Pump section and blood pump for blood pump

Abstract

A pump section (10) for a blood pump (100) is provided. The pump section (10) comprises a pump housing (14), a pump element (16), an outflow tube (18), and a stabilization device (20). The stabilization device (20) is located downstream of the blood outflow outlet (28) of the pump housing (14), and is configured to stabilize the pump section (10) by influencing at least one flow parameter of the blood flow generated by the pump element (16). This at least one flow parameter includes the differential pressure inside the outflow tube (18) versus outside the outflow tube (18), and / or the resulting blood flow direction D2.

Description

[Technical Field]

[0001] This disclosure relates to the field of medical technology. Specifically, this disclosure relates to pump sections for blood pumps and blood pumps. [Background technology]

[0002] Cardiac assist devices that support a patient's cardiac function, such as blood pumps, have been known for some time. Some of these blood pumps have an implantable blood pump section that can be inserted into the ventricle of the heart by minimally invasive means. Furthermore, some blood pumps have an external (i.e., external) motor that drives the pump element of the pump section to generate blood flow, allowing, for example, blood to be drawn from the left ventricle into the aorta. In some cases, the motor is connected to the pump section via a percutaneous flexible drive shaft, or the drive shaft is rotatably mounted inside a percutaneous catheter. The implantable component of the device can be inserted, for example, through the femoral artery via a puncture site in the patient's groin. Of course, the implantable component of the device can also be inserted, for example, via the axillary artery.

[0003] The pump section of such a blood pump may include a pump housing having a blood inlet and a blood outlet, a pump element at least partially disposed within the pump housing, and an outflow duct. The pump element should be configured to generate blood flow between the blood inlet and the blood outlet of the pump housing. The outflow duct surrounds the blood outlet of the pump housing and is designed to channel and guide the blood flow generated by the pump element, for example, from the left ventricle where the pump housing is located, through the aortic valve into the aorta. For this purpose, the outflow duct may have an elongated structure extending from the distal end to the proximal end along the longitudinal direction of the outflow duct. The distal end may be connected to the pump housing. Furthermore, the outer sheath of a known outflow duct has an outlet opening, or outlet hole, through which the blood flow generated by the pump element ultimately exits the pump section at a planned location (for example, a location posterior to the aortic valve and within the artery).

[0004] To minimize the invasive procedures required, the pump housing, pump elements, and outflow tube of the pump section should be made flexible. That is, they should be collapsible and expandable. For this purpose, the outflow tube is usually a thin polyurethane tube; this can be folded and placed inside the inlet sheath, and the pump section can be introduced into the patient's body using the inlet sheath. With such a flexible outflow tube, when the inlet sheath is removed and the pump elements begin to generate blood flow, the outflow tube "expands" due to the blood flow, achieving its intended operating form.

[0005] However, observations of pump sections with this type of configuration have shown that differences in blood flow velocity between the inside and outside of the outflow duct throughout the cardiac cycle can cause outflow duct fluttering. Outflow duct fluttering depends on various parameters, such as the rotational speed of the pump elements, afterload, preload, cardiac cycle, aortic valve status, and the positioning of the pump section and / or outflow duct within the ventricle and / or blood vessels. Such outflow duct fluttering can cause inflammation of the patient's surrounding tissues, placing unnecessary mechanical stress on those tissues. For example, endocardial inflammation can lead to ectopic beats. In addition, findings suggest that such flexible outflow duct configurations may result in lower overall positional stability of the pump section within the patient's body compared to blood pumps with rigid suction tubes. [Overview of the project] [Problems that the invention aims to solve]

[0006] In other words, the purpose of this disclosure is to provide a pump section for a blood pump that reduces fluttering of the outflow tube and improves the positional stability of the pump section. [Means for solving the problem]

[0007] According to the first embodiment, a pump section for a blood pump is provided. The pump section comprises a pump housing, a pump element, an outflow tube, and a stabilization device. The pump housing is provided with a blood inlet and a blood outlet. The pump element is at least partially disposed within the pump housing and configured to generate blood flow between the blood inlet and the blood outlet. The outflow tube surrounds the blood outlet of the pump housing. The outflow tube is configured to guide the blood flow generated by the pump element. The outflow tube is provided with an outlet for the blood flow. The stabilization device is located downstream of the blood outlet of the pump housing. The stabilization device is configured to stabilize the pump section by influencing at least one flow parameter of the blood flow generated by the pump element.

[0008] Specifically, "downstream of the blood flow outlet" should be understood as being downstream from the direction of blood flow generated by the pump element. The at least one flow parameter mentioned above can be any blood flow-related parameter, such as pressure, volumetric flow rate, or direction. By having the stabilization device operate downstream of the blood flow outlet in a manner that affects this at least one flow parameter, outflow pipe fluttering is reduced and the positional stability of the pump section is improved.

[0009] Preferably, at least one of the flow parameters listed above includes the differential pressure between the inside of the outflow tube and the outside of the outflow tube. The stabilization device should be configured such that its differential pressure is at least the minimum differential pressure; preferably the minimum differential pressure is 5 mmHg, more preferably 10 mmHg. Preferably, the stabilization device is equipped with a throttle (throttling valve) for the blood flow generated by the pump element. Even more preferably, the stabilization device is configured such that its differential pressure is at least the minimum differential pressure during systole.

[0010] This differential pressure is calculated by subtracting the external pressure of the outflow pipe from the internal pressure of the outflow pipe. That is, the internal pressure of the outflow pipe is preferably made at least 5 mmHg, and more preferably at least 10 mmHg, higher than the external pressure acting on the outflow pipe. In this way, the differential pressure will be at least 5 mmHg, especially during systole. In relation to this, it is preferable to equip the stabilization device with a throttle to generate this minimum differential pressure. This throttle can be formed at the outlet of the outflow pipe and / or by attaching a throttle ring to the outflow pipe and forming a throttle within the outflow pipe. The throttle ring should be arranged around the outer surface of the outflow pipe. The diameter of the throttle ring should be smaller than the diameter of the outflow pipe at the position where the throttle ring is located. In this way, the outflow pipe is locally constricted by the throttle ring, so that a throttle can be formed for the blood flow generated by the pump element and flowing through the outflow pipe. The differential pressure between the inside and outside of the outlet pipe is affected to at least its minimum value, thereby reliably reducing the fluttering effect at the outlet of the outlet pipe.

[0011] Preferably, the outflow tube has a distal end portion connected to the pump housing and a proximal end portion. The outflow tube may have an elongated configuration extending from the distal end portion to the proximal end portion along the longitudinal direction of the outflow tube. The resulting blood flow direction at the outlet of the outflow tube may be included in at least one of the flow parameters mentioned above. The stabilization device may be configured such that the axial component of the resulting blood flow direction is oriented away from the distal end portion along the longitudinal direction of the outflow tube, preferably along the longitudinal direction of the proximal end portion of the outflow tube. More preferably, the stabilization device is configured such that the resulting blood flow direction is substantially parallel to the longitudinal direction of the proximal end portion of the outflow tube.

[0012] Preferably, the stabilization device is provided with an outlet for the outflow tube. The outlet for the outflow tube should be configured such that the differential pressure is at least the minimum differential pressure, preferably during systole, and the resulting axial component in the blood flow direction is directed away from the distal end portion along the longitudinal extension direction of the outflow tube.

[0013] In other words, the blood flow vector at the outlet has an axial component parallel to the longitudinal extension direction of the outflow tube and a radial component perpendicular to the longitudinal extension direction of the outflow tube. The resulting blood flow direction is obtained by the vector sum of these two perpendicular components. The fact that the resulting blood flow direction is substantially parallel to the longitudinal extension direction means that the axial component of the blood flow vector is greater than the radial component of the blood flow vector.

[0014] If the resulting axial component of the blood flow direction is aligned with the longitudinal extension of the outflow tube and away from its distal end, a thrust is generated in the opposite direction to the blood flow at the outlet, affecting the pump section. This thrust can also be called the "axial thrust" affecting the pump section. Generating this axial thrust reduces fluttering of the outflow tube and improves the positional stability of the pump section.

[0015] Specifically, when a pump section is used to generate blood flow from the left ventricle to the aorta, the entire pump section is subjected to a force directed from the left ventricle towards the aorta during systole. This force acting on the pump section can lead to movement of the pump section within the left ventricle, and may even lead to the risk of periodic contact with the vascular endothelium (so-called "jack hammering") as the pump housing with the pump elements is ejected through the aortic valve during systole and re-enters during diastole. The axial thrust generated by the outlet, which is in the opposite direction to blood flow, counteracts this movement of the pump section, leading to improved positional stability of the pump section.

[0016] Preferably, the outlet of the outflow tube is formed in or by the proximal end portion of the outflow tube. That is, by allowing the thrust generated by the outlet to exert an effect over the entire longitudinal extension of the outflow tube, reduction of fluttering and improvement of positioning stability are further assisted. In addition, since the outlet is appropriately arranged, the blood flow guided by the outflow tube can be discharged at the expected location (for example, in the aorta behind the aortic valve).

[0017] In one embodiment, the pump section may further comprise a catheter connected to a pump housing, the catheter having a peripheral surface. The proximal end portion of the outflow tube may comprise a tapered portion tapered toward the catheter, and a mounting portion attached to the peripheral surface of the catheter. The tapered portion may have at least one outlet opening, preferably at least one outlet hole. The outlet of the outflow tube may be formed by the at least one outlet opening, preferably by a plurality of outlet openings evenly distributed in the circumferential direction around the tapered portion. The shape of the at least one outlet opening may be circular, oval, arcuate, semicircular, elongated semicircular, oval, rhombic, triangular or teardrop-shaped. The at least one outlet opening preferably has rounded corners. The mounting portion may be attached to the peripheral surface of the catheter by bonding, for example by adhesive or thermal bonding. The taper angle of the tapered portion toward the catheter may be at least 40°, preferably at least 70°, more preferably at least 85°.

[0018] By forming the at least one outlet opening in the tapered portion, it becomes easy to direct blood flow substantially parallel to the longitudinal extension direction of the outflow tube rather than in the radial direction of the outflow tube, for example. The more steeply the tapered portion is tapered toward the catheter, the larger the axial component of the blood flow vector becomes. Accordingly, the axial thrust generated by the outlet and acting on the pump section is further increased, and the positioning stability of the pump section is further improved.

[0019] The aforementioned at least one exit opening may extend to or into the attachment portion. That is, the at least one exit opening may extend to the area of ​​the catheter's circumferential surface where the attachment portion is attached. This reduces the risk of thrombus formation within the pocket.

[0020] The outflow tube may have an intermediate section connecting its distal and proximal ends, and the formation of the aforementioned at least one outlet opening may be limited to the proximal end. That is, the at least one outlet opening should not extend beyond the tapered portion into the intermediate section in the direction toward the distal end of the outflow tube. This helps to reduce the radial component of the blood flow vector at the at least one outlet opening.

[0021] Preferably, at least one of the aforementioned outlet openings is extended into the mounting slit in the mounting portion. The mounting slit in the mounting portion is used during the assembly of the pump section to allow the outflow pipe to be folded onto the pre-assembled pump housing. Extending at least one outlet opening into the mounting slit reduces the production steps required to form that at least one outlet opening. If multiple outlet openings are provided, it may be sufficient if one of those multiple outlet openings extends into the mounting slit in the mounting portion. Extending each outlet opening into the mounting slit in the mounting portion is also worth considering.

[0022] Alternatively, or in addition to the above, the pump section may further include a catheter having a circumferential surface, which is connected to the pump housing. The catheter may be provided with at least one attachment strut, preferably multiple attachment struts evenly distributed around the circumferential surface of the catheter. The proximal end of the outflow tube may be provided with an attachment portion, which may be attached to at least one attachment strut. The outlet of the outflow tube may be formed by at least one outlet gap, preferably multiple outlet gaps, formed between the proximal end of the outflow tube and the catheter. In addition, as described above, the proximal end may be provided with a tapered portion, which may have at least one outlet opening.

[0023] Providing at least one outlet gap between the proximal end of the outflow tube and the catheter directs the blood flow parallel to the longitudinal extension of the outflow tube, resulting in a blood flow vector with virtually no radial component. Consequently, the axial thrust generated by this blood flow improves the positional stability of the pump section and reduces outflow tube fluttering.

[0024] The aforementioned at least one attachment strut may be formed integrally with the catheter on its circumferential surface. Alternatively, the catheter may have an attachment ring having the aforementioned at least one attachment strut, the attachment ring being connected to the circumferential surface of the catheter. The connection between the attachment ring and the catheter may be formed by joining, for example, by adhesive or heat bonding. The at least one attachment strut may be made of a compressible spring structure, preferably made of Nitinol®. This allows the at least one attachment strut to be compressed to insert and remove the pump section into and from the patient, while simultaneously ensuring that the at least one outlet gap remains open during use in the patient's body.

[0025] Alternatively, or in addition to the above, the pump section may further include a catheter having a circumferential surface, which is connected to the pump housing. The proximal end of the outflow tube may further include at least one attachment strip, preferably multiple attachment strips, attached to the circumferential surface of the catheter. The proximal end of the outflow tube may further include at least one outlet pocket, preferably multiple outlet pockets, with an outlet opening. The at least one outlet pocket may be formed such that at least one attachment strip is attached to the circumferential surface of the catheter. The outlet of the outflow tube may be formed by the at least one outlet pocket, preferably multiple outlet pockets forming a cloverleaf shape. With this outlet configuration, the blood flow vector at the outlet will essentially have only an axial component, resulting in improved axial thrust to the pump section and reduced fluttering of the outflow tube.

[0026] Specifically, the outflow tube extends into at least one attachment strip at its proximal end. In this case, the proximal end should not have a taper toward the catheter. When the at least one attachment strip is attached to the catheter, a longitudinal stenosis along the longitudinal extension direction of the outflow tube is formed within the aforementioned at least one outlet pocket. Preferably, by providing three or four attachment strips to form three or four longitudinal stenosis and three or four outlet pockets, a three-leaf clover leaf shape or a four-leaf clover leaf shape can be generated.

[0027] Alternatively, or in addition to the above, the outflow pipe may be provided with at least one guide tube, preferably multiple guide tubes, and connected to the outflow pipe via fluid. The at least one guide tube may extend substantially parallel to the longitudinal direction of the outflow pipe. The outlet of the outflow pipe may be formed by the at least one guide tube. This allows the direction of the outflow opening to which the guide tube terminates to be such that the blood flow exits the guide tube substantially parallel to the longitudinal direction of the outflow pipe. Specifically, it is preferable to arrange at least one guide tube radially outward from the outflow pipe.

[0028] In particular, the outflow pipe is preferably provided with an intermediate section connecting the distal end and the proximal end, and this intermediate section preferably has multiple openings evenly distributed circumferentially around the intermediate section. A single guide pipe is preferably connected to each opening in the intermediate section. The fluid connection between the outflow pipe and the guide pipe can be formed by joining one end of the guide pipe to the outer surface of the outflow pipe around the openings in the intermediate section, for example, by adhesive or heat bonding.

[0029] The outer surface of at least one of the guide tubes can be joined at least partially to the outer surface of the outflow tube, for example, by adhesive or heat bonding. In addition to or instead of this, the pump section may further be provided with a positioning ring that surrounds the at least one guide tube and the outflow tube. If the at least one guide tube is located outside the outflow tube, the positioning ring can hold the at least one guide tube in place and firmly orient the outflow opening of the guide tube so that the blood flow exits the guide tube substantially parallel to the longitudinal direction of the outflow tube.

[0030] Ideally, the total outlet area should be 20 mm². 2 ~70mm 2 Preferably 30 mm 2 ~50mm 2 , more preferably 33 mm 2 ~35mm 2The total outlet area is calculated by adding up the areas of all openings through which the blood flow generated by the pump element exits the outflow tube. Therefore, this total outlet area may include the total area of ​​all outlet openings in the outflow tube, and / or the total area of ​​all outlet gaps, and / or the total area of ​​all outflow openings in the guide tube. The provided total outlet area is 70 mm². 2 In the following configuration, a throttle is formed at the outlet for the blood flow generated by the pump element and exiting the outflow tube. Consequently, a desirable minimum differential pressure, preferably at least 5 mmHg, is ensured between the inside and outside of the outflow tube. In addition, the outlet functions as a nozzle for the blood flow exiting the outflow tube, resulting in a desirable axial thrust. Consequently, outflow tube fluttering is reduced, and the positional stability of the pump section is improved.

[0031] Preferably, the outflow tube is made of a biocompatible material, such as a suitable polymer, such as polyurethane, polyamide, nylon, or silicone. Preferably, the outflow tube is made of polyurethane (PU) or polytetrafluoroethylene (PTFE).

[0032] Preferably, the connection angle between the outflow tube and the pump housing at its distal end is 0.5 to 4°, preferably 1 to 2°, and more preferably about 1.5°. This further aids in directing the blood flow out of the pump section housing in a manner that is beneficial for generating axial thrust and thereby improving the positional stability of the pump section.

[0033] According to the second embodiment, a blood pump, particularly an intravascular blood pump, is provided with the pump section described above.

[0034] The above summary and the subsequent detailed descriptions of preferred embodiments will be better understood when read in conjunction with the accompanying drawings. The drawings are referenced for illustrative purposes of this disclosure. These accompanying drawings are not drawn to faithful scale. In the drawings, the same or corresponding components are represented by the same reference number in various drawings. For clarity, components are not individually labeled in each drawing. The technical scope of this disclosure is not limited to the specific embodiments disclosed in the drawings.

[0035] The drawing is as follows: [Brief explanation of the drawing]

[0036] [Figure 1] This is a schematic diagram of the intravascular blood pump located in the left ventricle of the heart. [Figure 2] Figure 1 is a diagram illustrating a portion of the pump section of the blood pump. [Figure 3] This is a schematic diagram of the proximal end portion of the outflow pipe according to the first embodiment. [Figure 4] Figure 3 is a schematic side view of the proximal end of the outflow pipe. [Figure 5] This is another schematic side view of the proximal end portion of the outflow pipe shown in Figure 3. [Figure 6] This is a schematic partial side view of the outflow pipe according to the second embodiment. [Figure 7] This is a schematic partial side view of the outflow pipe according to the third embodiment. [Figure 8] Figure 7 is a schematic cross-sectional view of the outflow pipe along line XIII-XIII. [Figure 9] This is a schematic perspective view of the outflow pipe according to the fourth embodiment. [Figure 10] This is a schematic side view of the outflow pipe according to the fifth embodiment. [Figure 11] This is a schematic perspective view of the proximal end portion of the outflow pipe according to the sixth embodiment. [Modes for carrying out the invention]

[0037] Figure 1 shows the use of a blood pump 100 that assists the patient's heart H. In this example, the blood pump 100 is an intravascular blood pump 100. In this specific example, the intravascular blood pump 100 assists the left ventricular LV of the patient's heart H. As schematically shown, the intravascular blood pump 100 comprises a pump section 10 partially located within the left ventricular LV of the patient's heart H, and a motor 102 preferably located outside the patient's body.

[0038] The pump section 10 comprises a catheter 12, a pump housing 14, a pump element 16, an outflow tube 18, and a stabilizing device 20; these will be described in more detail later. The catheter 12 connects the motor 102 to the pump housing 14 of the pump section 10.

[0039] The intravascular blood pump 100 can be implanted in the patient's heart H using percutaneous transcatheter artery technology. For example, the intravascular blood pump 100 can be introduced via the femoral artery. However, alternative vascular access, such as via the subclavian or axillary artery, is equally viable. After passing through the femoral artery, the catheter 12 can be pushed into the aorta, allowing the pump section 10 to reach the patient's heart H via the aortic valve. The positioning of the pump section 10 in Figure 1 is purely illustrative, and other implantation methods are possible, such as placing the pump section 10 in the right ventricle of the patient's heart H.

[0040] The catheter 12 houses a flexible shaft 22 driven by a motor 102. The flexible shaft 22 drives the pump element 16 of the pump section 10. The distal end of the pump section 10 is equipped with a flexible non-invasive end 24, which has a pigtail or J-shape, which helps with navigation within the patient's vascular system, thereby facilitating the placement of the intravascular blood pump 100. Furthermore, the flexibility of the flexible non-invasive end 24 allows the pump section 10 itself to be non-invasively supported against the wall of the left ventricular LV.

[0041] As shown in Figure 2, the pump housing 14 has a blood inlet 26 and a blood outlet 28. A pump element 16 is at least partially disposed within the pump housing 14 and is configured to generate blood flow between the blood inlet 26 and the blood outlet 28. The outflow pipe 18 surrounds the blood outlet 28 of the pump housing 14 and has an outlet 60 for blood flow. The outflow pipe 18 is configured to guide the blood flow generated by the pump element 16.

[0042] The pump housing 14 is composed of a group of struts 30. The pump element 16 is provided in an impeller configuration and is accompanied by at least one blade 32. By rotating the impeller 16 around its central axis, blood is flowed from a blood inlet 26 at the distal end of the pump housing 14 to a blood outlet 28 located proximal to the blood inlet 26. The pump housing 14 has an inner covering layer 34 and an outer covering layer 36 surrounding the struts 30, the covering extending a fixed distance 38 minutes from the blood inlet 26 toward the blood outlet 28. The covering layers 34 and 36 are made of a suitable covering material, such as polyurethane.

[0043] The outflow tube 18 is connected to the outer covering layer 36 and covers and surrounds the blood flow outlet 28. The outflow tube 18 is collapsible. The outflow tube 18 is composed of a suitable biocompatible material, such as a suitable polymer, such as polyurethane, polyamide, nylon, or silicone. Preferably, the outflow tube 18 is made of polyurethane (PU) or polytetrafluoroethylene (PTFE). Of course, the outflow tube 18 may be made of another suitable material, such as polyethylene terephthalate (PET) or polyamide. As shown in Figure 1, the outflow tube 18 may have at least one outlet opening that forms the outlet 60. Here, these outlet openings are located in the aorta. The blood flow generated by the pump element 16 and exiting from the blood flow outlet 28 flows along the inside of the outflow tube 18 and is delivered to the aorta via the outlet opening of the outlet 60.

[0044] The impeller 16 is located a predetermined distance 42 minutes away from the blood inlet 26. Typically, the impeller 16 is positioned such that its leading edge 44 is surrounded by covering layers 34 and 36. The trailing edge 46 of the impeller 16 may also be surrounded by the covering, or it may extend beyond the trailing end of the covering. However, if the impeller 16 extends beyond the trailing end of the covering, at least a portion 48 of the total length 50 of the impeller 16 is surrounded by the covering layers 34 and 36.

[0045] As shown in Figure 2, the pump section 10 further includes a mesh 52. The mesh 52 defines a smaller opening than the opening defined by the struts 30 that form the pump housing 14. The mesh 52 is directly bonded to the struts 30 that form the pump housing 14, or to the outer coating layer 36. In certain embodiments, the mesh 52 will be directly bonded to one or more struts 54 that are upstream of the struts 30 that form the pump housing 14 (relative to the direction of blood flow generated by the pump element 16). In certain embodiments, the mesh 52 will not be directly bonded to any of the struts 30, 54. The mesh 52 is located upstream of the impeller 16. In certain embodiments, the mesh 52 will be located within the internal volume space defined by the struts 30, 54. In certain embodiments, the mesh 52 will be located outside of the struts 30, 54. The struts 30, 54 are made of a suitable material, for example, Nitinol®. The mesh is made of a suitable material, such as polyurethane.

[0046] In this embodiment, the impeller 16, pump housing 14, and outflow tube 18 are all compressible and expandable. When implanting the blood pump 100 in the patient's body, the rotor 16, pump housing 14, and outflow tube 18 are compressed while the pump section 10 is advanced through the patient's vascular system. Once the pump section 10 reaches its target location, the pump housing 14 and rotor 16 are extended. As a result, blood flow is generated by the pump element 16, causing the outflow tube 18 to expand.

[0047] Next, the stabilization device 20 will be described with reference to Figures 3 to 10.

[0048] The stabilization device 20 is located downstream of the blood flow outlet 28 of the pump housing 14. The stabilization device 20 is configured to stabilize the pump section by influencing at least one flow parameter of the blood flow generated by the pump element 16.

[0049] Specifically, the downstream of the blood flow outlet 28 should be understood as being downstream with respect to the direction of blood flow generated by the pump element 16. The at least one flow parameter mentioned above can be any blood flow-related parameter, such as pressure, volumetric flow rate, or blood flow direction. The stabilization device 20 operates downstream of the blood flow outlet 28 in a manner that affects the at least one flow parameter, thereby reducing fluttering of the outflow pipe 18 and improving the positional stability of the pump section 10.

[0050] Here, at least one of the flow parameters mentioned above includes the differential pressure between the inside of the outflow pipe 18 and the outside of the outflow pipe 18. The stabilization device 20 is configured such that its differential pressure is at least the minimum differential pressure. The minimum differential pressure is preferably 5 mmHg. In the embodiments described later, the stabilization device 20 is equipped with a throttle 62 for the blood flow generated by the pump element 16.

[0051] This differential pressure is calculated by subtracting the external pressure of the outflow tube 18 from the internal pressure of the outflow tube 18. Accordingly, the internal pressure of the outflow tube 18 is at least 5 mmHg higher than the external pressure acting on the outflow tube 18 during systole. In this connection, the stabilizing device 20 comprises a throttle 62, by which the minimum differential pressure is generated.

[0052] The throttle 62 may be formed by the outlet 60 of the outflow tube 18 as shown in FIGS. 3 to 5 and 7 to 11, and / or may be formed by attaching a throttle ring 64 to the outflow tube 18 to form the throttle 62 within the outflow tube 18 as shown in FIG. 6. By influencing the differential pressure between the inside of the outflow tube 18 and the outside of the outflow tube 18 to at least achieve the minimum differential pressure, the fluttering effect at the outlet 60 of the outflow tube 18 is reliably reduced over the entire cardiac cycle.

[0053] As can be seen in FIG. 6, the throttle ring 64 is disposed around the outer surface 66 of the outflow tube 18. The diameter D of the throttle ring 64 T is smaller than the diameter D of the outflow tube 18 at the position where the throttle ring 64 is disposed O . Accordingly, the throttle ring 64 locally constricts the outflow tube 18, forming the throttle 62 for blood flow generated by the pump element 16 and flowing through the outflow tube 18.

[0054] As can be seen in FIG. 2, the outflow tube 18 has a distal end portion 68 connected to the pump housing 14 and a proximal end portion 70. The outflow tube 18 has an elongated configuration extending from the distal end portion 68 to the proximal end portion 70 along the longitudinal extension direction D1 of the outflow tube 18.

[0055] As can be seen in FIG. 2, the connection angle C that the outflow tube 18 forms with respect to the pump housing at the distal end portion 68 is 0.5 to 4°, preferably 1 to 2°, more preferably about 1.5°.

[0056] Here, at least one of the flow parameters mentioned above includes the resulting blood flow direction D2 at the outlet 60 of the outflow tube 18, for example, as seen in Figure 5. The stabilization device 20 is configured such that the axial component D2a of the resulting blood flow direction D2 is aligned with the longitudinal extension direction D1 of the outflow tube 18, preferably the longitudinal extension direction D1 of the proximal end portion 70 of the outflow tube 18, and away from the distal end portion 68. More preferably, the resulting blood flow direction D2 is substantially parallel to the longitudinal extension direction D1 of the outflow tube 18, preferably the longitudinal extension direction D1 of the proximal end portion 70 of the outflow tube 18.

[0057] As can be seen in Figures 3 to 5 and Figures 7 to 10, the stabilization device 20 is equipped with an outlet 60 of the outflow tube 18. The outlet 60 of the outflow tube 18 is configured such that the aforementioned differential pressure is at least its minimum differential pressure, and that the resulting axial component D2a of the blood flow direction D2 is oriented away from the distal end portion 68 of the outflow tube 18 along the longitudinal extension direction D1 of the outflow tube 18, and in particular, that the resulting blood flow direction D2 is substantially parallel to the longitudinal extension direction D1 of the outflow tube 18.

[0058] In other words, the blood flow vector at outlet 60 has an axial component D2a parallel to the longitudinal extension direction D1 of the outflow pipe 18 and a radial component D2r perpendicular to the longitudinal extension direction D1 of the outflow pipe 18. The vector sum of these two perpendicular components D2a and D2r results in the blood flow direction D2. The fact that the resulting blood flow direction D2 is substantially parallel to the longitudinal extension direction D1 means that the axial component D2a of the blood flow vector is greater than the radial component D2r of the blood flow vector.

[0059] If the resulting axial component D2a of the blood flow direction D2 is oriented along the longitudinal extension direction D1 of the outflow pipe 18 and away from the distal end portion 68, a thrust is generated in the opposite direction to the blood flow at the outlet 60, extending to the pump section 10. This thrust can also be called the "axial thrust" extending to the pump section 10. The generation of this axial thrust reduces fluttering of the outflow pipe 18 and improves the positional stability of the pump section 10.

[0060] As can be seen in Figures 3-5 and 7-10, the outlet 60 of the outflow tube 18 is located within or formed by the proximal end portion 70 of the outflow tube 18. Consequently, the thrust generated by the outlet 60 has an effect throughout the entire longitudinal length of the outflow tube 18, further aiding in reducing fluttering and improving positional stability. In addition, the outlet 60 is appropriately positioned so that the blood flow guided by the outflow tube 18 is discharged into the aorta behind the aortic valve.

[0061] The catheter 12 has a circumferential surface 72. The proximal end portion 70 of the outflow tube 18 may be provided with a tapered portion 74 that tapers toward the catheter 12 and an attachment portion 76 that is attached to the circumferential surface 72 of the catheter 12. These tapered portion 74 and attachment portion 76 can be seen, for example, in Figure 4.

[0062] In the embodiments shown in Figures 3 to 5, the tapered portion 74 is provided with three outlet openings 78. However, as will be immediately apparent, the number of outlet openings 78 is not limited to three. Specifically, the outlet openings 78 are holes on the outer surface 66 of the outflow tube 18. Here, the outlet 60 is formed by three outlet openings 78 evenly distributed around the circumference of the tapered portion 74. In the embodiments shown in Figures 3 to 5, the shape of the outlet openings 78 is substantially rhomboid. However, the shape of the outlet openings 78 may be any other preferred shape. The mounting portion 76 is attached to the circumferential surface 72 of the catheter 12 (not shown in Figures 3 to 5) by joining, for example, by adhesive or heat bonding. The tapered portion 74 may have a taper angle A toward the catheter 12 of at least 40°, preferably at least 70°, and more preferably at least 85°. As can be seen, for example, in Figure 4, the outlet openings 78 extend into the mounting portion 76.

[0063] By positioning the outlet opening 78 within the tapered section 74, it is easily possible to direct the blood flow substantially parallel to the longitudinal extension direction D1 of the outflow tube 18, unlike the radial direction of the outflow tube 18. The steeper the taper of the tapered section 74 toward the catheter 12, the larger the axial component D2a of the blood flow vector becomes. That is, the axial thrust generated by the outlet 60 and extending to the pump section 10 is further increased, and the positional stability of the pump section 10 is further improved.

[0064] The outflow tube 18 has an intermediate section 80 connecting the distal end portion 68 and the proximal end portion 70, with three outlet openings 78 formed only in the proximal end portion 70. That is, these outlet openings do not extend beyond the tapered portion 74 into the intermediate section 80 in the direction toward the distal end portion 68 of the outflow tube 18. This helps to reduce the radial component D2r of the resulting blood flow direction D2 at the outlet openings 78.

[0065] For example, as can be seen in Figures 3 and 4, one of the three outlet openings 78 extends into the mounting slit 82 in the mounting portion 76. The mounting slit 82 in the mounting portion 76 is used during the assembly of the pump section 10 to fold the outflow pipe 18 onto the pre-assembled pump housing 14. As can be seen in Figure 5, it is sufficient if one of the three outlet openings 78 extends into a single mounting slit 82 in the mounting portion 76. However, it is also conceivable to extend each outlet opening 78 into the mounting slit 82 in the mounting portion 76.

[0066] In another embodiment, as shown in Figure 11, the tapered portion 74 is provided with two outlet openings 78 that form an outlet 60. Here, each of the two outlet openings 78 extends into a mounting slit 82 in the mounting portion 76. As can be seen in Figure 11, the outlet openings 78 in this embodiment are substantially teardrop-shaped.

[0067] In another embodiment, as shown in Figures 7 and 8, the catheter 12 is provided with three attachment struts 84 evenly distributed around the circumferential surface 72 of the catheter 12. The proximal end portion 70 of the outflow tube 18 is provided with an attachment portion 76 to which these three attachment struts 84 are attached. Here, the attachment portion 76 is a three-part attachment portion 76, and each portion of the attachment portion 76 is attached to one of the three attachment struts 84 of the catheter 12. In this embodiment, the outlet 60 of the outflow tube 18 is formed by three outlet gaps 86 formed between the proximal end portion 70 of the outflow tube 18 and the catheter 12.

[0068] As can be seen in Figure 7, the proximal end portion 70 of this embodiment is also provided with a tapered portion 74, but it lacks an outlet opening 78. However, the tapered portion 74 may also be provided with an outlet opening 78 in addition to the outlet gap 86, as described with reference to Figures 3 to 5.

[0069] Furthermore, the proximal end portion 70 does not need to have a tapered portion 74 and may be directly attached to the mounting strut 84. In this case, since it is not necessary to appropriately match the height of the mounting strut 84 with the diameter of the proximal end portion 70, a taper is not required to attach the mounting portion 76 of the proximal end portion 70 to the mounting strut 84.

[0070] If at least one outlet gap is provided between the proximal end portion 70 of the outflow tube 18 and the catheter 12, the blood flow will be directed parallel to the longitudinal extension direction D1 of the outflow tube 18, and as can be seen in Figure 7, the blood flow vector will be substantially devoid of a radial component D2r. Consequently, the axial thrust generated by this blood flow improves the positional stability of the pump section 10 and reduces fluttering of the outflow tube 18.

[0071] In this embodiment, the mounting strut 84 is integrally formed with the catheter 12 on the circumferential surface 72 of the catheter 12. Alternatively, the catheter 12 may be provided with a mounting ring (not shown) having at least one mounting strut, and the mounting ring may be connected to the circumferential surface 72 of the catheter 12. The connection between the mounting ring and the catheter 12 may be formed by joining, for example, by adhesive or heat bonding.

[0072] In another embodiment, as can be seen in Figure 9, the proximal end portion 70 of the outflow tube 18 is provided with attachment strips 88 attached to the circumferential surface 72 of the catheter 12. Specifically, the proximal end portion 70 is provided with four attachment strips 88, two of which can be seen in Figure 9. The proximal end portion 70 of the outflow tube 18 is further provided with an outlet pocket 90 with an outlet opening 92. Specifically, four outlet pockets 90 are formed with four attachment strips attached to the circumferential surface 72 of the catheter 12. In this embodiment, the outlet 60 of the outflow tube 18 is formed by these four outlet pockets 90. As can be schematically seen in Figure 9, the outlet pockets 90 have a four-leaf clover leaf shape.

[0073] Specifically, the outflow tube 18 extends into four attachment strips 88 located at its proximal end portion 70. In this case, the proximal end portion 70 does not have a taper toward the catheter 12. By attaching the attachment strips 88 to the catheter 12, a longitudinal stenosis 94 is formed along the longitudinal extension direction D1 of the outflow tube 18, resulting in four outlet pockets 90. As we move toward the left side of Figure 9, the longitudinal stenosis 94 fades out (becomes less pronounced), becoming the full-diameter outflow tube 18, as schematically shown by dashed lines in Figure 9.

[0074] In another embodiment, as can be seen in Figure 10, the outflow pipe 18 is equipped with guide tubes 95 that are fluidly connected to the outflow pipe 18. Specifically, the outflow pipe 18 is equipped with three guide tubes 95 that are evenly distributed circumferentially around the intermediate portion 80. Two of these guide tubes 95 are schematically shown in Figure 10. The guide tubes 95 extend substantially parallel to the longitudinal extension direction D1 of the outflow pipe 18. In this embodiment, the outlet 60 of the outflow pipe 18 is formed by these guide tubes 95. The guide tubes 95 terminate within the outflow opening 96, and the outflow opening 96 is oriented such that when blood exits from the guide tubes 95, it exits substantially parallel to the longitudinal extension direction D1 of the outflow pipe 18. As can be seen in Figure 10, these guide tubes 95 are arranged radially outward from the outer surface 66 of the outflow pipe 18.

[0075] In this embodiment, the intermediate portion 80 is provided with a plurality of openings 97 that are evenly distributed circumferentially around the intermediate portion 80. A single guide tube 95 is connected to each of the openings 97 in the intermediate portion 80. The fluid connection between the outflow pipe 18 and the guide tube 95 is formed by joining one end of the guide tube 95 to the outer surface 66 of the outflow pipe 18 around the openings 97 in the intermediate portion 80, for example, by adhesive or heat bonding. Alternatively, the guide tube 95 may be integrally formed with the outflow pipe 18.

[0076] The outer surface 98 of the guide tube 95 is partially joined to the outer surface 66 of the outflow tube 18, for example, by adhesive or heat bonding. That is, the outer surface 98 of each guide tube 95 is joined to the outer surface 66 of the outflow tube 18 where the outer surface 98 and the outer surface 66 are in contact with each other. In this embodiment, as can be seen in Figure 10, the pump section 10 is further provided with a positioning ring 99 that surrounds at least one of the guide tubes 95 and the outflow tube 18. The positioning ring 99 holds the guide tube 95 in place and ensures that the outflow opening 96 of the guide tube 95 is properly oriented so that when blood flows out of the inner tube 95, it flows substantially parallel to the longitudinal extension direction D1 of the outflow tube 18. If the guide tube 95 is also joined to the outflow tube 18 and is along their contact surface, the positioning ring 99 can be omitted.

[0077] The positioning ring 99 and throttle ring 64 in Figure 10 are made of, for example, silicone and are attached to the corresponding outlet pipe 18 and guide pipe 95 with a suitable adhesive.

[0078] Alternatively, the guide tube 95 shown in Figure 10 may be formed extending from the tapered portion 74 of the proximal end portion 70.

[0079] In the embodiments shown in Figures 3 to 5 and Figures 7 to 10, the total outlet area of ​​outlet 60 is 20 mm². 2 ~70mm 2 Specifically, 30mm 2 ~50mm 2 More specifically, 33mm 2 ~35mm 2 It is said that, in the embodiment shown in Figure 6, the throttling effect provided by the throttle ring 64 affects the blood flow, and consequently reduces fluttering in the outflow pipe, so the total outlet area of ​​outlet 60 is 70 mm². 2 It can also be made to exceed. However, even in the embodiment shown in Figure 6, the total outlet area of ​​outlet 60 is 70 mm². 2 It is preferable that it be less than [a certain value].

[0080] As those familiar with the subject will see, the features described above in relation to the various embodiments can be combined, as long as they do not contradict each other.

[0081] The total outlet area is calculated by adding up the areas of all openings through which the blood flow generated by the pump element 16 exits the outflow tube 18. That is, the total outlet area may include the total area of ​​all outlet openings 78 in the outflow tube 18, and / or the total area of ​​all outlet gaps 86, and / or the total area of ​​all outlet openings 96 in the guide tube 95. The provided total outlet area is 70 mm². 2 As described above, the outlet 60 forms a throttle 62 for the blood flow generated by the pump element 16 and exiting the outflow pipe 18. That is, a desirable minimum differential pressure of at least 10 mmHg is ensured between the inside of the outflow pipe 18 and the outside of the outflow pipe 18. In addition, the outlet 60 functions as a nozzle for the blood flow exiting the outflow pipe 18, resulting in a desirable axial thrust. Consequently, fluttering of the outflow pipe 18 is reduced and the positional stability of the pump section 10 is improved.

[0082] [Examples of implementation forms] As previously stated, the technology described herein can be implemented in various ways. In that sense, the foregoing disclosure is intended to encompass, but is not limited to, the systems, methods, and combinations and subcombinations thereof described in the following exemplary embodiments. Preferred embodiments are described in the following paragraphs. A1 A pump section for a blood pump, A pump housing having a blood inlet and a blood outlet, A pump element, at least partially disposed within the pump housing, configured to generate blood flow between the blood inlet and the blood outlet, An outflow pipe surrounding the blood flow outlet of the pump housing, wherein the outflow pipe is configured to guide the blood flow generated by the pump element and has an outlet for the blood flow, A stabilization device located downstream of the blood flow outlet of the pump housing, configured to stabilize the pump section by influencing at least one flow parameter of the blood flow generated by the pump element, A pump section equipped with a pump. A2 The pump section relating to paragraph A1, A pump section in which the flow parameters include pressure, volumetric flow rate, or the direction of the blood flow generated by the pump element. A3 The pump section relating to paragraph A1 or A2, The at least one of the flow parameters includes the differential pressure between the inside of the outlet pipe and the outside of the outlet pipe, and The stabilization device is configured such that the differential pressure is at least the minimum differential pressure. Pump section. The pump section relating to paragraph A3 of A4, A pump section in which the differential pressure between the inside and outside of the outlet pipe is calculated by subtracting the external pressure of the outlet pipe from the internal pressure of the outlet pipe. A5 The pump section relating to paragraph A3 or A4, A pump section in which the differential pressure is the minimum differential pressure over the entire cardiac cycle, including diastole and systole. A6 A pump section relating to any one of paragraphs A3 to A5, A pump section having a minimum differential pressure of 5 mmHg, preferably 10 mmHg. A7 A pump section relating to any one of the preceding paragraphs, The stabilization device comprises a pump section with a throttle for the blood flow generated by the pump element. A8 The pump section relating to paragraph A7, The aforementioned throttle comprises a throttle ring, preferably made of silicone, in the pump section. A9 is the pump section relating to paragraph A8, A pump section in which the throttle ring is disposed around the outer surface of the outlet pipe. A10 A pump section relating to paragraph A8 or A9, A pump section in which the diameter of the throttle ring is smaller than the diameter of the outlet pipe at the location where the throttle ring is positioned. A11 A pump section relating to any one of paragraphs A8 to A10, A pump section in which the outflow pipe is locally constricted by the throttle ring, thereby forming a throttle for the blood flow generated by the pump element and flowing through the outflow pipe. A12 A pump section relating to any one of the preceding paragraphs, The outflow pipe has a distal end portion connected to the pump housing and a proximal end portion, and the outflow pipe has an elongated configuration that extends from the distal end portion to the proximal end portion along the longitudinal direction of the outflow pipe. The at least one of the flow parameters includes the resulting blood flow direction at the outlet of the outflow tube, and The stabilization device is configured such that the resulting axial component of the blood flow direction is directed away from the distal end portion along the longitudinal extension direction of the outflow tube, and preferably the resulting blood flow direction is substantially parallel to the longitudinal extension direction of the outflow tube. Pump section. A13 is the pump section relating to paragraph A12, A pump section wherein the axial component of the resulting blood flow direction is directed away from the distal end portion along the longitudinal extension direction of the proximal end portion of the outflow pipe, and preferably the resulting blood flow direction is substantially parallel to the longitudinal extension direction of the proximal end portion of the outflow pipe. A14 A pump section relating to any one of the preceding paragraphs, A pump section having the outlet of the outflow pipe, wherein the stabilizing device is located. A15 A pump section relating to any one of the preceding paragraphs, A pump section wherein the outlet of the outflow pipe forms a throttle for the blood flow generated by the pump element and flowing through the outflow pipe. A16 A pump section relating to any one of the preceding paragraphs, A pump section in which the outlet of the outflow pipe is formed within or by the proximal end portion of the outflow pipe. A17 A pump section relating to any one of the preceding paragraphs, A pump section further comprising a catheter connected to the pump housing, wherein the catheter has a circumferential surface. A18 A pump section relating to any one of the preceding paragraphs, The proximal end portion of the outflow tube comprises a tapered portion tapered toward the catheter and an attachment portion attached to the circumferential surface of the catheter. The tapered portion has at least one outlet opening, preferably at least one outlet hole, and The outlet of the outflow pipe is formed by the at least one outlet opening. Pump section. A19 The pump section relating to paragraph A18, A pump section having a tapered portion having a plurality of outlet openings, preferably three outlet openings, that are evenly distributed in the circumferential direction around the tapered portion. A20 The pump section relating to paragraph A18 or A19, A pump section in which the shape of at least one outlet opening is circular, oval, arc, semicircle, semicircular, oval, rhombic, triangular, or teardrop-shaped. A21 A pump section relating to any one of paragraphs A18 to A20, A pump section in which at least one of the outlet openings has a rounded corner. A22 A pump section relating to any one of paragraphs A18 to A21, The tapered portion is a pump section having a taper angle toward the catheter of at least 40°, preferably at least 70°, and more preferably at least 85°. A23 A pump section relating to any one of paragraphs A16 to A22, A pump section further comprising a catheter connected to the pump housing, wherein the catheter has a circumferential surface and the catheter comprises at least one mounting strut. A24 is the pump section relating to paragraph A23, The catheter comprises a pump section having a plurality of mounting struts, preferably three mounting struts, evenly distributed around the circumferential surface of the catheter. A25 The pump section relating to paragraph A23 or A24, The proximal end portion of the outflow pipe is provided with a mounting portion attached to at least one mounting strut, and The outlet of the outflow tube is formed from at least one outlet gap formed between the proximal end portion of the outflow tube and the catheter. Pump section. A26 is the pump section relating to paragraph A25, A pump section in which the outlet is formed by a plurality of outlet gaps, preferably three outlet gaps, formed between the proximal end portion of the outflow tube and the catheter. A27 A pump section relating to any one of paragraphs A23 to A26, A pump section wherein the at least one mounting strut is formed integrally with the catheter on the circumferential surface of the catheter. A28 A pump section relating to any one of paragraphs A23 to A26, A pump section comprising a catheter, the mounting ring having at least one mounting strut, wherein the mounting ring is connected to the circumferential surface of the catheter. A29 The pump section relating to paragraph A16, The pump housing further comprises a catheter connected thereto, wherein the catheter has a circumferential surface. The proximal end portion of the outflow tube is provided with at least one attachment strip attached to the circumferential surface of the catheter. Pump section. A30 is the pump section relating to paragraph A29, The pump section wherein the proximal end portion comprises a plurality of attachment strips, preferably four attachment strips, attached to the circumferential surface of the catheter. A31 The pump section relating to paragraph A29 or A30, A pump section wherein the proximal end portion of the outflow pipe further comprises at least one outlet pocket, preferably a plurality of outlet pockets, having an outlet opening. A32 is the pump section relating to paragraph A31, The at least one exit pocket is formed such that the at least one attachment strip is attached to the circumferential surface of the catheter, and The outlet of the outflow pipe is formed by at least one outlet pocket, preferably a plurality of outlet pockets forming a cloverleaf shape. Pump section. A33 A pump section relating to any one of paragraphs A18 to A32, A pump section in which the aforementioned mounting portion is attached to the catheter by joining, particularly by adhesive or heat bonding. A34 A pump section relating to any one of paragraphs A18 to A33, A pump section in which at least one of the outlet openings extends into a mounting slit within the mounting portion. A35 A pump section relating to any one of the preceding paragraphs, A pump section comprising the outlet pipe and at least one guide pipe that is fluidly connected to the outlet pipe. A36 is the pump section relating to paragraph A35, A pump section comprising a plurality of guide pipes, preferably three guide pipes, that are fluid-connected to the outlet pipe. A37 Pump section relating to poparagraph A35 or A36, The at least one guide pipe extends substantially parallel to the longitudinal extension direction of the outflow pipe, and The outlet of the outflow pipe is formed by the at least one guide pipe. Pump section. A38 A pump section relating to any one of paragraphs A35 to A37, The outflow pipe includes an intermediate portion connecting the distal end portion and the proximal end portion, The aforementioned intermediate portion has a plurality of openings, preferably three, that are evenly distributed in the circumferential direction around the intermediate portion, and A guide tube is connected to each of the openings in the intermediate section. Pump section. A39 A pump section relating to any one of paragraphs A35 to A38, A pump section in which the outer surface of at least one guide pipe is at least partially joined to the outer surface of the outlet pipe. A40 A pump section relating to any one of paragraphs A35 to A39, A pump section further comprising a positioning ring surrounding at least one guide tube and the outflow tube, which is preferably made of silicone. A41 is the pump section relating to paragraph A40, A pump section in which the positioning ring is at least partially joined to the outer surface of the guide tube, preferably by adhesive or heat bonding. A42 is the pump section relating to paragraph A41, A pump section in which the positioning ring is at least partially joined to the outer surface of the outlet pipe, preferably by adhesive or heat bonding. A43 A pump section relating to any one of the preceding paragraphs, The aforementioned outlet has a total outlet area of ​​20 mm². 2 ~70mm 2 Preferably 30 mm 2 ~50mm 2 , more preferably 33 mm 2 ~35mm 2 This is the pump section. A44 A pump section relating to any one of the preceding paragraphs, The pump section having a strut structure made of Nitinol (registered trademark) as the pump housing. A45 A pump section relating to any one of the preceding paragraphs, A pump section wherein the pump housing has a mesh related to the blood inlet, and the mesh is made of polyurethane. A46 The pump section relating to paragraphs A44 and A45, A pump section in which an opening smaller than the opening defined by the strut structure is defined by the mesh. A47 A pump section relating to any one of the preceding paragraphs, A pump section in which the aforementioned outflow pipe is made of polyurethane. A48 A pump section relating to any one of the preceding paragraphs, The outlet pipe is a pump section in which the connection angle with respect to the pump housing at the distal end portion is 0.5 to 4°. A49 is the pump section relating to paragraph A48, A pump section having a connection angle of 1 to 2 degrees. A50 The pump section relating to paragraph A49, A pump section with a connection angle of approximately 1.5°. B1 is a pump section for a blood pump, A pump housing having a blood inlet and a blood outlet, A pump element, at least partially disposed within the pump housing, configured to generate blood flow between the blood inlet and the blood outlet, An outflow pipe surrounding the blood flow outlet of the pump housing, wherein the outflow pipe is configured to guide the blood flow generated by the pump element and has an outlet for the blood flow, A pump section comprising, wherein the outflow pipe has a distal end portion connected to the pump housing, and the connection angle of the outflow pipe with respect to the pump housing at the distal end portion is 0.5 to 4°, preferably 1 to 2°, and more preferably about 1.5°. A blood pump relating to paragraph B1, A blood pump further comprising a stabilization device located downstream of the blood flow outlet of the pump housing, wherein the stabilization device is configured to stabilize the pump section by influencing at least one flow parameter of the blood flow generated by the pump element. A blood pump comprising a pump section relating to any one of the preceding paragraphs C1. A blood pump relating to paragraph C1 of C2, A blood pump is an intravascular blood pump. A blood pump relating to paragraph C1 or C2 of C3, A blood pump equipped with an additional motor. A blood pump relating to paragraph C4, C3, A blood pump in which the pump element of the pump section is driven by the motor. A blood pump relating to paragraph C4 of C5, A blood pump in which a flexible shaft driven by the motor is housed in the catheter of the pump section. A blood pump relating to paragraph C5 of C6, A blood pump in which the pump element is driven by the flexible shaft.

[0083] The words “approximately,” “almost,” “substantially,” and similar words used in this application are intended to have a broad meaning that is consistent with the general and acceptable usage by persons skilled in the art to which the subject matter of this disclosure pertains. The terms “proximal” and “distal” used in this application are relative to medical staff or physicians. That is, when the blood pump is introduced into the patient’s body, the proximal refers to something relatively close to the physician, and the distal refers to something relatively far from the physician. As those skilled in the art who have reviewed this disclosure should understand, these words are intended to allow for the description of specific features without restricting the range of those features to the precise numerical range presented. Therefore, these words should be understood to mean that non-substantial or minor modifications or alterations to the subject matter are considered to be described within the technical scope and framework of this disclosure. The words “at least partially” or “partially” used in this application have both meanings: partially and entirely or completely. The terms "first," "second," or "third" do not indicate a specific order, but rather serve only to semantically distinguish between the various elements. [Explanation of symbols]

[0084] 10 pump sections, 12 catheters, 14 Pump housing, 16 Pump elements / impellers, 18 outflow pipe; 20 Stabilizer, 22 Flexible shaft, 24 Flexible non-invasive end, 26 blood flow inlet; 28 blood flow outlet; 30 Pump housing struts, 32 pump element blades, 34 inner coating layer, 36 outer coating layer, 38 fixed distance, 42. A predetermined distance, 44 leading edge, 46 trailing edge; 48 Pump elements / parts of the impeller, 50 pump element / impeller length, 52 mesh, 54 strut, 60 exit, 62 throttles, 64 Throttle ring, 66 Outer surface of the outflow pipe, 68 The distal end portion of the outflow pipe, 70 Proximal end portion of the outflow pipe, 72. The circumferential surface of the catheter, 74 Tapered section of the outflow pipe, 76 Outlet pipe mounting section, 78 Outlet opening in the tapered section, 80 The middle section of the outflow pipe, 82 mounting slits, 84 Mounting strut, 86 exit gap, 88 Mounting strips, 90 Exit pockets, 92 exit opening; 94 Longitudinal narrow section, 95 guide tubes, 96 Outlet opening, 97 Opening in the middle section, 98 Outer surface of guide tube, 99 Positioning ring, 100 blood pumps, 102 motor, A taper angle, C connection angle, D T Diameter of the throttle ring, D O The diameter of the outlet pipe at the location of the throttle ring, H patient's heart, LV left ventricle.

[0085] [Implementation Method] (1) A pump section (10) for a blood pump (100), A pump housing (14) having a blood inlet (26) and a blood outlet (28), A pump element (16) is at least partially disposed within the pump housing (14) and is configured to generate blood flow between the blood inlet (26) and the blood outlet (28). The outflow pipe (18) surrounds the blood flow outlet (28) of the pump housing (14), and the outflow pipe (18) is configured to guide the blood flow generated by the pump element (16), and has a blood flow outlet (60), A stabilization device (20) located downstream of the blood flow outlet (28) of the pump housing (14), configured to stabilize the pump section (10) by influencing at least one flow parameter of the blood flow generated by the pump element (16), A pump section equipped with a pump. (2) A pump section (10) according to Embodiment 1, The at least one of the flow parameters includes the differential pressure between the inside of the outlet pipe (18) and the outside of the outlet pipe (18), and The stabilization device (20) is configured such that the differential pressure is at least the minimum differential pressure, preferably the minimum differential pressure is 5 mmHg, and the stabilization device (20) preferably includes a blood flow throttle (62) generated by the pump element (16). Pump section. (3) A pump section (10) according to Embodiment 1 or 2, The outflow pipe (18) has a distal end portion (68) connected to the pump housing (14) and a proximal end portion (70), and the outflow pipe (18) has an elongated configuration that extends from the distal end portion (68) to the proximal end portion (70) along the longitudinal extension direction (D1) of the outflow pipe (18). The at least one of the flow parameters includes the resulting blood flow direction (D2) at the outlet (60) of the outflow tube (18), and The stabilization device (20) is configured such that the axial component (D2a) of the resulting blood flow direction (D2) is aligned with the longitudinal extension direction (D1) of the outflow tube (18), preferably the longitudinal extension direction (D1) of the proximal end portion (70) of the outflow tube (18), and is directed away from the distal end portion (68). Pump section. (4) A pump section (10) according to any of Embodiments 1 to 3, A pump section having the stabilizing device (20) and the outlet (60) of the outflow pipe (18). (5) A pump section (10) according to any of Embodiments 1 to 4, A pump section in which the outlet (60) of the outflow pipe (18) is formed within or by the proximal end portion (70) of the outflow pipe (18).

[0086] (6) A pump section (10) according to Embodiment 5, The pump section (10) further comprises a catheter (12) connected to the pump housing (14), the catheter (12) having a circumferential surface (72), The proximal end portion (70) of the outflow tube (18) comprises a tapered portion (74) tapered toward the catheter (12) and an attachment portion (76) attached to the circumferential surface (72) of the catheter (12), The tapered portion (74) has at least one exit opening (78), preferably at least one exit hole, and The outlet (60) of the outflow pipe (18) is formed by at least one outlet opening (78), preferably a plurality of outlet openings (78) evenly distributed circumferentially around the tapered portion (74), wherein the shape of the at least one outlet opening (78) is preferably a circle, oval, arc, semicircle, semicircular, oval, rhombic, triangular, or teardrop, and the at least one outlet opening (78) preferably has rounded corners. Pump section. (7) A pump section (10) according to Embodiment 6, The tapered portion (74) is a pump section in which the taper angle (A) toward the catheter (12) is at least 40°, preferably at least 70°, and more preferably at least 85°. (8) A pump section (10) according to Embodiment 5, The pump section (10) further comprises a catheter (12) connected to the pump housing (14), the catheter (12) having a circumferential surface (72), and the catheter (12) having at least one mounting strut (84), preferably a plurality of mounting struts (84) evenly distributed around the circumferential surface (72) of the catheter (12), The proximal end portion (70) of the outflow pipe (18) is provided with a mounting portion (76) attached to the at least one mounting strut (84), and The outlet (60) of the outflow tube (18) is formed by at least one outlet gap (86), preferably a plurality of outlet gaps (86), formed between the proximal end portion (70) of the outflow tube (18) and the catheter (12). Pump section. (9) A pump section (10) according to Embodiment 8, The at least one mounting strut (84) is formed integrally with the catheter (12) on the circumferential surface (72) of the catheter (12), or The catheter (12) comprises a mounting ring having at least one mounting strut (84), and the mounting ring is connected to the circumferential surface (72) of the catheter (12). Pump section. (10) A pump section (10) according to Embodiment 5, The pump section (10) further comprises a catheter (12) connected to the pump housing (14), the catheter (12) having a circumferential surface (72), The proximal end portion (70) of the outflow tube (18) comprises at least one attachment strip (88), preferably multiple attachment strips (88), attached to the circumferential surface (72) of the catheter (12), and the proximal end portion (70) of the outflow tube (18) further comprises at least one outlet pocket (90), preferably multiple outlet pockets (90), having an outlet opening (78), and the at least one outlet pocket (90) is formed such that the at least one attachment strip (88) is attached to the circumferential surface (72) of the catheter (12), and The outlet (60) of the outflow pipe (18) is formed by at least one outlet pocket (90), preferably a plurality of outlet pockets (90) forming a cloverleaf shape. Pump section.

[0087] (11) A pump section (10) according to any of embodiments 1 to 4, The outflow pipe (18) comprises at least one guide pipe (95), preferably a plurality of guide pipes (95), which are fluidly connected to the outflow pipe (18), and the at least one guide pipe (95) extends substantially parallel to the longitudinal extension direction (D1) of the outflow pipe (18), and The outlet (60) of the outflow pipe (18) is formed by the at least one guide pipe (95). Pump section. (12) A pump section (10) according to Embodiment 11, The outflow pipe (18) includes an intermediate portion (80) that connects the distal end portion (68) and the proximal end portion (70), The intermediate portion (80) has a plurality of openings (97) that are evenly distributed in the circumferential direction around the intermediate portion (80), and A guide tube (95) is connected to each opening (97) in the intermediate section (80). Pump section. (13) A pump section (10) according to any of embodiments 1 to 12, The aforementioned outlet (60) has a total outlet area of ​​20 mm². 2 ~70mm 2 Preferably 30 mm 2 ~50mm 2 , more preferably 33 mm 2 ~35mm 2 This is the pump section. (14) A pump section (10) for a blood pump (100), in particular a pump section (10) according to any of embodiments 1 to 13, A pump housing (14) having a blood inlet (26) and a blood outlet (28), A pump element (16) is at least partially disposed within the pump housing (14) and is configured to generate blood flow between the blood inlet (26) and the blood outlet (28). The outflow pipe (18) surrounds the blood flow outlet (28) of the pump housing (14), and the outflow pipe (18) is configured to guide the blood flow generated by the pump element (16), and has a blood flow outlet (60), A pump section comprising, wherein the outflow pipe (18) has a distal end portion (68) connected to the pump housing (14), and the connection angle (C) that the outflow pipe (18) makes with respect to the pump housing (14) at the distal end portion (68) is 0.5 to 4°, preferably 1 to 2°, and more preferably about 1.5°. (15) A blood pump (100), particularly an intravascular blood pump (100), comprising a pump section (10) according to any of embodiments 1 to 14.

Claims

1. A pump section (10) for a blood pump (100), A pump housing (14) having a blood inlet (26) and a blood outlet (28), The pump element (16) is at least partially disposed within the pump housing (14) and is configured to generate blood flow between the blood inlet (26) and the blood outlet (28). The outflow tube (18) surrounds the blood flow outlet (28) of the pump housing (14), and the outflow tube (18) is configured to guide the blood flow generated by the pump element (16), and has a blood flow outlet (60), A stabilization device (20) located downstream of the blood flow outlet (28) of the pump housing (14), configured to stabilize the pump section (10) by influencing at least one flow parameter of the blood flow generated by the pump element (16), A pump section equipped with a pump.

2. A pump section (10) according to claim 1, The at least one of the flow parameters includes the differential pressure between the inside of the outlet pipe (18) and the outside of the outlet pipe (18), and The stabilization device (20) is configured such that the differential pressure is at least the minimum differential pressure, preferably 5 mmHg, and the stabilization device (20) preferably includes a blood flow throttle (62) generated by the pump element (16). Pump section.

3. A pump section (10) according to claim 1 or 2, The outflow pipe (18) has a distal end portion (68) connected to the pump housing (14) and a proximal end portion (70), and the outflow pipe (18) has an elongated configuration that extends from the distal end portion (68) to the proximal end portion (70) along the longitudinal extension direction (D1) of the outflow pipe (18). The at least one of the flow parameters includes the resulting blood flow direction (D2) at the outlet (60) of the outflow pipe (18), and The stabilization device (20) is configured such that the axial component (D2a) of the resulting blood flow direction (D2) is aligned with the longitudinal extension direction (D1) of the outflow tube (18), preferably the longitudinal extension direction (D1) of the proximal end portion (70) of the outflow tube (18), and is directed away from the distal end portion (68). Pump section.

4. A pump section (10) according to claim 1, A pump section having the stabilizing device (20) and the outlet (60) of the outflow pipe (18).

5. A pump section (10) according to claim 1, A pump section in which the outlet (60) of the outflow pipe (18) is formed within or by the proximal end portion (70) of the outflow pipe (18).

6. A pump section (10) according to claim 5, The pump section (10) further comprises a catheter (12) connected to the pump housing (14), the catheter (12) having a circumferential surface (72), The proximal end portion (70) of the outflow tube (18) comprises a tapered portion (74) tapered toward the catheter (12) and an attachment portion (76) attached to the circumferential surface (72) of the catheter (12), The tapered portion (74) has at least one outlet opening (78), preferably at least one outlet hole, and The outlet (60) of the outflow pipe (18) is formed by at least one outlet opening (78), preferably a plurality of outlet openings (78) evenly distributed circumferentially around the tapered portion (74), wherein the shape of the at least one outlet opening (78) is preferably a circle, oval, arc, semicircle, semicircular, oval, rhombic, triangular, or teardrop, and the at least one outlet opening (78) preferably has rounded corners. Pump section.

7. A pump section (10) according to claim 6, The tapered portion (74) is a pump section in which the taper angle (A) toward the catheter (12) is at least 40°, preferably at least 70°, and more preferably at least 85°.

8. A pump section (10) according to claim 5, The pump section (10) further comprises a catheter (12) connected to the pump housing (14), the catheter (12) having a circumferential surface (72), and the catheter (12) having at least one mounting strut (84), preferably a plurality of mounting struts (84) evenly distributed around the circumferential surface (72) of the catheter (12), The proximal end portion (70) of the outflow pipe (18) is provided with a mounting portion (76) attached to the at least one mounting strut (84), and The outlet (60) of the outflow tube (18) is formed by at least one outlet gap (86), preferably a plurality of outlet gaps (86), formed between the proximal end portion (70) of the outflow tube (18) and the catheter (12). Pump section.

9. A pump section (10) according to claim 8, The at least one mounting strut (84) is formed integrally with the catheter (12) on the circumferential surface (72) of the catheter (12), or The catheter (12) comprises a mounting ring having at least one mounting strut (84), and the mounting ring is connected to the circumferential surface (72) of the catheter (12). Pump section.

10. A pump section (10) according to claim 5, The pump section (10) further comprises a catheter (12) connected to the pump housing (14), the catheter (12) having a circumferential surface (72), The proximal end portion (70) of the outflow tube (18) is provided with at least one attachment strip (88), preferably multiple attachment strips (88), attached to the circumferential surface (72) of the catheter (12), and the proximal end portion (70) of the outflow tube (18) is further provided with at least one outlet pocket (90), preferably multiple outlet pockets (90), having an outlet opening (78), and the at least one outlet pocket (90) is formed such that the at least one attachment strip (88) is attached to the circumferential surface (72) of the catheter (12), and The outlet (60) of the outflow pipe (18) is formed by at least one outlet pocket (90), preferably a plurality of outlet pockets (90) forming a cloverleaf shape. Pump section.

11. A pump section (10) according to claim 1, The outflow pipe (18) comprises at least one guide pipe (95), preferably a plurality of guide pipes (95), which are fluidly connected to the outflow pipe (18), and the at least one guide pipe (95) extends substantially parallel to the longitudinal extension direction (D1) of the outflow pipe (18), and The outlet (60) of the outflow pipe (18) is formed by the at least one guide pipe (95). Pump section.

12. A pump section (10) according to claim 11, The outflow pipe (18) includes an intermediate portion (80) that connects the distal end portion (68) and the proximal end portion (70), The intermediate portion (80) has a plurality of openings (97) that are evenly distributed in the circumferential direction around the intermediate portion (80), and A guide tube (95) is connected to each opening (97) in the intermediate section (80). Pump section.

13. A pump section (10) according to claim 1, The aforementioned outlet (60) has a total outlet area of ​​20 mm². ２ ~70mm ２ Preferably 30 mm ２ ~50mm ２ More preferably 33 mm ２ ~35mm ２ This is the pump section.

14. A pump section (10) for a blood pump (100), in particular a pump section (10) according to claim 1, A pump housing (14) having a blood inlet (26) and a blood outlet (28), The pump element (16) is at least partially disposed within the pump housing (14) and is configured to generate blood flow between the blood inlet (26) and the blood outlet (28). The outflow tube (18) surrounds the blood flow outlet (28) of the pump housing (14), and the outflow tube (18) is configured to guide the blood flow generated by the pump element (16), and has a blood flow outlet (60), A pump section comprising, wherein the outflow pipe (18) has a distal end portion (68) connected to the pump housing (14), and the connection angle (C) that the outflow pipe (18) makes with respect to the pump housing (14) at the distal end portion (68) is 0.5 to 4°, preferably 1 to 2°, and more preferably about 1.5°.

15. A blood pump (100), particularly an intravascular blood pump (100), comprising a pump section (10) according to claim 1.

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