Blood pump and catheter pump assembly

Abstract

The present invention relates to a blood pump (10) comprising a steering catheter (12) and a pump segment (14). The pump segment (14) is configured to be placed inside a human body and comprises an expandable and collapsible pump housing (20), an expandable and collapsible pump element (22) arranged within the pump housing (20), and an electric motor (32) configured to rotate the pump element (22). The steering catheter (12) comprises a distal end (16) and a proximal end (18), wherein the pump segment (14) is coupled to the distal end (16) of the steering catheter (12). The steering catheter (12) further comprises an elongated body (60) extending along a central axis between the distal end (16) and the proximal end (18), a working channel (64) extending at least partially within the body (60) from the proximal end (18) of the steering catheter (12) in a direction of the distal end (16) of the steering catheter (12), the working channel (64) being configured to removably receive a guide catheter (78).

Description

Technical Field

[0001] This invention relates to a blood pump, preferably an intravascular blood pump. More particularly, it relates to a percutaneously insertable blood pump for supporting blood circulation in humans or optionally, animals. For example, the blood pump may be designed for percutaneous insertion into a patient's femoral artery and guided through the patient's vascular system to, for example, support or replace the pumping action of the heart. The invention also relates to catheter pump assemblies including such a blood pump. Background Technology

[0002] This type of blood pump can be introduced into a patient either surgically or percutaneously and is used to transport blood from one location in the heart or circulatory system to another. For example, when deployed in the left heart, an intravascular blood pump can pump blood from the left ventricle into the aorta. Similarly, when deployed in the right heart, an intravascular blood pump can pump blood from the inferior vena cava into the pulmonary artery. Intravascular blood pumps can be powered by a motor located outside the patient's body via a slender drive shaft, or by an onboard motor located inside the patient's body. Some intravascular blood pump systems can operate in parallel with the natural heart to supplement cardiac output and partially or completely relieve the load on various parts of the heart.

[0003] The invention will be described in the context of a blood pump having an expandable and collapseable pump housing, in which an expandable and collapseable pump element driven by a motor is housed. The invention is also applicable to other types of intravascular blood pumps.

[0004] For example, the aforementioned expandable type of blood pump is known from EP 3 858 398 A1, which discloses a catheter pump assembly. An expandable and collapsible pump housing is disposed at the distal end of the manipulating catheter. The expandable and collapsible pump housing surrounds an expandable and collapsible pump element driven by a motor. The pump element can be an expandable and collapsible pump element. For example, the distal portion of the catheter pump assembly can be placed within the heart via a percutaneous approach using the Seldinger technique. In this document, "proximal" and "distal" are relative to the physician. Thus, "proximal" refers to the location relatively close to the physician during catheter placement, while "distal" refers to the location relatively far from the physician.

[0005] During blood pump intervention, a guiding catheter is used for hemodynamic support procedures. For known blood pumps with a non-collapseable pump segment, a relatively large-diameter guide (with a diameter of 14F (French) or larger) is used to allow the pump segment to be introduced. Because the manipulating catheter typically has a smaller diameter than the pump segment, this large-diameter guide allows the catheter pump assembly and the guiding catheter to be introduced side-by-side through the guide. During the insertion of the intravascular blood pump, it is preferable that the catheter pump assembly be as small as possible, as this allows for better manipulation of the intravascular blood pump across the patient's vascular system. The latter is a major advantage of expandable and collapseable pump segments, as their diameter is approximately 10F in the collapsed state. This is also advantageous, as it is preferable to use a small-diameter guide with a diameter of 11F or smaller, preferably 10F or only 9F.

[0006] However, it is preferable to use only a single access port into the body, rather than two or more access ports, to reduce the possibility of bleeding and complications. While expandable and collapsible pumps allow for small-diameter guides, it is not possible to use the same small-diameter guide to introduce the catheter pump assembly and guide catheter side by side.

[0007] Therefore, one object of the present invention is to provide a blood pump having a collapsible and expandable pump segment that allows access to a single small-diameter passage port in the human body. Summary of the Invention

[0008] According to a first aspect, the blood pump may include a manipulator catheter and a pump segment. The pump segment may be configured to be placed inside the human body. The pump segment may include an expandable and collapseable pump housing, an expandable and collapseable pump element disposed within the pump housing, and an electric motor configured to rotate the pump element. The manipulator catheter may include a distal end and a proximal end, wherein the pump segment may be coupled to the distal end of the manipulator catheter. The manipulator catheter may also include an elongated body extending along a central axis between the distal and proximal ends, with a working channel extending at least partially within the body from the proximal end of the manipulator catheter in a direction toward the distal end of the manipulator catheter. The working channel may be configured to removably receive a guide catheter. It must be noted that the body of the manipulator catheter does not need to extend to the proximal or distal end of the manipulator catheter, but may only constitute a part of the manipulator catheter.

[0009] Therefore, the guiding catheter is not routed alongside the manipulating catheter, but is at least partially received within the working channel of the manipulating catheter. Thus, a single small-diameter guide with a diameter of 11F or less can be used to place the blood pump and guiding catheter into the patient's vascular system. Preferably, the guiding catheter has an outer diameter in the range of 4F to 7F, preferably in the range of 5F to 6F. The working channel may extend along the entire length of the manipulating catheter, or it may extend only partially along the manipulating catheter.

[0010] The motor can be located near the proximal end of the pump housing. The motor may include a motor housing, a rotor, and a stator. The rotor and stator may be housed within the motor housing. The motor housing may have an outer diameter less than, equal to, or greater than the outer diameter of the actuation conduit. Preferably, the motor housing has an outer diameter of up to 12F, more preferably up to 11F. Even more preferably, the motor housing has an outer diameter of up to 10F. The distal end of the actuation conduit may be attached to the motor housing. The pump section, in a collapsed or compressed state, may have an outer diameter of up to 12F, preferably up to 11F, and even more preferably up to 10F.

[0011] Preferably, the manipulation catheter has a tubular shape. The manipulation catheter may also have a cylindrical shape. The central axis of the main body may be concentric with the longitudinal axis of the manipulation catheter.

[0012] Preferably, the main body includes a receiving arrangement structure separate from the working channel. The receiving arrangement structure may extend at least partially between the distal and proximal ends of the manipulating catheter. The blood pump may also include a motor cable coupled to a motor. The blood pump may further include at least one optical sensor and at least one optical fiber cable coupled to the optical sensor. The blood pump may also include a cleaning lumen coupled to the pump section. The receiving arrangement structure may be configured to receive at least one of the motor cable, the optical fiber cable, and the cleaning lumen. Because the receiving arrangement structure is spatially separate from the working channel, any element received in the receiving arrangement structure will not interfere with the guiding catheter received in the working channel.

[0013] Motor cables may include multiple wires. These wires may be placed close together or stacked. Motor cables may be ribbon cables.

[0014] The at least one optical sensor can be located at the pump section. Alternatively, another optical sensor can be used and located, for example, at the motor housing or the control conduit. The cleaning lumen can be coupled to the motor housing.

[0015] Preferably, the motor cable is not routed through the working channel from the proximal end of the control conduit to its lateral opening. Preferably, the motor cable is routed separately from the working channel from the proximal end of the control conduit to its lateral opening. Preferably, the at least one optical fiber cable is not routed through the working channel from the proximal end of the control conduit to its lateral opening. Preferably, the at least one optical fiber cable is routed separately from the working channel from the proximal end of the control conduit to its lateral opening. Preferably, the cleaning lumen is not routed through the working channel from the proximal end of the control conduit to its lateral opening. Preferably, the cleaning lumen is routed separately from the working channel from the proximal end of the control conduit to its lateral opening.

[0016] The accommodating arrangement may include a first lumen extending at least partially between the distal and proximal ends of the manipulating conduit. At least one of a motor cable, an optical fiber cable, and a cleaning lumen is disposed within the first lumen. Therefore, the manipulating conduit may be a multi-lumen conduit including a working channel and a first lumen separate from the working channel.

[0017] The first lumen may be offset from the central axis of the body. The first lumen may be configured such that it does not extend through the working channel, at least from the proximal end of the manipulating conduit to its lateral opening. The first lumen may extend along the entire length of the manipulating conduit, i.e., from the proximal end to the distal end. The first lumen may extend only partially along the body, and it need not terminate at the distal end and / or proximal end of the manipulating conduit. The first lumen may have a circular cross-section. The first lumen may also have another cross-sectional shape, such as sickle-shaped, quarter-circular, semi-circular, C-shaped, rectangular, curved rectangular, triangular, etc.

[0018] The accommodating arrangement may include a second lumen extending at least partially between the distal and proximal ends of the manipulating conduit. At least one of the motor cable, fiber optic cable, and cleaning lumen may be received in the second lumen, rather than within the first lumen. Therefore, the manipulating conduit may be a multi-lumen conduit, including a working channel, a first lumen separate from the working channel, and a second lumen separate from the working channel.

[0019] The second lumen may be offset from the central axis of the main body. The second lumen may be configured such that it does not extend through the working channel, at least from the proximal end of the manipulator to its lateral opening. The second lumen may extend along the entire length of the manipulator, i.e., from the proximal end to the distal end. The second lumen may extend only partially along the main body, and it need not terminate at the distal end and / or proximal end of the manipulator. The second lumen may have a circular cross-section. The second lumen may also have another cross-sectional shape, such as sickle-shaped, quarter-circular, semi-circular, C-shaped, rectangular, curved rectangular, triangular, etc.

[0020] The accommodating arrangement may include a third lumen extending at least partially between the distal and proximal ends of the manipulating conduit. The motor cable may be disposed within the first lumen. The fiber optic cable may be disposed within the second lumen, and the cleaning lumen may be disposed within the third lumen, or the cleaning lumen may be the third lumen. Alternatively, the cleaning lumen may be either the first or the second lumen.

[0021] The third lumen may be offset from the central axis of the main body. The third lumen may be configured such that it does not extend through the working channel, at least from the proximal end of the manipulator to its lateral opening. The third lumen may extend along the entire length of the manipulator, i.e., from the proximal end to the distal end. The third lumen may extend only partially along the main body, and it need not terminate at the distal end and / or proximal end of the manipulator. The third lumen may have a circular cross-section. The first lumen may also have another cross-sectional shape, such as sickle-shaped, quarter-circular, semi-circular, C-shaped, rectangular, curved rectangular, triangular, etc.

[0022] Therefore, the receiving arrangement of the manipulating catheter may include one or more lumens separate from the working channel, such that there is no interference between the one or more lumens and the working channel.

[0023] The receiving arrangement may further include at least one groove disposed on the outer surface of the manipulating conduit body. The at least one groove may be configured to receive at least one of a motor cable, an optical fiber cable, and a cleaning lumen. The receiving arrangement may include a combination of a lumen and a groove. After one or more of the motor cable, optical fiber cable, and cleaning lumen are received in the respective groove, the groove may be filled with a resin material.

[0024] The first to third lumens accommodating the arrangement structure can also be formed by embedding one of the motor cable, fiber optic cable, and cleaning lumen into the body of the control conduit, that is, by embedding it into the wall of the control conduit.

[0025] Preferably, the manipulator includes a lateral opening extending through the sidewall of the main body. The lateral opening may connect to the working channel and may be configured such that the guiding catheter can exit the main body through the lateral opening. The lateral opening may be longitudinal. The lateral opening may be teardrop-shaped. The lateral opening may penetrate the sidewall of the manipulator. The lateral opening may be located at a proximal distance from the manipulator. Therefore, the guiding catheter can be advanced and positioned within the manipulator independently of the blood pump or pump segment to reach the ostium of the coronary artery. Any hemodynamically supported procedures can then be performed through the guiding catheter.

[0026] The blood pump may also include a closure element configured to selectively open and close the lateral opening. In other words, the closure element is configured to seal the lateral opening if needed by the physician. Sealing the lateral opening can be advantageous for introducing the manipulator catheter through the access port. An unsealed (i.e., open) lateral opening has an exposed edge because it penetrates the sidewall of the manipulator catheter body. This exposed edge may become stuck in the access port or may become entangled. This can be prevented by closing the lateral opening via the closure element.

[0027] The closure element is movable relative to the manipulating catheter, wherein the movement of the closure element relative to the manipulating catheter selectively opens and closes the lateral opening. The physician can manually move the closure element relative to the manipulating catheter to determine when to open and when to close the lateral opening. The closure element may be configured to be axially movable relative to the manipulating catheter.

[0028] Preferably, the working channel is configured to selectively receive the closure element. The lateral opening can be closed or opened as the closure element is advanced or retracted within the working channel.

[0029] The closure element may include an elongated body and a plug disposed on the body of the closure element. The plug may be configured to seal a lateral opening when the closure element is received in a working channel. The plug may be disposed at the distal end of the elongated body of the closure element. Preferably, the plug has dimensions and shape corresponding to the size and shape of the lateral opening, such that the plug is preferably fully received in the lateral opening for sealing the lateral opening.

[0030] The elongated body may include a collar portion located at its distal end. The collar portion may be configured to abut an inner circumferential surface adjacent to the lateral opening of the working channel. Therefore, when the plug is properly positioned in the lateral opening, the collar portion abuts the inner circumferential surface, which prevents further advancement of the closure element relative to the manipulating catheter. Thus, the elongated body of the plug and / or closure element can be prevented from being pushed too far and, consequently, partially withdrawn into the blood vessel through the lateral opening.

[0031] The closure element may alternatively be configured as a tubular closure element, which is disposed at least partially around the outer peripheral surface of the body of the manipulating catheter. The tubular closure element may be movable relative to the body of the manipulating catheter. The tubular closure element may include a passage opening extending through the sidewall of the tubular closure element. The passage opening may be sized and configured to form a passageway to a working channel when the passage opening at least partially overlaps with a lateral opening by movement of the tubular closure element relative to the body of the manipulating catheter. Thus, when the passage opening at least partially overlaps with the lateral opening, the working channel is only connected to the environment surrounding the manipulating catheter. To close the lateral opening, the tubular closure element is moved such that the passage opening does not overlap with the lateral opening, and the tubular closure element seals the lateral opening.

[0032] The tubular closure element can be configured to be axially movable relative to the body of the manipulating catheter. The tubular closure element can additionally or alternatively be configured to be rotatable relative to the body of the manipulating catheter. The tubular closure element can be disposed on the body of the manipulating catheter to obtain a edgeless outer surface.

[0033] The manipulation catheter may include markers, which can be configured to indicate the location of the lateral opening via an imaging procedure. This allows the physician or operator to verify the correct location of the lateral opening within the artery before advancing the guide catheter through the working channel of the manipulation catheter, allowing the guide catheter to exit the main body through the lateral opening and enter the artery.

[0034] Preferably, the exit facilitator is disposed in a working channel in the distal region of the lateral opening. The exit facilitator may be configured to allow the guide catheter and / or closure element to be facilitated sliding through or along the direction toward the lateral opening. The exit facilitator may include a ramp configured to redirect or deflect the guide catheter and / or closure element from the working channel toward the lateral opening. The ramp may be located at the distal end of the lateral opening. The ramp may be spring-loaded or biased. The ramp may close the working channel such that the working channel terminates at the ramp. The exit facilitator may also include a contraction that minimizes the inner diameter of the working channel. The contraction may be partially located only in the distal region of the lateral opening, or may extend at least partially from the distal end of the lateral opening in the direction toward the distal end of the actuating catheter. Alternatively, the working channel may also terminate in the region of the lateral opening.

[0035] The bevel may include a first bevel and a second bevel. The second bevel may be disposed between the first bevel and the inner circumferential surface of the working channel. The second bevel may be made of an elastic material and bias the first bevel in a direction toward the lateral opening. The withdrawal facilitator divides the working channel into a first portion extending proximally from the lateral opening and a second portion extending distally from the lateral opening. The first portion may be concentric with the central axis of the manipulating catheter body. The second portion may be offset from the central axis of the manipulating catheter body.

[0036] According to another approach, the body of the manipulating catheter may include a distal portion and a proximal portion, wherein the proximal portion is movable relative to the distal portion between a closed position and an open position. When the proximal portion is in the closed position, the working channel is sealed, and when the proximal portion is in the open position, the working channel opens to the environment surrounding the manipulating catheter. In other words, when the proximal portion is in the open position, the guiding catheter can be withdrawn directly from the body of the manipulating catheter through the working channel. Therefore, the guiding catheter can be advanced and positioned within the manipulating catheter independently of the blood pump or pump segment to reach the ostium of the coronary artery. Any hemodynamically supported procedures can then be performed via the guiding catheter.

[0037] The manipulation catheter may include a guide structure extending at least partially along the body of the manipulation catheter. A distal portion is fixed to the guide structure, and a proximal portion is configured to be movable relative to the guide structure, preferably axially movable. The guide structure may include one or more sliders, with the proximal portion movable relative to the sliders. The sliders may be wires or flat rods. The distal portion may include a first abutting surface facing the proximal portion, wherein the first abutting surface may be inclined relative to the central axis of the manipulation catheter body. The first abutting surface may have a circular or elliptical shape. Therefore, the proximal end may include a second abutting surface facing the distal portion and inclined relative to the central axis of the body. The second abutting surface may have an annular shape. In the closed position, the second abutting surface completely abuts against the first abutting surface. The working channel may be provided only within the proximal portion; that is, the distal portion does not need to include a working channel.

[0038] The distal portion may include a centering element extending in a proximal direction. At least when the proximal portion is in the closed position, the centering element is configured to be received within a portion of the working channel of the proximal portion. The centering element may be conical, frustum-shaped, teardrop-shaped, or may have any other suitable shape that guides the proximal portion by facilitating movement of the proximal portion into the closed position during closure movement by inserting the centering element into the working channel. The centering element is also configured to guide the guiding catheter from the working channel into the blood vessel. The centering element may be concentric with or off-center from the central axis of the manipulating catheter body.

[0039] According to an alternative aspect, the proximal portion may be rotatable relative to the distal portion via a rotary joint. Preferably, a first lumen and / or a second lumen and / or a third lumen pass through the rotary joint. The distal portion may include a first abutting surface, and the proximal portion may include a second abutting surface, wherein the first abutting surface abuts the second abutting surface in the closed position, such that rotation of the proximal portion relative to the distal portion is only possible in the direction toward the open position. In other words, the abutting surfaces restrict rotation of the proximal portion so that the proximal portion cannot rotate beyond the closed position.

[0040] The working channel can be offset from the central axis of the main body. The working channel can also be concentric with the central axis of the main body. The working channel can have a circular cross-sectional shape along its entire length, or it can have a circular cross-sectional shape only partially along its length. The working channel can also have another cross-sectional shape partially or entirely along its length, such as teardrop, rectangle, semicircle, diamond, rhombus, anchor, triangle, constant-width body shape, polygon, basil polygon, circular triangle, triangle with rounded corners, triangle with rounded corners and curved edges, etc.

[0041] The working channel can be configured to removably receive the reinforcing shaft. Once the blood pump is placed and positioned within the human heart, the reinforcing shaft can be completely removed, and the guiding catheter for the intervention can be inserted into the working channel. After the intervention, the catheter can be removed, and the reinforcing shaft can be re-advanced to its full length to provide greater stability if the patient is repositioned and requires prolonged pump support post-intervention. The reinforcing shaft preferably has a higher rigidity than the manipulating catheter or the manipulating catheter itself.

[0042] The distal end of the reinforcing mandrel can be configured to allow passage over the exit facilitator. In other words, the reinforcing mandrel is configured to exit the working channel without opening. In the case where the exit facilitator includes a spring-loaded or biased ramp, advancing the reinforcing mandrel compresses the ramp, allowing the reinforcing mandrel to be advanced along the working channel toward the distal end of the manipulating catheter. In the case where the exit facilitator includes a constriction section, the reinforcing mandrel may have a distal portion with a smaller diameter compared to the rest of the reinforcing mandrel. When the reinforcing mandrel is fully advanced through the working channel, the smaller-diameter distal portion is positioned within or outside the constriction section.

[0043] The working channel may extend to the distal end of the manipulation catheter, or may terminate at the distal end of a lateral opening, or may terminate between the distal end of the lateral opening and the distal end of the manipulation catheter. The working channel may have a low-friction surface. The low-friction surface may be provided via a coating or by providing a liner within the body of the manipulation catheter. The low-friction surface may include a fluoropolymer.

[0044] A hemostatic valve can be located proximal to the working channel. When neither the manipulator nor the reinforcing mandrel is received in the working channel, the hemostatic valve prevents any bleeding through the working channel of the manipulator. The hemostatic valve can be configured as, for example, a self-sealing unit (e.g., a silicone seal with a cross slit, a spiral slit, etc.) or as a Tuosy-Bost (spiral seal). The manipulator can have an outer diameter of up to 12F, preferably up to 11F, and even more preferably up to 10F. The working channel can have an inner diameter of at least 4F, preferably at least 5F, and even more preferably at least 6F. The working channel preferably has an inner diameter that allows reception of a guide catheter with an outer diameter of at least 4F, preferably at least 5F, and even more preferably at least 6F. Therefore, the guide catheter can have an outer diameter in the range of 5F to 6F. The reinforcing mandrel can have an outer diameter in the range of 5F to 6F, and the small-diameter portion disposed at the distal end of the reinforcing mandrel can have an outer diameter smaller than the outer diameter of the rest of the reinforcing mandrel, for example, up to 2F, preferably up to 1F, and even more preferably up to 0.5F.

[0045] According to the second aspect, the catheter pump assembly includes the aforementioned blood pump. The catheter pump assembly may include a guide catheter configured to be removably received in a working channel. The catheter pump assembly may include a reinforcing mandrel configured to be removably received in the working channel. The reinforcing mandrel may be a hollow reinforcing mandrel. During blood pump placement, the reinforcing mandrel is preferably positioned in the working channel. The catheter pump assembly may also include a controller. A motor cable may be connected to the controller. An optical fiber cable may be connected to the controller. Attached Figure Description

[0046] The invention will be explained below by way of example with reference to the accompanying drawings. The drawings are not to scale. In the drawings, the same or corresponding parts illustrated in various figures are represented by the same numbers. For clarity, not every part is labeled in every figure. In the drawings: Figure 1 This is a schematic diagram of a catheter pump assembly, including a blood pump, located in the left ventricle of the heart. Figure 2 A schematic diagram of a blood pump is shown; Figure 3 This is a first side view of a blood pump; Figure 4 This is a second side view of the blood pump; Figure 5 This is a detailed view of the blood pump motor; Figure 6 It is the cross-section of the blood pump; Figure 7 yes Figure 6 Another cross-section of the blood pump shown; Figures 8a to 8f These are cross-sections of different embodiments of the manipulating catheter; Figure 9 This is a cross-section showing the first variant of the exit facilitator; Figure 10 This is a cross-section showing a second variation of the exit facilitator; Figure 11 This is a cross-section showing the third variant of the exit facilitator; Figure 12 This is a cross-section showing the fourth variant of the exit facilitator; Figure 13 It is the cross-section through the manipulator having a closure element according to the first variant; Figure 14 It is the cross-section through the manipulator having a closed element according to the second variant and an open lateral opening; Figure 15 Is it through Figure 14 The cross-section of the manipulation catheter has a closed lateral opening; Figure 16 Is it through Figures 13 to 15 The cross-section of the manipulation catheter is shown. Figure 17 It is the cross-section of the manipulator having a closing element and a closed lateral opening according to the third variant; Figure 18 Is it through Figure 17 The cross-section of the manipulation catheter has an open lateral opening; Figure 19 It is a side view of a manipulator with a closure element and a closed side opening according to the fourth variant; Figure 20 yes Figure 19 A side view of the manipulation catheter, which has an open lateral opening; Figure 21 It is the cross-section of the manipulation conduit having distal and proximal portions according to the first variant in the closed position; Figure 22 It is through the open position Figure 21 The cross-section of the manipulation catheter; Figure 23 It is the cross-section of the manipulation conduit having distal and proximal portions according to the second variant in the open position; and Figure 24 It is a partial cross-section through the manipulation catheter, which has distal and proximal portions, according to the third variant in the open position. Detailed Implementation

[0047] The following description and accompanying drawings merely illustrate the principles of the invention. Therefore, it will be appreciated that those skilled in the art will be able to design various arrangements that, while not explicitly described or shown herein, embody the principles of the invention and are included within its scope. Furthermore, all embodiments described herein are explicitly for illustrative purposes only, to aid the reader in understanding the principles of the invention and the concepts contributed by the inventors to the field, and should be understood as not being limited to these specifically described embodiments and conditions. Moreover, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.

[0048] Figure 1The use of a catheter pump assembly 1 including a blood pump 10 is illustrated. In this particular example, the blood pump 10 is used to support the left ventricle (LV) of a human heart (H). In this exemplary embodiment, the blood pump 10 is an intravascular blood pump and includes a manipulating catheter 12 and a pump segment 14 disposed at the distal end 16 of the manipulating catheter 12. The intravascular blood pump 10 can be placed within the heart (H) using percutaneous, transluminal techniques. For example, the intravascular blood pump 10 can be introduced via the femoral artery. However, alternative vascular accesses are also possible, such as those via the subclavian artery. After passing through the femoral artery, the catheter 12 can be advanced into the aorta, allowing the pump segment 14 to pass through the aortic valve and reach the heart (H). Figure 1 The positioning of pump segment 14 is used purely as an example, and different placements are possible, such as positioning pump segment 14 in the right ventricle of the heart H. The manipulating catheter may have an outer diameter of up to 12F, preferably up to 11F, and even more preferably up to 10F.

[0049] Pump section 14 includes a pump housing 20 and a pump element 22 disposed within the pump housing 20, see, for example Figures 2 to 4 Pump element 22 may be provided in the form of an impeller. Rotation of impeller 22 causes blood to flow from blood inlet 24 located distal to pump segment 14 to blood outlet 26 located proximal to blood inlet 24. A flexible, damage-resistant end 28 having a pigtail or J-shape is disposed distal to pump segment 14. Damage-resistant end 28 facilitates placement of intravascular blood pump 10 by aiding navigation within the patient's vascular system. Furthermore, the flexibility of the damage-resistant end 28 allows pump segment 14 to self-damage-resistantly support itself against the wall of the left ventricle (LV).

[0050] Figures 2 to 6The intravascular blood pump 10 is shown in more detail. An impeller 22 is located inside the pump housing 20. In this exemplary embodiment, both the impeller 22 and the pump housing 20 are compressible, i.e., expandable and collapsible. In this configuration, the intravascular blood pump 10 is transported through the patient's vascular system when both the impeller 22 and the pump housing 20 are in their compressed state. Once the pump segment 14 is in its target position, the pump housing 20 and the impeller 22 expand. As the impeller 22 rotates within the pump housing 20, blood is drawn into the blood inlet 24 at the distal end of the pump housing 20 and enters the downstream conduit 30, which is attached to the pump housing 20 and extends distally. Blood is then ejected from the downstream conduit 30 into the aorta through a more proximal blood outlet 26 located within the downstream conduit 30, the blood outlet 26 including multiple outlet openings. The downstream conduit 30 is made of a flexible material such that it can be compressed by the aortic valve while the patient's heart is pumping. The downstream conduit 30 typically expands primarily due to the active blood flow generated during the rotation of the impeller 22. By placing the blood inlet 24 within the left ventricle (LV) and the blood outlet 26 within the aorta, the intravascular blood pump 10 can support the patient's systemic blood circulation. If the intravascular blood pump 10 is constructed and positioned differently, it can be used, for example, to support the patient's pulmonary blood circulation.

[0051] like Figure 2 , 5 As shown in Figure 6, an electric motor 32 is provided to rotate the impeller 22. It should be noted that, for clarity, in... Figure 5 and 6 Downstream pipe 30 is not shown in the diagram. Motor 32 is located at the proximal end of pump housing 20 and includes a rotor 34 and a stator 36 disposed within motor housing 38. Rotor 34 is coupled to shaft 40, which is supported in proximal bearing 42 and one or more distal bearings 44. Shaft 40 extends into pump housing 20, and impeller 22 is located at the distal end of shaft 40. Figure 3 and Figure 4 Further depicted, the pump housing 20 includes a plurality of supports 46, wherein the proximal ends of the supports 46 are attached to the motor housing 38. This can be achieved, for example, by laser welding.

[0052] Motor cable 48 is attached to the proximal end of motor 32 to supply power to motor 32 and control motor 32 in a known manner. Specifically, printed circuit board 52 is disposed within motor housing 38, and motor cable 48 is attached to printed circuit board 52. Motor cable 48 is guided within actuation conduit 12 to controller 50 disposed externally (see...). Figure 1 This will be described in more detail below. The motor cable 48 may be a ribbon cable.

[0053] Alternatively, a cleaning lumen 54 may be provided, which is operatively coupled to the pump section 14 and the motor 32, respectively. The cleaning lumen 54 is guided within the actuation conduit 12, as will be explained in more detail below. Cleaning fluid applied via the cleaning lumen 54 flows through the proximal bearing 42 and the motor housing 38, and exits the motor housing 38 through the distal bearing 44 into the pump housing 20. It should be noted that cleaning of the blood pump 10 is optional and depends on the intended application of the blood pump 10, i.e., whether it is intended for short-term or long-term use. In the latter case, cleaning of the blood pump 10 is recommended.

[0054] Blood pump 10 may also include at least one sensor 56. Sensor 56 may be an optical sensor 56 attached to pump section 14, such as... Figure 1 As exemplarily illustrated, the optical sensor 56 is connected to the controller 50 via an optical fiber cable 58 guided within the manipulation conduit 12, as will be explained in more detail below. Of course, the blood pump 10 may also include two or more optical sensors 56, and therefore two or more optical fiber cables 58.

[0055] The manipulating catheter 12 is provided as a multi-lumen catheter and includes an elongated body 60 extending along the central axis CA between a distal end 16 and a proximal end 18 of the manipulating catheter 12. The body 60 is a tubular body 60 having a cylindrical shape. When the blood pump 10 is placed in the heart H, the proximal end 18 of the manipulating catheter 12 is positioned externally. See [link to relevant documentation] Figure 7 The Y-shaped member 62 is attached to the proximal end 18 of the manipulating conduit 12.

[0056] In this exemplary embodiment, a working channel 64 extends within the body 60 from the proximal end 18 of the manipulating catheter 12 to the distal end 16 of the manipulating catheter 12. The working channel 64 further extends through the first arm 72 of the Y-shaped member 62 to the proximal end of the first arm 72. A hemostatic valve 76 is attached to the proximal end of the first arm 72, and thus to the proximal end of the working channel 64. The hemostatic valve 76 can be configured as, for example, a self-sealing unit (e.g., a silicone seal with a cross slit, a spiral slit, etc.) or it can be configured as a Tuosy-Bost (spiral seal). The working channel 64 is configured to removably receive a guiding catheter 78 ( Figure 7 As shown), reinforced spindle 80 (as shown) Figure 6 (as shown) or closed element 108 (such as Figures 13 to 15(As shown). The guiding catheter 78, reinforcing shaft 80, or closure element 108 can be advanced through the working channel 64 via the hemostatic valve 76. Therefore, when the blood pump 10 has been placed in the heart H, the hemostatic valve 76 inhibits bleeding if the guiding catheter 78, reinforcing shaft 80, and closure element 108 are not received in the working channel 64. The reinforcing shaft 80 is preferably a hollow reinforcing shaft 80 and is designed to increase the stability of the blood pump 10, for example, in cases where the patient will be repositioned or long-term pump support beyond the intervention is required. Therefore, the reinforcing shaft 80 can be configured to be advanced to approach the distal end 16 of the manipulating catheter 12. The guiding catheter 78 can be a 5F to 6F guiding catheter 78, such that the working channel 64 has an inner diameter of at least 5F. Therefore, the reinforcing shaft 80 can also be a 5F to 6F reinforcing shaft 80.

[0057] The manipulating conduit 12 also includes a receiving arrangement 82 configured to receive cables and cleaning lumens, which is preferably separate from the working channel 64. The receiving arrangement 82 includes at least one lumen 66, 68, 70 separate from the working channel 64. The receiving arrangement 82 may include up to three lumens 66, 68, 70, see, for example, [reference needed]. Figure 8e Therefore, the manipulating conduit 12 may include a total of four lumens: a working channel 64, a first lumen 66, a second lumen 68, and a third lumen 70. Of course, the manipulating conduit 12 may also include more or fewer than four lumens. Furthermore, the receiving arrangement 82 may also include at least one groove (not shown) on the outer peripheral surface of the body 60. This at least one groove may be configured to receive a cable and a cleaning lumen. Additionally, the receiving arrangement 82 may also be configured to receive a cable and a cleaning lumen, since the cable and cleaning lumen are respectively embedded in the sidewalls of the body 60 or the manipulating conduit 12 (not shown).

[0058] In this exemplary embodiment, the lumens 66, 68, 70 of the receiving arrangement structure 82 extend almost from the proximal end 18 of the manipulation conduit 12 to the distal end 16 of the manipulation conduit 12. The lumens 66, 68, 70 are configured to receive the motor cable 48, the cleaning lumen 54, and the fiber optic cable 58. However, it is not necessary that each of the motor cable 48, the cleaning lumen 54, and the fiber optic cable 58 be individually received in one of the lumens 66, 68, 70 of the receiving arrangement structure 82. Instead, it is possible, for example, that the receiving arrangement structure 82 includes only one first lumen 66, in which the motor cable 48, the cleaning lumen 54, and the fiber optic cable 58 are received. Therefore, it is also possible that the receiving arrangement structure 82 includes a first lumen 66 and a second lumen 68, for example, in which the motor cable 48 and the fiber optic cable 58 are received in the first lumen 66, and the cleaning lumen 54 is received in the second lumen 68. For example, if the blood pump 10 does not include the cleaning lumen 54, the motor cable 48 can be received in the first lumen 66, and the fiber optic cable 58 can be received in the second lumen 68. Alternatively, the cleaning lumen 54 may be lumens 66, 68, 70 that house the arrangement structure 82.

[0059] like Figure 7 As shown, the motor cable 48, fiber optic cable 58, and cleaning lumen 54 exit the respective lumens 66, 68, 70 of the receiving arrangement structure 82 at the proximal end 18 of the manipulating catheter 12. At the proximal end 18 of the manipulating catheter 12, the motor cable 48, fiber optic cable 58, and cleaning lumen 54 are routed along the second arm 74 of the Y-shaped member 62 to the proximal end of the second arm 74 of the Y-shaped member 62, where they exit the Y-shaped member to connect to a suitable device, such as a controller 50. The receiving arrangement structure 82 may also extend from the proximal end 18 of the manipulating catheter 12 to the proximal end of the second arm 74 of the Y-shaped member 62. The second arm 74 of the Y-shaped member 62 may include a barrier to prevent bleeding through the second arm 74 of the Y-shaped member 62. The barrier may be located at the distal end of the second arm 74 of the Y-shaped member 62. Alternatively (not shown), the Y-shaped member 62 may also be located in the handle of the blood pump 10 or the catheter pump assembly 1, respectively.

[0060] From example Figure 5 As can be seen, the receiving arrangement structure 82 terminates near or immediately adjacent to the distal end 16 of the control conduit 12, where the motor cable 48, fiber optic cable 58, and cleaning lumen 54 enter the working channel 64. The motor cable 48, fiber optic cable 58, and cleaning lumen 54 are then routed to the distal end 16 of the control conduit 12.

[0061] The lumens 66, 68, 70 and the working channel 64 accommodating the arrangement structure 82 can have different geometries. Different variations are available in... Figures 8a to 8f The image shows a cross-section through the manipulating conduit 12. It must be noted that... Figures 8a to 8f The variations shown are not restrictive and can be combined among different variations.

[0062] Figure 8a A first variation is shown, in which the working channel 64 has a circular cross-section and is offset relative to the central axis CA of the body 60 of the manipulating conduit 12. Figure 8a In the variant shown, the receiving arrangement structure 82 includes a first cavity 66 and a second cavity 68. The first cavity 66 has a circular cross-section, and the second cavity 68 has a rectangular cross-section.

[0063] Figure 8b A second variation is shown, wherein the working channel 64 has a circular cross-section and is concentric with the central axis CA of the body 60 of the manipulating conduit 12. The receiving arrangement 82 includes a first lumen 66, a second lumen 68, and a third lumen 70. The first lumen 66, the second lumen 68, and the third lumen 70 have circular cross-sections. The first lumen 66, the second lumen 68, and the third lumen 70 may be evenly distributed around the working channel 64 within the body 60 of the manipulating conduit 12, or they may be incorporated into a portion of the manipulating conduit 12, such as... Figure 8b As shown.

[0064] exist Figure 8c In the variant shown, the working channel 64 does not have a circular cross-section, but rather a circular main shape with two opposing protrusions. The working channel 64 is offset relative to the central axis CA of the body 60 of the manipulating conduit 12. The receiving arrangement structure 82 includes a first lumen 66 and a second lumen 68. The first lumen 66 and the second lumen 68 have a quarter-circular or kidney-shaped cross-section.

[0065] Figure 8d A variation of the working channel 64 is shown, having a circular cross-section and being concentric with the central axis CA of the body 60 of the manipulating conduit 12. The receiving arrangement 82 includes only a first lumen 66 having a semi-circular cross-section.

[0066] exist Figure 8e In the variant shown, the working channel 64 has a circular cross-section and is concentric with the central axis CA of the body 60 of the manipulating conduit 12. The receiving arrangement 82 includes a first lumen 66, a second lumen 68, and a third lumen 70. The first lumen 66 has a one-third circular, arcuate, or kidney-shaped cross-section, the second lumen 68 has a one-third circular, arcuate, or kidney-shaped cross-section, and the third lumen 70 has a one-third circular, arcuate, or kidney-shaped cross-section. The first lumen 66, the second lumen 68, and the third lumen 70 can be evenly distributed around the working channel 64 within the body 60 of the manipulating conduit 12.

[0067] exist Figure 8fIn the variant shown, the working channel 64 has a triangular cross-section with rounded edges and curved sides, and is concentric with the central axis CA of the body 60 of the manipulating conduit 12. The receiving arrangement structure 82 includes a first lumen 66, a second lumen 68, and a third lumen 70. The first lumen 66 has a quarter-circle, arc, or kidney-shaped cross-section, the second lumen 68 has a quarter-circle, arc, or kidney-shaped cross-section, and the third lumen 70 has a quarter-circle, arc, or kidney-shaped cross-section. The first lumen 66, the second lumen 68, and the third lumen 70 can be evenly distributed around the working channel 64 within the body 60 of the manipulating conduit 12.

[0068] For example, from Figure 3 , 4 As can be seen from 6, 7, and 9 to 15, the manipulating catheter 12 includes a lateral opening 84 disposed between the distal end 16 and the proximal end 18 of the manipulating catheter 12. The lateral opening 84 is a longitudinal opening and has a drop shape. The lateral opening 84 penetrates the sidewall of the catheter 12 or the body 60, respectively, and connects the working channel 64 to the environment surrounding the manipulating catheter 12. The lateral opening 84 is positioned at a distance from the proximal end 18 of the manipulating catheter 12 such that when the blood pump 10 is placed in or during placement in the human body, the lateral opening 84 is located within the artery. A marker 86 may be provided, which allows the correct location of the lateral opening 84 to be tracked via imaging procedures. The marker 86 may be a radiopaque marker and may be disposed proximally to the body 60 near the lateral opening 84. Alternatively, the marker 86 may be disposed elsewhere, for example, distal to the lateral opening 84 or embedded within the body 60 of the manipulating catheter 12.

[0069] The lateral opening 84 is configured to allow the guiding catheter 78, received in the working channel 64, to exit the manipulating catheter 12 through the lateral opening 84, enabling the guiding catheter 78 to be advanced and positioned independently of the blood pump 10 and the manipulating catheter 12 to reach the ostium of the coronary artery. See also Figure 3 The guide catheter 78 is indicated by a dashed line. Any hemodynamically supported procedure can then be performed through the guide catheter 78. To allow the guide catheter 78 to advance smoothly within the working channel 64, the inner circumferential surface 116 of the working channel 64 can be a low-friction surface, for example, by providing a friction-reducing liner or coating, such as that made of a fluoropolymer.

[0070] The exit facilitator 88 can be located in the area of ​​the lateral opening 84. As the guide tube 78 is advanced along the working channel 64, the exit facilitator 88 helps the guide tube 78 exit through the lateral opening 84.

[0071] Figure 9A first variation of the withdrawal facilitator 88 is depicted. The withdrawal facilitator 88 includes a ramp 90 disposed in a working channel 64 opposite the distal end of a lateral opening 84. In this exemplary embodiment, the ramp 90 includes a first ramp portion 92 and a second ramp portion 94. The second ramp portion 94 is disposed between the first ramp portion 92 and the inner circumferential surface 116 of the working channel 64. The second ramp portion 94 is made of an elastic material such that it biases the first ramp portion 92 toward the lateral opening 84 away from the inner circumferential surface 116 of the working channel 64. When the guide conduit 78 is advanced along the working channel 64, it is deflected by the ramp 90 in a direction toward the lateral opening 84. Because the guide conduit 78 is made of a relatively flexible material, it may not be able to overcome the biasing force of the second ramp portion 94, and therefore may not be able to advance over the ramp 90 in a direction toward the distal end 16 of the manipulating conduit 12. However, if the reinforcing mandrel 80 is advanced along the working channel 64, its higher stiffness is sufficient to overcome the biasing force of the second inclined surface 94, causing the inclined surface 90 to be compressed by the reinforcing mandrel 80. Therefore, the reinforcing mandrel 80 can be advanced over the inclined surface 90 in the working channel 64. When the reinforcing mandrel 80 is removed, the biasing force of the second inclined surface 94 causes the inclined surface 90 to stand upright again.

[0072] Figure 10 A second variation of the withdrawal facilitator 88 is depicted. In this exemplary embodiment, the withdrawal facilitator 88 includes a contraction 96 that minimizes the inner diameter of the working channel 64 across the lateral opening 84 in the direction of the distal end 16 of the manipulating conduit 12. The contraction 96 may be partially disposed in a region of the distal end of the lateral opening 84, or may extend a certain length in the direction toward the distal end 16 of the manipulating conduit 12. The contraction 96 deflects the guide conduit 78 toward the lateral opening 84, while the reinforcing mandrel 80 is configured to proceed along the contraction 96. Thus, compared to the rest of the reinforcing mandrel 80, the reinforcing mandrel 80 may include a distal portion with a reduced diameter. When the reinforcing mandrel 80 is fully advanced along the working channel 64, the distal portion of the reinforcing mandrel 80 is disposed within the contraction 96. This has the further advantage that the contraction 96 constitutes an adjoining portion of the reinforcing mandrel 80, preventing the reinforcing mandrel 80 from being further advanced.

[0073] Figure 11A third variation of the exit facilitator 88 is depicted. In this exemplary embodiment, the exit facilitator 88 divides the working channel 64 into a first portion 100 and a second portion 102. The first portion 100 has a larger diameter than the second portion 102. The first portion 100 is concentric with the central axis CA of the body 60, while the second portion 102 is offset from the central axis CA of the body 60. Furthermore, a ramp 104 is provided connecting the first portion 100 and the second portion 102. The diameter change between the ramp 104 and the first portion 100 and the second portion 102 causes the guide tube 78 to deflect toward the lateral opening 84, while the reinforcing mandrel 80 is configured to be directly inserted into the second portion 102. Thus, the reinforcing mandrel 80 may include a distal portion having a reduced diameter compared to the remainder of the reinforcing mandrel 80 and not being concentric with the remainder of the reinforcing mandrel 80. When the reinforcing mandrel 80 is fully advanced along the working channel 64, the distal portion of the reinforcing mandrel 80 is disposed within the second portion 102. This has a further advantage, namely that the connecting structure between the first part 100 and the second part 102 forms the adjacent part of the reinforcing mandrel 80, so that the reinforcing mandrel 80 cannot be further advanced.

[0074] Figure 12 A fourth variation of the withdrawal facilitator 88 is depicted. In this exemplary embodiment, the withdrawal facilitator 88 includes a ramp 106 that completely closes the working channel 64. In other words, the working channel 64 terminates at the ramp 106 in the region of the lateral opening 84. The guide tube 78, advanced through the working channel 64, is thus deflected toward the lateral opening 84 and can be withdrawn from the body 60 of the manipulating tube 12 through the lateral opening 84. Therefore, the portion of the body 60 of the manipulating tube 12 located distal to the lateral opening 84 is sufficiently rigid. When using a reinforcing mandrel 80, the reinforcing mandrel 80 is only advanced through the working channel 64 up to the ramp 106.

[0075] The lateral opening 84 can be closed to prevent its exposed edges from getting stuck, for example, in a passageway or guide 98. Therefore, a closing element 108 can be provided to seal the lateral opening 84.

[0076] Figure 13 A cross-section of an actuating conduit 12 with a closure element 108 according to a first variant is shown. The closure element 108 includes an elongated body 110 and a plug 112 disposed at the distal end of the elongated body 110. In particular, the plug 112 is disposed on the outer peripheral surface of the elongated body 110 and protrudes radially outward from the elongated body 110.

[0077] The plug 112 is shaped and sized to correspond substantially to the shape and size of the lateral opening 84. The working channel 64 is configured to receive the closure element 108, such that the closure element 108 can be advanced through the working channel 64 until the plug 112 snaps into the lateral opening 84, thereby closing or sealing the lateral opening 84. The closure element 108 also provides the actuating conduit 12 with a rigidity comparable to the reinforcing mandrel 80 as described above. Figure 13 In the exemplary embodiment shown, the working channel 64 opens distal to the lateral opening 84. However, the working channel 64 may also terminate in the region of the lateral opening 84, such as... Figure 12 As shown.

[0078] To open the lateral opening 84, the closure element 108 is moved axially in the proximal direction within the working channel 64. This releases the plug 108 from the lateral opening 84. The closure element 108 is removed from the manipulating conduit 12, and, for example, a guide conduit 78 can be introduced through the working channel 64 and withdrawn from the body 60 of the manipulating conduit 12 via the lateral opening 84. The elongated body 110 of the closure element 108 may have a diameter of, for example, 5F or 6F.

[0079] Figure 14 and 15 A second variation of the closure element 108 is shown. Here, a plug 112 is disposed on the distal surface of the elongated body 110 of the closure element 108. A collar portion 114 is formed on the distal surface of the elongated body 110, surrounding the plug 112. In this exemplary embodiment, the collar portion 114 completely surrounds the plug 112, but the collar portion 114 and the plug 112 may be formed differently. For example, the plug 112 may be eccentrically disposed relative to the main axis of the elongated body 110, thereby forming a collar portion 114 that is only partially circumferential.

[0080] When the closing element 108 is advanced through the working channel 64 to close the lateral opening 84, the collar portion 114 abuts against the inner circumferential surface 116 of the working channel 64, preventing further movement of the closing element 108. When the collar portion 114 abuts against the inner circumferential surface 116 of the working channel 64, the plug 112 is fully fitted into the lateral opening 84, thereby sealing or closing the lateral opening 84. This is in Figure 15 As shown in the image.

[0081] exist Figure 14 and 15 In the illustrated embodiment, the working channel 64 terminates at a lateral opening 84 and is provided with an exit facilitator 88 having a ramp 106, similar to... Figure 12 As shown.

[0082] To assist the physician in correctly inserting the closure element 108 into the working channel 64, i.e., ensuring the plug 112 is correctly oriented to snap into the lateral opening 84, the working channel 64 and the closure element 108 may have matching cross-sectional shapes that allow for only one orientation, see [reference needed]. Figure 16 In this exemplary cross-section of the manipulating conduit 12, the working channel 64 is teardrop-shaped, but it can also have other shapes, such as a circle with a notch, etc.

[0083] Figure 17 and 18 A cross-section of the manipulation conduit 12 with a closure element 118 according to a third variation is depicted. In this exemplary embodiment, the closure element 118 is a tubular closure element 118 disposed around the outer peripheral surface of the body 60 of the manipulation conduit 12. The closure element 118 includes a passage opening 120 and is axially movable relative to the body 60 of the manipulation conduit 12.

[0084] To open the lateral opening 84, the tubular closure element 118 moves axially until the passage opening 120 overlaps with the lateral opening 84, thereby forming a passageway to the working channel 64. See [link to documentation]. Figure 18 This shows a fully open lateral opening 84. The passage opening 120 is sized and configured to fully expose the lateral opening 84 when it overlaps with it. Because the tubular closure element 118 has a significantly smaller radial thickness compared to the body 60 of the manipulating conduit 12, the exposed edge of the passage opening 120 is hardly jammed.

[0085] Although not shown, but Figure 17 and 18 The embodiment shown may also include an exit facilitator 88.

[0086] Figure 19 and 20 A cross-section of the manipulating conduit 12 according to a closure element 122 having a fourth variant is depicted. The closure element 122 is provided as a tubular closure element 122, and it includes components similar to... Figure 17 and 18 The passage opening 120 is shown. In this exemplary embodiment, the tubular closure element 122 is rotatably disposed around the body 60 of the manipulating conduit 12. By rotating the tubular closure element 122 relative to the body 60 of the manipulating conduit 12, the passage opening 120 can be aligned with the lateral opening 84 (in... Figure 19 (shown as dashed lines in the middle) overlap to form a connecting path to the working channel 84.

[0087] The tubular closure element 122 does not need to extend to the distal end 16 of the manipulating conduit 12, but can terminate slightly distally after the lateral opening 84. For example... Figure 19 and 20 As shown, the outer diameter of the main body 60 of the manipulating catheter can have a stepped configuration, that is, it can increase distal to the tubular closure element 122. Figure 19 and 20 In the diagram, the smaller diameter portion of the main body 60 is shown in dashed lines. This results in the flush outer surface of the manipulating conduit 12 and avoids the exposure of the circumferential edge of the tubular closure element 122.

[0088] Figure 20 and 21 A cross-section through the manipulation conduit 12 is depicted, wherein the body 60 is divided into a distal portion 124 and a proximal portion 126. In this exemplary embodiment, the distal portion 126 does not include the working channel 64. The distal portion 126 includes an elliptical first abutment surface 128 facing the proximal portion 126. The first abutment surface 128 is inclined relative to the central axis CA of the body 60. The proximal portion 128 includes an annular second abutment surface 130 facing the distal portion 124. The second abutment surface 130 is also inclined relative to the central axis CA of the body 60.

[0089] The body 60 of the manipulating catheter 12 also includes a guide structure 132 fixed to the distal portion 124. The proximal portion 126 is configured to be movable relative to the guide structure 132, and therefore also movable relative to the distal portion 124. In this exemplary embodiment, the guide structure 132 includes two tracks extending along the body 60, allowing a physician to move the distal portion 126 relative to the tracks of the guide structure 132. As shown, the guide structure 132 is at least partially embedded in the sidewall of the body 60 of the manipulating catheter 12.

[0090] The proximal portion 126 can be in a closed position (see...) Figure 21 ) and opening location (see Figure 22 The guide tube 78 moves between the guide tube 122 and the first abutment surface 128. In the closed position, the annular second abutment surface 130 completely abuts the first abutment surface 128, thereby sealing or closing the working channel 64. When the physician moves the proximal portion 126 axially relative to the guide structure 132 and the distal portion 124 into the open position, the annular second abutment surface 130 is lifted from the first abutment surface 128, thereby opening the working channel 64 to the environment surrounding the manipulating catheter 12. The guide catheter 78 can then be advanced through the working channel 64, whereby the inclined first abutment surface 128 acts as an exit facilitator as described above. In particular, the guide catheter 78 is deflected by the inclined first abutment surface 128 so that it can exit the working channel 64 in a direction away from the body 60 of the manipulating catheter 12.

[0091] To facilitate the movement of the proximal portion 126 into the closed position, the distal portion 128 may include a centering element 134 that protrudes from the first adjacent surface 128 in a direction toward the proximal portion 126. Figure 23The corresponding variation is illustrated exemplarily. Here, the centering element 134 is a cylinder with spherical ends. Other shapes of the centering element 134 are of course possible, such as a conical shape or a truncated conical shape. The centering element 134 can be concentric or eccentric with the central axis CA.

[0092] When the proximal portion 126 is in the open position ( Figure 23 When the centering element 134 (as shown) moves to the closed position, it enters the working channel 64. As the diameter of the centering element 134 increases along its distal direction, misalignment (e.g., due to the slightly curved guide structure 132) is corrected. Preferably, the maximum diameter of the centering element corresponds substantially to the inner diameter of the working channel 64. Figure 21 and 22 As shown, the first adjacent surface 128 and the second adjacent surface 130 may also be inclined. In addition, the centering element 134 also provides a guiding function for the guide conduit 78, enabling it to exit the working channel 64 in a direction away from the body 60 of the manipulating conduit 12.

[0093] Figure 24 A third variation of the manipulation catheter 12 with a body 60 is depicted, the body 60 having a distal portion 124 and a proximal portion 126 as a partial cross-section (i.e., only the proximal portion 126 is shown as a partial cross-section). In this exemplary embodiment, the proximal portion 126 is rotatably coupled to the distal portion 124 via a rotary joint 136. The distal portion 124 includes a first abutting surface 128, and the proximal portion includes a second abutting surface 130. In the closed position, the second abutting surface 130 abuts the first abutting surface 128, thereby limiting rotation beyond the closed position. Furthermore, lumens 66 to 70 (if provided) pass through the rotary joint 136.

[0094] In order to open the working channel 64 relative to the environment surrounding the manipulation conduit 12, Figure 24 In the open position shown, the proximal portion 126 is rotated relative to the distal portion 124. From Figure 24 As can be seen, the working channel 64 is fully exposed, allowing the guide tube 78, which is pushed through the working channel 64, to easily exit the working channel 64.

[0095] Of course, all of the above embodiments can be equipped with marker 86.

[0096] To place the blood pump 10 in the heart H, a single guide device 98 can be used, see [link to relevant documentation]. Figure 2The guide 98 can be a small-diameter guide, having a diameter of up to 12F, preferably up to 11F, and even more preferably up to 10F. Since the manipulating catheter 12 has a maximum diameter of 10F and the pump section 14 has a maximum diameter of 10F in the collapsed state, a single small-diameter guide 98 can be used. The pump section 14 is advanced, wherein the reinforcing mandrel 80 or the closure element 108 is received in the working channel 64. Once the lateral opening 84 is in the correct position, as indicated by reference numeral 86, the reinforcing mandrel 80 or the closure element 108 is removed from the working channel 64 via the hemostatic valve 76. Figures 17 to 20 In the embodiment shown, the closing elements 118 and 122 are moved to form a connecting path to the working channel 64. For Figures 21 to 24 In the illustrated embodiment, the proximal portion 126 moves relative to the distal portion 124 to the open position to expose and open the working channel 64. Thereafter, a guide catheter 78 is introduced via the hemostatic valve 76. The guide catheter 78 is advanced along the working channel 64 and withdrawn from the manipulating catheter 12 via the lateral opening 84 or the open working channel 64 to allow for hemodynamically supported procedures. Thereafter, the guide catheter 78 can be removed again, and the reinforcing shaft 80 or the closure element 108 can be reintroduced to increase the stability of the blood pump 10. Figures 17 to 20 In the embodiment shown, the closing elements 118, 122 move again to seal the lateral opening 84. For Figures 21 to 24 In the embodiment shown, the proximal portion 126 moves relative to the distal portion 124 to a closed position to close the working channel 64 again.

[0097] Exemplary Implementation As already described, the techniques described herein can be implemented in various ways. In this regard, the foregoing disclosure is intended to include, but is not limited to, the systems, methods, and combinations and sub-combinations thereof set forth in the following exemplary embodiments. Preferred embodiments are described in the following paragraphs: A1 A blood pump comprising: an actuating catheter and a pump segment configured to be placed inside a human body and including a pump housing, a pump element disposed within the pump housing, and an electric motor configured to rotate the pump element, the actuating catheter including: a distal end and a proximal end, wherein the pump segment is coupled to the distal end of the actuating catheter, the actuating catheter further comprising: an elongated body extending between the distal end and the proximal end along a central axis, and a working channel extending at least partially within the body from the proximal end of the actuating catheter in a direction toward the distal end of the actuating catheter, the working channel being configured to removably receive a guiding catheter.

[0098] A2 refers to the blood pump in paragraph A1, where the blood pump is an intravascular blood pump.

[0099] A3 The blood pump described in paragraph A1 or A2, wherein the pump housing is an expandable and collapseable pump housing.

[0100] A4 The blood pump described in any of the preceding paragraphs, wherein the pump element is an expandable and collapseable pump element.

[0101] A5 The blood pump described in any of the preceding paragraphs, wherein the blood pump further includes a motor cable coupled to a motor, and / or at least one optical sensor and at least one optical fiber cable coupled to the at least one optical sensor, and / or a cleaning lumen (54) coupled to the pump section.

[0102] A6 The blood pump according to any of the preceding paragraphs, wherein the body includes a receiving arrangement structure separate from the working channel, the receiving arrangement structure extending at least partially between the distal end and the proximal end of the manipulator.

[0103] A7 According to the blood pump described in paragraph A6, the receiving arrangement is configured to receive at least one of the motor cable, the optical fiber cable, and the cleaning lumen.

[0104] A8 The blood pump described in paragraph A7, wherein the motor cable and / or the at least one optical fiber cable and / or the cleaning lumen do not pass through the working channel at least from the proximal end of the manipulator to the lateral opening of the manipulator.

[0105] A9 The blood pump described in paragraph A7 or A8, wherein the motor cable and / or the at least one optical fiber cable and / or the cleaning lumen are routed separately from the working channel at least from the proximal end of the manipulator to the lateral opening of the manipulator.

[0106] A10 The blood pump described in any of paragraphs A6 to A9 above, wherein the accommodating arrangement includes a first lumen.

[0107] A11 According to the blood pump described in paragraph A10, wherein the first lumen extends at least partially between the distal end and the proximal end of the manipulating catheter.

[0108] A12 The blood pump according to paragraph A10 or A11, wherein at least one of the motor cable, the optical fiber cable and the cleaning lumen is disposed within the first lumen.

[0109] A13 The blood pump according to any one of paragraphs A10 to A12 above, wherein the first lumen is separate from the working channel.

[0110] A14 The blood pump according to any one of the preceding paragraphs A10 to A13, wherein the first lumen is offset from the central axis of the body.

[0111] A15 A blood pump according to any one of paragraphs A10 to A14 above, wherein the first lumen extends at least from the proximal end of the control catheter to the lateral opening of the control catheter without passing through the working channel.

[0112] A16 The blood pump described in any of the preceding paragraphs A6 to A15, wherein the accommodating arrangement includes a second lumen.

[0113] A17 The blood pump according to paragraph A16, wherein the second lumen extends at least partially between the distal end and the proximal end of the manipulating catheter.

[0114] A18 The blood pump according to paragraph A16 or A17, wherein at least one of the motor cable, the optical fiber cable and the cleaning lumen is not disposed in the first lumen, but is received in the second lumen.

[0115] A19 The blood pump according to any one of paragraphs A16 to A18 above, wherein the second lumen is separate from the working channel.

[0116] A20 The blood pump described in any of the preceding paragraphs A16 to A19, wherein the second lumen is offset from the central axis of the body.

[0117] A21 A blood pump according to any one of paragraphs A16 to A19 above, wherein the second lumen extends at least from the proximal end of the manipulator to the lateral opening of the manipulator without passing through the working channel.

[0118] A22 The blood pump described in any of the preceding paragraphs A6 to A21, wherein the accommodating arrangement includes a third lumen.

[0119] A23 The blood pump according to paragraph A22, wherein the third lumen extends at least partially between the distal end and the proximal end of the manipulator.

[0120] A24 The blood pump described in either paragraph A22 or A23 above, wherein the motor cable is disposed in the first lumen, and wherein the optical fiber cable is disposed in the second lumen, and wherein the cleaning lumen is disposed in the third lumen, or wherein the cleaning lumen is the third lumen.

[0121] A25 The blood pump described in any of paragraphs A22 to A24 above, wherein the third lumen is separate from the working channel.

[0122] A26 The blood pump described in any of the preceding paragraphs A22 to A25, wherein the third lumen is offset from the central axis of the body.

[0123] A27 The blood pump described in any of paragraphs A22 to A26 above, wherein the third lumen extends at least from the proximal end of the control catheter to the lateral opening of the control catheter without passing through the working channel.

[0124] A28 The blood pump described in any of the preceding paragraphs, wherein the manipulation catheter includes a lateral opening.

[0125] A29 The blood pump described in paragraph A28, wherein the lateral opening extends through the sidewall of the body.

[0126] A30 The blood pump according to paragraphs A28 or A29, wherein the lateral opening is connected to the working channel.

[0127] A31 The blood pump described in any of the preceding paragraphs A28 to A30, wherein the lateral opening is configured such that the guiding catheter can exit the body through the lateral opening.

[0128] A32 The blood pump described in any of the preceding paragraphs A28 to A31, wherein the blood pump further includes a closure element configured to selectively open and close the lateral opening.

[0129] A33 The blood pump described in paragraph A32, wherein the closure element is movable relative to the manipulation catheter.

[0130] A34 The blood pump described in paragraph A33, wherein the closure element selectively opens and closes the lateral opening relative to the movement of the manipulating catheter.

[0131] A35 The blood pump described in any of the preceding paragraphs A32 to A34, wherein the closure element is axially movable relative to the manipulating catheter.

[0132] A36 The blood pump according to any one of paragraphs A32 to A35 above, wherein the working channel is configured to removably receive the closure element.

[0133] A37 The blood pump described in any of the preceding paragraphs A32 to A36, wherein the closure element comprises an elongated body and a plug.

[0134] A38 The blood pump described in paragraph A37, wherein the plug is disposed on the body.

[0135] A39 The blood pump described in paragraph A37 or A38, wherein the plug is configured to seal the lateral opening when the closure element is received in the working channel.

[0136] A40 The blood pump according to any one of paragraphs A37 to A39 above, wherein the plug is disposed at the distal end of the elongated body of the closure element.

[0137] A41 The blood pump described in any of the preceding paragraphs A37 to A40, wherein the elongated body includes a collar portion.

[0138] A42 According to the blood pump described in paragraph A41, wherein when the plug seals the lateral opening, the collar portion abuts the inner circumferential surface of the working channel.

[0139] A43 The blood pump described in any of paragraphs A32 to A34 above, wherein the closure element is a tubular closure element disposed at least partially around the outer peripheral surface of the body of the manipulating catheter.

[0140] A44 The blood pump described in paragraph A43, wherein the tubular closure element is movable relative to the body of the manipulation catheter.

[0141] A45 The blood pump described in paragraph A43 or A44, wherein the tubular closure element includes a passage opening extending through the sidewall of the tubular closure element.

[0142] A46 According to the blood pump described in paragraph A45, the access opening is sized and configured to form a connecting path to the working channel when the access opening at least partially overlaps with the lateral opening by movement of the tubular closure element relative to the body of the manipulating catheter.

[0143] A47 The blood pump described in any of the preceding paragraphs A43 to A46, wherein the tubular closure element is configured to be axially movable relative to the body of the manipulation catheter.

[0144] A48 The blood pump described in any of the preceding paragraphs A43 to A47, wherein the tubular closure element is configured to rotate relative to the body of the manipulation catheter.

[0145] A49 The blood pump described in any of the preceding paragraphs, wherein the manipulation catheter includes a marker.

[0146] A50 The blood pump described in paragraph A49, wherein the marker is configured to indicate the location of the lateral opening via an imaging procedure.

[0147] A51 The blood pump described in any of paragraphs A28 to A50 above, wherein the exit facilitator is disposed in the working channel in the distal region of the lateral opening.

[0148] A52 The blood pump described in paragraph A51, wherein the exit facilitator includes an inclined plane.

[0149] A53 According to the blood pump in paragraph A52, the slope includes a first slope and a second slope.

[0150] A54 The blood pump described in paragraph A53, wherein the second bevel is disposed between the first bevel and the inner peripheral surface of the working channel.

[0151] A55 According to paragraphs A53 or A54, the blood pump, wherein the second bevel is made of an elastic material that biases the first bevel in the direction toward the lateral opening.

[0152] A56 The blood pump described in any of the preceding paragraphs A52 to A55, wherein the inclined plane closes the working channel.

[0153] A57 The blood pump described in any of the preceding paragraphs A52 to A56, wherein the working channel terminates at the inclined plane.

[0154] A58 The blood pump described in paragraph A51, wherein the exit facilitator includes a contraction section.

[0155] A59 The blood pump described in paragraph A58, wherein the constriction section minimizes the inner diameter of the working channel.

[0156] A60 The blood pump described in paragraphs A58 or A59, wherein the contraction minimizes the inner diameter of the working channel extending beyond the lateral opening in the direction of the distal end of the manipulation catheter.

[0157] A61 According to the blood pump described in paragraph A51, the exit facilitator divides the working channel into a first portion extending proximally from the lateral opening and a second portion extending distally from the lateral opening.

[0158] According to paragraph A61, the blood pump in section A62 is concentric with the central axis of the main body of the manipulating catheter.

[0159] A63 The blood pump described in paragraph A61 or A62, wherein the second portion is offset from the central axis of the body of the manipulating catheter.

[0160] A64 The blood pump described in any of the preceding paragraphs A1 to A27, wherein the main body of the manipulation catheter includes a distal portion and a proximal portion.

[0161] A65 The blood pump described in paragraph A64, wherein the distal portion is separate from the proximal portion.

[0162] A66 According to the blood pump described in paragraphs A64 or A65, the proximal portion is movable relative to the distal portion between a closed position and an open position.

[0163] A67 The blood pump described in paragraph A66, wherein the working channel is sealed when the proximal portion is in the closed position, and wherein the working channel is open when the proximal portion is in the open position.

[0164] A68 The blood pump described in any of the preceding paragraphs A64 to A67, wherein the manipulating catheter includes a guiding structure extending at least partially along the body of the manipulating catheter.

[0165] A69 The blood pump described in paragraph A68, wherein the distal portion is fixed to the guiding structure.

[0166] A70 The blood pump according to paragraphs A68 or A69, wherein the proximal portion is configured to be axially movable relative to the guide structure.

[0167] A71 The blood pump described in any of the preceding paragraphs A68 to A70, wherein the guiding structure is at least partially embedded in the sidewall of the body of the manipulating catheter.

[0168] A72 The blood pump described in any of the preceding paragraphs A64 to A71, wherein the distal portion includes a centering element extending in the proximal direction.

[0169] A73 The blood pump described in paragraph A72, wherein the centering element extends in a proximal direction.

[0170] A74 The blood pump described in paragraph A72 or A73, wherein when the proximal portion is in the closed position, the centering element is received in a portion of the working channel of the proximal portion (126).

[0171] A75 The blood pump described in any of paragraphs A64 to A74, wherein the distal portion includes a first adjacent surface facing the proximal portion.

[0172] A76 The blood pump described in paragraph A75, wherein the first adjacent surface is inclined relative to the central axis of the body.

[0173] A77 The blood pump described in any of the preceding paragraphs A64 to A76, wherein the proximal portion includes a second adjacent surface facing the distal portion.

[0174] A78 The blood pump described in paragraph A77, wherein the second adjacent surface is inclined relative to the central axis of the body.

[0175] A79 The blood pump described in paragraph A77 or A78, wherein, in the closed position, the second adjacent surface is adjacent to the first adjacent surface.

[0176] A80 The blood pump described in any of the preceding paragraphs A77 to A79, wherein the second adjacent surface has an annular shape.

[0177] A81 The blood pump described in any of the preceding paragraphs A74 to A80, wherein the first adjacent surface has a circular or elliptical shape.

[0178] A82 The blood pump according to any one of the preceding paragraphs A64 to A81, wherein the proximal portion is rotatable relative to the distal portion via a rotary joint.

[0179] A83 The blood pump described in any of the preceding paragraphs, wherein the working channel is offset from the central axis of the body.

[0180] A84 The blood pump described in any of the preceding paragraphs, wherein the working channel is configured to removably receive a reinforcing spindle.

[0181] A85 The blood pump described in any of the preceding paragraphs, wherein the working channel extends to the distal end of the manipulation catheter.

[0182] A86 The blood pump described in any of the preceding paragraphs, wherein the working channel extends to the lateral opening of the manipulation catheter.

[0183] A87 The blood pump described in any of the preceding paragraphs, wherein the working channel has a low-friction surface.

[0184] A88 The blood pump described in any of the preceding paragraphs, wherein the hemostatic valve is located at the proximal end of the working channel.

[0185] A89 The blood pump according to any one of the preceding paragraphs, wherein the manipulating catheter has an outer diameter of up to 12F, preferably up to 11F, and even more preferably up to 10F.

[0186] A90 The blood pump described in any of the preceding paragraphs, wherein the working channel has an inner diameter of at least 4F, preferably at least 5F, and even more preferably at least 6F.

[0187] B1 A catheter pump assembly comprising a blood pump according to any one of the preceding paragraphs A1 to A90.

[0188] B2 The conduit pump assembly according to paragraph B1, wherein the conduit pump assembly further includes a guide conduit configured to be removably received in the working channel.

[0189] B3 The catheter pump assembly according to paragraph B1 or B2, wherein the catheter pump assembly includes a reinforcing mandrel configured to be removably received in the working channel.

[0190] B4 The catheter pump assembly as described in paragraph B3, wherein the reinforcing mandrel is a hollow reinforcing mandrel.

[0191] B5 The conduit pump assembly according to any of the preceding paragraphs B1 to B4, wherein the conduit pump assembly includes a sealing element.

[0192] As used herein, the terms “approximately,” “about,” “substantially,” “actually,” and similar terms are intended to have a broad meaning consistent with the usage generally accepted by one of ordinary skill in the art to which the subject matter of this disclosure pertains. Those skilled in the art who read this disclosure will understand that these terms are intended to allow for the description of certain features described, rather than limiting the scope of those features to the precise numerical ranges provided. Therefore, these terms should be interpreted as indicating non-substantial or unreasonable modifications or alterations to the described subject matter and are considered to be within the scope of this disclosure. The terms “at least partially” or “partially” as used herein both respectively mean part and all or completely. Terms such as “first,” “second,” or “third” do not indicate a particular order but are merely intended to semantically distinguish these elements.

[0193] List of reference numerals 1. Conduit pump assembly 10 Blood Pumps 12 Manipulating the catheter 14 Pump Section 16 Manipulate the distal end of the catheter 18 Manipulate the proximal end of the catheter 20 Pump casing 22 Pump Components / Impeller 24. Blood flow entry point 26. Blood Outflow 28 Damage-resistant end caps 30 Downstream pipeline 32 motors 34 Rotors 36 stators 38 Motor housing 40 axis 42 Proximal bearing 44 Distal bearing 46 pillars 48 Motor cables 50 controllers 52 Printed Circuit Boards 54 Clean the lumen 56 sensors 58 Fiber Optic Cables 60 main body 62 Y-shaped parts 64 Work Channels 66 First lumen 68 Second lumen 70 Third lumen 72 Y-shaped first arm 74 Y-shaped second arm 76. Hemostatic valve 78. Guiding catheter 80 Reinforced Mandrel 82. Accommodation and Layout Structure 84 Lateral openings 86 marks 88 Exit Promotion Device 90 bevel 92 First oblique face 94 Second oblique face 96. Contraction section 98 guide The first part of the 100 work channel 102 The second part of the work passage 104 bevel 106 bevel 108 Enclosed Components 110 Slender body 112 Stopper 114. Ring section 116 Inner peripheral surface 118 Enclosed Components 120 passage opening 122 Enclosed element 124 Distal part 126 Proximal part 128 First Adjacent Surface 130 Second Adjacent Surface 132 Guiding Structure 134 Centering element 136 Rotary Joint CA central axis H Heart LV (Left Ventricle)

Claims

1. A blood pump (10), preferably an intravascular blood pump, comprising: Manipulate the conduit (12) and pump section (14). The pump section (14) is configured to be placed inside the human body and includes: Expandable and collapsible pump casing (20). An expandable and collapsible pump element (22) disposed within the pump housing (20), and an electric motor (32) configured to rotate the pump element (22). The manipulation catheter (12) includes: The distal end (16) and the proximal end (18), wherein the pump section (14) is coupled to the distal end (16) of the manipulating conduit (12), the manipulating conduit (12) further comprising: An elongated body (60) extending along the central axis (CA) between the distal end (16) and the proximal end (18). A working channel (64), which extends at least partially within the body (60) from the proximal end (18) of the manipulation conduit (12) along the distal end (16) of the manipulation conduit (12), The working channel (64) is configured to removably receive the guiding conduit (78).

2. The blood pump (10) according to claim 1. in, The body (60) includes a receiving arrangement (82) separate from the working channel (64), the receiving arrangement (82) extending at least partially between the distal end (16) and the proximal end (18) of the manipulating catheter (12), and wherein the blood pump (10) further includes: Motor cable (48) coupled to the motor (32), and / or at least one optical sensor, and at least one optical fiber cable (58) coupled to the at least one optical sensor (56), and / or cleaning cavity (54) coupled to the pump section (14). The receiving arrangement structure (82) is configured to receive at least one of the motor cable (48), the optical fiber cable (58), and the cleaning cavity (54).

3. The blood pump according to claim 2, in, The motor cable (48) and / or the at least one optical fiber cable (58) and / or the cleaning lumen (54) shall not pass through the working channel (64) at least from the proximal end of the manipulator (12) to the lateral opening (84) of the manipulator (12), and / or The motor cable (48) and / or the at least one optical fiber cable (58) and / or the cleaning lumen (54) are respectively laid separately from the working channel (64) from the proximal end of the control conduit (12) to the lateral opening (84) of the control conduit (12).

4. The blood pump (10) according to claim 2 or 3. in, The receiving arrangement structure (82) includes a first lumen (66) extending at least partially between the distal end (16) and the proximal end (18) of the manipulator (12), wherein at least one of the motor cable (48), the optical fiber cable (58) and the cleaning lumen (54) is disposed within the first lumen (66).

5. The blood pump (10) according to claim 4. in, The first lumen (66) is offset from the central axis of the body (60), and / or wherein, The first lumen (66) extends from the proximal end of the manipulator (12) to the lateral opening (84) of the manipulator (12) without passing through the working channel (64).

6. The blood pump (10) according to claim 4 or 5. in, The receiving arrangement structure (82) includes a second lumen (68) extending at least partially between the distal end (16) and the proximal end (18) of the manipulator (12), wherein at least one of the motor cable (48), the optical fiber cable (58) and the cleaning lumen (54) is not disposed within the first lumen (66) and is received in the second lumen (68).

7. The blood pump (10) according to claim 6. in, The second lumen (68) is offset from the central axis of the body (60), and / or wherein, The second lumen (68) extends from the proximal end of the manipulator (12) to the lateral opening (84) of the manipulator (12) without passing through the working channel (64).

8. The blood pump (10) according to any one of claims 6 or 7. in, The receiving arrangement structure (82) includes a third lumen (70) extending at least partially between the distal end (16) and the proximal end (18) of the manipulating conduit (12), wherein the motor cable (48) is disposed within the first lumen (70), and wherein the optical fiber cable (58) is disposed within the second lumen (68), and wherein the cleaning lumen (54) is disposed within the third lumen (70), or wherein the cleaning lumen (54) is the third lumen (70).

9. The blood pump (10) according to claim 8. in, The third lumen (70) is offset from the central axis of the body (60), and / or wherein, The third lumen (70) is not located in the working channel (64) at least from the proximal end of the manipulator (12) to the lateral opening (84) of the manipulator (12).

10. The blood pump (10) according to any one of the preceding claims. in, The manipulation conduit (12) includes a lateral opening (84) extending through the sidewall of the body (60), the lateral opening (84) being connected to the working channel (64), and the lateral opening being configured to allow the guiding conduit (78) to exit the body (60) through the lateral opening (84).

11. The blood pump (10) according to claim 10. in, The blood pump (10) also includes closure elements (108, 118, 122) configured to selectively open and close the lateral opening (84).

12. The blood pump (10) according to claim 11. in, The closure elements (108, 118, 122) are movable relative to the manipulation conduit (12), wherein the movement of the closure elements (108, 120, 122) relative to the manipulation conduit (12) selectively opens and closes the lateral opening (84).

13. The blood pump (10) according to claim 12. in, The closure element (108, 118) is axially movable relative to the manipulating conduit (12).

14. The blood pump (10) according to claim 12 or 13. in, The working channel (64) is configured to removably receive the closure element (108).

15. The blood pump (10) according to claim 13 or 14. in, The closure element (108) includes an elongated body (110) and a plug (112) disposed on the body (110), wherein the plug (112) is configured to seal the lateral opening (84) when the closure element (108) is received in the working channel (64), wherein the plug (112) is preferably disposed at the distal end of the elongated body (110) of the closure element (108).

16. The blood pump (10) according to claim 15. in, The elongated body (110) includes a collar portion (114) which abuts the inner circumferential surface (116) of the working channel (64) when the plug (112) seals the lateral opening (84).

17. The blood pump (10) according to claim 12. in, The closure element (120, 122) is a tubular closure element (118, 122) disposed at least partially around the outer peripheral surface of the body (60) of the manipulating conduit (12), wherein the tubular closure element (118, 122) is movable relative to the body (60) of the manipulating conduit (12), wherein the tubular closure element (118, 122) includes a passage opening (120) extending through the sidewall of the tubular closure element (118, 122), wherein the passage opening (120) is sized and configured such that when the passage opening (120) at least partially overlaps with the lateral opening (84) by movement of the tubular closure element (118, 122) relative to the body (60) of the manipulating conduit (12), a communication path to the working channel (64) is formed.

18. The blood pump (10) according to claim 17. in, The tubular closure element (118, 122) is configured to be axially movable relative to the body (60) of the manipulating conduit (12) and / or to be rotatable relative to the body (60) of the manipulating conduit (12).

19. The blood pump (10) according to any one of claims 10 to 18. in, The manipulation catheter (12) includes a marker (86) configured to indicate the location of the side opening (84) via an imaging procedure.

20. The blood pump (10) according to any one of claims 10 to 19. in, In the region at the far end of the lateral opening (84), an exit facilitator (88) is provided in the working channel (64).

21. The blood pump (10) according to claim 20, in, The exit facilitator (88) includes inclined planes (90, 106).

22. The blood pump (10) according to claim 21. in, The inclined surface (90) includes a first inclined surface (92) and a second inclined surface (94), wherein the second inclined surface (94) is disposed between the first inclined surface (92) and the inner peripheral surface (116) of the working channel (64), wherein the second inclined surface (94) is made of an elastic material and biases the first inclined surface (92) in a direction toward the lateral opening (84).

23. The blood pump (10) according to claim 21. in, The inclined plane (106) closes the working channel (64) so ​​that the working channel (64) terminates at the inclined plane (106).

24. The blood pump (10) according to claim 20, in, The exit facilitator (88) includes a contraction section (96) that minimizes the inner diameter of the working channel (64) beyond the lateral opening (84) along the distal direction of the manipulating conduit (12).

25. The blood pump (10) according to claim 20, in, The exit facilitator (88) divides the working channel (64) into a first portion (100) extending proximally from the lateral opening (84) and a second portion (102) extending distally from the lateral opening (84), wherein the first portion (100) is concentric with the central axis (CA) of the body (60) of the manipulating conduit (12), and wherein the second portion (102) is offset from the central axis (CA) of the body (60) of the manipulating conduit (12).

26. The blood pump (10) according to any one of claims 1 to 9, in, The main body (60) of the manipulating conduit (12) includes a distal portion (124) and a proximal portion (126), wherein the proximal portion (126) is movable relative to the distal portion (124) between a closed position and an open position, wherein when the proximal portion (126) is in the closed position, the working channel (64) is sealed, and wherein when the proximal portion (126) is in the open position, the working channel (64) is open.

27. The blood pump (10) according to claim 26. in, The manipulation conduit (12) includes a guide structure (132) extending at least partially along the body (60) of the manipulation conduit (12), wherein the distal portion (124) is fixed to the guide structure (132) and the proximal portion (126) is configured to be axially movable relative to the guide structure (132).

28. The blood pump (10) according to claim 26 or 27. in, The distal portion (124) includes a centering element (134) extending in the proximal direction, wherein the centering element (134) is received in a portion of the working channel (64) of the proximal portion (126) when the proximal portion (126) is in the closed position.

29. The blood pump (10) according to any one of claims 26 to 28. in, The distal portion (124) includes a first adjacent surface (128) facing the proximal portion (126), wherein the first adjacent surface (128) is inclined relative to the central axis (CA) of the body (60), wherein the proximal portion (126) includes a second adjacent surface (130) facing the distal portion (124), wherein the second adjacent surface (130) is inclined relative to the central axis (CA) of the body (60), and wherein, in the closed position, the second adjacent surface (130) abuts the first adjacent surface (128).

30. The blood pump (10) according to claim 29. in, The first adjacent surface (128) has a circular or elliptical shape, and / or wherein the second adjacent surface (130) has an annular shape.

31. The blood pump (10) according to claim 26. in, The proximal portion (126) is rotatable relative to the distal portion (124) via a rotary joint (136).

32. The blood pump (10) according to any one of the preceding claims. in, The working channel (64) is offset from the central axis of the main body (60).

33. The blood pump (10) according to any one of the preceding claims. in, The working channel (64) is configured to removably receive the reinforcing mandrel (80).

34. The blood pump (10) according to any one of the preceding claims. in, The working channel (64) extends to the distal end (16) of the manipulator (12), and / or wherein the working channel (64) extends to the lateral opening (84) of the manipulator (12), and / or wherein the working channel (64) has a low-friction surface, and / or wherein the hemostatic valve (76) is disposed at the proximal end of the working channel (64).

35. The blood pump (10) according to any one of the preceding claims. in, The manipulation conduit (12) has an outer diameter of up to 12F, preferably up to 11F and even more preferably up to 10F, and / or wherein the working channel (64) has an inner diameter of at least 4F, preferably at least 5F and even more preferably at least 6F.

36. A catheter pump assembly (1) comprising a blood pump (10) according to any one of the preceding claims.

37. The conduit pump assembly (1) according to claim 36. in, The duct pump assembly (1) also includes a guide duct (78) configured to be removably received in the working channel (64).

38. The conduit pump assembly (1) according to claim 36 or 37. in, The catheter pump assembly (1) further includes a reinforcing mandrel (80) configured to be removably received in the working channel (64), wherein the reinforcing mandrel (80) is preferably a hollow reinforcing mandrel (80).

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