Placement of blood pump and intravascular blood pump

Abstract

An intravascular blood pump inserted percutaneously into a patient's vasculature, comprising a pumping device (30) and a supply catheter. The pumping device includes a pump section having a blood flow inlet, a blood flow outlet, and an impeller for delivering blood from the inlet to the outlet, and further includes a drive section connected to the pump section and adapted to drive the impeller. A supply line supplies electrical energy to the drive section for driving the impeller. An anchoring structure (25A) is provided in the distal region of the intravascular blood pump. A connecting catheter (25) can be attached to the anchoring structure from the distal end for guiding the intravascular blood pump through the patient's vasculature in the distal direction.

Description

Technical Field

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

[0002] Thus, the present invention generally relates to intravascular blood pumps. Intravascular blood pumps are different from extracorporeal blood pumps or blood pumps placed in the patient's abdomen, chest, or other body cavities, and are placed within a blood vessel, for example within the patient's heart, which is also referred to as an "intracardiac" blood pump. The present invention particularly, but not exclusively, relates to intravascular blood pumps that are percutaneously inserted into the patient's vascular system. Background Art

[0003] Known intravascular blood pumps are used to maintain the patient's heart function, either for short-term applications (implanting the blood pump in the patient's body for several days or weeks) or long-term applications (implanting the blood pump in the patient's body for several weeks or months, such as six months or longer, and even up to, for example, two years). Different types of intravascular blood pumps are known, such as axial blood pumps, centrifugal blood pumps, or diagonal (sometimes also referred to as hybrid) blood pumps. Such types of intravascular blood pumps can be inserted into the patient's vascular system through a percutaneous incision with the aid of a catheter.

[0004] Typically, an intravascular blood pump includes a pump section having a blood flow inlet, a blood flow outlet, and an impeller that is rotatable about a rotation axis and is sized and shaped to convey blood from the blood flow inlet to the blood flow outlet. The intravascular blood pump also includes a drive section for driving the impeller. Hereinafter, the pump section and the drive section together are referred to as the "pumping device". In addition, an intravascular blood pump typically includes a supply catheter connected to the pumping device, and the proximal end of the supply catheter extends outside the patient's body. Herein, "proximal" refers to a position closer to the surgeon or in the direction towards the surgeon, while "distal" refers to a position away from the surgeon or in the direction away from the surgeon and into the patient. The supply catheter can enclose any supply line of the pumping device, such as a power line, a flushing fluid line, a sensing line, a drive cable, etc.

[0005] In the case where the impeller is driven by an internal motor, the pumping device can include the pump section and the drive section in a shared housing, the pump section including a blood flow inlet, a blood flow outlet, and an impeller, and the drive section being axially attached to the pump section and including a motor for driving the impeller. Electrical energy for driving the motor is provided via a supply line passing through the supply catheter. If the impeller is driven by an external motor outside the patient's body, the supply catheter will enclose a flexible drive cable that is part of the drive section, and the drive cable connects the external motor to the impeller and provides kinetic energy to the impeller.

[0006] Although the placement methods described herein may also be applicable to a cable-driven blood pump as described above, an intravascular blood pump including both a pump section and a drive section joined together is preferred in this context to form an integral, fully implantable pumping device.

[0007] Typically, an intravascular blood pump acting as a left ventricular assist device (LVAD) is inserted through the femoral artery and through the aorta into the left ventricle of a patient's heart. However, sometimes the inner diameter of the arterial blood vessel is reduced due to calcification, and this problem usually does not occur in venous blood vessels. In this case, it may not be possible to place the blood pump through the femoral artery. In other cases, the blood pump may be too large to be introduced even through an uncalcified arterial blood vessel. For example, long-term devices may be relatively large and have a large diameter (e.g., 16 French or larger, up to 18 French), so it is difficult to insert them via the arterial side. Therefore, other insertion techniques have been described, in which the blood pump is inserted via the venous side with a relatively large inner diameter (e.g., via the femoral vein) and then enters the left ventricle through a perforation in the atrial compartment. A further advantage of introducing the blood pump through the femoral vein is that since the blood pressure on the venous side of the ventricular system is very low, the risk of blood leaking from the femoral vein through the entry point is greatly reduced.

[0008] For example, it is known from US2006 / 0155158 A1 to use two wires inserted separately from the venous side and the arterial side, and the two wires are magnetically connected inside the patient's heart to form a continuous wire, which is used to pull the blood pump into the femoral artery and further through a perforation in the vena cava and the atrial compartment into the left ventricle. However, it is difficult to find and firmly connect the two wires inside the patient's heart.

[0009] Another problem that occurs in long-term applications is the desire for the patient to be mobile, for example, allowing the patient to get out of bed and walk around. That is, when the blood pump is inserted via the transfemoral artery approach (i.e., inserted through a small incision in the groin into the femoral artery or femoral vein), since the supply catheter exits the patient percutaneously in the groin, the patient's mobility is limited and it is difficult for the patient to walk. SUMMARY OF THE INVENTION

[0010] Accordingly, the present invention relates to placing an intravascular blood pump in a patient's heart to function as an LVAD. In this context, an intravascular blood pump and a placement tool particularly suitable for the disclosed placement method are further disclosed herein.

[0011] A method of placing an intravascular blood pump of the above type in a patient, which includes the following steps according to a first principle: placing a first wire through the patient's vascular system, including through the patient's heart, such that its first end extends outside the patient through a first percutaneous access on the arterial side of the vascular system, for example through the axillary artery or the subclavian artery, and its second end extends outside the patient through a second percutaneous access on the venous side of the vascular system, and then using the first wire in a further process of placing the intravascular blood pump into the patient through the second percutaneous access, that is, from the venous side of the patient's vascular system.

[0012] The placement of the first wire until it passes through the patient's vascular system such that it extends outside the patient from both the venous and arterial sides can be achieved in the following manner. First, an interatrial sheath is inserted from the venous side of the patient's vascular system through a perforation formed in the septum of the patient's heart into the left side of the heart, where the septal perforation is preferably a perforation of the atrial septum. Then, the first end of the first wire is advanced through the interatrial sheath into the left part of the heart. Thereafter, the interatrial sheath can be retracted. Second, the passage through the septum can be dilated, for example, by a PTA balloon catheter. Third, a guiding sheath is advanced through the septum such that the front part of the guiding sheath extends into the left part of the heart, preferably into the left ventricle. This process can be advantageously supported by a PTA balloon catheter. In the case where a PTA balloon catheter has been used, it can now be withdrawn from the vascular system. Fourth, a balloon catheter such as a Swan-Ganz catheter is advanced through the guiding sheath into the left part of the heart, preferably into the left ventricle. Then, the balloon of the balloon catheter is inflated and the first end of the first wire is guided towards and led out from the first percutaneous access with the patient's blood flow by means of the balloon catheter. As a result, the first wire now passes through the patient's vascular system, including the heart, and its two ends extend outside the patient.

[0013] Preferably, before inflating the balloon of the Swan-Ganz catheter, a second wire can be advanced through the arterial access, the above-mentioned "first" percutaneous access, into the left part of the heart, preferably into the left ventricle, and the balloon catheter can be guided and led out of the arterial access in the direction indicated by the second wire.

[0014] Further preferably, when the spacer sheath is inserted at the start of the operation, the spacer sheath can be inserted through a percutaneous access into the vein below the inferior vena cava, preferably into the femoral vein, which is typically accessed into the patient's groin by known Seldinger technique. Due to the natural curvature within the human ventricular system, including the curvature of the heart, it is relatively easy to advance the spacer sheath and the lead through the atrial septum into the left part of the heart, especially until entering the left ventricle, from the inferior vena cava. The percutaneous access to the vein below the inferior vena cava is different from the above-mentioned "second" percutaneous access and is thus referred to as the "third" percutaneous access. In this case, the snare catheter can be inserted through the second percutaneous access into the vein above the superior vena cava, such as into the subclavian vein or axillary vein, and advanced through the superior vena cava towards the first lead in the inferior vena cava, where it is used to grasp the first lead and move the second end of the first lead into the third percutaneous access and out of the second percutaneous access.

[0015] Once the first lead has been placed with both ends extending outside the ventricular system, there are various options for placing the intravascular blood pump on the left part of the heart with the aid of the first lead. The first option may include the following steps. First, connect the front end of the coupling catheter to the first end of the first lead, preferably in a formfitting manner, and use the first lead to guide through the patient's vascular system, including through the patient's heart, until the front end of the coupling catheter extends outside the patient's body through the second percutaneous access. Preferably, the balloon catheter is withdrawn from the patient's body while advancing the coupling catheter. Second, couple the distal end of the intravascular blood pump to the coupling catheter, preferably in a formfitting manner, and advance through the patient's vascular system, including through the atrial septum, to place its pump section into the left part of the heart, preferably across the aortic valve. In this configuration, the supply catheter of the intravascular blood pump extends through the heart into the left ventricle, forms a loop in the left ventricle, and abuts against the heart wall, thereby supporting the blood pump and preventing the blood pump from moving into the left ventricle during operation.

[0016] Optionally, the intravascular blood pump can be anchored in the vessel wall, such as in the aortic wall. This can be achieved by transforming a plurality of protrusions from the circumferential of the intravascular blood pump from a radially contracted configuration to a radially expanded configuration to engage with the vessel wall. In particular, the expanded protrusions can partially penetrate into the vessel wall. The protrusions can have stoppers to prevent them from penetrating too deep into the vessel wall. Third, decouple the coupling catheter from the distal end of the intravascular blood pump and withdraw it from the patient's body. Finally, the introducer sheath can be withdrawn from the patient's body.

[0017] A second option for placing the intravascular blood pump in the left part of the heart with the aid of a first wire in accordance with the first placement 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 wire extending outside the patient through the second percutaneous access. Second, the introducer sheath is guided along the first wire through the patient's vascular system, including through the patient's heart, until the front end of the introducer sheath extends outside the patient through the second percutaneous access. Third, the second end of the first wire is passed through a loop provided at the distal end of the intravascular blood pump and advanced through the introducer sheath until the second end of the first wire extends out of the front end of the introducer sheath. Fourth, the first end and the second end of the first wire extending out of the introducer sheath through the first percutaneous access are clamped and used to advance the intravascular blood pump along the introducer sheath through the patient's vascular system, including through the septum, so as to place its pump section in the left part of the heart, preferably across the aortic valve. Fifth, the first wire is released or disengaged from the loop provided at the distal end of the intravascular blood pump and withdrawn from the introducer sheath. Finally, the introducer sheath is withdrawn from the patient's body. Again, the intravascular blood pump can be anchored in the vessel wall, such as in the aortic wall, for example by changing a plurality of protrusions from the circumferential of the intravascular blood pump from a radially contracted configuration to a radially expanded configuration to engage with the vessel wall. As described above, the expandable protrusions can partially penetrate the vessel wall and can have stoppers to prevent them from penetrating too deep into the vessel wall.

[0018] In all aspects of the first placement principle as described above, the supply catheter can include a drive cable that connects the pump section to an external motor and provides kinetic energy to the pump section. The pump section can even include an expandable rotor. However, the described placement principle is particularly suitable for non-expandable blood pumps that require a relatively large cross-sectional area of the blood vessel when being pushed towards and into the heart, such as those provided in the venous vascular system. A directly driven intravascular blood pump is particularly preferably used, that is, a blood pump in which the drive section is axially connected to the pump section and implanted together with the pump section, because a long and flexible drive cable is not particularly suitable for being placed along a winding path into the left ventricle. In such a case, electrical energy can be supplied to the drive section via a supply line.

[0019] It may be advantageous for long-term applications not to arrange the supply catheter or the supply line on the arterial side of the patient's vascular system but on the venous side, where the tissue of the arterial blood vessel tends to grow in the supply catheter. Similarly, by such an arrangement, the supply catheter or the supply line is completely unobstructed to the arterial blood vessel, so that the intravascular blood pump placed in this way can achieve a correspondingly higher blood flow rate.

[0020] A method of placing an intravascular blood pump in a patient according to a second principle, the blood pump being insertable via an apical access. The method may include the step of entering the patient's thoracic cavity by puncturing the wall of the patient's heart at the apex to access the left ventricle of the heart. Entering the patient's thoracic cavity is preferably performed by minimally invasive surgery. The method further includes the steps of advancing a pumping device, i.e., a pump section including a drive section, through the puncture hole in the apical wall into the left ventricle, with the distal end of the pumping device facing forward, advancing the pumping device through the left ventricle and the aortic valve towards the aorta, and placing the blood pump such that the blood flow inlet is in the left ventricle, the blood flow outlet is in the aorta and the drive section is also in the aorta, while a supply catheter passes through the apical puncture hole and exits the patient's body percutaneously. This requires that the pump section of the intravascular blood pump be axially arranged between the drive section and the supply catheter or supply line, which will be further explained below.

[0021] Moreover, the placement method according to the second principle may further include the step of fixing the position of the blood pump in the patient's body by an anchoring device that engages with the inner wall of the patient's aorta. This method is particularly useful because the intravascular blood pump tends to move from the aorta into the left ventricle. This may be caused by the patient's movement and the pumping pressure of the blood pump pushing the blood pump back into the left ventricle. Although this is not a problem if the supply catheter extends through the aortic arch to provide a certain degree of fixation, it may still be advantageous.

[0022] As described above, the distal region of the intravascular blood pump is preferably provided with an anchoring structure, wherein the intravascular blood pump further includes at least a pumping device and a supply line as components, wherein the pumping device includes a pump section having an impeller and a drive section for driving the impeller, and the supply line supplies energy for driving the impeller.

[0023] The anchoring structure may include at least one of the aforementioned anchors, which is adapted to anchor the intravascular blood pump in the wall of the patient's blood vessel, such as in the patient's aorta, wherein the anchor may include expandable and contractible protrusions.

[0024] However, the intravascular blood pump may further or alternatively include a completely different anchoring structure, i.e., for the above placement method, for connecting the distal end of the intravascular blood pump to a coupling catheter according to a first option of the first placement principle, or to a first wire according to a second option of the first placement principle.

[0025] According to a first preferred embodiment, such an anchoring structure includes a hook or a loop at the distal end of an intravascular blood pump. The coupling catheter may then include a corresponding hook for hooking the hook or loop of the blood pump or a loop for being hooked by the hook of the blood pump. In one form, the loop may be made of a soft elastic material so as to form a non-invasive distal extension at the axial end of the intravascular blood pump. A typical pigtail-shaped or J-shaped non-invasive distal extension may be replaced by such a loop. Alternatively, a conventional non-invasive distal extension may preferably be provided with a loop at its distal end. When using the coupling catheter to guide the blood pump through the patient's vasculature by pushing the blood pump forward and slightly pulling the other end, the J-shaped or pigtail-shaped non-invasive extension may stretch and retract after release.

[0026] In a second preferred embodiment, such an anchoring structure may include a necked structure at the axial end of the end region of the intravascular blood pump. In this case, the coupling catheter may include a clamp for connecting to the necked structure. Preferably, the connecting member has a clamp which has a first clamp and a second clamp which are adapted to clamp around the head of the necked structure. If the same clamp is provided with a hook or a loop instead of the necked structure, it may equally be used to close around the hook or loop of the intravascular blood pump. The necked structure may extend distally from the axial end of the end region of the intravascular blood pump. Alternatively, the necked structure may be slightly hidden in the front cavity of the intravascular blood pump to avoid possible tissue damage.

[0027] Preferably, the connecting surface between the head and the neck of the necked structure is inclined 90° relative to the longitudinal axis of the intravascular blood pump, or the connecting surface may even be inclined greater than 90° relative to the longitudinal axis of the intravascular blood pump to form an undercut. In order to provide a perfect fit between the vertical or even negatively skewed connecting surfaces, the clamp surface is likewise inclined 90° or even greater than 90° relative to the longitudinal axis of the connecting catheter so as to form a mating undercut with the undercut of the necked structure. Thus, when using the connecting catheter to carefully pull the blood pump through the vasculature, the force acting on the head, more specifically the force acting on the connecting surface between the head and the neck, is purely an axial force, so any force for maintaining the first and second clamps closed behind the head may be small. These closing forces act radially in a direction perpendicular to the longitudinal axis of the blood pump, so any pulling force acting on the connecting surface when the blood pump is guided through the patient's vasculature will not generate a force component opposite to the clamp closing force. The clamp surface in a conventional connecting catheter is typically circular and thus not advantageous.

[0028] Different types of drives can be used. Preferably, the drive may include a stator that includes a plurality of poles, each pole having a coil winding that can be controlled to generate a rotating magnetic field. The impeller can then have a corresponding plurality of permanent magnets to couple to the rotating magnetic field to rotate the impeller. Alternatively, the drive may include an electric motor-driven rotor, the magnets of the rotor being magnetically coupled to form a magnetic coupling configured to transmit the rotation of the rotor to the impeller. In both of these drives, the electrical components are enclosed by a housing and do not come into contact with the blood. The rotational movement of the electric motor is magnetically transmitted to the impeller. However, other types of drives can equally be used, such as a drive flushed with a flushing fluid (such as a saline solution).

[0029] It should be understood that the intravascular blood pump is preferably a left ventricular assist device (LVAD) configured to pump blood from the left ventricle into the aorta. The blood flow inlet can be arranged at the proximal end of the pumping device, while the blood flow outlet can be arranged at the distal end of the pumping device. This can be referred to as a "pressure pump" because the blood is pushed away from the surgeon, i.e., away from the supply catheter. This applies to applications where the supply catheter is placed on the venous side of the patient's vasculature. Conversely, the blood flow inlet can be arranged at the distal end of the pumping device and the blood flow outlet can be arranged at the proximal end of the pumping device. This can be referred to as a "suction pump" because the blood is suctioned in the direction of the surgeon (i.e., the supply catheter direction). This applies to applications where the supply catheter is placed on the arterial side of the patient's vascular system.

[0030] Preferably, the intravascular blood pump is a pressure pump, more preferably a pressure pump in which the pump section is axially arranged between the drive section and the supply catheter or supply line. In prior art intravascular blood pumps in which the pump section and the drive section are integrated into a fully implantable pumping device, the arrangement is different, i.e., the pump section is axially arranged between the drive section and the supply catheter. Although such prior art intravascular blood pumps typically operate as suction pumps, the rotation of the impeller can be reversed so that the same blood pump can also be used as a pressure pump. However, since the main application of such a blood pump is as a suction pump, the fluidity is not good when the same blood pump is used as a pressure pump. Especially in the case where the pump section is not designed as a purely axial pump and at least includes a radial component, i.e., it is formed as a diagonal pump or a mixed pump or a centrifugal pump. The radial component of the pump has the effect of a centrifugal pump and thus helps to transmit kinetic energy from the pump to the blood flow. When such a pump runs in reverse, such a radial component will not only lose kinetic energy generation but even be counterproductive. This loss in performance must be accepted or compensated for by a higher rotational speed of the impeller, but there are certain limitations to the rotational speed.

[0031] Accordingly, a preferred design of the pressure blood pump according to the present invention includes a pumping device and a supply line. The pumping device generally includes a pump section, i.e., the pump section has a blood flow inlet, a blood flow outlet, and an impeller rotatable about a rotation axis, which is used to transport blood from the blood flow inlet to the blood flow outlet. The pumping device further includes 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 implanted together with the pump section, as is generally known in the art. The supply line is adapted to supply at least electrical energy to the drive section for driving the impeller. Accordingly, the supply line includes a cable or consists at least of a cable. However, the supply line is preferably formed as a supply conduit, which may include a cable and other components, such as a pressure line, 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 supply conduit. Thus, the supply line or supply conduit is connected to the pump section rather than the drive section.

[0032] If an intravascular blood pump is placed in a patient's vascular system such that the blood flow inlet is in the patient's heart and the blood flow outlet is in the aorta, the blood pump can operate as a pressure pump, i.e., in a direction away from the supply line or supply conduit and thus also away from the surgeon, which provides the following advantages: the supply line or supply conduit does not pass through the arterial vascular system and thus does not impede the blood flow supported or generated by the blood pump. Accordingly, a higher blood flow rate can be achieved in this way regardless of the type of blood pump. This will have particular advantages when the blood pump has a radial component (such as an axial-radial blood pump, a diagonal blood pump, or a centrifugal blood pump). Here, since the drive section is located at the distal end of the pump section, the impeller driven by the drive section can be arranged close to the blood flow outlet and transport the blood radially or at least with a radial component through the blood flow outlet, so that the blood pump can provide a relatively high blood flow rate.

[0033] The energy for driving the impeller is preferably transmitted in a conductive manner from the supply line across the pump section to the drive section. Accordingly, a conductive connection can be provided to extend along the pump section to electrically connect the supply line to the motor of the drive section.

[0034] An intravascular blood pump of the above type typically includes a cannula as part of the pump section, and such a cannula can also be provided in the intravascular blood pump described herein. The cannula is generally part of the pump section, which extends through the aortic valve and, in some applications, also through the aortic valve and the mitral valve simultaneously. To enable the blood pump to be maneuverable through the patient's vascular system, the cannula is bendable along its longitudinal axis. The cannula can be pre-bent into the shape it should assume when properly installed in the patient's heart.

[0035] When the blood flow inlet of the pump section is preferably arranged near the distal end of the cannula of the supply line or supply catheter, the blood flow outlet of the pump can be arranged at the distal end of the cannula, i.e., next to the motor section. Thus, the impeller driven by the motor in the drive section is also located next to the drive section so that blood can leave the pump section directly through the blood flow outlet.

[0036] When the manipulation cannula is advanced through the vein and the heart to cross the aortic valve, due to the large curvature of the cannula, specific measures must be taken to prevent the conductive connection between the supply line across the pump section and the drive section from breaking during such manipulation. For example, the corresponding power line can be loosely passed through the lumen of the cannula. However, this is not preferred because such an arrangement may cause turbulence and blood clotting. Instead, it is preferred to arrange the power line along the wall of the cannula.

[0037] For example, the strands of the cable of the supply line or specific strands or single wires, such as the motor cable of the motor in the drive section which usually has a polymer coating insulation layer, can extend along the wall of the cannula, preferably within the neutral bending plane of the cannula. The neutral bending plane of the cannula is the plane along which the cannula is most likely to bend. For example, compared with the regions of the cannula in the neutral bending plane region, the other regions of the cannula elongate under a smaller force. For example, the neutral bending plane of the cannula can be predetermined by the plane of the center of curvature of the cannula, which corresponds to the curvature that the cannula should have when properly placed in the patient's heart.

[0038] For example, the power line can extend along the wall of the cannula in a direction strictly parallel to the longitudinal direction of the cannula, preferably along a common bending plane, and can be stretchable in the longitudinal direction to prevent it from breaking due to elongation.

[0039] Alternatively, the power line can extend along the wall of the cannula within at least one flexible tube. As mentioned before, the flexible tube is preferably arranged along a common bending plane, but this is not necessary when the power line is loosely placed within the cannula.

[0040] Each of the power lines can be provided with a flexible tube, or a plurality of power lines can pass through one flexible tube or multiple flexible tubes.

[0041] In a particular embodiment, a plurality of flexible tubes are provided along the longitudinal axis of the cannula on opposite sides of the cannula wall to create a plane of common curvature within the cannula. For example, one flexible tube can be provided on each opposite side of the cannula, with two power lines passing through one tube and a third power line passing through the other tube together with the light rays of the pressure sensor. Alternatively, two tubes can be arranged on each side of the wall, one tube for each line. In the case of power lines (or other lines) arranged on opposite sides of the cannula wall, it is advantageous to provide at least an even number of inlet ports to the blood flow inlet such that the power lines arranged on opposite sides of the cannula can continue straight through the bridge separating adjacent inlet ports.

[0042] Preferably, the flexible tube is made of a shape memory alloy such as nitinol.

[0043] As another alternative, the power lines can extend in a meandering shape along the wall of the cannula. This has the effect that the elongation rate of the cannula wall due to bending of the cannula is higher than the elongation rate of the meanderingly extending power lines. This effect can be achieved even when the meanderingly extending power lines are not arranged along the neutral bending plane of the cannula, which, as described above, is predetermined by the curvature center plane of the cannula. In particular, when the power lines are not fully fixed to the cannula wall but are allowed to move slightly, bending of the cannula may not result in any elongation of the meanderingly extending power lines. For example, the meanderingly extending power lines can be fixed in or on the cannula wall only at certain points.

[0044] According to yet another alternative, the power lines can be arranged to extend helically around the cannula. The effect is substantially the same as that of the meanderingly extending power lines.

[0045] For example, the cannula can include a reinforcement structure such as an annular reinforcement element or a reinforcement winding extending helically along the cannula wall, and the helically extending power lines can be arranged in a specific relationship with those reinforcement windings or reinforcement elements.

[0046] In a first embodiment including helically extending power lines, the angular orientation of the power lines helically extending relative to the longitudinal axis of the cannula can be different from the angular orientation of the one or more helically extending reinforcement windings such that the reinforcement windings overlap the power lines. The angular orientation preferably differs by at least 5°, preferably at least 10°, to prevent the power lines from sliding between the reinforcement windings. More preferably, the angular orientation of the power lines is opposite to the angular orientation of the reinforcement windings, for example, one is +5° while the other is -10°, or one is +20° while the other is -20°.

[0047] In a second embodiment, a helically extending power line may be placed between one or more helically extending reinforcing windings so as to be nested therebetween. In the presence of a plurality of reinforcing windings, such windings may be nested with each other and in the case of a plurality of helically extending power lines, such windings may preferably be arranged such that one of the power lines is exactly placed between two reinforcing windings. This arrangement may result in more than one (e.g., two or three) helically extending reinforcing windings being present between adjacent power lines. Preferably, there may be two to nine helically extending reinforcing windings present. In the case of three power lines and nine reinforcing windings being present, three reinforcing windings may be arranged between each of the power lines. As a result, when more reinforcing windings are present, the angle between the longitudinal axis of the sleeve and the orientation of the reinforcing winding is shorter, which means that the number of turns of the power line around the sleeve according to the width of the reinforcing winding decreases as the number of helically extending reinforcing windings decreases. Accordingly, the angle of the helically extending power line can be controlled by the number and width of the reinforcing windings. Therefore, the helically extending reinforcing windings are preferably made of a flat wire of a predetermined width.

[0048] Most preferably, the reinforcing winding is made of a shape memory alloy (such as nitinol). Preferably, an electrical insulating layer is arranged between the helically extending reinforcing winding and the helically extending power line such that the reinforcing winding is arranged above the insulating layer and the power line is arranged below the insulating layer, and vice versa. In this way, the power lines are insulated from each other and more particularly from the reinforcing winding.

[0049] In yet another alternative embodiment, one or more of the power lines may be formed by corresponding ones of the helically extending reinforcing windings. Again, preferably in this case, the electrical insulating layer is arranged in such a way between the helically extending reinforcing windings that adjacent reinforcing windings are arranged above and below the insulating layer in an alternating manner to prevent the reinforcing windings from contacting each other and causing a short circuit.

[0050] In all of the above embodiments and alternatives, preferably the power lines are arranged within the sleeve wall for protection. Preferably, the sleeve wall includes a first lining and a second lining, the second lining being combined with and covering the first lining. At least one reinforcing member (such as the aforementioned reinforcing winding) may be arranged together with the power lines between the first lining and the second lining. For example, the first lining and the second lining may be made of polyurethane.

[0051] One or more electrical connectors, such as a printed circuit board or just an insulating coating, can be provided at the proximal end and / or the distal end of the cannula. For example, the electrical connector is provided at or away from the distal end of the cannula and is used to connect each motor cable to a stranded wire or a single wire. Thus, the stranded wire or the single wire forms the power line and is laid along the cannula in one of the ways described above. The stranded wire is better than the single wire because it can still conduct electricity even if one strand in the stranded wire breaks. Preferably, the stranded wire of the cable arriving through the supply line can form the power line across the cannula and can then be electrically connected to the respective motor cables of the drive section via the electrical connector provided at the distal end of the cannula. More preferably, the stranded wire is different from the stranded wire of the cable arriving from the supply line and can be suitable for the specific requirements for the purpose of extending across the entire cannula. In this case, electrical connectors are provided at both ends of the cannula to connect the specific stranded wire or the alternative specific single wire, one end being connected to the motor cable and the other end being connected to the stranded wire of the cable of the supply line. Finally, one or more electrical connectors can be provided only at the proximal end of the cannula, i.e., in the case where the motor cable extends through the entire cannula, for example, in the above embodiment, the motor cable is guided through one or more flexible tubes.

[0052] As mentioned, one or more anchors can be provided at the distal end of the pumping device (i.e., preferably the drive section) to anchor the pumping device in, for example, the aortic wall of the patient to stably fix the pumping device within the patient's heart.

[0053] Most preferably, the cannula is configured such that it does not wrinkle even when bent up to 180° along its longitudinal axis. For example, assuming the cannula extends from the left atrium to the aorta and bridges the left ventricle, the predetermined curvature of the cannula is approximately 180°, and when the cannula is maneuvered through the patient's vein, it must adopt an approximately longitudinally stretched configuration.

[0054] Generally, the blood pump can be configured for long-term use, where the blood pump is preferably configured to operate in a patient for at least four weeks, more preferably at least six months. Description of the Drawings

[0055] The foregoing detailed description of the invention and the preferred embodiments will be better understood when read in conjunction with the accompanying drawings. The drawings are referred to for the purpose of illustrating the present disclosure. However, the scope of the present disclosure is not limited to the specific embodiments disclosed in the drawings. In the following drawings:

[0056] Figures 1 to 11 Placement of an intravascular blood pump through the venous vasculature according to the first placement principle is shown;

[0057] Figures 12 to 15 Introduction of an intravascular blood pump through the venous vasculature according to the second placement principle is shown;

[0058] Figure 16Shows the introduction of an intravascular blood pump into the left ventricle through the apex of the human heart according to the third placement principle;

[0059] Figure 17 Shows an intravascular blood pump according to the first embodiment;

[0060] Figure 18 Shows an intravascular blood pump according to the second embodiment;

[0061] Figures 19A to 19C Shows intravascular blood pumps of the third and fourth embodiments;

[0062] Figure 20 Shows an intravascular blood pump according to the fifth embodiment;

[0063] Figures 21A to 21C Shows intravascular blood pumps of the sixth and seventh embodiments;

[0064] Figures 22A to 22C Shows an intravascular blood pump according to the eighth embodiment;

[0065] Figures 23A to 23D Shows intravascular blood pumps of the ninth and tenth embodiments; and

[0066] Figure 24 to Figure 30 Shows different anchoring structures provided at the distal end of the pumping device and suitable holders for connecting to the anchoring structures. Detailed Description

[0067] Figures 1 to 16 Shows various principles for placing an intravascular blood pump in a patient's heart. Figure 1 Shows a cross-section of the human heart 1, revealing the left ventricle 2, left atrium 3, right ventricle 4, right atrium 5, and the ascending portion of the aorta 6. For further understanding, relevant are the positions of the subclavian artery 7, superior vena cava 8, inferior vena cava 9, and femoral vein 10, as well as the positions of the aortic valve 11, mitral valve 12, atrial septum 13, and ventricular septum 14. The patient's skin is denoted by reference numeral 15.

[0068] The arterial vascular system or arterial vasculature includes the left atrium 3, left ventricle 2, aorta 6, and subclavian artery 7, while the venous vascular system or venous vasculature includes the femoral vein 10, inferior vena cava 9, superior vena cava 8, right atrium 5, and right ventricle 4. The atrial septum 13 separates the left atrium 3 and the right atrium 5, while the ventricular septum 14 separates the left ventricle 2 and the right ventricle 4.

[0069] According to this first placement principle, and according to the Seldinger technique, access to the venous vessel is made through percutaneous access 16A. Preferably, access is made to the femoral vein 10, but alternatively to the subclavian vein (not shown, leading to the superior vena cava 8) instead of the femoral vein. However, for the procedure described below, namely passing a wire through the venous system and the atrial septum into the left part of the heart in a first step, it is advantageous to access the femoral vein 10 and insert a septal sheath through the lower percutaneous access 16A towards the atrial septum 13 and puncture the atrial septum 13 using the tip of the septal sheath 17 as Figure 1 shown. Alternatively, a separate needle can be used to puncture the septum. Then, as Figure 2 shown, the first wire 20A is advanced through the septal sheath 17 into the left part of the heart until it enters the left ventricle 2. When entering from the inferior vena cava, it is relatively easy to advance the septal sheath and the wire through the atrial septum into the left part of the heart (especially until entering the left ventricle) because of the natural curvature inside the human ventricular system, including the curvature in the heart. However, the further procedural steps of this first placement principle are easier to perform from the superior vena cava. Therefore, as Figure 3 shown, a snare catheter 18 is advanced through a sheath 19 placed in the superior vena cava 8 to pull up the first wire 20A. The sheath 19 can subsequently be used to introduce an intravascular blood pump into the vascular system. The sheath 19 and the snare catheter 18 can be inserted through a superior percutaneous access into a vein above the superior vena cava, for example into the subclavian vein or the axillary vein, and advanced through the superior vena cava 8 towards the first wire 20A in the inferior vena cava 9, using an appropriate clamp provided at the end of the snare catheter 18 to grasp the first wire 20A. When the snare catheter 18 grasps the first wire 20A, it is then pulled into the sheath 19 and extended out through the superior percutaneous access (not shown) until the rear end 20Ar of the first wire 20A appears outside the patient's body, as Figure 3 indicated by the arrow in. For this purpose, the septal sheath 17 is withdrawn a short distance so that the snare catheter 18 can clamp the first wire 20A in the right atrium. After the rear end 20Ar has been pulled out through the superior percutaneous access (not shown), the septal sheath 17 can be completely withdrawn from the patient's body.

[0070] Next, as Figure 4 shown, a balloon catheter 22 (which is a PTA balloon as shown in the embodiment, but can be any kind of balloon) is guided along the wire 20A through the sheath 19, further through the atrial septum 13 and inflated to expand, thereby expanding the perfusion through the atrial septum. Once the perfusion through the atrial septum 13 has increased to a suitable size, the sheath 19 is advanced over the PTA balloon 22 to extend into the left atrium 3, as Figure 5 shown.

[0071] Thereafter, the PTA balloon 22 is withdrawn and replaced with the insertion of an operating catheter 23, which is the Swan Ganz catheter shown in the embodiment, but may also be any suitable guiding catheter, such as a pigtail catheter. The Swan Ganz catheter 23 is guided along the first wire 20A until it reaches the left ventricle 2, as Figure 6 shown. Then, a second wire 20B (preferably through the subclavian artery 7) is introduced into the left ventricle 2 to assist in guiding the first wire 20A further in the process of arterial percutaneous access 16B. More specifically, the second wire is visible in X-ray imaging. Then, the balloon 23A at the distal end of the Swan Ganz catheter 23 is inflated so that the natural blood flow supports the movement of the Swan Ganz catheter 23 together with the first wire 20A further through the vasculature into and through the subclavian artery 7. The second wire 20B can be optionally provided. Instead of the second wire 20B, a connecting catheter with a clamp can be used to attach to the front end 20Af of the first wire 20A. However, even when a connecting catheter is used to grasp the front end 20Af of the first wire 20A, the Swan Ganz catheter can still be used to further advance the first wire 20A because simply pulling the wire through the patient's vasculature may damage the patient's vascular tissue.

[0072] As Figure 8 shown, once the front end 20Af of the first wire 20A and the balloon 23A of the Swan Ganz catheter are visible to the surgeon, the connecting catheter 25 can be firmly fixed to the front end 20Af of the first wire 20A. The connecting catheter 25 can be the same as the snare catheter 18. Then, as Figure 9 shown, the coupling catheter 25 firmly connected to the first wire 20A is guided from the arterial percutaneous access 16B in the opposite direction towards the upper percutaneous access (not shown) on the venous side. When the connecting catheter 25 advances, the first wire 20A retracts, and at the same time the Swan Ganz catheter also retracts. Figure 9 This movement is shown, and at the same time the deflated balloon 23A of the Swan Ganz catheter 23 and the front end 25A of the connecting catheter 25 attached to the front end 20Af of the first wire 20A enter the sheath 19 in the backward direction.

[0073] Then, when the front end 25A of the connecting catheter 25 passes through the sheath 19 and reaches outside the patient, it is connected to the distal end of the pumping device 20 and used to guide the pumping device in the opposite direction through the sheath 19 into the right part of the heart until the pumping device 30 bridges the aortic valve 11, as Figure 10 shown. In the embodiment shown here, a soft pigtail extension is provided at the end of the pumping device 30, and the front end 25A of the connecting catheter 25 is attached to the ring at the distal end of the pigtail extension.

[0074] When reaching as Figure 10When in the position shown, disconnect the connecting catheter 25 and remove it, while the supply catheter 36 of the blood pump that extends through the heart into the left ventricle and forms a loop therein is further advanced so as to be in close contact with the heart wall of the left ventricle, as Figure 11 shown. In this configuration, the supply catheter 36 maintains the position of the pumping device 30 and prevents it from moving into the left ventricle during operation. Optionally, a protrusion 40 can be provided and the protrusion 40 extends from the pumping device 30 so as to anchor the pumping device 30 in the aorta 6, as Figure 11 shown.

[0075] The above-described placement method according to the first principle can be optionally changed as described hereinafter, wherein the first wire 20A extends through the patient's vasculature on both the venous side and the arterial side and extends out of the patient's body. According to a second option of the first placement principle, all the steps described above regarding Figures 1 to 8 can be performed in a similar manner. However, once the front end 20Af of the first wire 20A extends out of the arterial side of the patient's vasculature, the Swan-Ganz catheter 23 can be completely withdrawn, as Figure 12 shown. Then, the tube 24 is inserted into the sheath 19 and further guided along the wire 20A until its front end 24A also reaches outside the patient's body, as Figure 13 shown. Alternatively, the tube 24 can be guided through the vasculature in the opposite direction.

[0076] Then, as Figure 14 shown, the rear end 20Ar is passed through the loop 41A at the end of the pigtail 41 of the pumping device 30 and further into the sheath 19, as Figure 14 shown, and further through the tube 24 until it reaches the front end 24A of the tube 24 that extends out of the patient's body. Thus, both ends 20Af and 20Ar will extend outside the tube 24 on the arterial side of the patient. Then, as Figure 15 shown, both ends 20Af and 20Ar of the first wire 20A are pulled together with the tube 24 while the pumping device 30 is advanced until it reaches the desired position within the patient's heart. The diameter of the tube 24 is selected such that the pumping device 30 abuts against the tube 24 with its distal end when it advances into the vasculature. Accordingly, when the pumping device 30 reaches Figure 15 the position shown, the first wire 20A can be disengaged from the loop 41A of the pigtail extension 41 through the arterial percutaneous access 16B (not shown here), and the tube 24 can also be removed from the patient's body through the same arterial percutaneous access 16B. Finally, when the optional protrusion 40 extends into the wall of the aorta 6, the same final placement as Figure 11 shown is achieved.

[0077] A placement method according to the second placement principle is as Figure 16As shown. Herein, the patient's heart 1 is accessed through the patient's chest cavity, and a puncture hole is created through the apical wall of the heart to access the left ventricle 2. In this case, the pump section 32 is again arranged between the drive section 31 and the supply line 36 or supply catheter. An intravascular blood pump that is particularly suitable for placement inside a patient's heart according to this third placement principle will be described hereinafter. More specifically, the pumping device 30 advances through the puncture hole in the apical wall such that the blood flow inlet 33 of the pump section 32 is located in the left ventricle 2 and the blood flow outlet 34 of the pump section 32 is located in the patient's aorta 6. The supply line 36 extends through the puncture hole in the apical wall and extends outside the patient's body, while the drive section 31 is located in the aorta. Accordingly, all of the advantages described with respect to Figures 1 to 5 the first placement principle shown can also be achieved by this third placement principle.

[0078] Hereinafter, in connection with Figures 17 to 2 3, a preferred intravascular blood pump that is particularly applicable to the first and second placement principles will be described, which shows nine different embodiments of the intravascular blood pump.

[0079] As Figures 17 to 2 shown in 3, each of the blood pumps includes a pumping device 30 and a supply line 36, which in these embodiments is taken as an example of a supply catheter and is connected to the proximal end of the pumping device 30 in a conventional manner. The pumping device includes a drive section 31 and a pump section 32, wherein the pump section 32 includes a blood flow inlet 33 having various inlet ports, a blood flow outlet 34 having various outlet ports, and a cannula 35 that is bendable and extends between the blood flow inlet and the blood flow outlet. The pump section 32 also includes an impeller (not shown herein), the impeller is driven by a motor arranged in the drive section 31, the impeller is arranged in the region of the blood flow outlet 34 and has axial and radial components in order to push the blood diagonally out of the blood flow outlet 34. Importantly, in all embodiments, the pump section 32 is arranged between the supply line 36 and the drive section 31.

[0080] In as Figure 17In the first embodiment shown, the electrical connector 42 is provided at the distal end of the cannula 35 near the blood flow outlet 34. The electrical connector 42 is a printed circuit board on which individual motor cables are mounted, in the illustrated example three cables, namely the outer conductor, the neutral or zero conductor, and the protective conductor, collectively referred to as the motor cable 43. The corresponding power lines 44A, 44B, and 44C, which are collectively referred to as the power line 44, are also attached to the distal electrical connector 42. The electrical connector 42 is covered with an insulating material such as polyurethane. In the illustrated embodiment, the power line 44 is an extension of the corresponding conductor in the cable 45 that reaches the pumping device 30 through the supply conduit 36. Thus, the power line 44 is typically a stranded wire. The power line 44 extends strictly longitudinally along the longitudinal axis of the cannula 35, i.e., along the neutral bending plane of the cannula 35, so as to prevent the power line 44 from breaking when the cannula 35 is bent. Additionally, the power line 44 with appropriate stretching ability can be selected. If the conductors of the cable 45 cannot stretch sufficiently, more stretchable stranded wires can be used instead to form the power line 44 that extends across the entire cannula 35. For this purpose, one or more additional electrical connectors are required at the proximal position of the blood flow inlet 33 (not shown here).

[0081] Figure 18 A second embodiment is shown, which differs from the first embodiment in that the motor cable 43 forms the power line 44 and extends along the length of the cannula 35 to the proximal end of the pumping device, and each individual motor cable 43A, 43B, 43C is welded to the corresponding printed circuit board. Two measures are taken to avoid the rupture of the motor cable 43, and these measures can be taken separately or jointly here. First, the motor cable 43 is guided through the tube 46, and in the embodiment, one tube 46 is shown for each motor cable 43. The tube 46 is bendable and preferably has a low bending stiffness so as not to interfere with the operability of the pumping device. Further preferably, the tube 46 can be elastically bent, i.e., it will automatically return to its original shape once the bending force is reduced to a sufficiently low level. Second, the motor cable 43 is configured loosely, and it is loose enough so that the motor cable 43 can stretch without breaking when the tube 46 and the cannula 35 are bent together.

[0082] Figure 19A and Figure 19B A third embodiment is shown, which differs from the second embodiment in that two bendable tubes 46 are arranged on opposite sides of the cannula 35 so as to create a neutral bending plane inside the cannula 35. Although Figures 17 to 2 the pumping device 30 shown in 3 is in a stretched configuration, it will assume a bent configuration in the relaxed state, while Figure 19A and Figure 19B the bendable tubes 46 of the illustrated embodiment are preferably arranged along the plane of the predetermined curvature center of the cannula 35. In this case, the motor cable 43 does not particularly need to be relaxed too much. In Figure 19BAs can be seen, the first supply line 44A and the second supply line 44B can be arranged in one of the two flexible tubes 46, and the third supply line 44C together with the pressure line 47 (such as an optical fiber or a glass fiber bundle) can be arranged in the other of the two flexible tubes 46.

[0083] In Figure 19C In the fourth embodiment shown, the flexible tubes 46 are longitudinally arranged along the sleeve 35 at equal angular distances. In the shown embodiment, the angular distance between the flexible tubes 46 is 120°. In the case where a fourth flexible tube 46 (for example, for the pressure line 47) is provided, the angular distance will be 90°.

[0084] The fifth embodiment is as Figure 20 shown. Herein, the power lines 44 are not arranged along a strictly axial direction, but are arranged in a zigzag manner along the longitudinal axis of the sleeve 35. Especially in the case where the power lines 44 are all composed of stranded wires, which are represented here by the conductor extensions reaching the cable 45 through the supply line 36, it effectively prevents the power lines 44 from breaking when the sleeve 35 is bent. Alternatively, the power lines 44 arranged in a zigzag manner can be formed by a single wire, such as a separate motor cable 43. By fixing the power lines 44 to the wall of the sleeve 35 only at certain spaced points, the flexibility of the power lines 44 arranged in a zigzag manner can be further enhanced.

[0085] Figure 21A The sixth embodiment of the intravascular blood pump is shown, in which the sleeve 35 includes a strengthening element 48 to increase the stability of the sleeve 35. The strengthening element 48 can be annular (as Figure 21A shown), or can be formed by one or more spiral winding elements as Figure 21B and Figure 21C shown. The same or similar strengthening members can be similarly provided in the sleeve 35 of the above embodiments. For this embodiment, it is important that the power lines 44A to 44C extend spirally around the sleeve 35 along the longitudinal axis of the sleeve 35. The angular orientation of the power lines 44A to 44C extending spirally with respect to the longitudinal axis of the sleeve 35 is different from the angular orientation of the annular strengthening element 48. In Figure 21A the shown embodiment, the strengthening element 48 is formed as a spirally extending strengthening winding 48A, and the angular orientation of the spirally extending power lines 44A to 44C is different from the angular orientation of the spirally extending strengthening winding 48A, such that the strengthening winding 48A and the power lines 44 overlap. Preferably, the angular orientation difference is at least 5°, preferably at least 10°, and is about 20° in Figure 21B the embodiment.

[0086] In as Figure 21CIn the seventh embodiment shown, the angular orientation of the helically extending power line 44 is opposite to the angular orientation of the helically extending reinforcing winding 48A, i.e., about +40° and 40° compared to the circular orientation.

[0087] The eighth embodiment is as Figures 22A to 22C shown. Herein, the helically extending power lines 44A to 44C are placed between the helically extending reinforcing windings 48A such that each of the power lines 44 is nested between two of the power lines 48A. As can be seen from Figure 22B the cross-sectional view shown, there are a total of three helically extending reinforcing windings 48A present, the reinforcing windings being made of flat wire and 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 which are separated by respective three bridges, and one power supply line 44 is placed along each bridge.

[0088] Figures 23A to 23C The ninth embodiment showing more helically extending reinforcing windings 48A is shown. A total of six reinforcing windings 48A are arranged along the sleeve 35, and the power lines 44A to 44C are placed individually therebetween such that two reinforcing windings 48A are always positioned between adjacent ones of the power lines 44.

[0089] Figure 23C A cross-section through the wall of the sleeve 35 is shown. An electrical insulation layer 49 is arranged between the reinforcing windings 48A and the power lines 44A to 44C such that the reinforcing windings 48A are arranged below the insulation layer and the power lines 44A to 44C are arranged above the insulation layer 49. Further, it can be seen that the wall includes two liners 50, 51 which form the outer and inner layers of the sleeve 35. The reinforcing member 48 or the reinforcing winding 48A is placed between such liners and can be placed together with the power line 44 in the case of the embodiment shown in Figures 23A to 23C the figure.

[0090] The tenth embodiment is as Figure 23D shown. According to this embodiment, three reinforcing windings 48A are located between adjacent power lines 44. Thus, there are a total of nine reinforcing windings 48A present in this embodiment.

[0091] Alternatively, the reinforcing windings 48A can form the power lines 44 extending along the sleeve 35, and the insulation layer 49 can be used to isolate them from each other.

[0092] Regarding FIGS. 24 to Figure 30, a preferred anchoring structure and a preferred clamp will be described, which are used to attach the connecting conduit 25 to the corresponding anchoring structure of the pumping device 30. These anchoring structures and connecting conduits are useful in the placement method according to the first placement principle described above for guiding the blood pump from the venous system through the atrial septum into the left ventricle and up into the aorta.

[0093] Accordingly, Figure 24A The distal end 30A of the pumping device is shown, which can be the housing of the drive section 31 of the pumping device 30. An annulus 60 is provided on the distal end 30A, and the annulus can be composed of wires in a polymer sheath. Figure 24B It is described how to attach the connecting conduit 25 to the annulus 60. Accordingly, the pivotable clamps 26A and 26B extend into the annulus 60, and the spring element 27 presses the two clamps 26A and 26B together to keep the clamps 26A and 26B closed. Once the clamps 26A and 26B are retracted into the connecting conduit 25, the clamps 26A and 26B are prevented from opening. In this position, the pumping device 30 can be safely guided through the patient's vasculature. In Figure 24C , the connecting conduit 25 includes a hook 28 instead of the clamps 26A and 26B, which hooks into the annulus 60 at the distal end 30A of the pumping device 30. Once the hook is retrieved in the front end 25A of the conduit 25, the annulus 60 can be safely prevented from coming loose from the hook 28.

[0094] Figure 25A and Figure 25B A similar embodiment is shown, which is different from the above embodiment only in that the annulus 60 is not provided at the distal end of the housing of the pumping device 30 but at the end 41A of the pigtail 41, which forms the distal end 30A of the pumping device.

[0095] Correspondingly, the introducer set may include an intravascular blood pump having an anchoring structure at the distal end 30A of the pumping device 30 and a connecting conduit 25 adapted to be connected to the anchoring structure.

[0096] Figures 26A to 26C A different embodiment is shown, which has an annulus 60 at the distal end 30A of the pumping device 30. The annulus 60 is integrally formed in the housing of the pumping device 30.

[0097] The embodiments shown in FIGS. 24 to 26 relate to a placement method according to the first option of the first principle as Figures 9 to 11 described, while Figure 27 shows in context how to use the same anchoring structure according to as Figures 12 to 15Place the blood pump according to the second option of the first placement principle. Thus, the first wire 20A can be fed through the annulus 60 and the two ends 20Ar and 20Af through the tube 24. Then, the two ends 20Ar and 20Af can be clamped by the clamp 80 to guide the blood pump through the vasculature.

[0098] Figure 28A A neck-head structure is shown at the end 41A of the pigtail 41, rather than the annulus 60. Accordingly, the clamps 26A, 26B of the connecting catheter 25 have complementary surfaces to close around the neck-head structure. More specifically, the neck-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° with respect to the longitudinal axis of the pigtail 41. The corresponding clamping surfaces 26C on the clamps 26A and 26B are likewise inclined 90° with respect to the longitudinal axis of the connecting catheter 25. Figure 28C Shows how the two surfaces 72 and 26C fit together. Any force acting between the two surfaces 72 and 26C is strictly axial, which improves the connection.

[0099] Figure 29 A similar design is shown. However, here the head 70 is arranged in a recess at the distal end 30A of the pumping device 30 to prevent damage to the tissue in the patient's vasculature once the connecting catheter is separated.

[0100] Figure 30 The neck-head structure is shown again. However, in this embodiment the cooperating surfaces 26C and 72 are inclined more than 90° with respect to their respective longitudinal axes, such that each surface forms an undercut with respect to the head and the clamp, respectively. When the head 70 and the clamps 26A, 26B are moved in opposite axial directions, the clamping structure can self-reinforce, as Figure 30 indicated by the two arrows.

[0101] Accordingly, a kit for correctly placing an intravascular blood pump in a patient according to the first placement principle may include the following tools:

[0102] A spacer sheath 17, which may include a puncture tip or a separate puncture needle and dilator,

[0103] A first wire 20A,

[0104] A second wire 20B,

[0105] A guide sheath 19,

[0106] A snare catheter 18,

[0107] A balloon catheter 22 for expanding the septum, such as a PTA balloon catheter,

[0108] An operable catheter 23, such as a Swan Ganz catheter,

[0109] is connected to a catheter 25 (in accordance with a first option of the first placement principle described with respect to Figures 1 to 11 or a tube 24 (in accordance with a second option of the first placement principle described with respect to Figures 1 to 8 and Figures 12 to 15 ).

[0110] Preferred specific embodiments are specified in the following paragraphs:

[0111] 1. An intravascular blood pump for percutaneous insertion into a patient's vasculature, the intravascular blood pump comprising a pumping device and a supply line,

[0112] wherein the pumping device includes a pump section having a blood flow inlet, a blood flow outlet, and an impeller rotatable about a rotational axis, the impeller for transporting blood from the blood flow inlet to the blood flow outlet; and a drive section connected to the pump section and adapted to drive the impeller,

[0113] wherein the supply line is adapted to supply electrical energy at least to the drive section to drive the impeller, and

[0114] wherein the pump section is arranged along the rotational axis between the drive section and the supply line.

[0115] 2. The intravascular blood pump according to paragraph 1, comprising an electrical conductive connection extending along the pump section and electrically connecting the supply line to the motor of the drive section.

[0116] 3. The intravascular blood pump according to paragraph 1 or 2, wherein the pump section includes a cannula having a longitudinal axis and being bendable along the longitudinal axis.

[0117] 4. The intravascular blood pump according to paragraph 3, wherein the blood flow outlet of the pump section is arranged at the distal end of the cannula.

[0118] 5. The intravascular blood pump according to paragraph 3 or 4, wherein the electrical conductive connection includes one or more power lines extending along the wall of the cannula and electrically connecting the supply line to the motor of the drive section.

[0119] 6. The intravascular blood pump according to paragraph 5, wherein the motor of the drive section includes a plurality of motor cables and wherein an electrical connection is provided at or at a distance from the distal end of the cannula, preferably proximal to the blood flow outlet, wherein each of the plurality of motor cables is connected separately to one of the one or more power lines, the electrical connection being preferably a printed circuit board, and the electrical connection being preferably covered with an insulating material, more preferably with a polymer coating such as polyurethane.

[0120] 7. The intravascular blood pump according to paragraph 6, wherein each of the one or more power lines is a stranded wire.

[0121] 8. The intravascular blood pump according to paragraph 6, wherein each of the one or more power lines is a single wire.

[0122] 9. The intravascular blood pump according to paragraph 5, wherein the motor of the drive section includes a plurality of motor cables forming one or more power lines extending along the cannula, and wherein an electrical connection is provided at or near the proximal end of the cannula, preferably proximal to the blood flow inlet, wherein each of the plurality of motor cables is connected separately to the supply line, the electrical connection being preferably a printed circuit board, and the electrical connection being preferably covered with an insulating material, more preferably with a polymer coating such as polyurethane.

[0123] 10. The intravascular blood pump according to any one of paragraphs 5 to 9, wherein the one or more power lines extend along the wall of the cannula in a longitudinal direction parallel to the longitudinal axis of the cannula, preferably along the neutral bending plane of the cannula predetermined by the plane of the center of curvature of the cannula, and the one or more power lines are stretchable in the longitudinal direction.

[0124] 11. The intravascular blood pump according to any one of paragraphs 5 to 9, wherein the one or more power lines extend along the wall of the cannula within at least one bendable tube, the bendable tube being preferably arranged along the neutral bending plane of the cannula predetermined by the plane of the center of curvature of the cannula.

[0125] 12. The intravascular blood pump according to paragraph 11, wherein the one or more power lines are laid loosely within the at least one bendable tube.

[0126] 13. The intravascular blood pump according to paragraph 11 or 12, wherein each of the one or more power lines is provided with one bendable tube.

[0127] 14. The intravascular blood pump according to paragraphs 11 to 13, wherein a plurality of said at least one flexible tube are arranged on opposite sides of the wall of the cannula so as to create a neutral bending plane inside the cannula.

[0128] 15. The intravascular blood pump according to paragraph 14, wherein the cannula has an even number of blood flow inlet ports, more preferably four blood flow inlet ports.

[0129] 16. The intravascular blood pump according to any one of paragraphs 11 to 15, wherein the at least one flexible tube is made of a shape memory alloy.

[0130] 17. The intravascular blood pump according to paragraph 16, wherein the shape memory alloy is nitinol.

[0131] 18. The intravascular blood pump according to any one of paragraphs 5 to 9, wherein the one or more power lines extend in a zigzag shape along the wall of the cannula.

[0132] 19. The intravascular blood pump according to paragraph 18, wherein the one or more power lines extending in a zigzag shape are arranged along a neutral bending plane of the cannula predetermined by a plane of the center of curvature of the cannula.

[0133] 20. The intravascular blood pump according to any one of paragraphs 5 to 9, wherein the one or more power lines extend spirally along the wall of the cannula.

[0134] 21. The intravascular blood pump according to paragraph 20, wherein the cannula includes one or more reinforcing windings extending spirally along the wall of the cannula, and wherein an angular orientation of the one or more power lines extending spirally with respect to a longitudinal axis of the cannula is different from an angular orientation of the one or more reinforcing windings extending spirally, such that the one or more reinforcing windings and the one or more power lines overlap, wherein preferably the angular orientations differ by at least 5°, preferably at least 10°.

[0135] 22. The intravascular blood pump according to paragraph 20 or 21, wherein the cannula includes one or more reinforcing windings extending spirally along the wall of the cannula, and wherein an angular orientation of the one or more power lines extending spirally with respect to a longitudinal axis of the cannula is opposite to an angular orientation of the one or more reinforcing windings extending spirally, such that the one or more reinforcing windings and the one or more power lines overlap.

[0136] 23. The intravascular blood pump according to paragraph 20, wherein the cannula includes one or more reinforcing windings spirally extending along the wall of the cannula, and wherein the one or more power lines spirally extending are placed between the one or more reinforcing windings spirally extending.

[0137] 24. The intravascular blood pump according to paragraph 23, wherein the one or more reinforcing windings spirally extending include a plurality of reinforcing windings, the plurality of reinforcing windings being arranged in parallel in the axial direction with respect to the longitudinal axis of the cannula so as to be spirally nested with each other, and wherein the one or more power lines spirally extending include a plurality of power lines, the plurality of power lines being arranged such that one of the plurality of power lines is placed between two or more of the spirally extending reinforcing windings.

[0138] 25. The intravascular blood pump according to paragraph 24, wherein there are two to nine of the spirally extending reinforcing windings.

[0139] 26. The intravascular blood pump according to any one of paragraphs 23 to 25, wherein one or two or three of the spirally extending reinforcing windings are arranged between each of the one or more power lines spirally extending.

[0140] 27. The intravascular blood pump according to any one of paragraphs 23 to 26, wherein an electrical insulation layer is provided between the spirally extending reinforcing winding and the spirally extending power line such that the reinforcing winding is arranged above the insulation layer and the power line is arranged below the insulation layer, and vice versa.

[0141] 28. The intravascular blood pump according to paragraph 20, wherein the cannula includes one or more reinforcing windings that spirally extend along the wall of the cannula, and wherein at least one of the power lines is formed by a corresponding one of the reinforcing windings.

[0142] 29. The intravascular blood pump according to paragraph 28, wherein an electrical insulation layer is arranged between the spirally extending reinforcing windings such that adjacent reinforcing windings are arranged above and below the insulation layer in an alternating manner.

[0143] 30. The intravascular blood pump according to any one of paragraphs 20 to 29, wherein the one or more spirally extending reinforcing windings are made of flat wire.

[0144] 31. The intravascular blood pump according to any one of paragraphs 20 to 30, wherein the reinforcing winding is made of a shape memory alloy.

[0145] 32. The intravascular blood pump according to any one of paragraphs 5 to 31, wherein the one or more power lines are arranged within the wall of the cannula.

[0146] 33. The intravascular blood pump according to any one of paragraphs 5 to 32, wherein the wall of the cannula comprises a first liner and a second liner, the second liner being bonded to the first liner and covering the first liner, wherein at least one reinforcing member is arranged between the first liner and the second liner, preferably together with the one or more power lines.

[0147] 34. The intravascular blood pump according to paragraph 33, wherein the first liner and the second liner are made of polyurethane.

[0148] 35. The intravascular blood pump according to any one of paragraphs 3 to 34, wherein the cannula is configured not to wrinkle when bent up to 180° along its longitudinal axis.

[0149] 36. The intravascular blood pump according to any one of paragraphs 1 to 35, wherein the impeller is an axial-radial, diagonal or centrifugal delivery impeller.

[0150] 37. The intravascular blood pump according to any one of paragraphs 1 to 36, wherein the supply line is in the form of a supply catheter, the supply catheter preferably further comprising at least one pressure sensing line.

[0151] 38. The intravascular blood pump according to any one of paragraphs 1 to 37, comprising at least one anchor, the anchor being adapted to anchor the intravascular blood pump in the wall of a patient's blood vessel.

[0152] 39. The intravascular blood pump according to paragraph 38, wherein the anchor comprises an expandable and contractible protrusion.

[0153] 40. The intravascular blood pump according to any one of paragraphs 1 to 39, comprising an anchoring structure located in the distal region of the intravascular blood pump.

[0154] 41. The intravascular blood pump according to paragraph 40, wherein the anchoring structure comprises a hook or a loop located at the axial end of the distal region.

[0155] 42. The intravascular blood pump according to paragraph 41, wherein the loop is made of a soft elastic material and forms a non-invasive distal extension at the axial end of the intravascular blood pump.

[0156] 43. The intravascular blood pump according to paragraph 41, wherein the loop is provided at the non-invasive distal extension of the intravascular blood pump.

[0157] 44. The intravascular blood pump according to any one of paragraphs 40 to 43, wherein the anchoring structure includes a neck-like structure located at the axial end of the distal region.

[0158] 45. The intravascular blood pump according to paragraph 44, wherein the connecting surface between the head and the neck of the neck-like structure is inclined 90° with respect to the longitudinal axis of the intravascular blood pump, or the connecting surface is inclined more than 90° with respect to the longitudinal axis of the intravascular blood pump to form an undercut.

[0159] 46. The intravascular blood pump according to paragraph 44 or 45, wherein the neck-like structure is formed at a recess in the distal region.

[0160] 47. The intravascular blood pump according to paragraph 44 or 45, wherein the neck-like structure is formed at the end of a non-invasive distal extension.

[0161] 48. A guide set, comprising the intravascular blood pump according to any one of paragraphs 40 to 47 and a connecting catheter, the connecting catheter including a connector adapted to connect to the anchoring structure of the intravascular blood pump.

[0162] 49. The guide set according to paragraph 48, wherein the connector includes a hook adapted to hook into the anchoring structure of the intravascular blood pump.

[0163] 50. The guide set according to paragraph 48, wherein the connector includes a gripper having a first clamp and a second clamp adapted to close or clamp a hook or a loop of the intravascular blood pump.

[0164] 51. The guide set according to paragraph 50, wherein the gripper has a clamping surface, and wherein the clamping surface is inclined 90° with respect to the longitudinal axis of the connecting catheter.

[0165] 52. The guide set according to paragraph 50, wherein the gripper has a clamping surface, and wherein the clamping surface is inclined more than 90° with respect to the longitudinal axis of the connecting catheter to form an undercut.

[0166] 53. A method of placing an intravascular blood pump in a patient, the blood pump including a pump section having a blood flow inlet, a blood flow outlet, and an impeller, the impeller being rotatable about a rotation axis and sized and shaped to pump blood from the blood flow inlet to the blood flow outlet, the blood pump further including 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 the following steps:

[0167] Place a first wire through a patient's vascular system, including through the patient's heart, such that it extends out of the patient's body, with its first end passing through a first percutaneous access on the arterial side of the vascular system, preferably through the axillary artery or subclavian artery, and its second end passing through a second percutaneous access on the venous side of the vascular system, preferably through the subclavian vein or axillary vein, and

[0168] Use the first wire during a further process of placing the intravascular blood pump into the patient through the second percutaneous access.

[0169] 54. The method according to paragraph 53, including one or more of the following steps:

[0170] Insert a septal sheath from the venous side of the patient's vascular system, through a channel formed in the septum of the patient's heart into the left side of the heart, and advance the first end of the first wire through the septal sheath into the left part of the heart and pull back the septal sheath,

[0171] wherein preferably the septal sheath is inserted through a third percutaneous access into a vein below the inferior vena cava, preferably the femoral vein, further including the steps of: inserting a snare catheter through the second percutaneous access into a vein above the superior vena cava, advancing the snare catheter into the superior vena cava towards the first wire, grasping the first wire with the snare catheter, and moving the second end of the first wire into the third percutaneous access and out of the second percutaneous access by means of the snare catheter,

[0172] Preferably use a balloon catheter to expand the channel through the septum,

[0173] Preferably, advance a introducer sheath through the septum by means of the balloon catheter such that the front part of the introducer sheath extends into the left part of the heart, preferably into the left ventricle,

[0174] Withdraw the balloon catheter, if applicable,

[0175] Advance an operating catheter, preferably a Swan-Ganz catheter, through the introducer sheath into the left part of the heart, preferably into the left ventricle,

[0176] Preferably, advance a second wire through the first percutaneous access into the left part of the heart, preferably into the left ventricle, and

[0177] By means of the operating catheter, guide the first end of the first wire towards the first percutaneous access and withdraw it from the first percutaneous access, preferably by inflating the balloon of the Swan-Ganz catheter and following the patient's blood flow, preferably in the direction indicated by the second wire.

[0178] 55. The method according to paragraph 54 includes one or more of the following steps:

[0179] Preferably in a form - fitting manner, attach the front end of the coupling catheter to the first end of the first wire and use the first wire to guide the coupling catheter through the patient's vascular system, including through the patient's heart, until the front end of the coupling catheter extends out of the patient's body through the second percutaneous access, preferably while withdrawing the manipulable catheter from the patient's body.

[0180] Couple the distal end of the intravascular blood pump to the coupling catheter, preferably in a form - fitting manner, and advance the intravascular blood pump through the patient's vascular system, including through the septum, so as to place the pump section into the left part of the heart, preferably across the aortic valve.

[0181] Preferably, anchor the intravascular blood pump to the vessel wall, preferably on the aortic wall, preferably by changing a plurality of protrusions from the circumferential portion of the intravascular blood pump from a radially - contracted configuration to a radially - expanded configuration to engage with the vessel wall.

[0182] Decouple the coupling catheter from the distal end of the intravascular blood pump and withdraw the coupling catheter from the patient's body, and

[0183] Withdraw the introducer sheath from the patient's body.

[0184] 56. The method according to paragraph 54 includes one or more of the following steps:

[0185] Withdraw the manipulable catheter from the patient's body while keeping the first end of the first wire extending out of the patient's body through the second percutaneous access.

[0186] Guide the introducer sheath along the first wire through the patient's vascular system, including through the patient's heart, until the front end of the introducer sheath extends out of the patient's body through the second percutaneous access.

[0187] Pass the second end of the first wire through a loop provided at the distal end of the intravascular blood pump and advance the second end of the first wire through the introducer sheath until the second end of the first wire extends out of the front end of the introducer sheath.

[0188] Clamp the first end and the second end of the first wire extending out of the patient's body through the second percutaneous access and advance the intravascular blood pump along the introducer sheath through the patient's vascular system, including through the septum, so as to place the pump section into the left part of the heart, preferably across the aortic valve.

[0189] Release or disengage the first wire from the annulus disposed at the distal end of the intravascular blood pump, and withdraw the first wire from the introducer sheath,

[0190] Withdraw the introducer sheath from the patient's body, and

[0191] Preferably, anchor the intravascular blood pump in the vessel wall, preferably in the aortic wall, preferably by transforming a plurality of protrusions from the circumferences of the intravascular blood pump from a radially contracted configuration to a radially expanded configuration to engage with the vessel wall.

[0192] 57. A method of placing an intravascular blood pump in a patient, the blood pump comprising: a pumping device including a pump section having a blood flow inlet, a blood flow outlet, and an impeller, the impeller being rotatable about a rotation axis and sized and shaped to convey blood from the blood flow inlet to the blood flow outlet; and a drive section connected to the pump section and adapted to drive the impeller, the blood pump further including a supply line, preferably a supply catheter, connected to the pumping device and adapted to supply energy, preferably electrical energy, at least to the drive section for driving the impeller, the method comprising the steps of:

[0193] Enter the patient's chest cavity;

[0194] Create a puncture hole through the apex wall of the patient's heart to enter the left ventricle of the heart;

[0195] Advance the pumping device through the puncture hole in the apex wall such that the blood flow inlet of the pump section is located in the left ventricle of the heart, the blood flow outlet of the pump section is located in the patient's aorta, the supply line extends out of the patient's body through the puncture hole in the apex wall, and the drive section is located in the aorta.

[0196] 58. The method according to paragraph 57, including the step of anchoring the intravascular blood pump in the vessel wall, preferably in the aortic wall, preferably by transforming a plurality of protrusions from the circumferences of the intravascular blood pump from a radially contracted configuration to a radially expanded configuration to engage with the vessel wall.

[0197] 59. A kit for placing an intravascular blood pump in a patient, comprising the following tools:

[0198] A spacer sheath (17) which can include a puncture tip or a separate puncture needle and dilator,

[0199] A first wire (20A),

[0200] A second wire (20B),

[0201] An introducer sheath (19),

[0202] Snare catheter (18),

[0203] Balloon catheter (22),

[0204] Operable catheter (23),

[0205] Connecting catheter (25) or tube (24).

Claims

1. A guide set, comprising an intravascular blood pump for percutaneous insertion into a patient's vascular system and a connecting catheter (25) configured to be connected to the intravascular blood pump, the intravascular blood pump including a pumping device (30) and a supply line (36), wherein the pumping device (30) includes a pump section (32) having a blood flow inlet (33), a blood flow outlet (34), and an impeller rotatable about a rotation axis for transporting blood from the blood flow inlet to the blood flow outlet, and a drive section (31) connected to the pump section (32) and adapted to drive the impeller, and wherein the supply line (36) is adapted to supply energy for driving the impeller, and wherein an anchoring structure (60; 70) is provided in the distal region of the intravascular blood pump, and wherein the connecting catheter (25) includes a connector adapted to be connected to the anchoring structure (60; 70) of the intravascular blood pump.

2. The guide set according to claim 1, wherein the anchoring structure includes a hook or a ring located at the axial end (30A) of the distal region.

3. The guide set according to claim 2, wherein the ring is made of a soft elastic material and forms a non-invasive distal extension at the axial end of the intravascular blood pump.

4. The guide set according to claim 3, wherein the ring is provided at the non-invasive distal extension of the intravascular blood pump.

5. The guide set according to claim 1, wherein the anchoring structure includes a neck-like structure at the axial end (30A) of the distal region.

6. The guide set according to claim 5, wherein the connecting surface (72) between the head (70) and the neck (71) of the neck-like structure is inclined 90° with respect to the longitudinal axis of the intravascular blood pump, or the connecting surface (72) is inclined more than 90° with respect to the longitudinal axis of the intravascular blood pump to form an undercut.

7. The guide set according to claim 5, wherein the neck-like structure is formed in a recess in the distal region.

8. The guide set according to claim 5, wherein the neck-like structure is formed at the end of the non-invasive distal extension.

9. The guide set according to any one of claims 1-8, wherein the connector includes a hook adapted to hook into the anchoring structure (60; 70) of the intravascular blood pump.

10. The guide set according to any one of claims 1-8, the connector includes a gripper having a first clamp (26A) and a second clamp (26B) adapted to close or clamp the anchoring structure of the intravascular blood pump.

11. The guide set according to claim 10, wherein the gripper has a clamping surface (26C), wherein the clamping surface is inclined 90° with respect to the longitudinal axis of the connecting catheter (25).

12. The introducer set according to claim 10, wherein the gripper has a gripping surface (26C), and wherein the gripping surface is inclined more than 90° relative to the longitudinal axis of the connection conduit (25) to form an undercut.

13. The introducer set according to any one of claims 1 to 8, wherein the anchoring structure comprises at least one anchor adapted to anchor the intravascular blood pump in the wall of a patient's blood vessel.

14. The introducer set according to claim 13, wherein the anchor comprises an expandable and contractible protrusion (40).

Images