Device for connecting an implantable artificial heart to a patient's vascular system, and an artificial heart equipped with said connection device

Abstract

A device for connecting an implantable artificial heart to a patient's vascular system and an artificial heart provided with such a connection device. A connection device (1) intended to connect an artificial heart (2) implantable in a patient's pericardial cavity to the patient's vascular system has an interface component (4) with a mitral interface element (5), a tricuspid interface element (6), an aortic interface element (7) and a pulmonary interface element (8) intended to connect to the patient's left atrium, right atrium, aorta and pulmonary artery, respectively. Each of the interface elements (5-8) is provided with an orifice (9-12), at least some of the interface elements (5-8) having different orientations that correspond to the orientation of the artificial heart (2) and are suitable to respect the patient's anatomy. This connection device (1) in particular allows the artificial heart (2) to be fitted in place more easily and more quickly.

Description

[Technical field]

[0001] The present invention relates to a connection device for connecting an artificial heart to the vascular system of a patient, which artificial heart can be implanted in the pericardial cavity of the patient and can replace the natural left and right ventricles of said patient after ablation. The present invention also relates to an artificial heart equipped with such a connection device. [Background technology]

[0002] Totally implantable artificial hearts, such as those described in, for example, patent application FR-2784585 and patent application FR-2902345, have the function of replacing the patient's ventricle while preserving the atrium. To achieve this, they comprise a rigid prosthesis in which the artificial ventricle is placed.

[0003] Therefore, in order to implant this artificial heart in the pericardial cavity of a patient, it is necessary to create an interface between the patient's vascular system (atria and arteries) and the artificial heart, taking into account the patient's anatomy. To achieve this, the following points must be considered: - a defined orientation of the atria (left and right) with a more or less constant spacing, and - Orientation and arrangement of the arteries (aorta and pulmonary artery) which can vary considerably.

[0004] One solution currently in use comprises, on the one hand, an interface part (corresponding to a bezel system) for the insertion of the artificial heart and, on the other hand, two flexible conduits (or vascular conduits) for the removal of the artificial heart.

[0005] US Pat. No. 5,399,433 (FR-2902343) and US Pat. No. 5,399,444 (FR-2902344) describe a system of cooperating bezels as an insertion interface for the insertion of an artificial heart. The bezel system comprises a first bezel forming an integral part of the rigid prosthesis of the artificial heart and comprising a first and a second orifice communicating respectively with the artificial left and right ventricles of the artificial heart, and a second bezel comprising a third and a fourth orifice that can be connected respectively to the natural left and right atria of the patient via a collar that is sewn to the atrium. These first and second bezels are configured so that they can be removably connected to each other with the first and third orifices facing each other and the second and fourth orifices facing each other. This bezel system makes it easier to connect the artificial heart (with the first bezel attached) to the second bezel (pre-connected to the natural left atrium).

[0006] Each of the bezels in this insertion interface is performed before the artificial heart is placed. In contrast, the vascular conduit is first attached to the artificial heart using staples before being sutured to the patient's artery. The presence of the artificial heart means that the surgeon has less room to operate and therefore more difficult access to perform the suturing. Final placement of the artificial heart is performed by clipping the artificial heart to the insertion interface.

[0007] The presence of the artificial heart when the vascular conduit is sutured to the artery creates ergonomic problems: the artificial heart must be held in place by someone other than the surgeon who performs the sutures, and access to the artery is limited. This means that two people are needed to place the artificial heart.

[0008] In addition, the system for attaching the vascular conduit requires the use of several grafting aids and is difficult to assemble due to the sealing requirements (interference fit). [Prior art documents] [Patent documents]

[0009] [Patent Document 1] French Patent No. 2784585 [Patent Document 2] French Patent No. 2902345 [Patent Document 3] French Patent No. 2902343 [Patent Document 4] French Patent No. 2902344 Summary of the Invention [Problem to be solved by the invention]

[0010] The aim of the invention is to find a solution that allows simplifying and improving the implantation procedure of an artificial heart by allowing the surgeon to work in a less restrictive environment for placement and suturing. To this end, the invention relates to a connection device intended to connect to the vascular system of a patient an artificial heart that can be implanted in the pericardial cavity of the patient, said artificial heart being capable of replacing the patient's natural left and right ventricles after ablation of the latter. [Means for solving the problem]

[0011] According to the invention, the connection device comprises a single interface part configured to be attached to the artificial heart, the interface part comprising an interface element called a mitral interface element, an interface element called a tricuspid interface element, an interface element called an aortic interface element and an interface element called a pulmonary interface element, intended to connect to the left atrium, the right atrium, the aorta and the pulmonary artery of a patient, respectively, each of the interface elements being provided with an orifice and having a predetermined (suitable) orientation.

[0012] Thus, the present invention, and the connection device provided with interface parts comprising an assembly of interface elements with the appropriate orientation of these interface elements as specified below, makes it possible to simplify and improve the procedure for placing an artificial heart by allowing the surgeon to work in a less restricted environment for the placement and suturing procedure.

[0013] As will be explained below, the connection device provides many other advantages, including: - Improved ergonomics for surgeons, - Reducing the number of parts implanted and the number of parts required for implantation; - Faster transplant times.

[0014] In the context of the present invention, the relative orientation of the interface elements of the interface parts is adapted both to the characteristics of the artificial heart and to the given anatomy, in particular the average anatomy, of a patient suitable to receive the artificial heart, which the artificial heart is designed to respect.

[0015] In addition, the relative positions (and distances) of the interface elements of the interface parts are also adapted to both the characteristics of the artificial heart and to the given anatomy, in particular the average anatomy, of a patient suitable to receive the artificial heart.

[0016] Advantageously, therefore, the orientation of the mitral interface element and the orientation of the tricuspid interface element have an angle between them of 0° to 32°, preferably of 0° to 20°. Furthermore, in certain embodiments, the mitral interface element and the tricuspid interface element are arranged on a flat plate of the interface part, which allows for a particular ease of realization.

[0017] In addition, advantageously, the interface parts have at least some of the following orientations: - the orientation of the aortic interface element and the orientation of the mitral interface element have an angle between them of between 0° and 90°, preferably between 20° and 45°; - the orientation of the aortic interface element and the orientation of the tricuspid interface element have an angle between them of between 0° and 90°, preferably between 20° and 45°; - the orientation of the pulmonary interface element and the orientation of the mitral interface element have an angle between them of between 26° and 64°, preferably between 40° and 60°; - the orientation of the pulmonary interface element and the orientation of the tricuspid interface element have an angle between them of between 31° and 73°, preferably between 40° and 60°; the orientation of the aortic interface element and the orientation of the pulmonary interface element have an angle between them of between 39° and 79°, preferably between 55° and 70°.

[0018] In addition, advantageously, the interface components have at least some of the following distances: - the distance between the center of the orifice of the mitral valve interface element and the center of the orifice of the tricuspid valve interface element is between 42 mm and 76 mm, preferably between 45 mm and 60 mm; - the distance between the center of the orifice of the mitral interface element and the center of the orifice of the aortic interface element is between 37 mm and 65 mm, preferably between 40 mm and 55 mm; - the distance between the centre of the orifice of the mitral interface element and the centre of the orifice of the pulmonary interface element is between 50 mm and 80 mm, preferably between 60 mm and 70 mm; - the distance between the center of the orifice of the tricuspid interface element and the center of the orifice of the aortic interface element is between 34 mm and 64 mm, preferably between 35 mm and 50 mm; - the distance between the center of the orifice of the tricuspid interface element and the center of the orifice of the pulmonary interface element is between 59 mm and 91 mm, preferably between 70 mm and 80 mm; the distance between the centre of the orifice of the aortic interface element and the centre of the orifice of the pulmonary interface element is between 22 mm and 46 mm, preferably between 30 mm and 40 mm.

[0019] In a preferred embodiment, the interface components are made from one of the following materials: titanium or stainless steel.

[0020] In addition, advantageously, the aortic and pulmonary interface elements each include a thread to allow for screwing, as specified below.

[0021] In a preferred embodiment, the connection device also comprises: a first vascular conduit, the first end of which is intended to be sutured to the aorta and the second end of which is provided with a freely rotating mounted ring and capable of being screwed onto the aortic interface element; and / or a second vascular conduit, the first end of which is intended to be sutured to the pulmonary artery and the second end of which is provided with a ring mounted so as to rotate freely and which can be screwed onto the pulmonary interface element; and / or a first suture collar intended to be sutured to the left atrium and comprising a core configured to be mountable onto the mitral valve interface element; and / or a second suture collar intended to be sutured to the patient's right atrium and comprising a core configured to be mountable onto the tricuspid valve interface element; Also equipped.

[0022] The present invention also relates to an artificial heart implantable in a patient's pericardial cavity, which is capable of replacing the patient's native left and right ventricles following ablation of the patient's native left and right ventricles.

[0023] According to the invention, the artificial heart comprises at least one prosthesis in which at least the left and right artificial ventricles are arranged, and a connecting device as described above, adapted to be mounted in a housing provided in the prosthesis.

[0024] Advantageously, the interface part of the connection device comprises a centering tongue cooperating with a throat fitted in the outer wall of the prosthesis to make it easier to place the prosthesis on the connection device.

[0025] Once in place in the housing, the connection device is attached to the prosthesis.A variety of attachment means for removably attaching the interface component to the prosthesis are contemplated within the scope of the present invention.

[0026] In a first embodiment, the artificial heart is provided with screw attachment means, and in a second embodiment, the artificial heart is provided with clip attachment means.

[0027] The accompanying drawings will make clearer how the invention can be put into practice, in which identical reference numbers indicate similar elements, and in which: [Brief description of the drawings]

[0028] [Figure 1] FIG. 2 is a perspective view of the exterior of an interface component of the connection device. [Diagram 2] FIG. 2 is a schematic perspective view of a part of an artificial heart provided with a connecting device; [Diagram 3] 2 is a view similar to FIG. 1 showing different orientation and distance features of the interface elements of the interface part. [Figure 4] FIG. 13 is a perspective view of the inner surface of an interface component of a connection device provided with a vascular conduit that is partially shown. [Diagram 5] 2A-2C are perspective views of the inner surface of the interface component of FIG. 1 showing different support planes. [Figure 6] FIG. 1 is a schematic perspective view of a part of an artificial heart prosthesis provided with a housing intended to receive a connecting device. [Figure 7] FIG. 2 is a perspective view of a vascular conduit of the connection device. [Figure 8] FIG. 13 is a perspective view of a suture collar of the connecting device. [Figure 9] FIG. 2 is a schematic perspective view of a screw attachment means; [Figure 10] FIG. 2 is a schematic side view of a clip attachment means. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0029] A connection device 1 illustrating the invention and shown diagrammatically in a particular embodiment in FIG. 1 is designed to connect an artificial heart 2 to a patient's vascular system (not shown).

[0030] This artificial heart 2, partially shown in FIG. 2, can be implanted in the patient's thoracic and pericardial cavities and can replace the patient's native left and right ventricles after ablation.

[0031] To achieve this, the artificial heart 2 comprises a rigid prosthesis 3, in which artificial left and right ventricles (not shown) are intended to replace the patient's natural left and right ventricles.

[0032] The artificial heart 2 comprises all the means necessary for its operation. In particular, it may comprise at least some of the features indicated in the aforementioned patents FR 2 784 585 and FR 2 902 345. The artificial heart 2, and in particular the elements arranged in the prosthesis 3, will not be described further in the following description.

[0033] The connection device 1 is intended to connect the artificial heart 2 to the patient's left (native) atrium, right (native) atrium, aorta (native) and pulmonary artery (native).

[0034] To do this, this connection device 1 comprises, according to the invention, a (single) interface part 4 adapted to be able to be attached to a prosthesis 3 of an artificial heart 2, as shown in FIG.

[0035] This interface part 4 is a rigid hollow part, which follows the orientation of the artificial heart 2 and respects the patient's anatomy, as described below.

[0036] For this purpose, the interface part 4 is provided with four interface elements, as shown in FIG. 1 (showing the outer surface 28B of the interface part 4), namely: - an interface element, called the mitral valve interface element 5, intended to connect the artificial heart to the left (native) atrium of the patient; - an interface element, called tricuspid interface element 6, intended to connect the artificial heart to the right (native) atrium of the patient; - an interface element, called aortic interface element 7, intended to connect the artificial heart to the patient's (native) aorta, and - an interface element, called the pulmonary interface element 8, intended to connect the artificial heart to the patient's pulmonary (natural) artery.

[0037] As a result, the single interface part 4 makes it possible to perform a connection with the artificial heart 2 for the assembly of its four accesses (two for intake and two for extraction), shown by openings 9A to 12A in FIG. 6, for accessing the artificial left and right ventricles of the artificial heart 2.

[0038] Further, according to the invention, each of the interface elements 5 to 8 is provided with an orifice 9 to 12, at least some of the interface elements 5 to 8 having different orientations, as specified below.

[0039] "Orientation" refers to the direction of the axes of the orifices of the interface elements, as represented in FIG. 3 by axes 5A, 6A, 7A, and 8A for orifices 9, 10, 11, and 12 of interface elements 5, 6, 7, and 8, respectively.

[0040] The orientation may also be defined by interface or support planes P1, P2, P3, and P4, designated below, that are orthogonal to axes 5A, 6A, 7A, and 8A.

[0041] The orientation of the interface elements 5 to 8 is adapted to both the technical features of the artificial heart 2 and to the average anatomy of a potential patient, in particular to simplify the placement of the artificial heart 2 .

[0042] 3, the mitral interface element 5 and the tricuspid interface element 6 have the same orientation. Axes 5A and 6A are parallel. In addition, the mitral interface element 5 and the tricuspid interface element 6 are formed in a single and identical plate 13 of the interface piece 4, which is disposed in the plane of the atrial appendage of the patient.

[0043] However, in the context of the present invention, the orientation 5A of the mitral interface element 5 and the orientation 6A of the tricuspid interface element 6 may have a non-zero angle between them. More generally, they may have an angle between them of between 0° and 32°, preferably between 0° and 20°.

[0044] In addition, the orientation 7A of the aortic interface element 7 and the orientation 5A of the mitral interface element 5 have an angle therebetween between 0° and 90°, preferably between 20° and 45°.

[0045] Similarly, the orientation 7A of the aortic interface element 7 and the orientation 6A of the tricuspid interface element 6 have an angle between them of between 0° and 90°, preferably between 20° and 45°.

[0046] In addition, the orientation 8A of the pulmonary interface element 8 and the orientation 5A of the mitral valve interface element 5 have an angle therebetween of between 26° and 64°, preferably between 40° and 60°.

[0047] Similarly, the orientation 8A of the pulmonary interface element 8 and the orientation 6A of the tricuspid interface element 6 have an angle between them of between 31° and 73°, preferably between 40° and 60°.

[0048] Furthermore, the orientation 7A of the aortic interface element 7 and the orientation 8A of the pulmonary interface element 8 have an angle therebetween between 39° and 79°, preferably between 55° and 70°.

[0049] The orientation of the orifice (or interface plane) is determined by the design of the artificial heart 2 and is derived from the patient's biometric information.

[0050] Further, by way of illustration, in the particular example shown in FIG. 3, the following distances may be provided between the centers 5B to 8B of the various orifices 9 to 12 of the interface piece 4: the distance between the center 5B of the orifice 9 of the mitral interface element 5 and the center 6B of the orifice 10 of the tricuspid interface element 6, between 42 mm and 76 mm, preferably between 45 mm and 60 mm; the distance between the center 5B of the orifice 9 of the mitral interface element 5 and the center 7B of the orifice 11 of the aortic interface element 7, between 37 mm and 65 mm, preferably between 40 mm and 55 mm; the distance between the center 5B of the orifice 9 of the mitral interface element 5 and the center 8B of the orifice 12 of the pulmonary interface element 8, between 50 mm and 80 mm, preferably between 60 mm and 70 mm; the distance between the center 6B of the orifice 10 of the tricuspid interface element 6 and the center 7B of the orifice 11 of the aortic interface element 7, between 34 mm and 64 mm, preferably between 35 mm and 50 mm; the distance between the center 6B of the orifice 10 of the tricuspid interface element 6 and the center 8B of the orifice 12 of the pulmonary interface element 8, between 59 mm and 91 mm, preferably between 70 mm and 80 mm; and the distance between the centre 7B of the orifice 11 of the aorta interface element 7 and the centre 8B of the orifice 12 of the pulmonary interface element 8, between 22 mm and 46 mm, preferably between 30 mm and 40 mm.

[0051] In a preferred embodiment, the distances and angles between the interface elements 5 to 8 of the interface part 4 are defined based on a scan of the patient. Since each patient has specific physiological and anatomical characteristics, any spacing is compensated for by flexible components (suture collar and vascular conduit) described below that connect between the patient's vasculature and the connection device 1.

[0052] In a particular embodiment, the size of the interface component 4 is such that, in plan, it can be inscribed in a rectangle that is 12 centimeters long and 9 centimeters wide.

[0053] The material used to manufacture the interface part 4 must be rigid enough to withstand the attachment force. Specifically, a metallic material such as stainless steel 316L can be used.

[0054] In a preferred embodiment, the interface part 4 is made of titanium. Titanium is a biocompatible material with advantageous properties in terms of mass and mechanical strength. In this way, it is possible to manufacture an interface part 4 that is light and yet strong enough to withstand the forces of attachment of the vascular conduit (specified below) and the artificial heart 2. Once the artificial heart 2 is in place, the resulting stresses are limited.

[0055] Preference is given to pure titanium T40, which has good mechanical properties and excellent biocompatibility, and has a lower density than stainless steel (the mass of the connection device 1 needs to be limited for the patient).

[0056] In a preferred embodiment, the connection device 1 comprises a vascular conduit 14A which cooperates with the aortic interface element 7 of the interface piece 4, and a vascular conduit 14B which cooperates with the pulmonary interface element 8 of the interface piece 4, as shown in FIG.

[0057] Preferably, vascular conduits 14A and 14B are similarly constructed.

[0058] In the preferred embodiment shown in Fig. 7, the vascular conduit 14A comprises a textile tubular element 15A of longitudinal axis XX, with a first end 16A intended to be sewn to the aorta (not shown) and a second end 17A with a ring called loose ring 18A, i.e. mounted to rotate freely. The vascular conduit 14A is intended to be screwed onto the aortic interface element 7 by means of this loose ring 18A. This loose ring 18A allows the vascular conduit 14A to be screwed onto the aortic interface element 7 while maintaining its (correct) position during the screwing operation. The aortic interface element 7 comprises an internal thread 20A, as shown in Fig. 1, to allow the ring 18A (provided with an external thread 19A) to be screwed to connect the end 17A of the vascular conduit 14A to the interface part 4.

[0059] Similarly, the vascular conduit 14B comprises a textile tubular element 15B of longitudinal axis XX and has a first end 16B, as shown in FIG. 7, intended to be sewn to the pulmonary artery (not shown) and a second end 17B, which is provided with a ring, called loose ring 18B, i.e. mounted so as to be freely rotatable. The vascular conduit 14B is intended to be screwed onto the pulmonary interface element 8 by means of this loose ring 18B. This loose ring 18B allows the vascular conduit 14B to be screwed onto the pulmonary interface element 8 while maintaining its (correct) position during the screwing operation. The pulmonary interface element 8 comprises an internal thread 20B, as shown in FIG. 1, to allow the ring 18B (provided with an external thread 19B) to be screwed to connect the end 17B of the vascular conduit 14B to the interface part 4.

[0060] In a preferred embodiment, the rings 18A, 18B are made of titanium. They are sutured to the tubular elements 15A, 15B of the vascular conduits 14A, 14B via sutures 21A, 21B, which are shown diagrammatically in Fig. 7. Preferably, therefore, a screw attachment system is provided for the vascular conduits 14A and 14B, adapted to the connecting device 1. However, attachment systems other than screw attachments may also be envisaged within the scope of the invention.

[0061] During implantation, the tubular fabric elements 15A, 15B of the vascular conduits 14A, 14B are cut to the appropriate length (along the longitudinal axis XX) so that the connection device 1 can be connected to the aorta or pulmonary artery of the patient. When the tissue is soft, the surgeon can also use suturing techniques to adapt to the orientation and avoid the "kink" phenomenon.

[0062] The connection device 1 also comprises a suture collar 22A intended to be sutured to the left atrium of the patient and a suture collar 22B intended to be sutured to the right atrium of the patient.

[0063] Preferably, the sewing collars 22A, 22B are similarly constructed.

[0064] Each of the sewing collars 22A, 22B comprises a core 23A, 23B, preferably made of silicone, which is adapted to fit onto a mitral or tricuspid interface element, as shown in Fig. 8. More specifically, once the sewing collars 22A, 22B are in position, the cores 23A, 23B are clamped between the artificial heart 2 and the interface part 4. For this purpose, the core 23A is supported around the orifice 9 on a support plane P1, shown in Fig. 5, provided on the inner surface 28A of the interface part 4. Similarly, the core 23B is supported around the orifice 10 on a support plane P2, also provided on the inner surface 28A of the interface part 4.

[0065] Each of the suture collars 22A, 22B comprises, in addition to a silicone core 23A, 23B, an interface surface 24A, 24B intended to be sutured to the tissue of the patient (atrium).

[0066] Thus, the suture collars 22A, 22B are used to connect the atria (left and right) of the patient to the input elements of the artificial heart 2 via the mitral and tricuspid interface elements.

[0067] As mentioned above, the connection device 1 is configured so that it can be mounted in a housing 26 provided on the prosthesis 3 of the artificial heart 2, as shown in Fig. 6. The shape of the housing 26 is adapted to and complementary to the shape of the inner surface 28A (Fig. 5) of the interface part 4. In particular, the bearing surfaces P3 and P4 of the mitral and tricuspid interface elements 5 and 6, respectively, contact corresponding areas of the housing 26. As shown in Fig. 6, the prosthesis 3 comprises openings 9A, 10A, 11A, and 12A that are intended to be located opposite the orifices 9, 10, 11, and 12, respectively, of the interface part 4 when the interface part 4 is in place on the prosthesis 3.

[0068] To make fitting and retention easier, the interface part 4 of the connection device 1 is provided with a longitudinal centering tongue 27. As shown in Figures 4 and 5, this centering tongue 27 protrudes from an inner surface 28A of the plate 13 of the interface part 4 at one end of the plate 13. This centering tongue 27 is designed to be inserted into an elongated gorge 29 (Figure 6) that fits into the outer wall 30 of the prosthesis 3 of the artificial heart 2, at the level of the housing 26.

[0069] In the context of the present invention, the connection device 1, after being placed in the housing 26 as shown in FIG. 2, can be attached to the artificial heart 2 in various ways.

[0070] In the first embodiment, the artificial heart 2 comprises screw attachment means 31 for releasably attaching (by screwing) the interface part 4 to the prosthesis 3 . These attachment means 31, as shown in FIG. a leg 32 provided with a pin 33 and fixed to the interface part 4; (This pin 33 is provided at one of its ends with a head 34 movably mounted in a seat provided on the leg 32, and at its other (free) end with a thread 35 intended to receive a nut 36), and a support plate 37 fixed to the prosthesis 3 , intended to cooperate with the free ends of the pins 33 .

[0071] Once the connecting device 1 is placed on the prosthesis 3, the pin 33 is folded back onto the prosthesis 3 and an integral nut 36 is screwed to hold it against a support plate 37 to lock the connecting device 1. A safety anchor 38 can be placed to prevent unwanted loosening of the screws. Once the artificial heart 2 is implanted, the areas intended to be screwed are visible and easily accessible by the surgeon.

[0072] In addition, in the second embodiment, the artificial heart 2 comprises clip attachment means 39 for releasably attaching (by clipping) the interface part 4 to the prosthesis 3. These attachment means 39 comprise pins 40 (or clearances on the prosthesis 3) integrated in the artificial heart 2 and attachment feet 41 fixed to the interface part 4, as shown in figure 10. The attachment feet 41 are provided at their free ends with hooks 42, via which they can be hooked on the pins 40 with a slight force and locked when the force is released.

[0073] The interface component 4 as described above has the following advantageous features: - It is biocompatible; - It can be implanted for a long period of time. - Can be washed and suitable for sterilization - ensures a seal with the artificial heart 2, and - An ergonomic fast attachment mode is provided, which can shorten the duration of extracorporeal circulation.

[0074] Therefore, the interface part 4 is on the one hand, to the vascular conduits 14A and 14B, which are sutured (by means of sutures in the suture collars 22A and 22B) to the previously prepared atria (right and left) and to the arteries (aorta and pulmonary artery); on the opposite side, directly to the artificial heart 2 provided with a housing 26 into which the connection device 1 fits, to complete the surface in contact with the tissue; It is meant to be connected.

[0075] The main steps involved in the placement of the connection device 1 and the artificial heart 2 are described below.

[0076] After ablation of the patient's left and right ventricles, suture collars 22A and 22B are sutured to the patient's left and right atria. Interface piece 4 is then placed in the atrium. The atrial appendage plane forms a relatively rigid reference plane that allows interface piece 4 (with its interface elements at the proper distances and orientations specified above) to be accurately positioned relative to the artery.

[0077] When the interface part 4 is placed in the atrium, the orientation of the vascular conduits 14A and 14B and the distance for cutting these vascular conduits 14A and 14B to the appropriate length are naturally defined. Because the interface part 4 is adapted to the heart prosthesis 2 for quick attachment, the orientation of the heart prosthesis 2 is already respected and the sutures are not stressed when the heart prosthesis 2 is placed.

[0078] Each of the vascular conduits 14A and 14B are then cut to the appropriate length.

[0079] Each of the vascular conduits 14A, 14B is screwed via its end 17A, 17B to the corresponding interface element 7, 8 of the interface part 4 with the aid of rings 18A, 18B integrated into the vascular conduits 14A, 14B and sutured via its other end 16A, 16B to the corresponding artery (aorta, pulmonary artery).

[0080] Thus, the vascular conduits 14A and 14B are placed in the absence of the prosthesis 3, which facilitates the surgeon's work. Moreover, only one surgeon may perform these procedures.

[0081] Once the sutures have been made and the connection device 1 has been placed, the artificial heart 2 is mounted and attached to the connection device 1. For mounting, the interface part 4 is placed in a housing 26 provided for this purpose on the outer wall 30 of the prosthesis. For attachment, as mentioned above, screwing or clipping is performed depending on the embodiment selected for the attachment means.

[0082] This makes it possible to attach the artificial heart 2 to an interface part 4 (rigidity) that respects the patient's anatomy through: - respecting the average interval between the atria, - cutting the vascular conduit to the appropriate length; - respecting the average orientation of the vascular conduits, and - Carrying out stitching according to the areas of reinforcement that should be prioritized (allowing to limit the "pull-up" phenomenon).

[0083] The interface part 4 thus allows the patient to be ergonomically prepared before the artificial heart 2 is placed. In addition to saving time, this solution eliminates the need to use an implantation aid to place the vascular conduits 14A and 14B, since the connection device 1 already fulfills this need. As a result, fewer parts have to be supplied and therefore fewer parts are used in the operating room, which also results in cost savings. The interface part 4 thus serves both as an implantation aid and as an element of the implanted artificial heart 2.

[0084] The connection device 1 and the artificial heart 2 as described above therefore have many advantages. Among other things, they make it possible to obtain: - Improved ergonomics for surgeons, - Reduction in the number of parts to be implanted (especially no staples required), - Reducing the number of parts (or aids) required for transplantation, and - Faster transplant times. [Explanation of symbols]

[0085] 1 Connection device 2. Artificial Heart 3. Prosthetics 4 Interface parts 5 Mitral Valve Interface Elements 6 Tricuspid Valve Interface Elements 7 Aortic Interface Element 8 Lung Interface Elements

Claims

1. A connection device (1) intended to connect a patient's pericardial artificial heart (2) to the patient's vascular system, said artificial heart (2) being capable of replacing the patient's native left and right ventricles after ablation of said left and right ventricles, comprising: The connection device (1) comprises a single interface part (4) configured to be removably attached to the artificial heart (2); said single interface part (4) comprising an interface element called a mitral interface element (5), an interface element called a tricuspid interface element (6), an interface element called an aortic interface element (7) and an interface element called a pulmonary interface element (8) intended to connect to the left atrium, the right atrium, the aorta and the pulmonary artery of said patient, respectively, said four interface elements (5-8) being connected to each other by said single interface part (4); Each of the four interface elements (5-8) is provided with an orifice (9-12); A connection device, characterized in that the four interface elements (5-8) have predetermined orientations (5A-8A).

2. the orientation of the mitral valve interface element (5) and the orientation of the tricuspid valve interface element (6) having an angle between them of 0° to 32°; 2. The apparatus of claim 1.

3. the mitral valve interface element (5) and the tricuspid valve interface element (6) are arranged on a flat plate (13) of the interface part (4), 2. The apparatus of claim 1.

4. The interface parts (4) have at least some of the following orientation relationships: - the orientation (7A) of said aortic interface element (7) and the orientation (5A) of said mitral interface element (5) have an angle between 0° and 90°; - the orientation (7A) of said aortic interface element (7) and the orientation (6A) of said tricuspid interface element (6) have an angle between 0° and 92°; - the orientation (8A) of said pulmonary interface element (8) and the orientation (5A) of said mitral valve interface element (5) have an angle between 26° and 64°; - the orientation (8A) of said pulmonary interface element (8) and the orientation (6A) of said tricuspid interface element (6) have an angle between 31° and 73°; - the orientation (7A) of said aortic interface element (7) and the orientation (8A) of said pulmonary interface element (8) have an angle between 39° and 79°; 4. The device according to claim 1, further comprising at least some of the following:

5. The interface components (4) have at least some of the following distance relationships: - the distance between the centre (5B) of the orifice (9) of said mitral interface element (5) and the centre (6B) of the orifice (10) of said tricuspid interface element (6) is between 42 mm and 76 mm; - the distance between the centre (5B) of the orifice (9) of said mitral interface element (5) and the centre (7B) of the orifice (11) of said aortic interface element (7) is between 37 mm and 65 mm; the distance between the centre (5B) of the orifice (9) of said mitral valve interface element (5) and the centre (8B) of the orifice (12) of said pulmonary interface element (8) is between 50 mm and 80 mm; - the distance between the centre (6B) of the orifice (10) of said tricuspid interface element (6) and the centre (7B) of the orifice (11) of said aortic interface element (7) is between 34 mm and 64 mm; the distance between the center (6B) of the orifice (10) of said tricuspid interface element (6) and the center (8B) of the orifice (12) of said lung interface element (8) is between 59 mm and 91 mm; - the distance between the centre (7B) of the orifice (11) of said aorta interface element (7) and the centre (8B) of the orifice (12) of said pulmonary interface element (8) is between 22 mm and 46 mm; 5. The device according to claim 1, further comprising at least some of the following:

6. characterised in that each of the aortic interface element (7) and the pulmonary interface element (8) comprises a screw thread (20A, 20B).

6. Apparatus according to any one of claims 1 to 5.

7. said interface part (4) being made of one of the following materials: titanium, stainless steel; 7. Apparatus according to any one of claims 1 to 6.

8. a first vascular conduit (14A), a first end (16A) of which is intended to be sutured to the aorta of a patient and a second end (17A) of which is mounted so as to rotate freely and is provided with a ring (18A) that can be screwed onto said aortic interface element (7); a second vascular conduit (14B), the first end (16B) of which is intended to be sutured to the patient's pulmonary artery and the second end (17B) of which is mounted so as to rotate freely and is provided with a ring (18B) which can be screwed onto said lung interface element (8); The device according to claim 1 , further comprising:

9. a first suture collar (22A) intended to be sutured to the left atrium of the patient and comprising a core (23A) configured to be mountable onto said mitral valve interface element (5); a second suture collar (22B) intended to be sutured to the patient's right atrium and comprising a core (23B) configured to be mountable onto said tricuspid valve interface element (6); 9. The device according to claim 1, further comprising:

10. A heart artificial (2) implantable in the pericardial cavity of a patient and capable of replacing the patient's natural left and right ventricles after ablation of said left and right ventricles, comprising: At least one rigid prosthesis (3) in which at least the left and right artificial ventricles are arranged; A connection device (1) according to any one of claims 1 to 9, adapted to be installed in a housing (26) provided in the prosthesis (3); An artificial heart comprising:

11. 11. The artificial heart according to claim 10, characterized in that the interface part (4) of the connection device (1) comprises a centering tongue (27) cooperating with a throat (29) provided on the outer wall (30) of the prosthesis (3).

12. characterised in that it comprises screw attachment means (31) for removably attaching the interface part (4) to the prosthesis (3).

12. An artificial heart according to any one of claims 10 and 11.

13. a clip attachment means (39) for releasably attaching the interface part (4) to the prosthesis (3), 12. An artificial heart according to any one of claims 10 and 11.

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