Blood pump

Abstract

A blood pump (1) comprising a pump housing (2) having a blood flow inlet (21) and a blood flow outlet (22), and an impeller (3) arranged in the pump housing (2) and rotatably supported in the pump housing (2) by a bearing (60) for rotation about an axis of rotation. The impeller (3) has blades (31, 32) for transporting blood from the blood flow inlet (21) to the blood flow outlet (22). The bearing (60) comprises at least one stationary bearing part (4) coupled to the pump housing (2) and having a stationary bearing surface (61) facing radially outwards. The bearing (60) further comprises a rotating bearing surface (62) interacting with the stationary bearing surface (61) to form the bearing (60), wherein the rotating bearing surface (61) faces radially inwards and is formed on a radially exposed inner edge (50) of the blade (32). The blade (32) is designed to drag blood deposits outwards in a radial direction from the stationary bearing surface (61).

Description

[0001] Divisional application

[0002] This application is a divisional application of the invention application with application number 201680045303.2, international filing date of August 3, 2016, entry into the Chinese national phase date of February 1, 2018, and invention title "blood pump". Background Technology

[0003] This invention relates to blood pumps, specifically to intravascular blood pumps that maintain blood flow in a patient's blood vessels.

[0004] Different types of blood pumps are known, such as axial flow blood pumps, centrifugal blood pumps, or hybrid blood pumps in which blood flow is caused by both axial and radial forces. Intravascular blood pumps are inserted into a patient's blood vessel, such as the aorta, via a catheter. Blood pumps typically consist of a pump housing with a blood flow inlet and a blood flow outlet. To allow blood to flow from the blood flow inlet to the blood flow outlet, an impeller or rotor is rotatably supported within the pump housing about an axis of rotation, wherein the impeller is provided with one or more blades for delivering blood.

[0005] The impeller is typically supported within the pump housing by means of at least one support. Various types of supports are known, such as contact supports and non-contact supports. Generally, contact supports can include all types of supports whose support surfaces are in at least partial contact at any time during pump operation (i.e., continuously or intermittently), such as sliding supports, pivot supports, hydrodynamic supports, hydrostatic supports, ball supports, etc., or any combination thereof. In particular, a contact support can be a "blood-immersed support," where the support surface is in contact with blood. Contact supports can become hot during use and undergo mechanical wear caused by the contact between rotating and static support surfaces during pump operation. It is desirable to supply a cooling fluid, such as blood itself, to the support.

[0006] For example, US2011 / 0238172A1 discloses an apparatus for flushing gaps or support surfaces within a blood pump. The flushing passage extends through the impeller and is in fluid communication with the main blood flow channel and the support surface. Summary of the Invention

[0007] The object of this invention is to provide a blood pump that allows for efficient cooling and flushing of the support on which the impeller of the blood pump is rotatably supported.

[0008] According to the present invention, this objective is achieved by a blood pump having the following features. Preferred embodiments and further extensions of the invention are described in detail in the technical solutions subordinate thereto.

[0009] According to the invention, the impeller is rotatably supported in a pump housing by at least one support. The support includes at least one stationary support portion coupled to the pump housing and having a stationary support surface facing radially outward. The support also includes a rotating support surface that interacts with the stationary support surface to form the support, wherein the rotating support surface faces radially inward and is formed on at least one radially exposed inner edge of the blade, or on a support structure coupled to the radially exposed inner edge of the blade. Using the radially exposed inner edge of the blade for the support allows for an open support design that can improve the scouring of the support surface. Therefore, heat generation in the support can be reduced. Similarly, blood clogging and coagulation in the support area can be reduced. In particular, using the inner edge of the rotating blade as the mating portion of the support has the inherent advantage of centrifugating the blood boundary layer radially away from the support surface. That is, a centrifugal force is generated that helps to drag blood deposits of a density greater than the flowing blood away from the stationary support surface in a radially outward direction. Therefore, the design of the support facilitates the scouring of the mating surface of the support.

[0010] Preferably, the stationary support portion includes at least one pin or cone extending along the axis of rotation. The stationary support portion may be generally cylindrical or tapered, and its length along the axis of rotation may vary. For example, the stationary support portion may extend axially for less than half the length of the impeller, or it may extend approximately along the entire length of the impeller. In particular, if the stationary support portion is relatively short, the support may include two stationary support portions that extend axially from opposite axial ends of the impeller toward or into the impeller.

[0011] Regardless of the specific design and shape of the stationary support, the stationary support can be referred to as a "pin," and the support can be referred to as a "pin support." These terms are not limited to a specific pin design, but refer to all types of stationary supports and blade arrangements within the scope of this invention, particularly stationary supports having radially outward-facing support surfaces that interact with the radially exposed inner edges of the impeller blades.

[0012] The rotating support surface can extend approximately the entire length of the radially exposed inner edge of at least one blade. This results in a larger support surface, which is advantageous for, for example, heat dissipation. Indeed, the support being formed on a blade that itself provides high heat dissipation also improves heat dissipation. Alternatively, it can extend only a portion of the length of the radially exposed inner edge of the blade. In particular, to reduce the size of the contact area between the stationary support surface and the rotating support surface, the rotating support surface can be formed as one or more separate segments along the radially exposed inner edge of the blade. This can be achieved, for example, through a specific non-uniform profile of the inner blade edge, wherein the support surface can be formed by raised portions of the profile, or by a coating, insert, etc. Specific materials can be used for the coating and insert, as described in more detail below.

[0013] In one embodiment, the stationary support may have a central axial channel extending therethrough. For example, the stationary support or pin may have an axial passage. This allows blood to flow to the axial end surface of the pin to clean the gap between the pin and the impeller. Furthermore, if the impeller also has a central axial channel, blood can flow from the pin channel into the impeller channel.

[0014] The stationary support can be coupled to the pump housing by means of a support structure including at least one hole to allow blood to pass through it in the axial direction. For example, the stationary support can be supported by a strut connected to the pump housing. This can be particularly useful if the stationary support is placed in the area of ​​the blood flow inlet, as it allows a pin to be arranged in the blood flow inlet while blood can enter the pump housing through the hole defined by the strut. This can also be applied to the blood flow outlet if it is desired that blood exit the pump housing in the axial direction. Optionally or additionally, the dimensions and shape of the support structure can be designed to guide blood flow in the radial direction. The support structure can have a tapered shape, such as a straight or curved cone, forming, for example, a socket for the pin, widening in the downstream direction and arranged near the blood flow outlet.

[0015] Generally, the pin support concept described above applies to various impeller designs, and is particularly applicable to the at least one blade, provided that the rotational support surface is formed on the radially exposed inner edge of the blade or possibly on a support structure connected to the radially exposed inner edge of the blade. Specifically, the at least one blade may be attached to the outer surface of the impeller hub, the inner surface of the impeller hub, or both. If the blade is located on the outer surface of the hub, the radially exposed inner edge may be located in a region where the blade extends axially beyond the hub. If the blade is located on the inner surface of the hub, they may be considered inner blades and may be located within the impeller's passageways, as described in detail below. It is understood that a combination of "inner" and "outer" blades may be included in a single impeller.

[0016] According to one embodiment, the impeller includes at least one outer blade disposed on the outer surface of the impeller hub and sized and shaped to transport blood from a blood flow inlet to a blood flow outlet. Furthermore, the blood pump impeller has a blood flow channel extending through the impeller hub, wherein at least one inner blade is disposed within the channel and sized and shaped to transport blood through the channel. A rotating support surface is disposed on the radially exposed inner edge of at least one inner blade, or at least one outer blade, or both inner and outer blades.

[0017] In addition to the outer blades, inner blades are arranged in the impeller channels so that blood flow from the blood flow inlet to the blood flow outlet can be maintained by the inner blades, which pump blood through the blood flow channels of the impeller, particularly guiding the blood flow through the impeller channels in the same direction as the main blood flow from the blood flow inlet to the blood flow outlet (“forward flow direction”). Regardless of the flow direction in the blood flow channels of the impeller, the inner blades improve the overall circulation of blood within the pump housing, thereby improving the scouring and cooling of clearances, support surfaces, and other surfaces within the pump housing. Because the inner blades are located in the blood flow channels of the impeller and rotate with the impeller, the inner blades do not require additional space or additional drive mechanisms.

[0018] Preferably, the inner blades are sized and shaped to deliver blood through the channel to the support. Specifically, this means that blood can be delivered to the support, into the support, or along the support via the inner blades. The inner blades preferably generate an active flushing flow toward the support in the forward flow direction to flush and cool the support, which is particularly advantageous when the support is a contact support. Heat dissipation is maximized. Therefore, blood blockage and clotting in the support can be effectively reduced or avoided. In some pump designs, a flushing flow in the "reverse flow direction" (i.e., opposite to the "forward flow direction") may be advantageous. For example, large-diameter blood pumps, in addition to the inner blade impeller, can benefit from having a pressure gradient to drive very high blood return without affecting the overall pump flow.

[0019] The blood flow channel of the impeller can extend at least partially, preferably completely, along at least a portion of the impeller, particularly the impeller hub, axially. When at least a portion of the channel, particularly a portion of the channel with inner blades, is aligned with the axis of rotation, this can improve blood pumping by means of the inner blades, as the inner blades subsequently rotate about the axis of rotation. Furthermore, the inner blades can effectively remove any blood deposits in the support area by the action of highly turbulent blood flow near the pin support surface. In other words, the radially exposed inner edge of the inner blades can act like a wiper blade on the static support surface of the static support portion.

[0020] The impeller's channels may have one or more portions that do not extend along the axis of rotation but are angled relative to it. Specifically, one or more ends of the channels in the impeller may be angled relative to the axis of rotation. However, it is preferred that the blood flow channel extends along the axis of rotation completely through the impeller from a first axial end or opening to a second axial end or opening. The inner blades can then pump blood through the blood flow channels of the impeller in the axial direction. If the axial channel extends completely through the impeller along the axis of rotation, the impeller can be considered hollow or have a hollow hub, such as a hollow cylinder or a hollow cone, wherein the outer blades are disposed on the outer surface of the hollow hub, and the inner blades are disposed on the inner surface of the hollow hub. It should be understood that the impeller may be chosen from any other suitable hollow shape, not necessarily strictly cylindrical, such as generally cylindrical, tapered, or tubular.

[0021] In one embodiment, the support may be disposed within the blood flow channel. Positioning the support within the impeller channel improves flushing and cooling of the support, as the support is directly positioned within the blood flow pumped through the impeller channel. The stationary support may include at least one pin extending along the axis of rotation, wherein at least a portion of the pin engages the radially exposed inner edge of a blade, particularly an inner blade, or engages a support structure attached to the radially exposed inner edge of a blade to form at least one support. It should be understood that the pin may be generally cylindrical or may taper to form a cone shape. The latter will also allow for compensation of axial forces, allowing the support to function as both an axial and radial support. The pin may extend only toward the end of the channel or only into the end of the channel, or may extend a greater distance within the channel, for example, at least half, preferably at least three-quarters, of the length of the impeller channel. In a preferred embodiment, the pin may extend completely through the impeller channel, i.e., at least along the entire length of the channel within the impeller. The length of the pin may be greater than the length of the blood flow channel of the impeller. Regardless of the pin's length, the maximum diameter of the pin may be less than the minimum diameter of the impeller channel. This allows blood to flow through the channel across the pin.

[0022] Specifically, the inner blades may have at least one radially exposed inner edge defining the rotating support surface. That is, at least a portion of the radially inner edge of the inner blade may engage at least a portion of the stationary support surface, such as the circumferential surface of the pin, to form at least one support. Using the inner blades as a support structure simplifies the structure of the blood pump because no additional support structure is required. This is particularly advantageous when the pin extends fully through the impeller channel. The edges of the inner blades may contact the circumferential surface of the pin along their entire length or at least along their substantially entire length. Furthermore, since the inner blades constitute the dynamic part of the support, heat dissipation is maximized, especially when the inner blades are made of a material with a high heat transfer rate. Because the support extends through the blood flow channel of the impeller, the support is effectively cooled and flushed. The inner blades have multiple functions. They serve as a pumping device that actively flushes the support by pumping blood through the impeller channel, while also functioning as a support itself. In addition, they serve as a heat dissipation surface positioned in the turbulent region to maximize heat dissipation. Compared to the edge parallel to the pin surface, the radially inner edge of the blade may taper in the circumferential direction to improve the functionality of the hydrodynamic support.

[0023] In one embodiment, at least one outer blade and at least one inner blade are provided. At least one blade of the impeller can be arranged on the impeller hub such that the blade is divided by the hub into an inner portion constituting the inner blade and an outer portion constituting the outer blade. In other words, the inner blade can be aligned with the outer blade, or the inner blade can form a "continuation" of the outer blade via the impeller hub, particularly when the impeller has a hollow hub. Specifically, the inner and outer blades can have corresponding sizes and shapes. Regardless of the specific size and shape of the blades, the hollow hub can be continuous or interrupted by openings to allow blood to flow from the inner blade to the outer blade or in the opposite direction, which can facilitate hydraulic balance. Generally, hydraulic balance between the blood flow induced by the inner blade and the blood flow induced by the outer blade is important. Therefore, the two blade sets will cause blood flow in the forward direction, particularly within the operating pressure range up to 200 mmHg.

[0024] For example, the inner and outer blades can extend radially inward and radially outward by the same distance from the impeller hub, respectively. This design is simple because it essentially defines a set of blades divided into inner and outer blades by the hub of the hollow impeller. However, in another embodiment, the inner and outer blades may be misaligned or may not correspond in size and shape. The inner blades may, for example, be smaller than the outer blades. Depending on the hydraulic requirements, the inner and outer blades may differ in inlet angle, outlet angle, and / or pitch angle. Furthermore, regardless of whether the outer and inner blades are aligned or correspond in size and shape, the number of outer blades and inner blades may be the same or different. For example, there may be more inner blades than outer blades, such as three inner blades and two outer blades. It should be understood that there may be only a single inner blade or a single outer blade, or there may be two or more inner or outer blades. Typically, if more than one blade is provided, not all blades, for example, only one of them may form part of the support, while the other blades may be spaced apart from the stationary support surface. The inner blades or the outer blades, or both, can be helical about the axis of rotation; that is, they can be helical or differ in pitch. Alternatively, the blades can extend linearly in the axial direction.

[0025] The inner blades can correspond perfectly to the outer blades. In practice, both the inner and outer blades can be positioned as a single blade held in place by the outer hub, such that these blades extend toward the center of the hub and can form a radial support together with the center pin. The outer hub can house the magnet assembly that forms the rotor of the electric motor, which is driven by stator coils located on the outer surface of the pump housing.

[0026] In one embodiment, the pump housing may have a secondary blood flow inlet axially spaced from the blood flow inlet and blood flow outlet in the main flow direction. For example, the main blood flow inlet may be located at an upstream end of the pump housing, and the secondary blood flow inlet may be located at the opposite downstream end of the pump housing. However, the secondary blood flow inlet may also be circumferentially arranged in the pump housing. The secondary blood flow inlet can be used to generate flushing flow along the impeller. For this purpose, the impeller may include at least two blades, at least one of which is associated with the blood flow inlet to deliver blood from the blood flow inlet to the blood flow outlet in the main flow direction, and at least one of which is associated with the secondary blood flow inlet to deliver blood from the secondary blood flow inlet to the blood flow outlet in a direction opposite to the main flow direction.

[0027] The at least two blades may be arranged at axially opposite portions of the impeller adjacent to the middle portion of the impeller, and at least one blade associated with the secondary blood flow inlet is sized and shaped to deliver blood along the middle portion of the impeller. That is, the impeller can be considered a “double impeller” where blood is pumped toward the center of the impeller in two opposite directions by opposing blades arranged at opposite ends of the impeller. While the blade associated with the blood flow inlet generates the primary blood flow, the blade associated with the secondary blood flow inlet causes an active flushing flow along the impeller hub. In this embodiment, the impeller may include two of the aforementioned pin supports at its opposite axial ends, wherein the radially exposed inner edges of each blade are supported by their respective pins. The “secondary” blades are used to draw blood from outside the pump and force it through the radial gap between the magnetic actuator and the pump housing to clean and cool the motor formed by the magnetic actuator and the stationary stator coils positioned on the outer surface of the pump housing. It should be understood that the secondary pump can be designed as an axial flow pump, a mixed flow pump, or a generally radial pump.

[0028] In one embodiment, a support structure coupled to the radially exposed inner edge of the blade may be used for support, in addition to using the radially exposed inner edge of the blade as a rotary support surface itself. The rotary support surface may be defined by at least one ring engaging at least a portion of the pin. In addition to the rotary support surface being formed by the radially exposed inner edge of the inner blade, or alternatively, at least one ring may be separately disposed from the inner blade, or may be coupled to at least one or all of the inner blades. In other words, the support surface of the support structure may be formed by only at least one ring, or it may be formed by at least one ring together with the radially exposed inner edge of the blade.

[0029] Alternatively, or in addition to a ring, the support structure may include at least a portion of a connecting pin and may be coupled to at least one wing of at least one or all of the inner blades. At least one wing may have an arcuate shape corresponding in size and shape to the outer circumferential surface of the pin to form a support providing radial centering, particularly for the impeller. It should be understood that the aforementioned ring can be formed by such winglets. For example, at least two, such as two, three, or four, circumferentially adjacent winglets may be connected to form a ring. The winglets or ring may be arranged at one or more locations along the length of the impeller's passageway. These winglets may have a specific geometry to maximize the amount of blood or simply plasma entering the support area. Additionally, centrifugal force near the pin support can be used to radially remove red blood cells and other cellular blood components from the support area.

[0030] In another embodiment, the dimensions and shape of the rotary support surface can be designed to engage with the axial end of the stationary support to form at least one support, and can be coupled to at least one or all blades. The rotary support surface can be a continuous surface or can include separate segments that can be regularly arranged, for example, symmetrically arranged relative to the axis of rotation. The rotary support surface can be formed in dimensions and shape corresponding to the axial end surface of the pin, such as a cup, dome, hemisphere, cone, or any other suitable rotationally symmetrical surface. This type of support provides radial centering and axial support for the impeller.

[0031] The blood pump is preferably driven radially, wherein electrical devices are coupled to the pump housing and arranged circumferentially around the impeller and possibly the pump housing to generate a rotating magnetic field. A permanent magnet in the impeller is magnetically coupled to the rotating magnetic field of the stator coils, causing the impeller to rotate about its axis of rotation. The magnet can be incorporated into the impeller, particularly into the blades, preferably the outer blades. Radial drive allows for a compact design of the blood pump and can be designed independently of the support, particularly independent of the aforementioned pins extending into the channels of the impeller. However, it should be understood that any other suitable drive mechanism can be used in the blood pump. In particular, a drive mechanism suitable for intravascular catheter pumps is preferred, designed for miniaturization and high energy density.

[0032] The aforementioned support can be supported by an additional support. This additional support can be specifically designed to withstand axial loads in one or both axial directions along the axis of rotation to alleviate pin support stress. In one embodiment, both the stationary support and the impeller may include at least one magnet. The magnets in the stationary support and the impeller can be radially aligned and arranged respectively in the stationary support and the impeller, such that an axial repulsive magnetic force is generated between the stationary support and the impeller. Therefore, the respective axial end surfaces of the impeller and the stationary support will not contact each other due to the repulsive magnetic force, thereby avoiding wear and heat generation at the axial end surfaces. Simultaneously, the repulsive magnetic force helps to axially align the impeller within the pump housing. This can be particularly useful if the repulsive magnetic force acts on the impeller from two opposing axial ends in opposite directions.

[0033] In one embodiment, at least one of the stationary support surface and the rotating support surface may comprise a material having a greater hardness than the material of the impeller and the rest of the stationary support portion, respectively, to reduce wear on the support surface. For example, a coating or insert of a particular material may be used to reduce wear. A suitable material may be ceramic. To enhance heat dissipation, the blades may be made of metal, for example, while the rotating support surface on the blades, particularly the radially exposed inner edge of the blades, may be completely or partially coated with ceramic, or may have ceramic inserts. Inserts such as ceramic inserts may be embedded into or connected to the inner blade surface in contact with the pin surface to extend the support's lifespan. Due to the inherently high heat dissipation of the blades, high heat generation can be well accommodated without adversely affecting blood deposition or support wear in the support area. For heat dissipation, silicon carbide may be preferred for the inserts or coating. Furthermore, the mating material may be steel, which may be coated with, for example, a diamond coating. In addition, the relative velocity is preferably kept at a minimum that allows the mating portions to slide relative to each other, preferably less than 1.5 m / s, which corresponds to a shaft diameter of about 1 mm for a pump with an outer diameter of 6 mm and a design speed of 30,000 rpm.

[0034] In another embodiment, the impeller may include at least one secondary blade disposed on the axial end surface of the impeller. The secondary blade may improve flushing of the support surface or the clearance between the impeller and the pump housing, or may provide hydrodynamic axial support when interacting with a preferably smooth, corresponding inner surface of the pump housing. Attached Figure Description

[0035] The foregoing overview and the following detailed description of preferred embodiments will be better understood when read in conjunction with the accompanying drawings. Reference has been made to the accompanying drawings for the purposes of this disclosure. However, the scope of this disclosure is not limited to the specific embodiments disclosed in the drawings. In the drawings:

[0036] Figure 1 A perspective view of one embodiment of a blood pump is shown.

[0037] Figure 2 It shows Figure 1 A cross-sectional view of a blood pump.

[0038] Figure 3 It shows Figure 1 A 3D diagram of a part of the blood pump.

[0039] Figure 4 It shows Figure 3 The cross-sectional view of the portion shown.

[0040] Figure 5 It shows Figure 1 A 3D diagram of the impeller of a blood pump.

[0041] Figure 6 It shows Figure 5 The diagram shows a cross-sectional view of the impeller.

[0042] Figure 7 It shows Figure 1 A 3D diagram of the pins of a blood pump.

[0043] Figure 8 A perspective view of another embodiment of the impeller arrangement is shown.

[0044] Figure 9 A perspective view of another embodiment of the impeller arrangement is shown.

[0045] Figure 10 It shows Figure 9 A cross-sectional view of the impeller arrangement.

[0046] Figure 11 It shows Figure 9 A three-dimensional diagram of the impeller.

[0047] Figure 12 It shows Figure 9 A semi-transparent 3D image of the impeller.

[0048] Figure 13 It shows Figure 9 A three-dimensional diagram of the pin arrangement of the impeller.

[0049] Figure 14 A perspective view of an impeller according to another embodiment is shown.

[0050] Figure 15 A perspective view of an impeller according to another embodiment is shown.

[0051] Figure 16 A perspective view of an impeller according to another embodiment is shown.

[0052] Figure 17 It shows Figure 16 A cross-sectional view of the impeller.

[0053] Figure 18 It shows Figure 16 Enlarged cross-sectional view of the impeller.

[0054] Figure 19 A side elevation view of an impeller assembly according to another embodiment is shown.

[0055] Figure 20 It shows Figure 19 Cross-sectional view of the component.

[0056] Figure 21 It shows Figure 19 A three-dimensional cross-sectional view of the component.

[0057] Figure 22 A side elevation view of an impeller assembly according to another embodiment is shown.

[0058] Figure 23 It shows Figure 22 Cross-sectional view of the component.

[0059] Figure 24 It shows Figure 22 A three-dimensional cross-sectional view of the component.

[0060] Figure 25 A side elevation view of an impeller assembly according to another embodiment is shown.

[0061] Figure 26 It shows Figure 25 Cross-sectional view of the component.

[0062] Figure 27 It shows Figure 25 A three-dimensional cross-sectional view of the component.

[0063] Figure 28 A cross-sectional view of an impeller assembly according to another embodiment is shown.

[0064] Figure 29 It shows Figure 28 A three-dimensional diagram of the impeller.

[0065] Figure 30 It shows Figure 28 A three-dimensional view of the impeller and the stationary support.

[0066] Figure 31 A cross-sectional view of an impeller according to another embodiment is shown.

[0067] Figure 32 A cross-sectional view of an impeller according to another embodiment is shown.

[0068] Figure 33 A cross-sectional view of a blood pump according to another embodiment is shown.

[0069] Figure 34 It shows Figure 33 The impeller of the blood pump.

[0070] Figure 35 It shows Figure 33 The impeller of the blood pump along with the stationary support.

[0071] Figure 36 It shows Figure 33 The impeller of the blood pump, along with the stationary support and drive unit.

[0072] Figure 37 It shows Figure 33 A 3D diagram of a blood pump.

[0073] Figure 38 A cross-sectional view of a blood pump according to another embodiment is shown.

[0074] Figure 39 A cross-sectional view of one embodiment of the impeller is shown.

[0075] Figure 40 A cross-sectional view of one embodiment of the impeller is shown. Detailed Implementation

[0076] refer to Figure 1 and Figure 2 , Figure 1 and Figure 2 A perspective view and a cross-sectional view of the blood pump 1 are shown respectively. The blood pump 1 includes a pump housing 2 having a blood flow inlet 21 and a blood flow outlet 22. The blood pump 1 is designed as an intravascular pump, also known as a catheter pump, and is applied to a patient's blood vessels by means of a catheter 25. The blood flow inlet 21 is connected to a flexible cannula 23, which can be placed through a heart valve such as the aortic valve during use. The blood flow outlet 22 is located in the side surface of the pump housing 2 and can be placed in a heart vessel such as the aorta. The blood pump 1 is connected to the catheter 25 to supply power to the blood pump 1 to drive the pump 1 by means of a drive unit 5, as explained in more detail below. Generally, it should be understood that the flow in the blood pump can be in a direction opposite to that described in this disclosure. For example, in Figure 1 In the embodiments, 22 can represent a blood flow inlet, and 21 can represent a blood flow outlet.

[0077] Reference Figures 3 to 6 The impeller 3 is configured to transport blood from the blood flow inlet 21 to the blood flow outlet 22 and is rotatably mounted within the pump housing 2 about a rotation axis. The rotation axis is preferably the longitudinal axis of the impeller 3. The impeller 3 is rotatably supported by a support 60 formed by a pin 4 inside the impeller 3 and a support structure; therefore, the support 60 can be referred to as a pin support. The support structure consists of inner blades 32 (described in more detail below). Outer blades 31 are disposed on the hub 36 of the impeller 3 for transporting blood when the impeller 3 rotates. The rotation of the impeller 3 is caused by a drive unit 5 arranged circumferentially around the pump housing 2. The drive unit 5 includes the stator of an electric motor that generates a rotating magnetic field. Magnets in the outer blades 31 of the impeller 3 interact with the rotating magnetic field to cause the impeller 3 to rotate about the rotation axis. The outer blades 31 may also be made of a magnetic material. Figure 2 As shown, the outer blade 31 is thicker than the inner blade 32 to provide sufficient space for the magnet or magnetic material. The blood pump 1 shown is a hybrid blood pump, in which the main flow direction is axial. It should be understood that, depending on the arrangement of the impeller 3, and especially the arrangement of the blades 31, the blood pump 1 can also be a purely axial flow blood pump.

[0078] The impeller 3 includes a blood flow channel 33 extending completely through the impeller 3 along its axis of rotation. In this embodiment, the impeller 3 is hollow, i.e., the impeller hub 36 forms a cylindrical tube. Inner blades 32 are disposed within the channel 33. A pin 4 extends through the channel 33, wherein the diameter of the pin 4 is smaller than that of the channel 33 to allow blood to flow through the pin 4. Similarly... Figures 3 to 6 As shown, the radially exposed inner edge 50 of the inner blade 32 has a radially inwardly facing surface 62, which engages or contacts the outer circumferential surface 61 of the pin 4 to form a support 60 that rotatably supports the impeller 3. To improve the support 60, particularly its hydrodynamic characteristics, the edge 50 of the inner blade 32 may taper in the circumferential direction.

[0079] exist Figure 7 Pin 4, i.e., the stationary support portion, is shown separately. Pin 4 has a longitudinal body with a first axial end 41 and a second axial end 42. The first axial end 41 includes an enlarged portion to secure pin 4 in the pump housing 2, such that pin 4 is stationary. For example, in Figure 4 As can be seen, the enlarged portion 41 is formed as an opening toward the blood flow outlet 22 to guide blood flow. Instead of a single pin 4 that extends completely through the impeller 3, two shorter pins can be provided such that they extend into the first axial end 34 and the second axial end 35 of the impeller 3, respectively. The outer peripheral surface 61 of the pin 4 provides a static support surface for supporting 60.

[0080] Once the drive unit 5 causes the impeller 3 to rotate, blood is pumped from the blood flow inlet 21 to the blood flow outlet 22 by means of the outer blades 31. Simultaneously, blood is transported from the first axial end 34 to the second axial end 35 through the channel 33 of the impeller 3 by means of the inner blades 32. In this embodiment, the blood flow through the channel 33 of the impeller 3 is guided in the same direction as the main blood flow from the blood flow inlet 21 to the blood flow outlet 22, i.e., the blood flow through the channel 33 is forward. The support 60, formed by the pin 4 and the inner blades 32, is cooled and actively flushed by the blood flow induced by the inner blades 32 to prevent blood blockage and coagulation.

[0081] Typically, it is important that the blood flow induced by the inner blades and the blood flow induced by the outer blades are hydraulically balanced, so that the blade assembly both induce blood flow in the forward direction. This can be achieved by providing an opening in the impeller hub to connect the blood flow channel to the impeller environment. Figure 8An embodiment of impeller 603 is shown, wherein hub 636 includes a plurality of axially spaced rings that carry the blades. The blades are divided by hub 636 into outer blades 631 and inner blades 632, wherein the radially exposed inner edge 650 of the inner blades forms a supporting rotating surface, as described in conjunction with the foregoing embodiments. The plurality of openings, i.e., the spaces between the rings 636, allow for hydraulic balance of blood flow caused by the inner blades 632 and outer blades 631, respectively. It should be understood that the plurality of openings can be designed in different ways. For example, there can be more or fewer rings, and the axial dimensions of the rings and the spaces between the rings can be larger or smaller as desired. The openings can also be formed as simple holes in the impeller hub, which can take any size and shape depending on hydraulic requirements.

[0082] Figures 9 to 13 Another embodiment is shown, which, in addition to the design of the outer blade 131, inner blade 132, and pin 104, corresponds to... Figures 1 to 7 The embodiment shown. As... Figures 9 to 12 As shown, Figure 8 As in the embodiment, the inner blade 132 is aligned with the outer blade 131 such that the inner blade 132 forms a continuation of the outer blade 131 through the hub 136 of the impeller 103, or forms a mirror image at the hub 136. The inner blade 132 and the outer blade 131 are separated by the hub 136 of the hollow impeller 3 and correspond to each other in size and shape. In this embodiment, two inner blades 132 and two outer blades 131 are provided, wherein the outer blades 131 extend spirally on the outer surface of the hub 136, and the inner blades 132 extend spirally on the inner surface of the hub 136. The hub 136 is a hollow cylindrical shape with a channel 133 extending from a first axial end 134 to a second axial end 135. A tapered portion 137 is attached to the second axial end 135 to guide blood flow to the blood flow outlet 22 of the blood pump 1.

[0083] In this embodiment, ring 155 is attached to inner blade 132 to provide a rotational support surface 162 that engages with pin 104, particularly the outer surface 161 of pin 104, thereby forming support 160. Ring 155 provides radial centering of impeller 103 and guides rotation of impeller 103 about axis of rotation. Figure 13 The pin 104 shown is shorter than that in the previous embodiment. The pin 104 has a first axial end 141 and a second axial end 142, the first axial end 141 including a plate for securing the pin 104 in the pump housing. It should be understood that... Figures 9 to 12 Impeller 103 in the middle can also be with Figure 7The long pin 4 shown is used together. Ring 155 can provide a single support surface. However, specifically when the impeller 103 is used with the longer pin, two or more rings can be arranged along the length of the impeller 103, for example, one ring at each of the first axial ends 134 and the second axial ends 135. In the latter case, two short pins 104 can also be provided, one pin located at the first axial end 134 of the impeller and the other pin located at its second axial end 135. In both cases, the mating area of ​​the support can be minimized.

[0084] Figure 14 Another embodiment is shown, in which the wing 153 is attached to the inner blade 132 to define a support surface 162. This embodiment is similar to the embodiment where the ring 155 defines the rotating support surface 162. Compared to a closed ring, the individual wing 153 can improve erosion of the support 160. Figure 15 Another embodiment is shown, in which the impeller 103 does not have any additional support surface, but the rotating support surface 162 is defined by the radially inner edge 150 of the inner blade 132, as shown in Figures 1 to 7 As in the embodiments described above. Similarly, in other embodiments, in addition to the support surface 162 formed by the ring 155 or the wing 153, the radially exposed inner edge 150 of the inner blade 132 can be used as a rotational support surface. Next, the size and shape of one or more pins will be selected such that the radially inner edge 150 of the inner blade 132 engages with one or more pins. It will be further appreciated that the number of inner blades 132 can differ from the number of outer blades 131 to match the hydraulic performance of the two types of blades.

[0085] Figures 16 to 18 Another embodiment is shown, in which the support structure includes an annular portion 151 and a curved protrusion 152 forming an additional support surface 163, the dimensions and shape of which are designed to conform to the dimensions and shape of the axial end 142 of the pin 104. Specifically, the protrusion 152 may form a hemispherical shape corresponding to the hemispherical end 142 of the pin 104. It should be understood that the protrusion 152 may be connected to form a closed surface engaging with the pin 104. Similarly, the shapes of the protrusion 152 and the end 142 of the pin 104 do not necessarily have to be hemispherical, but may, for example, be conical. In this embodiment, the support provides not only radial centering of the impeller 103, but also axial support for the impeller 103. Furthermore, in this embodiment, the number of inner blades 132 differs from the number of outer blades 131. Three inner blades 132 are disposed in the channel 133 of the impeller 103, while only two outer blades 131 are disposed on the outer surface of the hub 136.

[0086] Reference Figures 19 to 21 , Figures 19 to 21An impeller assembly according to another embodiment is shown, which can be used in conjunction with... Figure 1 The illustrated blood pump is similar to those used in other blood pumps. Specifically, the impeller assembly can be combined as follows: Figure 1 It is used in an intravascular catheter pump as shown and described and is arranged in a pump housing connected to the catheter. Figures 19 to 21 The impeller assembly includes an impeller 203 having a set of outer blades 231 for conveying blood from a blood flow inlet to a blood flow outlet of the blood pump. The impeller 203 also has a blood flow channel 233 extending axially through the impeller 203. A set of inner blades 232 are disposed in the blood flow channel 233 at its downstream end. In this embodiment, the impeller 203 has a tapered shape such that blood flow (shown by arrows) is guided radially outward. The blood flow channel 233 is also tapered and its diameter increases towards the downstream end. However, any other shape, such as a cylinder, would be suitable for the blood flow channel 233.

[0087] Impeller 203 is supported by two supports 260, 263, one at the upstream end and the other at the downstream end. In the downstream support 263, a stationary support 211 configured to connect to the pump housing is provided. The stationary support 211 includes a tapered protrusion 206 that extends into the blood flow channel 233 of the impeller 203 and interacts with the inner blade 232 to form support 263. More specifically, the radially exposed inner edge 251 of the inner blade 232 interacts with the cone 206. The radially exposed inner edge 251 defines a rotating support surface 265 that engages with the stationary support surface 264 of the cone 206. Due to the tapered shape of the stationary support, support 263 provides axial and radial support to impeller 203. Simultaneously, the inner blade 232 actively pumps blood toward support 263 (shown by arrows), particularly along support surfaces 264, 265, to flush and cool support 263. The blood flow passing through the blood flow channel 233 of the impeller 203 leaves the channel 233 at the downstream end through the gap 214 between the impeller 203 and the stationary support 211, so as to merge with the main blood flow.

[0088] At its upstream end, the impeller 203 is supported by another support 260. The stationary support 210 is configured to be connected to the pump housing. Figure 21As best shown, the stationary support 210 is annular and includes a plurality of holes 212 that allow blood to enter the impeller region. The holes 212 can have any suitable number and design to allow blood passage. In this embodiment, the holes 212 are defined by a plurality of struts 213. Any number of struts 213 can be selected, such as at least two, three, four, or five. The struts 213 support pins 204 extending along the axis of rotation toward the impeller 203. Pins 204 define a stationary support surface 261 that interacts with a rotational support surface 262 defined on the radially exposed inner edge 250 of the outer blade 231. To form the radially exposed inner edge 250 on the outer blade 231, the outer blade 231 extends beyond the hub 236 of the impeller 203. That is, the outer blade 231 has an axial end that protrudes beyond the impeller hub 236. In this case, all three outer blades 231 extend beyond the hub 236 by approximately the same distance to form the radially exposed inner edge 250 that engages with the pins 204. However, it is sufficient if not all outer blades 231 form radially exposed inner edges. This type of support provides an open design in which support surfaces 261, 262 are in contact with blood. Support surfaces 261, 262 are effectively flushed and cooled. Figure 19 The arrows in the diagram illustrate the cleaning of support surfaces 261 and 262 as blade 231 rotates. Rotation of blade 231 causes blood deposits to be deposited radially outwards and centrifugally away from support 260. This flushing flow is independent of the main blood flow caused by blade 231.

[0089] like Figure 20 and Figure 21 As best shown, pin 204 has an axial channel 234 that allows blood to flow through. Specifically, the channel 234 of pin 204 is aligned with the blood flow channel 233 of impeller 203, which facilitates blood entry into the channel 233 of impeller 203 and increases the amount of blood flow through impeller 203 to provide effective active flushing of support 263 as described above. Blood will also enter the blood flow channel 233 from between the outer surface of pin 204 and the distal end of impeller 203 (in... Figure 20 (Indicated by arrows).

[0090] like Figure 20As schematically shown, impeller 203 can be further adjusted or driven by an arrangement including magnets or electromagnets 270, 271. Magnet 271 in stationary support 211 interacts with magnet 270 in impeller 203 to form magnetic coupling. Magnets 270, 271 can be arranged to induce attractive or repulsive magnetic forces to maintain axial alignment of impeller 203. It should be understood that any suitable drive can be used to cause rotation of impeller 203 about its axis of rotation. For example, magnet 270 in impeller 203 can interact with a rotating magnetic field induced by an electrical unit in stationary support 211, i.e., an axial electrical unit, or an electrical unit surrounding the impeller, i.e., a radial electrical unit. Optionally, magnet 271 can be a permanent magnet and can be part of a rotating disk that rotatably seals blood.

[0091] Figures 22 to 24 The text shows the relationship with... Figures 19 to 21 Another embodiment of the impeller assembly shown is substantially the same as the one illustrated. The only difference is that the secondary blades 235 are disposed on the downstream end surface of the impeller 203 in the gap 214. This enhances blood flow through the gap 214 to flush the gap 214. Furthermore, the secondary blades 235 provide axial hydrodynamic support when interacting with the surface of the stationary support 211.

[0092] Reference Figures 25 to 27 , Figures 25 to 27 Another embodiment of the impeller assembly is shown. In this embodiment, the impeller 303 has only outer blades 331 and no inner blades. However, inner blades can also be provided in this embodiment, which serve a similar function as... Figures 1 to 7 The illustrated embodiment describes the function of the inner blades. The impeller 303 is supported by a support 360, which includes a stationary support 311 with a pin 304. The pin 304 extends completely through a blood flow channel 333 of the impeller 303. The blood flow channel 333 has a diameter larger than that of the pin 304 to allow blood to flow through the pin 304, through the channel 333, and through a gap 314 located at the axial end surface of the impeller 303. Secondary blades 335 are provided to enhance blood flow through the gap 314 and to provide hydrodynamic support. However, it should be understood that the secondary blades 335 may be omitted.

[0093] As in the aforementioned embodiments, outer blades 331 are disposed on the outer surface of the hub 336 of the impeller 303 and extend axially beyond the hub 236 to form a radially exposed inner edge 350 and define a rotating support surface 362. The rotating support surface 362 engages the stationary support surface 361, which is defined by the axial end of the pin 304 projecting from the channel 333 of the impeller 303. In this way, the support 360 is configured to support the impeller 303 axially and radially. The larger diameter of the impeller channel 333 allows for a certain amount of pivoting of the impeller 303, which can be balanced by the hydrodynamic support formed by the secondary blades 335. The blades 331 shown do not intersect at the axis of rotation to form an open support 360, wherein blood can enter the support 360 in the axial direction (shown by arrows) to flush the support surfaces 361, 362. They may also intersect at the axis of rotation, still allowing blood to enter the support 360 in the axial direction.

[0094] Figures 28 to 30 Another embodiment of the impeller assembly is shown. It is similar to... Figures 19 to 21 The embodiments are similar, but do not include blood flow channels through the impeller. Figure 28 A cross-sectional view of an impeller 403 disposed within a pump housing 402 having a blood flow inlet 421 and a blood flow outlet 422 is shown. The blood flow inlet 421 is disposed at the axial end of the pump housing 402, while the blood flow outlet 422 is disposed radially around the pump housing 402. This is consistent with... Figures 1 to 7 The embodiment shown is similar. Therefore, as described in detail above, in this embodiment, a flexible sleeve can also be provided at the inlet end and a conduit at the opposite end. Similarly, an axial drive unit (not shown) can be provided at the downstream end of the impeller 403.

[0095] Impeller 403 includes a set of outer blades 431 projecting axially from hub 436 of impeller 403 to define a radially exposed inner edge 450. Impeller 403 is supported by support 460, which is formed by a rotating support surface 462 on the radially exposed inner edge 450 of the blades 431 and a stationary support surface 461 on pin 404 of stationary support portion 410. Stationary support portion 410 includes a hole 412 defined by a support column 413 to allow blood to enter the impeller region. As in the previous embodiment, an axial channel through pin 404 may be provided to allow blood to enter the gap 465 between impeller 403 and pin 404 to improve flushing of gap 465. To avoid contact between impeller 403 and pin 404 in the region of gap 465, permanent magnets 472, 473 are provided in impeller 403 and pin 404, respectively, to induce repulsive magnetic forces. It should be understood that this magnet arrangement can be used in any of the disclosed embodiments, or it can be omitted. In other arrangements, the magnet can be a ring-shaped magnet that allows blood to flow through its center along the axis of rotation.

[0096] Reference Figure 31 , Figure 31 Another embodiment of the impeller 703 is shown. As in the previous embodiment, the impeller 703 has a tapered hub 736, with a set of outer blades 731 disposed on the outer surface of the hub 736 to induce primary blood flow. However, the blades 731 do not extend axially beyond the hub 736 of the impeller. Instead, secondary blades 732 are disposed at the tip 743 of the impeller 703. The secondary blades 732 are smaller than the primary blades 731 and form radially exposed inner edges 750, configured to engage pins to form open supports as described in the previous embodiment. A shroud 740 is configured to surround and connect the secondary blades 732, allowing blood to flow from the inlet 741 to the outlet 742. Blood does not flow through the hub 736 of the impeller but only along the secondary blades 732.

[0097] Aside from omitting the shield 740, Figure 32 The embodiments shown are similar to Figure 31 The embodiments are largely the same. This provides a more open support design that can improve the scouring of the support. The secondary blade 732 can be formed to be completely straight in the axial direction, rather than as... Figure 31 and 32 The spiral shape shown is provided by the secondary centrifugal pump, which further improves the scouring of the support. Specifically, the deposited blood is centrifuged out radially outward away from the inner edge 750 of the secondary blades 732. The impeller 703, and especially the secondary blades 732, can be readily manufactured. For example, the tip 743 of the impeller 703, together with the secondary blades 732, can be manufactured as an injection-molded ceramic element.

[0098] refer to Figures 33 to 37 , Figures 33 to 37 Another embodiment of the blood pump is shown. It has the same... Figures 28 to 30 The illustrated embodiment has a substantially similar upstream portion. The blood pump has a pump housing 502 with a blood flow inlet 521 and a blood flow outlet 522. As described above, the impeller 503 has outer blades 531 on the outer surface of the impeller hub 536, the outer blades 531 forming a radially exposed inner edge 550. The support 560 is formed by a support surface 562 on the radially exposed inner edge 550 and a stationary support surface 561 on the pin 504 of the stationary support portion 510. Due to the tapered shape of the impeller hub 536, blood flow is guided radially outward from the blood flow inlet 521 to the blood flow outlet 522. As described above, magnets (not shown) that generate axial repulsive forces can be respectively provided in the impeller 503 and the pin 504 to adjust the axial position of the impeller 503.

[0099] In this embodiment, the impeller 503 has a second set of blades 532 in its downstream portion and a second support 563 substantially identical to that of the support 560. The blades 532 form radially exposed inner edges 552 that define a rotating support surface 565 that engages with a stationary support surface 564 on the pin 506. The pin 506 is included in another stationary support portion 511 substantially identical to the stationary support portion 510. It is connected to a conduit 525 that supplies, for example, electricity to the blood pump. A secondary blood flow inlet 523 is formed at the downstream end of the pump housing 502. A hole in the stationary support portion 511 allows blood to enter the impeller region from this side in a direction opposite to the main flow direction. The blades 532 are arranged to pump blood against the main flow direction along the middle portion 530 of the impeller 503 towards the blood flow outlet 522 via a gap 514, as indicated by the arrow. This allows flushing of the gap between the pump housing 502 and the intermediate portion 530 of the impeller 503, which includes a magnet 570 that is rotated by an electrically driven unit 505 arranged circumferentially around the impeller 503. The blade 532 is designed to induce sufficient reverse flow to flush the gap 514 without affecting the main blood flow. Specifically, the blade 532 can be smaller than the blade 531. Similarly, in other embodiments, any blade can have a coating or insert at its corresponding radially exposed inner edge, comprising a material with improved heat dissipation and abrasion resistance properties, such as ceramic. Due to the opposite pumping directions, the axial forces of the two axial impeller sections can be minimized.

[0100] Figure 38 It shows something roughly similar to Figures 33 to 37Another embodiment of the blood pump shown is described. The impeller 803 has two sets of blades 831, 832 to form supports 860, 863, respectively. Blade 831 causes the main blood flow from the blood flow inlet 821 to the blood flow outlet 822. As in the previous embodiment, the secondary blade 832 causes a reverse flushing flow from the secondary blood flow inlet 823 through the gap between the stator coil 805 and the magnet 870 to the blood flow outlet. The secondary blood flow inlet 823 points towards the conduit 825. The impeller hub 836 has a shoulder 837 that extends circumferentially around the hub 836 in a region of the blood flow outlet 822 to guide the main blood flow and, in particular, the flushing flow exiting the blood flow outlet 822. That is, a localized centrifugal jet pump is created because the main flow passes through the nearly vertical gap and the radial shoulder 837. It should be understood that the secondary blade 832 can be designed as a centrifugal pump with two or more blades, wherein the blades are not helical but straight to form a centrifugal pump.

[0101] Any of the blades described above can be designed according to hydraulic requirements. In particular, as shown in the embodiments, the blades can be helical. However, any of the blades described above, especially the secondary blades as described above, can be designed to constitute a centrifugal pump. In other words, the blades can be straight and can extend only in the axial direction. Figure 39 A cross-sectional view of the straight blade 1031 of the engagement pin 1004 is shown. The centrifugal pump, equipped with straight blades instead of helical blades, generates a greater centrifugal force, which facilitates the removal of blood deposits from the support surfaces 1061, 1062, as blood deposits have a higher density than blood. The deposits are transported radially outward away from the support surfaces 1061, 1062, which helps prevent blood blockage and clotting, and thus reduces the risk of thrombosis. Figure 39 The blade 1031 shown has an enlarged base 1050. Figure 40 Another embodiment is shown in which the blade 1131, which engages with pin 1104, does not have an enlarged base. This can improve the centrifugal flow of blood deposits radially outward away from the support surfaces 1161, 1162.

[0102] It should be understood that the described embodiments are merely illustrative and not restrictive. In particular, various aspects and features of the embodiments may be used in combination or independently in different embodiments. For example, features and different designs described relative to the outer blade, inner blade, pin, blood flow channel through the pin or impeller, drive unit, magnet for axial alignment, etc., may be combined in variations without departing from the scope of the invention.

[0103] Preferred embodiments are described below:

[0104] 1. A blood pump comprising a pump housing having a blood flow inlet and a blood flow outlet, and an impeller disposed in the pump housing, the impeller being rotatably supported in the pump housing by at least one support for rotating about a rotation axis, the impeller having at least one blade for conveying blood from the blood flow inlet to the blood flow outlet, wherein the support includes at least one stationary support portion coupled to the pump housing and having a radially outwardly facing stationary support surface, the support further including a rotating support surface interacting with the stationary support surface to form the support, wherein the rotating support surface is radially inwardly facing and formed on at least one radially exposed inner edge of the at least one blade or formed on a support structure coupled to the radially exposed inner edge of the blade.

[0105] 2. The blood pump according to claim 1, wherein the stationary support includes at least one pin or cone extending along the axis of rotation.

[0106] 3. The blood pump according to claim 1 or 2, wherein the stationary support is generally cylindrical or tapered in shape.

[0107] 4. The blood pump according to any one of claims 1 to 3, wherein the at least one stationary support extends axially for less than half the length of the impeller, or extends substantially along the entire length of the impeller.

[0108] 5. The blood pump according to any one of claims 1 to 4, comprising two supports, each support having a stationary support portion extending axially into the impeller at opposite axial ends of the impeller.

[0109] 6. The blood pump according to any one of claims 1 to 5, wherein the rotating support surface extends substantially along the entire length of the radially exposed inner edge of the at least one blade, or extends only along a portion of the length of the radially exposed inner edge of the at least one blade.

[0110] 7. The blood pump according to any one of claims 1 to 6, wherein the stationary support has a central axial channel extending therethrough.

[0111] 8. The blood pump according to any one of claims 1 to 7, wherein the stationary support is coupled to the pump housing by means of a support structure, the support structure including at least one hole to allow blood to pass through in the axial direction.

[0112] 9. The blood pump according to any one of claims 1 to 8, wherein the stationary support is connected to the pump housing by means of a support structure, the size and shape of which are designed to guide blood flow in the radial direction.

[0113] 10. The blood pump according to any one of claims 1 to 9, wherein the at least one blade is disposed on at least one of the outer surface of the impeller hub and the inner surface of the impeller hub.

[0114] 11. The blood pump according to any one of claims 1 to 10, wherein the at least one blade is disposed on the outer surface of the hub of the impeller and extends axially beyond the hub.

[0115] 12. The blood pump according to any one of claims 1 to 11, wherein the impeller has a blood flow channel extending through a hub of the impeller, wherein the impeller includes at least one outer blade and at least one inner blade, the at least one outer blade being disposed on an outer surface of the hub of the impeller and being sized and shaped to deliver blood from a blood flow inlet to a blood flow outlet, and the at least one inner blade being disposed in the channel and being sized and shaped to deliver blood through the channel.

[0116] 13. The blood pump according to claim 12, wherein the rotating support surface is formed on the radially exposed inner edge of at least one of the inner blade and the outer blade.

[0117] 14. The blood pump according to claim 12 or 13, comprising two supports, each support having a stationary support portion extending axially into the impeller at opposite axial ends, wherein a rotating support surface of one support is formed on the radially exposed inner edge of the at least one inner blade, and a rotating support surface of the other support is formed on the radially exposed inner edge of the at least one outer blade.

[0118] 15. The blood pump according to any one of claims 12 to 14, wherein the channel of the impeller extends at least partially or completely along the axis of rotation.

[0119] 16. The blood pump according to claim 15, wherein the at least one stationary support extends at least half or at least three-quarters of the length of the passage of the impeller, or extends completely through the passage of the impeller.

[0120] 17. The blood pump according to any one of claims 12 to 16, wherein the at least one blade is arranged on the impeller such that the blade is divided by the hub of the impeller into an inner portion constituting the inner blade and an outer portion constituting the outer blade.

[0121] 18. The blood pump according to any one of claims 12 to 17, wherein the maximum diameter of the stationary support is smaller than the minimum diameter of the impeller channel.

[0122] 19. The blood pump according to any one of claims 1 to 18, wherein the pump housing has a secondary blood flow inlet axially spaced from the blood flow inlet and the blood flow outlet in the main flow direction.

[0123] 20. The blood pump according to claim 19, wherein the impeller comprises at least two blades, at least one of the at least two blades being associated with the blood flow inlet to deliver blood from the blood flow inlet to the blood flow outlet in a primary flow direction, and at least another of the at least two blades being associated with a secondary blood flow inlet to deliver blood from the secondary blood flow inlet to the blood flow outlet in a direction opposite to the primary flow direction.

[0124] 21. The blood pump according to claim 20, wherein the at least two blades are arranged at axially opposite portions of the impeller adjacent to the intermediate portion, and the size and shape of the at least one blade associated with the secondary blood flow inlet are designed to deliver blood along the intermediate portion of the impeller.

[0125] 22. The blood pump according to any one of claims 1 to 21, wherein the support structure comprises at least one of at least one ring and at least one wing, the at least one ring surrounding at least a portion of the stationary support portion, and the at least one wing engaging at least a portion of the stationary support portion.

[0126] 23. The blood pump according to any one of claims 1 to 22, wherein the dimensions and shape of the rotating support surface are designed to engage the axial end of the stationary support portion.

[0127] 24. The blood pump according to any one of claims 1 to 23, comprising an electric motor for driving the impeller, the stator of the electric motor being coupled to the pump housing and arranged circumferentially around the impeller.

[0128] 25. The blood pump according to claim 24, wherein the stator of the electric motor includes at least one electrical device for generating a rotating magnetic field, and the impeller includes at least one permanent magnet.

[0129] 26. The blood pump according to any one of claims 1 to 25, wherein the stationary support and the impeller each include at least one magnet, the magnet in the stationary support and the magnet in the impeller being radially aligned and respectively arranged in the stationary support and the impeller, such that an axial repulsive magnetic force is generated between the stationary support and the impeller.

[0130] 27. The blood pump according to any one of claims 1 to 26, wherein at least one of the stationary support surface and the rotating support surface comprises a material having a greater hardness than the material of the impeller and the remainder of the stationary support portion, respectively.

[0131] 28. The blood pump according to any one of claims 1 to 27, wherein the impeller includes at least one secondary blade disposed on the axial end surface of the impeller.

[0132] 29. The blood pump according to claim 28, wherein the secondary blades constitute part of a hydrodynamic bearing.

[0133] 30. A blood pump comprising a pump housing having a blood flow inlet and a blood flow outlet, and an impeller disposed within the pump housing for rotation about a rotation axis, the impeller having a blood flow channel extending through a hub of the impeller, wherein the impeller includes outer blades and inner blades, the outer blades being disposed on an outer surface of the hub of the impeller and being sized and shaped to deliver blood from the blood flow inlet to the blood flow outlet, and the inner blades being disposed in the channel and being sized and shaped to deliver blood through the channel.

[0134] 31. The blood pump according to claim 30, wherein the impeller is rotatably supported in the pump housing by at least one support, wherein the inner blades disposed in the channel are sized and shaped to deliver blood through the channel to the support.

[0135] 32. The blood pump according to claim 30 or 31, wherein the passage of the impeller extends at least partially or completely along the axis of rotation.

[0136] 33. The blood pump according to any one of claims 30 to 32, wherein the impeller includes a support structure disposed in the channel.

[0137] 34. The blood pump according to claim 33 further includes at least one pin extending along the axis of rotation, wherein at least a portion of the pin engages a support structure of the impeller to form at least one support.

[0138] 35. The blood pump according to claim 34, wherein the pin extends at least half or at least three-quarters of the length of the passage of the impeller, or extends completely through the passage of the impeller.

[0139] 36. The blood pump according to claim 34 or 35, wherein the maximum diameter of the pin is smaller than the minimum diameter of the channel of the impeller.

[0140] 37. The blood pump according to any one of claims 33 to 36, wherein the inner blades of the impeller form part of the impeller's support structure and have at least one radial inner edge defining the support surface.

[0141] 38. The blood pump according to claims 37 and 34, wherein at least a portion of at least one radially inner edge of the inner blade engages at least a portion of the circumferential surface of the pin to form the at least one support.

[0142] 39. The blood pump according to any one of claims 34 to 36, wherein the impeller support structure includes at least one ring of at least a portion of the engagement pin.

[0143] 40. The blood pump according to any one of claims 34 to 36, wherein the impeller support structure includes at least one wing of at least a portion of the engagement pin.

[0144] 41. The blood pump according to any one of claims 34 to 36, wherein the impeller support structure includes at least one support surface, the at least one support surface being sized and shaped to engage with the axial end of the pin to form the at least one support.

[0145] 42. The blood pump according to any one of claims 30 to 41, wherein the inner blade is aligned with the outer blade.

[0146] 43. The blood pump according to any one of claims 1 to 42, wherein the blood pump is an intravascular blood pump.

[0147] 44. The blood pump according to any one of claims 1 to 43, wherein the blood pump is an axial flow blood pump, a centrifugal blood pump, or a hybrid blood pump.

Claims

1. A blood pump (1), comprising: The pump housing (2) has a blood flow inlet (21) and a blood flow outlet (22). An impeller (103) is arranged in the pump housing and rotatably supported in the pump housing by at least one of two supports (160) of the blood pump (1) for rotation about a rotation axis, each of the supports (160) having a stationary support portion extending axially into the impeller (103) at opposite axial ends of the impeller, the impeller (103) having at least one blade (131, 132) for conveying blood from the blood flow inlet to the blood flow outlet. At least one of the static support portions (104) is connected to the pump housing and has a static support surface (161) facing outward in the radial direction. The support (160) also includes a rotating support surface (162) that interacts with the static support surface (161) to form the support (160). The rotating support surface (162) faces inward in the radial direction and is formed on a support structure connected to the radially exposed inner edge of the blade.

2. The blood pump according to claim 1, wherein the stationary support portion includes at least one pin or cone extending along the axis of rotation, and the stationary support portion is generally cylindrical or tapered.

3. The blood pump according to claim 2, wherein at least one of the stationary support portions has a central axial channel extending therethrough.

4. The blood pump according to any one of claims 1-3, wherein the stationary support is coupled to the pump housing by means of a support structure, the support structure including at least one hole to allow blood to pass through in the axial direction, and / or the size and shape of the support structure are designed to guide blood flow in the radial direction.

5. The blood pump according to any one of claims 1 to 3, wherein, The at least one blade is disposed on at least one of the outer surface of the impeller hub and the inner surface of the impeller hub, wherein when the at least one blade is disposed on the outer surface of the impeller hub, the blade extends axially beyond the hub.

6. The blood pump according to any one of claims 1 to 3, wherein the impeller (103) has a blood flow channel (133) extending through a hub (136) of the impeller (103), wherein the impeller (103) includes at least one outer blade (131) and at least one inner blade (132), the at least one outer blade being disposed on an outer surface of the hub (136) and being sized and shaped for conveying blood from the blood flow inlet (21) to the blood flow outlet (22), the at least one inner blade being disposed in the blood flow channel (133) and being sized and shaped for conveying blood through the blood flow channel (133), wherein the rotating support surface is formed on the radially exposed inner edge of at least one of the inner blade and the outer blade.

7. The blood pump of claim 6, wherein a rotating support surface of one of the supports is formed on the radially exposed inner edge of the at least one inner blade, and a rotating support surface of the other of the supports is formed on the radially exposed inner edge of the at least one outer blade.

8. The blood pump according to claim 6, wherein the blood flow channel (133) of the impeller (103) extends at least partially or completely along the axis of rotation, wherein at least one of the stationary supports extends at least half or at least three-quarters of the length of the blood flow channel of the impeller, or extends completely through the blood flow channel.

9. The blood pump of claim 8, wherein the impeller has at least one radial opening to connect the blood flow channel to the environment of the impeller.

10. The blood pump of claim 7, wherein the at least one blade is arranged on the impeller such that the blade is divided by the hub of the impeller into an inner portion constituting the inner blade and an outer portion constituting the outer blade.

11. The blood pump according to any one of claims 1 to 3, wherein the pump housing has a secondary blood flow inlet axially spaced from the blood flow inlet and the blood flow outlet along the main flow direction, wherein the impeller includes at least two blades, at least one of the at least two blades being associated with the blood flow inlet to deliver blood from the blood flow inlet to the blood flow outlet along the main flow direction, and at least another of the at least two blades being associated with the secondary blood flow inlet to deliver blood from the secondary blood flow inlet to the blood flow outlet in a direction opposite to the main flow direction, wherein the at least two blades are arranged in an axially opposite portion of the impeller adjacent to the intermediate portion.

12. The blood pump of claim 11, wherein the size and shape of the at least one blade associated with the secondary blood flow inlet are designed to deliver blood along the middle portion of the impeller.

13. The blood pump according to any one of claims 1 to 3, wherein the support comprises at least one of at least one ring (155) and at least one wing (153), the at least one ring surrounding at least a portion of the stationary support portion (104), the at least one wing engaging at least a portion of the stationary support portion (104), and / or wherein the dimensions and shape of the rotating support surface are designed to engage the axial end (142) of the stationary support portion (104).

14. The blood pump according to any one of claims 1 to 3, comprising an electric motor for driving the impeller, wherein the stator of the electric motor is coupled to the pump housing and arranged circumferentially around the impeller, wherein the stator of the electric motor includes at least one electrical device for generating a rotating magnetic field, and the impeller includes at least one permanent magnet.

15. The blood pump according to any one of claims 1 to 3, wherein the stationary support and the impeller each include at least one magnet, the magnet in the stationary support and the magnet in the impeller being radially aligned and respectively arranged in the stationary support and the impeller, such that an axial repulsive magnetic force is generated between the stationary support and the impeller.

16. The blood pump according to any one of claims 1 to 3, wherein at least one of the stationary support surface and the rotating support surface comprises a material having a greater hardness than the material of the impeller and the remainder of the stationary support portion, respectively.

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