System for attaching heart valve to heart prosthesis and heart prosthesis provided with such attachment system

Abstract

The invention relates to a system for attaching a heart valve. The function of the system (1) is to attach a heart valve (3) to a heart prosthesis (2) intended to be implanted within the pericardial cavity of a patient and to replace the natural left and right ventricles of the patient, the system (1) comprising a male ring (10) provided with nails (11) and a mating part (12) provided with an opening (13), the male ring (10) or the mating part (12) being intended to be fixed to the heart prosthesis (2), the staples (11) and the opening (13) are configured such that, in the attached position, the staples (11) pass through the flange (9) of the heart valve (3) and into the opening (13).

Description

Technical Field

[0001] The present invention relates to a system for attaching a heart valve to a cardiac prosthesis that is implantable in the pericardial cavity of a patient and is capable of replacing the patient's natural left and right ventricles after ablation of the latter. The invention also relates to a cardiac prosthesis provided with such an attachment system. Background Art

[0002] For example, fully implantable cardiac prostheses described in patents FR-2784585 and FR-2902345 have the function of replacing a patient's ventricles while preserving the function of the atria. To achieve this goal, the cardiac prosthesis comprises a rigid prosthesis body within which an artificial ventricle is located. Implanting such a cardiac prosthesis (i.e., an artificial heart prosthesis) within the patient's pericardial cavity requires establishing an interface between the patient's vascular network (atria and arteries) and the cardiac prosthesis without compromising the patient's anatomy.

[0003] As is well known, the natural heart includes four heart valves, which separate the different heart chambers and ensure good blood circulation between them. These four heart valves are the two heart valves located between the atria and ventricles (the mitral valve and the tricuspid valve), and the two heart valves located between the ventricles and the arteries (the aortic valve and the pulmonary valve). Therefore, a fully implantable heart prosthesis used to replace the natural heart must include (artificial) heart valves to re-establish the specific connection between the atria and arteries.

[0004] In order to be able to use conventional heart valves used in valve replacement surgery for this purpose, the fully implanted heart prosthesis must contain a specific interface. A standard heart valve typically consists of three leaflets, three legs that open and close under pressure, and a base that allows the surgeon to sew the valve shut. The base can be flat or corrugated (wave-shaped).

[0005] Such heart valves may be used to draw blood into or out of the heart prosthesis.

[0006] Typically, for expulsion, the heart valve is flat-base, with its flat base resting in the prosthetic heart passageway, with the legs oriented toward the exterior of the ventricle. A fabric conduit is positioned above the heart valve within the prosthetic heart passageway. A locking system secures the assembly to the prosthetic heart, and the surgeon then sutures the conduit to the patient's artery.

[0007] This type of attachment for discharge is not entirely satisfactory and has the following disadvantages:

[0008] - A short distance between the highest point of the heart valve and the point where the tissue guide is sutured to the patient's artery (pulmonary artery or aorta), which may hinder the surgeon's ability to perform the suture;

[0009] - The need to compress the tissue conduit within the heart valve annulus and the prosthesis channel to ensure a blood-tight connection requires significant insertion effort by the surgeon. This operation is further complicated by the fact that the prosthesis has no gripping points and there is a risk of twisting the locking clip;

[0010] - the materials and dimensions of the assembly formed by the heart valve and the tissue conduit installed in the channel of the heart prosthesis are not optimal in terms of sealing; and

[0011] - This attachment method does not allow the use of heart valves with uneven bases, such as wavy shaped valves. Summary of the Invention

[0012] The present invention aims to overcome at least some of the above-mentioned disadvantages, with the aim of simplifying and improving the operation of attaching an artificial heart valve to a cardiac prosthesis (intended to be implanted in the pericardial cavity of a patient to replace the patient's natural left and right ventricles), and to enable 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 for attaching a (artificial) heart valve to a cardiac prosthesis.

[0013] According to the invention, the attachment system comprises a male ring provided with spikes and a mating part provided with openings, the male ring or the mating part being intended to be fixed to a cardiac prosthesis, and the spikes and the openings being configured such that in the so-called attachment position the spikes pass through the flange of the heart valve and into the openings.

[0014] Thus, thanks to the invention, the male ring and the mating part intended for holding the heart valve at the level of the flange can be adapted to this flange, i.e. to the base of the heart valve, as described below. Thus, the attachment system can be adapted to heart valves with varicose structures, in particular heart valves with a non-flat base (both for discharge and for inhalation).

[0015] As described below, this attachment system has many other advantages, including the following:

[0016] - The attachment system does not extend the operating room operation time (e.g., the interface does not require suturing);

[0017] -The attachment system can be easily installed by the surgeon;

[0018] - The attachment system ensures that blood does not leak from the inside of the ventricle to the outside of the cardiac prosthesis;

[0019] - The attachment system allows the heart valve to remain in its packaging and be opened only in the operating room for implantation; and

[0020] - The attachment system allows the preservation of the sinuses of Valsalva for the aspiration portion of the cardiac prosthesis.

[0021] According to an embodiment envisaged and as described below, one of the two elements (the male ring or the mating part) is intended to be fixed to the cardiac prosthesis.

[0022] Advantageously, the male ring and the mating part each have so-called contact surfaces intended for gripping at least the flange of the heart valve in the attachment position and having a shape adapted to the shape of the flange of the heart valve.

[0023] In a first embodiment, the spikes and openings are configured such that the spikes are substantially straight in the attached position.

[0024] Furthermore, in the second embodiment, the nail and the opening are configured such that the nail is bent (or kinked) in the attachment position, for example, angled or curved. This deformation enhances the retention of the nail in the opening, thereby enhancing the retention between the connected components.

[0025] The nail can have a constant diameter. However, in certain embodiments, the diameter of the nail decreases towards the free end, which makes it easier for the nail to remain in the opening.

[0026] In a preferred embodiment, the male ring comprising at least one annular support and the spike fixed to the annular support is a one-piece component, which makes manufacturing easier.In an alternative embodiment, the spike may be fitted to the annular support.

[0027] In a first embodiment, the mating part is a female ring.In this first embodiment, according to an alternative embodiment envisaged, one of the two rings (male or female) is intended to be attached to a cardiac prosthesis.

[0028] Advantageously, the female ring comprises a surface opposite the contact surface, which surface has a shape complementary to that of the so-called receiving surface of the cardiac prosthesis.

[0029] In a second embodiment, the mating component corresponds to a portion of a cardiac prosthesis.Preferably, the portion of the cardiac prosthesis comprises a tubular element provided on its inner periphery with an edge intended for receiving a flange of a cardiac valve.

[0030] Furthermore, in certain embodiments, for heart valves intended for expulsion, the spikes and openings are configured such that in the attachment position these spikes also pass through the flange of the catheter (intended to be sutured to the artery).

[0031] Furthermore, in certain embodiments, the attachment system further comprises at least one of the following elements:

[0032] -O-rings;

[0033] - Attachment clips;

[0034] -Retaining ring.

[0035] The present invention also relates to a cardiac prosthesis implantable in the pericardial cavity of a patient, the cardiac prosthesis being adapted to replace the patient's natural left and right ventricles and comprising at least one cardiac valve.

[0036] According to the invention, a cardiac prosthesis comprises at least one attachment system as described above for attaching a cardiac valve to the cardiac prosthesis.

[0037] In a preferred embodiment, the cardiac prosthesis comprises two, three or (preferably) four heart valves, each of which is attached to the cardiac prosthesis by an attachment system, for example as described above. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] The accompanying drawings clearly show how the invention can be implemented. In the figures, like reference numerals represent similar elements.

[0039] [ Figure 1 ] is an exploded perspective view of a first embodiment of the attachment system.

[0040] [ Figure 2 ]yes[ Figure 1 ] is a three-dimensional view of the attachment system in the installed position.

[0041] [ Figure 3 ]yes[ Figure 1 ] a stereoscopic view of the attachment system in the attached position.

[0042] [ Figure 4 ] is in [ Figure 3 ] a cross-sectional view of the attachment system showing the attachment locations.

[0043] [ Figure 5 ] is an exploded perspective view of a first variation of the second embodiment of the attachment system.

[0044] [ Figure 6 ]yes[ Figure 5 ] a cross-sectional view of the attachment system in the attached position.

[0045] [ Figure 7 ] is an exploded perspective view of a second variation of the second embodiment of the attachment system. DETAILED DESCRIPTION

[0046] The present invention is shown in Figures 1 to 7 The attachment system 1 schematically shown in various specific embodiments in FIG. 1 has the function of attaching an artificial heart valve (intended for replacing a patient's natural heart valve) to a cardiac prosthesis.

[0047] (exist Figure 1 as well as Figures 5 to 7 The cardiac prosthesis 2 (partially and schematically shown in FIG) can be implanted in the chest and pericardial cavities of a patient and is suitable for replacing the patient's natural left and right ventricles after they have been removed. To achieve this, the cardiac prosthesis 2 includes a rigid prosthesis body (not shown) in which artificial left and right ventricles are arranged to replace the patient's natural left and right ventricles.

[0048] The cardiac prosthesis 2 includes all the devices necessary for its operation. Specifically, the cardiac prosthesis may include at least some of the characteristics proposed in the aforementioned patents FR-2784585 and FR-2902345. In the following description, the cardiac prosthesis 2, in particular the elements arranged in the prosthesis body, will not be further described.

[0049] Like a natural heart, the heart prosthesis 2 intended to replace a patient's natural heart also includes four heart valves, namely, two heart valves (mitral valve and tricuspid valve) arranged between the atrium and artificial ventricle of the heart prosthesis 2 for inhalation; and two heart valves (aortic valve and pulmonary valve) arranged between the artificial ventricle of the heart prosthesis 2 and the patient's arteries (aorta and pulmonary artery) for exhalation.

[0050] In a preferred embodiment, at least one heart valve 3 (but preferably all four heart valves 3 ) each corresponds to a conventional heart valve used in valve replacement surgery.

[0051] In a specific embodiment, as [ Figure 1 ], each (artificial) heart valve 3 includes an annular base 4, which is provided with three legs 6 on a downstream surface 5. The heart valve 3 also includes three leaflets 7. Each leaflet 7 is attached to two adjacent legs 6 and the base 4. The three leaflets 7 of the heart valve 3 are configured to open and close under the pressure of the upstream part. In this specification, the terms upstream and downstream are defined according to the direction of blood flow through the heart valve 3, such as Figure 1 、 Figure 2 、 Figure 5 and Figure 7 As shown by arrow E in FIG.

[0052] Furthermore, the base 4 has an upstream surface 8 opposite the downstream surface 5 and includes a flange 9 surrounding the upstream surface 8 (around the entire periphery of the upstream surface). The upstream surface 8 (and the flange 9) can have a variety of shapes. In a first embodiment (not shown), the upstream surface 8 and the flange 9 are flat. In a second specific embodiment, specifically as shown in FIG. Figure 1 and Figure 5 As shown, the upstream surface 8 and flange 9 are curved or corrugated (eg, generally wavy in shape).

[0053] The function of the attachment system 1 is to attach such a heart valve 3 to the cardiac prosthesis 2 , whatever the shape of the base 4 of the heart valve.

[0054] To this end, specifically Figure 1 As shown, the attachment system 1 comprises an annular male ring 10 provided on one surface 10A (longitudinal direction) with a spike 11. The spike 11 corresponds to an elongated element (in particular a solid tube) protruding from the surface 10A.

[0055] In a preferred embodiment, the male ring 10 (which specifically comprises the annular support 20 and the spike 11 fixed to the annular support 20) is a one-piece component, which makes it easier to manufacture. For example, the one-piece component is made of titanium. In a variant embodiment not shown, the spike can also be a separate element assembled (for example, welded or bonded) to the annular support.

[0056] The attachment system 1 further comprises a mating part 12 intended for mating with the male ring 10. The mating part 12 is provided with openings 13. Each of these openings 13 is intended for receiving a spike 11 ( Figure 3 、 Figure 4 and Figure 6 ). Therefore, the mating component 12 includes at least as many openings 13 as the male ring 10 includes spikes 11 , and the spikes 11 and the openings 13 are shaped and arranged so that each spike 11 can be inserted into an opening 13 .

[0057] For the purposes of the present invention, the attachment position PF denotes the position in which the heart valve 3 is integrated into the heart prosthesis 2 and is attached to the heart prosthesis 2 by means of the attachment system 1 in the final position of the heart valve.

[0058] One of the following elements is intended for fixing to the cardiac prosthesis 2: a male ring 10, a mating part 12. As will be described below, this connection can be realized in a number of different embodiments.

[0059] Furthermore, as described below, the nail 11 and the opening 13 are configured such that in the attached position the PF nail 11 passes through the flange 9 (eg, made of silicone strip and porous polytetrafluoroethylene (PTFE) fabric) of the heart valve 3 and then enters the opening 13 .

[0060] Thus, in the attachment position PF, the male ring 10 and the mating part 12 clamp the flange 9 of the heart valve 3, as shown in FIG. Figure 3 、 Figure 4 and Figure 6 shown.

[0061] Furthermore, as will be described below, the spikes 11 are retained in the openings 13 by lateral contact, which allows the male ring 10 to be secured to the mating component 12 and held together, possibly with the aid of additional elements (e.g., clips) in a particular embodiment. This connection allows the heart valve 3 to be held in place by the flange 9, thereby attaching the heart valve 3 to the mating component 12 and, therefore, to the cardiac prosthesis 2 (to which the mating component 12 is secured).

[0062] The male ring 10 and the mating part 12 each have a so-called contact surface 10A and 14A ([ Figure 1 ]). The contact surfaces 10A and 14A are intended for clamping the flange 9 in the attachment position PF. The shape of these contact surfaces 10A and 14A is adapted to the shape of the flange 9 and therefore to the shape of the base 4.

[0063] Thus, the attachment system 1 can be adapted to the shape of the flange 9 and base 4 of the heart valve 3. In particular, the attachment system can be adapted to heart valves 3 having a corrugated base 4. In this way, the attachment system 1 can be used to attach any type of conventional heart valve 3, in particular heart valves 3 having a non-flat base 4, to integrate them into a cardiac prosthesis 2.

[0064] Furthermore, as described above, the attachment system 1 can be used to attach a heart valve 3 intended for draining blood from the cardiac prosthesis 2 or to attach a heart valve 3 intended for sucking blood into the cardiac prosthesis 2 .

[0065] As described in more detail below, the attachment system 1 represents an interface that allows satisfying the following constraints associated with its use in an implantable cardiac prosthesis 2:

[0066] -The attachment system is biocompatible;

[0067] - The attachment system allows for long-term implantation;

[0068] - The attachment system is washable and suitable for sterilization;

[0069] - the attachment system ensures sealing with the cardiac prosthesis 2; and

[0070] - The attachment system has an ergonomic quick-attach mode (which can reduce the duration of extracorporeal circulation).

[0071] The attachment system 1 can be produced in different ways. Specifically, the attachment system can be produced in two different ways, depending on how the mating component 12 or the male ring 10 is fixed to the cardiac prosthesis 2 .

[0072] exist Figures 1 to 4 In the first embodiment shown, the mating component 12 is a female ring 14, i.e., a separate component intended to be connected to the cardiac prosthesis 2. The female ring 14 is the opposite shape of the male ring 10. In this first embodiment, one of the two rings (the male ring 10 or the female ring 14) is attached to the cardiac prosthesis 2.

[0073] Thus, in a first (preferred) variant, the female ring 14 is attached to the cardiac prosthesis 2 in the usual manner, and in a second variant, the male ring 10 is attached to the cardiac prosthesis 2 in the usual manner.

[0074] Furthermore, in the second embodiment, the mating component 12 corresponds to the parts 15, 16 of the cardiac prosthesis 2, as described in accordance with Figures 5 to 7 As shown in two different variations, namely Figure 5 and Figure 6 The first variant is used to attach a heart valve 3 intended for discharge, and [ Figure 7 ] is used to attach a heart valve 3 intended for inhalation.

[0075] Therefore, in Figures 1 to 4 In the first embodiment shown, the mating part 12 is a female ring 14, for example made of titanium, initially independent of and separate from the cardiac prosthesis 2, and having an upstream surface 14B of a specific shape intended for contact with the cardiac prosthesis 2. This specific shape corresponds to the downstream surface 2A of the cardiac prosthesis 2 (called the receiving surface, as shown in [ Figure 1 ] are complementary in shape.

[0076] like Figures 1 to 4 As shown, this first embodiment comprising a female ring 14 relates to an attachment system 1 for attaching a heart valve 3 intended for expulsion.

[0077] [ Figure 1 ] The individual elements are shown in an exploded view. In this embodiment (thus intended for drainage), the function of the attachment system 1 is to connect a catheter 17 to the cardiac prosthesis 2 in addition to the heart valve 3. This catheter 17 is intended to convey the blood drained from the cardiac prosthesis 2 (in the direction of arrow E) through the heart valve 3 to an artery (aorta or pulmonary artery), to which the catheter 17 is sutured in the usual manner.

[0078] The fabric conduit 17 also includes a flange 18 at its upstream end. This flange 18 is made of, for example, polyester fiber and has a shape similar to that of the flange 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 pierce) the flange 18 of the conduit 17.

[0079] In order to be able to be passed or pierced by the spike 11, the flange 9 of the heart valve 3 and (where applicable) the flange 18 of the catheter 17 must include (appropriately sized) holes or (preferably) be made of a material that allows the spike 11 to pierce these flanges.

[0080] Figure 1 、 Figure 2 and Figure 3 Three consecutive steps of attaching the heart valve 3 and the catheter 17 to the heart prosthesis 2 are shown.

[0081] More precisely:

[0082] -[ Figure 1 ] shows an initial position P1, in which the various components have not yet been connected together (or assembled).

[0083] -[ Figure 2 ] shows an intermediate position P2 during assembly, in which the male ring 10 has been assembled to the flange 18 of the catheter 17 and to the flange 9 of the heart valve 3. The spikes 11 of the ring 10 pass through these flanges 9 and 18; and

[0084] -[ Figure 3 ] shows the attachment position PF. This attachment position PF is also shown in [ Figure 4 ] is shown (in cross section).

[0085] Thus, in this embodiment, the spike 11 of the male ring 10 pierces the flange 18 of the catheter 17 and the flange 9 of the heart valve 3 before being inserted into the opening 13 of the female ring 14 .

[0086] In a preferred embodiment, if Figures 1 to 7 As shown, when the male ring 10 is coaxially positioned relative to the longitudinal axis XX of the heart valve 3 and the catheter 17 , the spikes 11 of the male ring 10 are arranged parallel to this longitudinal axis XX.

[0087] In the first embodiment, as [ Figure 4 ] As shown in FIG, the female ring 14 includes cylindrical openings 13 (ie linear openings), which are inclined relative to the longitudinal axis XX, that is, the directions of the openings 13 present a non-zero angle relative to the longitudinal axis XX.

[0088] Therefore, if [ Figure 4 ], the nail 11 is subjected to pressure during assembly and to the constraints of the inclination of the opening 13, causing the nail 11 to bend (or bend). Therefore, when entering the opening 13, the nail 11 changes direction and presents a bend 11A at its attachment position PF ([ Figure 4 ]). In a modified embodiment (not shown), the nail-shaped member may have another bent shape different from this curved shape.

[0089] This mechanical deformation allows the four components (male ring 10 , flange 18 of the drainage duct 17 , flange 9 of the heart valve 3 and female ring 14 ) to be assembled into a one-piece assembly.

[0090] The female ring 14 can be adapted to the contents and shape of the cardiac prosthesis 2, thereby facilitating the integration of the cardiac valve 3. Whatever the embodiment considered, the male ring 10 and the female ring 14 can be adapted to allow attachment of any type of cardiac valve 3 without modifying the design of the cardiac prosthesis 2.

[0091] The attachment system 1 can be made in different sizes and / or shapes in order to be specifically adapted to various surgical heart valves 3 .

[0092] In the first embodiment, only the (preferred) embodiment for discharge is shown. An embodiment with cooperating male and female rings for suction can also be provided.

[0093] Furthermore, in order to fit the cardiac prosthesis 2 as closely as possible and to minimize the overall dimensions of the attachment system 1 , the second embodiment omits the female ring by adapting the shape of a portion of the cardiac prosthesis 2 to the corresponding shape of the male ring 10 .

[0094] Thus, in this second embodiment, the mating part 12 corresponds to the parts 15, 16 of the cardiac prosthesis 2. This second embodiment can also be used for attaching a cardiac valve 3 intended for expulsion or for attaching a cardiac valve 3 intended for inhalation.

[0095] exist Figure 5 and Figure 6 The first variant of the second embodiment shown (like Figures 1 to 4 Like the first embodiment of the present invention, this first variant is also intended for attaching a heart valve 3 for expulsion, the mating part 12 corresponding to a portion 15 of the cardiac prosthesis 2. In the present example, this portion 15 of the cardiac prosthesis 2 comprises a tubular element (or extension) 19.

[0096] In this embodiment, the tubular element 19 is provided with an edge 21 over its entire inner circumference 19A, the shape of which is adapted to the shape of the base 4 of the heart valve 3. The wavy shape of the heart valve 3 is thus integrated into the body of the heart prosthesis 2. Figure 6] As shown in FIG, the upstream surface 8 of the base 4 of the heart valve 3 rests against this edge 21 in the attachment position PF.

[0097] exist Figure 5 and Figure 6 In this variant, the purpose of the spike 11 of the male ring 10 is still to pierce the flange 18 of the catheter 17 and the flange 9 of the heart valve 3 and then to be housed in the mating part 1 previously machined in the body of the cardiac prosthesis 2 .

[0098] In this particular embodiment, as [ Figure 6 ] As shown, the opening 13 is parallel to the longitudinal axis XX of the attachment system 1, so that in the attachment position PF, the nail 11 is not bent (or folded), but remains straight and parallel to the longitudinal axis XX.

[0099] In this embodiment, in order to increase the holding force of the male ring 10, a clip 22 can be provided, which is produced in a conventional manner to hold the assembled parts together. For this purpose, a conventional groove 22A ([ Figure 6 ]), the groove is intended to receive the clip 22.

[0100] In addition, Figure 5 and Figure 6 In the example shown, in the groove 23A ([ Figure 6 ]) An O-ring 23 is also provided, which is intended to seal the assembled components against blood flow.

[0101] In the context of the present invention, the spike 11 may have a constant diameter regardless of the embodiment. However, in certain embodiments, the diameter of the spike 11 decreases toward its free end (i.e., the end opposite to the end connected to the surface 10A of the male ring 10), which facilitates installation and enhances retention when the spike is inserted into the cylindrical opening 13 (i.e., of constant diameter).

[0102] This first variant of the second embodiment comprising a portion 15 that is a counterpart of the male ring 10 allows a good adaptation to the cardiac prosthesis and minimizes the overall dimensions of the attachment system 1 .

[0103] This variant requires a modification of the design of the cardiac prosthesis 2 if, for example, the shape of the cardiac valve 3 changes, but nevertheless offers the advantage of reducing the protruding height of the legs of the cardiac valve 3 .

[0104] In addition, as [ Figure 7 ], a second variant of the second embodiment is intended for attaching a heart valve 3 for inhalation. In this case, the free ends of the leaflets 7 of the heart valve 3 are oriented towards the heart prosthesis 2, i.e. in contact with the heart valve 3. Figure 5 and Figure 6 The embodiment shown is in the opposite direction.

[0105] In this second variant, the fitting part 12 corresponds to a portion 16 of the cardiac prosthesis 2. In the present example, this portion 16 of the cardiac prosthesis 2 comprises a tubular element (or extension) 24.

[0106] In this embodiment, the tubular element 24 is provided with a rim 25 over its entire inner circumference 24A, the shape of which is adapted to the shape of the base 4 of the heart valve 3. The wavy shape of the heart valve 3 is thus integrated into the body of the cardiac prosthesis 2. The upstream surface 8 of the base 4 of the heart valve 3 rests against this rim 25 in an attachment location (not shown).

[0107] Furthermore, the male ring 10 that comes into contact with blood is blood-compatible.

[0108] In this embodiment, a retaining ring 26 (preferably a metal ring) is used to retain the male ring 10 with spikes 11 and the heart valve 3 in the cardiac prosthesis 2 for suction until it is mounted on a conventional metal frame plate 27 (which is already in place in the patient's chest when the cardiac prosthesis 2 is implanted). As an example, patents FR-2902343 and FR-2902344 describe a frame plate system that cooperates with suction of a cardiac prosthesis.

[0109] In an alternative embodiment (not shown), the annular support 20 of the male ring 10 may be sized and shaped to provide such retention (prior to installation on the metal frame plate) rather than the retaining ring 26 providing such retention.

[0110] For inhalation, an attachment system with cooperating male and female rings according to the first embodiment may also be provided. In such an embodiment (not shown), the female ring intended for attachment to the cardiac prosthesis replaces the [ Figure 7 ] in section 16 of the example.

[0111] Furthermore, in the context of the present invention, the attachment system 1 may comprise one or more of the following elements, depending on the particular embodiment under consideration:

[0112] -O-rings, e.g. Figure 5 and Figure 6 The O-ring 23 shown in FIG;

[0113] - Attachment clips, e.g. Figure 5 and Figure 6 The clip 22 shown in FIG; and

[0114] -Retaining ring, such as [ Figure 7 ] The retaining ring 26 shown in ].

[0115] Furthermore, regardless of which embodiment is considered, in order to meet the blood compatibility constraints, the part or parts of the attachment system 1 that come into contact with the blood (mainly Figures 1 to 4 The female ring 14 in the illustrated embodiment can be covered with a knitted prosthesis (polyester yarn knit fabric). Preferably, when applied to the female ring, this polyester fabric is cut as close as possible to the shape of the ring, wrapped around the ring and sewn to keep it in place.

[0116] Alternatively, in order to make the blood-contacting parts blood-compatible, other solutions may be provided, such as covering the blood-contacting surfaces with expanded polytetrafluoroethylene (cPTFE), titanium bead blasting, etc.

[0117] Regardless of the embodiment considered, the method of installing the attachment system 1 comprises at least one operation of piercing the flange 9 of the heart valve 3 (and, where appropriate, the flange 18 of the catheter 17) by means of the spike 11 of the male ring 10 and inserting the spike 11 into the mating opening 13 of the mating part 12. Depending on the embodiment, the method comprises other steps carried out before and after this operation.

[0118] As described above, the attachment system 1 replaces the suturing operation while providing a rigid framework for the heart valve 3 , which facilitates integration of the attachment system into the design of the heart prosthesis 2 .

[0119] The attachment system 1 has many advantages. Firstly, the attachment system has the following main advantages:

[0120] - reducing the distance between the highest point of the heart valve 3 and the highest point of the interface at the level of the drainage duct of the cardiac prosthesis 2;

[0121] - allows the use of heart valves 3 whose base 4 is not flat but wavy;

[0122] - The preparation and implantation of the cardiac prosthesis 2 are simplified.

[0123] Furthermore, the attachment system 1 has the following advantages:

[0124] - The attachment system does not extend the operating room operation time (e.g., the interface does not require suturing);

[0125] -The attachment system can be easily installed by the surgeon;

[0126] - the attachment system ensures that blood does not leak from the inside of the ventricle to the outside of the cardiac prosthesis 2;

[0127] - the attachment system allows the heart valve 3 to remain in its packaging and only be opened in the operating room for implantation; and

[0128] The attachment system allows the sinus of Valsalva to be preserved for the inhalation portion of the cardiac prosthesis 2 .

Claims

1. An attachment system intended for attaching a heart valve to a cardiac prosthesis, said cardiac prosthesis (2) being intended to be implanted in the pericardial cavity of a patient and to replace the patient's natural left and right ventricles, characterized in that The attachment system comprises a male ring (10) provided with a spike (11) and a mating part (12) provided with an opening (13), the male ring (10) or the mating part (12) being intended to be fixed to the cardiac prosthesis (2), and the spike (11) and the opening (13) being configured such that in an attachment position (PF) the spike (11) passes through the flange (9) of the cardiac valve (3) and enters the opening (13).

2. The system according to claim 1, It is characterized by: The male ring (10) and the mating part (12) each have a contact surface, which is intended to be used for clamping at least the flange (9) of the heart valve (3) in the attachment position (PF), and the contact surfaces (10A, 14A, 21, 25) have a shape that is adapted to the shape of the flange (9) of the heart valve (3).

3. The system according to claim 1 , It is characterized by: The spike (11) and the opening (13) are configured such that the spike (11) is substantially straight in the attachment position (PF).

4. The system according to claim 1 , It is characterized by: The spike (11) and the opening (13) are configured such that the spike (13) is bent in the attachment position (PF).

5. System according to any one of the preceding claims, It is characterized by: The diameter of the nail (11) decreases towards the free end.

6. System according to any one of the preceding claims, It is characterized by: The male ring, comprising at least one annular support (20) and the spike (11) fixed to the annular support (20), is a one-piece component.

7. The system according to any one of claims 1 to 6, It is characterized by: The matching component (12) is a female ring (14).

8. The system according to claims 2 and 7, It is characterized by: The female ring (14) comprises a surface (14B) opposite the contact surface (14A), the shape of the surface (14B) being complementary to the shape of the receiving surface (2A) of the cardiac prosthesis (2).

9. The system according to any one of claims 1 to 6, It is characterized by: The mating component (12) corresponds to a portion (15, 16) of the cardiac prosthesis (2).

10. The system according to claim 9, It is characterized by: The portion (15, 16) of the cardiac prosthesis (2) comprises a tubular element (19, 24) provided on its inner periphery (19A, 24A) with an edge (21, 25) intended to receive the flange (9) of the cardiac valve (3).

11. The system according to any one of the preceding claims, It is characterized by: For a heart valve (3) intended for expulsion, the spike (11) and the opening (13) are configured such that in the attachment position (PF) the spike (11) also passes through the flange (18) of the catheter (17).

12. The system according to any one of the preceding claims, It is characterized by: The system further comprises at least one of the following elements: -O-ring (23); - attachment clip (22); - Retaining ring (26).

13. A cardiac prosthesis that can be implanted in the pericardial cavity of a patient, the cardiac prosthesis (2) being capable of replacing the patient's natural left ventricle and right ventricle and comprising at least one cardiac valve (3), characterized in that: The cardiac prosthesis comprises at least one attachment system (1) according to any one of claims 1 to 12 for attaching the cardiac valve (3) to the cardiac prosthesis (2).

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

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