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WO2025157875A1 - Blood pump and catheter pump assembly - Google Patents

Blood pump and catheter pump assembly

Info

Publication number
WO2025157875A1
WO2025157875A1 PCT/EP2025/051586 EP2025051586W WO2025157875A1 WO 2025157875 A1 WO2025157875 A1 WO 2025157875A1 EP 2025051586 W EP2025051586 W EP 2025051586W WO 2025157875 A1 WO2025157875 A1 WO 2025157875A1
Authority
WO
WIPO (PCT)
Prior art keywords
working channel
blood pump
catheter
steering catheter
lumen
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/EP2025/051586
Other languages
French (fr)
Inventor
Thorsten Siess
Gerd Bruno Spanier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abiomed Europe GmbH
Original Assignee
Abiomed Europe GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Abiomed Europe GmbH filed Critical Abiomed Europe GmbH
Publication of WO2025157875A1 publication Critical patent/WO2025157875A1/en
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10Location thereof with respect to the patient's body
    • A61M60/122Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/13Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20Type thereof
    • A61M60/205Non-positive displacement blood pumps
    • A61M60/216Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller the blood flow through the rotating member having mainly axial components, e.g. axial flow pumps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40Details relating to driving
    • A61M60/403Details relating to driving for non-positive displacement blood pumps
    • A61M60/408Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
    • A61M60/411Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
    • A61M60/416Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor transmitted directly by the motor rotor drive shaft
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804Impellers
    • A61M60/806Vanes or blades
    • A61M60/808Vanes or blades specially adapted for deformable impellers, e.g. expandable impellers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/81Pump housings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/802Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/827Sealings between moving parts
    • A61M60/829Sealings between moving parts having a purge fluid supply
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/855Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/857Implantable blood tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80Constructional details other than related to driving
    • A61M60/855Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/865Devices for guiding or inserting pumps or pumping devices into the patient's body
    • A61M60/867Devices for guiding or inserting pumps or pumping devices into the patient's body using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter

Definitions

  • the present invention relates to a blood pump, preferably to an intravascular blood pump.
  • the present invention in particular relates to a percutaneously insertable blood pump for supporting blood circulation in humans or optionally also in animals.
  • the blood pump may be designed to be inserted percutaneously into a femoral artery of a patient and guided through the patient’s vascular system in order, for example, to support or replace the pumping action of the heart.
  • the present invention further relates to a catheter pump assembly comprising such a blood pump.
  • Such blood pumps may be introduced into a patient either surgically or percutaneously and are used to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system.
  • an intravascular blood pump may pump blood from the left ventricle of the heart into the aorta.
  • an intravascular blood pump may pump blood from the inferior vena cava into the pulmonary artery.
  • Intravascular blood pumps may be powered by a motor located outside of the patient's body via an elongated drive shaft or by an onboard motor located inside the patient's body.
  • the present invention will be described in the context of a blood pump having an expandable and collapsible pump housing, in which an expandable and collapsible pump element is housed driven by a motor, the present invention is also applicable in other types of intravascular blood pumps.
  • a blood pump of the aforementioned expandable type is known, e.g., from EP 3 858 398 A1 , which discloses a catheter pump assembly.
  • An expandable and collapsible pump housing is disposed at a distal end of a steering catheter.
  • the expandable and collapsible pump housing surrounds an expandable and collapsible pump element driven by a motor.
  • the pump element may be an expandable and collapsible pump element.
  • the distal portion of the catheter pump assembly may be placed inside the heart via a percutaneous access using the Seidinger technique, for example.
  • proximal and distal are seen relative to the physician.
  • proximal designates something which is relatively close to the physician
  • distal designates something which is relatively far away from the physician when the catheter is placed.
  • a guide catheter is used to conduct hemodynamically supported procedures.
  • a comparably large diameter introducer is used, having a diameter of 14F (French) or more to allow the pump section to be introduced.
  • the steering catheter usually has a smaller diameter than the pump section, such an introducer with a large diameter allows the catheter pump assembly and the guide catheter to be introduced side by side through the introducer.
  • the catheter pump assembly During insertion of an intravascular blood pump, it is preferable for the catheter pump assembly to be as small as possible as this allows for a better maneuverability of the intravascular blood pump through the patient’s vasculature.
  • the latter is a major advantage of an expandable and collapsible pump section, as the diameter thereof is about 10F in the collapsed state.
  • This is also advantageous, as it is preferred to use a small diameter introducer having a diameter of 11 F or less, preferably of 10F or only of 9F.
  • a blood pump may comprise a steering catheter and a pump section.
  • the pump section may be configured to be placed in a human body.
  • the pump section may comprise an expandable and collapsible pump housing, an expandable and collapsible pump element disposed within the pump housing and an electric motor configured to rotate the pump element.
  • the steering catheter may comprise a distal end and a proximal end, wherein the pump section may be coupled to a distal end of the steering catheter.
  • the steering catheter may further comprise an elongated main body extending between the distal end and the proximal end along a central axis, a working channel at least partially extending within the main body from the proximal end of the steering catheter in a direction of the distal end of the steering catheter.
  • the working channel may be configured to removably receive a guide catheter. It has to be noted that the main body of the steering catheter does not need to extend up to the proximal end or the distal end of the steering catheter, but may only constitute a portion of the steering catheter.
  • the guide catheter is not running side by side with the steering catheter, but is at least partially received within the working channel of the steering catheter.
  • a single small diameter introducer having a diameter of 11 F or less may be used to place the blood pump and a guide catheter into the vasculature of a patient.
  • the guide 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 steering catheter or may only partially extend along the steering catheter.
  • the motor may be disposed at a proximal end of the pump housing.
  • the motor may comprise a motor housing, a rotor and a stator.
  • the rotor and the stator may be disposed within the motor housing.
  • the motor housing may have an outer diameter which is smaller, equal to or larger than an outer diameter of the steering catheter.
  • the motor housing has an outer diameter of at most 12F, preferably of at most 11 F. Even more preferably, the motor housing has an outer diameter of at most 10F.
  • the distal end of the steering catheter may be attached to the motor housing.
  • the pump section may have an outer diameter in the collapsed or compressed state of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
  • the steering catheter has a tubular shape.
  • the steering catheter may have a cylindrical shape.
  • the central axis of the main body may be concentric with a longitudinal axis of the steering catheter.
  • the main body comprises a hosting arrangement separated from the working channel.
  • the hosting arrangement may at least partially extend between the distal end of the steering catheter and the proximal end of the steering catheter.
  • the blood pump may further comprise a motor cable coupled to the motor.
  • the blood pump may further comprise at least one optical sensor and at least one optical fiber cable coupled to the optical sensor.
  • the blood pump may further comprise a purge lumen coupled to the pump section.
  • the hosting arrangement may be configured to receive at least one of the motor cable, the optical fiber cable and the purge lumen. As the hosting arrangement is spatially separated from the working channel, any element received in the hosting arrangement is not interfering with the guide catheter being received in the working channel.
  • the motor cable may comprise a plurality of wires.
  • the plurality of wires may be disposed next to each other or the plurality of wires may be stacked.
  • the motor cable may be a ribbon cable.
  • the at least one optical sensor may be disposed at the pump section. Further optical sensors may also be used and may be disposed, e.g., at the motor housing or the steering catheter.
  • the purge lumen may be coupled to the motor housing.
  • the motor cable does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the motor cable runs separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the at least one optical fiber cable does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the at least one optical fiber cable runs separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the purge lumen does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the purge lumen runs separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the hosting arrangement may comprise a first lumen at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter. At least one of the motor cable, the optical fiber cable and the purge lumen is disposed within the first lumen.
  • the steering catheter may be a multi-lumen catheter comprising the working channel and a first lumen separated from the working channel.
  • the first lumen may be offset from the central axis of the main body.
  • the first lumen may be provided so that it does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the first lumen may extend along the entire length of the steering catheter, i.e., from the proximal end of the steering catheter to the distal end of the steering catheter.
  • the first lumen may extend only partially along the main body and it does not need to terminate at the distal end of the steering catheter and/ or the proximal end of the steering catheter.
  • the first lumen may have a circular cross section.
  • the first lumen may also have another cross- sectional shape such as a sickle-shape, quarter-circular shape, half-circular shape, C-shape, rectangular shape, curved rectangular shape, triangular shape, etc.
  • the hosting arrangement may comprise a second lumen at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter. At least one of the motor cable, the optical fiber cable and the purge lumen may not be disposed within the first lumen but may be received in the second lumen.
  • the steering catheter may be a multi-lumen catheter comprising the working channel, a first lumen separated from the working channel and a second lumen separated from the working channel.
  • the second lumen may be offset from the central axis of the main body.
  • the second lumen may be provided so that it does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the second lumen may extend along the entire length of the steering catheter, i.e., from the proximal end of the steering catheter to the distal end of the steering catheter.
  • the second lumen may extend only partially along the main body and it does not need to terminate at the distal end of the steering catheter and/ or the proximal end of the steering catheter.
  • the second lumen may have a circular cross section.
  • the second lumen may also have another cross-sectional shape such as a sickle-shape, quarter-circular shape, half-circular shape, C- shape, rectangular shape, curved rectangular shape, triangular shape, etc.
  • the hosting arrangement may comprise a third lumen at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter.
  • the motor cable may be disposed within the first lumen.
  • the optical fiber cable may be disposed within the second lumen and the purge lumen may be disposed within the third lumen or the purge lumen may be the third lumen.
  • the purge lumen may also be the first lumen or the second lumen.
  • the third lumen may be offset from the central axis of the main body.
  • the third lumen may be provided so that it does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
  • the third lumen may extend along the entire length of the steering catheter, i.e., from the proximal end of the steering catheter to the distal end of the steering catheter.
  • the third lumen may extend only partially along the main body and it does not need to terminate at the distal end of the steering catheter and/ or the proximal end of the steering catheter.
  • the third lumen may have a circular cross section.
  • the first lumen may also have another cross-sectional shape such as a sickle-shape, quarter-circular shape, half-circular shape, C-shape, rectangular shape, curved rectangular shape, triangular shape, etc.
  • the hosting arrangement of the steering catheter may comprise one or more lumens which are separated from the working channel so that there is no interference between the one or more lumens and the working channel.
  • the hosting arrangement may also comprise at least one recess provided on an outer surface of the main body of the steering catheter.
  • the at least one recess may be configured to receive at least one of the motor cable, the optical fiber cable and the purge lumen.
  • the hosting arrangement may comprise a combination of lumen and recess.
  • the recess may be filed with a resin material after the respective one or more of the motor cable, the optical fiber cable and the purge lumen are received in the respective recess.
  • the first to third lumen of the hosting arrangement may also be created by embedding the respective ones of the motor cable, the optical fiber cable and the purge lumen in the main body of the steering catheter, i.e., by embedding into a wall of the steering catheter.
  • the steering catheter comprises a lateral opening extending through a side wall of the main body.
  • the lateral opening may be connected to the working channel and may be configured so that a guide catheter can exit the main body through the lateral opening.
  • the lateral opening may be a longitudinal opening.
  • the lateral opening may be drop shaped.
  • the lateral opening may penetrate a side wall of the steering catheter.
  • the lateral opening may be provided at a certain distance from the proximal end of the steering catheter.
  • the guide catheter can therefore be advanced and positioned independently of the blood pump or the pump section respectively within the steering catheter to reach the ostia of the coronary arteries. Any hemodynamically supported procedure can then be performed through the guide catheter.
  • the blood pump may further comprise a closure element configured to selectively open and close the lateral opening.
  • the closure element is configured to seal the lateral opening if desired by the physician. Sealing the lateral opening may be advantageous for introducing the steering catheter through the access port.
  • a non-sealed (i.e., open) lateral opening has an exposed edge because it penetrates the side wall of the main body of the steering catheter. 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.
  • the closure element may be movable relative to the steering catheter, wherein a movement of the closure element relative to the steering catheter selectively opens and closes the lateral opening.
  • the physician may manually move the closure element relative to the steering catheter to decide when to open and when to close the lateral opening.
  • the closure element may be configured to be axially movable relative to the steering catheter.
  • the working channel is configured to selectively receive the closure element.
  • the lateral opening may be closed or opened.
  • the closure element may comprise an elongated main body and a plug disposed on the main body of the closure element.
  • the plug may be configured to seal the lateral opening when the closure element is received in the working channel.
  • the plug may be disposed at a distal end of the elongated main body of the closure element.
  • the plug has a size and shape that corresponds to the size and shape of the lateral opening so that the plug is preferably entirely received in the lateral opening for closing the lateral opening.
  • the elongated main body may comprise a collar portion at its distal end.
  • the collar portion may be configured to abut an inner peripheral surface of the working channel adjacent to the lateral opening. Accordingly, the collar portion abuts the inner peripheral surface when the plug is properly disposed in the lateral opening which inhibits further advancement of the closure element relative to the steering catheter. Hence, it can be avoided that the plug and/ or the elongated main body of the closure element are pushed too far and partially exit through the lateral opening into the blood vessel.
  • the closure element may alternatively be configured as a tubular closure element being at least partially disposed about an outer peripheral surface of the main body of the steering catheter.
  • the tubular closure element may be movable relative to the main body of the steering catheter.
  • the tubular closure element may comprise a passage opening extending through a side wall of the tubular closure element.
  • the passage opening may be sized and configured to create a passageway to the working channel when the passage opening is brought into at least partial overlap with the lateral opening by movement of the tubular closure element relative to the main body of the steering catheter.
  • the working channel is only connected to the environment surrounding the steering catheter when the passage opening at least partially overlaps with the lateral opening.
  • the tubular closure element is moved so that the passage opening does not overlap with the later opening and the tubular closure element seals the lateral opening.
  • the tubular closure element may be configured to be axially movable relative to the main body of the steering catheter.
  • the tubular closure element may additionally or alternatively be configured to be rotatable relative to the main body of the steering catheter.
  • the tubular closure element may be disposed on the main body of the steering catheter so that an edge- free outer surface is achieved.
  • the steering catheter may comprise a marker and the marker may be configured to indicate the position of the lateral opening by an imaging procedure. This allows the physician or operator to verify that the lateral opening is at the correct position within the artery before advancing the guide catheter through the working channel of the steering catheter so that the guide catheter enters the artery by exiting the main body through the lateral opening.
  • an exit facilitation device is disposed in the working channel in the area of a distal end of the lateral opening.
  • the exit facilitation device may be configured to allow for facilitated sliding of the guide catheter and/ or the closure element through or in a direction towards the lateral opening.
  • the exit facilitation device may comprise a ramp configured to redirect or deflect the guide catheter and/ or the closure element from the working channel towards the lateral opening.
  • the ramp may be provided at the distal end of the lateral opening.
  • the ramp may be spring loaded or biased.
  • the ramp may close the working channel so that the working channel terminates at the ramp.
  • the exit facilitation device may also comprise a constriction minimizing the inner diameter of the working channel.
  • the constriction may be provided only locally in the area of the distal end of the lateral opening or may at least partially extend from the distal end of the lateral opening in a direction of the distal end of the steering catheter.
  • the working channel may also terminate in the area of the lateral opening.
  • the ramp may comprise a first ramp part and a second ramp part.
  • the second ramp part may be disposed between the first ramp part and an inner peripheral surface of the working channel.
  • the second ramp part may be made of an elastic material biasing the first ramp part in a direction towards the lateral opening.
  • the exit facilitation device may divide 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 main body of the steering catheter.
  • the second portion may be offset from the central axis of the main body of the steering catheter.
  • the main body of the steering catheter may comprise a distal part and a proximal part, wherein the proximal part may be movable relative to the distal part between a closed position and an opened position.
  • the working channel is sealed when the proximal part is in the closed position and the working channel is open to an environment surrounding the steering catheter when the proximal part is in the opened position.
  • the guide catheter can exit the main body of the steering catheter directly out of the working channel.
  • the guide catheter can therefore be advanced and positioned independently of the blood pump or the pump section respectively within the steering catheter to reach the ostia of the coronary arteries. Any hemodynamically supported procedure can then be performed through the guide catheter.
  • the steering catheter may comprise a guide structure at least partially extending along the main body of the steering catheter.
  • the distal part is fixed to the guide structure and the proximal part is configured to be movable relative to the guide structure, preferably axially.
  • the guide structure may comprise one or more slides with the proximal part being movable relative to said slides.
  • the slides may be provided as a wire or a flat bar.
  • the distal part may comprise a first abutment surface facing the proximal part, wherein the first abutment surface may be oblique relative to the central axis of the main body of the steering catheter.
  • the first abutment surface may have a circular or elliptical shape.
  • the proximal end may comprise a second abutment surface facing the distal part and being oblique relative to the central axis of the main body.
  • the second abutment surface may have an annular shape. In the closed position, the second abutment surface entirely abuts against the first abutment surface.
  • the working channel may only be provided within the proximal part, i.e., the distal part need not comprise the working channel.
  • the distal part may comprise a centering element extending in the proximal direction.
  • the centering element is configured to be received in a portion of the working channel of the proximal part, at least when the proximal part is in the closed position.
  • the centering element may be cone- shaped, frustrum- shaped, drop-shaped or may have any other suitable shape which facilitates movement of the proximal part into the closed position by inserting the centering element into the working channel during a closing movement, thus guiding the proximal part.
  • the centering element is further configured to guide the guiding catheter from the working channel into the blood vessel.
  • the centering element may be concentric with the central axis of the main body of the steering catheter or may be excentric to the central axis of the main body of the steering catheter.
  • the proximal part may be rotatable relative to the distal part via a swivel joint.
  • the first lumen and/ or the second lumen and/or the third lumen pass through the swivel joint.
  • the distal part may comprise a first abutment surface and the proximal part may comprise a second abutment surface, wherein the first abutment surface abuts the second abutment surface in the closed position so that rotation of the proximal part relative to the distal part is only possible in a direction towards the open position.
  • the abutment surfaces limit the rotation of the proximal part so that the proximal part may not be rotated beyond the closed position.
  • the working channel may be offset from the central axis of the main body.
  • the working channel may also be concentric with the central axis of the main body.
  • the working channel may have a circular cross-sectional shape along its entire length or may have a circular cross-sectional shape only partially along its length.
  • the working channel may also have another cross-sectional shape partially or entirely along its length, e.g., drop shaped, rectangular shaped, half circular shaped, diamond shaped, rhombus shaped, anchor shaped, triangular shaped, shaped as a body of constant width, polygon shaped, Reuleaux polygon shaped, shaped as a circular triangle, shaped as a triangle with rounded corners, shaped as a triangle with rounded corners and curved sides, etc.
  • the working channel may be configured to removably receive a stiffening mandrel.
  • the stiffening mandrel When the blood pump is placed and positioned inside the heart of the human body, the stiffening mandrel can be fully removed and the guide catheter for the intervention can be inserted into the working channel. After the intervention, the guide catheter can be removed and the stiffening mandrel can be readvanced at full length to provide more stability should the patient be relocated and require prolonged pump support beyond the intervention.
  • the stiffening mandrel preferably has a higher stiffness than the guide catheter or the steering catheter.
  • the distal end of the stiffening mandrel may be configured to allow for passage over the exit facilitation device.
  • the stiffening mandrel is configured to not exit the working channel through the opening.
  • the exit facilitation device comprises a spring loaded or biased ramp
  • advancing the stiffening mandrel compresses the ramp so that the stiffening mandrel can be advanced towards the distal end of the steering catheter along the working channel.
  • the stiffening mandrel may have a distal portion having a smaller diameter compared to the remainders of the stiffening mandrel. When the stiffening mandrel is fully advanced through the working channel, the distal portion having the smaller diameter is disposed within the constriction or beyond the constriction.
  • the working channel may extend up to the distal end of the steering catheter or may terminate at the distal end of the lateral opening or may terminate between the distal end of the lateral opening and the distal end of the steering catheter.
  • the working channel may have a low friction surface.
  • the low friction surface may be provided via coating or by disposing an inner liner within the main body of the steering catheter.
  • the low friction surface may comprise a fluorinated polymer.
  • a hemostatic valve may be disposed at the proximal end of the working channel.
  • the hemostatic valve avoids any bleeding through the working channel of the steering catheter in case neither the guide catheter nor the stiffening mandrel is received in the working channel.
  • the hemostatic valve can be configured, for example, as a self-sealing unit (e.g. silicone seal with cross slit, helical slit, etc.) or also as a Tuohy-Borst (screw seal).
  • the steering catheter may have an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
  • the working channel may have an inner diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F.
  • the working channel preferably has an inner diameter which allows to receive a guide catheter having an outer diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F.
  • the guide catheter may have an outer diameter in the range of 5F to 6F.
  • the stiffening mandrel may have an outer diameter in the range of 5F to 6F and a small diameter portion disposed at the distal end of the stiffening mandrel may have an outer diameter being smaller than the outer diameter of the remaining stiffening mandrel, e.g., smaller by at most 2F, preferably smaller by at most 1 F and even more preferably smaller by at most 0,5F.
  • a catheter pump assembly comprises the blood pump described above.
  • the catheter pump assembly may comprise the guide catheter configured to be removably received in the working channel.
  • the catheter pump assembly may comprise the stiffening mandrel configured to be removably received in the working channel.
  • the stiffening mandrel may be a hollow stiffening mandrel.
  • the stiffening mandrel is preferably disposed in the working channel during placement of the blood pump.
  • the catheter pump assembly may also comprise a controller.
  • the motor cable may be connected to the controller.
  • the optical fiber cable may be connected to the controller.
  • FIG. 1 is a schematic representation of a catheter pump assembly comprising a blood pump, which is positioned within the left ventricle of the heart;
  • FIG. 2 shows a schematic representation of a blood pump
  • FIG. 3 is a first side view of a blood pump
  • FIG. 4 is a second side view of a blood pump
  • FIG. 5 is a detailed view of a motor of a blood pump
  • FIG. 6 is a cross section of a blood pump
  • FIG. 7 is another cross section of the blood pump shown in Fig. 6;
  • FIGS. 8a to 8f are cross sections of different embodiments of steering catheters
  • FIG. 9 is a cross section showing a first variant of an exit facilitation device
  • FIG. 10 is a cross section showing a second variant of an exit facilitation device
  • FIG. 11 is a cross section showing a third variant of an exit facilitation device
  • FIG. 12 is a cross section showing a fourth variant of an exit facilitation device
  • FIG. 13 is a cross section through a steering catheter with a closure element according to a first variant
  • FIG. 14 is a cross section through a steering catheter with a closure element and open lateral opening according to a second variant
  • FIG. 15 is a cross section through the steering catheter of FIG. 14 with closed lateral opening
  • FIG. 16 is a cross section through the steering catheters shown in FIGS. 13 to 15;
  • FIG. 17 is a cross section through a steering catheter with a closure element and closed lateral opening according to a third variant
  • FIG. 18 is a cross section through the steering catheter of FIG. 17 with opened lateral opening
  • FIG. 19 is a side view of a steering catheter with a closure element and closed lateral opening according to a fourth variant
  • FIG. 20 is a side view of the steering catheter of FIG. 19 with opened lateral opening;
  • FIG. 21 is a cross section through a steering catheter having a distal part and a proximal part according to a first variant in a closed position;
  • FIG. 22 is a cross section through the steering catheter of FIG. 21 in an opened position;
  • FIG. 23 is a cross section through a steering catheter having a distal part and a proximal part according to a second variant in an opened position;
  • FIG. 24 is a partial cross section through a steering catheter having a distal part and a proximal part according to a third variant in an opened position.
  • Fig. 1 shows the use of a catheter pump assembly 1 comprising a blood pump 10 for supporting, in this particular example, a left ventricle LV of a human heart H.
  • the blood pump 10 is an intravascular blood pump and comprises a steering catheter 12 and a pump section 14 mounted at a distal end 16 of the steering catheter 12.
  • the intravascular blood pump 10 may be placed inside the heart H using a percutaneous, transluminal technique.
  • the intravascular blood pump 10 may be introduced through a femoral artery.
  • alternative vascular access is equally possible, such as access through the subclavian artery.
  • the catheter 12 After passing through the femoral artery, the catheter 12 may be pushed into the aorta such that the pump section 14 reaches through the aortic valve into the heart H.
  • the positioning of the pump section 14 in Fig. 1 serves purely as an example, whereas different placements are possible, such as positioning the pump section 14 inside the right ventricle of the heart H.
  • the steering catheter may have an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
  • the pump section 14 comprises a pump housing 20 and a pump element 22 disposed within the pump housing 20, see, e.g., Figs. 2 to 4.
  • the pump element 22 may be provided in form of an impeller. Rotation of the impeller 22 causes blood to flow from a blood flow inlet 24 at a distal end of the pump section 14 to a blood flow outlet 26 located proximally of the blood flow inlet 24.
  • a flexible atraumatic tip 28 having the form of a pigtail or a J-form is disposed at the distal end of the pump section 14.
  • the atraumatic tip 28 facilitates placement of the intravascular blood pump 10 by aiding navigation inside the patient’s vascular system.
  • the softness of the flexible atraumatic tip 28 allows the pump section 14 to support itself atraumatically against the wall of the left ventricle LV.
  • Figs. 2 to 6 shows the intravascular blood pump 10 in further detail.
  • the impeller 22 is located inside the pump housing 20.
  • both the impeller 22 and the pump housing 20 are compressible, i.e., expandable and collapsible.
  • the intravascular blood pump 10 is transported through the patient’s vascular system while both the impeller 22 and the pump housing 20 are in their compressed state.
  • the pump housing 20 and impeller 22 are expanded.
  • the impeller 22 inside the pump housing 20 is rotated, blood is drawn into the blood flow inlet 24 at the distal end of the pump housing 20 and through the pump housing 20 into a downstream tubing 30, which is attached to the pump housing 20 and extends proximally.
  • the blood is then ejected from the downstream tubing 30 into the aorta through the more proximally located blood flow outlet 26 provided in the downstream tubing 30, the blood flow outlet 26 comprising a plurality of outlet openings.
  • the downstream tubing 30 is made of a flexible material such that it can be compressed by the aortic valve as the patient’s heart is pumping.
  • the downstream tubing 30 is typically expanded mainly due to the active blood flow generated by the impeller 22 during rotation.
  • the intravascular blood pump 10 may support the patient’s systemic blood circulation. If the intravascular blood pump 10 is configured and placed differently, it may be used, e.g., to support the patient’s pulmonary blood circulation instead.
  • an electric motor 32 is provided to rotate the impeller 22.
  • the motor 32 is provided at a proximal end of the pump housing 20 and comprises a rotor 34 and a stator 36 disposed within a motor housing 38.
  • the rotor 34 is coupled to a shaft 40 supported in a proximal bearing 42 and one or more distal bearings 44.
  • the shaft 40 extends into the pump housing 20 and the impeller 22 is provided at a distal end of the shaft 40.
  • the pump housing 20 comprises a plurality of struts 46 with the proximal end of the struts 46 being attached to the motor housing 38. This can be done by, e.g., laser welding.
  • a motor cable 48 is attached to the proximal end of the motor 32 to supply power to the motor 32 and to control the motor 32 in a known manner.
  • a printed circuit board 52 is disposed within the motor housing 38 and the motor cable 48 is attached to the printed circuit board 52.
  • the motor cable 48 is guided within the steering catheter 12 to a controller 50 provided extracorporeally (see Fig. 1), as will be described in more detail below.
  • the motor cable 48 may be a ribbon cable.
  • a purge lumen 54 may be provided which is operatively coupled to the pump section 14 and the motor 32 respectively. The purge lumen 54 is guided within the steering catheter 12 as will be explained in more detail below.
  • the purge fluid applied via the purge lumen 54 flows through the proximal bearing 42 and through the motor housing 38 and exits the motor housing 38 through the distal bearings 44 into the pump housing 20. It shall be noted that purging of the blood pump 10 is optional and depends on the intended application of the blood pump 10, i.e., if it is intended for short time application or for long time application. In the latter case, it is advisable to purge the blood pump 10.
  • the blood pump 10 may further comprise at least one sensor 56.
  • the sensor 56 may be an optical sensor 56 attached to the pump section 14 as exemplarily shown in Fig. 1 .
  • the optical sensor 56 is connected to the controller 50 by an optical fiber cable 58 guided within the steering catheter 12 as will be explained in more detail below.
  • the blood pump 10 may also comprise two or more optical sensors 56 and thus, two or more optical fiber cables 58.
  • the steering catheter 12 is provided as a multi-lumen catheter and comprises an elongated main body 60 extending between the distal end 16 and the proximal end 18 of the steering catheter 12 along a central axis CA.
  • the main body 60 is a tubular main body 60 having a cylindrical shape.
  • a Y-piece 62 is attached to the proximal end 18 of the steering catheter 12, see Fig. 7.
  • a working channel 64 extends within the main body 60 from the proximal end 18 of the steering catheter 12 to the distal end 16 of the steering catheter 12.
  • the working channel 64 further extends through a first arm 72 of the Y-piece 62 up to a proximal end of the first arm 72 of the Y-piece 62.
  • a hemostatic valve 76 is attached to the proximal end of the first arm 72 and hence to the proximal end of the working channel 64.
  • the hemostatic valve 76 may be configured, for example, as a self-sealing unit (e.g. silicone seal with cross slit, helical slit, etc.) or also as a Tuohy-Borst (screw seal).
  • the working channel 64 is configured to removably receive a guide catheter 78 (shown in Fig. 7), a stiffening mandrel 80 (shown in Fig. 6) or a closure element 108 (shown in Figs. 13 to 15).
  • the guide catheter 78, the stiffening mandrel 80 or the closure element 108 may be advanced through the working channel 64 via the hemostatic valve 76.
  • the hemostatic valve 76 inhibits bleeding in case neither the guide catheter 78 nor the stiffening mandrel 80 nor the closure element 108 are received in the working channel 64 when the blood pump 10 is already placed in the heart H.
  • the stiffening mandrel 80 is preferably a hollow stiffening mandrel 80 and is intended to increase the stability of the blood pump 10, e.g., in case the patient is to be relocated or requires prolonged pump support beyond the intervention.
  • the stiffening mandrel 80 may thus be configured to be advanced close to the distal end 16 of the steering catheter 12.
  • the guide catheter 78 may be a 5F to 6F guide catheter 78 so that the working channel 64 has an inner diameter of at least 5F. Accordingly, the stiffening mandrel 80 may also be a 5F to 6F stiffening mandrel 80.
  • the steering catheter 12 further comprises a hosting arrangement 82 configured to host cables and purge lumens, preferably separate from the working channel 64.
  • the hosting arrangement 82 comprises at least one lumen 66, 68, 70 which is separated from the working channel 64.
  • the hosting arrangement 82 may comprise up to three lumens 66, 68, 70, see for instance Fig. 8e.
  • the steering catheter 12 may comprise a total of four lumens, namely the working channel 64, a first lumen 66, a second lumen 68 and a third lumen 70.
  • the steering catheter 12 may also comprise more or less than four lumens.
  • the hosting arrangement 82 may also comprise at least one recess (not shown) on an outer peripheral surface of the main body 60.
  • the at least one recess may be configured to host cables and purge lumens.
  • the hosting arrangement 82 may also be configured to host cables and purge lumens in that said cables and purge lumens are embedded in a side wall of the main body 60 or the steering catheter 12 respectively (not shown).
  • the lumens 66, 68, 70 of the hosting arrangement 82 extend from the proximal end 18 of the steering catheter 12 nearly up to the distal end 16 of the steering catheter 12 in this exemplary embodiment.
  • the lumens 66, 68, 70 are configured to receive the motor cable 48, the purge lumen 54 and the optical fiber cable 58. However, it is not necessary that each of the motor cable 48, the purge lumen 54 and the optical fiber cable 58 are received separately in one of the lumens 66, 68, 70 of the hosting arrangement 82. Rather, it possible that the hosting arrangement 82, for instance, comprises only one first lumen 66 with the motor cable 48, the purge lumen 54 and the optical fiber cable 58 being received in the first lumen 66.
  • the hosting arrangement 82 comprises a first lumen 66 and a second lumen 68 with, for instance, the motor cable 48 and the optical fiber cable 58 being received in the first lumen 66 and the purge lumen 54 being received in the second lumen 68.
  • the motor cable 48 may be received in the first lumen 66 and the optical fiber cable 58 may be received in the second lumen 68.
  • the purge lumen 54 is a lumen 66, 68, 70 of the hosting arrangement 82.
  • the motor cable 48, the optical fiber cable 58 and the purge lumen 54 exit the respective lumen 66, 68, 70 of the hosting arrangement 82 at the proximal end 18 of the steering catheter 12.
  • the motor cable 48, the optical fiber cable 58 and the purge lumen 54 are routed along a second arm 74 of the Y-piece 62 to the proximal end of the second arm 74 of the Y-piece 62, where they exit the Y-piece to be connected to the appropriate device, e.g., the controller 50.
  • the hosting arrangement 82 may also extend from the proximal end 18 of the steering catheter 12 to the proximal end of the second arm 74 of the Y-piece 62.
  • the second arm 74 of the Y-piece 62 may comprise a barrier to inhibit bleeding through the second arm 74 of the Y-piece 62.
  • the barrier may be provided at the distal end of the second arm 74 of the Y-piece 62.
  • the Y-piece 62 may also be disposed in a handle of the blood pump 10 or catheter pump assembly 1 respectively.
  • the hosting arrangement 82 terminates adjacent or in close proximity to the distal end 16 of the steering catheter 12, where the motor cable 48, the optical fiber cable 58 and the purge lumen 54 enter the working channel 64.
  • the motor cable 48, the optical fiber cable 58 and the purge lumen 54 are then routed to the distal end 16 of the steering catheter 12.
  • the lumen 66, 68, 70 of the hosting arrangement 82 and the working channel 64 may have different geometrical shapes. Different variants are shown in Figs. 8a to 8f as cross sections through the steering catheter 12. It has to be noted that the variants shown in Figs. 8a to 8f are not limiting and may be combined between the different variants.
  • Fig. 8a shows a first variant with the working channel 64 having a circular cross section and being offset relative to the central axis CA of the main body 60 of the steering catheter 12.
  • the hosting arrangement 82 comprises a first lumen 66 and a second lumen 68.
  • the first lumen 66 has a circular cross section and the second lumen 68 has a rectangular cross section.
  • Fig. 8b shows a second variant with the working channel 64 having a circular cross section and being concentric with the central axis CA of the main body 60 of the steering catheter 12.
  • the hosting arrangement 82 comprises a first lumen 66, a second lumen 68 and a third lumen 70.
  • the first lumen 66 has a circular cross section
  • the second lumen 68 has a circular cross section
  • the third lumen 70 has a circular cross section.
  • the first lumen 66, the second lumen 68 and the third lumen 70 may be evenly distributed around the working channel 64 within the main body 60 of the steering catheter 12 or may be consolidated in a portion of the steering catheter 12, as shown in Fig. 8b.
  • the working channel 64 does not have a circular cross section, but has a circular main shape with two opposing bulges.
  • the working channel 64 is offset relative to the central axis CA of the main body 60 of the steering catheter 12.
  • the hosting arrangement 82 comprises a first lumen 66 and a second lumen 68.
  • the first lumen 66 and the second lumen 68 have a quarter-circular shaped or kidney-shaped cross section.
  • Fig. 8d shows a variant with the working channel 64 having a circular cross section and being concentric with the central axis CA of the main body 60 of the steering catheter 12.
  • the hosting arrangement 82 comprises only a first lumen 66 having a half-circular shaped cross section.
  • the working channel 64 has a circular cross section and is concentric with the central axis CA of the main body 60 of the steering catheter 12.
  • the hosting arrangement 82 comprises a first lumen 66, a second lumen 68 and a third lumen 70.
  • the first lumen 66 has a third of a circle, circular arc or kidney-shaped cross section
  • the second lumen 68 has a third of a circle, circular arc or kidney-shaped cross section
  • the third lumen 70 has a third of a circle, circular arc or kidney-shaped cross section.
  • the first lumen 66, the second lumen 68 and the third lumen 70 may be evenly distributed around the working channel 64 within the main body 60 of the steering catheter 12.
  • the working channel 64 has a triangular cross section with rounded edges and with curved sides and is concentric with the central axis CA of the main body 60 of the steering catheter 12.
  • the hosting arrangement 82 comprises a first lumen 66, a second lumen 68 and a third lumen 70.
  • the first lumen 66 has a quarter-circular, circular arc or kidney-shaped cross section
  • the second lumen 68 has a quarter-circular, circular arc or kidney-shaped cross section
  • the third lumen 70 has a quarter-circular, circular arc or kidney-shaped cross section.
  • the first lumen 66, the second lumen 68 and the third lumen 70 may be evenly distributed around the working channel 64 within the main body 60 of the steering catheter 12.
  • the steering catheter 12 comprises a lateral opening 84 disposed between the distal end 16 of the steering catheter 12 and the proximal end 18 of the steering catheter 12.
  • the lateral opening 84 is a longitudinal opening and has a drop shape.
  • the lateral opening 84 penetrates a side wall of the catheter 12 or main body 60 respectively and connects the working channel 64 with an environment surrounding the steering catheter 12.
  • the lateral opening 84 is disposed at a certain distance from the proximal end 18 of the steering catheter 12 so that it is located within the artery when the blood pump 10 is placed or in the process of being placed in the human body.
  • a marker 86 may be provided which allows to track the correct position of the lateral opening 84 by an imaging procedure.
  • the marker 86 may be a radiopaque marker and may be provided at the outer circumference of the main body 60 adjacent to the proximal end of the lateral opening 84.
  • the marker 86 may also be provided elsewhere, e.g., at the distal end of the lateral opening 84 or embedded in the main body 60 of the steering catheter 12.
  • the lateral opening 84 is configured so that the guide catheter 78 received in the working channel 64 can exit the steering catheter 12 through the lateral opening 84 so that the guide catheter 78 can be advanced and positioned independently of the blood pump 10 and the steering catheter 12 to reach the ostia of the coronary arteries, see Fig. 3, where the guide catheter 78 is denoted in dashed lines. Any hemodynamically supported procedure can then be performed through the guide catheter 78.
  • an inner peripheral surface 116 of the working channel 64 may be a low friction surface, e.g., by providing an inner liner or a coating reducing the friction, for instance composed of fluorinated polymers.
  • An exit facilitation device 88 may be provided in the region of the lateral opening 84.
  • the exit facilitation device 88 aids the exit of the guide catheter 78 through the lateral opening 84 when the guide catheter 78 is advanced along the working channel 64.
  • Fig. 9 depicts a first variant of an exit facilitation device 88.
  • the exit facilitation device 88 comprises a ramp 90 disposed in the working channel 64 opposite to the distal end of the lateral opening 84.
  • the ramp 90 comprises a first ramp part 92 and a second ramp part 94.
  • the second ramp part 94 is disposed between the first ramp part 92 and the inner peripheral surface 116 of the working channel 64.
  • the second ramp part 94 is made of an elastic material so that it biases the first ramp part 92 away from the inner peripheral surface 116 of the working channel 64 toward the lateral opening 84.
  • the guide catheter 78 is advanced along the working channel 64, it is deflected by the ramp 90 in a direction towards the lateral opening 84.
  • the guide catheter 78 may not overcome the biasing force of the second ramp part 94 and may thus not be advanced beyond the ramp 90 in a direction towards the distal end 16 of the steering catheter 12. If, however, the stiffening mandrel 80 is advanced along the working channel 64, the higher stiffness of the stiffening mandrel 80 is sufficient to overcome the biasing force of the second ramp part 94 so that the ramp 90 is compressed by the stiffening mandrel 80. The stiffening mandrel 80 can thus be advanced beyond the ramp 90 in the working channel 64. When the stiffening mandrel 80 is removed, the biasing force of the second ramp part 94 causes the ramp 90 to erect again.
  • Fig. 10 depicts a second variant of an exit facilitation device 88.
  • the exit facilitation device 88 comprises a constriction 96 minimizing the inner diameter of the working channel 64 beyond the lateral opening 84 in a direction of the distal end 16 of the steering catheter 12.
  • the constriction 96 may be provided locally in the area of the distal end of the lateral opening 84, or may extend a certain length in a direction towards the distal end 16 of the steering catheter 12.
  • the constriction 96 deflects the guide catheter 78 towards the lateral opening 84, whereas the stiffening mandrel 80 is configured to pass along the constriction 96.
  • the stiffening mandrel 80 may comprise a distal portion having a reduced diameter compared to the remainders of the stiffening mandrel 80.
  • the distal portion of the stiffening mandrel 80 is disposed within the constriction 96.
  • the constriction 96 constitutes an abutment for the stiffening mandrel 80 so that the stiffening mandrel 80 cannot be advanced further.
  • Fig. 11 depicts a third variant of an exit facilitation device 88.
  • the exit facilitation device 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 main body 60, whereas the second portion 102 is offset from the central axis CA of the main body 60.
  • a ramp 104 is provided connecting the first portion 100 and the second portion 102. The ramp 104 and the diameter change between the first portion 100 and the second portion 102 deflect the guide catheter 78 towards the lateral opening 84, whereas the stiffening mandrel 80 is configured to pass along into the second portion 102.
  • the stiffening mandrel 80 may comprise a distal portion having a reduced diameter compared to the remainders of the stiffening mandrel 80 and being not concentric with the remainders of the stiffening mandrel 80.
  • the distal portion of the stiffening mandrel 80 is disposed within the second portion 102.
  • Fig. 12 depicts a fourth variant of an exit facilitation device 88.
  • the exit facilitation device 88 comprises a ramp 106 which completely closes the working channel 64.
  • the working channel 64 terminates with the ramp 106 in the area of the lateral opening 84.
  • a guide catheter 78 advanced through the working channel 64 is thus deflected towards the lateral opening 84 and may exit the main body 60 of the steering catheter 12 through the lateral opening 84. Therefore, the portion of the main body 60 of the steering catheter 12 located distally of the lateral opening 84 is sufficiently stiff.
  • said stiffening mandrel 80 is only advanced through the working channel 64 up to the ramp 106.
  • the lateral opening 84 may be closed to avoid that an exposed edge of the lateral opening 84 gets stuck, e.g., in the access port or an introducer 98. Therefore, the closure element 108 may be provided which seals the lateral opening 84.
  • FIG. 13 A cross section through a steering catheter 12 with a closure element 108 according to a first variant is shown in Fig. 13.
  • the closure element 108 comprises an elongated main body 110 and a plug 112 disposed on a distal end of the elongated main body 110.
  • the plug 112 is disposed on an outer peripheral surface of the elongated main body 110 and protrudes radially outwardly from the elongated main body 110.
  • the plug 112 is shaped and sized to virtually correspond to the shape and size of the lateral opening 84.
  • the working channel 64 is configured to receive the closure element 108 so that the closure element 108 may be advanced through the working channel 64 until the plug 112 snaps into the lateral opening 84 and thereby closes or seals the lateral opening 84.
  • the closing element 108 also provides stiffness to the steering catheter 12 comparable to a stiffening mandrel 80 as discussed above.
  • the working channel 64 is open distally of the lateral opening 84. However, the working channel 64 may also terminate in the area of the lateral opening 84 as shown in Fig. 12.
  • the closure element 108 is axially moved in the proximal direction within the working channel 64. Thereby, the plug 108 is released from the lateral opening 84.
  • the closure element 108 is removed from the steering catheter 12 and, e.g., the guide catheter 78 may be introduced through the working channel 64 and may exit the main body 60 of the steering catheter 12 via the lateral opening 84.
  • the elongated main body 110 of the closure element 108 may have a diameter of, e.g., 5F or 6F.
  • FIG. 14 A second variant of a closure element 108 is shown in Figs. 14 and 15.
  • the plug 112 is disposed on a distal end surface of the elongated main body 110 of the closure element 108.
  • a collar portion 114 is formed on the distal end surface of the elongated main body 110 surrounding the plug 112.
  • the collar portion 114 completely surrounds the plug 112, but the collar portion 114 and the plug 112 may be formed differently.
  • the plug 112 may be provided eccentrically relative to a main axis of the elongated main body 110 thereby forming an only partially circumferential collar portion 114.
  • the working channel 64 terminates at the lateral opening 84 and an exit facilitation device 88 with a ramp 106 is provided, similar to that shown in Fig. 12.
  • the working channel 64 and the closure element 108 may have a matching cross-sectional shape allowing for only one orientation, see Fig. 16.
  • the working channel 64 is drop- shaped, but it may also have other shapes, e.g., circular with a notch or the like.
  • Figs. 17 and 18 depict a cross section through a steering catheter 12 with a closure element 118 according to a third variant.
  • the closure element 118 in this exemplary embodiment is a tubular closure element 118 disposed about the outer peripheral surface of the main body 60 of the steering catheter 12.
  • the closure element 118 comprises a passage opening 120 and is axially movable relative to the main body 60 of the steering catheter 12.
  • the tubular closure element 118 is axially moved until the passage opening 120 overlaps with the lateral opening 84, thereby creating a passageway to the working channel 64, see Fig. 18 showing a fully opened lateral opening 84.
  • the passage opening 120 is sized and configured to fully expose the lateral opening 84 when overlapping with the lateral opening 84.
  • the tubular closure element 118 has a distinctly smaller radial thickness compared to the main body 60 of the steering catheter 12, the exposed edge of the passage opening 120 is hardly getting stuck.
  • an exit facilitation device 88 may also be provided with the embodiment shown in Figs. 17 and 18.
  • Figs. 19 and 20 depict a cross section through a steering catheter 12 with a closure element 122 according to a fourth variant.
  • the closure element 122 is provided as a tubular closure element 122 and it comprises a passage opening 120 similar to the one shown in Figs. 17 and 18.
  • the tubular closure element 122 is rotatably disposed about the main body 60 of the steering catheter. By rotating the tubular closure element 122 relative to the main body 60 of the steering catheter 12, the passage opening 120 can be brought into an overlap with the lateral opening 84 (shown in dashed lines in Fig. 19) to create the passageway to the working channel 84.
  • the tubular closure element 122 need not extend up to the distal end 16 of the steering catheter 12, but may terminate distally slightly after the lateral opening 84.
  • the outer diameter of the main body 60 of the steering catheter may have a stepped configuration, i.e. it may increase distally of the tubular closure element 122.
  • the smaller diameter portion of the main body 60 is shown in dashed lines. This results in a flush outer surface of the steering catheter 12 and avoids an exposed and circumferential edge of the tubular closure element 122.
  • Figs. 20 and 21 depict a cross section through a steering catheter 12 with the main body 60 being divided into a distal part 124 and a proximal part 126.
  • the distal part 126 does not comprise the working channel 64 in this exemplary embodiment.
  • the distal part 126 comprises an elliptical first abutment surface 128 facing the proximal part 126.
  • the first abutment surface 128 is oblique relative to the central axis CA of the main body 60.
  • the proximal part 128 comprises an annular second abutment surface 130 facing the distal part 124.
  • the second abutment surface 130 is also oblique relative to the central axis CA of the main body 60.
  • the main body 60 of the steering catheter 12 further comprises a guide structure 132 fixed to the distal part 124.
  • the proximal part 126 is configured to be movable relative to the guide structure 132 and, hence, also relative to the distal part 124.
  • the guide structure 132 comprises two rails which extend along the main body 60 so that a physician may move the distal part 126 relative to the rails of the guide structure 132.
  • the guide structure 132 is at least partially embedded in a side wall of the main body 60 of the steering catheter 12.
  • the proximal part 126 can be moved between a closed position (see Fig. 21) and an opened position (see Fig. 22). In the closed position, the annular second abutment surface 130 entirely abuts the first abutment surface 128 thereby sealing or closing the working channel 64.
  • the physician moves the proximal part 126 axially relative to the guide structure 132 and the distal part 124 into the opened 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 steering catheter 12.
  • the guide catheter 78 may then be advanced through the working channel 64, whereby the oblique first abutment surface 128 acts like an exit facilitation device as described above.
  • the guide catheter 78 is deflected by the oblique first abutment surface 128 so that it can exit the working channel 64 in a direction away from the main body 60 of the steering catheter 12.
  • the distal part 128 may comprise a centering element 134 protruding from the first abutment surface 128 in a direction towards the proximal part 126.
  • a centering element 134 protruding from the first abutment surface 128 in a direction towards the proximal part 126.
  • the centering element 134 is cylindrically shaped with a spherical end.
  • Other shapes for the centering element 134 are of course also possible, e.g., a conical shape or a frustoconical shape.
  • the centering element 134 may be concentric or excentric to the central axis CA.
  • the centering element 134 When the proximal part 126 is moved from the opened position (shown in Fig. 23) to the closed position, the centering element 134 enters the working channel 64. Due to the increasing diameter of the centering element 134 in the distal direction, a misalignment (e.g., due to a slightly bended guiding structure 132) is corrected. Preferably, the largest diameter of the centering element virtually corresponds to the inner diameter of the working channel 64.
  • the first abutment surface 128 and the second abutment surface 130 may also be oblique as shown in Figs. 21 and 22.
  • the centering element 134 also establishes a guiding function for a guide catheter 78 so that it can exit the working channel 64 in a direction away from the main body 60 of the steering catheter 12.
  • Fig. 24 depicts a third variant of a steering catheter 12 with a main body 60 having a distal part 124 and a proximal part 126 as a partial cross section (i.e., only the proximal part 126 is shown as a section).
  • the proximal part 126 is rotatably coupled to the distal part 124 via a swivel joint 136.
  • the distal part 124 comprises a first abutment surface 128 and the proximal part comprises a second abutment surface 130. In the closed position, the second abutment surface 130 abuts the first abutment surface 128 thereby limiting a rotation beyond the closed position.
  • the lumens 66 to 70 (if provided) run through the swivel joint 136.
  • the proximal part 126 is rotated relative to the distal part 124 in the opened position shown in Fig. 24.
  • the working channel 64 is fully exposed so that the guide catheter 78 advanced through the working channel 64 can easily exit the working channel 64.
  • a single introducer 98 may be used, see Fig. 2.
  • the introducer 98 may be a small diameter introducer having a diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
  • the steering catheter 12 has a diameter of at most 10F and the pump section 14 has a diameter of at most 10F in the collapsed state
  • usage of a single introducer 98 with a small diameter is possible.
  • the pump section 14 is advanced with the stiffening mandrel 80 or the closure element 108 being received in the working channel 64.
  • the stiffening mandrel 80 or the closure element 108 is removed from the working channel 64 through the hemostatic valve 76.
  • the closure element 118, 122 is moved respectively to create the passageway to the working channel 64.
  • the proximal part 126 is moved relative to the distal part 124 in the opened position to expose and open the working channel 64.
  • the guide catheter 78 is introduced through the hemostatic valve 76. The guide catheter 78 is advanced along the working channel 64 and exits the steering catheter 12 via the lateral opening 84 or the opened working channel 64 to allow for hemodynamically supported procedures.
  • the guide catheter 78 may be removed again and the stiffening mandrel 80 or the closure element 108 may be again introduced to increase the stability of the blood pump 10.
  • the closure element 118, 122 is moved again to seal the lateral opening 84.
  • the proximal part 126 is moved relative to the distal part 124 in the closed position to close the working channel 64 again.
  • A1 Blood pump comprising: a steering catheter and a pump section, the pump section being configured to be placed in a human body and comprising a pump housing, a pump element disposed within the pump housing, and an electric motor configured to rotate the pump element,
  • the steering catheter comprising: a distal end and a proximal end, wherein the pump section is coupled to the distal end of the steering catheter, the steering catheter further comprising: an elongated main body extending between the distal end and the proximal end along a central axis, a working channel at least partially extending within the main body from the proximal end of the steering catheter in a direction of the distal end of the steering catheter, the working channel being configured to removably receive a guide catheter.
  • the blood pump further comprises a motor cable coupled to the 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 purge lumen (54) coupled to the pump section.
  • the main body comprises a hosting arrangement separated from the working channel, the hosting arrangement at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter
  • the hosting arrangement comprises a first lumen
  • A12 Blood pump according to paragraph A10 or A11 wherein at least one of the motor cable, the optical fiber cable and the purge lumen is disposed within the first lumen.
  • A18 Blood pump according to paragraph A16 or A17 wherein at least one of the motor cable, the optical fiber cable and the purge lumen is not disposed in the first lumen and is received in the second lumen.
  • the hosting arrangement comprises a third lumen.
  • the third lumen at least partially extends between the distal end of the steering catheter and the proximal end of the steering catheter.
  • A28 Blood pump according to any one of the preceding paragraphs, wherein the steering catheter comprises a lateral opening.
  • closure element is a tubular closure element at least partially disposed about an outer peripheral surface of the main body of the steering catheter.
  • tubular closure element comprises a passage opening extending through a side wall of the tubular closure element.
  • A46 Blood pump according to paragraph A45 wherein the passage opening is sized and configured to create a passageway to the working channel when the passage opening is brought into at least partial overlap with the lateral opening by movement of the tubular closure element relative to the main body of the steering catheter.
  • A60 Blood pump according to paragraph A58 or A59 wherein wherein the constriction minimizes the inner diameter of the working channel beyond the lateral opening in a direction of the distal end of the steering catheter.
  • the exit facilitation device 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 is concentric with the central axis (of the main body of the steering catheter.
  • the proximal part is movable relative to the distal part between a closed position and an opened position.
  • A67 Blood pump according to paragraph A66 wherein the working channel is sealed when the proximal part is in the closed position, and wherein the working channel is open when the proximal part is in the opened position.
  • A73 Blood pump according to paragraph A72 wherein the centering element extends in the proximal direction.
  • A84 Blood pump according to any one of the preceding paragraphs, wherein the working channel is configured to removable receive a stiffening mandrel.
  • A86 Blood pump according to any one of the preceding paragaphs wherein the working channel extends up to a lateral opening of the steering catheter.
  • A88 Blood pump according to any one of the preceding paragraphs, wherein a hemostatic valve is disposed at the proximal end of the working channel.
  • the steering catheter has an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
  • A90 Blood pump according to any one of the preceding paragraphs, wherein the working channel has an inner diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F.
  • B1 Catheter pump assembly comprising a blood pump according to any one of the preceding paragraphs A1 to A90.

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Abstract

The present invention relates to a blood pump (10) comprising a steering catheter (12) and a pump section (14). The pump section (14) is configured to be placed in a human body and comprises an expandable and collapsible pump housing (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 steering catheter (12) comprises a distal end (16) and a proximal end (18), wherein the pump section (14) is coupled to the distal end (16) of the steering catheter (12).The steering catheter (12) further comprises an elongated main body (60) extending between the distal end (16) and the proximal end (18) along a central axis, a working channel (64) at least partially extending within the main 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

Blood pump and catheter pump assembly
The present invention relates to a blood pump, preferably to an intravascular blood pump. The present invention in particular relates to a percutaneously insertable blood pump for supporting blood circulation in humans or optionally also in animals. For instance, the blood pump may be designed to be inserted percutaneously into a femoral artery of a patient and guided through the patient’s vascular system in order, for example, to support or replace the pumping action of the heart. The present invention further relates to a catheter pump assembly comprising such a blood pump.
BACKGROUND
Such blood pumps may be introduced into a patient either surgically or percutaneously and are used to deliver blood from one location in the heart or circulatory system to another location in the heart or circulatory system. For example, when deployed in the left heart, an intravascular blood pump may pump blood from the left ventricle of the heart into the aorta. Likewise, when deployed in the right heart, an intravascular blood pump may pump blood from the inferior vena cava into the pulmonary artery. Intravascular blood pumps may be powered by a motor located outside of the patient's body via an elongated drive shaft or by an onboard motor located inside the patient's body. Some intravascular blood pump systems may operate in parallel with the native heart to supplement cardiac output and partially or fully unload components of the heart.
The present invention will be described in the context of a blood pump having an expandable and collapsible pump housing, in which an expandable and collapsible pump element is housed driven by a motor, the present invention is also applicable in other types of intravascular blood pumps.
A blood pump of the aforementioned expandable type is known, e.g., from EP 3 858 398 A1 , which discloses a catheter pump assembly. An expandable and collapsible pump housing is disposed at a distal end of a steering catheter. The expandable and collapsible pump housing surrounds an expandable and collapsible pump element driven by a motor. The pump element may be an expandable and collapsible pump element. The distal portion of the catheter pump assembly may be placed inside the heart via a percutaneous access using the Seidinger technique, for example.
Herein, "proximal" and "distal" are seen relative to the physician. Thus, “proximal” designates something which is relatively close to the physician whereas “distal” designates something which is relatively far away from the physician when the catheter is placed. During intervention of the blood pumps, a guide catheter is used to conduct hemodynamically supported procedures. For known blood pumps having a non-collapsible pump section, a comparably large diameter introducer is used, having a diameter of 14F (French) or more to allow the pump section to be introduced. As the steering catheter usually has a smaller diameter than the pump section, such an introducer with a large diameter allows the catheter pump assembly and the guide catheter to be introduced side by side through the introducer. During insertion of an intravascular blood pump, it is preferable for the catheter pump assembly to be as small as possible as this allows for a better maneuverability of the intravascular blood pump through the patient’s vasculature. The latter is a major advantage of an expandable and collapsible pump section, as the diameter thereof is about 10F in the collapsed state. This is also advantageous, as it is preferred to use a small diameter introducer having a diameter of 11 F or less, preferably of 10F or only of 9F.
However, it is preferable to use only a single access port into the human body instead of two or more access ports, to reduce bleeding and complications that may occur. While expandable and collapsible pumps allow for a small diameter introducer, it is not possible to use the same small diameter introducer for introducing the catheter pump assembly and the guide catheter side by side.
Hence, it is an object of the invention to provide a blood pump having a collapsible and expandable pump section allowing for a single small diameter access port into the human body.
SUMMARY OF THE INVENTION
According to a first aspect, a blood pump may comprise a steering catheter and a pump section. The pump section may be configured to be placed in a human body. The pump section may comprise an expandable and collapsible pump housing, an expandable and collapsible pump element disposed within the pump housing and an electric motor configured to rotate the pump element. The steering catheter may comprise a distal end and a proximal end, wherein the pump section may be coupled to a distal end of the steering catheter. The steering catheter may further comprise an elongated main body extending between the distal end and the proximal end along a central axis, a working channel at least partially extending within the main body from the proximal end of the steering catheter in a direction of the distal end of the steering catheter. The working channel may be configured to removably receive a guide catheter. It has to be noted that the main body of the steering catheter does not need to extend up to the proximal end or the distal end of the steering catheter, but may only constitute a portion of the steering catheter.
Thus, the guide catheter is not running side by side with the steering catheter, but is at least partially received within the working channel of the steering catheter. Hence, a single small diameter introducer having a diameter of 11 F or less may be used to place the blood pump and a guide catheter into the vasculature of a patient. Preferably, the guide 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 steering catheter or may only partially extend along the steering catheter.
The motor may be disposed at a proximal end of the pump housing. The motor may comprise a motor housing, a rotor and a stator. The rotor and the stator may be disposed within the motor housing. The motor housing may have an outer diameter which is smaller, equal to or larger than an outer diameter of the steering catheter. Preferably, the motor housing has an outer diameter of at most 12F, preferably of at most 11 F. Even more preferably, the motor housing has an outer diameter of at most 10F. The distal end of the steering catheter may be attached to the motor housing. The pump section may have an outer diameter in the collapsed or compressed state of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
Preferably, the steering catheter has a tubular shape. The steering catheter may have a cylindrical shape. The central axis of the main body may be concentric with a longitudinal axis of the steering catheter.
Preferably, the main body comprises a hosting arrangement separated from the working channel. The hosting arrangement may at least partially extend between the distal end of the steering catheter and the proximal end of the steering catheter. The blood pump may further comprise a motor cable coupled to the motor. The blood pump may further comprise at least one optical sensor and at least one optical fiber cable coupled to the optical sensor. The blood pump may further comprise a purge lumen coupled to the pump section. The hosting arrangement may be configured to receive at least one of the motor cable, the optical fiber cable and the purge lumen. As the hosting arrangement is spatially separated from the working channel, any element received in the hosting arrangement is not interfering with the guide catheter being received in the working channel.
The motor cable may comprise a plurality of wires. The plurality of wires may be disposed next to each other or the plurality of wires may be stacked. The motor cable may be a ribbon cable.
The at least one optical sensor may be disposed at the pump section. Further optical sensors may also be used and may be disposed, e.g., at the motor housing or the steering catheter. The purge lumen may be coupled to the motor housing.
Preferably, the motor cable does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. Preferably, the motor cable runs separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. Preferably, the at least one optical fiber cable does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. Preferably, the at least one optical fiber cable runs separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. Preferably, the purge lumen does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. Preferably, the purge lumen runs separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
The hosting arrangement may comprise a first lumen at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter. At least one of the motor cable, the optical fiber cable and the purge lumen is disposed within the first lumen. Thus, the steering catheter may be a multi-lumen catheter comprising the working channel and a first lumen separated from the working channel.
The first lumen may be offset from the central axis of the main body. The first lumen may be provided so that it does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. The first lumen may extend along the entire length of the steering catheter, i.e., from the proximal end of the steering catheter to the distal end of the steering catheter. The first lumen may extend only partially along the main body and it does not need to terminate at the distal end of the steering catheter and/ or the proximal end of the steering catheter. The first lumen may have a circular cross section. The first lumen may also have another cross- sectional shape such as a sickle-shape, quarter-circular shape, half-circular shape, C-shape, rectangular shape, curved rectangular shape, triangular shape, etc.
The hosting arrangement may comprise a second lumen at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter. At least one of the motor cable, the optical fiber cable and the purge lumen may not be disposed within the first lumen but may be received in the second lumen. Thus, the steering catheter may be a multi-lumen catheter comprising the working channel, a first lumen separated from the working channel and a second lumen separated from the working channel.
The second lumen may be offset from the central axis of the main body. The second lumen may be provided so that it does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. The second lumen may extend along the entire length of the steering catheter, i.e., from the proximal end of the steering catheter to the distal end of the steering catheter. The second lumen may extend only partially along the main body and it does not need to terminate at the distal end of the steering catheter and/ or the proximal end of the steering catheter. The second lumen may have a circular cross section. The second lumen may also have another cross-sectional shape such as a sickle-shape, quarter-circular shape, half-circular shape, C- shape, rectangular shape, curved rectangular shape, triangular shape, etc.
The hosting arrangement may comprise a third lumen at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter. The motor cable may be disposed within the first lumen. The optical fiber cable may be disposed within the second lumen and the purge lumen may be disposed within the third lumen or the purge lumen may be the third lumen. Of course, the purge lumen may also be the first lumen or the second lumen.
The third lumen may be offset from the central axis of the main body. The third lumen may be provided so that it does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. The third lumen may extend along the entire length of the steering catheter, i.e., from the proximal end of the steering catheter to the distal end of the steering catheter. The third lumen may extend only partially along the main body and it does not need to terminate at the distal end of the steering catheter and/ or the proximal end of the steering catheter. The third lumen may have a circular cross section. The first lumen may also have another cross-sectional shape such as a sickle-shape, quarter-circular shape, half-circular shape, C-shape, rectangular shape, curved rectangular shape, triangular shape, etc.
Thus, the hosting arrangement of the steering catheter may comprise one or more lumens which are separated from the working channel so that there is no interference between the one or more lumens and the working channel.
The hosting arrangement may also comprise at least one recess provided on an outer surface of the main body of the steering catheter. The at least one recess may be configured to receive at least one of the motor cable, the optical fiber cable and the purge lumen. The hosting arrangement may comprise a combination of lumen and recess. The recess may be filed with a resin material after the respective one or more of the motor cable, the optical fiber cable and the purge lumen are received in the respective recess.
The first to third lumen of the hosting arrangement may also be created by embedding the respective ones of the motor cable, the optical fiber cable and the purge lumen in the main body of the steering catheter, i.e., by embedding into a wall of the steering catheter.
Preferably, the steering catheter comprises a lateral opening extending through a side wall of the main body. The lateral opening may be connected to the working channel and may be configured so that a guide catheter can exit the main body through the lateral opening. The lateral opening may be a longitudinal opening. The lateral opening may be drop shaped. The lateral opening may penetrate a side wall of the steering catheter. The lateral opening may be provided at a certain distance from the proximal end of the steering catheter. The guide catheter can therefore be advanced and positioned independently of the blood pump or the pump section respectively within the steering catheter to reach the ostia of the coronary arteries. Any hemodynamically supported procedure can then be performed through the guide catheter.
The blood pump may further comprise 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 desired by the physician. Sealing the lateral opening may be advantageous for introducing the steering catheter through the access port. A non-sealed (i.e., open) lateral opening has an exposed edge because it penetrates the side wall of the main body of the steering catheter. 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.
The closure element may be movable relative to the steering catheter, wherein a movement of the closure element relative to the steering catheter selectively opens and closes the lateral opening. The physician may manually move the closure element relative to the steering catheter to decide when to open and when to close the lateral opening. The closure element may be configured to be axially movable relative to the steering catheter.
Preferably, the working channel is configured to selectively receive the closure element. In advancing or retracting the closure element in the working channel, the lateral opening may be closed or opened.
The closure element may comprise an elongated main body and a plug disposed on the main body of the closure element. The plug may be configured to seal the lateral opening when the closure element is received in the working channel. The plug may be disposed at a distal end of the elongated main body of the closure element. Preferably, the plug has a size and shape that corresponds to the size and shape of the lateral opening so that the plug is preferably entirely received in the lateral opening for closing the lateral opening.
The elongated main body may comprise a collar portion at its distal end. The collar portion may be configured to abut an inner peripheral surface of the working channel adjacent to the lateral opening. Accordingly, the collar portion abuts the inner peripheral surface when the plug is properly disposed in the lateral opening which inhibits further advancement of the closure element relative to the steering catheter. Hence, it can be avoided that the plug and/ or the elongated main body of the closure element are pushed too far and partially exit through the lateral opening into the blood vessel.
The closure element may alternatively be configured as a tubular closure element being at least partially disposed about an outer peripheral surface of the main body of the steering catheter. The tubular closure element may be movable relative to the main body of the steering catheter. The tubular closure element may comprise a passage opening extending through a side wall of the tubular closure element. The passage opening may be sized and configured to create a passageway to the working channel when the passage opening is brought into at least partial overlap with the lateral opening by movement of the tubular closure element relative to the main body of the steering catheter. Thus, the working channel is only connected to the environment surrounding the steering catheter when the passage opening at least partially overlaps with the lateral opening. To close the lateral opening, the tubular closure element is moved so that the passage opening does not overlap with the later opening and the tubular closure element seals the lateral opening.
The tubular closure element may be configured to be axially movable relative to the main body of the steering catheter. The tubular closure element may additionally or alternatively be configured to be rotatable relative to the main body of the steering catheter. The tubular closure element may be disposed on the main body of the steering catheter so that an edge- free outer surface is achieved.
The steering catheter may comprise a marker and the marker may be configured to indicate the position of the lateral opening by an imaging procedure. This allows the physician or operator to verify that the lateral opening is at the correct position within the artery before advancing the guide catheter through the working channel of the steering catheter so that the guide catheter enters the artery by exiting the main body through the lateral opening.
Preferably, an exit facilitation device is disposed in the working channel in the area of a distal end of the lateral opening. The exit facilitation device may be configured to allow for facilitated sliding of the guide catheter and/ or the closure element through or in a direction towards the lateral opening. The exit facilitation device may comprise a ramp configured to redirect or deflect the guide catheter and/ or the closure element from the working channel towards the lateral opening. The ramp may be provided at the distal end of the lateral opening. The ramp may be spring loaded or biased. The ramp may close the working channel so that the working channel terminates at the ramp. The exit facilitation device may also comprise a constriction minimizing the inner diameter of the working channel. The constriction may be provided only locally in the area of the distal end of the lateral opening or may at least partially extend from the distal end of the lateral opening in a direction of the distal end of the steering catheter. Alternatively, the working channel may also terminate in the area of the lateral opening.
The ramp may comprise a first ramp part and a second ramp part. The second ramp part may be disposed between the first ramp part and an inner peripheral surface of the working channel. The second ramp part may be made of an elastic material biasing the first ramp part in a direction towards the lateral opening. The exit facilitation device may divide 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 main body of the steering catheter. The second portion may be offset from the central axis of the main body of the steering catheter.
According to another aspect, the main body of the steering catheter may comprise a distal part and a proximal part, wherein the proximal part may be movable relative to the distal part between a closed position and an opened position. The working channel is sealed when the proximal part is in the closed position and the working channel is open to an environment surrounding the steering catheter when the proximal part is in the opened position. In other words, when the proximal part is in the opened position, the guide catheter can exit the main body of the steering catheter directly out of the working channel. The guide catheter can therefore be advanced and positioned independently of the blood pump or the pump section respectively within the steering catheter to reach the ostia of the coronary arteries. Any hemodynamically supported procedure can then be performed through the guide catheter.
The steering catheter may comprise a guide structure at least partially extending along the main body of the steering catheter. The distal part is fixed to the guide structure and the proximal part is configured to be movable relative to the guide structure, preferably axially. The guide structure may comprise one or more slides with the proximal part being movable relative to said slides. The slides may be provided as a wire or a flat bar. The distal part may comprise a first abutment surface facing the proximal part, wherein the first abutment surface may be oblique relative to the central axis of the main body of the steering catheter. The first abutment surface may have a circular or elliptical shape. Accordingly, the proximal end may comprise a second abutment surface facing the distal part and being oblique relative to the central axis of the main body. The second abutment surface may have an annular shape. In the closed position, the second abutment surface entirely abuts against the first abutment surface. The working channel may only be provided within the proximal part, i.e., the distal part need not comprise the working channel.
The distal part may comprise a centering element extending in the proximal direction. The centering element is configured to be received in a portion of the working channel of the proximal part, at least when the proximal part is in the closed position. The centering element may be cone- shaped, frustrum- shaped, drop-shaped or may have any other suitable shape which facilitates movement of the proximal part into the closed position by inserting the centering element into the working channel during a closing movement, thus guiding the proximal part. The centering element is further configured to guide the guiding catheter from the working channel into the blood vessel. The centering element may be concentric with the central axis of the main body of the steering catheter or may be excentric to the central axis of the main body of the steering catheter. According to an alternative aspect, the proximal part may be rotatable relative to the distal part via a swivel joint. Preferably, the first lumen and/ or the second lumen and/or the third lumen pass through the swivel joint. The distal part may comprise a first abutment surface and the proximal part may comprise a second abutment surface, wherein the first abutment surface abuts the second abutment surface in the closed position so that rotation of the proximal part relative to the distal part is only possible in a direction towards the open position. In other words, the abutment surfaces limit the rotation of the proximal part so that the proximal part may not be rotated beyond the closed position.
The working channel may be offset from the central axis of the main body. The working channel may also be concentric with the central axis of the main body. The working channel may have a circular cross-sectional shape along its entire length or may have a circular cross-sectional shape only partially along its length. The working channel may also have another cross-sectional shape partially or entirely along its length, e.g., drop shaped, rectangular shaped, half circular shaped, diamond shaped, rhombus shaped, anchor shaped, triangular shaped, shaped as a body of constant width, polygon shaped, Reuleaux polygon shaped, shaped as a circular triangle, shaped as a triangle with rounded corners, shaped as a triangle with rounded corners and curved sides, etc.
The working channel may be configured to removably receive a stiffening mandrel. When the blood pump is placed and positioned inside the heart of the human body, the stiffening mandrel can be fully removed and the guide catheter for the intervention can be inserted into the working channel. After the intervention, the guide catheter can be removed and the stiffening mandrel can be readvanced at full length to provide more stability should the patient be relocated and require prolonged pump support beyond the intervention. The stiffening mandrel preferably has a higher stiffness than the guide catheter or the steering catheter.
The distal end of the stiffening mandrel may be configured to allow for passage over the exit facilitation device. In other words, the stiffening mandrel is configured to not exit the working channel through the opening. In case the exit facilitation device comprises a spring loaded or biased ramp, advancing the stiffening mandrel compresses the ramp so that the stiffening mandrel can be advanced towards the distal end of the steering catheter along the working channel. In case the exit facilitation device comprises a constriction, the stiffening mandrel may have a distal portion having a smaller diameter compared to the remainders of the stiffening mandrel. When the stiffening mandrel is fully advanced through the working channel, the distal portion having the smaller diameter is disposed within the constriction or beyond the constriction.
The working channel may extend up to the distal end of the steering catheter or may terminate at the distal end of the lateral opening or may terminate between the distal end of the lateral opening and the distal end of the steering catheter. The working channel may have a low friction surface. The low friction surface may be provided via coating or by disposing an inner liner within the main body of the steering catheter. The low friction surface may comprise a fluorinated polymer.
A hemostatic valve may be disposed at the proximal end of the working channel. The hemostatic valve avoids any bleeding through the working channel of the steering catheter in case neither the guide catheter nor the stiffening mandrel is received in the working channel. The hemostatic valve can be configured, for example, as a self-sealing unit (e.g. silicone seal with cross slit, helical slit, etc.) or also as a Tuohy-Borst (screw seal).The steering catheter may have an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F. The working channel may have an inner diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F. The working channel preferably has an inner diameter which allows to receive a guide catheter having an outer diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F. Thus, the guide catheter may have an outer diameter in the range of 5F to 6F. The stiffening mandrel may have an outer diameter in the range of 5F to 6F and a small diameter portion disposed at the distal end of the stiffening mandrel may have an outer diameter being smaller than the outer diameter of the remaining stiffening mandrel, e.g., smaller by at most 2F, preferably smaller by at most 1 F and even more preferably smaller by at most 0,5F.
According to a second aspect, a catheter pump assembly comprises the blood pump described above. The catheter pump assembly may comprise the guide catheter configured to be removably received in the working channel. The catheter pump assembly may comprise the stiffening mandrel configured to be removably received in the working channel. The stiffening mandrel may be a hollow stiffening mandrel. The stiffening mandrel is preferably disposed in the working channel during placement of the blood pump. The catheter pump assembly may also comprise a controller. The motor cable may be connected to the controller. The optical fiber cable may be connected to the controller.
BRIEF DESCRIPTION OF THE DRAWINGS
Hereinafter the invention will be explained by way of example with reference to the accompanying drawings. The accompanying drawings are not drawn to scale. In the drawings, identical or corresponding components illustrated in various figures are represented by the same numeral. For purposes of clarity, not every component may be labeled in every drawing. In the drawings:
FIG. 1 is a schematic representation of a catheter pump assembly comprising a blood pump, which is positioned within the left ventricle of the heart;
FIG. 2 shows a schematic representation of a blood pump; FIG. 3 is a first side view of a blood pump;
FIG. 4 is a second side view of a blood pump;
FIG. 5 is a detailed view of a motor of a blood pump;
FIG. 6 is a cross section of a blood pump;
FIG. 7 is another cross section of the blood pump shown in Fig. 6;
FIGS. 8a to 8f are cross sections of different embodiments of steering catheters;
FIG. 9 is a cross section showing a first variant of an exit facilitation device;
FIG. 10 is a cross section showing a second variant of an exit facilitation device;
FIG. 11 is a cross section showing a third variant of an exit facilitation device;
FIG. 12 is a cross section showing a fourth variant of an exit facilitation device;
FIG. 13 is a cross section through a steering catheter with a closure element according to a first variant;
FIG. 14 is a cross section through a steering catheter with a closure element and open lateral opening according to a second variant;
FIG. 15 is a cross section through the steering catheter of FIG. 14 with closed lateral opening;
FIG. 16 is a cross section through the steering catheters shown in FIGS. 13 to 15;
FIG. 17 is a cross section through a steering catheter with a closure element and closed lateral opening according to a third variant;
FIG. 18 is a cross section through the steering catheter of FIG. 17 with opened lateral opening;
FIG. 19 is a side view of a steering catheter with a closure element and closed lateral opening according to a fourth variant;
FIG. 20 is a side view of the steering catheter of FIG. 19 with opened lateral opening;
FIG. 21 is a cross section through a steering catheter having a distal part and a proximal part according to a first variant in a closed position; FIG. 22 is a cross section through the steering catheter of FIG. 21 in an opened position;
FIG. 23 is a cross section through a steering catheter having a distal part and a proximal part according to a second variant in an opened position; and
FIG. 24 is a partial cross section through a steering catheter having a distal part and a proximal part according to a third variant in an opened position.
DETAILED DESCRIPTION OF THE DRAWINGS
The following description and drawings merely illustrate the principles of the invention. It will thus be appreciated that those skilled in the art will be able to devise various arrangements that, although not explicitly described or shown herein, embody the principles of the invention and are included within its scope. Furthermore, all examples recited herein are principally intended expressly to be only for illustrative purposes to aid the reader in understanding the principles of the invention and the concepts contributed by the inventor(s) to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Also, 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.
Fig. 1 shows the use of a catheter pump assembly 1 comprising a blood pump 10 for supporting, in this particular example, a left ventricle LV of a human heart H. In this exemplary embodiment, the blood pump 10 is an intravascular blood pump and comprises a steering catheter 12 and a pump section 14 mounted at a distal end 16 of the steering catheter 12. The intravascular blood pump 10 may be placed inside the heart H using a percutaneous, transluminal technique. For example, the intravascular blood pump 10 may be introduced through a femoral artery. However, alternative vascular access is equally possible, such as access through the subclavian artery. After passing through the femoral artery, the catheter 12 may be pushed into the aorta such that the pump section 14 reaches through the aortic valve into the heart H. The positioning of the pump section 14 in Fig. 1 serves purely as an example, whereas different placements are possible, such as positioning the pump section 14 inside the right ventricle of the heart H. The steering catheter may have an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
The pump section 14 comprises a pump housing 20 and a pump element 22 disposed within the pump housing 20, see, e.g., Figs. 2 to 4. The pump element 22 may be provided in form of an impeller. Rotation of the impeller 22 causes blood to flow from a blood flow inlet 24 at a distal end of the pump section 14 to a blood flow outlet 26 located proximally of the blood flow inlet 24. A flexible atraumatic tip 28 having the form of a pigtail or a J-form is disposed at the distal end of the pump section 14. The atraumatic tip 28 facilitates placement of the intravascular blood pump 10 by aiding navigation inside the patient’s vascular system. Furthermore, the softness of the flexible atraumatic tip 28 allows the pump section 14 to support itself atraumatically against the wall of the left ventricle LV.
Figs. 2 to 6 shows the intravascular blood pump 10 in further detail. The 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 case, the intravascular blood pump 10 is transported through the patient’s vascular system while both the impeller 22 and the pump housing 20 are in their compressed state. Once the pump section 14 is at its target location, the pump housing 20 and impeller 22 are expanded. When the impeller 22 inside the pump housing 20 is rotated, blood is drawn into the blood flow inlet 24 at the distal end of the pump housing 20 and through the pump housing 20 into a downstream tubing 30, which is attached to the pump housing 20 and extends proximally. The blood is then ejected from the downstream tubing 30 into the aorta through the more proximally located blood flow outlet 26 provided in the downstream tubing 30, the blood flow outlet 26 comprising a plurality of outlet openings. The downstream tubing 30 is made of a flexible material such that it can be compressed by the aortic valve as the patient’s heart is pumping. The downstream tubing 30 is typically expanded mainly due to the active blood flow generated by the impeller 22 during rotation. By placing the blood flow inlet 24 inside the left ventricle LV and the blood flow outlet 26 inside the aorta, the intravascular blood pump 10 may support the patient’s systemic blood circulation. If the intravascular blood pump 10 is configured and placed differently, it may be used, e.g., to support the patient’s pulmonary blood circulation instead.
As shown in Figs. 2, 5 and 6, an electric motor 32 is provided to rotate the impeller 22. It should be noted that the downstream tubing 30 is not illustrated in Figs. 5 and 6 for lucidity reasons. The motor 32 is provided at a proximal end of the pump housing 20 and comprises a rotor 34 and a stator 36 disposed within a motor housing 38. The rotor 34 is coupled to a shaft 40 supported in a proximal bearing 42 and one or more distal bearings 44. The shaft 40 extends into the pump housing 20 and the impeller 22 is provided at a distal end of the shaft 40. As further depicted in Figs. 3 and 4, the pump housing 20 comprises a plurality of struts 46 with the proximal end of the struts 46 being attached to the motor housing 38. This can be done by, e.g., laser welding.
A motor cable 48 is attached to the proximal end of the motor 32 to supply power to the motor 32 and to control the motor 32 in a known manner. In particular, a printed circuit board 52 is disposed within the motor housing 38 and the motor cable 48 is attached to the printed circuit board 52. The motor cable 48 is guided within the steering catheter 12 to a controller 50 provided extracorporeally (see Fig. 1), as will be described in more detail below. The motor cable 48 may be a ribbon cable. In addition, a purge lumen 54 may be provided which is operatively coupled to the pump section 14 and the motor 32 respectively. The purge lumen 54 is guided within the steering catheter 12 as will be explained in more detail below. The purge fluid applied via the purge lumen 54 flows through the proximal bearing 42 and through the motor housing 38 and exits the motor housing 38 through the distal bearings 44 into the pump housing 20. It shall be noted that purging of the blood pump 10 is optional and depends on the intended application of the blood pump 10, i.e., if it is intended for short time application or for long time application. In the latter case, it is advisable to purge the blood pump 10.
The blood pump 10 may further comprise at least one sensor 56. The sensor 56 may be an optical sensor 56 attached to the pump section 14 as exemplarily shown in Fig. 1 . The optical sensor 56 is connected to the controller 50 by an optical fiber cable 58 guided within the steering catheter 12 as will be explained in more detail below. Of course, the blood pump 10 may also comprise two or more optical sensors 56 and thus, two or more optical fiber cables 58.
The steering catheter 12 is provided as a multi-lumen catheter and comprises an elongated main body 60 extending between the distal end 16 and the proximal end 18 of the steering catheter 12 along a central axis CA. The main body 60 is a tubular main body 60 having a cylindrical shape. When the blood pump 10 is placed in the heart H, the proximal end 18 of the steering catheter 12 is disposed extracorporeally. A Y-piece 62 is attached to the proximal end 18 of the steering catheter 12, see Fig. 7.
In this exemplary embodiment, a working channel 64 extends within the main body 60 from the proximal end 18 of the steering catheter 12 to the distal end 16 of the steering catheter 12. The working channel 64 further extends through a first arm 72 of the Y-piece 62 up to a proximal end of the first arm 72 of the Y-piece 62. A hemostatic valve 76 is attached to the proximal end of the first arm 72 and hence to the proximal end of the working channel 64. The hemostatic valve 76 may be configured, for example, as a self-sealing unit (e.g. silicone seal with cross slit, helical slit, etc.) or also as a Tuohy-Borst (screw seal). The working channel 64 is configured to removably receive a guide catheter 78 (shown in Fig. 7), a stiffening mandrel 80 (shown in Fig. 6) or a closure element 108 (shown in Figs. 13 to 15). The guide catheter 78, the stiffening mandrel 80 or the closure element 108 may be advanced through the working channel 64 via the hemostatic valve 76. Hence, the hemostatic valve 76 inhibits bleeding in case neither the guide catheter 78 nor the stiffening mandrel 80 nor the closure element 108 are received in the working channel 64 when the blood pump 10 is already placed in the heart H. The stiffening mandrel 80 is preferably a hollow stiffening mandrel 80 and is intended to increase the stability of the blood pump 10, e.g., in case the patient is to be relocated or requires prolonged pump support beyond the intervention. The stiffening mandrel 80 may thus be configured to be advanced close to the distal end 16 of the steering catheter 12. The guide catheter 78 may be a 5F to 6F guide catheter 78 so that the working channel 64 has an inner diameter of at least 5F. Accordingly, the stiffening mandrel 80 may also be a 5F to 6F stiffening mandrel 80.
The steering catheter 12 further comprises a hosting arrangement 82 configured to host cables and purge lumens, preferably separate from the working channel 64. The hosting arrangement 82 comprises at least one lumen 66, 68, 70 which is separated from the working channel 64. The hosting arrangement 82 may comprise up to three lumens 66, 68, 70, see for instance Fig. 8e. Thus, the steering catheter 12 may comprise a total of four lumens, namely the working channel 64, a first lumen 66, a second lumen 68 and a third lumen 70. Of course, the steering catheter 12 may also comprise more or less than four lumens. Furthermore, the hosting arrangement 82 may also comprise at least one recess (not shown) on an outer peripheral surface of the main body 60. The at least one recess may be configured to host cables and purge lumens. Furthermore, the hosting arrangement 82 may also be configured to host cables and purge lumens in that said cables and purge lumens are embedded in a side wall of the main body 60 or the steering catheter 12 respectively (not shown).
The lumens 66, 68, 70 of the hosting arrangement 82 extend from the proximal end 18 of the steering catheter 12 nearly up to the distal end 16 of the steering catheter 12 in this exemplary embodiment. The lumens 66, 68, 70 are configured to receive the motor cable 48, the purge lumen 54 and the optical fiber cable 58. However, it is not necessary that each of the motor cable 48, the purge lumen 54 and the optical fiber cable 58 are received separately in one of the lumens 66, 68, 70 of the hosting arrangement 82. Rather, it possible that the hosting arrangement 82, for instance, comprises only one first lumen 66 with the motor cable 48, the purge lumen 54 and the optical fiber cable 58 being received in the first lumen 66. Accordingly, it is also possible that the hosting arrangement 82 comprises a first lumen 66 and a second lumen 68 with, for instance, the motor cable 48 and the optical fiber cable 58 being received in the first lumen 66 and the purge lumen 54 being received in the second lumen 68. For instance, in case the blood pump 10 does not comprise a purge lumen 54, the motor cable 48 may be received in the first lumen 66 and the optical fiber cable 58 may be received in the second lumen 68. Furthermore, it is also possible that the purge lumen 54 is a lumen 66, 68, 70 of the hosting arrangement 82.
As shown in Fig. 7, the motor cable 48, the optical fiber cable 58 and the purge lumen 54 exit the respective lumen 66, 68, 70 of the hosting arrangement 82 at the proximal end 18 of the steering catheter 12. At the proximal end 18 of the steering catheter 12, the motor cable 48, the optical fiber cable 58 and the purge lumen 54 are routed along a second arm 74 of the Y-piece 62 to the proximal end of the second arm 74 of the Y-piece 62, where they exit the Y-piece to be connected to the appropriate device, e.g., the controller 50. The hosting arrangement 82 may also extend from the proximal end 18 of the steering catheter 12 to the proximal end of the second arm 74 of the Y-piece 62. The second arm 74 of the Y-piece 62 may comprise a barrier to inhibit bleeding through the second arm 74 of the Y-piece 62. The barrier may be provided at the distal end of the second arm 74 of the Y-piece 62. As an alternative (not shown), the Y-piece 62 may also be disposed in a handle of the blood pump 10 or catheter pump assembly 1 respectively.
As one can take from, e.g., Fig. 5, the hosting arrangement 82 terminates adjacent or in close proximity to the distal end 16 of the steering catheter 12, where the motor cable 48, the optical fiber cable 58 and the purge lumen 54 enter the working channel 64. The motor cable 48, the optical fiber cable 58 and the purge lumen 54 are then routed to the distal end 16 of the steering catheter 12.
The lumen 66, 68, 70 of the hosting arrangement 82 and the working channel 64 may have different geometrical shapes. Different variants are shown in Figs. 8a to 8f as cross sections through the steering catheter 12. It has to be noted that the variants shown in Figs. 8a to 8f are not limiting and may be combined between the different variants.
Fig. 8a shows a first variant with the working channel 64 having a circular cross section and being offset relative to the central axis CA of the main body 60 of the steering catheter 12. In the variant showing in Fig. 8a, the hosting arrangement 82 comprises a first lumen 66 and a second lumen 68. The first lumen 66 has a circular cross section and the second lumen 68 has a rectangular cross section.
Fig. 8b shows a second variant with the working channel 64 having a circular cross section and being concentric with the central axis CA of the main body 60 of the steering catheter 12. The hosting arrangement 82 comprises a first lumen 66, a second lumen 68 and a third lumen 70. The first lumen 66 has a circular cross section, the second lumen 68 has a circular cross section and the third lumen 70 has a circular cross section. The first lumen 66, the second lumen 68 and the third lumen 70 may be evenly distributed around the working channel 64 within the main body 60 of the steering catheter 12 or may be consolidated in a portion of the steering catheter 12, as shown in Fig. 8b.
In the variant shown in Fig. 8c, the working channel 64 does not have a circular cross section, but has a circular main shape with two opposing bulges. The working channel 64 is offset relative to the central axis CA of the main body 60 of the steering catheter 12. The hosting arrangement 82 comprises a first lumen 66 and a second lumen 68. The first lumen 66 and the second lumen 68 have a quarter-circular shaped or kidney-shaped cross section.
Fig. 8d shows a variant with the working channel 64 having a circular cross section and being concentric with the central axis CA of the main body 60 of the steering catheter 12. The hosting arrangement 82 comprises only a first lumen 66 having a half-circular shaped cross section. In the variant shown in Fig. 8e, the working channel 64 has a circular cross section and is concentric with the central axis CA of the main body 60 of the steering catheter 12. The hosting arrangement 82 comprises a first lumen 66, a second lumen 68 and a third lumen 70. The first lumen 66 has a third of a circle, circular arc or kidney-shaped cross section, the second lumen 68 has a third of a circle, circular arc or kidney-shaped cross section and the third lumen 70 has a third of a circle, circular arc or kidney-shaped cross section. The first lumen 66, the second lumen 68 and the third lumen 70 may be evenly distributed around the working channel 64 within the main body 60 of the steering catheter 12.
In the variant shown in Fig. 8f, the working channel 64 has a triangular cross section with rounded edges and with curved sides and is concentric with the central axis CA of the main body 60 of the steering catheter 12. The hosting arrangement 82 comprises a first lumen 66, a second lumen 68 and a third lumen 70. The first lumen 66 has a quarter-circular, circular arc or kidney-shaped cross section, the second lumen 68 has a quarter-circular, circular arc or kidney-shaped cross section and the third lumen 70 has a quarter-circular, circular arc or kidney-shaped cross section. The first lumen 66, the second lumen 68 and the third lumen 70 may be evenly distributed around the working channel 64 within the main body 60 of the steering catheter 12.
As one can take from Figs. 3, 4, 6, 7 and 9 to 15, for example, the steering catheter 12 comprises a lateral opening 84 disposed between the distal end 16 of the steering catheter 12 and the proximal end 18 of the steering catheter 12. The lateral opening 84 is a longitudinal opening and has a drop shape. The lateral opening 84 penetrates a side wall of the catheter 12 or main body 60 respectively and connects the working channel 64 with an environment surrounding the steering catheter 12. The lateral opening 84 is disposed at a certain distance from the proximal end 18 of the steering catheter 12 so that it is located within the artery when the blood pump 10 is placed or in the process of being placed in the human body. A marker 86 may be provided which allows to track the correct position of the lateral opening 84 by an imaging procedure. The marker 86 may be a radiopaque marker and may be provided at the outer circumference of the main body 60 adjacent to the proximal end of the lateral opening 84. Of course, the marker 86 may also be provided elsewhere, e.g., at the distal end of the lateral opening 84 or embedded in the main body 60 of the steering catheter 12.
The lateral opening 84 is configured so that the guide catheter 78 received in the working channel 64 can exit the steering catheter 12 through the lateral opening 84 so that the guide catheter 78 can be advanced and positioned independently of the blood pump 10 and the steering catheter 12 to reach the ostia of the coronary arteries, see Fig. 3, where the guide catheter 78 is denoted in dashed lines. Any hemodynamically supported procedure can then be performed through the guide catheter 78. To allow for a smooth advancement of the guide catheter 78 inside the working channel 64, an inner peripheral surface 116 of the working channel 64 may be a low friction surface, e.g., by providing an inner liner or a coating reducing the friction, for instance composed of fluorinated polymers.
An exit facilitation device 88 may be provided in the region of the lateral opening 84. The exit facilitation device 88 aids the exit of the guide catheter 78 through the lateral opening 84 when the guide catheter 78 is advanced along the working channel 64.
Fig. 9 depicts a first variant of an exit facilitation device 88. The exit facilitation device 88 comprises a ramp 90 disposed in the working channel 64 opposite to the distal end of the lateral opening 84. In this exemplary embodiment, the ramp 90 comprises a first ramp part 92 and a second ramp part 94. The second ramp part 94 is disposed between the first ramp part 92 and the inner peripheral surface 116 of the working channel 64. The second ramp part 94 is made of an elastic material so that it biases the first ramp part 92 away from the inner peripheral surface 116 of the working channel 64 toward the lateral opening 84. When the guide catheter 78 is advanced along the working channel 64, it is deflected by the ramp 90 in a direction towards the lateral opening 84. As the guide catheter 78 is made of a comparably flexible material, it may not overcome the biasing force of the second ramp part 94 and may thus not be advanced beyond the ramp 90 in a direction towards the distal end 16 of the steering catheter 12. If, however, the stiffening mandrel 80 is advanced along the working channel 64, the higher stiffness of the stiffening mandrel 80 is sufficient to overcome the biasing force of the second ramp part 94 so that the ramp 90 is compressed by the stiffening mandrel 80. The stiffening mandrel 80 can thus be advanced beyond the ramp 90 in the working channel 64. When the stiffening mandrel 80 is removed, the biasing force of the second ramp part 94 causes the ramp 90 to erect again.
Fig. 10 depicts a second variant of an exit facilitation device 88. In this exemplary embodiment, the exit facilitation device 88 comprises a constriction 96 minimizing the inner diameter of the working channel 64 beyond the lateral opening 84 in a direction of the distal end 16 of the steering catheter 12. The constriction 96 may be provided locally in the area of the distal end of the lateral opening 84, or may extend a certain length in a direction towards the distal end 16 of the steering catheter 12. The constriction 96 deflects the guide catheter 78 towards the lateral opening 84, whereas the stiffening mandrel 80 is configured to pass along the constriction 96. Therefore, the stiffening mandrel 80 may comprise a distal portion having a reduced diameter compared to the remainders of the stiffening mandrel 80. When the stiffening mandrel 80 is fully advanced along the working channel 64, the distal portion of the stiffening mandrel 80 is disposed within the constriction 96. This has the further advantage that the constriction 96 constitutes an abutment for the stiffening mandrel 80 so that the stiffening mandrel 80 cannot be advanced further. Fig. 11 depicts a third variant of an exit facilitation device 88. In this exemplary embodiment, the exit facilitation device 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 main body 60, whereas the second portion 102 is offset from the central axis CA of the main body 60. Furthermore, a ramp 104 is provided connecting the first portion 100 and the second portion 102. The ramp 104 and the diameter change between the first portion 100 and the second portion 102 deflect the guide catheter 78 towards the lateral opening 84, whereas the stiffening mandrel 80 is configured to pass along into the second portion 102. Therefore, the stiffening mandrel 80 may comprise a distal portion having a reduced diameter compared to the remainders of the stiffening mandrel 80 and being not concentric with the remainders of the stiffening mandrel 80. When the stiffening mandrel 80 is fully advanced along the working channel 64, the distal portion of the stiffening mandrel 80 is disposed within the second portion 102. This has the further advantage that the conjunction between the first portion 100 and the second portion 102 constitutes an abutment for the stiffening mandrel 80 so that the stiffening mandrel 80 cannot be advanced further.
Fig. 12 depicts a fourth variant of an exit facilitation device 88. In this exemplary embodiment, the exit facilitation device 88 comprises a ramp 106 which completely closes the working channel 64. In other words, the working channel 64 terminates with the ramp 106 in the area of the lateral opening 84. A guide catheter 78 advanced through the working channel 64 is thus deflected towards the lateral opening 84 and may exit the main body 60 of the steering catheter 12 through the lateral opening 84. Therefore, the portion of the main body 60 of the steering catheter 12 located distally of the lateral opening 84 is sufficiently stiff. In case a stiffening mandrel 80 is used, said stiffening mandrel 80 is only advanced through the working channel 64 up to the ramp 106.
The lateral opening 84 may be closed to avoid that an exposed edge of the lateral opening 84 gets stuck, e.g., in the access port or an introducer 98. Therefore, the closure element 108 may be provided which seals the lateral opening 84.
A cross section through a steering catheter 12 with a closure element 108 according to a first variant is shown in Fig. 13. The closure element 108 comprises an elongated main body 110 and a plug 112 disposed on a distal end of the elongated main body 110. In particular, the plug 112 is disposed on an outer peripheral surface of the elongated main body 110 and protrudes radially outwardly from the elongated main body 110.
The plug 112 is shaped and sized to virtually correspond to the shape and size of the lateral opening 84. The working channel 64 is configured to receive the closure element 108 so that the closure element 108 may be advanced through the working channel 64 until the plug 112 snaps into the lateral opening 84 and thereby closes or seals the lateral opening 84. The closing element 108 also provides stiffness to the steering catheter 12 comparable to a stiffening mandrel 80 as discussed above. In the exemplary embodiment shown in Fig. 13, the working channel 64 is open distally of the lateral opening 84. However, the working channel 64 may also terminate in the area of the lateral opening 84 as shown in Fig. 12.
To open the lateral opening 84, the closure element 108 is axially moved in the proximal direction within the working channel 64. Thereby, the plug 108 is released from the lateral opening 84. The closure element 108 is removed from the steering catheter 12 and, e.g., the guide catheter 78 may be introduced through the working channel 64 and may exit the main body 60 of the steering catheter 12 via the lateral opening 84. The elongated main body 110 of the closure element 108 may have a diameter of, e.g., 5F or 6F.
A second variant of a closure element 108 is shown in Figs. 14 and 15. Here, the plug 112 is disposed on a distal end surface of the elongated main body 110 of the closure element 108. A collar portion 114 is formed on the distal end surface of the elongated main 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 instance, the plug 112 may be provided eccentrically relative to a main axis of the elongated main body 110 thereby forming an only partially circumferential collar portion 114.
When the closure element 108 is advanced through the working channel 64 to close the lateral opening 84, the collar portion 114 abuts the inner peripheral surface 116 of the working channel 64 so that further movement of the closure element 108 is inhibited. When the collar portion 114 abuts the inner peripheral surface 116 of the working channel 64, the plug 112 is perfectly fitted into the lateral opening 84 thereby sealing or closing the lateral opening 84. This is shown in Fig. 15.
In the embodiment shown in Figs. 14 and 15, the working channel 64 terminates at the lateral opening 84 and an exit facilitation device 88 with a ramp 106 is provided, similar to that shown in Fig. 12.
To help the physician to correctly insert the closure element 108 into the working channel 64, i.e., so that the plug 112 is in the correct orientation to snap into the lateral opening 84, the working channel 64 and the closure element 108 may have a matching cross-sectional shape allowing for only one orientation, see Fig. 16. In this exemplary cross section of the steering catheter 12, the working channel 64 is drop- shaped, but it may also have other shapes, e.g., circular with a notch or the like.
Figs. 17 and 18 depict a cross section through a steering catheter 12 with a closure element 118 according to a third variant. The closure element 118 in this exemplary embodiment is a tubular closure element 118 disposed about the outer peripheral surface of the main body 60 of the steering catheter 12. The closure element 118 comprises a passage opening 120 and is axially movable relative to the main body 60 of the steering catheter 12.
To open the lateral opening 84, the tubular closure element 118 is axially moved until the passage opening 120 overlaps with the lateral opening 84, thereby creating a passageway to the working channel 64, see Fig. 18 showing a fully opened lateral opening 84. The passage opening 120 is sized and configured to fully expose the lateral opening 84 when overlapping with the lateral opening 84. As the tubular closure element 118 has a distinctly smaller radial thickness compared to the main body 60 of the steering catheter 12, the exposed edge of the passage opening 120 is hardly getting stuck.
Although not shown, an exit facilitation device 88 may also be provided with the embodiment shown in Figs. 17 and 18.
Figs. 19 and 20 depict a cross section through a steering catheter 12 with a closure element 122 according to a fourth variant. The closure element 122 is provided as a tubular closure element 122 and it comprises a passage opening 120 similar to the one shown in Figs. 17 and 18. In this exemplary embodiment, the tubular closure element 122 is rotatably disposed about the main body 60 of the steering catheter. By rotating the tubular closure element 122 relative to the main body 60 of the steering catheter 12, the passage opening 120 can be brought into an overlap with the lateral opening 84 (shown in dashed lines in Fig. 19) to create the passageway to the working channel 84.
The tubular closure element 122 need not extend up to the distal end 16 of the steering catheter 12, but may terminate distally slightly after the lateral opening 84. As shown in Figs. 19 and 20, the outer diameter of the main body 60 of the steering catheter may have a stepped configuration, i.e. it may increase distally of the tubular closure element 122. In Figs. W and 20, the smaller diameter portion of the main body 60 is shown in dashed lines. This results in a flush outer surface of the steering catheter 12 and avoids an exposed and circumferential edge of the tubular closure element 122.
Figs. 20 and 21 depict a cross section through a steering catheter 12 with the main body 60 being divided into a distal part 124 and a proximal part 126. The distal part 126 does not comprise the working channel 64 in this exemplary embodiment. The distal part 126 comprises an elliptical first abutment surface 128 facing the proximal part 126. The first abutment surface 128 is oblique relative to the central axis CA of the main body 60. The proximal part 128 comprises an annular second abutment surface 130 facing the distal part 124. The second abutment surface 130 is also oblique relative to the central axis CA of the main body 60.
The main body 60 of the steering catheter 12 further comprises a guide structure 132 fixed to the distal part 124. The proximal part 126 is configured to be movable relative to the guide structure 132 and, hence, also relative to the distal part 124. In this exemplary embodiment, the guide structure 132 comprises two rails which extend along the main body 60 so that a physician may move the distal part 126 relative to the rails of the guide structure 132. As shown, the guide structure 132 is at least partially embedded in a side wall of the main body 60 of the steering catheter 12.
The proximal part 126 can be moved between a closed position (see Fig. 21) and an opened position (see Fig. 22). In the closed position, the annular second abutment surface 130 entirely abuts the first abutment surface 128 thereby sealing or closing the working channel 64. When the physician moves the proximal part 126 axially relative to the guide structure 132 and the distal part 124 into the opened 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 steering catheter 12. The guide catheter 78 may then be advanced through the working channel 64, whereby the oblique first abutment surface 128 acts like an exit facilitation device as described above. In particular, the guide catheter 78 is deflected by the oblique first abutment surface 128 so that it can exit the working channel 64 in a direction away from the main body 60 of the steering catheter 12.
To facilitate the movement of the proximal part 126 into the closed position, the distal part 128 may comprise a centering element 134 protruding from the first abutment surface 128 in a direction towards the proximal part 126. An according variant is exemplarily shown in Fig. 23. Here, the centering element 134 is cylindrically shaped with a spherical end. Other shapes for the centering element 134 are of course also possible, e.g., a conical shape or a frustoconical shape. The centering element 134 may be concentric or excentric to the central axis CA.
When the proximal part 126 is moved from the opened position (shown in Fig. 23) to the closed position, the centering element 134 enters the working channel 64. Due to the increasing diameter of the centering element 134 in the distal direction, a misalignment (e.g., due to a slightly bended guiding structure 132) is corrected. Preferably, the largest diameter of the centering element virtually corresponds to the inner diameter of the working channel 64. The first abutment surface 128 and the second abutment surface 130 may also be oblique as shown in Figs. 21 and 22. Furthermore, the centering element 134 also establishes a guiding function for a guide catheter 78 so that it can exit the working channel 64 in a direction away from the main body 60 of the steering catheter 12.
Fig. 24 depicts a third variant of a steering catheter 12 with a main body 60 having a distal part 124 and a proximal part 126 as a partial cross section (i.e., only the proximal part 126 is shown as a section). In this exemplary embodiment, the proximal part 126 is rotatably coupled to the distal part 124 via a swivel joint 136. The distal part 124 comprises a first abutment surface 128 and the proximal part comprises a second abutment surface 130. In the closed position, the second abutment surface 130 abuts the first abutment surface 128 thereby limiting a rotation beyond the closed position. Furthermore, the lumens 66 to 70 (if provided) run through the swivel joint 136. To open the working channel 64 relative to the environment surrounding the steering catheter 12, the proximal part 126 is rotated relative to the distal part 124 in the opened position shown in Fig. 24. As one can take from Fig. 24, the working channel 64 is fully exposed so that the guide catheter 78 advanced through the working channel 64 can easily exit the working channel 64.
Of course, all embodiments described above may be equipped with a marker 86.
For placing the blood pump 10 in the heart H, a single introducer 98 may be used, see Fig. 2. The introducer 98 may be a small diameter introducer having a diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F. As the steering catheter 12 has a diameter of at most 10F and the pump section 14 has a diameter of at most 10F in the collapsed state, usage of a single introducer 98 with a small diameter is possible. The pump section 14 is advanced with the stiffening mandrel 80 or the closure element 108 being received in the working channel 64. As soon as the lateral opening 84 is in the correct position, as indicated by the marker 86, the stiffening mandrel 80 or the closure element 108 is removed from the working channel 64 through the hemostatic valve 76. For the embodiments shown in Figs. 17 to 20, the closure element 118, 122 is moved respectively to create the passageway to the working channel 64. For the embodiments shown in Figs. 21 to 24, the proximal part 126 is moved relative to the distal part 124 in the opened position to expose and open the working channel 64. Thereafter, the guide catheter 78 is introduced through the hemostatic valve 76. The guide catheter 78 is advanced along the working channel 64 and exits the steering catheter 12 via the lateral opening 84 or the opened working channel 64 to allow for hemodynamically supported procedures. Thereafter, the guide catheter 78 may be removed again and the stiffening mandrel 80 or the closure element 108 may be again introduced to increase the stability of the blood pump 10. For the embodiments shown in Figs. 17 to 20, the closure element 118, 122 is moved again to seal the lateral opening 84. For the embodiments shown in Figs. 21 to 24, the proximal part 126 is moved relative to the distal part 124 in the closed position to close the working channel 64 again.
EXEMPLARY IMPLEMENTATIONS
As already described, the technology described herein may be implemented in various ways. In that regard, the foregoing disclosure is intended to include, but not be limited to, the systems, methods, and combinations and subcombinations thereof that are set forth in the following exemplary implementations. Preferred embodiments are described in the following paragraphs:
A1 Blood pump comprising: a steering catheter and a pump section, the pump section being configured to be placed in a human body and comprising a pump housing, a pump element disposed within the pump housing, and an electric motor configured to rotate the pump element, the steering catheter comprising: a distal end and a proximal end, wherein the pump section is coupled to the distal end of the steering catheter, the steering catheter further comprising: an elongated main body extending between the distal end and the proximal end along a central axis, a working channel at least partially extending within the main body from the proximal end of the steering catheter in a direction of the distal end of the steering catheter, the working channel being configured to removably receive a guide catheter.
A2 Blood pump according to paragraph A1 , wherein the blood pump is an intravascular blood pump
A3 Blood pump according to paragraph A1 or A2, wherein the pump housing is an expandable and collapsible pump housing.
A4 Blood pump according to any one of the preceding paragraphs, wherein the pump element is an expandable and collapsible pump element.
A5 Blood pump according to any one of the preceding paragraphs, wherein the blood pump further comprises a motor cable coupled to the 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 purge lumen (54) coupled to the pump section.
A6 Blood pump according to any one of the preceding paragraphs, wherein the main body comprises a hosting arrangement separated from the working channel, the hosting arrangement at least partially extending between the distal end of the steering catheter and the proximal end of the steering catheter
A7 Blood pump according to paragraph A6, wherein the hosting arrangement is configured to receive at least one of the motor cable, the optical fiber cable and the purge lumen.
A8 Blood pump according to paragraph A7, wherein the motor cable and/ or the at least one optical fiber cable and/ or the purge lumen do not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
A9 Blood pump according to paragraph A7 or A8, wherein the motor cable and/ or the at least one optical fiber cable and/ or the purge lumen run separate from the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter. A10 Blood pump according to any one of the preceding paragraphs A6 to A9, wherein the hosting arrangement comprises a first lumen
A11 Blood pump according to paragraph A10, wherein the first lumen at least partially extends between the distal end of the steering catheter and the proximal end of the steering catheter.
A12 Blood pump according to paragraph A10 or A11 , wherein at least one of the motor cable, the optical fiber cable and the purge lumen is disposed within the first lumen.
A13 Blood pump according to any one of the preceding paragraphs A10 to A12, wherein the first lumen is separate from the working channel.
A14 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 main body.
A15 Blood pump according to any one of the preceding paragraphs A10 to A14, wherein the first lumen does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
A16 Blood pump according to any one of the preceding paragraphs A6 to A15, wherein the hosting arrangement comprises a second lumen.
A17 Blood pump according to paragraph A16, wherein the second lumen at least partially extends between the distal end of the steering catheter and the proximal end of the steering catheter.
A18 Blood pump according to paragraph A16 or A17, wherein at least one of the motor cable, the optical fiber cable and the purge lumen is not disposed in the first lumen and is received in the second lumen.
A19 Blood pump according to any one of the preceding paragraphs A16 to A18, wherein the second lumen is separate from the working channel.
A20 Blood pump according to any one of the preceding paragraphs A16 to A19, wherein the second lumen is offset from the central axis of the main body.
A21 Blood pump according to any one of the preceding paragraphs A16 to A19, wherein the second lumen does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
A22 Blood pump according to any one of the preceding paragraphs A6 to A21 , wherein the hosting arrangement comprises a third lumen. A23 Blood pump according to paragraph A22, wherein the third lumen at least partially extends between the distal end of the steering catheter and the proximal end of the steering catheter.
A24 Blood pump according to any one of the preceding paragraphs A22 or A23, wherein the motor cable is disposed within the first lumen and wherein the optical fiber cable is disposed within the second lumen and wherein the purge lumen is disposed within the third lumen or wherein the purge lumen is the third lumen.
A25 Blood pump according to any one of the preceding paragraphs A22 to A24, wherein the third lumen is separate from the working channel.
A26 Blood pump according to any one of the preceding paragraphs A22 to A25, wherein the third lumen is offset from the central axis of the main body.
A27 Blood pump according to any one of the preceding paragraphs A22 to A26, wherein the third lumen does not run in the working channel at least from the proximal end of the steering catheter to a lateral opening of the steering catheter.
A28 Blood pump according to any one of the preceding paragraphs, wherein the steering catheter comprises a lateral opening.
A29 Blood pump according to paragraph A28, wherein the lateral opening extends through a side wall of the main body.
A30 Blood pump according to paragraph A28 or A29, wherein the lateral opening is connected to the working channel.
A31 Blood pump according to any one of the preceding paragraphs A28 to A30, wherein the lateral opening is configured so that a guide catheter can exit the main body through the lateral opening.
A32 Blood pump according to any one of the preceding paragraphs A28 to A31 , wherein the blood pump further comprises a closure element configured to selectively open and close the lateral opening.
A33 Blood pump according to paragraph A32, wherein the closure element is movable relative to the steering catheter.
A34 Blood pump according to paragraph A33, wherein a movement of the closure element relative to the steering catheter selectively opens and closes the lateral opening. A35 Blood pump according to any one of the preceding paragraphs A32 to A34, wherein the closure element is axially movable relative to the steering catheter.
A36 Blood pump according to any one of the preceding paragraphs A32 to A35, wherein the working channel is configured to removably receive the closure element.
A37 Blood pump according to any one of the preceding paragraphs A32 to A36, wherein the closure element comprises an elongated main body and a plug.
A38 Blood pump according to paragraph A37, wherein the plug is disposed on the main body.
A39 Blood pump according to paragraph A37 or A38, wherein the plug is configured to seal the lateral opening when the closure element is received in the working channel.
A40 Blood pump according to any one of the preceding paragraphs A37 to A39, wherein the plug is disposed at a distal end of the elongated main body of the closure element.
A41 Blood pump according to any one of the preceding paragraphs A37 to A40, wherein the elongated main body comprises a collar portion.
A42 Blood pump according to paragraph A41 , wherein the collar portion abuts an inner peripheral surface of the working channel when the plug seals the lateral opening.
A43 Blood pump according to any one of the preceding paragraphs A32 to A34, wherein the closure element (is a tubular closure element at least partially disposed about an outer peripheral surface of the main body of the steering catheter.
A44 Blood pump according to paragraph A43, wherein the tubular closure element is movable relative to the main body of the steering catheter.
A45 Blood pump according to paragraph A43 or A44, wherein the tubular closure element comprises a passage opening extending through a side wall of the tubular closure element.
A46 Blood pump according to paragraph A45, wherein the passage opening is sized and configured to create a passageway to the working channel when the passage opening is brought into at least partial overlap with the lateral opening by movement of the tubular closure element relative to the main body of the steering catheter.
A47 Blood pump according to any one of the preceding paragraphs A43 to A46, wherein the tubular closure element is configured to be axially movable relative to the main body of the steering catheter. A48 Blood pump according to any one of the preceding paragraphs A43 to A47, wherein the tubular closure element is configured to be rotatable relative to the main body of the steering catheter.
A49 Blood pump according to any one of the preceding paragraphs, wherein the steering catheter comprises a marker
A50 Blood pump according to paragraph A49, wherein the marker is configured to indicate the position of the lateral opening by an imaging procedure.
A51 Blood pump according to any one of the preceding paragraphs A28 to A50, wherein an exit facilitation device is disposed in the working channel in the area of a distal end of the lateral opening.
A52 Blood pump according to paragraph A51 , wherein the exit facilitation device comprises a ramp.
A53 Blood pump according to paragraph A52, wherein the ramp comprises a first ramp part and a second ramp part.
A54 Blood pump according to paragraph A53, wherein the second ramp part is disposed between the first ramp part and an inner peripheral surface of the working channel.
A55 Blood pump according to paragraph A53 or A54, wherein second ramp part is made of an elastic material biasing the first ramp part in a direction towards the lateral opening.
A56 Blood pump according to any one of the preceding paragraphs A52 to A55, wherein the ramp closes the working channel.
A57 Blood pump according to any one of the preceding paragraphs A52 to A56, wherein the working channel terminates at the ramp.
A58 Blood pump according to paragraph A51 , wherein the exit facilitation device comprises a constriction.
A59 Blood pump according to paragraph A58, wherein the constriction minimizes the inner diameter of the working channel.
A60 Blood pump according to paragraph A58 or A59, wherein wherein the constriction minimizes the inner diameter of the working channel beyond the lateral opening in a direction of the distal end of the steering catheter. A61 Blood pump according to paragraph A51 , wherein the exit facilitation device divides the working channel into a first portion extending proximally from the lateral opening and a second portion extending distally from the lateral opening.
A62 Blood pump according to paragraph A61 , the first portion is concentric with the central axis (of the main body of the steering catheter.
A63 Blood pump according to paragraph A61 or A62, wherein the second portion is offset from the central axis of the main body of the steering catheter.
A64 Blood pump according to any one of the preceding paragraphs A1 to A27, wherein the main body of the steering catheter comprises a distal part and a proximal part.
A65 Blood pump according to paragraph A64, wherein the distal part is separate from the proximal part.
A66 Blood pump according to paragraph A64 or A65, the proximal part is movable relative to the distal part between a closed position and an opened position.
A67 Blood pump according to paragraph A66, wherein the working channel is sealed when the proximal part is in the closed position, and wherein the working channel is open when the proximal part is in the opened position.
A68 Blood pump according to any one of the preceding paragraphs A64 to A67, wherein the steering catheter comprises a guide structure at least partially extending along the main body of the steering catheter.
A69 Blood pump according to paragraph A68, wherein the distal part is fixed to the guide structure.
A70 Blood pump according to paragraph A68 or A69, wherein the proximal part is configured to be axially movable relative to the guide structure.
A71 Blood pump according to any one of the preceding paragraphs A68 to A70, wherein the guide structure is at least partially embedded in a side wall of the main body of the steering catheter.
A72 Blood pump according to any one of the preceding paragraphs A64 to A71 , wherein the distal part comprises a centering element extending in the proximal direction.
A73 Blood pump according to paragraph A72, wherein the centering element extends in the proximal direction. A74 Blood pump according to paragraph A72 or A73, wherein the centering element is received in a portion of the working channel of the proximal part (126) when the proximal part is in the closed position.
A75 Blood pump according to any one of the paragraphs A64 to A74, wherein the distal part comprises a first abutment surface facing the proximal part.
A76 Blood pump according to paragraph A75, wherein the first abutment surface is oblique relative to the central axis of the main body.
A77 Blood pump according to any one of the preceding paragraphs A64 to A76, wherein the proximal part comprises a second abutment surface facing the distal part.
A78 Blood pump according to paragraph A77, wherein the second abutment surface is oblique relative to the central axis of the main body.
A79 Blood pump according to paragraph A77 or A78, and wherein the second abutment surface abuts the first abutment surface in the closed position.
A80 Blood pump according to any one of the preceding paragraphs A77 to A79, wherein the second abutment surface has an annular shape.
A81 Blood pump according to any one of the preceding paragraphs A74 to A80 wherein the first abutment surface has a circular or elliptical shape.
A82 Blood pump according to any one of the preceding paragraphs A64 to A81 , wherein the proximal part is rotatable relative to the distal part via a swivel joint.
A83 Blood pump according to any one of the preceding paragraphs, wherein the working channel is offset from the central axis of the main body.
A84 Blood pump according to any one of the preceding paragraphs, wherein the working channel is configured to removable receive a stiffening mandrel.
A85 Blood pump according to any one of the preceding paragraphs, wherein the working channel extends up to the distal end of the steering catheter.
A86 Blood pump according to any one of the preceding paragaphs, wherein the working channel extends up to a lateral opening of the steering catheter. A87 Blood pump according to any one of the preceding paragraphs, wherein the working channel has a low friction surface.
A88 Blood pump according to any one of the preceding paragraphs, wherein a hemostatic valve is disposed at the proximal end of the working channel.
A89 Blood pump according to any one of the preceding paragraphs, wherein the steering catheter has an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F.
A90 Blood pump according to any one of the preceding paragraphs, wherein the working channel has an inner diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F.
B1 Catheter pump assembly comprising a blood pump according to any one of the preceding paragraphs A1 to A90.
B2 Catheter pump assembly according to paragraph B1 , wherein the catheter pump assembly further comprises a guide catheter configured to be removably received in the working channel.
B3 Catheter pump assembly according to paragraph B1 or B2, wherein the catheter pump assembly comprises a a stiffening mandrel configured to be removably received in the working channel
B4 Catheter pump assembly according to paragraph B3, wherein the stiffening mandrel is a hollow stiffening mandrel.
B5 Catheter pump assembly according to any one of the preceding paragraphs B1 to B4, wherein the catheter pump assembly comprises a closure element.
As utilized herein, the terms “approximately”, “about”, “substantially”, “virtually” and similar terms are intended to have a broad meaning in harmony with the common and accepted usage by those of ordinary skill in the art to which the subject matter of this disclosure pertains. It should be understood by those of skill in the art who review this disclosure that these terms are intended to allow a description of certain features described without restricting the scope of these features to the precise numerical ranges provided. Accordingly, these terms should be interpreted as indicating that insubstantial or inconsequential modifications or alterations of the subject matter described and are considered to be within the scope of the disclosure. The terms „at least partially” or “partially” as used herein mean both partial and entirely or complete respectively. Terms like “first”, “second” or “third” do not denote a specific order, but are only intended to semantically differentiate between the elements. LIST OF REFERENCE SIGNS
1 catheter pump assembly
10 blood pump
12 steering catheter
14 pump section
16 distal end of steering catheter
18 proximal end of steering catheter
20 pump housing
22 pump element/ impeller
24 blood flow inlet
26 blood flow outlet
28 atraumatic tip
30 downstream tubing
32 motor
34 rotor
36 stator
38 motor housing
40 shaft
42 proximal bearing
44 distal bearing
46 strut
48 motor cable
50 controller
52 printed circuit board
54 purge lumen
56 sensor
58 optical fiber cable
60 main body
62 Y-piece
64 working channel
66 first lumen
68 second lumen
70 third lumen
72 first arm of Y-piece
74 second arm of Y-piece
76 hemostatic valve 8 guide catheter 0 stiffening mandrel 2 hosting arrangement
84 lateral opening
86 marker
88 exit facilitation device
90 ramp
92 first ramp part
94 second ramp part
96 constriction
98 introducer
100 first portion of working channel
102 second portion of working channel
104 ramp
106 ramp
108 closure element
110 elongated main body
112 Plug
114 collar portion
116 inner peripheral surface
118 closure element
120 passage opening
122 closure element
124 distal part
126 proximal part
128 first abutment surface
130 second abutment surface
132 guide structure
134 centering element
136 swivel joint
CA central axis
H heart
LV left ventricle

Claims

1 . Blood pump (10), preferably intravascular blood pump, comprising: a steering catheter (12) and a pump section (14), the pump section (14) being configured to be placed in a human body and comprising: an expandable and collapsible pump housing (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 steering catheter (12) comprising: a distal end (16) and a proximal end (18), wherein the pump section (14) is coupled to the distal end (16) of the steering catheter (12), the steering catheter (12) further comprising: an elongated main body (60) extending between the distal end (16) and the proximal end (18) along a central axis (CA), a working channel (64) at least partially extending within the main 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).
2. Blood pump (10) according to claim 1 , wherein the main body (60) comprises a hosting arrangement (82) separated from the working channel (64), the hosting arrangement (82) at least partially extending between the distal end (16) of the steering catheter (12) and the proximal end (18) of the steering catheter (12), and wherein the blood pump (10) further comprises: a motor cable (48) coupled to the motor (32), and/ or at least one optical sensor (56) and at least one optical fiber cable (58) coupled to the at least one optical sensor (56), and/ or a purge lumen (54) coupled to the pump section (14), wherein the hosting arrangement (82) is configured to receive at least one of the motor cable (48), the optical fiber cable (58) and the purge lumen (54).
3. Blood pump according to claim 2, wherein the motor cable (48) and/ or the at least one optical fiber cable (58) and/ or the purge lumen (54) do not run in the working channel (64) at least from the proximal end of the steering catheter (12) to a lateral opening (84) of the steering catheter (12), and/ or wherein the motor cable (48) and/ or the at least one optical fiber cable (58) and/ or the purge lumen (54) run separate from the working channel (64) at least from the proximal end of the steering catheter (12) to a lateral opening (84) of the steering catheter (12).
4. Blood pump (10) according to claim 2 or 3, wherein the hosting arrangement (82) comprises a first lumen (66) at least partially extending between the distal end (16) of the steering catheter (12) and the proximal end (18) of the steering catheter (12), wherein at least one of the motor cable (48), the optical fiber cable (58) and the purge lumen (54) is disposed within the first lumen (66).
5. Blood pump (10) according to claim 4, wherein the first lumen (66) is offset from the central axis of the main body (60) and/ or wherein the first lumen (66) does not run in the working channel (64) at least from the proximal end of the steering catheter (12) to a lateral opening (84) of the steering catheter (12).
6. Blood pump (10) according to claim 4 or 5, wherein the hosting arrangement (82) comprises a second lumen (68) at least partially extending between the distal end (16) of the steering catheter (12) and the proximal end (18) of the steering catheter (12), wherein at least one of the motor cable (48), the optical fiber cable (58) and the purge lumen (54) is not disposed within the first lumen (66) and is received in the second lumen (68).
7. Blood pump (10) according to claim 6, wherein the second lumen (68) is offset from the central axis of the main body (60) and/ or wherein the second lumen (68) does not run in the working channel (64) at least from the proximal end of the steering catheter (12) to a lateral opening (84) of the steering catheter (12).
8. Blood pump (10) according to any one of the preceding claims 6 or 7, wherein the hosting arrangement (82) comprises a third lumen (70) at least partially extending between the distal end (16) of the steering catheter (12) and the proximal end (18) of the steering catheter (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 purge lumen (54) is disposed within the third lumen (70) or wherein the purge lumen (54) is the third lumen (70).
9. Blood pump (10) according to claim 8, wherein the third lumen (70) is offset from the central axis of the main body (60) and/ or wherein the third lumen (70) does not run in the working channel (64) at least from the proximal end of the steering catheter (12) to a lateral opening (84) of the steering catheter (12).
10. Blood pump (10) according to any one of the preceding claims, wherein the steering catheter (12) comprises a lateral opening (84) extending through a side wall of the main body (60), the lateral opening (84) being connected to the working channel (64), and the lateral opening being configured so that a guide catheter (78) can exit the main body (60) through the lateral opening (84).
11 . Blood pump (10) according to claim 10, wherein the blood pump (10) further comprises a closure element (108, 118, 122) configured to selectively open and close the lateral opening (84).
12. Blood pump (10) according to claim 11 , wherein the closure element (108, 118, 122) is movable relative to the steering catheter (12), wherein a movement of the closure element (108, 120, 122) relative to the steering catheter (12) selectively opens and closes the lateral opening (84).
13. Blood pump (10) according to claim 12, wherein the closure element (108, 118) is axially movable relative to the steering catheter (12).
14. Blood pump (10) according to claim 12 or 13, wherein the working channel (64) is configured to removably receive the closure element (108).
15. Blood pump (10) according to claim 13 or 14, wherein the closure element (108) comprises an elongated main body (110) and a plug (112) disposed on the main 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 a distal end of the elongated main body (110) of the closure element (108).
16. Blood pump (10) according to claim 15, wherein the elongated main body (110) comprises a collar portion (114), wherein the collar portion (114) abuts an inner peripheral surface (116) of the working channel (64) when the plug (112) seals the lateral opening (84).
17. Blood pump (10) according to claim 12, wherein the closure element (120, 122) is a tubular closure element (118, 122) at least partially disposed about an outer peripheral surface of the main body (60) of the steering catheter (12), wherein the tubular closure element (118, 122) is movable relative to the main body (60) of the steering catheter (12), wherein the tubular closure element (118, 122) comprises a passage opening (120) extending through a side wall of the tubular closure element (118, 122), wherein the passage opening (120) is sized and configured to create a passageway to the working channel (64) when the passage opening (120) is brought into at least partial overlap with the lateral opening (84) by movement of the tubular closure element (118, 122) relative to the main body (60) of the steering catheter (12).
18. Blood pump (10) according to claim 17, wherein the tubular closure element (118, 122) is configured to be axially movable relative to the main body (60) of the steering catheter (12) and/ or to be rotatable relative to the main body (60) of the steering catheter (12).
19. Blood pump (10) according to any one of the preceding claims 10 to 18, wherein the steering catheter (12) comprises a marker (86), the marker (86) being configured to indicate the position of the lateral opening (84) by an imaging procedure.
20. Blood pump (10) according to any one of the preceding claims 10 to 19, wherein an exit facilitation device (88) is disposed in the working channel (64) in the area of a distal end of the lateral opening (84).
21. Blood pump (10) according to claim 20, wherein the exit facilitation device (88) comprises a ramp (90, 106).
22. Blood pump (10) according to claim 21 , wherein the ramp (90) comprises a first ramp part (92) and a second ramp part (94), wherein the second ramp part (94) is disposed between the first ramp part (92) and an inner peripheral surface (116) of the working channel (64), wherein the second ramp part (94) is made of an elastic material biasing the first ramp part (92) in a direction towards the lateral opening (84).
23. Blood pump (10) according to claim 21 , wherein the ramp (106) closes the working channel (64) so that the working channel (64) terminates at the ramp (106).
24. Blood pump (10) according to claim 20, wherein the exit facilitation device (88) comprises a constriction (96) minimizing the inner diameter of the working channel (64) beyond the lateral opening (84) in a direction of the distal end of the steering catheter (12).
25. Blood pump (10) according to claim 20, wherein the exit facilitation device (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 main body (60) of the steering catheter (12) and wherein the second portion (102) is offset from the central axis (CA) of the main body (60) of the steering catheter (12).
26. Blood pump (10) according to any one of the preceding claims 1 to 9, wherein the main body (60) of the steering catheter (12) comprises a distal part (124) and a proximal part (126), wherein the proximal part (126) is movable relative to the distal part (124) between a closed position and an opened position, wherein the working channel (64) is sealed when the proximal part (126) is in the closed position, and wherein the working channel (64) is open when the proximal part (126) is in the opened position.
27. Blood pump (10) according to claim 26, wherein the steering catheter (12) comprises a guide structure (132) at least partially extending along the main body (60) of the steering catheter (12), wherein the distal part (124) is fixed to the guide structure (132), and the proximal part (126) is configured to be axially movable relative to the guide structure (132).
28. Blood pump (10) according to claim 26 or 27, wherein the distal part (124) comprises 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 part (126) when the proximal part (126) is in the closed position.
29. Blood pump (10) according to any one of the preceding claims 26 to 28, wherein the distal part (124) comprises a first abutment surface (128) facing the proximal part (126), wherein the first abutment surface (128) is oblique relative to the central axis (CA) of the main body (60), wherein the proximal part (126) comprises a second abutment surface (130) facing the distal part (124), wherein the second abutment surface (130) is oblique relative to the central axis (CA) of the main body (60), and wherein the second abutment surface (130) abuts the first abutment surface (128) in the closed position.
30. Blood pump (10) according to claim 29, wherein the first abutment surface (128) has a circular or elliptical shape, and/ or wherein the second abutment surface (130) has an annular shape.
31. Blood pump (10) according to claim 26, wherein the proximal part (126) is rotatable relative to the distal part (124) via a swivel joint (136).
32. Blood pump (10) according to any one of the preceding claims, wherein the working channel (64) is offset from the central axis of the main body (60).
33. Blood pump (10) according to any one of the preceding claims, wherein the working channel (64) is configured to removably receive a stiffening mandrel (80).
34. Blood pump (10) according to any one the preceding claims, wherein the working channel (64) extends up to the distal end (16) of the steering catheter (12) and/ or wherein the working channel (64) extends up to a lateral opening (84) of the steering catheter (12) and/ or wherein the working channel (64) has a low friction surface and/ or wherein a hemostatic valve (76) is disposed at the proximal end of the working channel (64).
35. Blood pump (10) according to any one of the preceding claims, wherein the steering catheter (12) has an outer diameter of at most 12F, preferably of at most 11 F and even more preferably of at most 10F, and/ or wherein the working channel (64) has an inner diameter of at least 4F, preferably of at least 5F and even more preferably of at least 6F.
36. Catheter pump assembly (1) comprising a blood pump (10) according to any one of the preceding claims.
37. Catheter pump assembly (1) according to claim 36, wherein the catheter pump assembly (1) further comprises a guide catheter (78) configured to be removably received in the working channel (64).
38. Catheter pump assembly (1) according to claim 36 or 37, wherein the catheter pump assembly (1) further comprises a stiffening mandrel (80) configured to be removably received in the working channel (64), wherein the stiffening mandrel (80) is preferably a hollow stiffening mandrel (80).
PCT/EP2025/051586 2024-01-26 2025-01-23 Blood pump and catheter pump assembly Pending WO2025157875A1 (en)

Applications Claiming Priority (2)

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DE102024200694.7 2024-01-26
DE102024200694 2024-01-26

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Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180021495A1 (en) * 2016-07-21 2018-01-25 Thoratec Corporation Gas-filled chamber for catheter pump motor assembly
US20210170081A1 (en) * 2019-01-21 2021-06-10 William R. Kanz Percutaneous Blood Pump Systems and Related Methods
EP3858398A1 (en) 2020-01-31 2021-08-04 ECP Entwicklungsgesellschaft mbH Intravascular blood pump
US20230256231A1 (en) * 2022-02-14 2023-08-17 Narwhal Medical LLC Expandable mechanical hemodynamic support systems, devices, and methods

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20180021495A1 (en) * 2016-07-21 2018-01-25 Thoratec Corporation Gas-filled chamber for catheter pump motor assembly
US20210170081A1 (en) * 2019-01-21 2021-06-10 William R. Kanz Percutaneous Blood Pump Systems and Related Methods
EP3858398A1 (en) 2020-01-31 2021-08-04 ECP Entwicklungsgesellschaft mbH Intravascular blood pump
US20230256231A1 (en) * 2022-02-14 2023-08-17 Narwhal Medical LLC Expandable mechanical hemodynamic support systems, devices, and methods

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