Blood pump placement and intravascular blood pump

Abstract

To provide methods of placing an intravascular blood pump in a patient for assisting the left ventricle of the patient's heart, placement tools for use in such methods, and an intravascular blood pump which is particularly suitable for the placement methods.SOLUTION: An intravascular blood pump for percutaneous insertion into a patient's vasculature comprises a pumping device 30 and a supply catheter. The pumping device comprises a pump section with a blood flow inlet, a blood flow outlet, and an impeller for conveying blood from the inlet to the outlet, and further comprises a drive section connected to the pump section and adapted to drive the impeller. The supply line supplies the drive section with electric energy for driving the impeller. An anchoring structure 25A is provided at a distal end region of the intravascular blood pump. A connecting catheter 25 may be attached to the anchoring structure from the distal side in order to guide the intravascular blood pump through the patient's vasculature in a distal direction.SELECTED DRAWING: Figure 10

Description

[Technical Field]

[0001] The present invention relates to a method of placing an intravascular blood pump in a patient to assist the left ventricle of the patient's heart, a placement tool for use in such a method, and an intravascular blood pump particularly suited for the placement method.

[0002] Accordingly, the present invention relates generally to intravascular blood pumps. In contrast to extracorporeal blood pumps, or blood pumps that are placed in a patient's abdominal, thoracic, or other body cavity, intravascular blood pumps are placed in a blood vessel, such as the patient's heart, and are also referred to as "intracardiac" blood pumps. The present invention particularly, but not exclusively, relates to intravascular blood pumps that are percutaneously inserted into a patient's vascular system. [Background technology]

[0003] Intravascular blood pumps are known to support the function of a patient's heart, either for short-term use, where the blood pump is implanted in the patient for a few days or weeks, or for long-term use, where the blood pump is implanted for a few weeks or months (e.g., six months or more), up to two years. Various types of intravascular blood pumps are known, such as axial blood pumps, centrifugal blood pumps, or diagonal flow blood pumps, which are sometimes referred to as mixed flow blood pumps. These types of intravascular blood pumps can be inserted into the patient's vascular system by a catheter through a percutaneous incision.

[0004] An intravascular blood pump typically includes a pump section having a blood inlet and a blood outlet, and an impeller rotatable about an axis of rotation and sized and shaped to transport blood from the blood inlet to the blood outlet. The intravascular blood pump further includes a drive section for driving the impeller. Hereinafter, the pump section and drive section will be collectively referred to as a "pump device." Furthermore, an intravascular blood pump typically includes a supply catheter connected to the pump device, the proximal end of which extends from the patient's body. As used herein, "proximal" refers to a position closer to or toward the surgeon, and "distal" refers to a position further from the surgeon or toward the patient. The supply catheter may enclose any supply lines for the pump device, such as power lines, purge fluid lines, sensor lines, drive cables, etc.

[0005] When the impeller is driven by an internal motor, the pump device may include both a pump section and a drive section within a common housing, the pump section including a blood flow inlet, a blood flow outlet, and the impeller, and the drive section axially attached to the pump section including a motor for driving the impeller. Electrical energy for driving the motor is supplied via a supply line through a supply catheter. When the impeller is driven by an external motor located outside the patient's body, the supply catheter may enclose a flexible drive cable as part of the drive section, the drive cable connecting the external motor to the impeller and supplying kinetic energy to the impeller.

[0006] The deployment methods described herein may also be suitable for the cable-driven blood pumps described above, but preferred in this context are intravascular blood pumps that include both a pump portion and a drive portion attached together to form a fully implantable pump device.

[0007] Typically, intravascular blood pumps functioning as left ventricular assist devices (LVADs) are inserted into the left ventricle of a patient's heart via the femoral artery and aorta. However, calcification can sometimes reduce the internal diameter of arterial vessels, a problem that typically does not occur in venous vessels. In this situation, it may be impossible to place the blood pump via the femoral artery. In other situations, the blood pump may be too large to introduce even through non-calcified arterial vessels. For example, long-term devices may be relatively bulky and large in diameter (e.g., 16 French or larger, up to 18 French) and therefore difficult to insert via the arterial side. Therefore, other insertion techniques have been described in which the blood pump is inserted via the venous side, which has a relatively large internal diameter, for example, via the femoral vein and then through a perforation of the atrial septum into the left ventricle. Introducing a blood pump via the femoral vein has the added advantage that the blood pressure on the venous side of the ventricular system is very low, significantly reducing the risk of blood leakage from the femoral vein through the entry point.

[0008] For example, it is known from U.S. Patent Application Publication No. 2006 / 0155158 A1 to use two guidewires, one inserted from the venous side and one from the arterial side, and magnetically connected within a patient's heart to form a continuous guidewire for leading a blood pump into the femoral vein, through the vena cava, through a puncture in the atrial septum, and into the left ventricle. However, there are problems with locating and reliably connecting the two guidewires within the patient's heart.

[0009] Another problem arises in long-term use where patient mobility is desirable, for example, to allow the patient to leave bed and ambulate. That is, when the blood pump is inserted via a femoral approach, i.e., via the femoral artery or vein accessed through a small incision in the groin, the delivery catheter exits the patient percutaneously at the groin, limiting the patient's mobility and making ambulation difficult. Summary of the Invention [Means for solving the problem]

[0010] Accordingly, the present invention relates to the deployment of an intravascular blood pump in a patient's heart to function as an LVAD. In this regard, further disclosed herein are intravascular blood pumps, as well as deployment tools particularly suited for use in the disclosed deployment methods.

[0011] A method of placing an intravascular blood pump of the above type in a patient includes, in accordance with a first principle, placing a first guidewire through the patient's vascular system, including through the patient's heart, so that the first guidewire extends from the patient's body with a first end via a first percutaneous access on the arterial side of the vascular system, such as via the axillary or subclavian artery, and a second end via a second percutaneous access on the venous side of the vascular system, and then using the first guidewire in a further procedure to place the intravascular blood pump within the patient's body via the second percutaneous access, i.e., from the venous side of the patient's vascular system.

[0012] Positioning a first guidewire throughout a patient's vascular system so that it exits the patient's body from both veins and arteries can be achieved in the following manner. First, a transseptal sheath is inserted from the venous side of the patient's vascular system into the left side of the heart through a perforation made in the patient's septum, preferably a perforation in the atrial septum. Next, a first end of the first guidewire is advanced through the transseptal sheath into the left side of the heart. The transseptal sheath can then be withdrawn. Second, the passage through the septum can be dilated, for example, with a PTA balloon catheter. Third, an introducer septal sheath is advanced through the septum so that the front of the introducer septal sheath extends into the left side of the heart, preferably the left ventricle. This process can be advantageously supported by a PTA balloon catheter. If a PTA balloon catheter is used, it can be withdrawn from the vascular system. Fourth, a balloon catheter, such as a Swan-Ganz catheter, is advanced through the introducer septal sheath into the left side of the heart, preferably the left ventricle. The balloon of the balloon catheter is then inflated, and the first end of the first guidewire is guided toward and out of the first percutaneous access with the aid of the balloon catheter after the patient's bloodstream, so that the first guidewire passes through the patient's vascular system, including the heart, and exits the patient's body with both ends.

[0013] Preferably, before inflating the balloon of the Swan-Ganz catheter, a second guidewire may be advanced through the arterial access (the "first" percutaneous access described above) into the left portion of the heart, preferably the left ventricle, and the balloon catheter is guided along the direction indicated by the second guidewire toward and out of the arterial access.

[0014] More preferably, when the transseptal sheath is inserted at the beginning of the procedure, it can be inserted via percutaneous access into a vein below the inferior vena cava, preferably the femoral vein, which can typically be accessed in the patient's groin using the known Seldinger technique. When the transseptal sheath and guidewire are advanced through the atrial septum to the left side of the heart, particularly the left ventricle, they emerge relatively easily from the inferior vena cava due to the natural curvature of the human ventricular system, including the curvature in the heart. Percutaneous access to a vein below the inferior vena cava may differ from the "second" percutaneous access described above and, therefore, may be referred to as "third" percutaneous access. In this case, a snare catheter may be inserted into a vein above the superior vena cava, such as the subclavian or axillary vein, via a second percutaneous access and advanced toward the first guidewire through the superior vena cava and into the inferior vena cava, where the snare catheter is used to capture the first guidewire and direct the second end of the first guidewire out of the second percutaneous access to a third percutaneous access.

[0015] After the first guidewire is positioned to extend from the ventricular system using both ends, there are various options for positioning the intravascular blood pump on the left side of the heart with the help of the first guidewire. The first option may comprise the following steps: First, the front end of the coupling catheter is attached to the first end of the first guidewire, preferably in a form-fitting manner, and the coupling catheter is guided through the patient's vascular system, including through the patient's heart, using the first guidewire until the front end of the coupling catheter extends from the patient's body via a second percutaneous access. Preferably, the balloon catheter is withdrawn from the patient's body while the coupling catheter is being advanced. Second, the distal end of the intravascular blood pump is coupled to the coupling catheter, preferably in a form-fitting manner, and advanced through the patient's vascular system, including through the atrial septum, to position its pump portion in the left part of the heart, preferably across the aortic valve. In this configuration, the intravascular blood pump's supply catheter, which extends through the heart into the left ventricle, can form a loop in the left ventricle and lie against the heart wall, thereby supporting the blood pump and preventing it from migrating into the left ventricle during operation.

[0016] Optionally, the intravascular blood pump may be anchored to a vessel wall, such as the aortic wall. This may be accomplished by moving multiple spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the vessel wall. In particular, the expandable spikes may partially penetrate the vessel wall. The spikes may have stops that prevent them from penetrating too deeply into the vessel wall. Third, the coupling catheter is detached from the distal end of the intravascular blood pump and withdrawn from the patient's body. Finally, the introducer septum sheath may be withdrawn from the patient's body.

[0017] A second option for deploying an intravascular blood pump in the left portion of the heart with the aid of a first guidewire according to the first deployment principle may include the following steps: First, the balloon catheter is withdrawn from the patient's body while keeping the first end of the first guidewire extending from the patient's body through the second percutaneous access; Second, the introducer septum is guided along the first guidewire through the patient's vascular system, including through the patient's heart, until the front end of the introducer septum extends from the patient's body through the second percutaneous access; Third, the second end of the first guidewire is fed through a loop provided at the distal end of the intravascular blood pump and advanced through the introducer septum until the second end of the first guidewire extends from the front end of the introducer septum. Fourth, the first and second ends of the first guidewire extending from the introducer septum sheath are grasped and used via the first percutaneous access to advance the intravascular blood pump along the introducer septum sheath through the patient's vasculature, including through the septum, so that the pump section can be positioned on the left side of the heart, preferably across the aortic valve. Fifth, the first guidewire is released from or de-energized from the loop at the distal end of the intravascular blood pump and withdrawn from the introducer septum sheath. Finally, the introducer septum sheath can be withdrawn from the patient's body. Again, the intravascular blood pump can be anchored to a wall of a blood vessel, such as the aortic wall, by, for example, moving multiple spikes from around the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the vessel. As described above, the expandable spikes can partially penetrate the vessel wall and can have stops to prevent the spikes from penetrating too deeply into the vessel wall.

[0018] In all embodiments of the first arrangement principle described above, the supply line may include a drive cable connecting the pump unit to an external motor and providing kinetic energy to the pump unit. The pump unit may even include an expandable rotor. However, the described arrangement principle is particularly suitable for non-expandable blood pumps that require a relatively large vascular cross-sectional area to be advanced toward and into the heart, such as those provided by the venous vasculature. It is particularly preferred to apply intravascular blood pumps with direct drive, i.e., blood pumps in which the drive unit is axially connected to and implanted with the pump unit, because a long, flexible drive cable is not particularly suitable for being routed along the entire wind-bearing path to the left ventricle. In this case, electrical energy can be supplied to the drive unit via the supply line.

[0019] Placing the feeding catheter or line on the venous side of the patient's vasculature, rather than the arterial side, can be advantageous for long-term use, where arterial vascular tissue tends to grow into the feeding catheter. Also, in this position, the feeding catheter or line does not impede arterial blood flow at all, and therefore higher blood flow rates can be achieved with an intravascular blood pump so positioned.

[0020] According to a second principle of a method for placing an intravascular blood pump in a patient, the blood pump can be inserted via transapical access. This method can include accessing the patient's thoracic cavity by creating a puncture in the wall of the patient's heart at the apex to access the left ventricle of the heart. Accessing the patient's thoracic cavity is preferably performed via a minimally invasive procedure. This method includes advancing a pump device, i.e., a pump portion including a drive unit, into the left ventricle through the apical wall puncture and advancing the distal end of the pump device forward; advancing the pump device through the left ventricle and the aortic valve toward the aorta; and positioning the blood pump so that the blood inlet is located in the left ventricle, the blood outlet is located in the aorta, and the drive unit is also located in the aorta, but the supply catheter extends through the puncture at the apex and exits the patient's body through the skin. This requires that the pump unit of the intravascular blood pump be axially positioned between the drive unit and the supply catheter or supply line, as further described below.

[0021] The second principle placement method may also include the step of securing the position of the blood pump within the patient's body with an anchor device that engages the inner wall of the patient's aorta. This is particularly useful because intravascular blood pumps tend to migrate from the aorta into the left ventricle. This can be caused by patient movement and the pumping pressure of the blood pump, which pushes the blood pump backward into the left ventricle. If the delivery catheter extends through the aortic arch, this is less of an issue and may still be advantageous, thereby providing some degree of fixation.

[0022] As described above, the distal end region of the intravascular blood pump preferably includes an anchor structure, and the intravascular blood pump further includes, as a minimum component, a pump device and a supply line, the pump device including a pump section having an impeller and a drive section for driving the impeller, while the supply line provides energy for driving the impeller.

[0023] The anchor structure may include at least one anchor adapted to anchor the intravascular blood pump to the wall of the patient's blood vessel, such as the patient's aorta, as already mentioned, and the anchor may include an expandable and collapsible spike.

[0024] However, the intravascular blood pump may additionally or alternatively be provided with a completely different anchor structure for use in the above-described placement method, i.e., for connecting the distal end of the intravascular blood pump to the coupling catheter according to the first option of the first placement principle, or to the first guide wire according to the second option of the first placement principle.

[0025] According to a first preferred embodiment, such an anchor structure includes a hook or loop at the distal end of the intravascular blood pump. The coupling catheter can then include a corresponding hook for hooking onto the hook or loop of the blood pump, or the loop to which the hook of the blood pump is hooked. In one form, the loop can be made of a soft, elastic material to form an atraumatic distal extension at the axial end of the intravascular blood pump. A typical pigtail-shaped or J-shaped atraumatic distal extension can be replaced by such a loop. Alternatively, a conventional atraumatic distal extension can preferably be provided with a loop at its distal end. By both pushing the blood pump forward using the coupling catheter and slightly pulling on the other end, the J-shaped or pigtail-shaped atraumatic extension can be stretched and recoiled while the blood pump is guided through the patient's vasculature, allowing it to recoil after release.

[0026] In a second preferred embodiment, such an anchor structure may comprise a neck-head structure at the axial end of the end region of the intravascular blood pump. In this case, the coupling catheter may comprise a gripper for connecting to the neck-head structure. Preferably, the connector has a gripper with a first grip and a second grip adapted to grip around the head of the neck-head structure. If a hook or loop is provided instead of the neck-head structure, the same gripper can be similarly used to close around the hook or loop of the intravascular blood pump. The neck-head structure may extend distally from the axial end of the end region of the intravascular blood pump. Alternatively, the neck-head structure may be provided somewhat concealed within the front cavity of the intravascular blood pump to avoid potential tissue damage.

[0027] Preferably, the connecting surface between the head and neck of the neck-head structure is inclined 90° relative to the longitudinal axis of the intravascular blood pump, or the connecting surface may be inclined even more than 90° relative to the longitudinal axis of the intravascular blood pump to form an undercut. To provide a perfect fit between the vertically or even negatively inclined connecting surfaces, the gripper surface is similarly inclined only or even more than 90° relative to the longitudinal axis of the connecting catheter to form a fit with and undercut the undercut of the neck-head structure. In this way, when the blood pump is carefully pulled through the vasculature using the connecting catheter, the forces acting on the head, more specifically, on the connecting surface between the head and neck, are purely axial, and the forces required to keep the first and second grips closed behind the head can be minimal. These closing forces act radially, perpendicular to the longitudinal axis of the blood pump; therefore, any pulling forces acting on the connecting surfaces as the blood pump is guided through the patient's vasculature do not have a force component that counteracts the closing force of the grippers. Disadvantageously, the gripper surfaces on conventional connecting catheters are typically rounded.

[0028] Different types of drives can be used. Preferably, the drive may include a stator including multiple posts, each with a coil winding that can be controlled to generate a rotating magnetic field. The impeller, in turn, may have a corresponding number of permanent magnets for coupling to the rotating magnetic field to cause rotation of the impeller. Alternatively, the drive may include a rotor driven by an electric motor, the rotor including multiple permanent magnets, and the impeller including a corresponding number of permanent magnets magnetically coupled to the rotor magnets to form a magnetic coupling configured to transmit rotation of the rotor to the impeller. In both drives, the electrical components are enclosed by a housing and are not in contact with the blood. The rotational motion of the electric motor is magnetically transmitted to the impeller. However, other types of drives, such as drives purged with a purging fluid such as saline, may be used as well.

[0029] It will be appreciated that the intravascular blood pump is preferably a left ventricular assist device (LVAD) configured to pump blood from the left ventricle to the aorta. The blood inlet may be located at the proximal end of the pump device, and the blood outlet may be located at the distal end of the pump device. This may be referred to as a "forced pump" because blood is forced away from the surgeon, i.e., away from the supply catheter. This applies to applications in which the supply catheter is placed on the venous side of the patient's blood vessel. Conversely, the blood inlet may be located at the distal end of the pump device, and the blood outlet may be located at the proximal end of the pump device. This may be referred to as a "suction pump" because blood is sucked in a direction toward the surgeon, i.e., toward the supply catheter. This applies to applications in which the supply catheter is placed on the arterial side of the patient's blood vessel.

[0030] Preferably, the intravascular blood pump is a forced pump, more preferably a forced pump in which the pump section is axially disposed between the drive section and the supply catheter or supply line. Prior art intravascular blood pumps with the pump section and drive section integrated into a fully implantable pump device have a different arrangement: the pump section is axially disposed between the drive section and the supply catheter. These prior art intravascular blood pumps typically operate as suction pumps, but the impeller rotation can be reversed so that the same blood pump can also be used as a forced pump. However, because the primary application of such blood pumps is for use as suction pumps, the flow characteristics of the same blood pump when used as a forced pump are not as good. This is especially true when the pump section is not designed as a purely axial pump but includes at least a radial component, i.e., a mixed-flow or mixed-type pump, or a centrifugal pump. The radial component of the pump has the effect of a centrifugal pump and contributes to the kinetic energy transferred from the pump to the blood flow. When such a pump is operated in reverse, the radial component is not only lost but even counterproductive in terms of kinetic energy generation. This loss in performance must be tolerated or compensated for by a higher impeller rotational speed, but there is a certain limit to the rotational speed.

[0031] Thus, a preferred design of the forced blood pump according to the present invention comprises a pump device and a supply line. The pump device comprises a pump section in the usual manner, i.e., the pump section has a blood inlet, a blood outlet, and an impeller rotatable about a rotation axis for transporting blood from the blood inlet to the blood outlet. The pump device further comprises a drive section connected to the pump section and adapted to drive the impeller. Preferably, the drive section is axially connected to the pump section and embedded together with the pump section, as is commonly known in the art. The supply line is adapted to supply at least electrical energy to the drive section for driving the impeller. Thus, the supply line comprises at least an electrical cable or consists of an electrical cable. However, the supply line is preferably formed as a supply catheter, which may include the electrical cable as well as further components, such as pressure lines, for example, in the form of one or more glass fibers. Importantly, the pump section is arranged along the rotation axis between the drive section and the supply line or catheter. Thus, the supply line or catheter is attached to the pump section and not to the drive section.

[0032] When this intravascular blood pump is placed in the patient's vascular system so that the blood flow inlet is located in the patient's heart and the blood flow outlet is located in the aorta, the blood pump can operate as a forced pump, i.e., away from the supply line or catheter, and therefore away from the surgeon, offering the advantage that the supply line or catheter does not pass through the arterial vasculature and therefore does not interfere with the blood flow supported or generated by the blood pump. Therefore, higher blood flow rates can be achieved in this manner, regardless of the type of blood pump. Particular advantages arise when the blood pump has a radial component, such as an axial-radial blood pump, a mixed-flow blood pump, or a centrifugal blood pump. Here, the drive unit is located distal to the pump unit, so that the impeller driven by the drive unit is located near the blood flow outlet and can pump blood radially, or at least with a radial component, through the blood flow outlet, allowing the blood pump to provide a relatively high blood flow rate.

[0033] Energy for driving the impeller is preferably conductively transferred from the supply line across the pump section to the drive section, and therefore a conductive connection may be provided extending along the pump section to electrically connect the supply line with the motor of the drive section.

[0034] Intravascular blood pumps of the above types typically include a cannula as part of the pump section, and such a cannula may also be provided in the intravascular blood pumps described herein. The cannula is usually the part of the pump section that extends through the aortic valve, and in some applications, extends through both the aortic and mitral valves. The cannula is bendable along its longitudinal axis to allow the blood pump to operate through the patient's vasculature. The cannula may be pre-curved to the shape it will assume when properly installed in the patient's heart.

[0035] The blood flow inlet of the pump section is preferably located at the distal end of the cannula, close to the supply line or supply catheter, but the blood flow outlet of the pump can be located at the distal end of the cannula, i.e., next to the motor section, so that the impeller driven by the motor in the drive section is similarly located next to the drive section so as to be able to push blood out of the pump section directly through the blood flow outlet.

[0036] Because the cannula undergoes significant flexing as it is manipulated into place through the veins and heart and across the aortic valve, certain measures must be taken to prevent the conductive connection between the supply line and the drive section across the pump section from rupturing during such manipulation. For example, the corresponding power lines could run loosely through the lumen of the cannula. However, this is not preferred because such an arrangement could cause turbulence and blood clotting. Rather, it is preferable to route the power lines along the wall of the cannula.

[0037] For example, stranded wires of an electrical cable of a supply line, or a particular stranded wire or single supply line, such as a motor cable of a motor in a drive unit, which typically carries insulation of polymer lacquer, may extend along the wall of the cannula, preferably in the neutral bending plane of the cannula. For example, the neutral bending plane of the cannula is the plane along which the cannula is most likely to bend, since other regions of the cannula are designed to elongate with less force compared to regions of the cannula in the region of the neutral bending plane. For example, the neutral bending plane of the cannula may be predetermined by the central curved surface of the cannula, which corresponds to the curvature the cannula will assume when properly positioned in the patient's heart.

[0038] For example, the transmission lines may extend along the wall of the cannula in a strictly longitudinal direction parallel to the longitudinal axis of the cannula, preferably along mutually curved planes, and may be longitudinally stretchable to prevent them from rupturing due to stretching.

[0039] Alternatively, the transmission lines may extend along the walls of the cannula inside at least one bendable tube. As previously explained, the bendable tubes are preferably arranged along mutually bending surfaces, although this is not a requirement if the transmission lines are laid loosely inside the tubes.

[0040] There can be one bendable tube for each transmission line, or multiple transmission lines can pass through one or more bendable tubes.

[0041] In certain embodiments, multiple bendable tubes are provided on opposite sides of the cannula wall along the longitudinal axis of the cannula to create mutually bending surfaces within the cannula. For example, one bendable tube can be provided on the opposite side of the cannula with two power transmission lines through one tube and a third power transmission line through another tube, along with the optical fiber of the pressure sensor. Alternatively, two tubes can be provided on each side of the wall, one tube for each line. In situations where power transmission lines (or other lines) are located on opposite sides of the cannula wall, it is advantageous to provide an even number of inlet ports, at least at the blood flow inlet, so that the power transmission lines located on the opposite side of the cannula continue straight through a bridge separating adjacent inlet ports.

[0042] Preferably, the bendable tube is made from a shape memory alloy such as Nitinol.

[0043] Alternatively, the transmission line may extend in a serpentine manner along the wall of the cannula. This has the effect that the extension of the cannula wall resulting from bending the cannula is much greater than the extension of the serpentine transmission line. This effect can be achieved even if the serpentine transmission line is not positioned along the neutral bending plane of the cannula, which may be predetermined by the central curved surface of the cannula, as described above. In particular, if the transmission line is not completely fixed to the cannula wall but is allowed to deviate slightly, bending the cannula may not cause the serpentine transmission line to extend at all. For example, the serpentine transmission line may be fixed only at specific points in or on the wall of the cannula.

[0044] According to yet another alternative, the transmission line may be arranged to extend helically around the cannula, the effect of which is substantially the same as that of a serpentine transmission line.

[0045] For example, the cannula may include reinforcing structures such as ring-shaped reinforcing elements or reinforcing windings that extend helically along the wall of the cannula, and the helically extending transmission lines may be positioned in a specific relationship to those reinforcing windings or reinforcing elements.

[0046] In the first embodiment including a helically extending transmission line, the angular orientation of the helically extending transmission line relative to the longitudinal axis of the cannula may differ from the angular orientation of one or more of the helically extending reinforcing windings so that the reinforcing windings and the transmission line overlap. To prevent the transmission line from slipping between the reinforcing windings, the angular orientation preferably differs by at least 5°, preferably at least 10°. More preferably, the angular orientation of the transmission line is opposite to the angular orientation of the reinforcing windings, e.g., +5° on one side and −10° on the other, or +20° on one side and −20° on the other.

[0047] In a second embodiment, a helically extending transmission line can be nested between one or more helically extending reinforcing windings. If multiple reinforcing windings are present, the windings can be nested within one another, and if multiple helically extending transmission lines are provided, they can preferably be configured so that exactly one of the transmission lines is located between two reinforcing windings. The configuration can be such that multiple helically extending reinforcing windings, for example, two or three, are present between adjacent transmission lines. Preferably, there can be two to nine helically extending reinforcing windings. If there are three transmission lines and nine reinforcing windings, three reinforcing windings can be located between each transmission line. As a result, the more reinforcing windings there are, the smaller the angle between the longitudinal axis of the cannula and the orientation of the reinforcing windings, which means that, depending on the width of the reinforcing windings, the number of helical turns of the transmission line around the cannula decreases with the number of reinforcing windings. Thus, the angle of the helical transmission line can be controlled by the number and width of the reinforcing windings. Therefore, it is preferable to fabricate the helical reinforcing windings from flat wire of a predetermined width.

[0048] Most preferably, the reinforcing windings are made of a shape memory alloy such as Nitinol. Preferably, an electrical insulating layer is disposed between the helically extending reinforcing windings and the helically extending transmission lines, with the reinforcing windings above the insulating layer and the transmission lines below the insulating layer, or vice versa. In this manner, the transmission lines are insulated from each other and, more particularly, from the reinforcing windings.

[0049] In yet another alternative embodiment, one or more transmission lines may be formed by each of the helically extending reinforcing windings, and again, to prevent the reinforcing windings from contacting each other and shorting out, it is preferable to place an electrical insulating layer between the helically extending reinforcing windings such that adjacent reinforcing windings are alternately positioned above and below the insulating layer.

[0050] In all of the above embodiments and alternatives, it is preferable to place the power lines inside the cannula wall to protect them. Preferably, the cannula wall comprises a first foil and a second foil, the second foil being coupled to and covering the first foil. At least one reinforcing member, such as the aforementioned reinforcing winding, may be disposed between the first and second foils, preferably together with the power lines. For example, the first and second foils may be made of polyurethane.

[0051] The proximal and / or distal ends of the cannula may be provided with one or more electrical connectors, such as a printed circuit board or simply an insulating coating. For example, an electrical connector may be provided at or distal to the distal end of the cannula and used to connect each of the motor cables with a stranded wire or a single wire. Thus, the stranded wire or single wire forms a power transmission line and is laid along the cannula in one of the above-described ways. A stranded wire is preferred over a single wire because it remains conductive even if one strand in the stranded wire breaks. Preferably, the stranded wires of the electrical cable arriving via the supply line may form a power transmission line extending across the cannula and then be electrically connected to the individual motor cables of the drive unit via electrical connectors provided at the distal end of the cannula. More preferably, the stranded wires may be different from the stranded wires of the electrical cable arriving from the supply line, allowing them to be adapted to specific requirements for extending across the cannula. In this case, electrical connectors are provided at both ends of the cannula to connect a particular stranded wire, or another particular single wire, at one end to the motor cable and at the other end to the stranded wires of the supply line electrical cable. Finally, one or more electrical connectors may be provided only at the proximal end of the cannula, i.e., when the motor cable extends across the entire cannula, as in the above embodiment where the motor cable is guided through one or more bendable tubes.

[0052] As described above, one or more anchors may be provided at the distal end of the pump device, i.e., preferably at the drive portion, to stably fix the position of the pump device inside the patient's heart, for example, to anchor the pump device to the patient's aortic wall.

[0053] Most preferably, the cannula is configured to not buckle when bent up to 180° along its longitudinal axis. For example, if the cannula is intended to extend from the left atrium to the aorta, thereby bridging the left ventricle, the predetermined cannula curvature may not deviate too far from 180°, but the cannula will need to assume a nearly longitudinally stretched configuration when manipulated through a patient's veins.

[0054] Generally, the blood pump may be configured for long-term use, with the blood pump preferably configured to operate in a patient for at least four weeks, and more preferably for at least six months.

[0055] The foregoing summary, as well as the following detailed description of the preferred embodiments, will be better understood when read in conjunction with the accompanying drawings. For purposes of illustrating the present disclosure, reference is made to the drawings. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the drawings. [Brief explanation of the drawings]

[0056] [Figure 1] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 2] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 3] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 4] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 5]FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 6] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 7] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 8] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 9] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 10] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 11] FIG. 1 illustrates placement of an intravascular blood pump through the venous vasculature according to a first placement principle. [Figure 12] FIG. 1 illustrates the introduction of an intravascular blood pump via the venous vasculature according to a second placement principle. [Figure 13] FIG. 1 illustrates the introduction of an intravascular blood pump via the venous vasculature according to a second placement principle. [Figure 14] FIG. 1 illustrates the introduction of an intravascular blood pump via the venous vasculature according to a second placement principle. [Figure 15] FIG. 1 illustrates the introduction of an intravascular blood pump via the venous vasculature according to a second placement principle. [Figure 16] FIG. 10 illustrates an intravascular blood pump introduced into the left ventricle via the apex of the human heart according to the third placement principle. [Figure 17] 1A and 1B are diagrams showing an intravascular blood pump according to a first embodiment. [Figure 18] FIG. 10 shows an intravascular blood pump according to a second embodiment. [Figure 19A] 10A and 10B show intravascular blood pumps according to third and fourth embodiments. [Figure 19B] 10A and 10B show intravascular blood pumps according to third and fourth embodiments. [Figure 19C] 10A and 10B show intravascular blood pumps according to third and fourth embodiments. [Figure 20] FIG. 10 shows an intravascular blood pump according to a fifth embodiment. [Figure 21A] 10A and 10B show intravascular blood pumps according to sixth and seventh embodiments. [Figure 21B] 10A and 10B show intravascular blood pumps according to sixth and seventh embodiments. [Figure 21C] 10A and 10B show intravascular blood pumps according to sixth and seventh embodiments. [Figure 22A] FIG. 13 shows an intravascular blood pump according to an eighth embodiment. [Figure 22B] FIG. 13 shows an intravascular blood pump according to an eighth embodiment. [Figure 22C] FIG. 13 shows an intravascular blood pump according to an eighth embodiment. [Figure 23A] 10A and 10B show intravascular blood pumps according to ninth and tenth embodiments. [Figure 23B] 10A and 10B show intravascular blood pumps according to ninth and tenth embodiments. [Figure 23C] 10A and 10B show intravascular blood pumps according to ninth and tenth embodiments. [Figure 23D] 10A and 10B show intravascular blood pumps according to ninth and tenth embodiments. [Figure 24A] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 24B] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 24C] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 25A]10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 25B] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 26A] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 26B] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 26C] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 27] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 28A] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 28B] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 28C] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 29] 10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. [Figure 30]10A-10C show different anchoring structures provided at the distal end of the pump device, together with suitable grippers on the connecting catheter for attachment to the anchoring structures. DETAILED DESCRIPTION OF THE INVENTION

[0057] Figures 1 through 16 illustrate various principles for placing an intravascular blood pump in a patient's heart. Figure 1 shows a cross-section of a human heart 1 exposing the left ventricle 2, left atrium 3, right ventricle 4, right atrium 5, and the upper part of the aorta 6. Relevant for further understanding are the locations of the subclavian artery 7, superior vena cava 8, inferior vena cava 9, and femoral vein 10, as well as the aortic valve 11, mitral valve 12, atrial septum 13, and ventricular septum 14. Designated by reference numeral 15 is the patient's skin.

[0058] The arterial vasculature includes the left atrium 3, left ventricle 2, aorta 6, and subclavian artery 7, while the venous vasculature includes the femoral vein 10, inferior vena cava 9, superior vena cava 8, right atrium 5, and right ventricle 4. An interatrial septum 13 separates the left atrium 3 from the right atrium 5, and an interventricular septum 14 separates the left ventricle 2 from the right ventricle 4.

[0059] According to the first placement principle, the venous vessels are accessed via percutaneous access 16A according to the Seldinger technique. Preferably, the femoral vein 10 is accessed; alternatively, the subclavian vein (not shown, leading to the superior vena cava 8) can be accessed instead. However, in the process described below, i.e., in the first step, to place a guidewire through the venous system and the atrial septum into the left side of the heart, it is advantageous to use the distal end of the transseptal sheath 17 to access the femoral vein 10 and then insert the transseptal sheath through the lower percutaneous access 16A toward the atrial septum 13, piercing it, as shown in FIG. 1 . Alternatively, a separate needle can be used to pierce the septum. Next, as shown in FIG. 2 , a first guidewire 20A is advanced through the transseptal sheath 17 into the left side of the heart and into the left ventricle 2. Due to the natural curvature of the human ventricular system, including the curvature of the heart, advancing a transseptal sheath and guiding a wire through the atrial septum to the left side of the heart, particularly the left ventricle, is relatively easy when coming from the inferior vena cava. However, the further procedural steps of the first placement principle are easier to perform when coming from the superior vena cava. Thus, as shown in Figure 3, a snare catheter 18 is advanced through a septal sheath 19 placed in the superior vena cava 8 to raise a first guidewire 20A. The septal sheath 19 can later be used to introduce an intravascular blood pump into the vascular system. The septal sheath 19 and snare catheter 18 can be inserted into a vein above the superior vena cava, such as the subclavian or axillary vein, via superior vena cava access, and advanced through the superior vena cava 8 toward the first guidewire 20A in the inferior vena cava 9. An appropriate grip on the end of the snare catheter 18 is used to capture the first guidewire 20A. Once the first guidewire 20A has been captured using the snare catheter 18, it is then retracted into the septal sheath 19 and routed out of the upper percutaneous access (not shown) until the trailing end 20Ar of the first guidewire 20A emerges outside the patient's body, as generally indicated by the arrow in Figure 3. To this end, the transseptal sheath 17 is withdrawn a short distance to allow the snare catheter 18 to grasp the first guidewire 20A in the right atrium.After the trailing end 20Ar has been withdrawn via upper percutaneous access (not shown), the transseptal sheath 17 can be completely withdrawn from the patient's body.

[0060] Next, as shown in Figure 4, a balloon catheter 22, which in the embodiment shown is a PTA balloon but which may be any type of balloon, is guided along guidewire 20A through septum 19 and further through the atrial septum and inflated to expand, thereby increasing perfusion through atrial septum 13. Once perfusion through atrial septum 13 has been increased to an appropriate amount, septum 19 is advanced over PTA balloon 22 so that it extends into left atrium 3, as shown in Figure 5.

[0061] The PTA balloon 22 is then withdrawn, and a steerable catheter 23, which in the illustrated embodiment is a Swan-Ganz catheter but may be any suitable guide catheter, such as a pigtail catheter, can be inserted instead. The Swan-Ganz catheter 23 is guided along the first guidewire 20A until it reaches the left ventricle 2, as shown in FIG. 6 . Next, a second guidewire 20B is introduced into the left ventricle 2, preferably via the subclavian artery 7, to assist in further guiding the first guidewire 20A to the arterial percutaneous access 16B. More specifically, the second guidewire is visible on X-ray imaging. The balloon 23A at the distal end of the Swan-Ganz catheter 23 is then inflated, and natural blood flow supports further movement of the Swan-Ganz catheter 23 along the first guidewire 20A through the vasculature and into the subclavian artery 7. The provision of the second guidewire 20B is optional. Instead of the second guidewire 20B, a connecting catheter with a grip can be used to attach to the leading end 20Af of the first guidewire 20A. However, even when the connecting catheter is used to capture the leading end 20Af of the first guidewire 20A, simply pulling the guidewire through the patient's vasculature may be harmful to the patient's vascular tissue, so the first guidewire 20A is further advanced by pushing it using a Swan-Ganz catheter.

[0062] As shown in FIG. 8, once the forward end 20Af of the first guidewire 20A and the balloon 23A of the Swan-Ganz catheter are visible to the surgeon, the connecting catheter 25 can be securely fastened to the forward end 20Af of the first guidewire 20A. The connecting catheter 25 can be the same as the snare catheter 18. Then, as shown in FIG. 9, the connecting catheter 25, now securely attached to the first guidewire 20A, is guided in the opposite direction from the arterial percutaneous access 16B toward the venous upper percutaneous access (not shown). While the connecting catheter 25 is being advanced, the first guidewire 20A is retracted, and simultaneously, the Swan-Ganz catheter 23 is also retracted. FIG. 9 illustrates such movement as the (currently deflated) balloon 23A of the Swan-Ganz catheter 23, along with the forward end 25A of the connecting catheter 25 attached to the forward end 20Af of the first guidewire 20A, enters the septum 19 in the rearward direction.

[0063] 10, the front end 25A of the connecting catheter 25 is then attached to the distal end of the pump device 30 as it reaches outside the patient's body through the septum 19 and is used to guide the pump device 30 in a retrograde direction through the septum 19 into the right portion of the heart until it bridges the aortic valve 11. In the embodiment shown, a soft pigtail extension is provided at the end of the pump device 30, and the front end 25A of the connecting catheter 25 is attached to a loop at the distal end of the pigtail extension.

[0064] 10 is reached, the connecting catheter 25 is cut and removed, while the blood pump's supply catheter 36, which extends through the heart into the left ventricle and forms a loop therein, is further advanced against the heart wall of the left ventricle, as shown in FIG. 11. In this configuration, the supply catheter 36 supports the position of the pump device 30 and prevents it from migrating into the left ventricle during its operation. Optionally, as also shown in FIG. 11, spikes 40 may be provided and extend from the pump device 30 to anchor the pump device 30 to the aorta 6.

[0065] The above-described placement method according to the first principle, in which the first guidewire 20A extends entirely out of the patient's body on both the venous and arterial sides through the patient's vasculature, can be optionally modified as described below. According to a second option of the first placement principle, all steps described above in connection with FIGS. 1 through 8 can be performed in the same manner. However, as shown in FIG. 12, once the leading end 20Af of the first guidewire 20A reaches outside the arterial side of the patient's vasculature, the Swan-Ganz catheter 23 can be completely withdrawn. Next, as shown in FIG. 13, the tube 24 is inserted into the septum sheath 19 and similarly guided further along the guidewire 20A using its leading end 24A until it reaches outside the patient's body. Alternatively, the tube 24 can be guided in the opposite direction through the vasculature.

[0066] Next, as shown in FIG. 14, the rear end 20Ar is fed through the loop 41A at the end of the pigtail 41 of the pump device 30, into the septum 19, and then through the entire tubing 24 until it reaches the outside of the front end 24A of the tubing 24 outside the patient's body. Thus, both the end 20Af and the end 20Ar extend out of the tubing 24 on the arterial side of the patient. Next, as shown in FIG. 15, both the end 20Af and the end 20Ar of the first guidewire 20A are pulled along with the tubing 24, and simultaneously, the pump device 30 is advanced until it reaches the desired location within the patient's heart. The diameter of the tubing 24 is selected so that the pump device 30 will contact the tubing 24 at its distal end while it is advanced through the vasculature. 15, the first guidewire 20A can be detached from the loop 41A of the pigtail extension 41 via the arterial percutaneous access 16B (not shown here), and the tube 24 can be removed from the patient's body via the same arterial percutaneous access 16B. Finally, once any spikes 40 are extended into the wall of the aorta 6, the same final placement as shown in FIG.

[0067] A placement method according to the second placement principle is shown in FIG. 16 . Here, the patient's heart 1 is accessed through the patient's thoracic cavity, and a puncture is created through the apical wall of the heart to access the left ventricle 2. In this case, the pump unit 32 is again positioned between the drive unit 31 and the supply line 36 or supply catheter. The intravascular blood pumps described later in this specification are particularly suitable for placement within a patient's heart according to this third placement principle. More specifically, the pump device 32 is advanced through the apical wall puncture so that the blood inlet 33 of the pump unit 30 is positioned in the left ventricle 2 and the blood outlet 34 of the pump unit 32 is positioned in the patient's aorta 6. The supply line 36 extends from outside the patient's body through the apical wall puncture, and the drive unit 31 is positioned in the aorta. Thus, all of the advantages described above in connection with the first placement principle as shown in FIGS. 1 through 5 are similarly achieved with this third placement principle.

[0068] Preferred intravascular blood pumps that are particularly useful for the first and second placement principles are described below in connection with Figures 17 to 23, which show nine different embodiments of intravascular blood pumps.

[0069] Each of the blood pumps shown in Figures 17-23 includes a pump section 30 and a supply line 36, illustrated in these embodiments as a supply catheter, attached in the usual manner to the proximal end of the pump device 30. The pump device includes a drive section 31 and a pump section 32, which includes a blood flow inlet 33 with various inlet ports, a blood flow outlet 34 with various outlet ports, and a flexible cannula 35 extending between the blood flow inlet and the blood flow outlet. The pump section 32 further includes an impeller (not shown) driven by a motor located in the drive section 31. The impeller is located in the region of the blood flow outlet 34 and has axial and radial components to propel blood from the blood flow outlet 34 in a diagonal flow. Importantly, in all embodiments, the pump section 32 is located between the supply line 36 and the drive section 31.

[0070] In a first embodiment shown in FIG. 17 , an electrical connector 42 is provided at the distal end of the cannula 35, adjacent to the blood flow outlet 34. The electrical connector 42 is a printed circuit board to which individual motor cables are attached; in the illustrated example, there are three cables: an outer conductor, a neutral or zero conductor, and a protective conductor, collectively referred to as motor cables 43. Also attached to the distal electrical connector 42 are corresponding power transmission lines 44A, 44B, and 44C, collectively referred to as power transmission lines 44. The electrical connector 42 is covered by an insulating material, such as polyurethane. In the illustrated embodiment, the power transmission lines 44 are extensions of corresponding conductors in the electrical cable 45 that reach the pump device 30 via the delivery catheter 36. Thus, the power transmission lines 44 are typically stranded wires. The transmission line 44 extends longitudinally strictly along the longitudinal axis of the cannula 35, i.e., along the neutral bending plane of the cannula 35, thereby preventing rupture of the transmission line 44 when the cannula 35 is bent. Additionally, a transmission line 44 with appropriate stretchability can be selected. If the conductors of the electrical cable 45 are not sufficiently stretchable, they can be replaced with more stretchable stranded wire to form the transmission line 44 that extends across the cannula 35. For this purpose, one or more additional electrical connectors are required proximal to the blood inlet 33 (shown here).

[0071] FIG. 18 shows a second embodiment, which differs from the first embodiment in that the motor cables 43 form the power transmission lines 44 and extend along the length of the cannula 35 to the proximal end of the pump device 30. Each of the individual motor cables 43A, 43B, and 43C is soldered to a corresponding printed circuit board. Two measures are taken here to prevent the motor cables 43 from bursting, and these measures can be taken individually or, as shown here, together. First, the motor cables 43 are guided through tubes 46, one tube 46 per motor cable 43 shown in the embodiment. The tubes 46 are bendable and preferably have low bending stiffness so as not to interfere with the operability of the pump device. Even more preferably, the tubes 46 are elastically bendable, i.e., they automatically return to their original shape when the bending force is sufficiently reduced. Second, the motor cables 43 are arranged with slack, sufficient to allow the motor cables 43 to expand and contract without bursting when the bendable tubes 46 are bent together with the cannula 35.

[0072] 19A and 19B illustrate a third embodiment, which differs from the second embodiment in that two bendable tubes 46 are arranged on opposite sides of the cannula 35 to create a neutral bending plane within the cannula 35. As shown in FIGS. 17 through 23, the pump device 30 is shown in a retracted configuration and assumes a curved configuration in a relaxed state. The bendable tubes 46 in the embodiment illustrated in FIGS. 19A and 19B are preferably arranged along a predetermined central bending plane of the cannula 35. In this case, there is no particular need to provide significant slack in the motor cable 43. As seen in FIG. 19B, the first and second supply lines 44A and 44B can be arranged in one of the two bendable tubes 46, and the third supply line 44C, along with a pressure line 47, such as an optical fiber or glass fiber strand, can be arranged in the other of the two bendable tubes 46.

[0073] 19C, the bendable tubes 46 are longitudinally spaced at equal angular distances along the cannula 35. In the example shown, the angular distance between the bendable tubes 46 is 120°. If a fourth bendable tube 46 is provided, for example, for a pressure line 47, the angular distance would be 90°.

[0074] A fifth embodiment is shown in FIG. 20. Here, the power transmission lines 44 are not arranged strictly axially, but rather in a serpentine arrangement along the longitudinal axis of the cannula 35. In particular, when the power transmission lines 44 are each composed of stranded wires, here represented as an extension of the conductors of the power transmission lines 45 arriving through the delivery catheter 36, rupture of the power transmission lines 44 due to bending of the cannula 35 is effectively prevented. Alternatively, the power transmission lines 44 arranged in a serpentine arrangement can be formed by a single wire, such as an individual motor cable 43. The flexibility of the power transmission lines 44 arranged in a serpentine arrangement can be further enhanced by anchoring the power transmission lines 44 only at specific, spaced apart points against the wall of the cannula 35.

[0075] FIG. 21A shows a sixth embodiment of an intravascular blood pump in which the cannula 35 includes a reinforcing element 48 to enhance the stability of the cannula 35. The reinforcing element 48 may be ring-shaped, as shown in FIG. 21A, or may be formed by one or more helical windings, as shown in FIGS. 21B and 21C. The same or similar reinforcing material may be similarly provided in the cannula 35 of the previous embodiments. Important to this embodiment is the fact that the electrical transmission lines 44A to 44C extend helically around the cannula 35 along the longitudinal axis of the cannula 35. The angular orientation of the helical electrical transmission lines 44A to 44C relative to the longitudinal axis of the cannula 35 is different from the angular orientation of the ring-shaped reinforcing element 48. In the particular embodiment shown in Figure 21A, the reinforcing element 48 is formed as a helically extending reinforcing winding 48A, and the angular orientation of the helically extending transmission lines 44A-44C differs from the angular orientation of the helically extending reinforcing winding 48A, such that the reinforcing winding 48A overlaps the transmission lines 44. Preferably, the angular orientation differs by at least 5°, preferably at least 10°, and in the example of Figure 21B, about 20°.

[0076] In a seventh embodiment shown in FIG. 21C, the angular orientation of the helically extending transmission line 44 is opposite to the angular orientation of the helically extending reinforcing winding 48A, i.e., approximately +40° and −40° compared to the circular orientation.

[0077] An eighth embodiment is shown in Figures 22A-22C. Here, helically extending power transmission lines 44A-44C are disposed between helically extending reinforcing windings 48A, such that each power transmission line 44 is nested between two power transmission lines 48A. As can be seen from the cross-sectional view shown in Figure 22B, there are a total of three helically extending reinforcing windings 48A, which are made of flat wire, preferably comprising a shape-memory material such as nitinol. As can be seen in Figure 22C, the blood flow inlet 33 has three inlet ports separated by three respective bridges along which one of the power supply lines 44 is routed.

[0078] 23A-23C show a ninth embodiment having even more spirally extending reinforcing windings 48A. In total, six reinforcing windings 48A are disposed along the cannula 35, and the transmission lines 44A-44C are individually disposed between adjacent transmission lines 44 such that there are always two reinforcing windings 48A disposed between adjacent transmission lines 44.

[0079] 23C shows a cross section through the wall of cannula 35. An electrical insulation layer 49 is disposed between reinforcing winding 48A and transmission lines 44A-44C, such that reinforcing winding 48A is disposed below the insulation layer and transmission lines 44A-44C are disposed above insulation layer 49. In addition, it will be seen that the wall comprises two foils 50, 51 which form the outer and inner layers of the wall of cannula 35. Reinforcing member 48 or reinforcing winding 48A, if applicable, is disposed between these foils, along with transmission lines 44, as in the embodiment shown in FIGS. 23A-23C.

[0080] A tenth embodiment is shown in Figure 23D, in which three reinforcing windings 48A are disposed between adjacent transmission lines 44. Thus, in this embodiment, there are a total of nine reinforcing windings 48A.

[0081] Alternatively, the reinforcing windings 48A can form the transmission lines 44 that run along the cannula 35, and an insulating layer 49 can be used to isolate them from each other.

[0082] 24 through 30, preferred anchoring structures and preferred grips are described for attaching connecting catheter 25 to corresponding anchoring structures of pump device 30. These anchoring structures and connecting catheters are useful in the above-described deployment method according to the first deployment principle for guiding a blood pump from the venous vasculature, through the atrial septum, to the left ventricle and aorta.

[0083] Thus, FIG. 24A shows the distal end 30A of the pump device, which may be the housing of the drive section 31 of the pump device 30. A loop 60 is provided at the distal end 30A and may consist of a wire within a polymeric sheath. FIG. 24B shows how the connecting catheter 25 is attached to the loop 60. Thus, the pivotable grips 26A, 26B reach the loop 60, and the spring element 27 presses the two grips 26A, 26B together, holding them closed. When the grips 26A, 26B are retracted within the connecting catheter 25, the grips 26A, 26B are prevented from opening. In this position, the pump device 30 is safely guided through the patient's vascular system. In FIG. 24C, the connecting catheter 25 includes a hook 28 instead of the grips 26A, 26B, which hooks onto the loop 60 at the distal end 30A of the pump device 30. When the hook is withdrawn at the front end 25A of the catheter 25, the loop 60 is safely prevented from coming loose from the hook 28.

[0084] 25A and 25B show a similar embodiment that differs from the above embodiment only in that the loop 60 is provided not at the distal end of the housing of the pump device 30, but at the distal end 43A of the pigtail 41 that forms the distal end 30A of the pump device.

[0085] Thus, the introducer set may include an intravascular blood pump having an anchoring structure at the distal end 30A of the pump device 30, and a connecting catheter 25 adapted to connect to the anchoring structure.

[0086] 26A-26C show a different embodiment having a loop 60 at the distal end 30A of the pump device 30, where the loop 60 is integrally formed within the housing of the pump device 30.

[0087] While the embodiment shown in Figures 24-26 relates to a deployment method according to a first option of the first principle, as described in connection with Figures 9-11, Figure 27 shows how the same anchoring structure can be used in connection with a second option for deploying a blood pump according to the first deployment principle, as described in connection with Figures 12-15. Thus, first guidewire 20A can be fed through loop 60, and both ends 20Ar and 20Af can be fed through septum 24. Ends 20Ar and 20Af can then be grasped by gripper 80 to guide the blood pump through the vasculature.

[0088] FIG. 28A shows a neck-and-head structure at the end 41A of the pigtail 41, rather than the loop 60. Accordingly, the grips 26A, 26B of the connecting catheter 25 have complementary surfaces that close around the neck-and-head structure. More specifically, the neck-and-head structure includes a head 70 and a neck 71, and a connecting surface 72 between the head 70 and the neck 71. The connecting surface 72 is inclined 90° relative to the longitudinal axis of the pigtail 41. The corresponding cooperating surface 26C on the grips 26A, 26B is similarly inclined 90° relative to the longitudinal axis of the connecting catheter 25. FIG. 28C shows how the two surfaces 72, 26C cooperate. Any force acting between the two surfaces 72, 26C is strictly axial, thereby improving the connection.

[0089] 29 shows a similar design, however, here the head 70 is recessed in the distal end 30A of the pump device 30 to prevent damage to tissue in the patient's vasculature after the connecting catheter 25 is removed.

[0090] Figure 30 again shows the neck-head structure. However, in this embodiment, the cooperating surfaces 26C, 72 are inclined at greater than 90° to their respective longitudinal axes, so that each surface forms an undercut for the head and gripper, respectively. This gripper structure is self-reinforcing when the head 70 and grippers 26A, 26B are moved in opposite axial directions, as indicated by the two arrows in Figure 30.

[0091] Thus, a kit for the correct placement of an intravascular blood pump in a patient according to the first placement principle consists of the following tools: a transseptal sheath 17, which may include a puncture tip or a separate puncture needle and dilator; - a first guide wire 20A; a second guidewire 20B; - an introducer sheath 19; - a snare catheter 18; a balloon catheter 22 for extending the septum, such as a PTA balloon catheter; a steerable catheter 23, such as a Swan-Ganz catheter; - either a connecting catheter 25 (according to the first option of the first placement principle described in relation to Figures 1 to 11) or a tube 24 (according to the second option of the first placement principle described in relation to Figures 1 to 8 and Figures 12 to 15).

[0092] Preferred embodiments are identified in the following sections. 1. An intravascular blood pump for percutaneous insertion into a patient's vascular system, said intravascular blood pump comprising a pump device and a supply line; - the pump device comprises a pump portion having a blood inlet, a blood outlet, and an impeller rotatable about a rotation axis to transport blood from the blood inlet to the blood outlet, and a drive portion connected to the pump portion and adapted to drive the impeller; - the supply line is adapted to supply the drive with electrical energy for driving at least the impeller; - an intravascular blood pump, characterized in that the pump part is arranged along the axis of rotation between the drive part and the supply line. 2. An intravascular blood pump as described in item 1, characterized in that it has a conductive connection extending along the pump section and electrically connecting the supply line to the motor of the drive section. 3. An intravascular blood pump according to item 1 or 2, characterized in that the pump section has a vertical axis and is provided with a cannula that is bendable along the vertical axis. 4. An intravascular blood pump according to item 3, characterized in that the blood flow outlet of the pump section is positioned at the distal end of the cannula. 5. An intravascular blood pump according to paragraph 3 or 4, characterized in that the conductive connection comprises one or more power transmission lines extending along the wall of the cannula and electrically connecting the supply line with the motor of the drive unit. 6. An intravascular blood pump according to paragraph 5, wherein the motor of the drive unit includes a plurality of motor cables, and an electrical connector is preferably provided at the distal end of the cannula proximal to the blood flow outlet or at a distance distal to the distal end of the cannula, each of the plurality of motor cables being connected to one of the one or more power transmission lines, and the electrical connector is preferably a printed circuit board, and the electrical connector is preferably covered by an insulating material, more preferably by a polymer coating such as polyurethane. 7. An intravascular blood pump according to item 6, characterized in that each of the one or more power transmission lines is a stranded wire. 8. An intravascular blood pump according to item 6, characterized in that each of the one or more power transmission lines is a single wire. 9. An intravascular blood pump according to paragraph 5, wherein the motor of the drive unit includes a plurality of motor cables constituting the one or more power transmission lines extending along the cannula, an electrical connector is preferably provided at or near the proximal end of the cannula proximal to the blood inlet, each of the plurality of motor cables being connected to a respective one of the supply lines, the electrical connector being preferably a printed circuit board, and the electrical connector being preferably covered with an insulating material, more preferably with a polymer coating such as polyurethane. 10. An intravascular blood pump according to any one of paragraphs 5 to 9, wherein the one or more power transmission lines extend in a longitudinal direction parallel to the longitudinal axis of the cannula, along the wall of the cannula, preferably along a neutral bending plane of the cannula predetermined by a central curved surface of the cannula, and are extensible in the longitudinal direction. 11. An intravascular blood pump according to any one of paragraphs 5 to 9, characterized in that the one or more power transmission lines extend along the wall of the cannula inside at least one bendable tube predetermined by the central curvature surface of the cannula, preferably arranged along the neutral bending surface of the cannula. 12. An intravascular blood pump according to item 11, characterized in that the one or more power transmission lines are laid loosely inside the at least one bendable tube. 13. An intravascular blood pump according to item 11 or 12, characterized in that each of the one or more power transmission lines is provided with one bendable tube. 14. An intravascular blood pump according to any one of items 11 to 13, characterized in that at least one of the plurality of bendable tubes is arranged on the opposite side of the wall of the cannula so as to form a neutral bending surface inside the cannula. 15. An intravascular blood pump according to item 14, characterized in that the cannula has an even number of blood flow inlet ports, more preferably four blood flow inlet ports. 16. An intravascular blood pump according to any one of items 11 to 15, characterized in that the at least one bendable tube is made of a shape memory alloy. 17. An intravascular blood pump according to item 16, characterized in that the shape memory alloy is nitinol. 18. An intravascular blood pump according to any one of items 5 to 9, characterized in that the one or more power transmission lines extend in a serpentine manner along the wall of the cannula. 19. An intravascular blood pump according to item 18, characterized in that the one or more serpentine power transmission lines are arranged along a neutral bending plane of the cannula, which is predetermined by a central curved surface of the cannula. 20. An intravascular blood pump according to any one of items 5 to 9, characterized in that the one or more power transmission lines extend spirally along the wall of the cannula. 21. An intravascular blood pump according to paragraph 20, wherein the cannula includes one or more reinforcing windings extending helically along the wall of the cannula, and the angular orientation of the one or more helically extending power transmission lines relative to the longitudinal axis of the cannula differs from the angular orientation of the one or more helically extending reinforcing windings such that the one or more reinforcing windings and the one or more power transmission lines overlap, preferably the angular orientation differs by at least 5°, preferably at least 10°. 22. An intravascular blood pump according to paragraph 20 or 21, wherein the cannula includes one or more reinforcing windings that extend helically along the wall of the cannula, and the angular orientation of the one or more helically extending power transmission lines relative to the longitudinal axis of the cannula is opposite to the angular orientation of the one or more helically extending reinforcing windings such that the one or more reinforcing windings and the one or more power transmission lines overlap. 23. An intravascular blood pump according to paragraph 20, characterized in that the cannula includes one or more reinforcing windings extending helically along the wall of the cannula, and the one or more helically extending power transmission lines are disposed between the one or more helically extending reinforcing windings. 24. An intravascular blood pump according to paragraph 23, characterized in that the one or more helically extending reinforcing windings include a plurality of reinforcing windings arranged axially parallel to the longitudinal axis of the cannula so as to be helically nested within one another, and the one or more helically extending power transmission lines include a plurality of power transmission lines configured such that exactly one power transmission line of the plurality of power transmission lines is arranged between two or more of the helically extending reinforcing windings. 25. An intravascular blood pump according to item 24, characterized in that there are two to nine of the reinforcing windings. 26. An intravascular blood pump according to any one of items 23 to 25, characterized in that one, two, or three of the one or more spirally extending reinforcing windings are arranged between each of the one or more spirally extending power transmission lines. 27. An intravascular blood pump according to any one of items 23 to 26, characterized in that the electrical insulation layer is disposed between the reinforcing winding extending in a spiral shape and the electrical transmission line extending in a spiral shape, such that the reinforcing winding is disposed on top of the electrical insulation layer and the electrical transmission line is disposed below the electrical insulation layer, or vice versa. 28. An intravascular blood pump according to paragraph 20, characterized in that the cannula includes one or more reinforcing windings extending helically along the wall of the cannula, and at least one of the power transmission lines is formed by each of the reinforcing windings. 29. An intravascular blood pump according to item 28, characterized in that the electrical insulating layers are arranged between the spirally extending reinforcing windings so that adjacent reinforcing windings are arranged alternately above and below the electrical insulating layers. 30. An intravascular blood pump according to any one of items 20 to 29, characterized in that the one or more spirally extending reinforcing windings are made of flat wire. 31. An intravascular blood pump according to any one of items 20 to 30, characterized in that the reinforcing winding is made of a shape memory alloy. 32. An intravascular blood pump according to any one of paragraphs 5 to 31, characterized in that the one or more power transmission lines are arranged inside the wall of the cannula. 33. An intravascular blood pump according to any one of paragraphs 5 to 32, characterized in that the wall of the cannula comprises a first foil and a second foil coupled to and covering the first foil, and at least one reinforcing member is disposed between the first foil and the second foil, preferably together with the one or more power transmission lines. 34. An intravascular blood pump according to item 33, characterized in that the first foil and the second foil are made of polyurethane. 35. An intravascular blood pump according to any one of paragraphs 3 to 34, wherein the cannula is configured not to buckle when bent up to 180° along its longitudinal axis. 36. An intravascular blood pump according to any one of items 1 to 35, characterized in that the impeller is an impeller that pumps in an axial, radial, diagonal, or centrifugal direction. 37. An intravascular blood pump according to any one of paragraphs 1 to 36, characterized in that the supply line is in the form of a supply catheter, preferably further including at least a pressure sensor line. 38. An intravascular blood pump according to any one of paragraphs 1 to 37, characterized in that it comprises at least one anchor adapted to anchor the intravascular blood pump to the wall of a patient's blood vessel. 39. An intravascular blood pump according to claim 38, wherein the anchor comprises an expandable and collapsible spike. 40. An intravascular blood pump according to any one of items 1 to 39, characterized in that the intravascular blood pump is provided with an anchoring structure in the distal end region of the intravascular blood pump. 41. An intravascular blood pump according to paragraph 40, characterized in that the anchoring structure comprises a hook or loop at the axial end of the distal end region. 42. An intravascular blood pump according to paragraph 41, characterized in that the loop is made of a soft, elastic material and forms an atraumatic distal extension at the axial end of the intravascular blood pump. 43. An intravascular blood pump according to item 41, characterized in that the loop is provided in an atraumatic distal extension of the intravascular blood pump. 44. An intravascular blood pump according to any one of items 40 to 43, characterized in that the anchor fixing structure comprises a neck-head structure at the axial end of the distal end region. 45. An intravascular blood pump according to item 44, wherein the connection surface between the head and neck of the neck-head structure is inclined at 90° with respect to the longitudinal axis of the intravascular blood pump, or the connection surface is inclined at more than 90° with respect to the longitudinal axis of the intravascular blood pump so as to form an undercut. 46. ​​An intravascular blood pump according to item 44 or 45, characterized in that the neck-head structure is formed in a recess in the distal end region. 47. An intravascular blood pump according to item 44 or 45, characterized in that the neck-head structure is formed at the end of an atraumatic distal extension. 48. An introducer set comprising an intravascular blood pump according to any one of paragraphs 40 to 47 and a connecting catheter having a connector adapted to connect to the anchoring structure of the intravascular blood pump. 49. An introducer set according to paragraph 48, wherein the connector comprises a hook adapted to hook onto the anchoring structure of the intravascular blood pump. 50. An introducer set according to paragraph 48, characterized in that the connector comprises a gripper having a first grip and a second grip adapted to close or grip around the hook or loop of the intravascular blood pump. 51. An introducer set according to paragraph 50, wherein the gripper has a gripping surface that is inclined at 90° relative to the longitudinal axis of the connecting catheter. 52. An introducer set according to paragraph 50, wherein the gripper has a gripping surface that is inclined at more than 90° relative to the longitudinal axis of the connecting catheter so as to form an undercut. 53. A method of placing an intravascular blood pump in a patient, the blood pump comprising a pump section having a blood inlet and a blood outlet, and an impeller rotatable about an axis of rotation and sized and shaped to transport blood from the blood inlet to the blood outlet, the blood pump further comprising a supply line, preferably a supply catheter, connected to the pump section and adapted to supply energy, preferably electrical energy, to drive the impeller, the method comprising: - placing a first guidewire through the patient's vascular system, including through the patient's heart, whereby the first guidewire exits the patient's body with a first end via a first percutaneous access on the arterial side of the vascular system, preferably via the axillary or subclavian artery, and a second end via a second percutaneous access on the venous side of the vascular system, preferably via the subclavian or axillary vein; - using the first guidewire in a further procedure of positioning the intravascular blood pump within the patient via the second percutaneous access. 54. The method according to paragraph 53, - inserting a transseptal sheath from the venous side of the patient's vasculature through a passageway created in the septum of the patient's heart to a left side of the heart, advancing the first end of the first guidewire through the transseptal sheath to the left side of the heart, and retracting the transseptal sheath; - preferably, the transseptal sheath is inserted into a vein below the inferior vena cava, preferably the femoral vein, via a third percutaneous access, and further comprising the steps of inserting a snare catheter into a vein above the superior vena cava via the second percutaneous access, advancing the snare catheter towards the first guidewire into the superior vena cava, capturing the first guidewire with the snare catheter, and moving the second end of the first guidewire to and from the third percutaneous access with the help of the snare catheter; - dilating the passageway through the septum, preferably using a balloon catheter; - advancing the introducer septum sheath through the septum, preferably with the aid of the balloon catheter, so that the anterior portion of the introducer septum sheath extends into a left portion of the heart, preferably the left ventricle; - withdrawing the balloon catheter, if applicable; - advancing a steerable catheter, preferably a Swan-Ganz catheter, through the introducer septum sheath into the left portion of the heart, preferably the left ventricle; - preferably advancing a second guidewire through said first percutaneous access into a left portion of said heart, preferably into said left ventricle; - guiding the first end of the first guide wire towards and out of the first percutaneous access with the help of the steerable catheter, preferably along a direction indicated by the second guide wire, preferably by inflating a balloon of the Swan-Ganz catheter and tracking the patient's blood flow. 55. The method according to paragraph 54, - attaching a front end of a coupling catheter to the first end of the first guidewire, preferably in a form-fitting manner, and guiding the coupling catheter through the patient's vascular system, including through the patient's heart, using the first guidewire until the front end of the coupling catheter extends from the patient's body via the second percutaneous access; and - coupling a distal end of the intravascular blood pump to the coupling catheter, preferably in a form-fitting manner, and advancing the intravascular blood pump through the patient's vascular system, including through the septum, to position the pump portion in the left portion of the heart, preferably across the aortic valve; - a preferred step of anchoring the intravascular blood pump to the wall of the blood vessel, preferably the aortic wall, by moving a plurality of spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the blood vessel; - disconnecting the coupling catheter from the distal end of the intravascular blood pump and withdrawing the coupling catheter from the patient's body; - withdrawing the introducer septum sheath from the patient's body. 56. The method according to paragraph 54, - withdrawing the steerable catheter from the patient's body while maintaining the first end of the first guidewire extending from the patient's body through the second percutaneous access; - guiding the introducer septum sheath along the first guidewire and through the patient's vascular system, including through the patient's heart, until a leading end of the introducer septum sheath extends from the patient's body via the second percutaneous access; - feeding the second end of the first guidewire through a loop at the distal end of the intravascular blood pump and advancing the second end of the first guidewire through the introducer septum sheath until the second end of the first guidewire extends from the front end of the introducer septum sheath; - grasping the first and second ends of the first guidewire extending from the introducer septum sheath via the second percutaneous access to position the pump section in the left portion of the heart, preferably across the aortic valve, and advancing the intravascular blood pump through the patient's vascular system, including along the introducer septum sheath and through the septum; - releasing or deactivating the first guidewire from the loop at the distal end of the intravascular blood pump and withdrawing the first guidewire from the introducer septum sheath; - withdrawing the introducer sheath from the patient's body; - anchoring the intravascular blood pump to a wall of a blood vessel, preferably an aortic wall, by moving a plurality of spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the blood vessel. 57. A method of placing an intravascular blood pump in a patient, the blood pump comprising a pump device comprising a pump section having a blood inlet, a blood outlet, and an impeller rotatable about an axis of rotation and sized and shaped to transport blood from the blood inlet to the blood outlet, and a drive section connected to the pump section and adapted to drive the impeller, the blood pump further comprising a supply line, preferably a supply catheter, connected to the pump device and adapted to supply energy, preferably electrical energy, to at least the drive section for driving the impeller, the method comprising: - accessing the patient's thoracic cavity; - forming a puncture through the apical wall of the patient's heart to access the left ventricle of the heart; - advancing the pump device through the puncture in the apical wall such that the blood inlet of the pump portion is positioned in the left ventricle of the heart, the blood outlet of the pump portion is positioned in the patient's aorta, the supply line extends from the patient's body through the puncture in the apical wall, and the drive portion is positioned in the aorta. 58. A method according to paragraph 57, preferably comprising the step of anchoring the intravascular blood pump to a wall of a blood vessel, preferably the aortic wall, by moving a plurality of spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the blood vessel. 59. A kit for placing an intravascular blood pump in a patient, comprising the following tools: - a transseptal sheath (17) which may include a puncture tip or a separate puncture needle and dilator; - a first guidewire (20A); - a second guidewire (20B); - an introducer sheath (19); - a snare catheter (18); a balloon catheter (22); a steerable catheter (23); - either a connecting catheter (25) or a tube (24).

Claims

1. An intravascular blood pump for percutaneous insertion into a patient's vascular system, said intravascular blood pump comprising a pump device (30) and a supply line (36); - said pump device (30) comprises a pump part (32) having a blood inlet (33), a blood outlet (34) and an impeller rotatable about a rotation axis for transporting blood from said blood inlet to said blood outlet, and a drive part (31) connected to said pump part (32) and adapted to drive said impeller; - said supply line (36) is adapted to supply energy for driving said impeller; an intravascular blood pump, characterized in that an anchoring structure (60; 70) is provided in the distal end region of said intravascular blood pump;

2. 2. The intravascular blood pump of claim 1, wherein the anchoring structure comprises a hook or loop (60) at an axial end (30A) of the distal end region.

3. 3. The intravascular blood pump of claim 2, wherein the loop (60) is made of a soft, elastic material and forms an atraumatic distal extension at the axial end of the intravascular blood pump.

4. 4. The intravascular blood pump of claim 3, wherein the loop (60) is provided in an atraumatic distal extension (40) of the intravascular blood pump.

5. 5. An intravascular blood pump according to claim 2, wherein the anchoring structure comprises a neck-and-head structure at an axial end (30A) of the distal end region.

6. 6. The intravascular blood pump according to claim 5, wherein a connection surface (72) between the head (70) and the neck (71) of the neck-head structure is inclined at 90° to the longitudinal axis of the intravascular blood pump, or the connection surface (72) is inclined at more than 90° to the longitudinal axis of the intravascular blood pump so as to form an undercut.

7. 7. An intravascular blood pump according to claim 5 or 6, characterized in that the neck-head structure is formed in a recess in the end region.

8. 7. An intravascular blood pump according to claim 5 or 6, characterized in that the neck-and-head structure is formed at the end of an atraumatic distal extension (40).

9. 11. An introducer set comprising an intravascular blood pump according to claim 1 or any one of claims 4 to 10 and a connecting catheter (25) comprising a connector adapted to connect to the anchoring structure (60; 70) of the intravascular blood pump.

10. 10. The introducer set of claim 9, wherein the connector comprises a hook adapted to hook onto the anchoring structure of the intravascular blood pump.

11. 10. The introducer set of claim 9, wherein the connector comprises a gripper having a first grip (26A) and a second grip (26B) adapted to close or grip around the anchoring structure of the intravascular blood pump.

12. 12. An introducer set according to claim 11, wherein the gripper has a gripping surface (26C), the gripping surface being inclined at 90 degrees relative to the longitudinal axis of the connecting catheter.

13. 12. An introducer set as described in claim 11, wherein the gripper has a gripping surface (26C) that is inclined at more than 90 degrees relative to the longitudinal axis of the connecting catheter so as to form an undercut.

14. 14. An intravascular blood pump according to any one of claims 1 to 13, characterized in that the anchoring structure comprises at least one anchor adapted to anchor the intravascular blood pump to a wall of a patient's blood vessel.

15. 15. An intravascular blood pump according to claim 14, characterized in that the anchor (41) comprises an expandable and collapsible spike.

16. 1. A kit for placing an intravascular blood pump in a patient, comprising the following tools: a transseptal sheath (17) which may include a puncture tip or a separate puncture needle and dilator; a first guidewire (20A), a second guidewire (20B), - an introducer sheath (19); - a snare catheter (18), a balloon catheter (22), a steerable catheter (23), - a connecting catheter (25) or a tube (24).

17. 1. A method of placing an intravascular blood pump in a patient, the blood pump comprising a pump section having a blood inlet and a blood outlet, and an impeller rotatable about an axis of rotation and sized and shaped to transport blood from the blood inlet to the blood outlet, the blood pump further comprising a supply line, preferably a supply catheter, connected to the pump section and adapted to supply energy, preferably electrical energy, to drive the impeller, the method comprising: - placing a first guidewire through the patient's vascular system, including through the patient's heart, whereby the first guidewire exits the patient's body with a first end via a first percutaneous access on the arterial side of the vascular system, preferably via the axillary or subclavian artery, and a second end via a second percutaneous access on the venous side of the vascular system, preferably via the subclavian or axillary vein; using the first guidewire in a further procedure of placing the intravascular blood pump within the patient via the second percutaneous access.

18. 18. The method of claim 17, inserting a transseptal sheath from the venous side of the patient's vasculature through a passageway created in the septum of the patient's heart into the left side of the heart, advancing the first end of the first guidewire through the transseptal sheath into the left portion of the heart, and withdrawing the transseptal sheath; Preferably, the transseptal sheath is inserted into a vein below the inferior vena cava, preferably the femoral vein, via a third percutaneous access, and further comprising the steps of inserting a snare catheter into a vein above the superior vena cava via the second percutaneous access, advancing the snare catheter towards the first guidewire into the superior vena cava, capturing the first guidewire with the snare catheter, and moving the second end of the first guidewire to and from the third percutaneous access with the help of the snare catheter; - dilating said passageway through said septum, preferably using a balloon catheter; - advancing the introducer septum sheath through the septum, preferably with the aid of the balloon catheter, so that the front part of the introducer septum sheath extends into the left part of the heart, preferably into the left ventricle; - withdrawing the balloon catheter, if applicable; - advancing a steerable catheter, preferably a Swan-Ganz catheter, through the introducer septum sheath into the left portion of the heart, preferably the left ventricle; - preferably advancing a second guidewire through said first percutaneous access into the left part of said heart, preferably into said left ventricle; - guiding the first end of the first guide wire towards and out of the first percutaneous access with the aid of the steerable catheter, preferably along a direction indicated by the second guide wire, preferably by inflating a balloon of the Swan-Ganz catheter and tracking the patient's blood flow.

19. 20. The method of claim 18, - attaching a front end of a coupling catheter, preferably in a form-fitting manner, to the first end of the first guidewire and guiding the coupling catheter through the patient's vascular system, including through the patient's heart, using the first guidewire until the front end of the coupling catheter extends from the patient's body via the second percutaneous access; - coupling a distal end of the intravascular blood pump to the coupling catheter, preferably in a form-fitting manner, and advancing the intravascular blood pump through the patient's vascular system, including through the septum, to position the pump portion, preferably across the aortic valve, in the left portion of the heart; - a preferred step, preferably anchoring the intravascular blood pump to the wall of the blood vessel, preferably the aortic wall, by moving a plurality of spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the blood vessel; - disconnecting the coupling catheter from the distal end of the intravascular blood pump and withdrawing the coupling catheter from the patient's body; - withdrawing the introducer septum sheath from the patient's body.

20. 20. The method of claim 18, - withdrawing the steerable catheter from the patient's body while keeping the first end of the first guidewire extending from the patient's body through the second percutaneous access; - guiding the introducer septum sheath along the first guidewire through the patient's vascular system, including through the patient's heart, until the leading end of the introducer septum sheath extends out of the patient's body via the second percutaneous access; - feeding the second end of the first guidewire through a loop at the distal end of the intravascular blood pump and advancing the second end of the first guidewire through the introducer septum sheath until the second end of the first guidewire extends from the front end of the introducer septum sheath; - grasping the first and second ends of the first guidewire extending from the introducer septum sheath via the second percutaneous access to position the pump section, preferably across the aortic valve and into the left portion of the heart, and advancing the intravascular blood pump along the introducer septum sheath and through the patient's vascular system, including through the septum; - releasing or deactivating the first guidewire from the loop at the distal end of the intravascular blood pump and withdrawing the first guidewire from the introducer septum sheath; - withdrawing the introducer sheath from the patient's body; - anchoring the intravascular blood pump to the wall of a blood vessel, preferably the aortic wall, by moving a plurality of spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the blood vessel.

21. 1. A method of placing an intravascular blood pump in a patient, the blood pump comprising: a pump device comprising: a pump section having a blood inlet, a blood outlet, and an impeller rotatable about an axis of rotation and sized and shaped to transport blood from the blood inlet to the blood outlet; and a drive section connected to the pump section and adapted to drive the impeller, the blood pump further comprising a supply line, preferably a supply catheter, connected to the pump device and adapted to supply energy, preferably electrical energy, to at least the drive section for driving the impeller, the method comprising: - accessing the patient's thoracic cavity; forming a puncture through the apical wall of the patient's heart to access the left ventricle of the heart; advancing the pump device through the puncture in the apical wall such that the blood inlet of the pump portion is positioned in the left ventricle of the heart, the blood outlet of the pump portion is positioned in the patient's aorta, the supply line extends from the patient's body through the puncture in the apical wall, and the drive portion is positioned in the aorta.

22. 22. The method of claim 21, preferably comprising the step of anchoring the intravascular blood pump to a wall of a blood vessel, preferably an aortic wall, by moving a plurality of spikes from the periphery of the intravascular blood pump from a radially collapsed configuration to a radially expanded configuration and engaging the wall of the blood vessel.

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