Heart assist pump inlet protection

Abstract

A heart assist device (10) configured to be implanted inside a heart of a patient, comprising a device inlet (12) configured to open in a first chamber (C1), a device outlet (14) configured to open in a receiving lumen (CR), a rotary pump (16) connecting the device inlet (12) to the device outlet, the rotary pump comprising an impeller (20) placed in a pump body (18) between a pump inflow and a pump outflow. The device inlet is coaxially arranged at an upstream portion of the pump body. The pump body further comprises a spacing structure (22) extending at least partially radially from an outer surface (S) of the pump body, the spacing structure being configured to maintain a predetermined space (E) between any anatomical wall of the heart (100) of the patient and the device inlet.

Description

Technical Field

[0001] This invention relates to percutaneously implantable cardiac assist devices. Background Technology

[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% from age 70 onwards.

[0003] Currently, heart transplantation remains the reference treatment for irreversible biventricular dysfunction. However, the eligibility criteria for transplantation (candidate selection) and the shortage of grafts mean that this therapy is only available to a select few patients. Furthermore, the waiting lists are very long, resulting in lengthy wait times, which is incompatible with the unstable health conditions of some candidates.

[0004] One way to overcome this graft shortage has been to develop systems based on a combination of left ventricular assist devices (LVADs) and right ventricular assist devices (RVADs), which preserve the autologous heart in place and assist both ventricles via two external chambers. Although it is the most commonly used device in clinical practice, it still carries significant risks of major complications (infection, thromboembolism), and the complexity of its installation increases the risk of death during the procedure.

[0005] As an alternative treatment, the development of total artificial hearts has gradually emerged, aiming to allow patients to return home and have a good quality of life. However, there are many drawbacks that limit its development, including ergonomic limitations, major surgery, and immediate patient death when the pump stops.

[0006] In addition, most patients with biventricular dysfunction are elderly and have serious comorbidities and / or diseases, in which case no reasonable treatment solution is available because major open-heart surgery is ruled out.

[0007] In the absence of satisfactory solutions for treating end-stage biventricular dysfunction, future directions include the miniaturization of LVADs to allow for implantation via percutaneous or minimally invasive approaches, and the development of fully percutaneous implantable right ventricular assist devices to limit surgical and infection risks, which could be a solution for many patients without treatment options.

[0008] Developing miniaturized RVADs for endpoint therapy, either in combination with or without an LVAD, implantable without major surgery, is a solution aimed at increasing the number of patients awaiting treatment, especially those ineligible for heart transplantation. Another benefit is avoiding re-intervention in the event of complications or pump failure, and the possibility of percutaneous pump replacement, particularly in frail elderly patients. However, percutaneous delivery of assistive devices within the right ventricle presents several challenges, such as the sizing of their components and the positioning and fixation of these components within the patient's heart.

[0009] Regarding human anatomy, the optimal location for a cardiac assist device is within the ventricles or atria of the heart. However, the ventricles are small chambers, and their elastic walls can be affected by the low pressure caused by the cardiac assist device pumping the patient's blood through the heart. Therefore, it is necessary to prevent the natural anatomical walls of the ventricles or atria from being drawn towards or into the cardiac assist device.

[0010] Therefore, the technical problem to be solved by the present invention is to provide an auxiliary device that can be safely implanted and maintained inside the ventricle or atrium of a human heart without damaging the device or the patient's heart. Summary of the Invention

[0011] The present invention aims to solve this problem and therefore relates to a cardiac assist device configured to be implanted inside a patient's heart and configured to drive blood flow from a first chamber of the patient's heart toward a receiving lumen of the patient's heart via bypassing at least one second chamber of the patient's heart, the second chamber providing fluid communication between the receiving lumen and the first chamber, said assist device comprising: - Device inlet, configured to open in the first chamber. - Device outlet, configured to open within the receiving cavity. - A rotary pump that connects the device inlet to the device outlet, the rotary pump including a pump body having a pump inlet in fluid communication with the device inlet and a pump outlet in fluid communication with the device outlet, the pump body extending at least partially along an elongation axis and having an outer surface, the rotary pump further including an impeller disposed in the pump body between the pump inlet and the pump outlet.

[0012] The device inlet is coaxially arranged at the upstream portion of the pump body, and the pump body further includes a spacer structure extending radially at least partially from the outer surface of the pump body, the spacer structure being configured to maintain a predetermined space between any anatomical wall of the patient's heart and the device inlet.

[0013] Therefore, this solution achieves the aforementioned objectives. In particular, it allows for the acquisition of a cardiac assist device that can be safely implanted in any chamber of a patient's heart without the risk of damage to the anatomical walls of the chamber or the device itself due to low pressure generated by the device's pump. It also avoids blockage of the device inlet, thereby preventing any malfunction of the device.

[0014] The apparatus according to the invention may include one or more of the following features, which may be used individually or in combination with each other: - The device inlet has at least one inlet opening that opens laterally relative to the elongation axis, and wherein the spacer structure includes at least one remote portion facing the inlet opening at a certain distance. - The spacer structure includes at least one radial portion extending along a secondary elongation axis, the secondary elongation axis extending radially relative to the elongation axis. - The septum structure can be configured to move freely relative to any anatomical wall of the patient's heart. - The reserved space can range from 15 to 30 mm. - The spacer structure can be radially elastically deformable. The spacer structure may extend at least partially along the elongation axis and may have a distal end and a proximal end relative to the elongation axis, each end being fixed to the pump body. The spacer structure may extend at least partially along the elongation axis and may have a distal end and a proximal end relative to the elongation axis, the proximal end being fixed to the pump body and the distal end being free. - The spacer structure can be fixed to the pump body by means of a retaining ring that binds the pump body. - The spacer structure may at least partially surround the device inlet. - The device inlet may have at least one inlet opening configured to allow blood flow through the pump body, the spacer structure surrounding the at least one inlet opening. - The spacer structure may at least partially surround the pump body. - The spacer structure may include several different spacer elements distributed around the outer surface. - The spacer structure may include a plurality of spacer elements connected to each other to form a spacer structure that at least partially surrounds the pump body. - The spacer structure may be radially expandable relative to the elongation axis. - The spacing structure can be an expandable mesh. - The spacer structure may be made at least partially of a nickel-titanium material. Attached Figure Description

[0015] The invention will be better understood by reading the following detailed description of one or more embodiments of the invention, as given by illustration, and other objects, details, features, and advantages will become clearer. These are merely illustrative and non-limiting examples with reference to the accompanying drawings. In these drawings: - Figure 1 It is a schematic longitudinal cross-sectional view of the patient's heart. - Figure 2 Is with Figure 1 The same schematic view, in which a cardiac assist device has been inserted into the patient's heart. - Figure 3 This is a perspective view of a first embodiment of the auxiliary device according to the present invention. - Figure 4a This is a side view of a second embodiment of the auxiliary device according to the present invention. - Figure 4b yes Figure 4a A perspective view of the implementation method. - Figure 5 This is a perspective view of other auxiliary devices according to the present invention. - Figure 6 This is a perspective view of a preferred embodiment of the present invention. - Figure 7 yes Figure 6 The implementation method of the outflow sleeve. Detailed Implementation

[0016] Traditionally, it can be like Figure 1 As shown, deoxygenated blood flow from the patient's body is guided to the patient's heart 100 via the inferior / superior vena cava 101 and enters the patient's heart 100 through the right atrium 102. The deoxygenated blood flow then passes through the tricuspid valve and enters the right ventricle 104. The deoxygenated blood flow then leaves the right ventricle 104 through the pulmonary valve and flows into the lungs through the pulmonary artery 106. The blood flow is oxygenated in the lungs and returns to the heart 100 again through the pulmonary veins, and re-enters the heart 100 through the mitral valve inside the left atrium 108, and then enters the left ventricle 110. The oxygenated blood flow then passes through the aortic valve and leaves the heart 100, flowing through the aorta into the patient's body. For simplification purposes, in this invention, the vena cava 101 is considered to be part of the human heart 100 in a broad interpretation.

[0017] This invention relates to a cardiac assist device 10 configured for implantation within a patient's heart 100. The cardiac assist device 10 can be implanted in any chamber of the patient's heart 100. The cardiac assist device 10 is typically configured to allow blood flow from the first chamber C1 of the patient's heart 100 to a receiving lumen C by bypassing a second chamber of the patient's heart 100. R Circulation, in which blood naturally flows through the second chamber.

[0018] The term "bypass" refers to the bypassing of blood flow in at least one of the chambers (right atrium 102, right ventricle 104, left atrium 108, left ventricle 110) of the natural pathway of blood flow within the patient's heart 100 once the cardiac assist device 10 is implanted and in operation.

[0019] Each chamber of the patient’s heart 100 is defined by at least one anatomical wall with some natural elasticity.

[0020] Regardless of the implementation method and implantation location, the assistive device 10 includes: - Device inlet 12, configured to allow blood flow from the first chamber C1 into the auxiliary device 10. - Device outlet 14, the device outlet being configured to allow blood flow to occur in the receiving lumen C R The internal flow flows out from the auxiliary device 10. - Rotary pump 16, which connects device inlet 12 to device outlet 14.

[0021] Once implanted, the device inlet 12, device outlet 14, and rotary pump 16 can be located in the same chamber or in different chambers of the patient's heart 100. Depending on the size of the patient's heart 100, the device inlet 12 can be positioned very close to the anatomical wall of the patient's heart 100. The rotary pump 16 includes a pump body 18 having a pump inlet 18i and a pump outlet 18o. The pump body 18 extends at least partially along the elongation axis X. The pump body 18 has an outer surface S.

[0022] Rotary pump 16 is preferably an axial flow pump (see...) Figure 6Therefore, the rotary pump 16 extends axially along the extension axis X. Thus, the pump inlet 18i, any impeller 20 (see below), and pump outlet 18o are aligned along the extension axis X. Therefore, the device inlet 12 is aligned along the extension axis X to guide blood flow from the device inlet 12 to the pump outlet 18o along the extension axis X. Therefore, the auxiliary device 10 extends linearly along the extension axis X from the pump inlet 18i to the pump outlet 18o, and preferably from the inlet inlet 12 to the pump outlet 18o. This particular linear shape allows the auxiliary device 10 to maintain a small diameter throughout its length, making it easily implantable via a catheter without requiring deformation of the pump body 18 during (or after) implantation.

[0023] Device inlet 12 is coaxially arranged at the upstream portion of device 10 and includes at least one inlet opening 12o that allows blood to flow through pump body 18. The at least one inlet opening 12o can open axially or radially relative to the elongation axis X. Device inlet 12 has at least one inlet opening 12o configured to allow blood flow through pump body 18. Preferably, the at least one inlet opening 12o opens laterally relative to the elongation axis X.

[0024] On the other side of the pump body 18, the device outlet 14 is coaxially arranged at the downstream portion of the device 10 and includes at least one outlet opening O, which allows blood to flow through the receiving lumen C. R Internal outflow device 10.

[0025] like Figure 2 and Figure 7 As can be seen, the device outlet 14 is configured to change the orientation of the outlet opening O relative to the extension axis X. In other words, the device outlet 14 extends at least partially along an outflow axis Y that is different from the extension axis X. More precisely, the outflow axis Y and the extension axis X intersect each other at an angle ranging from 1 to 189°. Preferably, the outflow axis Y and the extension axis X intersect each other at an angle ranging from 1 to 90°. In this way, the outlet opening O is not aligned with the pump outlet 18o. This variable misalignment between the outlet opening O and the pump outlet 18o allows the device 10 to adapt to a wider variety of heart sizes and shapes without causing any damage.

[0026] In contrast to the rotary pump 16, the device outlet 14 is deformable. The device outlet 14 is preferably a flexible cylinder. The device outlet 14 is configured to adapt to the shape of the patient's heart 100. Preferably, the device outlet 14 is made of a flexible tubular material and can be, for example, a coated mesh or braided or spiral stent made of, for example, nitinol and / or stainless steel. Depending on the material used, the device outlet 14 can be folded and unfolded, thus allowing for easy insertion, and once implanted, it can also adapt to the patient's heart shape based on the position of the rotary pump 16 within the patient's heart 100. This flexibility precisely provides the possibility of changing the angle between the pump outlet 18° and the device outlet O, thereby improving the adaptation of the device 10 to the natural shape of the patient's heart 100 without affecting the shape of the rotary pump 16.

[0027] exist Figure 6 and Figure 7 In some specific embodiments shown, the device outlet 14 includes a deformable sleeve 140. The deformable sleeve 140 has a generally tubular shape with a tapered end at its distal end. Thus, the deformable sleeve 140 includes a central portion formed of a coil (e.g., made of nitinol and / or stainless steel), a proximal end configured to secure the deformable sleeve 140 to the pump outlet 18o, and a distal end formed of a mesh and having a tapered shape, the tapered shape having a small diameter at the upstream end and a large diameter at the downstream end. The tapered end can be coiled during implantation and expanded after implantation. The deformable sleeve 140 is also coated with, for example, PU, ​​PTFE, or ePTFE. The diameter of the coil ranges from 6 to 10 mm, preferably 8 mm, and the larger diameter of the tapered end ranges from 18 to 21 mm, preferably 20 mm. The wall thickness of the coil and the tapered end ranges from 0.2 to 0.4 mm. The coil is formed from a single wound wire (spiral), thus forming a parallel filament structure. This specific structure allows the deformable cannula 140 to fold with a small bending radius while maintaining high radial force (compared to the prior art) and avoiding cannula kinking, which would impede blood flow.

[0028] To facilitate blood flow through the assist device 10 once it is implanted inside the patient's heart 100, the rotary pump 16 includes a motor and an impeller 20. More specifically, the pump body 18 surrounds the impeller 20, which extends between the pump inlet 18i and the pump outlet 18o. The impeller 20 is preferably magnetically coupled to the motor.

[0029] The rotary pump 16 provides a fluid pressure ranging from 70 to 130 mmHg for the left implant and from 10 to 40 mmHg for the right implant. The rotary pump 16 also provides a fluid flow rate ranging from 2 to 4 L / min for the left implant and from 2 to 4 L / min for the right implant.

[0030] Impeller 20 generates low pressure to drive blood flow within the assistive device 10. This negative pressure is thus applied to the chambers of the patient's heart 100, where the assistive device 10 is implanted (more specifically, where the device inlet 12 is located). Consequently, the negative pressure is also applied to the anatomical walls of the chambers of the patient's heart 100. If the device inlet 12 is positioned close to the anatomical wall of the chamber, the anatomical wall can deform and be pulled towards the device inlet 12. Such deformation may result in injury and / or blockage of the device inlet 12.

[0031] To avoid such deformation and / or blockage problems, the pump body 18 includes a spacer structure 22, such as Figure 3 , Figure 4a and Figure 4b As can be seen, the septum structure 22 extends at least partially radially from the outer surface S. More precisely, the septum structure 22 extends at least partially away from the elongation axis X. Thus, the septum structure 22 is configured to maintain a predetermined space E between any anatomical wall of the patient's heart 100 and the device inlet 12.

[0032] Preferably, the space E ranges from 15 mm to 30 mm.

[0033] The spacer member 22 extends at least partially along the elongation axis X. Therefore, it has a longitudinal length along the elongation axis X ranging from 10 mm to 40 mm.

[0034] exist Figure 3 , Figure 4a , Figure 4b In the illustrated embodiments, the spacer structure 22 has a distal end and a proximal end relative to the elongation axis X, each end being fixed to the pump body 18. In those embodiments, the spacer structure 22 at least partially surrounds the device inlet 12. More specifically, the spacer structure 22 surrounds at least one inlet opening 12o.

[0035] Especially Figure 3 In the described embodiment, the spacer structure 22 includes several different spacer elements 220 distributed around the outer surface 6 of the pump body 18, and more particularly above the device inlet 12. These spacer elements 220 may be, for example, arched or curved support struts.

[0036] In some alternative embodiments, the spacer 22 has a distal end and a proximal end relative to the elongation axis X, the distal end being a free end. The spacer 22 may include at least one spike extending at least partially along the elongation axis X. Also in those embodiments, the spacer 22 may include a plurality of different spacer elements 220 distributed around the outer surface 6 of the pump body 18 and more particularly above the device inlet 12, resembling a crown.

[0037] like Figure 4a and Figure 4b As shown, the spacer structure 22 includes a plurality of spacer elements 220 connected to each other to form a spacer structure that at least partially surrounds the pump body 18. Figure 4a and Figure 4b In this case, the spacer structure is at least partially made of mesh. More specifically, in Figure 4a , Figure 4b In some embodiments, the complete spacer structure is an expandable mesh. This mesh can be radially elastically deformable. In some embodiments, the spacer structure can be expandable struts.

[0038] Regardless of the detailed structure of the spacer element 220, the spacer element 22 includes at least one radial portion extending along the secondary elongation axis X2. This secondary elongation axis X2 extends radially relative to the elongation axis X. This ensures that at least a portion of the spacer element is located away from the pump body 18, and particularly away from the inlet opening 12o.

[0039] Regardless of the implementation, the spacer structure 22 includes a portion that at least partially surrounds the pump body 18. In a preferred embodiment, the spacer structure 22 includes a portion that at least partially surrounds the device inlet 12. More specifically, the spacer structure 22 surrounds at least one inlet opening 12o. Preferably, the spacer structure 22 includes at least one remote portion that faces the inlet opening 12o at a distance.

[0040] In some implementations, for example in Figure 4a , Figure 4b In the embodiment depicted above, the spacer structure 22 is secured to the pump body 18 by means of a retaining ring 24 that binds the pump body 18. Figure 3 In one embodiment, the spacer structure 22 is welded to the pump body 18. In some other embodiments, the spacer structure 22 forms a single piece with the pump body 18 and is part of surface S.

[0041] To facilitate easy adaptation of the assistive device 10 to the specific shape of the chambers of the patient's heart 10, the septum structure 22 is radially elastically deformable. For example, the septum structure may be made at least partially of a nitinol material.

[0042] To avoid any tension on the anatomical walls of the patient's heart 100, the septal structure 22 is configured to move freely relative to any anatomical wall of the patient's heart 100. Thus, regardless of the movement of the implanted assistive device 10, the septal structure 22 will not pull or tear the anatomical walls, nor will it be pulled or torn by the anatomical walls to which it is attached, and therefore remains fully functional and is able to create the necessary space E between any anatomical wall of the patient's heart 100 and the device inlet 12.

[0043] To facilitate implantation of the assistive device 10, the septum structure is radially expandable relative to the elongation axis X. Therefore, the septum structure 22 is inserted into the patient's heart 100 in a folded configuration, and once the assistive device 10 is properly positioned within the patient's heart 100, the septum structure 22 expands within the ventricles of the patient's heart, thereby protecting the device inlet 12 once everything is in place. In its expanded configuration, the septum structure 22 exhibits an expanded diameter ranging from 15 mm to 30 mm. In its expanded configuration, the septum structure 22 is configured to maintain a predetermined space E between the anatomical walls of the patient's heart 100 and the device inlet 12.

[0044] The auxiliary device 10 further includes a support device configured to secure and stabilize the device 10 within the patient's heart 100. The support device includes at least one outlet support element 25, and in some embodiments includes a pump support element 26. In cases where the device 10 includes a deformable sleeve 140 as described above, the tapered end of the deformable sleeve 140 forms the outlet support device 25. In those embodiments, at least one outlet support device 25 is integral with the device outlet 14, thereby forming the deformable sleeve 140.

[0045] At least one outlet support element 25 is configured to fit tightly against the membrane to secure the pump 16 and the device outlet 14 within the patient's heart 100 (or vena cava 101) and to allow blood flow from the device inlet 12 through at least one membrane of the patient's heart 100, more particularly through the receiving lumen C. R The lumen membrane M1 is driven to the device outlet 14.

[0046] When the assist device 10 is implanted inside the patient's heart 100, the outlet support element 24 passes through the luminal membrane M1 and guides the patient's blood through the luminal membrane M1. At least one outlet support element 25 passes through the luminal membrane M1 via an artificial anastomosis created percutaneously by a surgeon or interventional cardiologist. The anastomosis has an opening with a diameter ranging from 5 to 15 mm, which is located in the receiving lumen C. RThe opening is internally open. The opening is also surrounded by an edge having the regular elasticity and width of the membrane M of the patient's heart 100. Therefore, at least one outlet support element 25 has a central aperture with a diameter ranging from 5 to 15 mm, corresponding to the diameter of the orifice at the anastomosis of the luminal membrane M1.

[0047] In an advantageous embodiment, the device 10 is at least partially deployable from a retracted configuration to an expanded configuration for ease of implantation. Therefore, more specifically, at least one outlet support element 25 is deployable from a retracted configuration to an expanded configuration: - The retractable configuration allows at least one outlet support element 25 to be introduced through the receiving lumen C. R The luminal membrane M1, and - The expansion configuration allows at least one outlet support element 25 to remain in place inside the lumen membrane M1.

[0048] When expanding, at least one outlet support element 25 has an outer diameter ranging from 10 mm to 30 mm.

[0049] In order to reliably drive the receiving cavity C R The internal blood flow, with outlet support element 25 configured to extend from both the inner and outer sides of the luminal membrane M1 once the device 10 is installed inside the patient's heart 100. Therefore, outlet support element 24 is configured to radially engage with the edge of the orifice of the luminal membrane M1. This radial engagement ensures a tight and secure fit between the luminal membrane M1 and the outlet support element 25 (and thus with the device outlet 14). This radial engagement ensures that the blood flow driven by the auxiliary device 10 (approximately 30% to 70% of the total patient blood flow) flows through the luminal membrane M1, from inside the auxiliary device 10 to the receiving lumen C of the patient's heart 100. R internal.

[0050] In embodiments where the auxiliary device 10 is a right auxiliary device, at least one outlet support element 25 is configured to be fixed to a luminal membrane M1 that connects the right atrium 102 or vena cava 101 to a receiving lumen C, which serves as the patient's heart 100. R The pulmonary artery 106 is separated. In this particular embodiment, the outlet support element 25 is configured to be fixed to the wall of the superior vena cava 101 or the right atrium 102, which serves as the luminal membrane M1.

[0051] Preferably, the support element 25 includes a first expandable flange and a second expandable flange, and the expansion configuration of each support element 25 allows the lumen or chamber membrane M1 to be clamped between the first expandable flange and the second expandable flange.

[0052] As already mentioned, in some embodiments, the support device further includes a pump support element 26 configured to secure the pump 16, and more specifically, the pump body 18 of the pump 16, to the chamber membrane of the first chamber C1. More specifically, this chamber membrane is the wall of the right atrium 102 and / or the inferior vena cava 101. Depending on the shape of the pump support element 26, it can also expand within the inferior vena cava 101, fitting like a spherical object inside a spherical lumen and thus securing the device 10.

[0053] Each support element 25, 26 is preferably deployable from a retracted configuration to an expanded configuration. The retracted configuration allows each support element 25, 26 to be safely introduced through or into the luminal membrane M1 or ventricular membrane of the patient's heart 100. Conversely, the expanded configuration allows each support element 25, 26 to be secured in a suitable position within the luminal membrane M1 or ventricular membrane. Preferably, the second support element 26 does not penetrate any membrane but deploys within the inferior vena cava 101 or right atrium 102.

Claims

1. A cardiac assist device (10) configured to be implanted inside a patient's heart (100) and configured to drive blood flow from a first chamber of the patient's heart (100) toward a receiving lumen (C) of the patient's heart (100) by bypassing at least one second chamber of the patient's heart (100). R The second chamber allows the receiving cavity (C) to... R The auxiliary device (10) is in fluid communication with the first chamber and includes: - Device inlet (12), the device inlet being configured to open in the first chamber (C1), - Device outlet (14), the device outlet being configured in the receiving cavity (C R Open in ) - A rotary pump (16) connecting the device inlet (12) to the device outlet (14), the rotary pump (16) comprising a pump body (18) having a pump inlet (18i) in fluid communication with the device inlet (12) and a pump outlet (18o) in fluid communication with the device outlet (14), the pump body (18) having an outer surface (S) extending at least partially along an elongation axis (X), the rotary pump (16) further comprising an impeller (20) disposed in the pump body (18) between the pump inlet (18i) and the pump outlet (18o), The device inlet (12) is coaxially arranged at the upstream portion of the pump body (18). The pump body (18) further includes a spacer structure (22) that extends at least partially radially from the outer surface (S) of the pump body (18) relative to the elongation axis (X), and the spacer structure (22) is configured to maintain a predetermined space (E) between any anatomical wall of the patient's heart (100) and the device inlet (12).

2. The cardiac assist device (10) according to the preceding claim, wherein, The device inlet (12) has at least one inlet opening (12o) that opens laterally relative to the elongation axis (X), and wherein the spacer structure (22) includes at least one remote portion facing the inlet opening (12o) at a distance.

3. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) includes at least one radial portion extending along a secondary elongation axis (X2) that extends radially relative to the elongation axis (X).

4. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) is configured to move freely relative to any anatomical wall of the patient's heart (100).

5. The cardiac assist device (10) according to any one of the preceding claims, wherein, The predetermined space (E) ranges from 15 to 30 mm.

6. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) is radially elastically deformable.

7. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) extends at least partially along the elongation axis (X) and has a distal end and a proximal end relative to the elongation axis (X), each end being fixed to the pump body (18).

8. The cardiac assist device (10) according to any one of claims 1 to 4, wherein, The spacer structure (22) extends at least partially along the elongation axis (X) and has a distal end and a proximal end relative to the elongation axis (X), the proximal end being fixed to the pump body (18) and the distal end being free.

9. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) is fixed to the pump body (18) by means of a retaining ring that binds the pump body.

10. The cardiac assist device (10) according to the preceding claim, wherein, The spacer structure (22) at least partially surrounds the device inlet (12).

11. The cardiac assist device (10) according to the preceding claim, wherein, The device inlet (12) has at least one inlet opening (12o) configured to allow blood flow through the pump body (18), and the spacer structure (22) surrounds the at least one inlet opening (12o).

12. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) at least partially surrounds the pump body (18).

13. The cardiac assist device (10) according to any one of the preceding claims, wherein, The spacer structure (22) includes several different spacer elements (220) distributed around the outer surface (S).

14. The cardiac assist device (10) according to any one of claims 1 to 11, wherein, The spacer structure (22) includes a plurality of spacer elements (220) connected to each other to form a spacer structure that at least partially surrounds the pump body (18).

15. The cardiac assist device (10) according to the preceding claim, wherein, The spacer structure is radially expandable relative to the elongation axis (X).

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