Blood pumps and blood pump systems

Abstract

This disclosure relates to a blood pump 10 comprising a pumping area 12 having a blood inlet 14 and a blood outlet 16, and an axial flow pump 18 having a longitudinal axis LA and at least partially disposed within the pumping area 12. The axial flow pump 18 comprises a motor 20 and a pump element 22, the motor 20 being configured to drive the pump element 22 so as to generate flow between the blood inlet 14 and the blood outlet 16 of the pumping area 12. The pumping area 12 comprises a main section 24 and an inlet section 26. The inlet section 26 is configured to be located within the space of the patient's heart. The blood pump 10 further comprises a radially extending mounting section 28 disposed around the main section 24, the mounting section 28 being configured to be attached to the outer surface of the patient's heart. This disclosure further relates to a blood pump system comprising the blood pump.

Description

Technical Field

[0001] The present invention relates to a blood pump and a blood pump system.

Background Art

[0002] Various blood pumps are known from the prior art and are also called assist artificial hearts. The blood pump assists a heart with impaired normal function by transporting blood, for example, from the left ventricle to the aorta. Some blood pumps can be introduced percutaneously during heart surgery through the vascular system, such as by the applicant's Impella® series of blood pumps. Those blood pumps are also called intracardiac or intravascular blood pumps because they reach the heart valve and form a direct connection, for example, between the left ventricle and the aorta, or between the right ventricle or right atrium and the pulmonary artery. Naturally, it is also possible to perform unloading of blood from the venous system to the patient's heart.

[0003] Other blood pumps are introduced during surgery and bypass the heart valve in that the blood pump is located substantially outside the heart. A part of the blood pump reaches the heart wall, and the blood pump is further connected to each blood vessel to bypass each heart valve. Such a blood pump is also called an extracardiac blood pump. Extracardiac blood pumps known from the prior art use a centrifugal pump to transport blood. However, those blood pumps are relatively large in size and are thus limited in medical applications. In particular, pediatric applications are often impossible due to the reduced available space in the chest of pediatric patients. In other cases, the application of those pumps requires making a hole in the heart, and since this hole is particularly large compared to the small heart of a pediatric patient, the pediatric application of those blood pumps may not be desirable.

[0004] Therefore, the object of this disclosure is to provide a relatively small blood pump. Another object of this disclosure is to provide further improvements to known blood pumps. A further object of this disclosure is to provide a blood pump system that enables the facilitated placement of a blood pump in a patient. [Overview of the project]

[0005] According to a first embodiment, a blood pump is provided comprising a pumping section and an axial flow pump. The axial flow pump has a longitudinal axis. The pumping section may have a blood inlet and a blood outlet. The axial flow pump may be disposed at least partially within the pumping section. The axial flow pump may have a motor, in particular an electric motor, and a pumping element, the motor being configured to drive the pumping element so that a flow is generated between the blood inlet and the blood outlet of the pumping section. The pumping section may comprise a main section and an inlet section, the inlet section being configured to be located within a space in the patient's heart. The space may be, for example, the left ventricle or the right ventricle, the left atrium or the right atrium. The blood pump may further comprise a radially extending mounting section disposed around the main section, the mounting section being configured to be attached to the outer surface of the patient's heart.

[0006] Therefore, the blood pump according to this disclosure may be an extracardiac blood pump having an axial flow pump. This configuration allows for a particularly small pumping area having an outer diameter of 12 mm or less. In addition, the length of the pumping area may be 35 mm or less. Thus, the blood pump according to the present invention can be more easily placed in the chest cavity of a pediatric patient.

[0007] The pumping area may be the pump housing. The pump element may be an impeller. The inlet may be arranged concentrically with the longitudinal axis of the axial flow pump. Preferably, the longitudinal axis of the pumping area coincides with the longitudinal axis of the axial flow pump.

[0008] A blood flow inlet may be provided in the inlet portion, and a blood flow outlet may be provided in the main portion.

[0009] A portion of the blood pump according to the present invention is labeled as an inlet, but blood flow can also be generated in a flow direction toward the inlet, for example, when the blood pump is configured to unload blood from the patient's vascular system into the patient's heart.

[0010] Preferably, a connection path connecting a blood inlet and a blood outlet is formed within the pumping area. The connection path may be partially formed by an annular gap. The annular gap may be defined by the inner circumferential surface of the pumping area and, in particular, by at least a portion of the axial flow pump between the inner circumferential surface of the pumping area and the outer circumferential surface of the housing of the axial flow pump.

[0011] The main body may include a pump mounting section extending radially inward from the inner circumferential surface of the main body. The motor of the axial flow pump may include a magnetic circuit jacket partially disposed on the pump mounting section. This allows for a particularly compact design and optimal blood flow between the blood inlet and blood outlet. The magnetic circuit jacket may at least partially form the housing of the axial flow pump. The magnetic circuit jacket may be made of an iron-chromium-aluminum alloy, i.e., FeCrAl alloy. The ferrite iron-chromium-aluminum alloy may contain 1% to 7% aluminum (Al). The ferrite iron-chromium-aluminum alloy may contain 20% to 25% chromium (Cr). Preferably, the ferrite iron-chromium-aluminum alloy contains 5.8% Al and / or preferably 20.5% to 23.5% Cr. Furthermore, the ferritic iron-chromium-aluminum alloy preferably contains 0% to 0.08% carbon (C), 0% to 0.7% silicon (Si), and / or 0% to 0.4% manganese (Mn). This allows for excellent dimensional stability. In addition, the above material has excellent oxidation properties and a low tendency towards aging degradation and low resistance change. The ferritic iron-chromium-aluminum alloy may be Kanthal APM.

[0012] The magnetic circuit jacket may have a smaller diameter section and a larger diameter section. The larger diameter section may be positioned at the pump mounting area. This allows for optimal blood flow along the motor.

[0013] The magnetic circuit jacket may have a tapered transition section between a smaller diameter section and a larger diameter section. The tapered transition section may have a smooth gradient, in particular, to allow for optimal blood flow.

[0014] The main body may have a clamping portion extending axially on its outer circumferential surface. The mounting portion may be detachably attached to the clamping portion so that it can be mounted at any position along the axial extension of the clamping portion. The clamping portion is preferably concentric with the longitudinal axis of the axial flow pump. Therefore, the position of the blood pump can be individually adapted to the patient by mounting the mounting portion at different positions along the axial extension of the clamping portion. Thus, the axial distance from the mounting portion to the inlet can be adjusted. In other words, the extent to which the inlet extends into the space of the patient's heart can be adjusted.

[0015] The mounting section may comprise a perforated annular member and a tangential fastener. The tangential fastener may be tangential to a circle concentric with the longitudinal axis of the axial flow pump. The perforated annular member may be arranged around the main body. The perforated annular member may have a first circumferential end and a second circumferential end, which are spaced apart from each other so that a slot is formed between the first and second circumferential ends. The tangential fastener may be configured to move the first circumferential end relative to the second circumferential end so that the size of the slot is variable. Narrowing the slot reduces the area covered by the annular member perpendicular to the longitudinal axis, thus creating a clamping force that clamps the mounting section to the main body. In particular, the tangential fastener may be a screw, and tightening the tangential fastener narrows the slot. Conversely, loosening the tangential fastener reduces the clamping force and allows the mounting section to be detached from the main body.

[0016] A sealing element may be provided in the slot. Preferably, the sealing element is a highly elastic sealing element. Preferably, the sealing element is made from a biocompatible material. The sealing element seals the slot and thus prevents bypass blood flow from the patient's heart space along the outer surface of the pumping area.

[0017] The tangential fasteners preferably extend through a sealing element. In other words, the sealing element may be arranged around the outer surface of the tangential fasteners. The position of the sealing element is thus firmly defined.

[0018] The pumping section may be a multi-part component, and the main section may comprise a first main section part and a second main section part. The first main section part may be made of a metallic material, preferably titanium or a titanium alloy. The second main section part may be made of a plastic material, preferably polycarbonate. Naturally, the first main section part may also be made of a plastic material, preferably polycarbonate, or a different metallic material. Therefore, the second main section part may also be made of a metallic material, preferably titanium or a titanium alloy. The first and second main sections part may be attached to each other by preferred methods such as gluing, clamping, bonding, or welding. The inlet section may be formed separately from the main section or may be formed integrally with the main section as a single piece. This allows for the streamlined assembly of the blood pump and further cost reductions can be achieved by selecting the appropriate material combinations.

[0019] Preferably, the blood outlet is provided in the second main part. The blood outlet may comprise a first discharge port. The first discharge port may extend tangentially to a circle that is concentric with the longitudinal axis of the axial flow pump. This allows for a particularly compact design of the blood pump.

[0020] The blood pump may further comprise a tubular graft connected to a first discharge port. The tubular graft may be configured to be attached to the patient's blood vessel, for example, the patient's aorta.

[0021] The blood pump may further comprise a fixing member and a bushing with a circumferential undercut. The bushing may be positioned around a first discharge port. A tubular graft may be positioned around the bushing. In particular, the axial end of the tubular graft may be positioned around the bushing. The fixing member may be configured to clamp the tubular graft to the circumferential undercut. This allows for easy and secure attachment and removal of the tubular graft to and from the pumping area.

[0022] An exoskeleton may be placed around the tubular graft. The exoskeleton can prevent any damage to the tubular graft and may further allow for better placement of the tubular graft within the patient's chest.

[0023] The exoskeleton may comprise a plurality of hinged first members. All first members may be uniformly formed. Each first member may consist of an annular base member, two mounting projections positioned on either side of the annular base member, and two mounting openings positioned on either side of the annular base member. The mounting projections may be provided for each knob. The mounting openings may be provided for each knob. The mounting projections protrude radially outward from the annular base member. The mounting projections and mounting openings are offset by 180°. In other words, mounting projections or mounting openings are provided at 90° intervals, as seen circumferentially around the annular base member, so that the mounting openings are always located between the mounting projections. Thus, the mounting projections of one first member may be connected to the mounting openings of another first member, thereby forming a hinge.

[0024] Preferably, the first member closest to the first discharge port is hinged to the pumping area. Preferably, this first member is hinged to a stationary member.

[0025] The exoskeleton may further include a second member that is hinged to a first member that is farthest from the first discharge port. The second member has no two mounting openings and only two mounting protrusions. The mounting protrusions may be provided on respective knobs. A sleeve may be coupled to the second member, and the sleeve is disposed around the tubular graft. The sleeve can prevent buckling of the tubular graft.

[0026] The second member may include an axially extending through-hole, and the tubular graft may extend through the axially extending through-hole. The diameter of the axially extending through-hole may at least partially decrease in the direction towards the first discharge port. In other words, the diameter of the axially extending through-hole widens in the direction away from the first discharge port. Preferably, the diameter change is a smooth transition. Thus, no sharp curves or the like that can damage the tubular graft or promote buckling of the tubular graft are formed.

[0027] A first sensor may be disposed proximate to the blood flow outlet, preferably within the pumping region. The first sensor may be a first optical sensor. The first sensor may be configured to detect a pressure parameter, particularly a pressure parameter indicating the pressure within the blood vessel to which the tubular graft is attached. The blood vessel may be the aorta, and thus, the pressure parameter may supply one indicating the aortic pressure.

[0028] A second sensor may be disposed proximate to the blood flow inlet. The second sensor may be a second optical sensor. The second sensor may be configured to detect a pressure parameter, particularly a pressure parameter indicating the pressure within the heart chamber. The first pressure sensor may be attached to the inlet portion and may detect, for example, a pressure parameter supplying one indicating the left ventricular pressure.

[0029] Preferably, the pressure parameter is sent to a control unit configured to adjust the rotational speed of the pump element. The control unit can be part of the blood pump or part of a blood pump system comprising the blood pump. Based on the transmitted pressure parameter, the control unit can calculate the bandwidth of the motor current applied to the motor. The motor current essentially corresponds to the rotational speed of the motor. In particular, the control unit can be configured to adjust the motor current applied to the motor, and thus the rotational speed of the pump element, over time such that an overall blood flow rate consistent with the expected blood flow rate of the heart is achieved. The control unit can be configured to adjust the motor current such that a continuous total blood flow rate or a pulsatile total blood flow rate is achieved. In particular, the rotational speed of the pump element can be in the range of 17,000 rpm to 33,000 rpm, preferably in the range of 20,000 rpm to 26,000 rpm. Accordingly, the motor current can be in the range of 100 mA to 700 mA, preferably in the range of 150 mA to 380 mA.

[0030] The diameter of the main part of the pumping area may be larger than the diameter of the inlet of the pumping area. The pumping area may include a tapered part connecting the main part and the inlet of the pumping area. This greatly facilitates the placement of the blood pump, particularly the placement of the inlet into the space of the patient's heart.

[0031] The blood flow inlet of the pumping area can include at least one radial inlet opening, particularly a plurality of radial inlet openings. In particular, the blood flow inlet can include five radial inlet openings. The plurality of radial inlet openings are preferably evenly distributed around the circumference of the inlet. The blood flow inlet preferably further includes an axial inlet opening. This ensures that no tissue suction occurs over the time of use of the blood pump, which otherwise could impair the function of the blood pump.

[0032] An axial flow pump may comprise a drive shaft driven by a motor, and the pump element may be supported on the drive shaft. The motor rotor may be supported on the drive shaft such that the rotor is positioned radially inward from the motor stator. Alternatively, the pump element may be supported on a drive assembly, which comprises magnets that form the motor rotor and are positioned adjacent to electrically magnetized zones within the stator of the motor's drive region. Alternatively, the pump element may comprise magnets positioned adjacent to electrically magnetized zones within the stator of the drive region. Based on the attractive force between the magnets of the drive assembly or pump element and the magnetized zones within the stator of the drive region, rotation may be transmitted to the drive assembly and therefore to the pump element, or directly to the pump element. In particular, a rotating magnetic field may be established within the stator of the drive region, in which a control unit applies appropriate current or voltage to the stator in a controlled manner, thereby rotating the drive assembly or pump element. Therefore, the pump element may be driven non-contact.

[0033] When the pump elements are driven without contact, the axial flow pump may include bearing assemblies supporting the pump elements or the drive assemblies, respectively. The bearing assembly may include a first bearing disposed within the inlet at a first shaft end of the pump element. The bearing assembly may include a second bearing disposed at a second shaft end of the pump element. A corresponding bearing assembly is disclosed in PCT / EP2023 / 051785 (Application No.), which is incorporated herein by reference in its entirety for all purposes.

[0034] The pumping area may include a second discharge port extending tangentially to a circle concentric with the longitudinal axis of the axial flow pump. The second discharge port may be configured to guide and / or support an elongated connection assembly. Alternatively, the pumping area may include a guide opening extending tangentially to a circle concentric with the longitudinal axis of the axial flow pump, through the pumping area, in particular through the main section, and preferably through the second main section. The guide opening may be configured to guide and / or support an elongated connection assembly. The elongated connection assembly may include one or more of a catheter, a motor cable, a first optical fiber, and a second optical fiber. The second discharge port or guide opening may each be positioned parallel to the first discharge port. The second discharge port or guide opening may have the same orientation as the first discharge port.

[0035] The main portion may include a circumferential region having increased surface roughness. The circumferential region having increased surface roughness is preferably produced by material ablation, preferably by laser material ablation, or preferably by laser bead blasting. Preferably, the circumferential region is surrounded by the patient's tissue when the blood pump is placed in the patient. In particular, the circumferential region may be surrounded by a portion of the patient's heart when the blood pump is placed in the patient.

[0036] Preferably, the main part of the pumping area has a central mounting opening at the shaft end opposite the inlet. Preferably, a cover closes the central mounting opening. The cover may be made of a plastic material, particularly polycarbonate.

[0037] Preferably, the central mounting opening has an annular surface that is recessed toward the inlet. The annular surface may be coplanar with the shaft end face of the axial flow pump and, in particular, with the shaft end face of the magnetic circuit jacket. This allows for the definition of the correct mounting position of the axial flow pump.

[0038] According to a second embodiment, the blood pump assembly comprises a blood pump as described above and an expandable member. The expandable member may be configured to be positioned within the inlet at the free-axial end of the inlet. The expandable member may be an inflatable and deflated balloon. During the placement of the blood pump, the inflated expandable member is positioned in the inlet of the blood pump, with it being the furthest outer portion. When entering the punctured heart of the patient, the expandable member widens the puncture site and facilitates the placement of the inlet into the patient's heart. After the placement of the blood pump, the expandable member may be deflated and removed from the patient's body, for example, by using a guidewire or hose configured for the inflation and deflation of the expandable member. Preferably, the expandable member is inflated with a liquid, preferably a NaCl solution.

[0039] The expandable member preferably comprises a base portion and a tip portion. The tip portion may have a conical shape. The base portion may be provided at the inlet when the expandable member is inflated. The tip portion may extend from the axial inlet opening when the expandable member is inflated. The expandable member may have a central opening for the passage of a guide wire.

[0040] Therefore, a method for positioning a blood pump assembly as described above may then include the steps of puncturing the patient's heart and positioning at least a portion of the blood pump assembly through the puncture site. The step of positioning at least a portion of the blood pump assembly through the puncture site may include introducing a guidewire through the puncture site. The step of positioning at least a portion of the blood pump assembly through the puncture site may include expanding the puncture site. The step of positioning at least a portion of the blood pump assembly through the puncture site may include inflating the expandable member, preferably with a liquid, such as a NaCl solution. The step of positioning at least a portion of the blood pump assembly through the puncture site may include advancing the blood pump along the guidewire. The step of positioning at least a portion of the blood pump assembly through the puncture site may include moving the tip of the expandable member through the puncture site. The step of positioning at least a portion of the blood pump assembly through the puncture site may include deflating and removing the expandable member after the inlet has been received into the space of the patient's heart.

[0041] Therefore, according to the method of the present invention, there is no need to remove tissue for the placement of the blood pump. Rather, the patient's heart is punctured and the puncture site is dilated. Thus, the recovery of the patient's heart is greatly promoted after the removal of the blood pump, especially when the patient is a child.

[0042] The above summary and the following detailed description of preferred embodiments will be better understood when read in conjunction with the accompanying drawings. The drawings are referenced for illustrative purposes of this disclosure. However, the scope of this disclosure is not limited to the specific embodiments disclosed in the drawings. [Brief explanation of the drawing]

[0043] [Figure 1] This is a first perspective view of a blood pump according to the first embodiment. [Figure 2] This is a second perspective view of the blood pump shown in Figure 1. [Figure 3] Figure 1 is a side view of the blood pump. [Figure 4] Figure 1 is a top view of the blood pump. [Figure 5] This is a rear view of the blood pump shown in Figure 1 with the cover removed. [Figure 6] This is a cross-sectional view of the blood pump along line AA shown in Figure 4. [Figure 7] This is a modified diagram of the blood pump shown in Figure 6. [Figure 8] Figure 1 is a perspective view of the pumping area of ​​a blood pump. [Figure 9] Figure 8 is a side view of the pumping area. [Figure 10] Figure 1 is a perspective view of the blood pump mounting section. [Figure 11] Figure 10 is a front view of the mounting section. [Figure 12] This is a side view of a blood pump according to the second embodiment. [Figure 13] Figure 12 is a front view of the blood pump. [Figure 14] Figure 12 is a partial cross-sectional view of the blood pump. [Figure 15] Figure 14 is a cross-sectional view of the blood pump. [Figure 16] Figure 1 is a perspective view of a blood pump assembly equipped with a blood pump. [Figure 17] Figure 16 is a cross-sectional view of the blood pump assembly. [Modes for carrying out the invention]

[0044] Within the figures, similar reference numbers indicate similar or identical elements. Furthermore, for reasons of clarity, not all reference numbers are depicted in every figure.

[0045] First exemplary embodiment Figures 1 and 2 show perspective views of a blood pump 10 according to a first exemplary embodiment. The blood pump 10 comprises a housing in the form of a pumping section 12. The pumping section 12 is essentially cylindrical and has a blood inlet 14 and a blood outlet 16 (see, for example, Figure 6). The pumping section 12 comprises a main section 24 and an inlet section 26. The blood inlet 14 is located in the inlet section 26. The main section 24 has a blood outlet 16. The main section 24 and the inlet section 26 are connected by a tapered section 98. When the blood pump 10 is placed in a patient, the inlet section 26 is configured to be located within the space of the patient's heart. For example, if the blood pump 10 is configured as a left ventricular support device, the space of the patient's heart is the left ventricle. Generally, the heart is then punctured in the apical region, and the inlet section 26 is gently pushed through a puncture hole to extend through the patient's heart into the left ventricle, as will be described in more detail below.

[0046] The blood inlet 14 comprises an axial inlet opening 102 and a plurality of radial inlet openings 100 that are evenly distributed along the circumference of the inlet portion 26. In a first exemplary embodiment, the blood inlet 14 comprises five radial inlet openings 100.

[0047] Furthermore, the blood pump 10 includes a radially extending attachment portion 28 arranged around the main portion 24. The attachment portion 28 is configured to be attached to the outer surface of the patient's heart. In particular, the attachment portion 28 may be attached to felt, cloth, fabric, tissue, nonwoven fabric or similar material (not shown, hereinafter referred to as felt) that is attached to the outer surface of the patient's heart. In particular, the attachment portion 28 may be sewn to the felt or directly to the outer surface of the patient's heart. The attachment portion 28 will be described in more detail below, particularly with reference to Figures 10 and 11.

[0048] Axial flow pump 18 As depicted in Figures 6 and 7, the blood pump 10 further comprises an axial flow pump 18. The axial flow pump 18 has a motor 20 and a pump element 22 in the form of an impeller. The axial flow pump 18 defines a longitudinal axis LA that coincides with the longitudinal axis of the pumping area 12. The motor 20 is configured to drive the pump element 22 so that blood flow is generated between the blood inlet 14 and the blood outlet 16. The motor 20 is configured essentially similarly to the motor disclosed in International Publication No. 2008 / 116765 A2, which is incorporated herein by reference in its entirety for all purposes. The motor 20 comprises a magnetic circuit jacket 34. In the embodiments of Figures 6 and 7, the magnetic circuit jacket 34 is not perfectly cylindrical along its axial extension and comprises a smaller diameter portion 36 and a larger diameter portion 38 connected by a tapered transition portion 40. The tapered transition portion 40 allows for a smooth transition between the smaller diameter portion 36 and the larger diameter portion 38. The smaller diameter portion 36 is oriented toward the entrance portion 26, while the larger diameter portion 40 is oriented toward away from the entrance portion 26.

[0049] When the pump element 22 rotates at a given rotational speed, blood is drawn into the pumping area 12 through the blood flow inlet 14, i.e., through the radial inlet opening 100 and the axial inlet opening 102. The blood flow thus generated first flows from the blood flow inlet 14 through the annular gap AG defined by the inner circumferential surface 32 of the main body 24 and the axial flow pump 18, which is essentially parallel to the longitudinal axis LA. The blood flow is then deflected toward the blood flow outlet 16, for example, in the tangential direction. The annular gap AG is part of the connecting path that connects the blood flow inlet 14 and the blood flow outlet 16, as seen, for example, in Figure 6. As depicted in Figure 4, the blood flow outlet 16 is oriented tangentially to the longitudinal axis LA.

[0050] Main section 24 and entrance section 26 The main body 24 is a multi-part member comprising a first main body part 58, a second main body part 60, and a third main body part 61. The first main body part 58 is integrally formed with the inlet 26 and the tapered portion 98. The first main body part 58 may be made of a metallic material, and in particular titanium or a titanium alloy. The second main body part 60 is attached to the axial end of the first main body part 58 opposite the inlet 26. The second main body part 60 is made of a plastic material, and in particular polycarbonate. The first main body part 58 and the second main body part 60 are fixed to each other by gluing. The third main body part 61 is disposed radially inward within the first main body part 58. The third main body part 61 is designed so as not to obstruct blood flow as possible. As shown in Figures 6 and 7, the third main part 61 covers the sharp edge area on the inner circumferential surface of the first main part 58. The third main part 61 is made of a plastic material, particularly polycarbonate. The third main part 61 is fixed to the first main part 58 and the third second part 60 by adhesive.

[0051] The axial flow pump 18 is mounted on a pump mounting portion 30 that extends radially inward from the inner circumferential surface 32 of the main body 24. In particular, the pump mounting portion 30 extends radially inward from the inner circumferential surface of the second main body part 60, and the larger diameter portion 38 of the magnetic circuit jacket 34 of the motor 20 is supported within the pump mounting portion 30. To mount the axial flow pump 18, the main body 24 is provided with a central mounting opening 116 at the free-axis end opposite to the inlet portion 26. The central mounting opening 116 is provided with an annular surface 118 that is recessed toward the inlet portion 26. When mounting the axial flow pump 18, it is pushed into the main body 24 through the central mounting opening 116 until the annular surface 118 is flush with the respective axial end faces of the axial flow pump 18 or the magnetic circuit jacket 34. The axial flow pump 18 is further attached to the pump mounting portion 30 by gluing. Subsequently, the cover 114 is attached by adhesive to close the central mounting opening 116. In the rear view shown in Figure 5, the cover 114 is not shown.

[0052] In addition, the main portion 24 includes a circumferential region 112 having increased surface roughness. The circumferential region 112 having increased surface roughness is preferably produced by material ablation, preferably by laser material ablation, or preferably by laser bead blasting. The circumferential region 112 is surrounded by the patient's cardiac tissue when the blood pump 10 is placed in the patient, thereby improving the attachment between the blood pump 10 and the patient's heart.

[0053] Mounting part 28 As shown in Figures 1-7, 10, and 11, the mounting portion 28 comprises a perforated annular member 46, a tangential fastener 48, and a plurality of mounting flaps 122 extending radially outward from the annular member 46. The annular member 46 comprises a first circumferential end 50 and a second circumferential end 52 that face each other in the circumferential direction. A slot or gap 54 is formed between the first circumferential end 50 and the second circumferential end 52. The first circumferential end 50 and the second circumferential end 52 can be moved relative to each other by tightening or loosening the tangential fastener 48. Thus, the circumferential extension of the slot 54 is variable.

[0054] Tightening the tangential fastener 48 reduces the size of the area covered by the perforated annular member 46, which is perpendicular to the longitudinal axis LA. Thus, the mounting portion 28 can be fixed to the outer circumferential surface 44 of the main portion 24 and positioned around the main portion 24 by the clamping force induced by tightening the tangential fastener 48. Releasing the tangential fastener 48 increases the size of the area covered by the perforated annular member 46 and detaches the annular member 46 from the outer circumferential surface 44 of the main portion 24. Since a portion of the outer circumferential surface 44 of the main portion 24 defines the clamping portion 42, the mounting portion 28 can be mounted at any position along the axial extension of the clamping portion 42 by tightening and releasing the tangential fastener 28. This allows for adjustment of the axial extension of the portion extending into the space of the patient's heart. Figures 6 and 7 illustrate two different positions of the mounting portion 28 along the clamping portion 42 of the main portion 24.

[0055] Each mounting flap 122 is provided with a plurality of axially extending through-holes, which are configured for attachment to felt or the outer surface of the patient's heart, such that surgical sutures can be passed through these holes. Furthermore, each mounting flap 122 has a space between it that reaches the perforated annular member 46. This is necessary to allow the first circumferential end 50 and the second circumferential end 52 of the perforated annular member 46 to move relative to each other by the tangential fasteners 48.

[0056] Furthermore, the mounting portion 28 includes a sealing element 56 that seals the slot 54. The sealing element 56 is a highly flexible sealing element made of a biocompatible material. In this exemplary embodiment, the sealing element 56 is disposed within the slot 54 with a tangential fastener 48 extending through the sealing element 56. The sealing element 56 obstructs bypass blood flow along the outer circumferential surface of the pumping area 12 when the blood pump 10 is placed in the patient.

[0057] Blood outlet 16, tubular graft 64, and exoskeleton 72 As depicted in Figures 8 and 9, the blood flow outlet 16 includes a first discharge port 62 extending tangentially from the main body 24 with respect to the longitudinal axis LA. In this exemplary embodiment, the first discharge port 62 is provided to a second main body part 60. The first discharge port 62 is configured to support a tubular graft 64 through which blood pumped by the axial flow pump 18 is delivered to the patient's blood vessels. As described above, this exemplary embodiment is configured as a left ventricular assist device so that the tubular graft 64 is attached to the patient's aorta.

[0058] For securing the tubular graft 64, the blood pump 10 comprises a fixing member 66 and a bushing 68, referring to Figures 6 and 7. The bushing 68 is provided with a circumferential undercut 70. The bushing 68 is positioned around the outer circumferential surface of the first discharge port 62 such that the circumferential undercut 70 is oriented toward the origin of the first discharge port 62 on the main body 24. The bushing 68 also includes a tapered portion to facilitate the placement of the axial end of the tubular graft 64 onto the bushing 68. The fixing member 66 is configured as a clamp and clamps the tubular graft 64 to the circumferential undercut 70. In this exemplary embodiment, the clamping force is generated by the fastener. Naturally, the fixing member 66 can be configured differently, as long as a sufficiently high adhesive force can be generated.

[0059] To provide sufficient stability for the tubular graft 64 when placed inside the patient's body, the blood pump 10 includes an exoskeleton 72 extending from a fixation member 66 along a portion of the tubular graft 64. The exoskeleton 72 comprises a plurality of first members 74.

[0060] The first members 74 are identical, each comprising an annular base member 80, two mounting openings 82, and two mounting projections 84. The two mounting openings 82 extend axially from the annular base member 80 and provide for two knobs that are opposite each other. The two mounting projections 84 also extend axially from the annular base member 80 in the opposite direction to the two knobs that have mounting openings 82 and provide for two knobs that are also opposite each other. Thus, each knob is offset by 90° along the circumference of the annular base member 80. For example, as seen in Figure 1, multiple first members 74 are hinged together such that the mounting projections 84 of one first member 74 are supported within the mounting openings 82 of an adjacent first member 74. To connect the first members 74 to each other, the first members are always offset by 180°. In this exemplary embodiment, the exoskeleton 72 comprises a total of seven first members 74, but the exoskeleton 72 may also comprise more or fewer first members 74, depending on the required conditions.

[0061] In addition, the exoskeleton 72 includes a second member 76 attached to the first member 74 furthest from the first discharge port 62. The second member 76 also includes an annular base member and two mounting projections 86 that provide axially extending knobs opposite each other. Thus, the second member 76 can be hinged to an adjacent first member 74. A sleeve 78 is coupled to the second member 76, and the tubular graft 64 extends through the sleeve 78. Furthermore, the annular member of the second member 76 defines an axial through-hole 88 disposed around the tubular graft 64. As shown in Figures 6 and 7, the diameter of the axial through-hole 88 smoothly decreases in part toward the first discharge port 62. The sleeve 78 and the smoothly decreasing diameter suppress buckling or bending of the tubular graft 64.

[0062] To attach the exoskeleton 72 to the pumping area 12, the fixing member 66 is provided with two axially extending knobs 124, each knob 124 having a mounting opening configured to receive the respective mounting projection 84 of the first member 74 closest to the pumping area 12. Thus, the knobs 124 are provided opposite each other on the fixing member 66.

[0063] First sensor 90 and second sensor 92 The blood pump 10 includes a first sensor 90. The first sensor 90 is an optical sensor configured to detect pressure parameters. In particular, the first sensor 90 is intended to deliver pressure parameters that provide an indication of the pressure found in the blood vessel to which the tubular graft 64 is attached. In this exemplary embodiment, since the blood pump 10 is configured as a left ventricular assist device, the first sensor 90 is therefore configured to deliver pressure parameters that provide an indication of the aortic pressure. Thus, the first sensor 90 is located within the main body 24 in close proximity to the blood flow outlet 16, referring to Figures 6 and 7. In this embodiment, the first sensor 90 is located adjacent to the pump attachment 30.

[0064] The blood pump 10 includes a second sensor 92. The second sensor 92 is an optical sensor configured to detect pressure parameters. In particular, the second sensor 92 is intended to deliver pressure parameters that provide an indication of the pressure found in the space of the patient's heart through which the inlet 26 extends. In this exemplary embodiment, since the blood pump 10 is configured as a left ventricular assist device, the second sensor 92 is therefore configured to deliver pressure parameters that provide an indication of left ventricular pressure. Thus, the second sensor 92 is positioned in the inlet 26 in close proximity to the blood flow inlet 14, referring to Figure 1. In this embodiment, the second sensor 92 is positioned adjacent to the axial inlet opening 102.

[0065] A first sensor 90 is connected to a control unit (not shown) via a first optical fiber 94. A second sensor 92 is connected to the control unit via a second optical fiber 96. The control unit is configured to calculate the signals transmitted by the first sensor 90 and the second sensor 92, and to adjust the rotational speed of the axial flow pump 18 based on these signals. Based on the transmitted pressure parameters, the control unit may calculate the bandwidth of the motor current applied to the motor 20. The motor current essentially corresponds to the rotational speed of the motor 20. In particular, the control unit is configured to adjust the motor current applied to the motor 20, and therefore the rotational speed of the pump element 22, over time so that an overall blood flow consistent with the expected blood flow of the heart is achieved. The control unit is configured to adjust the motor current so that a continuous or pulsed total blood flow is achieved. In particular, the rotational speed of the pump element 22 is in the range of 17,000 rpm to 33,000 rpm, preferably in the range of 20,000 rpm to 26,000 rpm. Therefore, the motor current is in the range of 100mA to 700mA, preferably in the range of 150mA to 380mA.

[0066] Guide opening 106 As shown in Figures 8 and 9, the pumping area 12 includes a guide opening 106 that extends tangentially with respect to the longitudinal axis LA through the pumping area 12. In particular, the guide opening 106 extends through the main section 24, specifically through the second main section part 60. The guide opening 106 is configured to guide and support an elongated connection assembly 104. In this exemplary embodiment, the elongated connection assembly 104 comprises a catheter 108, a motor cable 110 configured to apply current to the motor 20, a first optical fiber 94, and a second optical fiber 96. The guide opening 106 is positioned parallel to the first discharge port 62. In this exemplary embodiment, the guide opening 106 has the same orientation as the first discharge port 62.

[0067] In particular, the catheter 108 is supported within the guide opening 106 and the motor cable 110, and the first optical fiber 94 and the second optical fiber 96 are arranged within the catheter 108. Furthermore, a purge fluid channel may also be provided within the catheter 108, for example, to apply purge fluid into the pumping area 12 in a known manner.

[0068] Second Embodiment Figures 12 to 15 depict a second exemplary embodiment of the blood pump 210. The blood pump 210 differs from the blood pump 10 according to the first exemplary embodiment in that the axial flow pump 218 is configured differently. Furthermore, a second sensor 92 is provided on the outer circumferential surface of the blood inlet 14, as shown in Figure 12. In addition, the pumping area 212 does not have a guide opening but includes a second discharge port 228 that extends tangentially from the pumping area 212.

[0069] As depicted in Figure 13, the second discharge port 228 extends parallel to, but in the opposite direction to, the first discharge port 62. The second discharge port 228 is configured to guide and support the elongated connecting assembly 104.

[0070] The axial flow pump 218 comprises a pump element 222 in the form of an impeller that is driven without contact. Thus, the pump element 222 comprises a magnet 226 that forms the rotor of the motor 220 and is disposed adjacent to an electrically magnetized zone of the stator of the drive area 224 of the motor 220. The stator of the drive area 224 of the motor 220 is configured to generate a rotating magnetic field. The drive area 224 is disposed in the pump mounting section 30 of the main unit 24 and is configured to drive the pump element 222 in a non-contact manner. Based on the attractive force between the magnet 226 of the pump element 222 and the magnetized zone in the stator of the drive area 224, rotation is directly transmitted to the pump element 222. In particular, the rotating magnetic field is established within the stator of the drive area 224 that rotates the pump element 222, in which a control unit applies an appropriate current or voltage to the stator of the drive area 224 in a controlled manner.

[0071] The axial flow pump 218 includes bearing assemblies 230, 232 that support the pump element 222. The bearing assembly includes a first bearing 230 disposed at the inlet 14 at the first shaft end of the pump element 222. The bearing assembly includes a second bearing 232 disposed at the second shaft end of the pump element 222. A similar bearing assembly is disclosed in its entirety in PCT / EP2023 / 051785 (Application No.), which is incorporated herein by reference.

[0072] Blood pump assembly 300 A blood pump assembly 300 is shown in Figures 16 and 17. The blood pump assembly 300 comprises a blood pump 10 according to the first embodiment or a blood pump 210 according to the second embodiment. Here, the blood pump 10 according to the first embodiment is shown exemplarily.

[0073] The blood pump assembly 300 may include a control unit that can be provided outside the body. Furthermore, the blood pump assembly 300 includes an expandable member 302, shown by a dashed line in Figure 16. The expandable member 302 is an inflatable and deflated balloon-like member that is positioned at the inlet 14 before the blood pump 10 is placed inside the patient's heart. In particular, the expandable member 302 is positioned at the axial inlet opening 102 so as to completely seal the axial inlet opening 102 when inflated and so as to be the outermost part.

[0074] For the expansion and contraction of the expandable member 302, an expansion and contraction hose 306 is provided, which can be guided by a guide wire 304, as shown in Figure 16.

[0075] Figure 17 shows the expandable member 302 in an expanded state. The expandable member 302 comprises a base portion 308 and a tip portion 310. The base portion 308 is disposed within the inlet portion 14, and the tip portion 310 extends from the inlet portion 14 through the axial inlet opening 102. The tip portion has a conical shape. Furthermore, the expandable member 302 is provided with a central opening 312 to allow a guide wire (not shown in Figure 17) to reach the expandable member 302.

[0076] For the placement of the blood pump 10, the patient's heart is typically punctured at the apex. Next, a guidewire 304 is pushed through the puncture hole and guided along the guidewire until a dilator is positioned within the puncture hole. The puncture hole is then dilated by the dilator, for example, to 26 French. The dilator is then removed again, and the blood pump 10, having an inflated expandable member 302, is advanced along the guidewire. The inlet 14 of the blood pump 10 is introduced into the space of the patient's heart through the puncture hole. A highly flexible expandable member 302 is provided to avoid any trauma during insertion and to facilitate the placement of the blood pump 10. In particular, the conical shape of the tip 310 of the expandable member 302 allows for easy insertion through the puncture hole, as the pre-dilated puncture site is further expanded by the expandable member 302.

[0077] After the blood pump 10 is placed inside the patient, the expandable member 302 is deflated and gently removed by pulling it with a guide wire 304 or an expansion and contraction hose 306. Because the expandable member 302 has only small dimensions in its deflated state, it can be withdrawn from the patient's heart through the puncture site without any problems.

[0078] Example Implementation As already described herein, the technologies described herein can be implemented in a variety of ways. In this regard, the foregoing disclosure is intended to include, but is not limited to, systems, methods, and combinations and partial combinations thereof as specified in the following exemplary implementations. Preferred embodiments are described in the following paragraphs. A1 A blood pump comprising a pumping area having a blood inlet and a blood outlet, and a pump at least partially disposed within the pumping area, wherein the pump has a motor and a pumping element, the motor being configured to drive the pumping element such that a flow is generated between the blood inlet and the blood outlet of the pumping area, the pumping area comprising a main section and an inlet section, the inlet section being configured to be located within the space of the patient's heart, and the blood pump further comprising a mounting section disposed around the main section, the mounting section being configured to be attached to the outer surface of the patient's heart. A2 A blood pump as described in paragraph A1, wherein the pump is an axial flow pump having a longitudinal axis. A3 A blood pump as described in paragraph A1 or A2, wherein the pumping area is the pump housing. A blood pump described in any one of paragraphs A1 to A3 of A4, wherein the pump element is an impeller. A5 A blood pump as described in any one of paragraphs A1 to A4, wherein the pumping area has a longitudinal axis, and the longitudinal axis of the pumping area preferably coincides with the longitudinal axis of an axial flow pump. A6 A blood pump as described in any one of paragraphs A1 to A5, wherein a blood flow inlet is provided at the inlet portion and / or a blood flow outlet is provided at the outlet portion. A7 A blood pump as described in any one of paragraphs A1 to A6, wherein the main part comprises a pump mounting portion extending radially inward from the inner circumferential surface of the main part. A8 A blood pump as described in paragraph A7, wherein the pump is a blood pump disposed in a pump mounting section. A9 A blood pump as described in any one of paragraphs A1 to A8, wherein the motor comprises a magnetic circuit jacket. A10 A blood pump according to paragraph A7 or A8, wherein the motor comprises a magnetic circuit jacket disposed on the pump mounting portion, or a drive area disposed on the pump mounting portion and configured to drive the pump elements in a non-contact manner. A11 A blood pump as described in paragraph A9 or A10, wherein the magnetic circuit jacket comprises a smaller diameter portion and a larger diameter portion. A12 A blood pump as described in paragraph A11, wherein the magnetic circuit jacket has a tapered transition portion between a smaller diameter portion and a larger diameter portion. A13 A blood pump as described in paragraph A11 or A12, wherein the larger diameter portion is disposed in the pump mounting section. A14 A blood pump as described in any one of paragraphs A1 to A13, wherein the mounting portion is a mounting portion that extends radially. A15 A blood pump according to any one of paragraphs A1 to A14, wherein the main part comprises a clamping portion extending in the axial direction on its outer circumferential surface. A16 A blood pump as described in paragraph A15, wherein the mounting portion is detachably attached to the clamping portion such that the mounting portion can be mounted at any position along the axial extension of the clamping portion. A17 A blood pump according to any one of paragraphs A1 to A16, wherein the mounting portion comprises a perforated annular member and a tangential fastener. A18 A blood pump as described in paragraph A17, wherein a perforated annular member is arranged around a main body and may have a first circumferential end and a second circumferential end, which are spaced apart from each other such that a slot is formed between the first circumferential end and the second circumferential end. A19 A blood pump as described in paragraph A18, wherein the tangential fastener is configured to move a first circumferential end relative to a second circumferential end such that the size of the slot is variable. A20 A blood pump according to paragraph A18 or A19, wherein a sealing element is disposed within a slot. A21 A blood pump as described in paragraph A20, wherein the tangential fastener extends through a sealing element. A22 A blood pump as described in paragraph A20 or A21, wherein the sealing element is made of a highly elastic material. A23 A blood pump as described in any one of paragraphs A1 to A22, wherein the pumping area is a multi-part component. A24 A blood pump as described in paragraph A23, wherein the main part comprises a first main part and a second main part. A25 A blood pump as described in paragraph A24, wherein the main body comprises a third main body part disposed within a first main body part and / or a second main body part. A26 A blood pump as described in paragraph A24 or A25, wherein the first main part is made of a metallic material, preferably titanium or a titanium alloy. A27 A blood pump as described in any one of paragraphs A24 to A26, wherein the second main part is made of a plastic material, preferably polycarbonate. A28 A blood pump according to any one of paragraphs A24 to A27, wherein the third main part is made of a plastic material, preferably polycarbonate. A29 A blood pump as described in any one of paragraphs A1 to A28, wherein the blood outlet comprises a first discharge port. A30 A blood pump as described in paragraph A29, wherein the first discharge port extends tangentially with respect to the longitudinal axis of the pump. A31 A blood pump as described in any one of paragraphs A24 to A30, wherein the blood outlet is provided to a second main part. A32 A blood pump as described in any one of paragraphs A29 to A31, wherein the blood pump further comprises a tubular graft connected to a first discharge port. A33 A blood pump as described in paragraph A32, the blood pump further comprising a fixing member and a bushing with a circumferential undercut, wherein the bushing is disposed around a first discharge port, a tubular graft is disposed around the bushing, and the fixing member is configured to clamp the tubular graft to the circumferential undercut. A34 A blood pump as described in paragraph A32 or A33, wherein an exoskeleton is arranged around a tubular graft. A35 A blood pump as described in paragraph A34, wherein the exoskeleton comprises a plurality of hinged first members, each first member preferably comprising an annular base member. A36 A blood pump as described in paragraph A35, wherein each of the first members comprises two mounting protrusions. A37 A blood pump as described in paragraph A36, wherein each of the mounting projections is provided on an axially extending knob, the knob preferably extending from an annular base member. A38 A blood pump as described in paragraph A37, wherein the knobs extend in a first direction and are provided opposite to each other. A39 A blood pump as described in any one of paragraphs A35 to A38, wherein each of the first members comprises two mounting openings. A40 A blood pump as described in paragraph A39, wherein each of the mounting openings is provided with a knob extending axially, the knob preferably extending from an annular base member. A41 A blood pump as described in paragraph A40, wherein the knobs extend in a second direction and are provided opposite to each other. A42 A blood pump as described in one of paragraphs A35 to A41, wherein the exoskeleton comprises a second member hinged to a first member furthest from the pumping area. A43 A blood pump as described in paragraph A42, wherein a sleeve is connected to a second member, and the sleeve is arranged around a tubular graft. A44 A blood pump according to paragraph A42 or A43, wherein a second member comprises an axial through hole, a tubular graft extending through the axial through hole, and the diameter of the axial through hole decreases at least partially in the direction toward the pumping area. A45 A blood pump as described in any one of paragraphs A1 to A45, wherein a first sensor is disposed in close proximity to the blood flow outlet. A46 A blood pump as described in paragraph A45, wherein the first sensor is located within the pumping area. A47 A blood pump as described in paragraph A45 or A46, wherein the first sensor is a first optical sensor. A48 A blood pump as described in any one of paragraphs A1 to A47, wherein a second sensor is disposed in close proximity to the blood inlet. A49 A blood pump as described in paragraph A48, wherein the second sensor is a second optical sensor. A50 A blood pump as described in any one of paragraphs A1 to A49, wherein the diameter of the main part is greater than the diameter of the inlet. A51 A blood pump as described in paragraph A50, wherein the pumping section comprises a tapered section connecting the main section and the inlet section. A52 A blood pump according to any one of paragraphs A1 to A51, wherein the blood inlet comprises at least one radial inlet opening, preferably a plurality of radial inlet openings. A53 A blood pump as described in paragraph A52, wherein a plurality of radial inlet openings are equally distributed around the circumference of the inlet. A54 A blood pump as described in any one of paragraphs A1 to A53, wherein the blood inlet has an axial inlet opening. A55 A blood pump according to any one of paragraphs A1 to A54, wherein the inlet portion is integrally formed with at least a portion of the main portion, preferably with a first main portion part. A56 A blood pump as described in one of paragraphs A1 to A55, wherein the pump comprises a drive shaft driven by a motor, and the pump elements are supported on the drive shaft. A57 A blood pump according to one of paragraphs A1 to A55, wherein the motor comprises a drive unit having a stator, and the pump element comprises a magnet disposed adjacent to an electrically magnetized zone within the stator of the drive unit. A58 A blood pump as described in any one of paragraphs A1 to A57, wherein the pumping area comprises a second discharge port. A59 A blood pump as described in paragraph A58, wherein the second discharge port extends tangentially with respect to the longitudinal axis of the pump. A60 A blood pump as described in any one of paragraphs A1 to A57, wherein the pumping area comprises a guide opening. A61 A blood pump as described in paragraph A60, wherein the guide opening extends tangentially with respect to the longitudinal axis through the pumping area. A62 A blood pump according to any one of paragraphs A56 to A61, wherein a second discharge port or guide opening is configured to guide an elongated connecting assembly. A63 A blood pump as described in paragraph A62, wherein the elongated connecting assembly comprises one or more of a catheter, a motor cable, a first optical fiber, a second optical fiber, and a purge fluid channel. A64 A blood pump according to any one of paragraphs A1 to A63, wherein the main part comprises a circumferential area having increased surface roughness. A65 A blood pump as described in paragraph A64, wherein the circumferential region having increased surface roughness is generated by material ablation. A66 A blood pump according to paragraph A64 or A65, wherein the circumferential region having increased surface roughness is produced by laser material ablation or laser bead blasting. A67 A blood pump according to any one of paragraphs A1 to A66, wherein the pumping area comprises a connecting path connecting a blood inlet and a blood outlet, preferably the connecting path being partially formed by an annular gap. A blood pump assembly comprising a blood pump as described in any one of paragraphs A1 to A67, and an expandable member, wherein the expandable member is configured to be disposed within the inlet at the free axial end of the inlet, and the expandable member is preferably configured to be inflatable and deflated. B2 A blood pump assembly as described in paragraph B1, wherein the expandable member comprises a base portion and a tip portion. A blood pump assembly as described in paragraph B2, wherein the tip portion has a conical shape. A blood pump assembly as described in paragraph B2 or B3 of B4, wherein when an expandable member is inflated, the base portion is provided to the inlet portion. A blood pump assembly as described in any one of paragraphs B2 to B4 of B5, wherein when an expandable member is inflated, the tip extends from an axial inlet opening. A blood pump assembly as described in any one of paragraphs B1 to B5 of paragraph B6, wherein the expandable member has a central opening for a guide wire to pass through. A blood pump assembly as described in any one of paragraphs B1 to B6, wherein the expandable member is expanded with a liquid, preferably a NaCl solution. A method for placing a blood pump assembly described in any one of paragraphs B1 to B6 of paragraph C1 into a patient, - The step of puncturing the patient's heart, - The step of positioning at least a portion of the blood pump assembly through the puncture site. Methods that include... A method according to paragraph C1, wherein the step of positioning at least a portion of a blood pump assembly through a puncture site includes introducing a guidewire through the puncture site. A method according to paragraph C1 or C2, wherein the step of positioning at least a portion of a blood pump assembly through a puncture site includes expanding the puncture site. A method according to any one of paragraphs C1 to C3, wherein the step of positioning at least a portion of the blood pump assembly through a puncture site includes inflating an expandable member. A method according to paragraph C4, wherein the step of positioning at least a portion of the blood pump assembly through a puncture site includes advancing the blood pump along a guide wire. A method according to paragraph C5, wherein the step of positioning at least a portion of a blood pump assembly through a puncture site includes moving the tip of an expandable member through the puncture site. A method according to paragraph C6, wherein the step of positioning at least a portion of a blood pump assembly through a puncture site includes contracting and removing an expandable member after the inlet has been received into the space of the patient's heart.

[0079] The term "at least in part," as used herein, refers to either the whole or only in part. Terms such as "first," "second," or "third" do not indicate a specific order and are intended solely to semantically differentiate elements from one another. [Explanation of Symbols]

[0080] 10 Blood pump, 12 Pumping area, 14 Blood inlet, 16 Blood outlet, 18 Axial flow pump, 20 Motor, 22 Pump element / impeller, 24 Main body, 26 Inlet, 28 Mounting part, 30 Pump mounting part, 32 Inner surface of main body, 34 Magnetic circuit jacket, 36 Smaller diameter portion of magnetic circuit jacket, 38 Larger diameter portion of magnetic circuit jacket, 40 Tapered transition portion of magnetic circuit jacket, 42 Clamping part, 44 Outer surface of main body, 46 Perforated annular member of mounting part, 48 Tangential fastener, 50 First circumferential end of perforated annular member, 52 Second circumferential end of perforated annular member, 54 Slot, 56 Sealing element, 58 First main body part, 60 Second main body part, 61 62 Third main part, 64 First discharge port, 64 Tubular graft, 66 Fixing member, 68 Bushing, 70 Circumferential undercut of bushing, 72 Exoskeleton, 74 First member of exoskeleton, 76 Second member of exoskeleton, 78 Sleeve, 80 Annular base member of first member, 82 Mounting opening of first member, 84 Mounting projection of first member, 86 Mounting projection of second member, 88 Axial through hole of second member, 90 First sensor, 92 Second sensor, 94 First optical fiber of first sensor, 96 Second optical fiber of second sensor, 98 Tapered section, 100 Radial inlet opening, 102 Axial inlet opening, 104 Elongated connection assembly, 106 Guide opening, 108 Catheter, 110 Motor cable, 112 Circumferential area with increased surface roughness, 114 Cover, 116 Central mounting opening, 118 Annular surface, 120 Drive shaft, 122 Mounting flap, 124 Knob, 210 Blood pump, 212 Pumping area, 220 Motor, 222 Pump element / impeller, 224 Drive area, 226 Magnet, 228 Second discharge port, 230 First bearing, 232 Second bearing, 300 Blood pump assembly, 302 Expandable member, 304 Guide wire, 306 Inflation and deflation hose, 308 Base of expandable member, 310 Tip of expandable member, 312 Central opening of expandable member, AGAnnular gap, LA longitudinal axis.

Claims

1. A blood pump (10), A pumping area (12) having a blood inlet (14) and a blood outlet (16), The system comprises an axial flow pump (18) having a longitudinal axis (LA) and at least partially disposed within the pumping area (12), The axial flow pump (18) has a motor (20) and a pump element (22), The motor (20) is configured to drive the pump element (22) so that flow is generated between the blood inlet (14) and the blood outlet (16) of the pumping area (12), The pumping area (12) comprises a main section (24) and an inlet section (26), The aforementioned inlet portion (26) is configured to be located within the space of the patient's heart. The blood pump (10) further comprises a radially extending mounting portion (28) arranged around the main portion (24), The blood pump (10) is characterized in that the mounting portion (28) is configured to be attached to the outer surface of the patient's heart.

2. A blood pump (10) according to claim 1, The blood pump (10) is characterized in that the main portion (24) includes a pump mounting portion (30) extending radially inward from the inner circumferential surface (32) of the main portion (24), and the motor (20) includes a magnetic circuit jacket (34) disposed on the pump mounting portion (30), or the motor (220) includes a drive area (224) disposed on the pump mounting portion (30) and configured to drive the pump element (222) in a non-contact manner.

3. A blood pump (10) according to claim 1 or 2, The blood pump (10) is characterized in that the main part (24) has a clamping part (42) extending in the axial direction on its outer peripheral surface (44), and the mounting part (28) is detachably attached to the clamping part (42) so that the mounting part (28) can be attached to any position along the axial extension of the clamping part (42).

4. A blood pump (10) according to any one of claims 1 to 3, The blood pump (10) is characterized in that the mounting portion (28) comprises a perforated annular member (46) and a tangential fastener (48), the perforated annular member (46) is disposed around the main portion (24) and comprises a first circumferential end (50) and a second circumferential end (52) spaced apart from each other so that a slot (54) is formed between the first circumferential end (50) and the second circumferential end (52), the tangential fastener (48) is configured to move the first circumferential end (50) relative to the second circumferential end (52) so that the size of the slot (54) is variable, preferably a sealing element (56) is disposed in the slot (54), and preferably the tangential fastener (48) extends through the sealing element (56).

5. A blood pump (10) according to any one of claims 1 to 4, wherein the pumping area (12) is a multi-part member, and the main part (24) comprises a first main part (58) and a second main part (60), preferably the first main part (58) is made of a metallic material, preferably titanium or a titanium alloy, and preferably the second main part (60) is made of a plastic material, preferably polycarbonate.

6. A blood pump (10) according to any one of claims 1 to 5, The blood flow outlet (16) comprises a first discharge port (62) extending tangentially with respect to the longitudinal axis (LA) of the axial flow pump (18), and preferably the blood flow outlet (16) is provided to the second main part (60), characterized in that the blood pump (10).

7. A blood pump (10) according to claim 6, The blood pump (10) is characterized in that it further comprises a tubular graft (64) connected to the first discharge port (62).

8. A blood pump (10) according to claim 7, The blood pump (10) further comprises a fixing member (66) and a bushing (68) with a circumferential undercut (70), wherein the bushing (68) is disposed around the first discharge port (62), the tubular graft (64) is disposed around the bushing (68), and the fixing member (66) is configured to clamp the tubular graft (64) to the circumferential undercut (70).

9. A blood pump (10) according to claim 7 or 8, A blood pump (10) characterized in that an exoskeleton (72) is disposed around the tubular graft (64), the exoskeleton (72) comprises a plurality of hinged first members (74), the exoskeleton (72) preferably further comprises a second member (76) hinged to the first member (74) furthest from the first discharge port (62), and preferably a sleeve (78) is connected to the second member (76), and the sleeve (78) is disposed around the tubular graft (64).

10. A blood pump (10) according to claim 9, The blood pump (10) is characterized in that the second member (76) has an axial through hole (88), the tubular graft (64) extends through the axial through hole (88), and the diameter of the axial through hole (88) decreases at least partially in the direction toward the first discharge port (62).

11. A blood pump (10) according to any one of claims 1 to 10, A blood pump (10) characterized in that a first sensor (90) is disposed in close proximity to the blood outlet (16) in the pumping area (12), and / or a second sensor (92) is disposed in close proximity to the blood inlet (14), wherein the first sensor (90) is preferably a first optical sensor, and / or the second sensor (92) is preferably a second optical sensor.

12. A blood pump (10) according to any one of claims 1 to 11, A blood pump (10) characterized in that the diameter of the main portion (24) is larger than the diameter of the inlet portion (26), the pumping area (12) includes a tapered portion (98) connecting the main portion (24) and the inlet portion (26), preferably the blood flow inlet (14) includes at least one radial inlet opening (100), preferably a plurality of radial inlet openings (100), the plurality of radial inlet openings (100) are preferably equally distributed around the circumference of the inlet portion (26), and the blood flow inlet (14) preferably includes an axial inlet opening (102).

13. A blood pump (10, 210) according to any one of claims 1 to 12, The axial flow pump (18) comprises a drive shaft (120) driven by the motor (20), and the pump element (22) is supported on the drive shaft (120), or A blood pump (10, 210) characterized in that the motor (220) comprises a drive area (224) having a stator, and the pump element (222) comprises a magnet (226) disposed adjacent to an electrically magnetized zone within the stator of the drive area (224).

14. A blood pump (10, 210) according to any one of claims 1 to 13, The blood pump (10, 210) is characterized in that the pumping area (212) includes a second discharge port (228) extending tangentially with respect to the longitudinal axis (LA) of the axial flow pump (218), or a guide opening (108) extending tangentially with respect to the longitudinal axis (LA) through the pumping area (12), wherein the second discharge port (228) or the guide opening (108) is configured to guide an elongated connection assembly (104), and the elongated connection assembly (104) preferably includes one or more of a catheter (108), a motor cable (110), a first optical fiber (94), and a second optical fiber (96).

15. A blood pump assembly (300) comprising a blood pump (10) according to any one of claims 1 to 14, and an expandable member (302), wherein the expandable member (302) is configured to be disposed within the inlet portion (26) at the free axis end of the inlet portion (26).

Images