heart valve 3. The wavy shape of the heart valve 3 is thus incorporated into the body of the cardiac prosthesis 2. The upstream face 8 of the base 4 of the heart valve 3 rests on this rim 25 in the attachment position (not shown).

[0087] Furthermore, the male ring 10 that comes into contact with blood is made hemocompatible.

[0088] In this embodiment, inflow is intended and a retaining ring 26, preferably a metal annulus, is used to hold the male ring 10 with spikes 11 and heart valves 3 in the cardiac prosthesis 2 when it is implanted until the cardiac prosthesis 2 is placed on a conventional metal bezel 27 already in place in the patient's chest. By way of example, French Patents Nos. 2902343 and 2902344 describe systems of cooperating bezels for the inflow of cardiac prostheses.

[0089] In an alternative embodiment (not shown), the annular support 20 of the male ring 10 may be sized and shaped to provide this retention (prior to installation on the metal bezel) in place of the retaining ring 26.

[0090] It is also possible to provide an attachment system according to the first embodiment in which a male ring and a female ring cooperate for inflow. In such an embodiment (not shown), part 16 of the example in FIG. 7 is replaced by a female ring intended to be attached to a cardiac prosthesis.

[0091] Furthermore, in the context of the present invention, depending on the particular embodiment considered, the mounting system 1 may comprise one or more of the following elements: an O-ring, such as the O-ring 23 shown in FIGS. 5 and 6; a mounting clip, such as the clip 22 shown in Figures 5 and 6; A retaining ring, such as the retaining ring 26 shown in FIG.

[0092] Furthermore, in order to meet hemocompatibility constraints, whatever the embodiment considered, the part or parts of the attachment system 1 that come into contact with blood (mainly the female ring 14 in the embodiment shown in Figures 1 to 4) may be covered with a knitted prosthesis (a knitted structure of polyester yarns). Preferably, in application to the female ring, this polyester fabric is cut as close as possible to the shape of the ring, wrapped around the ring, and stitched to hold the ring in place.

[0093] Alternatively, other solutions may be provided to make blood-contacting parts hemocompatible, for example by covering the blood-contacting surfaces with cPTFE, bead-blasted titanium, etc.

[0094] Regardless of the embodiment considered, the method for installing the mounting system 1 comprises at least one operation consisting of piercing the collar 9 of the heart valve 3 (and, where appropriate, the collar 18 of the conduit 17) by the spike 11 of the male ring 10 and inserting said spike 11 into the cooperating opening 13 of the cooperating part 12. Depending on the embodiment, the method comprises other steps that are performed before or after this operation.

[0095] The attachment system 1, as described above, replaces suturing while providing a rigid support structure for the heart valve 3, which facilitates the incorporation of the heart valve 3 into the design of the heart prosthesis 2.

[0096] The mounting system 1 has many advantages. First, the mounting system 1 offers the following important advantages: shortening the distance between the highest point of the heart valve 3 and the highest point of the coaptation at the level of the drainage conduit of the cardiac prosthesis 2, allowing the use of heart valves 3 whose base 4 is not flat but incorporates a wavy shape, - Simplifying the preparation and implantation of the cardiac prosthesis 2.

[0097] Furthermore, the mounting system 1 has the following advantages: The attachment system does not increase the time spent in the operating room (e.g., no suturing is required with the joining components), The attachment system can be easily applied by the surgeon, the attachment system 1 ensures that there is no leakage of blood from the inside of the ventricle to the outside of the cardiac prosthesis 2, The mounting system 1 allows the heart valve 3 to be kept in its packaging and opened for implantation only in the operating room; and The attachment system 1 allows the sinuses of Valsalva to be retained for the inflow part of the cardiac prosthesis 2 .

Claims

1. 1. An attachment system intended to attach a heart valve to a heart prosthesis, comprising: the cardiac prosthesis (2) is implanted in the pericardial cavity of a patient and is intended to replace the patient's natural left and right ventricles; 1. The attachment system comprises a male ring (10) with spikes (11) and a cooperating part (12) with openings (13), wherein the male ring (10) or the cooperating part (12) is intended to be fixed to the cardiac prosthesis (2), and the spikes (11) and the openings (13) are configured in such a way that the spikes (11) pass through a collar (9) of the heart valve (3) and enter the openings (13) at a so-called attachment point (PF).

2. 2. The system according to claim 1, wherein the male ring (10) and the cooperating part (12) each have so-called contact surfaces (10A, 14A, 21, 25) intended to grip at least the collar (9) of the heart valve (3) in the mounting position (PF), the contact surfaces (10A, 14A, 21, 25) having a shape adapted to the shape of the collar (9) of the heart valve (3).

3. 3. A system according to claim 1 or 2, characterized in that the spike (11) and the opening (13) are configured such that the spike (11) is substantially straight at the mounting position (PF).

4. 3. A system according to claim 1 or 2, characterized in that the spike (11) and the opening (13) are configured such that the spike (13) is bent at the mounting position (PF).

5. 5. A system according to any one of claims 1 to 4, characterized in that the spike (11) has a diameter that decreases towards its free end.

6. 6. A system according to any one of claims 1 to 5, characterized in that the male ring (10) comprising at least one annular support (20) and the spikes (11) fixed to said annular support (20) are in one piece.

7. A system according to any one of claims 1 to 6, characterized in that said cooperating part (12) is a female ring (14).

8. 8. The system according to claims 2 and 7, characterized in that the female ring (14) has a surface (14B) opposite the contact surface (14A), the surface (14B) having a shape complementary to the shape of the so-called receiving surface (2A) of the cardiac prosthesis (2).

9. 7. A system according to any one of claims 1 to 6, characterized in that the cooperating part (12) corresponds to a part (15, 16) of the cardiac prosthesis (2).

10. 10. The system according to claim 9, wherein the portions (15, 16) of the cardiac prosthesis (2) comprise tubular elements (19, 24) that comprise edges (21, 25) on their inner circumference (19A, 24A) intended to receive the collar (9) of the heart valve (3).

11. 11. A system according to any one of claims 1 to 10, characterized in that for the heart valve (3) intended for evacuation, the spike (11) and the opening (13) are configured so that the spike (11) also passes through a collar (18) of the conduit (17) at the attachment point (PF).

12. The system comprises the following components: - an O-ring (23), - a mounting clip (22), - retaining ring (26) The system according to claim 1 , further comprising at least one of:

13. a cardiac prosthesis (2) capable of replacing the patient's natural left and right ventricles and comprising at least one cardiac valve (3); 13. A cardiac prosthesis implantable in the pericardial cavity of a patient, characterized in that the cardiac prosthesis (2) comprises at least one attachment system (1) according to any one of claims 1 to 12 for attaching the heart valve (3) to the cardiac prosthesis (2).

14. 14. The cardiac prosthesis according to claim 13, characterized in that the cardiac prosthesis (2) comprises two, three or four cardiac valves (3), each of which is attached to the cardiac prosthesis (2) by an attachment system (1) according to any one of claims 1 to 12.

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