Transmembrane right heart assist device

Abstract

A right cardiac assist device (10) is percutaneously implanted within a patient's heart (100), comprising an inlet (12), an outlet (14), a pump (16) connecting the inlet and the outlet, and is designed to be located within the patient's right atrium or vena cava. The assistance device comprises at least one support element (20) configured to be secured to a first membrane of the patient's heart (100) by passing through the first membrane that separates the right atrium from the pulmonary artery of the patient's heart (100) by passing through the first membrane. The support element (20) is in close fit with the outlet to secure the pump, the inlet (12) and the outlet (14) inside the patient's heart (100) and to enable blood flow of the patient to be driven from the inlet (12) to the outlet (14) through the first membrane.

Description

Technical Field

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

[0002] Heart failure remains a major health problem, with its prevalence estimated to increase from 1-2% to 10% starting at age 70 in the adult population of developed countries.

[0003] Today, most heart assist devices are implanted in the left ventricle, because that is where most research has been directed over the past few years. The left ventricle has long been considered the only active part of the heart because it is larger and stronger than the right ventricle. As a result, until now the right ventricle has also been considered a passive reservoir, not important enough to be included in heart assist device research. As a result, the few existing assist devices for the right side of the heart are temporary, mostly outside the heart or body, and require the patient to be immobilized.

[0004] Most patients with right ventricular dysfunction actually suffer from biventricular dysfunction, as most right ventricular dysfunction is a long-term consequence of left ventricular dysfunction. Although biventricular dysfunction affects only a minority of heart failure patients, it remains a major therapeutic challenge due to its alarming prognosis. Therefore, today, the reference treatment for irreversible biventricular dysfunction remains heart transplantation. However, the eligibility criteria for transplantation (selection of candidates) and the shortage of transplants make this therapy available only to a few selected patients. In addition, waiting lists are long, resulting in long waiting times, which are incompatible with the unstable health status of some candidates.

[0005] One way to overcome this lack of grafts is that some systems have been developed based on the combination of left ventricular assist device (LVAD) and right ventricular assist device (RVAD), which leave the native heart in place and assist both ventricles through two external chambers. Although it is the most useful device in clinical practice, it still carries a significant risk of complications (infectious, thromboembolic), and the complexity of the installation will increase the risk of mortality during surgery.

[0006] As an alternative therapy, the development of total artificial hearts has gradually emerged, and the problem of allowing patients to go home with a good quality of life has also arisen. However, there are many disadvantages that limit their development, including ergonomic limitations, arduous surgery, and instantaneous death of the patient when the pump stops.

[0007] Furthermore, most of these patients with biventricular dysfunction are elderly patients with significant comorbidities and / or illnesses, in which case there are no reasonable treatment options as major open-heart surgery is excluded.

[0008] Despite these engineering difficulties, some participants described clinical cases and small series of cases using two implanted LVADs to treat biventricular failure. Even if the idea seems attractive, the combination of two LVADs potentially faces a double risk of complications (infection, surgery, ...) and is limited by the anatomical and physiological constraints of the right ventricle (small size and special shape of the cavity, thinner walls compared to the left ventricle, low pressure, low system resistance). Finally, the use of LVAD devices outside of official indications does not seem to be a solution that satisfies the market.

[0009] In the absence of satisfactory solutions for the treatment of advanced biventricular dysfunction, future directions include miniaturization of the LVAD to allow implantation via percutaneous or minimally invasive approaches and development of a fully percutaneously implantable right heart assist device to limit surgical and infection risks, which may be a solution for many patients who have no treatment options.

[0010] Hybrid mini-RVADs, implanted without major surgery, whether combined with an LVAD or not, are a solution aimed at increasing the number of patients treated as destination therapy, especially those who are not eligible for a heart transplant. Another benefit is that in the event of complications or pump failure, re-intervention can be avoided and percutaneous replacement is possible, especially in frail elderly patients. However, percutaneous delivery of assist devices within the right ventricle presents some problems, such as the size of their components, as well as the positioning and fixation of said components within the patient's heart.

[0011] With regard to human anatomy, the best location for assist devices is within the ventricles of the heart. In this way, the assist device can support both the superior and inferior vena cava, as the inlet of the assist device will be located in the common volume of the inferior and superior vena cava. Due to the uncertainty of the anatomical location within the right ventricle (e.g., strong trabeculation), it is best to place assist devices, especially pumps, in the right atrium or vena cava.

[0012] Therefore, the technical problem to be solved by the present invention is to provide an auxiliary device that can be safely implanted in the ventricle of a human heart without damaging either the device or the patient's heart. Summary of the invention

[0013] The present invention aims to solve this problem and therefore relates to a right heart assist device configured to be percutaneously implanted into a patient's heart, the assist device comprising: -Entrance, - outlet conduit, a rotary pump comprising a pump body surrounding a rotor, said rotary pump connecting the inlet to the outlet catheter and being designed to be located in the right atrium or vena cava of the patient, in, - the assist device further comprises at least one support element, the at least one support element being configured to be fixed to a first membrane of the patient's heart by passing through a first membrane, the first membrane separating the right atrium or the vena cava from the pulmonary artery of the patient's heart by passing through the first membrane, -The at least one support element is configured to fit tightly with the outlet catheter to secure the pump, the inlet and the outlet catheter inside the patient's heart or in the vena cava and enable the patient's blood flow to be driven from the inlet to the outlet catheter through the first membrane of the patient's heart.

[0014] The solution thus achieves the above-mentioned objectives. In particular, it allows obtaining a functional assist device designed to be safely implanted percutaneously in the right heart of a patient without causing damage to either the device or the patient's heart.

[0015] The device according to the present invention may include one or more of the following features, which may be isolated from each other or combined with each other: - the auxiliary device may further comprise a second support element, which is configured to be fixed to the second membrane of the patient's heart by passing through the second membrane. 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 a membrane separating the left atrium from the right atrium of the patient's heart, - The pump may be configured to be anchored 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, the pump being configured to be anchored to the patient's heart at the end of the pump body surrounding the rotor, - the pump may be configured to be anchored directly to the patient's heart via the end of the pump body surrounding the rotor, - the pump may be configured to be anchored to the patient's heart by a connecting element connecting the end of the pump body surrounding the rotor to the patient's heart, - the device may be generally Y-shaped or T-shaped, - each support element can be deployed from a retracted configuration, the retracted configuration enabling each support element to be safely introduced through the first membrane or the second membrane of the patient's heart, to an expanded configuration enabling each support element to be maintained in position within the first membrane or the second membrane, - each support element may comprise two expandable flanges, said expanded configuration of each support element being able to clamp the first or second membrane between the two flanges, a first expandable flange may extend from a first end of the support element and a second expandable flange may extend from a second end of the support element, the first expandable flange being configured to be located on a first side of the first or second membrane and the second expandable flange being configured to be located on a second side of the first or second membrane, - the rotor of the rotary pump may be part of an electric motor designed to be pushed inside the pump body so as to snap the motor and the pump body together, The pump body may comprise a compression chamber configured to surround an impeller connected to the rotor.

[0016] Another object of the present invention is a right heart assist kit, comprising: - a right heart assist device according to any of the preceding claims, - a control unit for controlling the rotary pump, - an electric power source for supplying said rotary pump.

[0017] Finally, the present invention also aims to provide a method for implanting a right heart assist device according to any of the preceding claims, wherein the method comprises the following steps: - piercing said first and second membranes, - fixing said first supporting element in said first membrane, - introducing the pump body and the outlet conduit through the first support element into the right atrium of the patient's heart, - releasing the pump body and the outlet catheter into the right atrium, - fixing the outlet conduit to the first supporting element, - Locking the motor in the pump body. BRIEF DESCRIPTION OF THE DRAWINGS

[0018] - Figure 1 A schematic diagram of a longitudinal section of a patient's heart;

[0019] - Figure 2A is with Figure 1 The same schematic diagram further shows two holes created in the first and second membranes according to the present invention;

[0020] - Figure 2B is with Figure 2A The same schematic diagram wherein first and second support elements according to the invention have been added to the heart;

[0021] - Figure 2C is with Figure 2B The same schematic diagram, wherein according to the invention a pump has been added to the support element;

[0022] - Figure 3A and Figure 3B are two schematic transparent perspective views of a patient's heart with an implanted device according to the invention;

[0023] - Figure 4 is a perspective view of a pump body according to the present invention;

[0024] - Figure 5A is a perspective view of the motor facing the pump body according to the present invention;

[0025] - Figure 5B is a perspective view of a motor and a pump body engaged together according to the present invention;

[0026] - Figure 6 Is based on implantation Figure 2C Another schematic longitudinal cross-sectional view of a patient's heart of an alternative embodiment of a device;

[0027] - Figure 7 is a perspective view of a support element according to the invention,

[0028] - Figure 8 yes Figure 7 Detailed perspective view of

[0029] - Fig. 9A and Fig. 9B are two perspective views of a support element according to the invention cooperating with a patient's cardiac membrane. DETAILED DESCRIPTION Auxiliary devices

[0030] like Figure 2A , Figure 2B and Figure 2C or Figure 3A and Figure 3B As shown, the present invention relates to a right heart assist device 10 configured to be percutaneously implanted into a heart 100 or a vena cava 101 of a patient.

[0031] The auxiliary device 10 thus comprises a series of independent and automatic functional elements: -Entrance 12, - outlet conduit 14, a rotary pump 16 connecting said inlet 12 to said outlet duct 14, - At least one supporting element 20 (distal or proximal anchoring).

[0032] In some alternative embodiments, the auxiliary device 10 comprises below 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 anchoring), - and a second supporting element 18 (proximal anchoring).

[0033] In order to keep the assist device 10 in place, the device 10 needs to be anchored at at least one end into the patient's heart 100. This anchoring is achieved by support elements 18, 20. More specifically, the pump 16 is configured to be anchored to the patient's heart 100 at one of the ends of the pump body 22.

[0034] Traditionally, if you can Figure 1 As shown, deoxygenated blood from the patient's body is directed to the patient's heart 100 via the inferior vena cava / superior vena cava 101 and enters the patient's heart 100 through the right atrium 102. The deoxygenated blood then passes through the tricuspid valve and enters the right ventricle 104. The deoxygenated blood then leaves the right ventricle 104 by passing through the pulmonary valve and flows to the lungs through the pulmonary artery 106. The blood is oxygenated in the lungs, flows to the heart 100 again through the pulmonary veins, and re-controls the heart 100 through the mitral valve in the left atrium 108, and then enters the left ventricle 110. The oxygen-rich blood then passes through the aortic valve and leaves the heart 100 through the aorta and flows to the patient's body. For simplicity, the human heart 100 is explained in a broad sense, and the vena cava 101 is considered to be a part of the human heart 100 in the present invention.

[0035] More specifically, the rotary pump 16 is designed to be located in the right atrium 102 of the patient's heart 100. In some alternative embodiments (not shown), the rotary pump 16 is designed to be located in the superior vena cava 101 or in the inferior vena cava 101.

[0036] At least one support element 20 (or the first support element 20 in an alternative embodiment having two support elements 18, 20) is configured to be fixed to a first membrane M1 that separates the right atrium 102 from the pulmonary artery 106 of the patient's heart 100. The first membrane M1 can also separate the superior vena cava 101 from the pulmonary artery 106 of the patient's heart 100.

[0037] In an embodiment comprising two support elements 18, 20, the second support element 18 is configured to be fixed to the second membrane M2. Figure 2C and Figure 6 As shown, the second membrane M2 preferably separates the left atrium 108 from the right atrium 102. In some alternative embodiments including two support elements 18, 20 (not shown), the second membrane M2 may be the wall of the superior (or inferior) vena cava 101 or other structures of the right atrium 102.

[0038] In this specification, the term "membrane" refers to a physiological region in the general shape of a "membrane", which may include several anatomical structures consistent with the anatomy of the human heart.

[0039] As described above, the device 10 according to the present invention comprises a series of independent and automatic functional elements 12, 14, 16, 18, 20, which enable a significant reduction in length and diameter and enable percutaneous implantation of the device. This greatly simplifies the implantation process. In addition, in the case where the functional elements 12, 14, 16, 18, 20 cannot be inserted separately, the anatomical structure of the heart 100 of a particular patient has very little space in the right ventricle 104, which does not allow accurate and precise positioning, nor does it allow satisfactory stability of the auxiliary device. More specifically, the right ventricle 104 is a complex three-dimensional structure with a triangular sagittal section and a crescent-shaped cross section. Therefore, its anatomical structure makes percutaneous implantation of any support device very difficult. In order to correctly position the auxiliary device 10 in the right atrium 102, each support element 18, 20 is designed to facilitate the delivery of the device 10 and correctly position the auxiliary device 10 with blood flow. In addition, the presence of at least three independent functional elements 16, 18, 20 enables the device 10 to be securely fixed to at least one anatomical site of the patient's heart 100 without compromising the function of the device 10, and in an embodiment including two support elements 18, 20, the presence of at least three independent functional elements 16, 18 and 20 enables the device 10 to be securely fixed to two different and independent anatomical sites of the patient's heart 100. Figure 6 In the illustrated embodiment, these separate anatomical portions are a first membrane M1 separating the right atrium 102 of the patient's heart 100 from the pulmonary artery 106 and a second membrane M2 separating the left atrium 108 from the right atrium. 2。

[0040] like Figure 4 and Figure 5A As shown, the rotary pump 16 is in the shape of a slender column extending along the rotation axis X. Therefore, the rotary pump 16 includes: - an elongated, generally cylindrical pump body 22 having a compression chamber 24 (see Figure 4 ), an electric machine 25 having a rotor (not shown), and - Impeller 26 (see Figure 5A ).

[0041] like Figure 4 As shown, the pump body 22 has two ends: - a first end 221 comprising said compression chamber 24, A second end 222 configured to accommodate the motor 25 and, in some embodiments, further configured to cooperate with the second support element 18 .

[0042] like Figure 4 As shown, in some embodiments, the pump body 22 is at least partially, preferably completely, made of a mesh material, such as Nitinol. For example, the material used can be Nitinol, which enables the pump body 22 to adopt a folded configuration or an unfolded configuration. The folded configuration ensures easy implantation.

[0043] Once the rotary pump 16 is assembled, the motor 25 is located within the second end 222 of the pump body 22, and the impeller 26 is located within the compression chamber 24 of the pump body. The rotor of the motor 25 is configured to drive the impeller 26. Thus, the pump 16 is a combination of the motor and the impeller to generate blood flow. Depending on the embodiment, the generated blood flow can be a continuous flow or a pulsating flow.

[0044] To enable assembly of the pump 16, the motor 25 comprises a fixing ring 27 (see Figure 5A and Figure 5B ).exist Figure 5A and Figure 5B In the embodiment shown, the fixing ring 27 presents a diameter slightly larger than the diameter of the motor 25 so that it can cooperate with a corresponding fixing groove of the pump body 22 by clamping. In some alternative embodiments (not shown), the fixing ring 27 is present at least on the fixing groove. Therefore, the fixing ring 27 is configured to cooperate with a complementary slender fixing element of the pump body 22 so as to lock the pump body 22 axially and radially relative to the motor 25. Whatever the embodiment, the fixing ring 27 of the motor 25 and the pump body 22 act as a ratchet mechanism to safely lock the motor 25 in the pump body 22. In some embodiments, the power supply of the motor 25 is ensured by a motor cable 250. As shown in FIG. Figure 5A and Figure 5B As shown, the motor cable 250 and the motor 25 are connected at the second end 222 of the body pump 22 .

[0045] 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.

[0046] Once implanted and activated, the rotary pump 16 is designed to generate a blood flow rate of 1 to 5 L / min (preferably 3 L / min) and a pressure of 10 to 75 mmHg (preferably 20 mmHg). Once started, the impeller 26 has a rotational speed in the range of 6000 to 30000, preferably 8000 to 30000.

[0047] In some embodiments, to avoid any type of blood backflow, the device 10 also includes an anti-reflux system (not shown). The anti-reflux system can be integrated in the rotary pump 16, or in some other embodiments can be a one-way valve located in the outlet conduit 14.

[0048] The compression chamber 24 includes a device inlet 12 and a chamber outlet 28. The device inlet 12 is an axial opening at the first end 221 of the pump body 22. The chamber outlet 28 is a radial opening in the peripheral wall of the pump body 22. The diameter of the device inlet 12 ranges from 6 to 14 mm, preferably 10 mm. The diameter of the chamber outlet 28 ranges from 6 to 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.

[0049] Once the device 10 is implanted in the patient's heart 100, the device inlet 12 leads to the right atrium 102 of the patient's heart 100, and the outlet catheter 14 leads to the right pulmonary artery 106 of the patient's heart 100. As previously described, blood is thus pumped from the right atrium 102 or the vena cava 101 into the right pulmonary artery 106 through the first membrane M1 of the patient's heart 100. (See Figure 2C , Figure 3A and Figure 3B ).

[0050] like Figure 3A and Figure 3B As shown, in contrast to the pump 16, the outlet conduit 14 is a flexible cylinder that is configured to adapt to the morphology of the patient's heart 100. In some embodiments, the outlet conduit 14 can be viewed as a mesh stent display, or other flexible tubular material, which preferably partially has a non-coated surface. Since the outlet conduit 14 is made of a flexible braided stent or other flexible tubular material, it can be folded and unfolded, thereby facilitating introduction, and once implanted, it can also adapt to the patient's heart shape depending on the position of the pump body 22 within the patient's heart 100. This flexibility further provides the possibility of changing the angle between the pump body 22 and the outlet conduit 14, thereby improving the adaptability of the device 10 to the natural shape of the patient's heart 100. Therefore, the device 10 presents a roughly Y-shape or a roughly T-shape, depending on the respective dimensions of the compression chamber 24 relative to the motor 25 and the position of the chamber outlet 28 on the circumference of the compression chamber 24. The diameter D of the outlet conduit c The range is 6 to 16 mm, preferably 14 mm.

[0051] like Figure 2A , Figure 2B and Figure 2C As shown, the first support element 20 is configured to be fixed to the first membrane M1 by passing through the first membrane M1, and the first membrane M1 separates the right atrium 102 of the patient's heart 100 from the pulmonary artery 106.

[0052] The first support element 20 is configured to closely mate with the outlet conduit 14, and more specifically, closely mate with the downstream end of the outlet conduit 14 (see Fig. 9A ) in order to stabilize the pump 16.

[0053] like Figure 2A , Figure 2B and Figure 2C As shown, in the present embodiment, the second support element 18 is configured to be fixed to the second membrane M2 by passing through the second membrane M2 , and the second membrane M2 separates the left atrium 108 from the right atrium 102 of the patient's heart 100 .

[0054] As previously described, the second support element 18 is configured to cooperate with the pump body 22 to stabilize the pump 16 within the patient's heart 100 (see Figure 2C or Figure 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 anchored to the patient's heart 100 at the end 222 of the pump body 22 surrounding the rotor. In some embodiments, as Figure 6 As shown, the pump 16 is configured to be anchored to the patient's heart 100 by a connecting element that connects the end 222 of the pump body 22 around the rotor to the patient's heart 100. More specifically, the second support element 18 and the pump body 22 are matched at the second end 222 of the pump body 22 by a motor cable 250 connected to the motor 25. Therefore, the motor cable 250 is fixed to the pump body 22 and the second support element 18, which ensures the function of the connecting element and also ensures the stability of the pump 16.

[0055] The first support element 20 and the second support element 18 are substantially identical in structure and shape. Generally, each of the support elements 18, 20 is a cylindrical stent-like element made at least in part of a mesh material. Each of the first and second support elements 18, 20 includes a central ring 30 designed to be inserted into a hole formed in the membrane of the patient's heart 100. The diameter D of the central ring 30 is r In the range of 6 to 12 mm, and adapted to the diameter of the hole in the membrane. The thickness T of the central ring 30 r In the range of 1 to 5 mm. Therefore, the center ring 30 is designed to cooperate with the inner wall of the hole by friction (see Fig. 9B ). exist Figure 7In the illustrated embodiment, the first side of the center ring 30 corresponds to the first end of the support elements 18, 20, and the second side of the center ring 30 corresponds to the second end of the support elements 18, 20. In order to be able to securely cooperate with the membranes M1, M2, each support element 18, 20 includes two expandable flanges or discs, one at each end. 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. The first expandable flange is configured to be located on the first side of the first or second membrane M1, M2, and the second expandable flange is configured to be located on the second side of the second or first membrane M1, M2. More specifically, as Figure 7 As shown, each side of the center ring 30 carries at least one radial strand 32 that extends radially outward from the center ring 30. In some embodiments, the center ring 30 carries three radial strands 32 on each side. Figure 7 In the embodiment shown, the central ring 30 carries approximately twenty radial strands 32 on each side. Fig. 9B In the embodiment shown, the central ring 30 carries eight radial strands 32 on each side. The length L of each radial strand is s In the range of 2 to 10 mm, preferably 4 mm. Figure 7 and Fig. 9B In the illustrated embodiment, each radial strand is a double strand in a generally U-shape, the free ends of the U being secured to the central ring 30. The radial strands 32 are designed to engage by friction with a corresponding surface of the membrane surrounding a hole formed in the membrane of the patient's heart 100 (see Fig. 9B ). Thus, on both sides of the formed hole, the membrane is clamped between the radial strands 32 on each side of the center ring 30. Since the center ring 30 is expandable, the radial strands 32 on each side of the center ring 30 form an expandable flange on each side of the center ring 30, and the expanded configuration of each support element 18, 20 is therefore able to clamp the first or second membrane M1, M2 between the two flanges or discs. More generally, each support element 18, 20 thus surrounds the inner wall and edge of the formed hole, and the support element 18, 20 is thus safely retained in the formed hole while keeping the formed hole open. Each support element 20, 18 is configured to resist the pressure difference between the left atrium and the right atrium, which is approximately 20 mmHg.

[0056] The mesh structure of each support element 18, 20 enables connection with the pump body 22 or the outlet conduit 14. The mesh structure of each support element 18, 20 ensures that they can be deployed from a retracted configuration to an expanded configuration. The retracted configuration enables each support element 18, 20 to be safely introduced through the first or second membrane M1, M2 of the patient's heart 100, and the expanded configuration enables each support element 18, 20 to remain in a proper position within the first or second membrane M1, M2.

[0057] The connection between the first support element 20 and the outlet catheter 14 is configured to be tight to ensure that the blood flowing out of the outlet catheter enters the right pulmonary artery 106 and does not flow back into the right atrium 102. o Greater than or equal to the diameter D of the center ring 30 of the first support element 20 r When the outlet conduit is deployed, it pushes against the inner surface of the center ring 30 and creates a tight connection.

[0058] In order to inform the patient of the status of the device 10, the right heart assist device 10 is part of a right heart assist kit, which includes the right heart assist device 10 connected to the control unit 34 (see Figure 3A and Figure 3B ). The control unit 34 comprises a screen or any type of interface, which is capable of conveying relevant information to the patient or the doctor, for example. Implantation method

[0059] In order to implant the right heart assist device 10 into the patient's heart 100, the implantation method is performed according to the following steps: - piercing the second membrane M2 with a needle, a guide wire or other suitable tool, - piercing the first membrane M1 with a needle or any suitable tool, - now, the second support element 18 is introduced into the pores of the second membrane M2 by means of a conduit, - now, the second supporting element 18 is released and fixed in the first membrane M2, - introducing the first support element 20 into the pores of the second membrane M1 through a conduit, - releasing and fixing the first supporting element 20 in the first membrane M1, - introducing the pump body 22 and the already attached outlet conduit 14 via a catheter through the second support element 18 into the right atrium 102 of the patient's heart, - releasing the pump body 22 and the already attached outlet catheter into the right atrium 102 of the patient's heart 100, - fixing the free end of the outlet conduit 14 to the first supporting element 20, - introducing the electric motor 25 via a catheter through the second support element 18 into the right atrium 102 of the patient's heart 100, - Push the motor 25 into the second end 222 of the pump body 22, - Locking the motor 25 in the pump body 22 .

[0060] According to an embodiment, the second end 222 is fixed directly to the second support element 18, or the motor cable 250 already connected to the motor 25 is grabbed with a lasso, and the lasso is pulled until the tension is adjusted and fixed to the second support element 18 to secure the pump body 22 to the patient's heart 100.

Claims

1. A right heart assist device (10) configured to be percutaneously implanted into a patient's heart (100), the assist device (10) comprising: - entrance (12), - an outlet conduit (14), a rotary pump (16) comprising a pump body (22) surrounding a rotor, said rotary pump (16) connecting said inlet (12) to said outlet conduit (14) and being designed to be located in the right atrium (102) or in the vena cava (101) of a patient, in, - the assist device (10) further comprises at least one supporting element (20), the at least one supporting element (20) being configured to be fixed to the first membrane (M1) of the patient's heart (100) by passing through the first membrane (M1), the first membrane (M1) separating the right atrium (102) or the vena cava (101) from the pulmonary artery (106) of the patient's heart (100) by passing through the first membrane (M1), -The at least one support element (20) is configured to fit tightly with the outlet catheter (14) to stabilize the pump (16), the inlet (12) and the outlet catheter (14) inside the patient's heart (100) or inside the vena cava (101), and enable the patient's blood flow to be driven from the inlet (12) to the outlet catheter (14) through the first membrane (M1) of the patient's heart (100).

2. A right heart assist device (10) according to the preceding claim, wherein the assist device (10) further comprises a second support element (18), the second support element being configured to be fixed to the second membrane (M2) of the patient's heart (100) by passing through a second membrane (M2), the second support element (18) being configured to cooperate directly or indirectly with the pump body (22).

3. A right heart assist device (10) according to the preceding claim, wherein the first membrane (M1) is a wall of the superior or inferior vena cava (101).

4. A right heart assist device (10) according to the preceding claim, wherein the second membrane (M2) is a membrane separating the left atrium (108) from the right atrium (102) of the patient's heart (100).

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

6. A right heart assist device (10) according to the preceding claim, 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 anchored to the patient's heart (100) at the end (222) of the pump body (22) surrounding the rotor.

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

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

9. A right heart assist device (10) according to any preceding claim, wherein the device (10) is generally Y-shaped or T-shaped.

10. A right heart assist device (10) according to any of the preceding claims, wherein each support element (18, 20) is capable of being deployed from a retracted configuration to an extended configuration, wherein the retracted configuration enables each support element (18, 20) to be safely introduced through the first or second membrane (M1, M2) of the patient's heart (100), and the extended configuration enables each support element (18, 20) to be maintained in an appropriate position within the first or second membrane (M1, M2).

11. A right heart assist device (10) according to the preceding claim, wherein each support element (18, 20) comprises two expandable flanges, and the expanded configuration of each support element (18, 20) is capable of clamping the first or second membrane (M1, M2) between the two flanges.

12. A right heart assist device (10) according to the preceding claim, wherein a first expandable flange extends from a first end of the support element (18, 20) and a second expandable flange extends from the second end of the support element (18, 20), the first expandable flange being configured to be located on a first side of the first or second membrane (M1, M2) and the second expansion flange being configured to be located on a second side of the first or second membrane (M1, M2).

13. A right heart assist device (10) according to any of the preceding claims, wherein the rotor of the rotary pump (16) is part of a motor (25), and the motor (25) is designed to be pushed into the interior of the pump body (22) so as to engage the motor (25) and the pump body (22) together.

14. A right heart assist device (10) according to any of the preceding claims, wherein the pump body (22) includes a compression chamber (24) configured to surround an impeller (26) connected to the rotor.

15. A right heart assist kit, comprising: - a right heart assist device (10) according to any of the preceding claims, - a control unit (34) for controlling the rotary pump, - an electric power source for supplying said rotary pump with electric power.

16. A method for implanting a right heart assist device according to any preceding claim, wherein the method comprises the following steps: - piercing said first and second membranes (M1, M2), - fixing the first supporting element (20) inside the first membrane (M1), - introducing the pump body (22) and the outlet conduit (14) through the first support element (20) into the right atrium (102) of the patient's heart (100), - releasing the pump body (22) and the outlet catheter (14) into the right atrium (102), - fixing the outlet duct (14) to the first supporting element (20), - Locking the motor (25) in the pump body (22).

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