Membrane cross-section type right heart assist device

Abstract

A right heart assist device (10) to be percutaneously implanted inside a patient's heart (100), comprising an inlet (12), an outlet (14), and a pump (16) connecting the inlet to the outlet, and being designed to be disposed inside the patient's right atrium or vena cava. This assist device comprises at least one support element (20) configured to be fixed to the first membrane by passing through the first membrane separating the right atrium of the patient's heart (100) from the pulmonary artery. The support element (20) cooperates closely with the outlet to immobilize the pump, the inlet (12), and the outlet (14) inside the patient's heart (100), enabling the patient's blood flow to be sent from the inlet (12), through the first membrane, to the outlet (14).

Description

Technical Field

[0001] The present invention relates to a heart assist device implantable percutaneously.

Background Art

[0002] Heart failure remains a major health problem, with an estimated prevalence of 1-2% in the adult population of developed countries, increasing to 10% over the age of 70.

[0003] Because most research in the past few years has been directed at the left ventricle, most current heart assist devices are implanted in the left ventricle. The left ventricle is larger and more powerful than the right ventricle and has thus been considered the only active part of the heart for a very long time. As a result, the right ventricle has been considered a passive reservoir until recently and has not been considered important enough to merit research on heart assist devices. Thus, all of the few assist devices that already exist for the right side of the heart are all temporary, and most of them are outside the heart or the body and require the patient to be immobile.

[0004] Since most right ventricular dysfunction is a long-term consequence of left ventricular dysfunction, most patients suffering from right ventricular dysfunction actually suffer from biventricular dysfunction. Although only a small number of heart failure patients progress to biventricular dysfunction, its poor prognosis poses a major therapeutic challenge. Thus, the current reference treatment for irreversible biventricular dysfunction remains heart transplantation. However, due to transplantation eligibility criteria (selection of candidates) and a shortage of grafts, this treatment can be used only for a very few selected patients. Furthermore, the waiting list is very long, and thus the waiting time is long, which is incompatible with the precarious health of some candidates.

[0005] As one way to overcome the deficiencies of this graft, several systems based on a combination of a left ventricular assist device (LVAD) and a right ventricular assist device (RVAD) that leave the native heart intact and assist the two ventricles with two external chambers have been developed. This is the most clinically applicable device, but there is still a significant risk of complications (infectious, thromboembolic), and the complexity of the implantation increases the risk of death during surgery.

[0006] As an alternative treatment, under the issue of ensuring a good quality of life and being able to return home, the development of a total replacement artificial heart has been gradually progressing. However, there are many drawbacks that limit their development, including ergonomic limitations, extensive surgery, and the immediate death of patients in the event of pump failure.

[0007] Furthermore, most patients with biventricular dysfunction are elderly patients with severe comorbidities and / or diseases. In this case, extensive open-heart surgery is excluded, and there is no appropriate treatment available.

[0008] Despite these technical difficulties, some researchers have reported several clinical cases and small series using two implantable LVADs for biventricular failure. Although this idea seems attractive, the combination of two LVADs is potentially exposed to a double risk of complications (infectious, surgical, etc.) due to the anatomical and physiological constraints of the right ventricle (smaller chamber size, special shape, thinner walls, lower pressure, and lower peripheral resistance than the left ventricle). Ultimately, off-label use of LVAD devices does not seem to be a solution to satisfy the market.

[0009] In the absence of a satisfactory solution for treating end-stage biventricular dysfunction, future directions include the miniaturization of LVADs that enable implantation via percutaneous or minimally invasive access, and the development of a percutaneously fully implantable right heart assist to limit surgical and infection risks, which may provide a solution for many patients without a treatment strategy.

[0010] The development of a hybrid, miniaturized RVAD used as destination therapy, implanted without major surgery and either in combination with or without an LVAD, is a strategy aimed at increasing the number of patients treated, particularly in patients ineligible for heart transplantation. Further advantages are the avoidance of reintervention in the case of complications or pump failure, particularly in frail elderly patients, and the possibility of percutaneous replacement thereof. However, the percutaneous delivery of an assist device into the right ventricle of the heart has several problems, such as sizing of its components and positioning and fixation of said elements within the patient's heart.

[0011] Regarding the anatomical structure of the human body, the best position for an assist device is inside the ventricle of the heart. In this way, the inlet of the assist device will be placed within the common volume of the superior and inferior vena cava, so the assist device can support the superior and inferior vena cava. Due to the uncertain anatomical situation inside the right ventricle (for example, there is strong trabeculation), it is preferable to place the assist device, particularly the pump, inside the right atrium or inside the vena cava. Summary of the Invention Problems to be Solved by the Invention

[0012] Therefore, the technical problem to be solved by the present invention is to propose an assist device that can be safely implanted inside the ventricle of the human heart without damaging either the device or the patient's heart. Means for Solving the Problems

[0013] The present invention aims to solve this problem and thus provides a right heart assist device configured to be percutaneously implanted inside a patient's heart, - an inlet, - an outlet conduit, - a pump body surrounding a rotor, connecting the inlet to the outlet conduit and designed to be placed inside the patient's right atrium or vena cava, a rotary pump, comprising - The auxiliary device further comprises at least one support element configured to be fixed to the first membrane by passing through the first membrane, and the first membrane separates the right atrium or the superior vena cava of the patient's heart from the pulmonary artery by passing through the first membrane. - The at least one support element is configured to cooperate closely with the outlet conduit to fix the pump, the inlet, and the outlet conduit inside the patient's heart or vena cava, and to enable the patient's blood flow to flow from the inlet through the first membrane of the patient's heart to the outlet conduit. Relates to an auxiliary device.

[0014] Therefore, this solution achieves the above object. In particular, this makes it possible to obtain a functional auxiliary device designed to be safely implanted percutaneously inside the patient's right heart without damaging the patient's heart or the device itself.

[0015] The device according to the present invention may include one or more of the following features, either independently of each other or in combination with each other: - The auxiliary device may further comprise a second support element configured to be fixed to the second membrane by passing through the second membrane of the patient's heart, and the second support element is configured to cooperate directly or indirectly with the pump body. - The first membrane may be the wall of the superior or inferior vena cava. - The second membrane may be the membrane separating the left atrium and the right atrium of the patient's heart. - The pump may be configured to be attached to the patient's heart at one of the ends of the pump body. - The rotor of the pump may be surrounded by one end of the pump body, and the pump is configured to be attached to the patient's heart at the end of the pump body surrounding the rotor. - The pump may be configured to be directly attached to the patient's heart by the end of the pump body surrounding the rotor. - The pump may be configured to be attached to the patient's heart by a connecting element that connects the end of the pump body surrounding the rotor to the patient's heart. - The device may generally assume a Y-shaped or T-shaped configuration. - Each support element may be deployable from a contracted configuration to an expanded configuration, the contracted configuration enabling each support element to be safely introduced through the first or second membrane of the patient's heart, and the expanded configuration enabling each support element to remain in a fixed position within the first or second membrane. - Each support element may include two expandable flanges, and the expanded configuration of each support element may enable the first or second membrane to be sandwiched between the two flanges. - The first expandable flange may extend from the first end of the support element, and the second expandable flange may extend from the second end of the support element. The first expandable flange is configured to be disposed on the first side of the first or second membrane, and the second expandable flange is configured to be disposed on the second side of the first or second membrane. - The rotor of the rotary pump may be part of the motor designed to be pushed inside the pump body to fit the motor and the pump body together. - The pump body may include a compression chamber configured to surround the impeller connected to the rotor.

[0016] A further object of the present invention is a right auxiliary kit, - the right auxiliary device according to any one of the preceding claims, - a control unit for controlling the rotary pump, - a power source for supplying power to the rotary pump, and relates to a right auxiliary kit comprising the same.

[0017] Finally, the present invention is a method of implanting the right heart assist device according to any one of the preceding claims, - a step of piercing the first and second membranes, - a step of fixing the first support element inside the first membrane, - a step of introducing the pump body and the outlet conduit through the first support element into the right atrium of the patient's heart. - liberating the pump body and the outlet conduit into the right atrium; - fixing the outlet conduit (14) to a first support element; - locking the motor inside the pump body; A method including these steps is also an object of the present invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0018]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3A

Figure 3B

Figure 4

Figure 5A

Figure 5B

Figure 6

Figure 7

Figure 8

Figure 9A

Figure 9B

DETAILED DESCRIPTION OF THE INVENTION

[0019] Auxiliary device As can be seen from FIGS. 2A, 2B, and 2C, or FIGS. 3A and 3B, the present invention relates to a right heart assist device 10 configured to be percutaneously implanted inside a patient's heart 100 or inside a large vein 101.

[0020] Thus, the auxiliary device 10 includes a series of independent and autonomous functional elements: - an inlet 12, - an outlet conduit 14, - a rotary pump 16 connecting the inlet 12 to the outlet conduit 14, - at least one support element 20 (distal or proximal attachment), and the like.

[0021] In some alternative embodiments, the auxiliary device 10 includes, in addition to the inlet 12, the outlet conduit 14, and the rotary pump 16 connecting the inlet 12 to the outlet conduit 14, - a first support element 20 (distal attachment), - a second support element 18 (proximal attachment), and the like.

[0022] To maintain the auxiliary device 10 in a fixed position, it is necessary to attach the device 10 inside the patient's heart 100 at at least one of its ends. This attachment is realized by the support elements 18, 20. More specifically, the pump 16 is configured to be attached to the patient's heart 100 at one of the ends of the pump body 22.

[0023] Typically, as can be seen from FIG. 1, the oxygen-poor blood flow from the patient's body is guided by the inferior / superior vena cava 101 to the patient's heart 100, enters the patient's heart 100 and passes through the right atrium 102. Then, this oxygen-poor blood flow passes through the tricuspid valve and enters the right ventricle 104. Then, this oxygen-poor blood flow exits the right ventricle 104 through the pulmonary valve and flows through the pulmonary artery 106 towards the lungs. This blood flow is oxygenated in the lungs and flows back towards the heart 100 by the pulmonary veins, enters the heart 100 again, passes through the mitral valve inside the left atrium 108, and enters the left ventricle 110. Then, this oxygen-rich blood flow passes through the aortic valve and flows from the heart 100 through the aorta to the patient's body. For the sake of simplicity, in the present invention, the vena cava 101 is considered to be a part of the human heart 100 when the human heart 100 is interpreted in a broad sense.

[0024] More precisely, the rotary pump 16 is designed to be disposed inside the right atrium 102 of the patient's heart 100. In some alternative embodiments (not shown), the rotary pump 16 is designed to be disposed inside the superior vena cava 101 or the inferior vena cava 101.

[0025] At least one support element 20 (or in an alternative embodiment with two support elements 18, 20, the first support element 20) is configured to be fixed to a first membrane M1 that separates the right atrium 102 of the patient's heart 100 from the pulmonary artery 106. The first membrane M1 can also separate the superior vena cava 101 of the patient's heart 100 from the pulmonary artery 106.

[0026] In an embodiment with two support elements 18, 20, the second support element 18 is configured to be fixed to a second membrane M2. This second membrane M2 preferably separates the left atrium 108 from the right atrium 102, as can be seen from FIGS. 2c and 6. In some alternative embodiments (not shown) with two support elements 18, 20, the second membrane M2 can be the wall of the superior (or inferior) vena cava 101 or other structures of the right atrium 102.

[0027] As used herein, the term "membrane" refers to a physiological region that may include several anatomical structures that exhibit a general shape of a membrane and are consistent with the anatomical structure of the human heart.

[0028] As described above, the device 10 according to the present invention includes a series of independent and autonomous functional elements 12, 14, 16, 18, 20 that enable a significant reduction in length and diameter and its percutaneous implantation. This significantly facilitates the implantation process. Further, in the anatomical structure of the heart 100 of a particular patient where there is very little space inside the right ventricle 104, if the functional elements 12, 14, 16, 18, 20 cannot be inserted separately, neither the accurate and precise positioning nor the satisfactory stability of the assist device can be obtained. More precisely, the right ventricle 104 has a triangular shape in the sagittal section and a complex three-dimensional structure with a semi-circular cross-section. Therefore, due to its anatomical structure, it is difficult to implant any support device percutaneously. To properly place the assist device 10 inside the right atrium 102, each support element 18, 20 is designed to facilitate the delivery of the device 10 and properly place the assist device 10 in accordance with the blood flow. Also, the presence of at least three independent functional elements 16, 18, 20 makes it possible to safely fix the device 10 to at least one anatomical site of the patient's heart 100 without impairing the function of the device 10. In an embodiment having two support elements 18, 20, the presence of at least three independent functional elements 16, 18, 20 makes it possible to safely fix the device 10 to two different independent anatomical sites of the patient's heart 100. In the embodiments illustrated in FIGS. 2c and 6, these independent anatomical sites are, respectively, a first membrane M1 that separates the right atrium 102 and the pulmonary artery 106 of the patient's heart 100, and a second membrane M2 that separates the left atrium 108 and the right atrium.

[0029] As can be seen from FIGS. 4 and 5A, the rotary pump 16 has an elongated generally cylindrical shape extending along the rotation axis X. Therefore, the rotary pump 16 - an elongated generally cylindrical pump body 22 (see FIG. 4) having a compression chamber 24, and - A motor 25 having a rotor (not shown); - An impeller 26 (see FIG. 5A); and is provided with.

[0030] As can be seen from FIG. 4, the pump body 22 includes - A first end portion 221 having a compression chamber 24; - A second end portion 222 configured to accommodate the motor 25 and further configured to cooperate with the second support element 18 in some embodiments. The pump body 22 has two end portions.

[0031] As can be seen from FIG. 4, in some embodiments, the pump body 22 is at least partially, preferably completely, made of a mesh material, such as nitinol. The material used can be, for example, nitinol. This enables the pump body 22 to take a folded configuration or a deployed configuration. The folded configuration facilitates implantation.

[0032] When the rotary pump 16 is assembled, the motor 25 is located inside the second end portion 222 of the pump body 22, and the impeller 26 is located inside the compression chamber 24 of the pump body 22. The rotor of the motor 25 is configured to drive the impeller 26. Thus, the pump 16 is a combination of a motor and an impeller for generating blood flow. The resulting blood flow can be a continuous flow or a pulsatile flow depending on the embodiment.

[0033] To enable the assembly of the pump 16, the motor 25 includes a fixed ring 27 (see FIGS. 5A and 5B). In the embodiments shown in FIGS. 5A and 5B, the fixed ring 27 has a diameter slightly larger than that of the motor 25 and can thus cooperate by clamping with the corresponding fixed slots of the pump body 22. In some alternative embodiments (not shown), the fixed ring 27 has at least one fixed groove. Thus, the fixed ring 27 is configured to cooperate with complementary elongate fixing elements of the pump body 22 to lock the pump body 22 axially and radially relative to the motor 25. Regardless of the embodiment, the fixed ring 27 of the motor 25 and the pump body 22 function as a ratchet mechanism for securely locking the motor 25 inside the pump body 22. In some embodiments, power supply to the motor 25 is ensured by a motor cable 250. As can be seen from FIGS. 5A and 5B, the motor cable 250 and the motor 25 are connected at the second end 222 of the pump body 22.

[0034] The diameter of the motor 25 ranges from 6 to 12 mm, and the length of the motor 25 ranges from 25 to 40 mm. The diameter of the impeller 26 ranges from 6 to 12 mm, preferably 9 mm, and the length of the impeller 26 ranges from 4 to 10 mm, preferably 7 mm.

[0035] When implanted and activated, the rotary pump 16 is designed to generate a blood flow rate in the range of 1 to 5 L / min (preferably 3 L / min) and a pressure in the range of 10 to 75 mmHg (preferably 20 mmHg). Once started, the rpm of the impeller 26 ranges from 6000 to 30000, preferably from 8000 to 30000.

[0036] In some embodiments, to avoid any type of blood flow backflow, the device 10 further includes a backflow prevention system (not shown). This backflow prevention system may be integrated into the rotary pump 16 or, in some other embodiments, may be a one-way valve disposed in the outlet conduit 14.

[0037] The compression chamber 24 comprises a device inlet 12 and a chamber outlet 28. The device inlet 12 is an axial opening located at the first end 221 of the pump body 22. The chamber outlet 28 is a radial opening located at the peripheral wall of the pump body 22. The diameter of the device inlet 12 is in the range of 6-14 mm, preferably 10 mm. The diameter of the chamber outlet 28 is in the range of 6-16 mm, preferably 11 mm. The chamber outlet 28 of the compression chamber 24 is connected to the outlet conduit 14 of the device 10.

[0038] When the device 10 is implanted in a patient's heart 100, the device inlet 12 leads to the right atrium 102 of the patient's heart 100 and the outlet conduit 14 leads to the right pulmonary artery 106 of the patient's heart 100. Thus, as previously mentioned, blood is pumped from the right atrium 102 or vena cava 101 through the first membrane M1 of the patient's heart 100 to the right pulmonary artery 106. (See Figures 2C, 3A, and 3B).

[0039] As can be seen from Figures 3A and 3B, the outlet conduit 14, in contrast to the pump 16, is a flexible cylinder configured to adapt to the morphology of the patient's heart 100. In some embodiments, the outlet conduit 14 can be considered as a mesh stent or other flexible tubular material exhibiting flexibility, preferably with a partially uncoated surface. Because the outlet conduit 14 is made of a flexible braided stent or other flexible tubular material, it can be folded and unfolded, thus allowing for easy introduction, and furthermore, once implanted, it can adapt to the shape of the patient's heart depending on the position of the pump body 22 inside the patient's heart 100. This flexibility also allows the angle between the pump body 22 and the outlet conduit 14 to change, thus improving the adaptability of the device 10 to the natural shape of the patient's heart 100. Thus, the device 10 exhibits a generally Y-shape or a generally T-shape depending on the size of each of the compression chambers 24 relative to the motor 25 and the position of the chamber outlets 28 on the circumference of the compression chambers 24. The diameter D of the outlet conduit c is in the range of 6 to 16 mm, and is preferably 14 mm.

[0040] As can be seen from FIGS. 2A, 2B, and 2C, the first support element 20 is configured to be fixed to the first membrane M1 by passing through a first membrane M1 that separates the right atrium 102 of the patient's heart 100 from the pulmonary artery 106.

[0041] The first support element 20 is configured to cooperate closely with the outlet conduit 14, more specifically the downstream end of the outlet conduit 14 (see FIG. 9A), to secure the pump 16.

[0042] As can be seen from FIGS. 2A, 2B, and 2C, in embodiments where a second support element 18 is present, the second support element 18 is configured to be fixed to the second membrane M2 by passing through a second membrane M2 that separates the left atrium 108 of the patient's heart 100 from the right atrium 102. 2を and is configured to be fixed to the second membrane M2 by passing through it.

[0043] As already described, the second support element 18 is configured to cooperate with the pump body 22 to secure the pump 16 inside the patient's heart 100 (see FIGS. 2C or 6). In these embodiments, the rotor of the pump 16 is surrounded by one end 222 of the pump body 22, and the pump 16 is configured to be attached to the patient's heart 100 at the end 222 of the pump body 22 that surrounds the rotor. In some embodiments, as can be seen in FIG. 6, the pump 16 is configured to be attached to the patient's heart 100 by a connecting element that connects the end 222 of the pump body 22 that surrounds the rotor to the patient's heart 100. More precisely, the second support element 18 and the pump body 22 cooperate by means of a motor cable 250 that is connected to the motor 25 at a second end 222 of the pump body 22. Thus, the motor cable 250 is fixed to the pump body 22 and the second support element 18, ensures the function of the connecting element, and guarantees the fixation of the pump 16.

[0044] The first support element 20 and, when present, the second support element 18 exhibit substantially the same structure and shape. Generally speaking, each of the support elements 18, 20 is an element such as a cylindrical stent that is at least partially made of a mesh material. Each of the first support element 20 and the second support element 18 includes a central ring 30 designed to be inserted into a hole made in the membrane of the patient's heart 100. The diameter D r of the central ring 30 is in the range of 6 to 12 mm and is adapted to the diameter of the hole in the membrane. The thickness T r of the central ring 30 is in the range of 1 to 5 mm. Thus, the central ring 30 is designed to cooperate with the inner wall of the hole by friction (see FIG. 9B). In the embodiment shown in FIG. 7, the first side of the central ring 30 corresponds to the first end of the support elements 18, 20, and the second side of the central ring 30 corresponds to the second end of the support elements 18, 20. To enable safe cooperation with the membranes M1, M2, each support element 18, 20 includes two expandable flanges or disks, one at each end. The first expandable flange extends from the first end of the support elements 18, 20, and the second expandable flange extends from the second end of the support elements 18, 20. The first expandable flange is configured to be disposed on the first side of the first membrane M1 or the second membrane M2, and the second expandable flange is configured to be disposed on the second side of the first membrane M1 or the second membrane M2. More specifically, as can be seen from FIG. 7, the central ring 30 includes at least one radial strand 32 that extends radially outward from the central ring 30 on each side. In some embodiments, the central ring 30 includes three radial strands 32 on each side. In the embodiment illustrated in FIG. 7, the central ring 30 includes approximately 20 radial strands 32 on each side. In the embodiment illustrated in FIG. 9B, the central ring 30 includes eight radial strands 32 on each side. The length L of each radial strand s7 and 9B, each radial strand is a double strand generally U-shaped, the free end of the U being fixed to the central ring 30. The radial strands 32 are designed to cooperate by friction with the surface of the corresponding membrane surrounding the hole drilled in the membrane of the patient's heart 100 (see FIG. 9B). The membrane is thus sandwiched between the radial strands 32 on each side of the central ring 30, on either side of the drilled hole. As the central ring 30 is expandable, the radial strands 32 on each side of the central ring 30 form expandable flanges on each side of the central ring 30, so that in the expanded configuration of each support element 18, 20, the first membrane M1 or the second membrane M2 can be sandwiched between the two flanges or disks. More generally, in this manner, each support element 18, 20 engages the inner walls and edges of the drilled hole such that the support element 18, 20 remains safely within the drilled hole while maintaining said hole open. Each support element 20, 18 is configured to withstand a pressure differential between the left and right atria on the order of about 20 mmHg.

[0045] The mesh structure of each support element 18, 20 allows for connection to the pump body 22 or the outlet conduit 14. The mesh structure of each support element 18, 20 allows each support element 18, 20 to be deployed from a contracted configuration to an expanded configuration. The contracted configuration allows each support element 18, 20 to be safely introduced through the first membrane M1 or second membrane M2 of the patient's heart 100, and the expanded configuration allows each support element 18, 20 to remain in place within the first membrane M1 or second membrane M2.

[0046] The connection between the first support element 20 and the outlet conduit 14 is configured to be tight so that blood flow out of the outlet conduit enters the right pulmonary artery 106 and does not flow back into the right atrium 102. The diameter D of the outlet conduit 14 is o is the diameter D of the central ring 30 of the first support element 20 r is greater than or equal to 1 mm so that when the outlet conduit is deployed it presses against the inner surface of the central ring 30 creating a tight connection.

[0047] To inform the patient about the state of the device 10, the right auxiliary device 10 is part of a right auxiliary kit that includes the right auxiliary device 10 connected to a control unit 34 (see FIGS. 3A and 3B). The control unit 34 is provided with a screen or any type of interface that enables, for example, communicating relevant information to the patient or the physician.

[0048] Implantation method To implant the right auxiliary device 10 into the patient's heart 100, the implantation method is carried out according to the following steps: - Pierce the second membrane M2 with a needle, guide wire, or other suitable tool, - Pierce the first membrane M1 with a needle or any suitable tool, - When present, introduce the second support element 18 into the hole of the second membrane M2 by means of a catheter, - When present, release and fix the second support element 18 inside the first membrane M2, - Introduce the first support element 20 into the hole of the second membrane M1 by means of a catheter, - Release and fix the first support element 20 inside the first membrane M1, - Pass the pump body 22 and the already attached outlet conduit 14 through the second support element 18 by means of a catheter and introduce them into the right atrium 102 of the patient's heart, - Release the pump body 22 and the already attached outlet conduit inside the right atrium 102 of the patient's heart 100, - Fix the free end of the outlet conduit 14 to the first support element 20, - Introduce the motor 25 into the right atrium 102 of the patient's heart 100 through the second support element 18 by means of a catheter, - Push the motor 25 into the second end 222 of the pump body 22, - Lock the motor 25 inside the pump body 22.

[0049] Depending on the embodiment, to immobilize the pump body 22 to the patient's heart 100, the second end 222 is either directly fixed to the second support element 18 or the motor cable 250 already connected to the motor 25 is grasped in a lanyard manner and pulled until the tension is adjusted and it is fixed to the second support element 18.

Claims

1. A right ventricular assist device (10) configured to be implanted percutaneously inside the patient's heart (100), Entrance (12), Outlet conduit (14) and A rotary pump (16) comprises a pump body (22) surrounding a rotor, the inlet (12) is connected to the outlet conduit (14), and is designed to be positioned inside the patient's right atrium (102) or vena cava (101), Equipped with, The auxiliary device (10) comprises a first film (M １ The first film (M １ The first membrane (M １ ) is the first film (M １ By passing through the right atrium (102) or superior vena cava (101) of the patient's heart (100), it separates the pulmonary artery (106), The at least one support element (20) fixes the pump (16), the inlet (12), and the outlet conduit (14) inside the patient's heart (100) or vena cava (101), and the patient's blood flow from the inlet (12) to the first membrane (M) of the patient's heart (100). １ Configured to cooperate closely with the outlet conduit (14) in order to enable it to be sent through to the outlet conduit (14), Right ventricular assist device (10).

2. The auxiliary device (10) is located on the second membrane (M) of the patient's heart (100). ２ By passing through the second film (M ２ The right heart assist device (10) according to claim 1, further comprising a second support element (18) configured to be fixed to the pump body (22), wherein the second support element (18) is configured to cooperate directly or indirectly with the pump body (22).

3. The first film (M １ The right ventricular assist device (10) according to claim 1, wherein the wall of the superior or inferior vena cava (101).

4. The second membrane (M ２ ) is a membrane that separates the left atrium (108) and the right atrium (102) of the patient's heart (100). The right heart assist device (10) according to claim 2.

5. The right heart assist device (10) according to any one of claims 1, wherein the pump (16) is configured to be attached to the patient's heart (100) or vena cava (101) at one of the ends of the pump body (22).

6. The right heart assist device (10) according to claim 1, wherein the rotor of the pump (16) is surrounded by one end (222) of the pump body (22), and the pump (16) is configured to be attached to the patient's heart (100) at the end (222) of the pump body (22) that surrounds the rotor.

7. The right heart assist device (10) according to claim 1, wherein the pump (16) is configured to be directly attached to the patient's heart (100) by the end (222) of the pump body (22) surrounding the rotor.

8. The right heart assist device (10) according to claim 6, wherein the pump (16) is configured to be attached to the patient's heart (100) by a connecting element that connects the end (222) of the pump body (22) surrounding the rotor to the patient's heart (100).

9. The right ventricular assist device (10) according to claim 1, wherein the device (10) is generally Y-shaped or T-shaped.

10. Each support element (18, 20) can be deployed from a contracted configuration to an expanded configuration, and the contracted configuration is the first or second membrane (M) of the patient's heart (100). １ M ２ ) enables the safe introduction of each support element (18, 20) through the first or second membrane (M １ M ２ The right heart assist device (10) according to claim 2, which allows it to remain in a fixed position within ).

11. Each support element (18, 20) is provided with two expandable flanges, and the expansion configuration of each support element (18, 20) is such that the first or second membrane (M) is between the two flanges. １ M ２ The right ventricular assist device (10) according to claim 10, which allows the insertion of )

12. The first expandable flange extends from the first end of the support element (18, 20), and the second expandable flange extends from the second end of the support element (18, 20), and the first expandable flange is the first or second membrane (M １ M ２ The second expandable flange is configured to be positioned on the first side of the first or second membrane (M １ M ２ The right ventricular assist device (10) according to claim 11, configured to be positioned on the second side of the ).

13. The right heart assist device (10) according to claim 1, wherein the rotor of the rotary pump (16) is part of the motor (25) designed to be pushed into the pump body (22) in order to engage the motor (25) with the pump body (22).

14. The right heart assist device (10) according to claim 1, wherein the pump body (22) comprises a compression chamber (24) configured to surround an impeller (26) connected to the rotor.

15. It is a right ventricular assist kit, A right ventricular assist device (10) according to any one of claims 1 to 14, A control unit (34) for controlling the rotary pump, A power supply for supplying power to the rotary pump, A right ventricular assist kit equipped with the necessary components.

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