Pump segment for blood pump and blood pump

Abstract

A pump segment (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 stabilizing device (20). A stabilization device (20) is located downstream of the blood flow outlet (28) of the pump housing (14) and is configured to stabilize the pump segment (10) by influencing at least one flow parameter of the blood flow generated by the pump element (16). The at least one flow parameter comprises a pressure difference inside the outflow tube (18) and outside the outflow tube (18) and / or a final blood flow direction D2.

Description

Technical Field

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

[0002] Cardiac assist devices for assisting a patient's cardiac function, such as blood pumps, are known from the prior art. Such blood pumps may include an implantable pump segment, which can be inserted into the ventricle of the heart, for example, via a minimally invasive procedure. Furthermore, the blood pump may include, for example, an external (or extracorporeal) motor to drive the pump element of the pump segment, thereby generating blood flow to unload blood from the left ventricle into the aorta. The motor may be connected to the pump segment via a percutaneous flexible drive shaft, which may be rotatably mounted within a percutaneous catheter. For example, the implantable component of the device may be inserted via the femoral artery through a puncture site in the patient's groin. Of course, the implantable component of the device may also be inserted via, for example, the axillary artery.

[0003] The pump segment 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 conduit. The pump element may be configured to generate blood flow between the blood inlet and the blood outlet of the pump housing. The outflow conduit may surround the blood outlet of the pump housing to guide and direct the blood flow generated by the pump element (e.g., from the left ventricle, where the pump housing with the pump element may be positioned) through the aortic valve into the aorta. For this purpose, the outflow conduit may have an elongated configuration extending from a distal end to a proximal end along the longitudinal direction of the outflow conduit. The distal end may be connected to the pump housing. Furthermore, known outflow conduits have an outlet opening, i.e., an outlet orifice, in their sheath through which the blood flow generated by the pump element will ultimately exit the pump segment at the intended location (e.g., in the aorta after the aortic valve).

[0004] To minimize necessary invasive surgery, the pump housing, pump element, and outflow tubing of the pump segment can have a flexible construction. That is, they can be foldable and deployable. For this purpose, the outflow tubing is typically a thin polyurethane tube, which, for example, can be folded into a guide sheath that can be used to introduce the pump segment into the patient. Utilizing this flexible construction of the outflow tubing, once the guide sheath is removed and once the pump element begins to generate blood flow, the blood flow will cause the outflow tubing to “expand” to its intended and operable form.

[0005] However, it has been observed that with this pump segment configuration, outflow tube fibrillation may occur due to the different blood flow velocities on the inner and outer sides of the outflow tube within a cardiac cycle. Outflow tube fibrillation depends on various parameters, such as the pump element rotation speed, afterload, preload, cardiac cycle, aortic valve condition, and the positioning of the pump segment and / or outflow tube within the ventricle and / or blood vessel. This outflow tube fibrillation can cause irritation to surrounding tissues, resulting in undesirable mechanical stresses. For example, endocardial irritation may lead to ectopic pulsations. Furthermore, it has been found that the overall positioning stability of the pump segment within the patient's body may be reduced compared to blood pumps with rigid aspiration tubes, utilizing this flexible outflow tube configuration.

[0006] Therefore, one object of this disclosure is to provide a pump segment for a blood pump that reduces outflow tube vibration and provides improved positioning stability of the pump segment. Summary of the Invention

[0007] According to a first aspect, a pump segment for a blood pump is provided. The pump segment includes a pump housing, a pump element, an outlet tube, and a stabilizing device. The pump housing has a blood inlet and a blood outlet. The pump element is at least partially disposed within the pump housing, wherein the pump element is configured to generate blood flow between the blood inlet and the blood outlet. The outlet tube surrounds the blood outlet of the pump housing. The outlet tube is configured to guide the blood flow generated by the pump element. The outlet tube has an outlet for the blood flow. The stabilizing device is located downstream of the blood outlet of the pump housing. The stabilizing device is configured to stabilize the pump segment by influencing at least one flow parameter of the blood flow generated by the pump element.

[0008] Specifically, downstream of the blood outlet will be understood as the flow direction relative to the blood flow generated by the pump element. The at least one flow parameter can be any parameter associated with blood flow, such as pressure, volumetric flow rate, direction, etc. By influencing the at least one flow parameter downstream of the blood outlet, the stabilizing device is used to reduce outflow tube vibration and improve the positioning stability of the pump section.

[0009] Preferably, the at least one flow parameter includes the pressure difference between the inside and outside of the outflow tube. The stabilizing device can be configured such that the pressure difference is at least a minimum pressure difference, preferably 5 mmHg, more preferably 10 mmHg. Preferably, the stabilizing device includes a throttling section for the blood flow generated by the pump element. More preferably, the stabilizing device is configured such that the pressure difference is at least the minimum pressure difference during cardiac contraction.

[0010] The pressure differential is calculated by subtracting the external pressure of the outflow tube from the internal pressure. That is, the internal pressure of the outflow tube is preferably at least 5 mmHg higher than the external pressure acting on the outflow tube, more preferably at least 10 mmHg. In other words, the pressure differential is at least 5 mmHg, especially during cardiac systole. In this respect, the stabilizing device may include a throttling section to generate a minimum pressure differential. The throttling section may be formed by the outlet of the outflow tube and / or a throttling ring attached to the outflow tube, the throttling ring forming the throttling section within the outflow tube. The throttling ring may be disposed around the outer surface of the outflow tube. The diameter of the throttling ring may be smaller than the diameter of the outflow tube at the location where the throttling ring is positioned. Therefore, the throttling ring can locally constrict the outflow tube, thereby forming a throttling section for the blood flow generated by the pump element to pass through the outflow tube. By influencing the pressure differential between the inside and outside of the outflow tube to at least a minimum pressure differential, the fibrillation effect at the outlet of the outflow tube is reliably reduced.

[0011] Preferably, the outflow tube has a distal end and a proximal end connected to the pump housing. The outflow tube may have an elongated configuration extending from the distal end to the proximal end along the longitudinal extension direction of the outflow tube. The at least one flow parameter may include the final blood flow direction at the outlet of the outflow tube. The stabilizing device may be configured such that the axial portion of the final blood flow direction is guided away from the distal end along the longitudinal extension direction of the outflow tube, preferably along the longitudinal extension direction of the proximal end of the outflow tube. More preferably, the stabilizing device is configured such that the final blood flow direction is substantially parallel to the longitudinal extension direction of the proximal end of the outflow tube.

[0012] Preferably, the stabilizing device includes an outlet of the outflow tube. The outlet of the outflow tube may be configured such that the pressure differential is at least a minimum pressure differential, preferably during cardiac contraction, and such that the axial portion of the final blood flow direction is guided away from the distal end along the longitudinal extension of the outflow tube.

[0013] In other words, the blood flow vector at the outlet has an axial portion parallel to the longitudinal extension direction of the outflow tube and a radial portion perpendicular to the longitudinal extension direction of the outflow tube. The addition of the two perpendicular portions of the vector produces the final blood flow direction. The fact that the final blood flow direction is essentially parallel to the longitudinal extension direction means that the axial portion of the blood flow vector is larger than the radial portion of the blood flow vector.

[0014] Because the axial portion of the final blood flow direction is guided away from the distal end of the outflow tube along its longitudinal extension, a thrust is generated in the pump section that is opposite to the blood flow direction at the outlet. This thrust can also be referred to as the "axial thrust" in the pump section. By generating this axial thrust, the vibration of the outflow tube is reduced, and the positioning stability of the pump section is improved.

[0015] Specifically, when the pump segment is used to generate blood flow from the left ventricle to the aorta, the entire pump segment experiences a force in the direction from the left ventricle to the aorta during cardiac systole. This force on the pump segment may cause movement of the pump segment within the left ventricle, or even movement of the pump housing, where the pump element is ejected through the aortic valve during cardiac systole and retracts during cardiac diastole, potentially periodically contacting the endothelium (the so-called "jack-hammering effect"). An axial thrust generated at the outlet, opposite to the direction of blood flow, counteracts this movement of the pump segment, resulting in increased positional stability of the pump segment.

[0016] Preferably, the outlet of the outflow tube is formed in or from the proximal end of the outflow tube. Therefore, the thrust generated by the outlet acts throughout the entire longitudinal extension of the outflow tube, further aiding in reducing fibrillation and improving positional stability. Additionally, the outlet is appropriately positioned to drain the blood flow guided by the outflow tube at its intended location (e.g., in the aorta posterior to the aortic valve).

[0017] In one embodiment, the pump section may further include a conduit connected to the pump housing, wherein the conduit has a circumferential surface. The proximal end of the outlet tube may include a tapered portion that tapers towards the conduit and an attachment portion attached to the circumferential surface of the conduit. The tapered portion may include at least one outlet opening, preferably at least one outlet orifice. The outlet of the outlet tube may be formed by said at least one outlet opening, preferably by a plurality of outlet openings evenly distributed circumferentially around the tapered portion. The shape of said at least one outlet opening may be circular, elongated oval, arched, semi-circular, elongated semi-circular, elliptical, rhomboid, triangular, or teardrop-shaped. The at least one outlet opening preferably has rounded corners. The attachment portion may be attached to the circumferential surface of the conduit by bonding, for example by adhesive or by thermal bonding. The tapered portion may have a taper angle of at least 40 degrees towards the conduit, preferably at least 70 degrees, and more preferably at least 85 degrees.

[0018] For example, forming the at least one outlet opening in the conical section facilitates guiding blood flow substantially parallel to the longitudinal extension direction of the outflow tube, rather than along its radial direction. The steeper the taper of the conical section towards the catheter, the larger the axial portion of the blood flow vector becomes. Therefore, the axial thrust on the pump segment generated by the outlet is further increased, and the positional stability of the pump segment is further improved.

[0019] The at least one outlet opening may extend to or into the attachment portion. That is, the at least one outlet opening may extend to the circumferential surface of the catheter to which the attachment portion is attached. This reduces the risk of blood clots forming in the bag.

[0020] The outflow tube may include a middle section connecting the distal end and the proximal end, and the at least one outlet opening may be formed only in the proximal end. That is, the at least one outlet opening does not extend beyond the tapered section into the middle section in a direction toward the distal end of the outflow tube. This helps to reduce the radial portion of the blood flow vector at the at least one outlet opening.

[0021] Preferably, the at least one outlet opening extends into a mounting slot in the attachment. During pump section assembly, the mounting slot in the attachment is used to fold the outlet tube onto the already assembled pump housing. Extending the at least one outlet opening into the mounting slot reduces the production steps required to form the at least one outlet opening. If multiple outlet openings are provided, it may be sufficient for one of the multiple outlet openings to extend into the mounting slot in the attachment. It is also conceivable that each outlet opening extends into the mounting slot in the attachment.

[0022] Alternatively or additionally, the pump section may further include a conduit connected to the pump housing, wherein the conduit has a circumferential surface. The conduit may include at least one attachment post, preferably a plurality of attachment posts evenly distributed around the circumferential surface of the conduit. The proximal end of the outlet tube may include an attachment portion attached to said at least one attachment post. The outlet of the outlet tube may be formed by at least one outlet gap, preferably a plurality of outlet gaps, formed between the proximal end of the outlet tube and the conduit. Additionally, the proximal end may include a tapered portion, and the outlet may include at least one outlet opening in the tapered portion as described above.

[0023] By providing at least one outlet gap between the proximal end of the outflow tube and the catheter, blood flow is guided parallel to the longitudinal extension direction of the outflow tube, and the blood flow vector has essentially no radial portion. Therefore, the axial thrust generated by the blood flow improves the positional stability of the pump segment and reduces outflow tube vibration.

[0024] The at least one attachment post may be integrally formed with the catheter on its circumferential surface. Alternatively, the catheter may include an attachment ring having at least one attachment post, wherein the attachment ring is attached to the circumferential surface of the catheter. The connection between the attachment ring and the catheter may be formed by bonding, for example by adhesive or by thermal bonding. The at least one attachment post may be a foldable spring structure, preferably made of nitinol. Thus, the at least one attachment post can be foldable during insertion and removal of the pump segment from the patient, while ensuring that the at least one outlet gap remains open during use in the patient.

[0025] Alternatively or additionally, the pump segment may further include a conduit connected to the pump housing, wherein the conduit has a circumferential surface. The proximal end of the outflow tube may include at least one attachment strip, preferably multiple attachment strips, attached to the circumferential surface of the conduit. The proximal end of the outflow tube may further include at least one outflow pocket with an outlet opening, preferably multiple outflow pockets. The at least one outflow pocket may be formed such that the at least one attachment strip is attached to the circumferential surface of the conduit. The outlet of the outflow tube may be formed by the at least one outflow pocket, wherein preferably multiple outflow pockets are formed in a cloverleaf shape. With this configuration of the outlet, the blood flow vector at the outlet has essentially only an axial portion, thereby resulting in increased axial thrust of the pump segment and reduced dissonance of the outflow tube.

[0026] Specifically, the outflow tube extends into the at least one attachment strip at its proximal end. In this case, the proximal end does not taper towards the conduit. By attaching the at least one attachment strip to the conduit, the longitudinal contraction along the longitudinal extension direction of the outflow tube creates the at least one outflow pocket. Preferably, three or four attachment strips can be provided, forming three or four longitudinal contractions and three or four outflow pockets, thereby forming a cloverleaf shape or a tetraclover shape.

[0027] Alternatively or additionally, the outflow tube may include at least one guide tube, preferably multiple guide tubes, which are fluidly connected to the outflow tube. The at least one guide tube may extend substantially parallel to the longitudinal direction of the outflow tube. The outlet of the outflow tube may be formed by the at least one guide tube. Thus, the guide tube may terminate at an outflow opening oriented such that blood flow exits the guide tube substantially parallel to the longitudinal direction of the outflow tube. Specifically, at least one guide tube may be located radially outward of the outflow tube.

[0028] Specifically, the outflow tube may include a middle section connecting the distal end and the proximal end, wherein the middle section may include a plurality of openings evenly distributed circumferentially around the middle section. Each opening in the middle section may be connected to a guide tube. The fluid connection between the outflow tube and the guide tube may be formed by bonding one end of the guide tube to the outer surface of the outflow tube around the opening in the middle section, for example by adhesive or by thermal bonding.

[0029] The outer surface of the at least one guide tube may be at least partially bonded to the outer surface of the outflow tube, for example, by adhesive or by thermal bonding. Additionally or alternatively, the pump section may further include a positioning ring surrounding the at least one guide tube and the outflow tube. When the at least one guide tube is positioned outside the outflow tube, the positioning ring can be used to hold the at least one guide tube in place and ensure that the outflow opening of the guide tube is oriented such that blood flow exits the guide tube substantially parallel to the longitudinal extension direction of the outflow tube.

[0030] Preferably, the outlet has a total outlet area between 20 mm² and 70 mm², more preferably between 30 mm² and 50 mm², and even more preferably between 33 mm² and 35 mm². The total outlet area is calculated by adding the areas of all openings through which the blood flow generated by the pump element exits the outflow tube. That is, the 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. By providing a total outlet area equal to or less than 70 mm², the outlet forms a throttling section for the blood flow generated by the pump element to exit the outflow tube. Therefore, a desired minimum pressure differential, preferably at least 5 mmHg, is ensured between the inside and outside of the outflow tube. Furthermore, the outlet then functions as a nozzle for the blood flow to exit the outflow tube, thereby generating the desired axial thrust. Therefore, outflow tube vibration is reduced, and the positioning 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 outflow tube has a connection angle of 0.5 to 4 degrees, more preferably 1 to 2 degrees, and more preferably about 1.5 degrees, relative to the pump housing at its distal end. This further helps to guide blood flow away from the pump housing in a manner that is beneficial to generating axial thrust, and thus improves the positional stability of the pump segment.

[0033] According to the second aspect, a blood pump, particularly an intravascular blood pump, includes the pump segment as described above. Attached Figure Description

[0034] The foregoing overview and the following detailed description of preferred embodiments will be better understood when read in conjunction with the accompanying drawings. Reference is made to the accompanying drawings for the purposes of this disclosure. The accompanying drawings are not drawn to scale. In the drawings, the same or corresponding parts illustrated in different figures are indicated by the same reference numerals. For clarity, not every part is labeled in every figure. The scope of this disclosure is not limited to the specific embodiments disclosed in the drawings.

[0035] In the attached diagram: Figure 1 It is a schematic representation of an intravascular blood pump located in the left ventricle of the heart; Figure 2 yes Figure 1 A diagram of a portion of the pump section of a blood pump; Figure 3 This is a schematic diagram of the proximal end of the outflow tube according to the first embodiment; Figure 4 yes Figure 3 A schematic side view of the proximal end of the outflow tube shown; Figure 5 yes Figure 3 Another schematic side view of the proximal end of the outflow tube shown; Figure 6 This is a schematic partial side view of the outflow tube according to the second embodiment; Figure 7 This is a schematic partial side view of the outflow tube according to the third embodiment; Figure 8 yes Figure 7 A schematic cross-sectional view of the outflow pipe along line XIII-XIII; Figure 9 This is a schematic perspective view of the outflow tube according to the fourth embodiment; Figure 10 This is a schematic side view of the outflow tube according to the fifth embodiment; and Figure 11 This is a schematic perspective view of the proximal end of the outflow tube according to the sixth embodiment. Detailed Implementation

[0036] Figure 1 The use of a blood pump 100 for supporting a patient's heart H is illustrated. The blood pump 100 in this example is an intravascular blood pump 100. In this particular example, the intravascular blood pump 100 supports the left ventricle LV of the patient's heart H. As schematically shown, the intravascular blood pump 100 includes a pump segment 10 partially disposed within the left ventricle LV of the patient's heart H and a motor 102 preferably disposed outside the patient's body.

[0037] Pump section 10 includes conduit 12, pump housing 14, pump element 16, outlet pipe 18, and stabilizing device 20, which will be explained in more detail below. Conduit 12 connects motor 102 to pump housing 14 of pump section 10.

[0038] The intravascular blood pump 100 can be placed within the patient's heart H using percutaneous or transluminal techniques. For example, the intravascular blood pump 100 can be introduced via the femoral artery. However, alternative vascular accesses are also possible, such as those via the subclavian or axillary arteries. After passing through the femoral artery, the catheter 12 can be pushed into the aorta, allowing the pump segment 10 to pass through the aortic valve and reach the patient's heart H. Figure 1 The positioning of pump segment 10 is used purely as an example, and different placements are possible, such as positioning pump segment 10 inside the right ventricle of the patient's heart H.

[0039] 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 segment 10. At the distal end of the pump segment 10, the pump segment 10 includes a flexible, damage-resistant tip 24 in a pigtail or J-shape, which facilitates placement of the intravascular blood pump 100 by aiding navigation within the patient's vascular system. Furthermore, the flexibility of the damage-resistant tip 24 allows the pump segment 10 to self-damage-resistantly support itself against the wall of the left ventricle (LV).

[0040] like Figure 2 As shown, 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, wherein the pump element 16 is configured to generate blood flow between the blood inlet 26 and the blood outlet 28. An outlet conduit 18 surrounds the blood outlet 28 of the pump housing 14 and has an outlet 60 for blood flow. The outlet conduit 18 is configured to guide the blood flow generated by the pump element 16.

[0041] The pump housing 14 comprises a series of supports 30. The pump element 16 is provided in the form of an impeller having at least one blade 32. Rotation of the impeller 16 about a central axis causes blood to flow from a blood inlet 26 located 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 includes an inner coating layer 34 and an outer coating layer 36 surrounding the supports 30, the coatings extending a fixed distance 38 from the blood inlet 26 toward the blood outlet 28. The coatings 34, 36 are made of a suitable coating material, such as polyurethane.

[0042] The outflow tube 18 is connected to the outer coating layer 36 and covers and surrounds the blood outlet 28. The outflow tube 18 is foldable. The outflow tube 18 is made 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 can also be made of another suitable material, such as polyethylene terephthalate (PET) or polyamide. Figure 1 As shown, the outflow tube 18 may include at least one outlet opening forming an outlet 60. Here, the outlet opening is located in the aorta. The blood flow generated by the pump element 16 and exiting 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.

[0043] Impeller 16 is offset from blood inlet 26 by a predetermined distance 42. Impeller 16 is typically positioned such that its leading edge 44 is surrounded by coatings 34, 36. The trailing edge 46 of impeller 16 may also be surrounded by coatings, or may extend beyond the tail end of the coating. However, if impeller 16 extends beyond the coating, at least a portion 48 of the entire length 50 of impeller 16 is surrounded by coatings 34, 36.

[0044] like Figure 2 As described, pump section 10 also includes a mesh 52. The opening of mesh 52 is smaller than the opening defined by the struts 30 forming pump housing 14. Mesh 52 is directly coupled to the struts 30 forming pump housing 14 or the outer coating 36. In some embodiments, mesh 52 may be directly coupled to one or more struts 54 upstream of the struts 30 forming pump housing 14 (relative to the direction of blood flow generated by pump element 16). In some embodiments, mesh 52 may not be directly coupled to any struts 30, 54. Mesh 52 is positioned upstream of impeller 16. In some embodiments, mesh 52 may be positioned within the internal space volume defined by struts 30, 54. In some embodiments, mesh 52 may be positioned outside the struts 30, 54. The struts 30, 54 are formed of a suitable material, such as nitinol. The mesh is formed of a suitable material, such as polyurethane.

[0045] In this embodiment, both the impeller 16, pump housing 14, and outflow tube 18 are compressible and expandable. To place the blood pump 100 into a patient's body, the pump section 10 is propelled through the patient's vascular system while the rotor 16, pump housing 14, and outflow tube 18 are in their compressed state. Once the pump section 10 is in its target position, the pump housing 14 and rotor 16 expand. The blood flow generated by the pump element 16 then causes the outflow tube 18 to expand.

[0046] Now refer to Figures 3 to 10 Explain the stabilizing device 20.

[0047] Stabilizer 20 is located downstream of blood outlet 28 of pump housing 14. Stabilizer 20 is configured to stabilize the pump section by influencing at least one flow parameter of the blood flow generated by pump element 16.

[0048] Specifically, downstream of blood outlet 28 will be understood as the direction of flow relative to the blood flow generated by pump element 16. The at least one flow parameter can be any parameter associated with blood flow, such as pressure, volumetric flow rate, or blood flow direction. By influencing the at least one flow parameter downstream of blood outlet 28, stabilizing device 20 is used to reduce vibration of outflow tube 18 and improve the positioning stability of pump section 10.

[0049] Here, the at least one flow parameter includes the pressure difference between the inside and outside of the outflow tube 18. The stabilizing device 20 is configured such that the pressure difference is at least a minimum pressure difference. The minimum pressure difference is preferably 5 mmHg. In the embodiment described below, the stabilizing device 20 includes a throttling section 62 for the blood flow generated by the pump element 16.

[0050] The pressure difference is calculated by subtracting the external pressure of the outflow tube 18 from the internal pressure of the outflow tube 18. That is, during cardiac contraction, the internal pressure of the outflow tube 18 is at least 5 mmHg higher than the external pressure acting on the outflow tube 18. In this respect, the stabilizing device 20 includes a throttling section 62 to generate a minimum pressure difference.

[0051] The throttling section 62 can be formed from the outlet 60 of the outlet pipe 18, see Figures 3 to 5 And 7 to 11, and / or formed by a throttling ring 64 attached to the outlet pipe 18, the throttling ring 64 forming a throttling section 62 within the outlet pipe 18, see Figure 6 By controlling the pressure difference between the inside and outside of the outflow tube 18 to at least a minimum pressure difference, the fibrillation effect at the outlet 60 of the outflow tube 18 is reliably reduced throughout the cardiac cycle.

[0052] As in Figure 6 As can be seen, the throttling ring 64 is arranged around the outer surface 66 of the outlet pipe 18. The diameter D of the throttling ring 64 is... T The diameter D of the outlet pipe 18 at the position where the throttling ring 64 is located is smaller than the diameter D of the outlet pipe 18. O Therefore, the throttling ring 64 partially constricts the outflow tube 18, thereby forming a throttling section 62 for the blood flow generated by the pump element 16 to pass through the outflow tube 18.

[0053] The outlet pipe 18 has a distal end 68 connected to the pump housing 14 (see...) Figure 2 The outflow tube 18 has an elongated structure extending from the distal end 68 to the proximal end 70 along the longitudinal extension direction D1 of the outflow tube 18.

[0054] As in Figure 2 As can be seen, the outlet pipe 18 has a connection angle C relative to the pump housing at its distal end 68, which is between 0.5 and 4 degrees, preferably between 1 and 2 degrees, and more preferably about 1.5 degrees.

[0055] Here, one of the flow parameters also includes the final blood flow direction D2 at the outlet 60 of the outflow tube 18, for example, see Figure 5 The stabilizing device 20 can be configured such that the axial portion D2a of the final flow direction D2 is guided away from the distal end 68 along the longitudinal extension direction D1 of the outflow tube 18, preferably along the longitudinal extension direction D1 of the proximal end 70 of the outflow tube 18. More preferably, the final blood flow direction D2 is substantially parallel to the longitudinal extension direction D1 of the outflow tube 18, preferably parallel to the longitudinal extension direction D1 of the proximal end 70 of the outflow tube 18.

[0056] As in Figures 3 to 5As can be seen in 7 to 10, the stabilizing device 20 includes an outlet 60 of the outflow tube 18. The outlet 60 of the outflow tube 18 is configured such that the pressure differential is at least a minimum pressure differential, and such that the axial portion D2a of the final blood flow direction D2 is guided away from the distal end 68 of the outflow tube 18 along the longitudinal extension direction D1 of the outflow tube 18, and in particular, the final blood flow direction D2 is substantially parallel to the longitudinal extension direction D1 of the outflow tube 18.

[0057] That is, the blood flow vector at outlet 60 has an axial portion D2a parallel to the longitudinal extension direction D1 of the outflow tube 18 and a radial portion D2r perpendicular to the longitudinal extension direction D1 of the outflow tube 18. The two perpendicular portions of the vector D2a and D2r are added to produce the final blood flow direction D2. The final blood flow direction D2 is substantially parallel to the longitudinal extension direction D1, which means that the axial portion D2a of the blood flow vector is greater than the radial portion D2r of the blood flow vector.

[0058] Because the axial portion D2a of the final blood flow direction D2 is guided away from the distal end 68 along the longitudinal extension direction D1 of the outflow tube 18, a thrust is generated on the pump section 10 opposite to the blood flow direction at the outlet 60. This thrust can also be referred to as the "axial thrust" on the pump section 10. By generating this axial thrust, the vibration of the outflow tube 18 is reduced, and the positioning stability of the pump section 10 is improved.

[0059] As in Figures 3 to 5 As can be seen in sections 7 to 10, the outlet 60 of the outflow tube 18 is formed in or by the proximal end 70 of the outflow tube 18. Therefore, the thrust generated by the outlet 60 acts throughout the entire longitudinal extension of the outflow tube 18, thereby further assisting in reducing fibrillation and improving positional stability. Additionally, the outlet 60 is appropriately positioned to drain the blood flow guided by the outflow tube 18 into the aorta downstream of the aortic valve.

[0060] The conduit 12 has a circumferential surface 72. The proximal end 70 of the outflow tube 18 may include a tapered portion 74 that tapers toward the conduit 12 and an attachment portion 76 that attaches to the circumferential surface 72 of the conduit 12. For example, in Figure 4 The tapered portion 74 and the attachment portion 76 can be seen in the image.

[0061] exist Figures 3 to 5 In this embodiment, the tapered portion 74 includes three outlet openings 78. However, it will be readily understood that the number of outlet openings 78 is not limited to three. Specifically, the outlet openings 78 are holes in the outer surface 66 of the outflow pipe 18. Here, the outlet 60 is formed by three outlet openings 78 evenly distributed around the circumference of the tapered portion 74. Figures 3 to 5In this embodiment, the outlet opening 78 is substantially rhomboid in shape. However, the shape of the outlet opening 78 can be any other suitable shape. The attachment portion 76 is attached to the circumferential surface 72 of the conduit 12 by means of engagement. Figures 3 to 5 (Not shown in the image), for example, by adhesive or by thermal bonding. The tapered portion 74 may have a taper angle A of at least 40 degrees toward the conduit 12, preferably at least 70 degrees, and more preferably at least 85 degrees. As shown in Figure 4 As can be seen, for example, the outlet opening 78 extends into the attachment portion 76.

[0062] For example, forming an outlet opening 78 in the tapered portion 74 facilitates guiding blood flow substantially parallel to the longitudinal extension direction D1 of the outflow tube 18, rather than along the radial direction of the outflow tube 18. The steeper the taper of the tapered portion 74 toward the catheter 12, the larger the axial portion D2a of the blood flow vector becomes. Therefore, the axial thrust generated by the outlet 60 on the pump section 10 is further increased, and the positional stability of the pump section 10 is further improved.

[0063] The outflow tube 18 includes a middle portion 80 connecting the distal end 68 and the proximal end 70, and three outlet openings 78 are formed only in the proximal end 70. That is, the outlet openings do not extend across the tapered portion 74 into the middle portion 80 in a direction toward the distal end 68 of the outflow tube 18. This helps to reduce the radial portion D2r of the final blood flow direction D2 at the outlet opening 78.

[0064] As in Figure 3 and 4 As can be seen, for example, one of the three outlet openings 78 extends into the mounting slit 82 in the attachment 76. During the assembly of the pump section 10, the mounting slit 82 in the attachment 76 is used to fold the outlet pipe 18 onto the already assembled pump housing 14. Figure 5 As can be seen, it would be sufficient for one of the three outlet holes 78 to extend into a single mounting slit 82 in the attachment 76. However, it is also conceivable that each outlet opening 78 extends into the mounting slit 82 in the attachment 76.

[0065] In another embodiment, such as Figure 11 As shown, the tapered portion 74 includes two outlet openings 78 forming an outlet 60. Here, each of the two outlet openings 74 extends into a mounting slot 82 in the attachment portion 76. (As in...) Figure 11 As can be seen, the outlet opening 78 in this embodiment is basically teardrop-shaped.

[0066] In another embodiment, such as Figure 7 and Figure 8As shown, the conduit 12 includes three attachment struts 84 evenly distributed around a circumferential surface 72 of the conduit 12. The proximal end 70 of the outflow tube 18 includes attachment portions 76 attached to the three attachment struts 84. Here, the attachment portions 76 are three-part attachment portions 76, wherein each portion of the attachment portion 76 is attached to one of the three attachment struts 84 of the conduit 12. In this embodiment, the outlet 60 of the outflow tube 18 is formed by three outlet gaps 86 formed between the proximal end 70 of the outflow tube 18 and the conduit 12.

[0067] As in Figure 7 As can be seen, the proximal end portion 70 of this embodiment also includes a tapered portion 74 without an outlet opening 78. However, in addition to the outlet gap 86, the tapered portion 74 may also include, as shown in reference... Figures 3 to 5 The aforementioned outlet opening 78.

[0068] Furthermore, the proximal end 70 does not need to have a tapered portion 74 and can be directly attached to the attachment post 84. In this case, the height of the attachment post 84 and the diameter of the proximal end 70 need to be matched accordingly so that no taper is needed to attach the attachment portion 76 of the proximal end 70 to the attachment post 84.

[0069] By providing at least one outlet gap between the proximal end 70 of the outflow tube 18 and the catheter 12, blood flow is guided parallel to the longitudinal extension direction D1 of the outflow tube 18, and the blood flow vector has essentially no radial portion D2r, as... Figure 7 This can be seen in the image. Therefore, the axial thrust generated by the blood flow improves the positional stability of the pump section 10 and reduces the vibration of the outflow tube 18.

[0070] In this embodiment, the attachment post 84 is integrally formed with the conduit 12 on the circumferential surface 72 of the conduit 12. Alternatively, the conduit 12 may include an attachment ring (not shown) having at least one attachment post, wherein the attachment ring is attached to the circumferential surface 72 of the conduit 12. The connection between the attachment ring and the conduit 12 may be formed by bonding, for example by adhesive or by thermal bonding.

[0071] In another embodiment, as in Figure 9 As can be seen, the proximal end 70 of the outflow tube 18 includes attachment strips 88 that attach to the circumferential surface 72 of the conduit 12. Specifically, the proximal end 70 includes four attachment strips 88, two of which can be... Figure 9 As seen in the image, the proximal end 70 of the outflow tube 18 also includes an outflow pocket 90 having an outlet opening 92. Specifically, four outflow pockets 90 are formed such that four attachment strips are attached to the circumferential surface 72 of the conduit 12. In this embodiment, the outlet 60 of the outflow tube 18 is formed by four outflow pockets 90. Figure 9As can be seen schematically, the pocket 90 forms a four-leaf clover shape.

[0072] Specifically, the outflow tube 18 extends into four attachment strips 88 at its proximal end 70. In this case, the proximal end 70 does not taper towards the conduit 12. By attaching the attachment strips 88 to the conduit 12, a longitudinal constriction 94 is formed along the longitudinal extension direction D1 of the outflow tube 18, thereby creating four outflow pockets 90. Figure 9 On the left side, the longitudinal contraction section 94 gradually merges into the full diameter of the outflow pipe 18, which is in Figure 9 The middle part is schematically shown by a dashed line.

[0073] In another embodiment, as in Figure 10 As can be seen, the outflow pipe 18 includes guide tubes 95 that are in fluid connection with the outflow pipe 18. Specifically, the outflow pipe 18 has three guide tubes 95 that are evenly distributed in a circumferential direction around the central portion 80. Figure 10 Two guide tubes 95 are schematically shown. The guide tubes 95 extend substantially parallel to the longitudinal extension direction D1 of the outflow tube 18. In this embodiment, the outlet 60 of the outflow tube 18 is formed by the guide tubes 95. The guide tubes 95 terminate at an outflow opening 96, which is oriented such that blood flow exits the guide tubes 95 substantially parallel to the longitudinal extension direction D1 of the outflow tube 18. (As shown in...) Figure 10 As can be seen, the guide tube 95 is located radially outside the outer surface 66 of the outflow tube 18.

[0074] In this embodiment, the intermediate portion 80 includes a plurality of openings 97 evenly distributed circumferentially around the intermediate portion 80. Each opening 97 in the intermediate portion 80 is connected to a guide tube 95. The fluid connection between the outflow tube 18 and the guide tube 95 is formed by bonding one end of the guide tube 95 around the opening 97 in the intermediate portion 80 to the outer surface 66 of the outflow tube 18, for example by adhesive or thermal bonding. Alternatively, the guide tube 95 may be integrally formed with the outflow tube 18.

[0075] The outer surface 98 of the guide tube 95 is partially bonded to the outer surface 66 of the outlet tube 18, for example, by adhesive or by thermal bonding. That is, the outer surface 98 of each guide tube 95 is bonded to the outer surface 66 of the outlet tube 18, wherein the outer surfaces 98 and 66 are in contact with each other. In this embodiment, as in... Figure 10As can be seen, the pump section 10 also includes a positioning ring 99 surrounding the at least one guide tube 95 and the outflow tube 18. The positioning ring 99 serves to hold the guide tube 95 in place and ensure that the outflow opening 96 of the guide tube 95 is oriented such that blood flow exits the guide tube 95 substantially parallel to the longitudinal extension direction D1 of the outflow tube 18. The positioning ring 99 may be omitted when the guide tubes 95 are also coupled to the outflow tube 18 along their contact surfaces.

[0076] Figure 10 The positioning ring 99 and the throttling ring 64 are made of, for example, silicone resin and are attached to the outflow tube 18 and the guide tube 95 respectively by a suitable adhesive.

[0077] Alternatively, Figure 10 The guide tube 95 shown can also be formed to extend from the tapered portion 74 of the proximal end 70.

[0078] exist Figures 3 to 5 and Figures 7 to 10 In one embodiment, outlet 60 has a total outlet area between 20 mm² and 70 mm², specifically between 30 mm² and 50 mm², and more specifically between 33 mm² and 35 mm². Figure 6 In one embodiment, outlet 60 can also have a total outlet area greater than 70 mm² because the throttling ring 64 provides a throttling effect on blood flow, thereby reducing dissipation in the outflow tube. However, more preferably, also in Figure 6 In one embodiment, outlet 60 has a total outlet area of ​​less than 70 mm².

[0079] It will be apparent to those skilled in the art that the features described with respect to the different embodiments above can be combined, as long as they do not contradict each other.

[0080] The total outlet area is calculated by adding the areas of all the 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 outflow openings 96 in the guide tube 95. By providing a total outlet area equal to or less than 70 mm², the outlet 60 forms a throttling section 62 for the blood flow generated by the pump element 16 to exit the outflow tube 18. This ensures a desired minimum pressure differential of at least 10 mmHg between the interior and exterior of the outflow tube 18. Furthermore, the outlet 60 then functions as a nozzle for the blood flow to exit the outflow tube 18, resulting in a desired axial thrust. This reduces the vibration of the outflow tube 18 and improves the positioning stability of the pump section 10.

[0081] Exemplary Implementation As already described, the techniques described herein can be implemented in various ways. In this regard, the foregoing disclosure is intended to include, but is not limited to, the systems, methods, and combinations and sub-combinations thereof set forth in the following exemplary embodiments. Preferred embodiments are described in the following paragraphs: A1 is the pump segment for the blood pump, which includes: A pump housing with a blood inlet and a blood outlet; A pump element is at least partially disposed in the pump housing, wherein the pump element is configured to generate blood flow between a blood inlet and a blood outlet; An outflow tube surrounding the pump housing and the blood flow outlet, wherein the outflow tube is configured to guide the blood flow generated by the pump elements, and wherein the outflow tube has an outlet for the blood flow; and A stabilizing device located downstream of the blood flow outlet of the pump housing, wherein the stabilizing device is configured to stabilize the pump segment by influencing at least one flow parameter of the blood flow generated by the pump element.

[0082] A2 According to the pump section described in paragraph A1, where Flow parameters include the pressure, volumetric flow rate, or direction of the blood flow generated by the pump elements.

[0083] A3 The pump section described in paragraph A1 or A2, wherein The at least one flow parameter includes the pressure difference between the inside and outside of the outlet pipe, and The stabilizing device is configured such that the pressure difference is at least the minimum pressure difference.

[0084] A4 According to the pump section described in paragraph A3, where The pressure difference 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.

[0085] A5 The pump section described in paragraphs A3 or A4, wherein The pressure gradient is the minimum pressure difference throughout the entire cardiac cycle, including diastole and systole.

[0086] A6 The pump section described in any of paragraphs A3 to A5, wherein The minimum pressure difference is 5 mmHg, preferably 10 mmHg.

[0087] A7 Based on the pump section described in any of the preceding paragraphs, wherein The stabilizing device includes a throttling section for the blood flow generated by the pump element.

[0088] A8 According to the pump section described in paragraph A7, where The throttling section includes a throttling ring, which is preferably made of silicone resin.

[0089] A9 According to the pump section described in paragraph A8, where The throttling ring is set around the outer surface of the outlet pipe.

[0090] A10 The pump section described in paragraphs A8 or A9, wherein The diameter of the throttling ring is smaller than the diameter of the outlet pipe at the location where the throttling ring is positioned.

[0091] A11 The pump section described in any of paragraphs A8 to A10, wherein The throttling ring partially constricts the outflow tube, thereby forming a throttling section for the blood flow generated by the pump element to pass through the outflow tube.

[0092] A12 Based on the pump section described in any of the preceding paragraphs, wherein The outlet tube has a distal end and a proximal end connected to the pump housing, wherein the outlet tube has an elongated structure extending from the distal end to the proximal end along the longitudinal direction of the outlet tube. The at least one flow parameter includes the final blood flow direction at the outlet of the outflow tube, and The stabilizing device is configured such that the axial portion of the final blood flow direction is guided away from the distal end along the longitudinal extension of the outflow tube, preferably, the final blood flow direction is substantially parallel to the longitudinal extension of the outflow tube.

[0093] A13 According to the pump section described in paragraph A12, wherein The final axial end of the blood flow direction is guided away from the distal end along the longitudinal extension direction of the proximal end of the outflow tube. Preferably, the final blood flow direction is substantially parallel to the longitudinal extension direction of the proximal end of the outflow tube.

[0094] A14 According to the pump section described in any of the preceding paragraphs, wherein The stabilizing device includes the outlet of the outflow pipe.

[0095] A15 Based on the pump section described in any of the preceding paragraphs, wherein The outlet of the outflow tube forms a throttling section for the blood flow generated by the pump element to pass through the outflow tube.

[0096] A16 According to the pump section described in any of the preceding paragraphs, wherein The outlet of the outflow tube is formed in or from the proximal end of the outflow tube.

[0097] A17 According to the pump section described in any of the preceding paragraphs, wherein The pump section also includes a conduit connected to the pump housing, wherein the conduit has a circumferential surface.

[0098] A18 According to the pump section described in any of the preceding paragraphs, wherein The proximal end of the outflow tube includes a tapered portion that tapers towards the catheter and an attachment portion that attaches to the circumferential surface of the catheter. The tapered portion includes at least one outlet opening, preferably at least one outlet orifice, and The outlet of the outflow pipe is formed by the at least one outlet opening.

[0099] A19 According to the pump section described in paragraph A18, wherein The conical portion includes multiple outlet openings, preferably three outlet openings, which are evenly distributed around the conical portion in a circumferential direction.

[0100] A20 The pump section described in paragraphs A18 or A19, wherein The shape of the at least one outlet opening is circular, elongated oval, arched, semi-circular, elongated semi-circular, elliptical, rhomboid, triangular, or teardrop-shaped.

[0101] A21 The pump section described in any of paragraphs A18 to A20, wherein The at least one outlet opening has rounded corners.

[0102] A22 The pump section described in any of paragraphs A18 to A21, wherein The tapered portion has a taper angle of at least 40 degrees, preferably at least 70 degrees, and more preferably at least 85 degrees toward the conduit.

[0103] A23 The pump section described in any of paragraphs A16 to A22, wherein The pump section also includes a conduit connected to the pump housing, wherein the conduit has a circumferential surface and wherein the conduit includes at least one attachment post.

[0104] A24 According to the pump section described in paragraph A23, wherein The catheter includes multiple attachment struts, preferably three attachment struts, which are evenly distributed around the circumferential surface of the catheter.

[0105] A25 The pump section described in paragraphs A23 or A24, wherein The proximal end of the outflow tube includes an attachment portion attached to the at least one attachment post, and The outlet of the outflow tube is formed by at least one outlet gap formed between the proximal end of the outflow tube and the conduit.

[0106] A26 According to the pump section described in paragraph A25, wherein The outlet is formed by a plurality of outlet gaps between the proximal end of the outflow tube and the conduit, preferably three outlet gaps.

[0107] A27 The pump section described in any of paragraphs A23 to A26, wherein The at least one attachment post is integrally formed with the catheter on the circumferential surface of the catheter.

[0108] A28 The pump section described in any of paragraphs A23 to A26, wherein The catheter includes an attachment ring having at least one attachment post, wherein the attachment ring is attached to the circumferential surface of the catheter.

[0109] A29 According to the pump section described in paragraph A16, wherein The pump section also includes a conduit connected to the pump housing, wherein the conduit has a circumferential surface. The proximal end of the outflow tube includes at least one attachment strip attached to the circumferential surface of the conduit.

[0110] A30 According to the pump section described in paragraph A29, wherein The proximal end includes multiple attachment strips, preferably four attachment strips, which are attached to the circumferential surface of the catheter.

[0111] A31 The pump section as described in paragraphs A29 or A30, wherein The proximal end of the outflow tube also includes at least one outflow pocket with an outlet opening, preferably multiple outflow pockets.

[0112] A32 According to the pump section described in paragraph A31, wherein The at least one outlet pocket is formed such that the at least one attachment strip is attached to the circumferential surface of the conduit, and The outlet of the outflow tube is formed by at least one outlet pocket, wherein, preferably, multiple outlet pockets are formed in an alfalfa leaf shape.

[0113] A33 The pump section described in any of paragraphs A18 to A32, wherein The attachment is attached to the conduit by bonding, particularly by adhesive or by thermal bonding.

[0114] A34 The pump section described in any of paragraphs A18 to A33, wherein The at least one outlet opening extends into the mounting slit in the attachment.

[0115] A35 According to the pump section described in any of the preceding paragraphs, wherein The outflow tube includes at least one guide tube that is fluidly connected to the outflow tube.

[0116] A36 According to the pump section described in paragraph A35, wherein The outflow tube includes multiple guide tubes that are fluidly connected to the outflow tube, preferably three guide tubes.

[0117] A37 The pump section described in paragraphs A35 or A36, wherein The at least one guide tube extends substantially parallel to the longitudinal extension direction of the outflow tube, and The outlet of the outflow pipe is formed by the at least one guide pipe.

[0118] A38 The pump section described in any of paragraphs A35 to A37, wherein The outflow tube includes a middle section connecting the distal end and the proximal end. The middle portion includes multiple openings, preferably three, which are evenly distributed around the middle portion in a circumferential direction, and Each opening in the middle section is connected to a guide tube.

[0119] A39 The pump section described in any of paragraphs A35 to A38, wherein The outer surface of at least one guide tube is at least partially bonded to the outer surface of the outflow tube.

[0120] A40 The pump section described in any of paragraphs A35 to A39, wherein The pump section also includes a positioning ring surrounding the at least one guide tube and the outlet tube, the positioning ring preferably being made of silicone resin.

[0121] A41 According to the pump section described in paragraph A40, wherein The positioning ring is at least partially bonded to the outer surface of the guide tube, preferably by adhesive or thermal bonding.

[0122] A42 According to the pump section described in paragraph A41, wherein The positioning ring is at least partially attached to the outer surface of the outlet tube, preferably by adhesive or thermal bonding.

[0123] A43 According to the pump section described in any of the preceding paragraphs, wherein The total export area is between 20 mm² and 70 mm², preferably between 30 mm² and 50 mm², and even more preferably between 33 mm² and 35 mm².

[0124] A44 According to the pump section described in any of the preceding paragraphs, wherein The pump housing has a strut structure made of nickel-titanium.

[0125] A45 According to the pump section described in any of the preceding paragraphs, wherein The pump housing has a mesh associated with the blood inlet, which is made of polyurethane.

[0126] A46 The pump section described in paragraphs A44 and A45, wherein The opening defined by the net is smaller than the opening defined by the support structure.

[0127] A47 According to the pump section described in any of the preceding paragraphs, wherein The outlet tube is made of polyurethane.

[0128] A48 According to the pump section described in any of the preceding paragraphs, wherein The outlet pipe has a connection angle of 0.5 to 4 degrees relative to the pump housing at its distal end.

[0129] A49 According to the pump section described in paragraph A48, wherein The connection angle is between 1 and 2 degrees.

[0130] A50 According to the pump section described in paragraph A49, wherein The connection angle is approximately 1.5 degrees.

[0131] B1 is the pump segment used in the blood pump, which includes: A pump housing with a blood inlet and a blood outlet; A pump element, at least partially disposed within a pump housing, wherein the pump element is configured to generate blood flow between a blood inlet and a blood outlet; and An outflow tube surrounding the pump housing and the blood flow outlet, wherein the outflow tube is configured to guide the blood flow generated by the pump elements, wherein the outflow tube has an outlet for the blood flow; The outlet pipe has a distal end connected to the pump housing, and the outlet pipe has a connection angle between 0.5 degrees and 4 degrees relative to the pump housing at the distal end, preferably between 1 degree and 2 degrees, and more preferably about 1.5 degrees.

[0132] B2 Based on the blood pump described in paragraph B1, where The blood pump also includes a stabilizing device located downstream of the blood flow outlet of the pump housing, wherein the stabilizing device is configured to stabilize the pump section by influencing at least one flow parameter of the blood flow generated by the pump elements.

[0133] C1 blood pump, including the pump segment described in any of the preceding paragraphs.

[0134] C2 Based on the blood pump described in paragraph C1, where A blood pump is an intravascular blood pump.

[0135] C3 Based on the blood pump described in paragraphs C1 or C2, where Blood pumps also include motors.

[0136] C4 Based on the blood pump described in paragraph C3, where Pump components in the motor-driven pump section.

[0137] C5 Based on the blood pump described in paragraph C4, where The pump section's conduit houses a flexible shaft driven by a motor.

[0138] C6 Based on the blood pump described in paragraph C5, where Flexible shaft driven pump element.

[0139] As used herein, the terms “approximately,” “about,” “substantially,” and similar terms are intended to have a broad meaning consistent with common and accepted usage by one of ordinary skill in the art to which the subject matter of this disclosure pertains. As used herein, “proximal” and “distal” are relative to a medical professional or physician. Thus, when a blood pump is introduced into a patient, “proximal” refers to something relatively close to the physician, while “distal” refers to something relatively far from the physician. Those skilled in the art who read this disclosure will understand that these terms are intended to allow for the description of certain features, rather than limiting the scope of these features to the precise numerical ranges provided. Therefore, these terms should be interpreted as indicating non-substantial or insignificant modifications or alterations to the subject matter and are considered within the scope of this disclosure. The terms “at least partially” or “partially” as used herein mean both partially and wholly or completely, respectively. Terms such as “first,” “second,” or “third” do not indicate a particular order but are merely intended to semantically distinguish these elements.

[0140] List of reference numerals 10 Pump Section 12 catheters 14 Pump housing 16 Pump Components / Impeller 18 Outflow tube 20 Stabilizing Device 22 Flexible shaft 24 Flexible, damage-resistant tips 26. Blood flow entry point 28. Blood Outflow 30. Support for pump housing 32 Pump element blades 34 Inner Coating Layer 36. Outer coating layer 38 Fixed distance 42. Pre-determined distance 44. Prelude 46. ​​Trailing edge 48 Pump Components / Impeller Section 50 Pump element / impeller length 52.com 54 pillars 60 Exports 62 Throttling section 64 Throttling ring 66. Outer surface of the outlet pipe 68. Distal end of the outflow tube 70 Proximal end of the outflow tube 72. Circumferential surface of the conduit 74. The tapered part of the outflow pipe 76. Attachment to the outflow pipe 78. Outlet opening in the conical section 80 The middle part of the outflow tube 82 Install slits 84 Attached support 86 Exit gap 88. Attachment strip 90 out of the pocket 92 Exit opening 94. Longitudinal contraction section 95 guide tube 96. Outflow opening 97. Opening in the middle section 98. Outer surface of the guide tube 99 Positioning Rings 100 blood pumps 102 motors A taper angle C Connection Angle D T Diameter of the throttle ring D O Diameter of the outlet pipe at the throttling ring position H patient's heart LV (Left Ventricle)

Claims

1. A pump section (10) for a blood pump (100), said pump section (10) comprising: A pump housing (14) having a blood inlet (26) and a blood outlet (28); A pump element (16) is at least partially disposed in the pump housing (14), wherein the pump element (16) is configured to generate blood flow between the blood inlet (26) and the blood outlet (28); An outflow tube (18) surrounding the blood flow outlet (28) of the pump housing (14), wherein the outflow tube (18) is configured to guide the blood flow generated by the pump element (16), wherein the outflow tube (18) has an outlet (60) for the blood flow; and A stabilizing device (20) located downstream of the blood flow outlet (28) of the pump housing (14), wherein the stabilizing device (20) 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).

2. The pump section (10) according to claim 1, wherein The at least one flow parameter includes the pressure difference between the inside and outside of the outlet pipe (18), and The stabilizing device (20) is configured such that the pressure difference is at least a minimum pressure difference, wherein, The minimum pressure difference is preferably 5 mmHg, wherein the stabilizing device (20) preferably includes a throttling section (62) for the blood flow generated by the pump element (16).

3. The pump section (10) according to claim 1 or 2, wherein The outlet pipe (18) has a distal end (68) and a proximal end (70) connected to the pump housing (14), wherein, The outflow tube (18) has an elongated structure extending from the distal end (68) to the proximal end (70) along the longitudinal extension direction (D1) of the outflow tube (18). The at least one flow parameter includes the final blood flow direction (D2) at the outlet (60) of the outflow tube (18), and The stabilizing device (20) is configured such that the axial portion (D2a) of the final blood flow direction (D2) is guided away from the distal end (68) along the longitudinal extension direction (D1) of the outflow tube (18), preferably along the longitudinal extension direction (D1) of the proximal end (70) of the outflow tube (18).

4. The pump section (10) according to any one of claims 1 to 3, wherein, The stabilizing device (20) includes the outlet (60) of the outflow pipe (18).

5. The pump section (10) according to any one of the preceding claims, wherein The outlet (60) of the outflow pipe (18) is formed in or by the proximal end (70) of the outflow pipe (18).

6. The pump section (10) according to claim 5, wherein The pump section (10) also includes a conduit (12) connected to the pump housing (14), wherein, The catheter (12) has a circumferential surface (72). The proximal end (70) of the outflow tube (18) includes a tapered portion (74) that tapers toward the conduit (12) and an attachment portion (76) that is attached to the circumferential surface (72) of the conduit (12). The tapered portion (74) includes 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 around the conical portion (74) in the circumferential direction, wherein the shape of the at least one outlet opening (78) is preferably circular, elongated oval, arched, semi-circular, elongated semi-circular, elliptical, rhomboid, triangular or teardrop-shaped, wherein the at least one outlet opening (78) preferably has rounded corners.

7. The pump section (10) according to claim 6, wherein The tapered portion (74) has a taper angle (A) toward the conduit (12), the taper angle being at least 40 degrees, preferably at least 70 degrees, and more preferably at least 85 degrees.

8. The pump section (10) according to claim 5, wherein The pump section (10) also includes a conduit (12) connected to the pump housing (14), wherein, The conduit (12) has a circumferential surface (72), wherein the conduit (12) includes at least one attachment post (84), preferably a plurality of attachment posts (84) evenly distributed around the circumferential surface (72) of the conduit (12). The proximal end (70) of the outflow tube (18) includes an attachment (76) attached to the at least one attachment post (84), and The outlet (60) of the outflow tube (18) is formed by at least one outlet gap (86), preferably multiple outlet gaps (86), formed between the proximal end (70) of the outflow tube (18) and the conduit (12).

9. The pump section (10) according to claim 8, wherein The at least one attachment post (84) is integrally formed with the conduit (12) on the circumferential surface (72) of the conduit (12), or The catheter (12) includes an attachment ring having at least one attachment post (84), wherein, The attachment ring is connected to the circumferential surface (72) of the conduit (12).

10. The pump section (10) according to claim 5, wherein The pump section (10) also includes a conduit (12) connected to the pump housing (14), wherein, The catheter (12) has a circumferential surface (72). The proximal end (70) of the outflow tube (18) includes at least one attachment strip (88), preferably multiple attachment strips (88), attached to the circumferential surface (72) of the conduit (12). The proximal end (70) of the outflow tube (18) also includes at least one outlet pocket (90), preferably multiple outlet pockets (90), having an outlet opening (78). 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 conduit (12), and the outlet (60) of the outflow tube (18) is formed by the at least one outlet pocket (90). Preferably, the multiple outlet pockets (90) are formed in the shape of a clover leaf.

11. The pump section (10) according to any one of claims 1 to 4, wherein The outflow pipe (18) includes at least one guide pipe (95) fluidly connected to the outflow pipe (18), preferably multiple guide pipes (95), wherein, The at least one guide tube (95) extends substantially parallel to the longitudinal extension direction (D1) of the outlet tube (18), and The outlet (60) of the outflow pipe (18) is formed by the at least one guide pipe (95).

12. The pump section (10) according to claim 11, wherein The outflow tube (18) includes a middle portion (80) connecting the distal end (68) and the proximal end (70). The middle portion (80) includes a plurality of openings (97) evenly distributed circumferentially around the middle portion (80), and Each opening (97) in the middle section (80) is connected to a guide tube (95).

13. The pump section (10) according to any one of the preceding claims, wherein The outlet (60) has a total outlet area between 20 mm² and 70 mm², preferably between 30 mm² and 50 mm², and more preferably between 33 mm² and 35 mm².

14. A pump section (10) for a blood pump (100), particularly a pump section according to any one of the preceding claims, said pump section (10) comprising: A pump housing (14) having a blood inlet (26) and a blood outlet (28); A pump element (16) is at least partially disposed in the pump housing (14), wherein the pump element (16) is configured to generate blood flow between the blood inlet (26) and the blood outlet (28); and An outflow tube (18) surrounds the blood flow outlet (28) of the pump housing (14), wherein the outflow tube (18) is configured to guide the blood flow generated by the pump element (16), wherein the outflow tube (18) has an outlet (60) for the blood flow. The outlet pipe (18) has a distal end (68) connected to the pump housing (14), and the outlet pipe (18) has a connection angle (C) at the distal end (68) relative to the pump housing (14) between 0.5 degrees and 4 degrees, preferably between 1 degree and 2 degrees, and more preferably about 1.5 degrees.

15. A blood pump (100), particularly an intravascular blood pump (100), comprising a pump segment (10) according to any one of the preceding claims.

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