Stator blade device for guiding a fluid flow out of an outlet opening of a ventricular assist device, a ventricular assist device having a stator blade device, a method of operating a stator blade device, and a method of manufacturing the same

Abstract

The invention relates to a stator blade arrangement (105) for guiding a fluid flow out of an outlet opening (110) of a ventricular assist device (100). The stator blade arrangement (105) has at least one stator blade (115) which can be connected to the ventricular assist device (100) and can be arranged in the region of the outlet opening (110). The at least one stator blade (115) is designed so that it can be folded together to adopt an insertion state of the ventricular assist device (100) and can be unfolded to adopt a flow guiding state. The at least one stator blade (115) is designed to protrude radially or obliquely from the ventricular assist device (100) in the flow guiding state.

Description

[0001] describe

[0002] The invention relates to a stator blade arrangement for guiding a fluid flow out of an outlet opening of a cardiac support system. The invention also relates to a cardiac support system having a stator blade arrangement, a method for operating a stator blade arrangement, and a manufacturing method for manufacturing a stator blade arrangement. Furthermore, the invention relates to a computer program and a machine-readable storage medium on which the computer program is stored.

[0003] For cardiovascular support of patients with heart failure, systems that take over part or all of the pumping function of the heart, so-called ventricular assist devices (VADs), can be used. These systems can be subdivided into temporary systems for short-term cardiac support, for example to bridge the time until a suitable donor heart is available and implantable, and permanent systems for long-term maintenance on or in the patient. One component of such a system can be a pump for pumping blood flow, typically a centrifugal pump (turbine pump), which can be driven by an integrated electric motor and can generate the required blood flow by means of an impeller. In this case, the pump can be implanted in different locations. For example, the pump can be sutured to the heart from the outside by means of invasive surgery, sternotomy, or the pump can be placed in the aorta via the femoral or aortic in a minimally invasive manner by means of a catheter and completely or partially placed in the ventricle. In the case where the pump can be introduced in a minimally invasive manner, the maximum possible outer diameter of the pump can be limited to allow the pump to be inserted via the femoral or aortic, which is why the pump can have an axial design. The pump can pump blood flow from the ventricle into the aorta and deliver blood flow in the aorta. This may result in a total pressure loss due to the cross-sectional jump of the pump relative to the aorta and thus reduce pump efficiency. In addition, a velocity component may be imparted to the blood flow by the impeller in the circumferential direction, i.e. an angular momentum or swirl component, wherein the energy contained in this swirl component is ineffective and therefore not available for pressure buildup.

[0004] The object of the present invention is to influence the flow of fluid in which a heart support system is located. In particular, the object of the present invention is to influence the blood flow in a vessel in which the heart support system is arranged. The object of the present invention is also to optimize the efficiency of a pump in a heart support system.

[0005] These objects are achieved by a stator blade arrangement for guiding a fluid flow out of an outlet opening of a heart support system and a heart support system having a stator blade arrangement. Advantageous embodiments and further developments of the invention are specified in the dependent claims, which also relate to a method for operating a stator blade arrangement and a manufacturing method for manufacturing a stator blade arrangement. By means of the measures listed in the dependent claims, advantageous developments and improvements can be achieved for the device specified in the independent claim.

[0006] The invention is based on the recognition that the flow behavior of a fluid flowing out of an outlet opening of a heart support system can be modified by means of a suitable stator blade arrangement. By means of the stator blade arrangement, the angular momentum in the fluid flow imparted by the impeller of the pump of the heart support system can be advantageously reduced. In addition, the angular momentum can be partially converted into pressure energy, which can advantageously increase the efficiency of the pump.

[0007] A stator blade arrangement is presented for guiding a fluid flow out of an outlet opening of a heart support system. The stator blade arrangement has at least one stator blade. The at least one stator blade is connectable to a heart support system and is arranged in the region of the outlet opening. In addition, the at least one stator blade is formed such that it can be folded together to adopt an insertion state of the heart support system and can be unfolded to adopt a flow guiding state. The at least one stator blade is designed to protrude radially or obliquely from the heart support system in the flow guiding state.

[0008] The stator blade arrangement may, for example, have a fixing device for fixing the stator blade arrangement to the heart support system, or the stator blade arrangement may, for example, be formed as part of a pump housing section of the heart support system. The at least one stator blade may, for example, have a blade-shaped guide surface. The term "guiding flow" may be understood to mean, for example, adjusting the flow behavior by guiding a fluid along a surface (for example in the form of at least one stator blade). The heart support system may, for example, be a heart pump, such as a right ventricular support system, a left ventricular support system, a biventricular support system or a vascular or valve prosthesis. For minimally invasive transfemoral or transaortic insertion, the heart support system may, for example, have an elongated cylindrical shape with an outer diameter of 5 to 8 mm. The outlet opening may, for example, be arranged in the region of an impeller of a blood pump of the heart support system. The outlet opening may, for example, be arranged in a section of the pump housing of the heart support system and be cut or punched out of the section. The fluid may, for example, be blood that can be pumped by means of the heart support system. The insertion state of the heart support system may, for example, describe a state into which the heart support system may be transformed for insertion into a blood vessel; for this purpose, the heart support system may, for example, have a cylindrical shape with an outer diameter that is smaller than the diameter of a human aorta. In the insertion state, the stator blade arrangement may, for example, be folded together axially with the longitudinal axis of the heart support system. When the heart support system is implanted at the destination and ready for operation, the stator blade arrangement may, for example, be transformed from the insertion state to the flow guiding state by unfolding at least one stator blade. For this purpose, the stator blades may, for example, be opened to protrude radially or obliquely from the heart support system in the flow guiding state. In the flow guiding state, the stator blades may also be opened to protrude, for example, obliquely at a specific spatially variable angle to the radius. In this case, the inclination angle of the stator blades may have a radial and a tangential component.

[0009] According to one embodiment, the stator blade arrangement can be at least partially formed by a shape memory material. For this purpose, the at least one stator blade can, for example, be made of a shape memory material, or the stator blade can have a support structure formed by a shape memory material and consumed with another material such as silicone or polyurethane. The shape memory material can, for example, be a shape memory polymer or a shape memory alloy, such as Nitinol. In addition, the entire stator blade arrangement may also be made of a shape memory alloy, such as Nitinol. Due to its shape memory properties, the use of shape memory materials, such as Nitinol, allows particularly simple implementation of the insertion state and the unfolding during the transition to the flow guiding state. The use of Nitinol as a shape memory material is advantageous because the Nitinol material is a reliable material in the medical field, in particular in the cardiovascular medical field (for example for heart valve prostheses, stents and vascular prostheses), and due to its shape memory properties, it is possible to deliver even complex structures to a destination in a smaller installation space and place them at the destination.

[0010] The stator blade arrangement according to one embodiment may also be formed at least partially from a biocompatible material. A biocompatible material may be a material in which components of human or animal tissue remain unchanged, in particular invariant, when in contact with this biocompatible material. For example, the biocompatible material may be nitinol or a biocompatible silicone or polyurethane. Forming at least a portion of the stator blade arrangement from a biocompatible material is advantageous for using the stator blade arrangement as a device that can be implanted in a human body, for example in conjunction with a heart support system.

[0011] According to one embodiment, the at least one stator blade can be formed such that it abuts in layers on the heart support system in the inserted state. For this purpose, for example, the stator blade can be foldable in the direction of the heart support system in the inserted state. In the inserted state, the stator blade can, for example, abut on a pump housing segment. This allows a compact design and is also advantageous in order to be able to, for example, introduce the stator blade arrangement together with the heart support system into an insertion device, such as a catheter, in order to allow a minimally invasive insertion of the stator blade arrangement or of a heart support system connected to the stator blade arrangement.

[0012] In addition, the at least one stator blade can be formed so that it can be partially inserted into the outlet opening in the inserted state. For this purpose, the stator blade can, for example, be formed to correspond to the outlet opening at least in cross section. If the stator blade arrangement is formed, for example, as part of a housing segment of a heart support system, the housing segment can also be cut from a tube, wherein the shape of the at least one stator blade for forming the outlet opening can also be cut into the tube, wherein the stator blade can be folded away from the housing segment to open the outlet opening. This embodiment advantageously allows a compact design, which is particularly advantageous for designs suitable for minimally invasive introduction.

[0013] According to one embodiment, the stator blade arrangement may also have at least one further stator blade, which may be connected to the heart support system and arranged in the area of ​​the outlet opening. The at least one further stator blade may be formed such that it may be folded together to adopt an insertion state of the heart support system and may be unfolded to adopt a flow guiding state. The at least one further stator blade may be designed to protrude radially or obliquely from the heart support system in the flow guiding state. For example, the at least one further stator blade may be arranged opposite to the stator blade. The stator blade arrangement may also have a plurality of stator blades, which may be arranged equidistantly in the circumferential direction around the heart support system. Depending on the shape of the stator blades and the outlet opening, the design of the at least one further stator blade may be advantageous in guiding the outflowing fluid flow, thereby increasing the efficiency of the pump of the heart support system.

[0014] According to one embodiment, the stator blade arrangement may also have a sleeve, which is movable relative to the stator blades and is formed to close the stator blades in the insertion state and to release the stator blades in order to start the transition into the flow guiding state. The sleeve may be a mounting device for maintaining the insertion state, for example to close the stator blades in the insertion state and thereby press them against a tube of a heart support system. The sleeve may, for example, be formed cylindrically and designed such that the stator blade arrangement with the sleeve can be inserted into a commercially available catheter in the insertion state. The sleeve may, for example, be used to hold the stator blades in a folded together state and thereby additionally stabilize them in the insertion state, even if the stator blade arrangement is, for example, made entirely or partially of a shape memory material.

[0015] According to one embodiment, the stator blade arrangement can be detachably connected or detachably connected to a pump housing segment of the heart support system. For this purpose, the stator blade arrangement can have, for example, a fixing device or a connecting device for connecting the stator blade arrangement or at least one stator blade to the pump housing segment of the heart support system in a form-fitting manner, which fixing device or connecting device can be separated mechanically or due to being formed from a shape memory material. This embodiment saves costs in order to be able to, for example, replace the stator blade arrangement independently of the pump housing or to be able to change the position of the stator blades relative to the pump housing segment.

[0016] A heart support system having an embodiment of the above-described stator blade arrangement is also presented. In particular, the stator blade arrangement can be designed as part of a pump housing of the heart support system, which is advantageous with regard to the design.

[0017] By this method, a method for operating an embodiment of the aforementioned stator blade arrangement is also presented. The method has the following steps: deploying the at least one stator blade during a transition from an insertion state into a flow guiding state, wherein the at least one stator blade protrudes radially or obliquely from the heart support system in the flow guiding state.

[0018] A manufacturing method for manufacturing an embodiment of the aforementioned stator blade arrangement comprises the step of providing the stator blade arrangement with at least one stator blade. The at least one stator blade can be connected to a heart support system and is arranged in the region of an outlet opening of the heart support system. The at least one stator blade is formed such that it can be folded together to adopt an insertion state of the heart support system and can be unfolded to adopt a flow guiding state. The at least one stator blade can protrude radially or obliquely from the heart support system in the flow guiding state, wherein the stator blade arrangement is particularly designed as a part of a pump housing of the heart support system.

[0019] The method can be implemented, for example, in a control device, for example, in the form of software or hardware, or in the form of a mixture of software and hardware.

[0020] A computer program product or a computer program with a program code, which can be stored on a machine-readable carrier or storage medium, such as a semiconductor memory, a hard drive memory or an optical memory, and is used to execute, implement and / or control the steps of a method according to one of the above-described embodiments, is also advantageous, in particular if the program product or the program is executed on a computer or a device.

[0021] Exemplary embodiments of the method presented here are shown in the accompanying drawings and are explained in more detail in the following description. The accompanying drawings show:

[0022] Figure 1 is a schematic diagram of a cardiac support system having a stator blade arrangement for directing a fluid flow out of an outlet opening of the cardiac support system according to an exemplary embodiment;

[0023] Figure 2 is a schematic diagram of a stator blade arrangement for directing a fluid flow out of an outlet opening of a heart support system in a flow directing state according to an exemplary embodiment;

[0024] Figure 3 is a schematic diagram of a stator blade arrangement for directing a fluid flow out of an outlet opening of a heart support system in an inserted state according to an exemplary embodiment;

[0025] Figure 4 is a flow chart of a method for operating a stator blade arrangement according to an exemplary embodiment; and

[0026] Figure 5 is a flow chart of a manufacturing method for operating a stator blade arrangement according to an exemplary embodiment.

[0027] In the following description of advantageous exemplary embodiments of the invention, identical or similar reference numerals are used for elements having a similar effect shown in the individual figures, wherein a repeated description of these elements is omitted.

[0028] Figure 1 A schematic diagram of a heart support system 100 having a stator vane arrangement 105 for directing a fluid flow out of an outlet opening 110 of the heart support system 100 according to an exemplary embodiment is shown. A perspective view of the heart support system 100 is shown. As the heart support system 100, a left ventricle heart support system for the aortic valve position is shown by way of example.

[0029] The stator blade arrangement 105 has at least one stator blade 115. The at least one stator blade 115 may be connected to the heart support system 100. In addition, the at least one stator blade 115 may be arranged in the region of the outlet opening 110 of the heart support system 100. The at least one stator blade 115 is formed such that it can be folded together to assume an insertion state of the heart support system 100 and can be unfolded to assume a flow guiding state. In the flow guiding state, the at least one stator blade 115 protrudes radially or obliquely from the heart support system 100. The stator blade arrangement 105 is shown here by way of example in the flow guiding state; therefore, the stator blades 115 are unfolded and protrude radially from the heart support system 100. Two stator blades 115 are shown here by way of example, which are arranged opposite to each other in the unfolded state. Alternatively, the stator blades 115 may also protrude obliquely from the heart support system 100 at an acute or obtuse angle to a radius of the heart support system 100. In this case, the inclination angle of the stator blades 115 may have a radial and a tangential component. According to the exemplary embodiment shown here, the plane of the stator blades 115 extends in the direction of the longitudinal extension axis of the heart support system 100 .

[0030] The cardiac support system 100 has a cylindrical elongated structure with a substantially constant outer diameter and a rounded tapered end for easy positioning in a blood vessel, such as the aorta, with the aid of a catheter. The elongated axial design shown here allows transfemoral implantation of the cardiac support system 100, wherein the outer diameter of the cardiac support system 100 is limited in the inserted state by the diameter of the femoral artery in the region of the implantation site. In the following, the cardiac support system 100 is also referred to as pump 100 for short.

[0031] The pump 100 has an impeller 120 which is formed as an axial flow impeller with respect to the longitudinal axis of the pump 100. The impeller 120 is arranged in a pump housing section 135 of the heart support system 100 between an inlet pipe 125 having an inlet opening for introducing a fluid to be delivered and a section of the heart support system 100 comprising a drive device 130. The impeller 120 can rotate about a rotation axis 122 which is parallel to the longitudinal direction of the pump housing section 135. The impeller 120 is surrounded by the pump housing section 135 which has a lateral surface which is arranged coaxially with the rotation axis 122 of the impeller 120 and which has an outlet opening 110 which is interrupted by the outlet opening 110. The fluid to be delivered by the heart support system 100, for example blood, can be introduced through the inlet opening of the inlet pipe 125 and discharged through the outlet openings 110 which are arranged on the circumference of the pump housing section 135 so as to return to the aorta in the implanted state of the heart support system 100. The pump housing section 135 has here, as an example, two window-like outlet openings 110 .

[0032] According to an exemplary embodiment, the stator blade arrangement 105 is at least partially formed of a shape memory material and additionally or alternatively at least partially formed of a biocompatible material. In addition, according to an exemplary embodiment, the stator blade arrangement 105 can be removably connected or removably connected to a pump housing segment 135 of the heart support system.

[0033] According to an exemplary embodiment, the heart support system 100 has a stator blade arrangement 105 as part of a pump housing of the heart support system 100 , for example as part of a pump housing segment 135 .

[0034] For minimally invasive insertion, the pump 100 has an outer diameter that is significantly smaller than the aorta, and blood flows out into the aorta in the implanted state during operation of the cardiac support system 100, as described below. Figure 2 Schematically shown. Without the stator blade arrangement 105, this would result in a permanent total pressure loss due to the large sudden cross-sectional jump and would therefore reduce the pump efficiency. In addition, a velocity component is applied to the fluid by the impeller 120 in the circumferential direction, namely the vortex component. The energy contained in this vortex component is ineffective and is therefore lost. By means of the exemplary embodiment of the stator blade arrangement 105 shown here, the aforementioned vortex in the flow is reduced by at least one stator blade 115 and at least partially converted into pressure energy in order to increase the efficiency of the pump 100.

[0035] At least one stator blade 115 protrudes from a lateral surface of the pump housing segment 135 in a flow-guiding state. In the flow-guiding state, at least one stator blade 115 can protrude from the lateral surface of the pump housing segment 135 in a direction having a direction component parallel to a radial direction relative to the rotation axis 122 of the impeller 120 and a direction component perpendicular to the radial direction. At least one stator blade 115 can be parallel to the rotation axis 122 of the impeller 120. However, in principle, at least one stator blade 115 can also extend obliquely relative to the rotation axis 122 of the impeller 120.

[0036] The guidance of the flow by means of the deployed stator blades 115 in the flow-guiding state of the stator blade arrangement 105 allows the efficiency of the pump 100 to be increased. In this case, blood is fed from the ventricle via the inlet pipe 125 to the active pump part, in particular to the impeller 120. The impeller 120 is partially surrounded on the outside by a pump housing segment 135, which has an outlet opening 110 and is cylindrical here as an example. According to the exemplary embodiment shown here, the pump housing segment 135 also has a bar 140, also called a strut. At least one stator blade 115 is arranged in the region of the outlet opening 110 or the bar 140. At least one stator blade 115 is flexible, foldable and deployable. The stator blades 115 can be folded together to adopt an inserted state, and the stator blades 115 can be deployed to adopt a flow-guiding state, as described below with reference to the following Figure 2 and 3 shown.

[0037] To assume the inserted state and the flow guiding state, according to an exemplary embodiment, the stator blade arrangement 105 and additionally or alternatively the entire pump housing segment 135 having the stator blade arrangement 105 is formed from Nitinol (a biocompatible shape memory alloy), whereby at least one stator blade 115 is folded into a small diameter.

[0038] According to an exemplary embodiment, the stator blade arrangement 105 comprises a sleeve as a mounting device in order to maintain the small diameter in the folded state by means of further mounting means, for example by means of a tube. The sleeve is movable relative to the stator blade 115 and is formed to enclose the stator blade 115 in the inserted state and to release the stator blade 115 in order to initiate the transition into the flow-guiding state. If the stator blades are formed from Nitinol according to an exemplary embodiment, at least one stator blade 115 is deployed into the desired deployed state, i.e. into the flow-guiding state, by the influence of body heat after implantation of the cardiac support system 100 and removal of the further mounting means. Optionally, in this case, the entire stator blade 115 is not formed from Nitinol, but is only partially composed of Nitinol in the form of a support structure, which is made of Nitinol and filled with another material, such as silicone or polyurethane.

[0039] Figure 2 A schematic diagram of a stator blade arrangement 105 for guiding a fluid flow out of an outlet opening of a heart support system 100 in a flow guiding state according to an exemplary embodiment is shown. According to the flow guiding state, the stator blades 115 are shown in an unfolded state and protrude radially from the heart support system 100, i.e. they protrude radially from a lateral surface of the pump housing segment 135 relative to a rotation axis 122 of the impeller 120 parallel to the longitudinal direction of the pump housing segment 135. The heart support system 100 shown here and the stator blade arrangement 105 shown here are similar to or correspond to the above-described Figure 1 By way of example, a heart support system 100 with a stator blade arrangement 105 is arranged in the aorta 205 .

[0040] According to the exemplary embodiment shown here, the stator blade arrangement 105 comprises a stator blade 115 and at least one further stator blade 115', which can be connected to the heart support system 100 and is arranged in the region of the outlet opening and is formed such that it can be folded together to assume an insertion state of the heart support system 100 and can be unfolded to assume a flow guiding state. In the flow guiding state shown here, the at least one further stator blade 115', like the stator blade 115, protrudes radially from the heart support system 100, i.e. it protrudes radially from a lateral surface of the pump housing segment 135 coaxial with the rotation axis 122 of the impeller 120.

[0041] The outer diameter of the heart support system 100 is significantly smaller than the blood vessel (i.e. the aorta 205) in which it can be arranged. This is shown here by the marking 210 marking the outer diameter of the heart support system and the marking 215 marking the diameter of the aorta. When blood flows out of the outlet opening of the heart support system 100 into the aorta 205, due to the large sudden cross-sectional jump, a permanent total pressure loss occurs without the stator blade arrangement 105 and the pump efficiency is thus reduced; in addition, a velocity component in the circumferential direction, i.e. the vortex component, is applied to the fluid (blood) by the impeller. The energy contained in this vortex component is ineffective and is therefore lost. In the flow guiding state shown here, the described vortex is reduced and converted into pressure energy by means of the stator blades 115 and optionally further stator blades 115', which increases the efficiency of the pump.

[0042] Figure 3 A schematic diagram of a stator blade arrangement 105 in an inserted state for directing a fluid flow out of an outlet opening of a heart support system 100 according to an exemplary embodiment is shown. The inserted state is shown as another aspect of the stator blade arrangement 105 and the heart support system 100 described with reference to the previous figures.

[0043] In the inserted state, the heart support system 100 and the stator blade arrangement 105 have an outer diameter that is significantly smaller than the diameter of the aorta 205, as indicated by markers 210 and 215. This is advantageous for minimally invasive insertion of the heart support system 100 and the stator blade arrangement 105.

[0044] Optionally, at least one stator blade 115 is formed so that it abuts in layers in the inserted state, as exemplified herein by another stator blade 115'. The stator blade 115' abuts on the pump housing of the heart support system 100 and does not significantly increase the outer diameter 210 of the heart support system 100 in the folded state. According to the exemplary embodiment shown here, at least one stator blade 115 is further formed so that it can be partially inserted into the outlet opening in the inserted state, as exemplified by stator blade 115. The described shapes of the stator blade 115 and the further stator blade 115' provide the following advantages: they are tightly clamped against the pump housing of the heart support system 100 in the folded state, or are additionally or alternatively at least partially located in the outlet opening and thus allow minimally invasive implantation. The stator blade 115 and the further stator blade 115' are optionally designed as part of the pump housing of the heart support system 100.

[0045] Figure 4A flow chart of a method 400 for operating a stator blade arrangement according to an exemplary embodiment is shown. With this method 400, the exemplary embodiment of the aforementioned stator blade arrangement is operated. The method 400 has at least one deployment step 405. In the deployment step 405, at least one stator blade is deployed during the transition from the insertion state into the flow guiding state. In the flow guiding state, at least one stator blade protrudes radially or obliquely from the heart support system.

[0046] Figure 5 A flow chart of a manufacturing method 500 for manufacturing a stator blade arrangement according to an exemplary embodiment is shown. With this manufacturing method 500, an exemplary embodiment of the aforementioned stator blade arrangement is manufactured. The method 500 has at least one providing step 505. In the providing step 505, a stator blade arrangement with at least one stator blade is provided, which at least one stator blade is connectable to a heart support system and is arranged in the region of an outlet opening of the heart support system and is formed such that it can be folded together to adopt an insertion state of the heart support system and can be unfolded to adopt a flow guiding state, wherein the at least one stator blade protrudes radially or obliquely from the heart support system in the flow guiding state. The stator blade arrangement is provided in particular as part of a pump housing of the heart support system.

[0047] If an exemplary embodiment includes an “and / or” connection between a first feature and a second feature, this should be understood to mean that the exemplary embodiment according to one embodiment has both the first and second features and according to another embodiment has only the first feature or only the second feature.

[0048] In summary, special attention should be paid to the following preferred features of the present invention:

[0049] The invention relates to a stator blade arrangement 105 for guiding a fluid flow out of an outlet opening 110 of a heart support system (100). The stator blade arrangement 105 has at least one stator blade 115, which can be connected to the heart support system 100 and is arranged in the region of the outlet opening 110. The at least one stator blade 115 is formed such that it can be folded together to assume an insertion state of the heart support system 100 and can be unfolded to assume a flow guiding state. The at least one stator blade 115 is designed to protrude radially or obliquely from the heart support system 100 in the flow guiding state.

[0050] Specifically, the present invention may have the following aspects:

[0051] 1. A stator blade arrangement (105) for directing a fluid flow out of an outlet opening (110) of a cardiac support system (100), wherein the stator blade arrangement (105) has the following features:

[0052] At least one stator blade (115) is connectable to the heart support system (100) and is arranged in the area of ​​the outlet opening (110) and is formed so that it can be folded together to adopt an insertion state of the heart support system (100) and can be unfolded to adopt a flow guiding state, wherein the at least one stator blade (115) is designed to protrude radially or obliquely from the heart support system (100) in the flow guiding state.

[0053] 2. The stator blade arrangement (105) according to aspect 1, wherein the stator blade arrangement (105) is at least partially formed from a shape memory material.

[0054] 3. The stator blade arrangement (105) according to one of the preceding aspects, wherein the stator blade arrangement (105) is at least partially formed from a biocompatible material.

[0055] 4. The stator blade arrangement (105) according to one of the preceding aspects, wherein the at least one stator blade (115) is formed such that it abuts in a layered manner on the heart support system (100) in an inserted state.

[0056] 5. The stator blade arrangement (105) according to one of the preceding aspects, wherein the at least one stator blade (115) is formed such that it can be partially inserted into the outlet opening (110) in an inserted state.

[0057] 6. A stator blade device (105) according to one of the preceding aspects, comprising at least one additional stator blade (115'), which is connectable to a heart support system (100) and is arranged in the area of ​​an outlet opening (110) and is formed so that it can be folded together to assume an insertion state of the heart support system (100) and can be unfolded to assume a flow guiding state, wherein the at least one additional stator blade (115') is designed to protrude radially from the heart support system (100) in the flow guiding state.

[0058] 7. A stator blade arrangement (105) according to one of the preceding aspects, comprising a sleeve which is movable relative to the stator blade (115) and is formed to close the stator blade (115) in an inserted state and to release the stator blade (115) in order to start a transition into a flow guiding state.

[0059] 8. The stator blade arrangement (105) according to one of the preceding aspects, wherein the stator blade arrangement (105) is detachably connectable or detachably connectable to a pump housing segment (135) of the heart support system (100).

[0060] 9. A cardiac support system (100) having a stator blade arrangement (105) according to one of aspects 1 to 8, wherein the stator blade arrangement (105) is specially designed as a part of a pump housing of the cardiac support system (100).

[0061] 10. A method (400) for operating a stator blade arrangement (105) according to one of aspects 1 to 8, wherein the method (400) comprises at least the following steps:

[0062] The at least one stator blade (115) is deployed (405) during a transition from an insertion state to a flow directing state, wherein the at least one stator blade (115) protrudes radially or obliquely from the heart support system (100) in the flow directing state.

[0063] 11. A manufacturing method (500) for manufacturing a stator blade arrangement (105) according to one of the preceding aspects 1 to 8, wherein the manufacturing method (500) comprises at least the following steps:

[0064] A stator blade arrangement (105) is provided (505) with at least one stator blade (115), the at least one stator blade being connectable to a heart support system (100) and being arranged in the region of an outlet opening (110) of the heart support system (100), and being formed so as to be foldable together to assume an insertion state of the heart support system (100) and to be unfoldable to assume a flow guiding state, wherein the at least one stator blade (115) is designed to protrude radially or obliquely from the heart support system (100) in the flow guiding state, wherein the stator blade arrangement (105) is particularly designed as a part of a pump housing of the heart support system (100).

[0065] 12. A computer program configured to execute and / or control the method (400) according to aspect 10 and / or the manufacturing method (500) according to aspect 11.

[0066] 13. A machine-readable storage medium having stored thereon the computer program according to clause 12.

Claims

1. A cardiac support system comprising: an inlet tube extending in a longitudinal direction, the inlet tube including an inlet opening configured to receive blood into the cardiac support system; a pump housing connected to the inlet pipe and extending in the longitudinal direction, the pump housing comprising: a lateral surface including at least one outlet opening configured to receive blood discharged therethrough from the pump housing; and a stator blade arrangement arranged in the region of the at least one outlet opening, the stator blade arrangement comprising at least one stator blade, the at least one stator blade being configured to be unfolded from a folded state into a flow-guiding state after the inlet pipe and the pump housing segment are inserted into a blood vessel using a catheter, wherein the at least one stator blade is configured to protrude radially or obliquely outwardly from a lateral surface of the pump housing in the flow-guiding state; an impeller positioned within the inner diameter of the lateral surface, having an axis of rotation parallel to the longitudinal direction of the pump housing; and A drive device is positioned on a side of the impeller facing away from the inlet duct and is configured to drive the impeller.

2. The cardiac support system according to claim 1 further comprises a sleeve, which is configured to be movable relative to the at least one stator blade, wherein the sleeve is configured to enclose the at least one stator blade in a folded state and release the at least one stator blade to initiate the unfolding of the at least one stator blade from the folded state to the flow guiding state.

3. The cardiac support system according to claim 1, wherein: The inlet tube includes a rounded, tapered end configured to be received in a blood vessel.

4. The cardiac support system according to claim 1, wherein: The at least one stator blade includes an edge extending parallel to the axis of rotation of the impeller.

5. The cardiac support system according to claim 1, wherein: The at least one stator blade extends obliquely with respect to the rotation axis of the impeller.

6. The cardiac support system of claim 1, wherein: The at least one stator blade is configured to protrude from the lateral surface of the pump housing segment in a direction having a directional component parallel to a radial direction relative to the rotation axis of the impeller and a directional component perpendicular to the radial direction in the flow guiding state.

7. The cardiac support system of claim 1, wherein: The stator blade arrangement is at least partially formed from a shape memory material.

8. The cardiac support system of claim 1, wherein: The stator blade arrangement is at least partially formed from a biocompatible material.

9. The cardiac support system of claim 1, wherein: The at least one stator blade abuts on the lateral surface of the pump housing in a folded state.

10. The cardiac support system of claim 1, wherein: The at least one stator blade is partially inserted into the at least one outlet opening in a folded state.

11. The cardiac support system of claim 1, wherein: The at least one stator blade includes a plurality of stator blades.

12. The cardiac support system of claim 11, wherein: The plurality of stator blades are positioned equidistantly around the circumference of the pump housing.

13. The cardiac support system of claim 1, wherein: The at least one outlet opening comprises an outlet window bounded by one or more strips.

14. The cardiac support system of claim 1, wherein: The at least one outlet opening comprises a plurality of outlet openings, each of the plurality of outlet openings comprising an outlet window, wherein each outlet window is separated from at least one adjacent outlet window by a bar.

15. A method of manufacturing a heart pump system, comprising: providing an inlet tube, wherein the inlet tube extends in a longitudinal direction, wherein the inlet tube includes an inlet opening configured to receive blood into the heart pump system; A pump housing is connected to the inlet pipe, wherein the pump housing extends in the longitudinal direction, wherein the pump housing comprises: a lateral surface including at least one outlet opening configured to receive blood discharged therethrough from the pump housing; and a stator blade arrangement arranged in the region of the outlet opening, the stator blade arrangement comprising at least one stator blade; positioning an impeller within an inner diameter of the pump housing, the impeller having an axis of rotation parallel to a longitudinal direction of the pump housing; and positioning a drive device on a side of the impeller facing away from the inlet duct, the drive device being configured to drive the impeller; The at least one stator blade is configured to be unfolded from a folded state to a flow guiding state, wherein the at least one stator blade is configured to protrude radially or obliquely outward from a lateral surface of the pump housing in the flow guiding state.

16. The method of claim 15, further comprising providing a sleeve configured to move relative to the at least one stator blade to release the at least one stator blade and initiate deployment of the at least one stator blade from the folded state to the flow directing state.

17. The method according to claim 15, wherein: The inlet tube includes a rounded, tapered end configured to be received in a blood vessel.

18. The method of claim 15, wherein the stator blade arrangement is at least partially formed from a shape memory material.

19. The method according to claim 15, wherein: The stator blade arrangement is at least partially formed from a biocompatible material.

20. The method according to claim 15, wherein: The at least one stator blade is partially inserted into the at least one outlet opening in a folded state.

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