[go: up one dir, main page]

WO2025226734A1 - Boîtier de roue de pompe cardiaque avec poche magnétique cylindrique, anneau d'extrémité et rinçage de palier de roue - Google Patents

Boîtier de roue de pompe cardiaque avec poche magnétique cylindrique, anneau d'extrémité et rinçage de palier de roue

Info

Publication number
WO2025226734A1
WO2025226734A1 PCT/US2025/025853 US2025025853W WO2025226734A1 WO 2025226734 A1 WO2025226734 A1 WO 2025226734A1 US 2025025853 W US2025025853 W US 2025025853W WO 2025226734 A1 WO2025226734 A1 WO 2025226734A1
Authority
WO
WIPO (PCT)
Prior art keywords
impeller
pocket
wall
shaft
flushing
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/US2025/025853
Other languages
English (en)
Inventor
Johannes Bette
Jörg LITZ
Attila FABIUNKE
Johannes STIGLOHER
Vladimir Popov
Joachim Roland Barth
Marvin MITZE
Thorben PAULI
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.)
Kardion GmbH
Original Assignee
Kardion 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 Kardion GmbH filed Critical Kardion GmbH
Publication of WO2025226734A1 publication Critical patent/WO2025226734A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/205—Non-positive displacement blood pumps
    • A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
    • A61M60/237—Non-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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/818—Bearings
    • A61M60/82—Magnetic bearings
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/17—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps
    • A61M60/174—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart inside a ventricle, e.g. intraventricular balloon pumps discharging the blood to the ventricle or arterial system via a cannula internal to the ventricle or arterial system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/408—Details 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
    • A61M60/411—Details 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/419—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being permanent magnetic, e.g. from a rotating magnetic coupling between driving and driven magnets
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/403—Details relating to driving for non-positive displacement blood pumps
    • A61M60/422—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being electromagnetic, e.g. using canned motor pumps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
    • A61M60/804—Impellers
    • A61M60/806—Vanes or blades

Definitions

  • This disclosure relates to components of a cardiac support system, in particular to mechanical circulatory support system including an impeller housing and an impeller supported by one or more bearings.
  • CS Cardiogenic shock
  • MI Acute myocardial infarction
  • Miniature, catheter based intracardiac blood pumps have been developed for percutaneous insertion into a patient's body as an acute therapy for CS patients. They generally include an elongate body carried on the distal end of a catheter.
  • the pump has a blood intake port configured for positioning in the left ventricle, spaced apart from a blood exit port configured for delivering blood into the ascending aorta.
  • the pump includes a drive portion and a pump portion, which may be positioned within the elongate body of the pump.
  • PCT percutaneous coronary intervention
  • PCT percutaneous coronary intervention
  • PCI includes a variety of techniques, e.g. balloon angioplasty, stent implantation, rotablation and lithotripsy.
  • a PCI is considered high risk if either the patient has relevant comorbidities (e.g. frailty or advanced age), the PCI per se is very complex (e.g. bifurcation or total occlusions) or hemodynamic status is challenging (e.g. impaired ventricular function).
  • Patients at risk of cardiogenic shock are another example indication where catheter based intracardiac blood pumps may be used. The catheter based intracardiac blood pumps may be used to assist with pumping blood during these and other procedures.
  • Impellers are generally stiff and thus limit the amount of bend or radius of the pump system when advancing the system across tortuous vessels.
  • existing impellers require complex assembly and welding procedures related to securing magnets with the impellers.
  • a minimally invasive miniaturized percutaneous mechanical left ventricular support system is provided, optimized for treatment of patients experiencing cardiogenic shock.
  • the system includes a low profile (e.g., 18 French to 19 French) mechanical circulatory support (MCS) device which includes an axial rotary blood pump and an elongate inlet tube, carried by the distal end of a nine French catheter.
  • MCS mechanical circulatory support
  • the system can be positioned to span the MCS device across the aortic valve into the left ventricle, where it actively unloads the left ventricle by pumping blood from the left ventricle into the ascending aorta and systemic circulation, and may provide flow rates of up to about 6 L per minute at 60 mmHg. In some embodiments, flow rates between 0.6 L per minute and 6 L per minute may be provided.
  • the motor is completely sealed by encapsulation within a motor housing, having a magnetic coupling to allow the motor to drive the impeller without the need for a shaft to exit the housing.
  • the magnetic coupling includes a cylindrical driving magnet array positioned within the motor housing, concentrically positioned within a cylindrical driven magnet array located outside of the motor housing and mechanically coupled to the impeller.
  • the impeller rotates with respect to the motor housing about a pivot jewel bearing.
  • the magnetic coupling is flushed by a constant blood flow through flushing holes on proximal and distal ends of the magnetic coupling.
  • the sealed motor enables elimination of a purging process necessary for certain competitive devices.
  • the impeller includes a proximal portion having a housing for the driven magnets and a distal portion having the impeller blades.
  • the housing includes a cylindrical pocket extending axially into the housing from a proximal end of the housing. Radially inner and outer walls form the pocket and connect at a distal end by a transverse floor at the bottom of the pocket.
  • the driven magnets are located inside the pocket.
  • An end ring is welded to a proximal end of the housing to encapsulate the magnets inside the pocket.
  • the ring is welded along a first circumferential weld-seam at an interface with a radially outer surface of the outer wall of the housing.
  • the ring is further welded along a second circumferential weld-seam at an interface with a proximal end of the inner wall of the housing.
  • an impeller for a heart pump having a first portion and a second portion extending longitudinally from the first portion.
  • the first portion includes a shaft and one or more blades extending radially from the shaft.
  • the second portion includes a pocket, one or more magnets positioned within the pocket, and an end ring coupled to an end of the second portion.
  • the end ring encapsulates the one or more magnets within the pocket.
  • the impeller further includes a first circumferential weld-seam at an interface of the end ring and the end of the pocket and a second circumferential weld-seam at an interface of the end ring and the end of the pocket, wherein the first circumferential weldseam extends around a side wall of the second portion and the second circumferential weldseam extends along a face of the second portion.
  • the impeller further includes an outer wall and an inner wall extending longitudinally away from the first portion, wherein a radial distance between the outer wall and the inner wall defines the pocket.
  • the impeller further includes a first circumferential weld-seam at an interface of the end ring and the end of the outer wall and a second circumferential weld-seam at an interface of the end ring and the end of the inner wall.
  • the impeller further includes one or more alignment recesses within a wall of the pocket opposite the end ring.
  • a longitudinal distance between the one or more blades and the one or more magnets is less than 1 mm.
  • a mechanical circulatory support system including an elongate flexible catheter shaft and a circulatory support device.
  • the elongate flexible catheter shaft has a proximal end and a distal end.
  • the circulatory support device is carried by the distal end of the elongate flexible catheter shaft.
  • the circulatory support device includes a tubular housing, a motor, an impeller, and a sealed motor housing.
  • the motor has a shaft that is rotationally fixed with respect to a drive magnet array.
  • the impeller is rotationally fixed with respect to a driven magnet array.
  • the sealed motor housing is coupled with the tubular housing and encases the motor and the drive magnet array.
  • the impeller further includes a pocket and an end ring fixedly coupled at an end of a second portion.
  • the driven magnet array is housed within the pocket.
  • the end ring encapsulates the driven magnet array within the pocket.
  • the mechanical circulatory support system further includes an outer wall and an inner wall extending longitudinally away from a first portion, wherein a radial distance between the outer wall and the inner wall defines the pocket, and wherein a first circumferential weld-seam couples the end ring to an end of the outer wall and a second circumferential weldseam couples the end ring to an end of the inner wall.
  • the impeller further includes one or more blades, wherein a longitudinal distance between the driven magnet array and the one or more blades is less than 1 mm. In some embodiments, the impeller further includes one or more alignment recesses at an end of the pocket opposite the end ring.
  • a method of manufacturing an impeller including providing a workpiece, machining a pocket within an end of the workpiece, inserting one or more magnets into the pocket, and encasing the one or more magnets within the pocket with a cover.
  • the method further includes machining an impeller body from the workpiece, the impeller body having a first portion and a second portion, wherein the first portion comprises a shaft and one or more blades extending radially from the shaft; and the second portion comprises a cylindrical wall having a thickness.
  • the method further includes balancing the impeller.
  • balancing the impeller further includes mounting the impeller to a balancing device, spinning the balancing device, measuring an amount and a direction of imbalance of the impeller, and removing material from the cover.
  • the method further includes aligning the one or more blades.
  • machining the pocket further includes removing material from the workpiece between an outer dimension and an inner dimension along a longitudinal direction of the workpiece.
  • encasing the one or more magnets within the pocket with the cover further includes welding the cover to the outer dimension and the inner dimension at an end of the pocket.
  • FIG. 1 is a side elevational view of an embodiment of a MCS system in accordance with the present disclosure.
  • FIG. 2A is a partial perspective view of a distal pump region of an embodiment of a MCS device.
  • FIG. 2B is a side elevational view of an embodiment of a distal region of the MCS device shown in FIG. 2.
  • FIG. 3A is a cross-sectional view of an example MCS device having a driving magnet and an impeller with a driven magnet encapsulated with a back-iron welded along two circumferential weld-seams along a longitudinal length of the impeller.
  • FIG. 3B is example pins for a bearing configuration for the MCS device of FIG. 3A.
  • FIG. 4 is a cross-sectional view of another embodiment of an impeller with a driven magnet housing having a cylindrical pocket and proximal end ring welded along a first circumferential weld-seam along a longitudinal length of the impeller and a second circumferential weld-seam at a proximal end of the impeller.
  • FIG. 5A is a cross-sectional view of an MCS device with a driving magnet and the impeller of FIG. 4.
  • FIG. 5B is a cross-sectional view of an MCS device with a driving magnet and an impeller with the pin of FIG. 3B.
  • FIG. 5C is a side view of an MCS device with an impeller for directing fluid flow.
  • FIG. 6 is a perspective cross-sectional view of the impeller as taken along the line A-A in FIG. 4.
  • FIGS. 7A-7C are sequential perspective views of assembly of the driven magnets and the end ring of the impeller of FIG. 4.
  • FIGS. 8-11 are views of an MCS device with an impeller having a distally directed purging flow and a proximally directed purging flow to avoid accumulation of heat and/or formation of a thrombus in the bearing.
  • FIGS. 12-15 are perspective views of a two-part impeller assembly.
  • MCS Mechanical Circulatory Support
  • the MCS system as described herein may include a temporary (generally no more than about 6 hours, but it may be used longer) left ventricular support device for use during high-risk percutaneous coronary intervention (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and/ or depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option.
  • PCI percutaneous coronary intervention
  • the MCS system as described herein may include a long-term left ventricular support device for use during and/or after high- risk PCI performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and/or depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option.
  • the MCS system as described herein may include a long-term (e.g., one or more days, weeks, or months) left ventricular support device for use in patients when a health care provider has determined it is an appropriate therapeutic option.
  • the embodiments of MCS systems and devices as described herein may be placed across the aortic valve via a single femoral arterial access.
  • the solutions proposed herein have features that function to direct blood flow across the contacting surfaces of the bearing (e.g., the pin and cone bearing, the bearing between the impeller component and the motor housing) with a sufficient flow rate and flow turbulence to avoid accumulation of heat and/or formation of a thrombus in the bearing for the expected duration of use of the MCS device.
  • the expected use of the MCS system 100 may be for example, up to 72 hours of operation, up to 7 days of operation, with a flow rate of up to 61/min (e.g.
  • factors that may contribute to a design that reduces risk of blood coagulation may include the design of the bearing 330 (e.g., the size and materials which impact heat capacity and conductance, the contact surfaces and friction coefficient; forces applied to the bearing surfaces (e.g. hydrodynamic thrust, magnetic pull, vibration); speed of the impeller; boundary between fluids and device surfaces.
  • references in the specification to “one embodiment,” “an embodiment”, or “in some embodiments” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the disclosure. Moreover, the appearance of these or similar phrases throughout the specification does not necessarily mean that these phrases all refer to the same embodiment, nor are separate or alternative embodiments necessarily mutually exclusive. Various features are described herein which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but may not be requirements for other embodiments.
  • lateral means away from a central longitudinal axis
  • proximal means towards or near a particular reference point
  • distal means away or far from a particular reference point
  • the mechanical circulatory support (MCS) system of the present disclosure includes an impeller having a housing with a cylindrical pocket and welded end ring. A magnet or magnet array is located inside the pocket.
  • the ring is welded along a circumferential weldseam at an interface with a radially outer wall of the housing.
  • the ring is further welded along an axial weld-seam at an interface with an axial proximal end of an inner wall of the housing.
  • the inner and outer walls define lateral sides of the pocket, with a bottom of the pocket defined by a transverse floor connecting distal ends of the inner and outer walls.
  • the two walls may have differing axial lengths, for example with the inner wall extending farther proximally than the outer wall.
  • the ring may be machined after assembly to balance the mass distribution of the impeller about a central, rotational longitudinal axis.
  • the MCS system may be a temporary (e.g., generally no more than about 6 days) support system for enhancing cardiac output in cardiogenic shock patients such as caused by a myocardial infarction (e.g., Acute ST-elevation myocardial infarction which is a heart attack in an ST segment which encompasses the region between the end of ventricular depolarization and the beginning of ventricular repolarization on an electrocardiogram (ECG)).
  • ECG electrocardiogram
  • a pump of the system is placed across the aortic valve typically via transvascular access and pumps blood from the left ventricle to the ascending aorta.
  • the MCS device of the present disclosure may be similar to the MCS device disclosed in U.S. Patent Application No.
  • An expandable sheath allows 8 to 14 French (e.g., 8 to 10.5 French) initial access size for easy insertion and closing, expandable to allow introduction of at least about a 14 French and preferably an 18 to 19 French device. Access may be accomplished via transfemoral, transaxillary, transaortal or transapical approach.
  • the MCS device may include an inlet tube portion that extends across the aortic valve of a heart.
  • An impeller (for example, see FIGS. 3A and 4) of the MCS may be located at least partially at the outflow section (in the ascending aorta) of the inlet tube drawing blood from the left ventricle of the heart and may eject the blood into the ascending aorta.
  • the MCS device can include a motor, which can be mounted directly proximal to the impeller in an encapsulated housing eliminating the need to purge the motor prior to or during use.
  • the MCS device can actively unload blood from the left ventricle by pumping blood from the ventricle and ejecting the pumped blood into the ascending aorta and systemic circulation.
  • the pump is operated or is configured to operate without purging blood or other fluids from the system.
  • One implementation of the system includes an 18 to 19 French axial rotary blood pump and inlet tube assembly mounted on a catheter such as a catheter no larger than 10.5 French.
  • the ventricular support pump can be driven by a ventricular support controller to provide at least about 4.0 or 5.0 and up to about 6.0 liters/minute (l/min) of partial left ventricular support, at about 60 mm Hg pressure differential. No system purging is needed due to the encapsulated motor and magnetic bearing design.
  • the MCS device can be driven by the MCS controller to provide between about 0.4 l/min and about 6.0 1/min of, for example, partial left ventricular support.
  • the MCS device can be driven by the MCS controller to provide between about 0.61/min and about 6.0 1/min of, for example, partial left ventricular support.
  • the overall MCS system can include a series of related subsystems and accessories, including one or more of the following:
  • the MCS device may include an elongate flexible catheter shaft with an inlet tube, an impeller, a motor, and sensors and associated housings, and a proximal hub, an insertion tool, a proximal cable, an infection shield, a guidewire guide tube, and/or a guidewire aid.
  • the MCS device may be provided sterile.
  • the MCS device may contain the electrical cables and a guidewire lumen for over-the wire insertion.
  • the proximal hub may contain a guidewire outlet with a valve to maintain hemostasis and connect the ventricular support shaft to the proximal cable, where the proximal cable connects the MCS device to the MCS controller.
  • the proximal cable may be about 3.5 m (approx. 177 inch) in length and extend from a sterile field to a non-sterile field where the MCS controller is located.
  • An MCS device insertion tool can be a part of the MCS device to facilitate the insertion of a pump of the MCS device into an introducer sheath and to protect an inlet tube and hemostasis valves from potential damage or interference when passing through the introducer sheath.
  • a peel-away guidewire aid may be pre-mounted on the MCS device to facilitate the insertion of a guidewire, for example an 0.018” placement guidewire, into the inlet tube and into the MCS shaft.
  • a guidewire for example an 0.018” placement guidewire
  • a 3 m long, 0.018” wide placement guidewire may be used, having a soft coiled pre-shaped tip for atraumatic wire placement into the left ventricle.
  • the guidewire may be provided sterile.
  • An introducer sheath that is expandable between a low profile in a range of 8 to 14 French (e.g., 8 to 10.5 French) to a larger profile in a range of 14 to 21 French (e.g., 14 to 19 French) with a usable length of at least about 250 mm or 275 mm may be used.
  • the introducer sheath may maintain access into the femoral artery and provide hemostasis for the 0.035” guidewire, the 5 to 6 French diagnostic catheters, the 0.018” placement guidewire, and the insertion tool.
  • the housing of the introducer sheath may accommodate the MCS insertion tool.
  • the introducer sheath may be provided sterile.
  • An introducer dilator compatible with the introducer sheath may be used to facilitate atraumatic insertion of the introducer sheath into the femoral artery.
  • the introducer dilator may be provided sterile.
  • An MCS controller may be used, which drives and operates the MCS device, observes its performance and condition as well as providing error and status information.
  • the powered controller may be designed to support at least about 12 hours of continuous operation and contains a basic interface to indicate and adjust the level of support provided to the patient. Moreover, the MCS controller may provide an optical and/or audible alarm notification in case the MCS device detects an error during operation.
  • the MCS controller may be provided non- sterile and be contained in an enclosure designed for cleaning and re-use outside of the sterile field. The controller enclosure may contain a socket into which the extension cable is removably plugged. Any of the above features may be included in the embodiments shown in the figures.
  • FIG. 1 there is illustrated an embodiment of the MCS system
  • distal and proximal directions are indicated by arrows in a number of figures.
  • distal and proximal as used herein have their usual and customary meaning as described above, and include, without limitation, a direction more distant from an entry point of the patient’s body as measured along the delivery path, and a direction less distant from an entry point of the patient’s body as measured along the delivery path, respectively.
  • the MCS system 100 includes an introducer sheath 102 having a proximal introducer hub 104 with a central lumen for axially movably receiving a MCS shaft 106 and being expandable to axially movably receive an MCS device 101 that includes an impeller housing of the present disclosure, as further described.
  • the MCS shaft 106 extends between a proximal hub 108 and a distal end 110.
  • the proximal hub 108 may be provided with an integrated microcontroller for device identification and tracking of the running time which could be used to prevent overuse to avoid excessive wear or other technical malfunction.
  • the microcontroller or memory device could disable the device, for example to prevent using a used device. They could communicate with the controller, which could display information about the device or messages about its usage.
  • An atraumatic cannula tip with radiopaque material allows the implantation/explantation to be visible under fluoroscopy.
  • the MCS device 101 can include a tubular housing.
  • the tubular housing of the MCS device 101 is used broadly herein and may include any component of the MCS device
  • the MCS device 101 may be carried by a distal region of the MCS shaft 106.
  • the MCS device 101 may be provided with at least one central lumen for axially movably receiving a guidewire 112.
  • the proximal hub 108 is additionally provided with an infection shield 114.
  • a proximal cable 116 extends between the proximal hub 108 and a connector 118 for releasable connection to a control system typically outside of the sterile field, to drive the MCS device 101 and communicate with sensors in the MCS device 101.
  • the MCS system 100 may include an insertion tool, having an elongate tubular body having a length able to contain the MCS device 101, for example within the range of from about 85 mm to about 160 mm (e.g., about 114 mm) and an inside diameter able to slidably contain the MCS device 101, for example within the range of from about 6 mm to about 6.5 mm, extending distally from a proximal introducer hub 104.
  • the tubular body may include a central lumen adapted to axially movably receive the MCS shaft 106 and the MCS device 101 there through, and sufficient collapse resistance to maintain patency when passed through the hemostatic valves of the introducer sheath.
  • the MCS device 101 can be positioned within the tubular body, such as to facilitate passage of the MCS device 101 through the hemostatic valve(s) on the proximal end of a proximal introducer hub 104.
  • a marker 222 can be provided on the MCS shaft 106 spaced proximally from the distal tip 204 (see FIG. 2) such that as long as the marker 222 is visible on the proximal side of the hub 120, the clinician knows that the MCS device 101 is within the tubular body.
  • the hub 120 may be provided with a first engagement structure for engaging a complimentary second engagement structure on the introducer sheath 102 to lock the insertion tool into the introducer sheath 102.
  • the hub 120 may also be provided with a locking mechanism for clamping onto the MCS shaft 106 to prevent the MCS shaft 106 from sliding proximally or distally through the insertion tool once the MCS device 101 has been positioned at the desired location in the heart.
  • the hub 120 may additionally be provided with a hemostasis valve to seal around the MCS shaft 106 and also accommodate passage of a pump having the larger diameter.
  • the MCS device 101 as packaged may be prepositioned within the insertion tool and the guidewire aid may be pre-loaded within the MCS device 101 and the MCS shaft 106.
  • An embodiment of an MCS system 100 is shown in FIGS. 2A-2B.
  • the MCS system 100 may include a motorized pump, intended to be inserted in a patient’s left ventricle across an aortic valve, on the distal end of an MCS shaft 106 (e.g., a catheter) that is connected to a computer-controlled power source intended to remain outside of the patient. Further details of an example MCS system 100 are provided in U.S. Application No.
  • FIG. 2A illustrates additional details of a distal pump region 200 of the MCS system 100, showing a distal portion of the MCS shaft 106.
  • the MCS shaft 106 may be elongate and/or flexible.
  • the MCS shaft 106 may be referred to as a catheter shaft.
  • the distal pump region 200 extends between a bend relief 202 at the distal end of MCS shaft 106 and a distal tip 204 (or nose piece).
  • the MCS device 101 may include a tubular housing 250 which may include an inlet tube 210 (or inlet cannula), a distal tip 204 (or nose piece), and/or a motor housing 214.
  • the tubular housing 250 may include one or more pump inlets 206 and/or pump outlets 208, which may be part of the inlet tube 210, or part of other structures such as an intermediate structure joining a proximal end of the inlet tube 210 to the motor housing 214.
  • a guidewire guide aid as further described herein, may extend into and out of various components of the system, such as the tubular housing 250 and/or the MCS shaft 106 of the MCS device 101.
  • a pump inlet 206 (or inlet windows) comprising one or more windows or openings is in fluid communication with the pump outlet 208 (or outlet windows) comprising one or more windows or openings by way of a flow path extending axially through the inlet tube 210 (or inlet cannula).
  • the pump inlet 206 (or inlet windows) may be positioned at about the transition between the inlet tube 210 and the proximal end of distal tip 204.
  • the pump inlet 206 may be generally within about 5 cm, 3 cm, or less distance from the first guidewire port 216.
  • the distal tip 204 is radiopaque.
  • the distal tip 204 may be made from a polymer containing a radiopacifier such as barium sulfate, bismuth, tungsten, iodine.
  • a radiopaque marker is positioned on the inlet tube between the pump outlet 208 and the second guidewire port 218 to indicate the current position of the aortic valve.
  • the inlet tube 210 may include a highly flexible slotted (e.g., laser cut) metal (e.g., Nitinol) tube having a polymeric (e.g., Polyurethane) tubular layer to isolate the flow path.
  • the inlet tube 210 tube may have an axial length within the range of from about 60 mm and about 100 mm, and in one implementation is about 67.5 mm.
  • the outside diameter may be within the range of from about 5 mm to about 6.5 mm, and in one implementation is about 5.5 mm.
  • the connections between the inlet tube 210 and the distal tip 204 and to the motor (or motor housing 214) may be secured such as through the use of laser welding, adhesives, threaded or other interference fit engagement structures, or may be via press fit.
  • An impeller 212 may be positioned in the flow path between the pump inlet 206 and pump outlet 208 (see for example FIG. 3 A). In the illustrated embodiment, the impeller 212 is positioned adjacent to the pump outlet 208. As is discussed further below, the impeller 212 is rotationally driven by a motor contained within motor housing 214. In some embodiments, the motor driving the impeller 212 is positioned on the proximal side of the impeller 212.
  • the impeller 212 may include the impeller housing of the present disclosure, as further described.
  • the guidewire 112 may extend proximally throughout the length of the catheter or the MCS shaft 106 through a guidewire lumen therein.
  • the guidewire 112 exits the inlet tube 210 via second guidewire port 218, extends proximally across the outside of the impeller 212 and motor housing 214, and reenters the MCS shaft 106 via a third guidewire port 220.
  • the third guidewire port 220 may be located proximal to the motor, and, in the illustrated embodiment, is located (or formed) on the bend relief 202.
  • Third guidewire port 220 may be in communication with a guidewire lumen of the MCS shaft 106 which extends proximally throughout the length of the MCS shaft 106 and exits at a proximal guidewire port carried by the proximal hub 108.
  • FIG. 2B is a side, cross-sectional view and a detail view respectively of the distal pump region 200 of an embodiment of the MCS system 100 showing an embodiment of the guidewire aid 260.
  • the MCS system 100 can be provided in either a rapid exchange configuration or over the wire configuration.
  • a first guidewire port 216 (such as a distal-facing opening) on a distal face of the distal tip 204 may be in communication, via a first guidewire lumen through the distal tip 204 and at least a portion of the flow path in the inlet tube 210, with the second guidewire port 218 extending, for example, through a side wall of the inlet tube 210, and distal to the impeller 212.
  • This allows the guidewire 112 to exit the inlet tube 210 of the distal pump region 200 at the second guidewire port 218 and extend proximally along the outside of the catheter or the MCS shaft 106 from the second guidewire port 218.
  • the guidewire 112 may extend proximally throughout the length of the catheter or the MCS shaft 106 through a guidewire lumen therein. In some embodiments, however, the guidewire 112 may exit the inlet tube 210 via the second guidewire port 218, extend proximally across the outside of the impeller 212 and motor housing 214, and reenters the MCS shaft 106 via the third guidewire port 220.
  • the third guidewire port 220 may be located proximal to the motor, and, in the illustrated embodiment, is located (or formed) on the bend relief 202.
  • Third guidewire port 220 may be in communication with a guidewire lumen of the MCS shaft 106 which extends proximally throughout the length of the MCS shaft 106 and exits at a proximal guidewire port carried by the proximal hub 108.
  • the pump may be provided assembled with the removable guidewire aid 260 having a guidewire guide tube 262 which tracks the intended path of the guidewire from the first guidewire port 216, proximally through the distal tip 204 (or nose piece) and back outside of the inlet tube 210 via the second guidewire port 218 and back into the MCS shaft 106 via the third guidewire port 220.
  • the guidewire guide tube 262 may extend proximally within the MCS shaft 106 to a proximal end 264, in communication with, or within the guidewire lumen, which extends to the proximal hub 108.
  • the proximal end 264 may be positioned within about 5 mm or 10 mm of the distal end of the MCS shaft 106, or may extend into the lumen of the MCS shaft 106 for at least about 10 mm or 20 mm, such as within the range of from about 10 mm to about 50 mm.
  • the third guidewire port 220 may be located within a proximal end of the tubular housing, such as the motor housing or backend, or in any other components of the device at a location that is proximal to the impeller.
  • the guidewire aid 260 may have a funnel 266.
  • the funnel 266 may be located at a distal end of the guidewire guide tube 262 and provided pre-positioned at a distal end of the inlet tube, for example at the distal tip 204 (or nose piece).
  • the funnel 266 may increase in width in the distal direction, from a narrow proximal end in communication with the guidewire guide tube 262, to a wider distal opening at a distal end of the funnel 266.
  • the funnel 266 may be conical, frustoconical, pyramidal, segmented, or other shapes. A proximal end of the funnel 266 may be attached to a distal end of the guidewire guide tube 262.
  • the proximal end of the guidewire 112 may be inserted into the funnel 266, passing through the first guidewire port 216 and guided along the intended path by tracking inside of the guidewire guide tube 262.
  • the guidewire guide tube 262 may then be removed by sliding the guidewire guide tube 262 distally out of the distal tip 204 and peeling it apart longitudinally, leaving the guidewire 112 in place.
  • the guidewire aid 260 may have a pull tab 268.
  • a distal end of the guidewire guide tube 262 is attached to the pull tab 268 of the guidewire aid 260.
  • the pull tab 268 may be a structure capable of being gripped by a human hand, for example with a lateral, planar extension as shown.
  • the guidewire aid 260 for example, the pull tab 268, the guidewire guide tube 262 and/or the funnel 266, may be provided with a tearable line.
  • the tearable line may be an axially extending split line.
  • the guidewire aid 260 may include a proximal opening 270 configured to slip over and removably receive the distal end of the MCS system 100, in particular the distal tip 204 and fragile struts that define the pump inlets 206.
  • a guidewire guide tube 262 having a lumen therethrough may be positioned within the proximal opening 270 and aligned to pass through the first guidewire port 216 of the distal tip 204.
  • the proximal opening 270 may further be configured to slip over and removably receive a distal end of a tubular body of an insertion tool.
  • the MCS system 100 may be dimensioned so that an annular space defined between the outer surface of the MCS system 100 such as the inlet tube 210, the motor housing 214, the bend relief (or strain relief) 202, and the inner surface of the tubular body of the insertion tool, may removably receive the guidewire guide tube 262 therein, when the MCS system 100, guidewire aid 260 and insertion tool are assembled together.
  • the lumen of the guidewire guide tube 262 may be in communication with a distal flared opening of the funnel 266 which gets larger in crosssection in the distal direction.
  • the guidewire aid 260 may be provided assembled on the MCS system 100 with the guidewire guide tube 262 pre-loaded along a guidewire path, for example into the MCS system 100 through the first guidewire port 216, through a portion of the fluid path within the inlet tube 210, out of the MCS system 100 through the second guidewire port 218, along the exterior of the MCS system 100 and back into the MCS shaft 106 through the third guidewire port 220.
  • a pull tab 268 may be provided on the guidewire aid 260 to facilitate grasping and removing the guidewire aid 260, including the guidewire guide tube 262, following loading of the guidewire 112.
  • the guidewire aid 260 may have a longitudinal slit or tear line, for example along the funnel 266, proximal opening 270 and guidewire guide tube 262, to facilitate removal of the guidewire aid 260 from the MCS system 100 and guidewire 112.
  • the distal end of the guidewire guide tube 262 is attached to the guidewire aid 260.
  • the guidewire guide tube 262 may be provided with an axially extending split line such as a weakening, slot or perforated tearable line. Removal of the guidewire guide tube 262 may be accomplished such as by grasping the pull tab 268 and pulling out the guidewire guide tube 262 as it splits along the split line to release the guidewire 112.
  • the inside surface of the guidewire guide tube 262 may be provided with a lubricious coating, such as PTFE.
  • the guidewire aid 260 features described herein may be used with a variety of different MCS systems and/or pump devices.
  • the guidewire aid 260 may be used for guidewire paths that enter and exit a pump housing, as described, or that do not exit a housing.
  • the guidewire aid 260 is described herein as being used with an MCS system configured for temporary operation for high-risk PCI procedures.
  • the system may include rotating impeller with a radial shaft seal and a motor rotating the impeller via a shaft extending through the seal.
  • the guidewire aid 260 may be used with a variety of different devices.
  • the guidewire aid 260 may also be used with a pump having a magnetic drive, where the motor rotates a first magnet within a sealed motor housing that magnetically communicates with a second magnet of the impeller that is external to the sealed housing to rotate the impeller.
  • the guidewire aid 260 is not limited to use with only the particular pump embodiments described herein.
  • FIG. 3A illustrates an example embodiment of a pump 300 (for example, a rotor bearing system) that can provide contactless torque transfer and include a radial and axial motor mount.
  • the pump 300 may be a rotor bearing system for MCS devices or systems described herein, such as those of FIGS. 1 and 2A-2B.
  • the pump 300 has a pump housing 340 that encapsulates a motor, drive shaft, and drive magnet array hermetically sealed from the surrounding environment.
  • a first magnet array 342 (or drive magnet array) may be seated on a shaft 358 that can be driven by a motor.
  • the first magnet array 342 may rotate about a longitudinal axis 312.
  • the pump housing 340 may have a first cylindrical portion having a first outer diameter 364 (for example, in a range of 5 to 7 mm, preferably 6 mm) that radially encompasses the motor (not shown), a second cylindrical portion having a second outer diameter 362 that is less than the first outer diameter (e.g., less than the first outer diameter by a range of 0.3 to 1 mm, preferably by 0.5 mm), and a third cylindrical portion having a third outer diameter 360 that is less than the second outer diameter (e.g., less than the second outer diameter by 1.7 to 2.3 mm, preferably by 2.0 mm).
  • a first outer diameter 364 for example, in a range of 5 to 7 mm, preferably 6 mm
  • second cylindrical portion having a second outer diameter 362 that is less than the first outer diameter (e.g., less than the first outer diameter by a range of 0.3 to 1 mm, preferably by 0.5 mm)
  • a third cylindrical portion having a third outer diameter 360 that is less
  • the second cylindrical portion with the second outer diameter 362 may securely mate with an inlet tube referred to as a second housing 322, wherein the second cylindrical portion and the second housing 322 may be sized so the outer diameter of the second housing 322 is flush with the outer circumference of the first cylindrical portion having the first outer diameter 364 (for example, the thickness of the second housing 322 may be equal to the difference between the first outer diameter and second outer diameter divided by 2).
  • the third outer diameter 360 of the pump housing 340 may be, for example, in a range of 3.2 to 3.8 mm, preferably 3.5 mm.
  • the pump 300 may include the impeller 212 for conveying a liquid.
  • the impeller 212 may include the second magnet array 344 (or driven magnet array) in the form of, for example, a series of circumferentially-spaced axial magnets, or as a magnetic cylinder, and which magnets may be hollow.
  • the second magnet array 344 may be mounted or positioned to rotate about the longitudinal axis 312.
  • the second magnet array 344 may be positioned within a hollow, cylindrical jacket 306 such that the second magnet array 344 is arranged in a form of a hollow cylinder defining a cavity.
  • the first magnet array 342 can magnetically couple with the second magnet array 344. In an operable state, the first magnet array 342 can rotate around the longitudinal axis 312 of the impeller. In response to the rotation of the first magnet array 342, the second magnet array 344 coupled with the first magnet array 342 can rotate.
  • the jacket 306 may include a back-iron 346 positioned around (or covering) a radial exterior of the second magnet array 344.
  • the back-iron 346 may be an outer covering surrounding the second magnet array 344.
  • the back-iron 346 may enclose a pocket 341 formed in the side of the impeller housing.
  • the pocket 341 may be open radially outwardly.
  • the back- iron 346 may be welded along two circumferential weld-seams 347, 349 along the longitudinal length of the jacket 306.
  • the two circumferential weld-seams 347, 349 can be defined by a circumferential extension around the outer periphery of the jacket 306.
  • the two- circumferential weld-seams 347, 349 can couple a cover to the jacket 306 to contain the back- iron 346.
  • the jacket 306 may be cylindrical having a constant outer diameter (OD) (e.g., -5.5 mm, in a range of 4 mm to 8 mm), inner diameter (ID) (e.g., ⁇ 3.9 mm, in a range of 2.5 to 6.5 mm) and thickness (e.g., ⁇ 0.8 mm, in a range of 0.5 mm to 2 mm).
  • a first circumferential weld-seam 347 can be positioned distally of the distal end of the back-iron 346 along the outer periphery of the jacket 306.
  • a second circumferential weld-seam 349 can be positioned proximally of the proximal end of the back-iron 346.
  • the second circumferential weld-seam 349 can be positioned at the proximal end of the back-iron 346.
  • the cover may be longitudinally aligned and parallel with the back-iron
  • one or more of the circumferential weld-seams 347, 349 between the cover and the jacket 306 may form a butt-weld where the cover is placed end-to-end with an end of the jacket 306. In some embodiments, one or more of the circumferential weld-seams
  • the circumferential weld-seams 347, 349 may require a buffer on either side of the weld-seam to account for melting the cover and jacket 306. Accordingly, the circumferential weld-seam 347, 349 may require some additional longitudinal length of the jacket 306 as a buffer. Thus, the longitudinal length of the jacket 306 may be extended to account for two circumferential weld-seam 347, 349.
  • the first magnet array 342 may have an outer diameter of 3 mm, a magnet height of 1 mm, and a length of 3.2 mm (e.g., in a range of 3 to
  • the second magnet array 344 may have an outer diameter of 5.3 mm (e.g., in a range of 5 to 5.3 mm), a magnet height of 0.6 mm (e.g., in a range of 0.5 to 0.6 mm), and a length of
  • the stagger 348 between the first magnet array 342 and the second magnet array 344 may be 1 mm (e.g., in a range of 0.1 to 1.2 mm).
  • the jacket 306 of the impeller 212 may have an outer diameter of 5.3 mm (e.g., less than the second outer diameter 362 by a range of 0.1 to 0.4, preferably 0.2 mm) and a length of 15 mm.
  • the impeller 212 may convert the mechanical power transferred by the shaft 358 into hydraulic power to convey a blood flow against a blood pressure.
  • the impeller 212 can include blades or vanes 303 which induce blood flow. The orientation of the blades or vanes 303 can induce fluid flow against the blood pressure.
  • contact between components that move with respect to one another, in particular the components of the radial bearing 330A may generate friction and heat. Accumulation of heat can cause stagnant blood to coagulate, which can pose a safety risk to the patient or impede proper function of the MCS device.
  • the impeller 212 may include a tapered portion 302 integrated with the jacket 306.
  • the tapered portion 302 may be conical in shape.
  • the outer surface of the tapered portion 302 may be connected with or continuous with the outer surface of the jacket 306.
  • the first magnet array 342 (or drive magnet array) and the second magnet array 344 (or driven magnet array) at least partially axially overlap in an overlap area 310.
  • the first magnet array 342 may be axially staggered in relation to the second magnet array 344.
  • the centers of the first magnet array 342 and the second magnet array 344 are marked by vertical lines Ci, C2, respectively wherein the axial stagger 348 of the centers is identified between these two vertical lines Ci, C2.
  • the second magnet array 344 can be positioned radially of the first magnet array 342.
  • the second magnet array 344 can be driven by the first magnet array 342. Accordingly, the second magnet array 344 can experience a radial passive magnetic coupling with the first magnet array 342.
  • the pump 300 can include a first bearing 320, a second bearing 314, and a third bearing 328.
  • the first bearing 320 can be disposed within the distal tip of the pump housing 340.
  • the first bearing 320 can be configured to assist in rotation of the pump housing 340 relative to the impeller 212.
  • the first bearing 320 may be configured for engaging a ball 316A and/or cone 318A.
  • a second bearing 314 may be a radial, hydrodynamic, and blood lubricated plain bearing.
  • the second bearing 314 may be arranged on the end (for example, a distal end) of the tapered portion 302 of the impeller 212.
  • the second bearing 314 may absorb radial forces applied to the impeller 212 and may position the axis of rotation of the impeller 212 and the second magnet array 344 (or driven magnet array) in alignment with the longitudinal axis 312 of the shaft 358 about which the shaft 358 may rotate, or the first magnet array 342.
  • the second bearing 314 may be arranged between the impeller 212 and an insert 326, which may be fastened, in particular clamped in or pressed in, in a ring-shaped, distal end of the second housing 322, which is in turn fastened onto the pump housing 340.
  • the second housing 322 may form an exterior skin or cover of the pump 300.
  • the second housing 322, which may be referred to as an impeller housing, may include one or more pump outlet 208 (or outlet windows).
  • the insert 326 may be a bearing star that may be firmly attached (for example, glued, welded, or friction fitted) to the second housing 322.
  • the insert 326 may have an outer diameter of 6 mm (e.g., in a range of 5 to 7 mm) and a length of 3 mm (e.g., in a range of 2 to 5 mm).
  • the second housing 322 may have an outer diameter of 6 mm (e.g., in a range of 5 to 7 mm), a length of 18 mm (e.g., in a range of 15 to 21 mm), and a wall thickness of 0.25 mm (e.g., in a range of 0.15 to 0.5 mm).
  • the insert 326 and second housing 322 may be manufactured as a single piece, which may have a consistent inner diameter.
  • an extended inlet cannula may be connected to the combined insert 326 and second housing 322 for example by laser welding.
  • the second bearing 314 may have a diameter of 1 mm (e.g., in a range of 0.75 to 1.5 mm) and a length of 1 mm (e.g., in a range of 0.75 to 2 mm).
  • the third bearing 328 can be disposed within the impeller 212. In some embodiments, the third bearing 328 can be positioned distally of the ball 316A and/or cone 318A. The third bearing 328 can be configured to support the ball 316A and/or cone 318A within the impeller 212.
  • the second magnet array 344 may experience a force directed proximally, i.e. to the right as oriented in FIG. 3A, so that the ball 316A of the impeller 212 is pushed onto a cone 318A arranged in the pump housing 340, and so that the first bearing 320 and the third bearing 328, which in this case form a combined axial and radial bearing 330A, are held in contact.
  • the ball 316A and cone 318A may be flipped, such that the ball 316A may be a part of the pump housing 340, and the cone 318A may be a part of the impeller 212.
  • the ball 316A may rotate in the cone 318A, so that both radial and axial forces can be absorbed and the axial and radial bearing is achieved.
  • the combined axial and radial bearing 330 may be a solid body bearing.
  • the ball 316A is arranged in the tapered portion 302.
  • the ball 316A may have a diameter, for example, in a range of 0.5 mm to 0.9 mm, preferably 0.7 mm, and the cone 318A may have an opening diameter of 1 mm, a longitudinal height of 0.8 mm, and a cone angle within a range of 70° to 90°, preferably 80°.
  • the combined axial and radial bearing 330 may provide relative axial positioning of the impeller 212, the pump housing 340, and/or the shaft 358 to each other and may absorb an axial force caused by the arrangement (or relative positions) of the first magnet array 342 and the second magnet array 344.
  • the axial force on the pump 300 may be adjusted, so that the exerted force settings can be optimized.
  • the ball 316A may be replaced with a pin. For example, as described herein with reference to FIGS. 3B, 8, and 10.
  • the impeller 212 can held axially and radially in the pump by the second bearing 314 (e.g. journal bearing) and the third bearing 328 (e.g., a ball 316A or pin 316B with a convex hemispherical surface mating with a cone 318A or cup 318B having a concave hemispherical surface), which allow the impeller 212 to rotate in the pump about the longitudinal axis 312.
  • the bearing 330 may have a silicon carbide pin and sapphire cone.
  • the bearing 330 may have a lubrication chamber in association with contacting surfaces of the bearing components that provides a biocompatible lubricant to the bearing.
  • a portion of the pump housing 340 that encapsulates the first magnet array 342, may at least in part be radially surrounded by jacket 306 in the form of a hollow cylinder attached to the impeller 212.
  • a channel 308 in the form of a hollow cylinder may be formed between the pump housing 340 and the jacket 306 of the impeller 212, through which a liquid (for example, blood) can flow.
  • the channel 308 can be a coupling purge flow space for purging a volume between the jacket 306 and a motor housing as described in greater detail herein with reference to FIGS. 5 A and 5B.
  • the impeller 212 may include one or more bores or perforations called flushing outlets 356.
  • the flushing outlets 356 are formed in the tapered portion 302 (or conical portion) of the impeller 212, or in a transition portion between the tapered portion 302 and the jacket 306.
  • the flushing outlets 356 may be in fluid communication with the channel 308 such that, for example, fluid (for example, blood) can flow into the area between the pump housing 340 and the jacket 306 via the channel 308 and exit via the flushing outlets 356.
  • the fluid can flow through a flushing inlet 352 formed between the proximal end of the jacket 306 and the motor housing.
  • the flushing inlet can be a circumferential gap between the jacket 306 and the motor housing.
  • liquid for example, blood
  • Purging flow 354 indicates the direction of flow of the liquid through the channel 308 and the flushing outlets 356.
  • the purging flow can introduce new blood into the channel 308 to prevent blood from stagnating and coagulating.
  • the purging flow can be referred to as a flushing flow.
  • Pump flow 350 indicates the direction of flow of liquid transferred by the vanes 303 of the impeller 212.
  • FIG. 3A illustrates the flushing outlets 356 at an angle. In some embodiments, the flushing outlets 356 may be orthogonal to the longitudinal axis 312 of the shaft 358.
  • a build-up can occur, for example, in an area between the jacket 306 and the pump housing 340 shown in FIG. 3A, and reduce pumping efficiency of the pump 300.
  • the build-up can reduce the amount of torque transferred between the pump housing 340 and the impeller 212 and therefore reduce the amount of blood being pumped through the pump outlet 208.
  • the purging flow 354 described herein can prevent or mitigate such build-up caused by flow of blood during use of the pump 300, and allow the pump 300 to operate purgeless (that is, without having to purge).
  • the axial stagger 348 between the first magnet array 342 (or the drive magnet array) and the second magnet array 344 (or the driven magnet array) may generate a defined axial force on the impeller 212 in the proximal direction (that is, from left to right in the exemplary embodiment in FIG. 3A).
  • This force generated by the axial stagger 348 may be opposed by a hydraulic force applied on the impeller 212 during operation in the distal direction (that is, from right to left in the exemplary embodiment in FIG. 3A).
  • This hydraulic force applied on the impeller 212 may be in the opposite direction of the pump flow 350 generated by the spinning vanes 303 of the impeller 212.
  • the axial force originating from the coupling of the first magnet array 342 and the second magnet array 344 may be larger than the maximum expected hydraulic force, which ensures that the impeller 212 is at all times held in a defined axial position.
  • the combined axial and radial bearing 330 may not be unnecessarily overloaded, and friction and wear as well as reduction of torque transmitted to the rotor can be minimized.
  • the amount of the axial force may be varied by adjusting one or more of the dimensions (for example, length, thickness, outer diameter) of one or more of the first magnet array 342, the second magnet array 344, the axial stagger 348, and the segment angle, A (if in a Halbach configuration such as the one shown in FIG. 3A).
  • a first magnet array 342 and the second magnet array 344 axially overlap.
  • the first magnet array 342 may be seated on the shaft 358 driven by the motor (not shown), where the shaft 358 may rotate about the longitudinal axis 312.
  • the shaft 358 may also function as a back-iron.
  • the second magnet array 344 may be mounted such that it can rotate about the longitudinal axis 312.
  • both the first magnet array 342 and also the second magnet array 344 each has two pole pairs, that is to say respectively four poles that are each radially magnetized, which is indicated by small arrows.
  • both the first magnet array 342 and the second magnet array 344 may each have one pole pair or at least one pole pair (for example, two pole pairs, three pole pairs, four pole pairs).
  • the first magnet array 342 may form an inner ring seated on the shaft 358.
  • the shaft 358 may function as a back-iron.
  • the first magnet array 342 may include two pole pairs (or four poles) that may be each radially magnetized.
  • the second magnet array 344 may form an outer ring arranged in a Halbach array.
  • the second magnet array 344 may not need a back-iron.
  • the second magnet array 344 may include four tangentially magnetized magnet ring segments between the four radial segments, which can guide the magnetic field generated around the second magnet array 344.
  • this arrangement may efficiently prevent stray magnetic fields outside of the coupling (that is, between the first magnet array 342 and the second magnet array 344) and may increase the efficiency of the magnetic coupling between the first magnet array 342 and the second magnet array 344.
  • changing a segment angle can change the amount of axial force between the first magnet array 342 and the second magnet array 344.
  • the segment angle may be 45° and the pump 300 may have an outer diameter (for example, the first outer diameter 364 shown in FIG. 3A) of 6.2 mm.
  • the outer diameter (for example, the first outer diameter 364) of the pump 300 can limit the sizes of the first magnet array 342 and the second magnet array 344.
  • the inner and outer diameter of the first magnet array 342 are 1.0 mm and 3.0 mm, respectively.
  • the inner and outer diameter of the second magnet array are 4.1 mm and 5.3 mm, respectively.
  • the pump 300 can have the outer diameter greater than or less than 6.2 mm, which can result in smaller, larger, or the same sizes or dimensions (for example, the inner diameter and the outer diameter) for the first magnet array 342 and the second magnet array 344.
  • an axis Ai-Ai may correspond to a distal end of the pocket 341 within the jacket 306 defining the distal end of the second magnet array 344.
  • An axis Bi- Bi may correspond to a distal boundary of the cavity for receiving the pump housing 340.
  • the axis Bi-Bi can correspond to a plane intersecting the flushing outlets 356.
  • Distance Di represents the longitudinal distance between the axis Ai-Ai and the axis Bi- Bi. As shown in FIG.
  • the first circumferential weld-seam 347 is positioned between the axis Ai-Ai and the axis Bi-Bi for securing the lateral cover to the jacket 306 and enclosing the second magnet array 344 within the pocket 341.
  • the circumferential weldseam 347 requires longitudinal space adjacent to the circumferential weld-seam 347 to properly form a weld-seam.
  • the distance Di includes the longitudinal buffer length adjacent to the first circumferential weld-seam 347.
  • FIG. 3B illustrates an example of a radial bearing 330B for use within the impeller 212 described herein with reference to FIG. 3A.
  • the radial bearing 330B can include a pin 316B and a receptacle 317 for receiving the pin 316B.
  • the pin 316B can be the same or similar to the ball 316A described herein with reference to FIG. 3A. Accordingly, the pin 316B can be configured to engage the receptacle 317 so that the first bearing 320 and the third bearing 328 can be held in contact to support the impeller. For example, the pin 316B may rotate in the receptacle 317, so that both radial and axial forces can be absorbed and the axial and radial bearing is achieved.
  • the pin 316B can have multiple dimensions. In some embodiments, the pin 316B can have a primary dimension 366 and one or more secondary dimensions. The primary dimension 366 can be orthogonal to at least one of the secondary dimensions.
  • the primary dimension 366 can define an axial length of the pin 316B along a longitudinal axis 312.
  • the one or more secondary dimensions can include a first secondary dimension 368 and a second secondary dimension 370.
  • the first secondary dimension 368 can define a width or a first radius of the pin 316B extending radially from the longitudinal axis 312.
  • the second secondary dimension 370 can define a hemispheric end of the pin 316B.
  • the first secondary dimension 368 and the second secondary dimension 370 can be the same.
  • the first secondary dimension 368 and the second secondary dimension 370 can be in a range of 0.25 mm to 0.45 mm, preferably 0.35 mm.
  • the receptacle 317 for receiving the pin 316B can be configured to axially and/or rotatably support the pin 316B.
  • the pin 316B may rotate within the receptacle 317.
  • heat may be generated as the pin 316B rotates which can transfer to the surrounding blood and cause the blood to coagulate.
  • the receptacle 317 can be the same or similar to the cone 318A described herein with reference to FIG. 3 A.
  • the receptacl e 317 can b e a cup 318B .
  • the cup 318B can have a hemi spheri c groove or depression.
  • the hemispheric groove or depression can correspond to the size of the pin 316B.
  • the hemispheric groove or depression can have the same radius as the second secondary dimension 370.
  • the cup 318B can have a radius in the range of 0.25 mm to 0.45 mm, preferably 0.35 mm.
  • the cone 318A may have an opening diameter of 1 mm, a longitudinal height of 0.8 mm, and a cone angle within a range of 70° to 90°, preferably 80°.
  • FIGS. 4-7C illustrate an embodiment of an axially compact impeller.
  • the axially compact impeller can include an end ring for securing a driven magnet within the jacket section of the impeller.
  • Implementing the end ring can reduce the axial length of the jacket section by eliminating an axial distance needed for welding.
  • FIG. 4 illustrates an embodiment of an impeller 400A that may be used in any of the MCS systems and devices described herein.
  • the impeller 400A has a reduced longitudinal dimension relative to the impeller 212 of FIGS. 3A-3B.
  • the impeller 400A may have a distal first portion 401 and a proximal second portion 405.
  • the first portion 401 can include a shaft or tapered portion 402 and at least one blade or vane 403 extending radially from the shaft or tapered portion 402.
  • the second portion 405 can include a cylindrical jacket 406 and at least one magnet 444.
  • the second portion 405 may extend longitudinally and proximally away from the first portion 401 terminating in a proximal end opposite the first portion 401.
  • the impeller 400A may be similar to the impeller 212 described above, except as otherwise described.
  • the at least one blade or vane 403, the shaft or tapered portion 402, the jacket 406 of the impeller 400A, and the at least one magnet 444 may be the same as or similar to, the vanes 303, the tapered portion 302, the jacket 306 of the impeller 212 and the second magnet array 344, respectively.
  • the impeller 400A may also similarly include a ball 316A and flushing outlets 356 as described above.
  • the ball 316A may be replaced with a pin 316B as described in greater detail below with reference to FIG. 5B.
  • the jacket 406 of the second portion 405 of the impeller 400A can further include an inner wall 420 and an outer wall 422.
  • the inner wall 420 and the outer wall 422 can extend proximally along the second portion 405 defining a pocket 441 between the inner wall 420 and the outer wall 422.
  • the inner wall 420 and the outer wall 422 may have a circular cross-sectional shape (for example, see FIGS. 6-7C).
  • the inner wall 420 can define a hollow cylinder or cavity 407. Accordingly, the pocket 441 and the cavity 407 may be continuous openings adjacent to the inner wall 420.
  • the pocket 441 may be radially positioned relative to the cavity 407 with the inner wall 420 separating the pocket 441 from the cavity 407.
  • the at least one magnet 444 may be disposed within the pocket 441.
  • the at least one magnet 444 can extend axially from a distal end of the pocket 441 toward a proximal end of the impeller 400A.
  • the at least one magnet 444 may be an array or plurality of elongated magnets disposed intermittently and circumferentially throughout the pocket 441.
  • the at least one magnet 444 can engage the distal boundary of the pocket 441 corresponding to the axis A2-A2.
  • the jacket 406 can further include an end ring 428 also referred to as a cover or impeller ring.
  • the end ring 428 may be positioned at a proximal end of the impeller 400A.
  • the end ring 428 may cover an opening of the pocket 441 thereby encapsulating the contents of the pocket 441.
  • the end ring 428 may encapsulate the at least one magnet 444 within the pocket 441.
  • the end ring 428 can be positioned proximal relative one or more of the inner wall 420, the outer wall 422, and/or the at least one magnet 444.
  • the end ring 428 may be an annular end cover for fully encapsulating the at least one magnet 444 within the pocket 441.
  • the end ring 428 may form a ring to close off the pocket 441 from the environment thereby defining a proximal boundary for the pocket 441 and advantageously fluidly sealing off and separating the at least one magnet 444 from the anatomical environment of a patient.
  • the end ring 428 may be fixedly coupled to the inner wall 420 and the outer wall 422 at the proximal ends of the inner wall 420 and outer wall 422, respectively.
  • the end ring 428 may be welded to the inner wall 420 and outer wall 422.
  • the end ring 428 may be laser welded via a circumferential weld-seam 447 and an axial weld-seam 449. As described above, the laser weld-seams require a buffer to accommodate the melted metal during the welding process.
  • a circumferential weld-seam positioned along a longitudinal side of the jacket 406 may require a longitudinal buffer adjacent to the circumferential weld-seam extending circumferentially around the outer periphery of the jacket 406 and a circumferential weld-seam positioned along a proximal face of the jacket 406 may require a radial buffer adjacent to the circumferential weld-seam extending about the proximal face of the jacket 406. Accordingly, replacing the circumferential weld-seams 347, 349 disclosed in relation to the impeller 212 shown in FIG. 3A with axial weld-seams can advantageously reduce the longitudinal length of the impeller.
  • the cavity 407 may be sized to receive a housing and/or an output shaft connected to a motor.
  • the proximal end of the cavity 407 may be open to the environment for receiving an output shaft.
  • the axis B2-B2 can be parallel with the axis A2-A2 along a plane extending through the center of the flushing outlets 356.
  • Magnets can be coupled to an output shaft and axially inserted within the cavity 407.
  • the at least one magnet 444 can be magnetically coupled to magnets axially inserted within the cavity 407.
  • the at least one magnet 444 can be radially passively magnetically coupled to magnets axially inserted within the cavity 407. Rotation of the magnets axially inserted within the cavity 407 can transmit rotational forces to the at least one magnet 444 to cause rotation of the impeller blades or vanes 403.
  • the first portion 401 of the impeller 400A may create a flow when rotated about a longitudinal axis 312.
  • the at least one blade or vane 403 causes the flow.
  • the impeller 400A may expel liquid (such as blood) entering the hollow cylinder or cavity 407 of the impeller 400A defined by the jacket 406 along the purging flow 354 through the plurality of flushing outlets 356.
  • the axis A2-A2 and the axis B2-B2 may be longitudinally displaced by a distance D2.
  • the axis A2-A2 can correspond to a distal end of the pocket 441 and the axis B2-B2 can correspond to a plane along the longitudinal length of the impeller 400A corresponding to the flushing outlets 356.
  • axis B2-B2 can be the same as axis B1-B1.
  • the distance D2 may be less than the distance Di shown in FIG. 3A.
  • no circumferential weld-seam is positioned between axis A2-A2 and axis B2- B2.
  • D2 does not include a longitudinal buffer length of a corresponding circumferential weld-seam.
  • the longitudinal length of the impeller 400A may be further reduced by removing additional circumferential weld-seams.
  • the longitudinal length of the impeller 400A can be further reduced by moving the weld-seam 447 from the lateral side of the jacket 406 to the proximal end of the impeller 400A.
  • the impeller 400A can optimize the space available at the proximal end of the impeller 400A.
  • the distance D2 may be 1 mm or greater.
  • the distance D2 may be less than 1 mm.
  • the distance D2 may be 0.5 mm.
  • the distance D2 can be 0.45 mm. In some embodiments, the distance from the axis B2-B2 to the proximal end of the impeller 400A is about 4.5 mm. In some embodiments, the distance from the axis B2-B2 to the proximal end of the impeller 400A is 4.45 mm. Shortening the length of the MCS device may advantageously enhance navigation within a patient’s anatomy. For example, a shorter insertable object, such as the MCS device, may be more navigable within complex anatomies such as an aortic arch.
  • the inner wall 420 and outer wall 422 may be shortened in the longitudinal direction.
  • the corresponding longitudinal length of the pocket 441 may correspondingly be reduced.
  • the length of the at least one magnet 444 may be also reduced.
  • the at least one magnet 444 may be reduced from around 3.5 mm to around 3.2 mm. Decreasing the length of the inner wall 420, the outer wall 422, and the corresponding length of the at least one magnet 444, may advantageously increase axial forces of the magnetic coupling between the impeller 400A and the output shaft of the MCS device, as described in greater detail below.
  • the longitudinal length of the first portion 401 may be reduced.
  • the at least one blade or vane 403 of the first portion 401 may be less than 8.4 mm.
  • the at least one blade or vane 403 of the first portion 401 may have a longitudinal length of 8 mm. Reducing the length of the at least one blade or vane 403 may reduce speed and thus decrease hemolysis. In some embodiments, the speed may be reduced to about 37500 rpm.
  • FIG. 5A illustrates the impeller 400A of FIG. 4 axially and magnetically coupled with an output drive 500.
  • the output drive 500 may include a cup or cone 518, a housing 540, a magnet array 542, and a shaft 558.
  • the shaft 558 may be the same as the output shaft described in FIG. 3 A.
  • the cup or cone 518, the housing 540, the magnet array 542, and the shaft 558 may be the same as or similar to the cup or cone 318A, the pump housing 340, the first magnet array 342, and the shaft 358 described above, respectively.
  • the housing 540 may contain the magnet array 542 and the shaft 558.
  • the cup or cone 518 may be positioned at the distal end of the housing 540.
  • the housing 540 may be inserted within the cavity 407 of the impeller 400A.
  • the magnet array 542 may at least partially overlap with the at least one magnet 444 in the longitudinal direction.
  • the at least one magnet 444 may be positioned radially outward of the magnet array 542.
  • the cup or cone 518 may engage the ball 316A.
  • the ball 316A may be replaced with an elongated cylindrical pin such that the cup or cone 518 may engage a proximal end of the pin. For example, as described herein with reference to FIG. 3B.
  • the pocket 441 may be longitudinally aligned with an interior cavity 510 defined by the housing 540.
  • the distal end of the pocket 441 and the distal end 512 of the interior cavity 510 of the housing 540 may be aligned with the axis A2- A2 as shown in FIGS. 4 and 5A.
  • the axis A2-A2 may correspond to both distal boundaries of the pocket 441 and the cavity of the housing 540, respectively.
  • An MCS device implementing the impeller 400 can be shortened because the impeller 400 can have a deeper cavity 407 compared to the impeller 212, thereby allowing the housing 540 to sit deeper within the cavity 407.
  • the cavity 407 can be made deeper to better align the at least one magnet 444 of the impeller 400 with the magnet array 542 of the output drive 500. For example, moving the weld-seams 347, 349, 447, 449 to the proximal end of the impeller 400 can shift the position of the welding buffer material to the proximal end of the impeller 400. Accordingly, the at least one magnet 444 can be shifted distally within the pocket of the impeller 400 compared to the impeller 212.
  • Shifting the at least one magnet 444 distally can better align the at least one magnet 444 with the magnet array 542 of the output drive 500.
  • the at least one magnet 444 and the magnet array 542 can have the same axial offset.
  • the proximal edge of the at least one magnet 444 may be coplanar with the proximal edge of the magnet array 542.
  • FIG. 5B illustrates an embodiment of an impeller 400B that may be used in any of the MCS systems and devices described herein.
  • the impeller 400B can be the same or substantially the same as the impeller 400A described herein with reference to FIG. 5A.
  • the impeller 400B can differ from the impeller 400A as described herein with reference to FIG. 5B.
  • the impeller 400B can include a radial bearing 330 having a pin 316B as described herein with reference to FIG. 3B.
  • the impeller 400B can include a cavity 407 sized to receive a housing 540 and/or an shaft 558 connected to a motor.
  • the MCS system 100 can include an electrically powered motor contained in the housing 540 that magnetically couples to the impeller 400B to rotate the impeller 400B to generate blood flow.
  • the at least one magnet 444 e.g., a driven magnet
  • the magnet array 542 e.g., drive magnet
  • friction and heat can be generated as the impeller 400B rotates at high speeds. The friction and heat can creates a risk of heat accumulation resulting in coagulation of stagnant blood. Coagulation can pose a safety risk to the patient and/or impede the proper function of the MCS system 100.
  • a purging flow 354 can be provided between the inner wall 420 and the housing 540 in the examples shown in FIGS. 5A and 5B.
  • the purging flow 354 can include a flow of liquid (e.g., blood) through the channel 308 positioned between the inner wall 420 and the housing 540.
  • the purging flow 354 can enter the channel 308 at a flushing inlet 352 near the proximal end of the impeller 400A, 400B and can exit the channel 308 at the flushing outlets 356 positioned near the distal end of the cavity 407.
  • the flushing inlet 352 can be a circumferential gap between the proximal end of the impeller 400A, 400B and the motor housing 540.
  • the channel 308 may be shaped to direct the purging flow 354 past contacting surfaces of the bearing 330.
  • the transitions in the channel 308 may be curved or rounded to provide a smooth flow.
  • the channel 308 may be arranged so that there are no stagnant areas in the flow path of the purging flow 354. For example, all areas of the channel 308, in particular the area around the bearing 330, may intersect the purging flow 354 without the ability of the blood to bypass the area, and/or may include turbulent flow to exchange blood in the area to prevent stagnation. This may be demonstrated with Computerized Flow Dynamic modeling.
  • the motor housing 540 can include a taper 541 at its distal end from a first outer diameter encompassing the drive magnets 552 to a second outer diameter encompassing the cone or cup portion of the bearing 330.
  • the second outer diameter in relation to the outer diameter of the cone or cup portion of the bearing 330 may be equal or slightly larger (e g., in a range of 100% to 150% the outer diameter of the cone or cup portion of the bearing, in a range of 0 mm to 0.5 mm larger than the outer diameter of the cone or cup portion of the bearing).
  • the inner surface of the jacket 406 may have a shape that has a flow diverter 562 that follows the taper 541 of the motor housing 540 with an offset (e g., in a range of 0.1 mm to 0.3 mm) that defines the channel 308 therebetween.
  • the impeller 400A, 400B can include one or more radially-oriented channels 560.
  • the radially-oriented channels 560 can extend from the longitudinal axis 312 radially outward toward the flushing outlets 356.
  • the radially-oriented channels 560 may be in fluid communication with the channel 308.
  • the radially-oriented channels 560 may be part of the channel 308.
  • the radially-oriented channels 560 may a part of the channel 308 that surrounds the bearing 330.
  • the radially-oriented channels 560 may join a part of the channel 308 that surrounds the bearing 330.
  • the radially-oriented channels 560 may include a plurality of channels, wherein each of the plurality of channels are a portion of the channel 308 that joins a part of the channel 308 that surrounds the bearing 330 and extends toward a flushing outlet 356.
  • the plurality of channels may include between 4 and 16 channels.
  • the purging flow 354 can pass the flow diverter 562 into the radially- oriented channels 560 and out the flushing outlets 356.
  • FIG. 5C illustrates an embodiment of an impeller 400A, 400B that may be used in any of the MCS systems and devices described herein.
  • the impeller 400A, 400B may be disposed with a distal pump region 200 of an MCS system.
  • the MCS system can include an outer housing structure having a plurality of outlet windows 564 and a plurality of inlet windows 566.
  • the plurality of outlet windows 564 may accommodate a fluid outflow 568 induced by the impeller 400A, 400B.
  • the plurality of outlet windows 564 may be the same or similar to the pump outlets 208 described herein with reference to FIG. 2A.
  • the plurality of outlet windows 564 may intersect with the flushing outlets 356 of the impeller 400A, 400B. Accordingly, the plurality of outlet windows 564 may accommodate an outflow of the purging flow 354.
  • the plurality of inlet windows 566 may accommodate an inlet flow 570 for the purging flow 354.
  • the plurality of inlet windows 566 may intersect a flushing inlet 352 to the channel 308.
  • the plurality of inlet windows 566 may intersect an circumferential gap between the proximal end of the impeller 400A, 400B and the motor housing 540.
  • FIG. 6 illustrates a cutaway perspective view of the distal end of the impeller 400 distal of axes Ai-Ai, A2-A2 shown in FIGS. 3A-5B.
  • the impeller 400 can include a plurality of recesses 600.
  • the impeller 400 may further include one or more ribs or channel dividers 602.
  • the plurality of recesses 600 may be provided in the distal boundary, such as a distal end or floor, of the pocket 441.
  • the distal boundary may transversely or radially extend between, and connect distal ends of, the inner wall 420 and the outer wall 422.
  • the plurality of recesses 600 may be distributed circumferentially about the distal boundary of the pocket 441.
  • the plurality of recesses 600 may facilitate alignment and/or calibration of the impeller 400.
  • the impeller 400 may be a unitary and/or symmetric body. A unitary and/or symmetric body can present a challenge to accurately indicate where a defect may be located along and/or within the impeller 400.
  • the plurality of recesses 600 can provide asymmetry to the impeller 400. Accordingly, the plurality of recesses 600 can assist with identifying the sides of the impeller 400 to help indicate where a defect is located.
  • the plurality of recesses 600 may provide markers for rotational orientation of axisymmetric parts and enable adjustment of manufacturing parameters after measurement of the first portion(s) from the machine.
  • the at least one blade or vane 403 can be identified for calibration by aligning a visual marker 604 of one of the blades or vanes 403 with one of the plurality of recesses 600. Identification of the at least one blade or vane 403 with reference to the recesses 600 may be used to determine which blade is off tolerance for further machining of the blade(s) or vane(s) 403.
  • the end ring 428 described above regarding FIGS. 4-5B may be machined to rotationally balance the impeller.
  • the end ring 428 can be positioned at the proximal end of the impeller 400. In some embodiments, removing material from the end ring can reduce vibration.
  • the one or more channel dividers 602 may extend along a distal boundary of the cavity 407.
  • the one or more channel dividers 602 may be configured to assist with expelling fluid from the cavity 407.
  • the one or more channel dividers 602 may direct fluid to one or more of the plurality of flushing outlets 418.
  • the one or more channel dividers 602 may extend radially along the distal boundary of the cavity 407.
  • the one or more channel dividers 602 may be non-linear. In some embodiments, the one or more channel dividers 602 may be curved in the radial direction. For example, the one or more channel dividers 602 may extend from a central point within the cavity 407 about a first radial axis and reach the lateral boundary of the cavity 407 about a second radial axis. In some embodiments, the one or more channel dividers 602 may curve in the direction of rotation about the longitudinal axis 312. In some embodiments, the one or more channel dividers 602 may be curved in the longitudinal direction. For example, the one or more channel dividers 602 may follow a constant slope. Alternatively, the one or more channel dividers 602 may follow an increasing longitudinal angle such as a parabolic shape. The one or more channel dividers 602 may be uniform and share the same geometric properties.
  • FIGS. 7A-7C illustrate a method for manufacturing an impeller 701 from a workpiece 700.
  • the impeller 701 can include blades or vanes 703, an inner wall 720, an outer wall 722, a pocket 741, and a cover 728.
  • the blades or vanes 703, the inner wall 720, the outer wall 722, the pocket 741, and the cover 728 may be the at least one blade or vane 403, the inner wall 420, the outer wall 422, the pocket 441, and the end ring 428 described above with reference to FIG. 4, respectively.
  • the method begins with providing a workpiece 700.
  • the workpiece 700 can be material prepared for machining.
  • the workpiece 700 can be a bar or rod of machinable metal.
  • the workpiece can be a cylindrical metal rod.
  • an impeller 701 is formed from the workpiece 700 such as by subtractive manufacturing (e.g., machining by boring, turning, milling, drilling, grinding), by additive manufacturing (e.g., 3D printing, directed energy deposition, powder bed fusion), and/or by assembling subcomponents together. Machining the impeller 701 from the workpiece 700 can include machining the blades or vanes 703, the inner wall 720, and/or the pocket 741. In some embodiments, the blades or vanes 703 and inner wall 720 can be machined from the workpiece 700 first.
  • the pocket 741 can be machined from the proximal end of the workpiece 700 at a location between the inner wall 720 and the outer wall 722.
  • the pocket 741 can be machined from the proximal end of the workpiece 700 first.
  • the inner wall 720 can be machined from the workpiece 700 relative to the pocket 741. After machining the impeller 701 from the workpiece 700, the inner wall 720 can define an inner dimension for the pocket 741 and the outer wall 722 can define an outer dimension for the pocket 741.
  • the pocket 741 may be machined longitudinally and/or axially into the workpiece 700.
  • the pocket 741 can be subtractively machined from the proximal end (e.g., a longitudinal end of the workpiece 700 opposite the blades or vanes 703). Subtractive machining of the workpiece 700 by axially machining the pocket 741 can leave the proximal ends of the inner wall 720 and outer wall 722 along the proximal end of the workpiece 700.
  • FIG. 7B The method then moves to FIG. 7B where one or more magnets 744 are inserted into the pocket 741.
  • Each of the one or more magnets 744 can have a polarity.
  • the one or more magnets 744 can be arranged in an array forming a driven magnet array.
  • the one or more magnets 744 may have different polarities.
  • one set of the one or more magnets 744 may have a first polarity and a second set of the one or more magnets 744 may have a second polarity.
  • the one or more magnets 744 may be positioned within the pocket 741 according to polarity. In some embodiments, the one or more magnets 744 may follow a polarity pattern.
  • magnets 744 having a first polarity may be surrounded by magnets 744 having a second polarity, and vice versa. Accordingly, the one or more magnets 744 may be arranged in an alternating pattern. In other embodiments, the one or more magnets 744 may follow a different pattern. For example, the pattern may include one or more non-magnetic objects within the array disposed between magnets 744.
  • an end ring or cover 728 encases and/or encapsulates the one or more magnets 744 within the pocket 741 (not visible in FIG. 7C).
  • the end ring or cover 728 can be fixedly coupled to the proximal end of the inner wall 720 and the outer wall 722.
  • the end ring or cover 728 may be axially coupled to the inner wall 720 and circumferentially coupled to the outer wall 722.
  • the end ring or cover 728 may be laser welded to the outer wall 722 via a first circumferential weld-seam 747 and may be laser welded to the inner wall 720 via a second circumferential weld-seam 749.
  • the first and second circumferential weld-seams 747, 749 may extend along the entirety of the mating surfaces between the end ring or cover 728 and the inner walls 720 and/or the outer walls 722. Positioning the circumferential weld-seams 747, 749 of an end ring or cover 728 to a proximal end of the impeller 701 can advantageously eliminate the necessity of having excess material between the pocket 741 and the blades or vanes 703. Accordingly, the distal boundary of the pocket 741 may be positioned closer to the blades or vanes 703. The one or more magnets 744 may thus also be distally positioned within the pocket 741 to be closer to the blades or vanes 703.
  • the described impeller 701 is advantageous because the space between first and second portions of the impeller 701 is reduced thereby reducing the longitudinal length of the MCS device itself.
  • an MCS device implementing the impeller 701 can be shortened because the impeller 701 has a deeper cavity defined by the inner wall 720 which can allow the motor housing to sit deeper within the cavity as described in greater detail above.
  • the method can further include balancing the impeller 701. Balancing the impeller 701 can further include mounting the impeller 701 to a balancing device and spinning the balancing device. An amount and/or a direction of imbalance of the impeller 701 may be measured. Based on the measured amount and/or direction of imbalance, the method can further include removing material from the end ring or cover 728. Positioning the end ring or cover 728 may provide greater access for machining and enable further balancing and reduction of mass and/or longitudinal size by machining the proximally located end ring or cover 728. Balance may be required for a smooth rotation of the impeller 701.
  • the impeller 701 may be balanced by mounting the impeller 701 to a balancing device, spinning the impeller via the balancing device, measuring the amount and direction of imbalance of the impeller 701, and removing material from the impeller 701.
  • the balancing device may be configured to rotate/spin.
  • the balancing device may spin at relatively high speeds.
  • the balancing device may spin between 15000 and 45000 rpm.
  • the balancing device may spin at about 37500 rpm. Material may be removed from an unbalanced side of the impeller 701.
  • the end ring or cover 728 may be machined post coupling for balancing the impeller 701.
  • Positioning the end ring or cover 728 at a proximal end of the impeller 701 may advantageously provide access to the end ring or cover 728 without disassembling the impeller 701 because the proximal end is readily accessible. Accordingly, the end ring or cover 728 positioned at the proximal end may be readily worked for removing material to balance the impeller 701. These steps may be repeated until the desired balance is achieved.
  • the method can further include indicating where defects are located along and/or within the impeller 701. Indicating where defects are located along and/or within the impeller 701 can include identifying a defect and noting where the defect is located relative to the plurality of recesses 600. Material can then be removed from the impeller 701 corresponding to the location of the defects relative to the plurality of recesses 600.
  • the method can further include aligning the one or more blades or vanes 703.
  • Aligning the one or more blades or vanes 703 can further include machining a plurality of recesses 600 described above regarding FIG. 6 within a distal end of the pocket 741.
  • the plurality of recesses 600 may be distributed circumferentially about the distal boundary of the pocket 741.
  • Aligning the one or more blades or vanes 703 can further include comparing the plurality of recesses 600 with the one or more blades or vanes 703 and checking for rotational orientation of axisymmetric parts.
  • the one or more blades or vanes 703 may be identified for calibration by aligning a visual marker 604 of the one or more blades or vanes 403 described above with one of the plurality of recesses 600.
  • FIGS. 8-11 show an example of an impeller 800 having a proximally directed purging flow and a distally directed purging flow.
  • the impeller 800 may be the same or similar to the impellers 400A, 400B, 701 described herein with reference to FIGS. 4-7C with some differences in the flow space arrangement.
  • the channel 308 can be a first channel
  • the impeller 800 can include a second channel 802.
  • the channel 308 can accommodate the purging flow 354.
  • the channel 308 can a coupling purge flow space for purging a volume between the jacket 406 and a motor housing 540.
  • the purging flow 354 can be a first purging flow.
  • the purging flow 354 can be a distally directed purging flow which enters the flushing inlet 352 located between the proximal end of the jacket 406 and the motor housing 540 (e.g., a first flushing inlet) and flows distally toward the flushing outlets 356.
  • Blood flow through the channel 308 is generated by radially-oriented channels 560 in the impeller 800 that, when spinning, create a centrifugal force that ejects blood radially from the channel 308 at the flushing outlet 356 (e.g., opening of channel 308 to a radially outer surface of the impeller 800 which may be exposed to a similar pressure as the area around the flushing inlet 352), which in turn creates a pressure differential within the channel 308 to pull blood into it through the flushing inlet 352.
  • radially-oriented channels 560 in the impeller 800 that, when spinning, create a centrifugal force that ejects blood radially from the channel 308 at the flushing outlet 356 (e.g., opening of channel 308 to a radially outer surface of the impeller 800 which may be exposed to a similar pressure as the area around the flushing inlet 352), which in turn creates a pressure differential within the channel 308 to pull blood into it through the flushing inlet 352.
  • the second channel 802 can accommodate a second purging flow 804.
  • the second channel 802 can include a second flushing inlet 806.
  • the second channel 802 can extend between the second flushing inlet 806 and the flushing outlets 356.
  • the second purging flow 804 can be a proximally directed purging flow.
  • the second channel 802 can be a bearing purge flow space for purging a volume surrounding the bearing 330.
  • the second flushing inlet 806 may be located distally of the flushing outlets 356.
  • the second flushing inlet 806 may be positioned at a base region of the blade or vanes 403.
  • the second flushing inlet 806 may be an annular opening that surrounds the shaft or tapered portion 402.
  • the second flushing inlet 806 may be located in a transition section of the impeller 800 located between the blades or vanes 403 and the jacket 406.
  • the second flushing inlet 806 may separate the shaft or tapered portion 402 from the transition section of the impeller 800.
  • the transition section may be connected to the blades or vanes 403 (e.g., at a proximal end of the blades or vanes 403) and the blades or vanes 403 may be connected to the shaft or tapered portion 402, so that although the shaft or tapered portion 402 and transition section are separated by the second flushing inlet 806, the transition section and the shaft or tapered portion 402 may be connected through the blades or vanes 403. This can be seen in FIG. 14 discribed in greater detail below
  • the second purging flow 804 may enter the second flushing inlet 806 and exit through the flushing outlets 356. Accordingly, the second channel 802 may begin at the second flushing inlet 806 and pass over the bearing 330 and through a gap located between the distal end of the cavity 407 and motor housing 540.
  • the second flushing inlet 806 can allow blood to enter the second channel 802 and flow past the contacting surfaces of the bearing 330 before being expelled from the radially-oriented channels 560.
  • the channel 308 and the second channel 802 may merge in the radially- oriented channels 560 and exit through the flushing outlets 356.
  • the flushing outlets 356 may be rectangular-shaped with at least two rounded comers.
  • the flushing outlets 356 may be positioned at a most radially outer surface of the impeller 800, which may facilitate generation of centrifugal force on blood in the radially-oriented channels 560.
  • the flushing outlets 356 may be positioned between the shaft or tapered portion 402 and an outer circumference of the transition section.
  • the flushing outlets 356 may be positioned more radially distant from the axis of rotation than the first flushing inlet 352 and/or the second flushing inlet 806, if present.
  • the flushing outlet 356 may include a plurality of flushing outlets 356 separated by the channel dividers 602 while any or all flushing inlets are circumferentially continuous and not separated by dividers.
  • FIGS. 12-15 illustrate an impeller assembly 900A, 900B, 900C respectively.
  • the impeller assembly 900A, 900B, 900C can be the same or similar to any of the impellers described herein with reference to FIGS. 3A-11.
  • the impeller assembly 900A, 900B may be the same or similar to the impeller described herein with reference to FIGS. 5 A and 5B.
  • the impeller assembly 900C may be the same or similar to the impeller described herein with reference eto FIGS. 8-11.
  • the impeller assembly 900A, 900B. 900C may have any of the features described herein.
  • the impeller assembly 900A, 900B, 900C may be a separable into different components.
  • the impeller assembly 900A, 900B, 900C may be separable into one, two, three, or more components.
  • the impeller assembly 900A, 900B, 900C may be separable between an impeller section 902 and a jacket section 904.
  • FIGS. 12-14 show views of the impeller section 902 and the jacket section 904 as separate components from one another (e.g., prior to joining them together).
  • the impeller section 902 may include the shaft or tapered portion 402 and blades or vanes 403. Additionally, the impeller section 902 may include the plurality of radi ally-oriented channels 560. The plurality of radially-oriented channels 560 may be separated from one another by a channel divider 602. As shown in FIGS. 12 and 14, a hemispherical surface of the pin 316B of the bearing 330 is shown protruding from the proximal end of the shaft or tapered portion 402 through an opening around the bearing 330. As shown in FIG. 14, the opening may be joined to the second flushing inlet 806.
  • the second flushing inlet 806 may be frustoconical, narrowing toward the proximal direction to guide blood toward the bearing 330 (e.g. surfaces of the bearing in moving contact), and may be coaxial with the bearing 330 and the shaft or tapered portion 402.
  • the opening to second flushing inlet 806 may fully encircle the shaft or tapered portion 402, separating it from the transition section.
  • the transition section may be connected to the proximal end of the blades or vanes 403.
  • the blades or vanes 403 may connect to the shaft or tapered portion 402.
  • the shaft or tapered portion 402 may be connected to the second bearing 314 (e.g., a journal bearing, a pin and cone bearing, a hydrodynamic bearing).
  • the jacket section 904 may include the inner wall 420, the outer wall 422, the driven magnets (magnet 444), and the cavity 407. As described herein, the jacket section 904 may be cylindrical having a constant outer diameter, inner diameter, and thickness, and may not have a flow diverter 562, as shown in FIG. 14. In this arrangement the proximally- facing axial surfaces of the channel dividers 602 that are for connecting to a distal face of the jacket section 904, may have a similar thickness (e.g., ⁇ 0.8 mm, in a range of 0.5 mm to 2 mm) as the thickness of the jacket section 904.
  • a similar thickness e.g., ⁇ 0.8 mm, in a range of 0.5 mm to 2 mm
  • the channel dividers 602 may extend radially inward from the radially-oriented channels 560 to the frustoconical opening creating vanes 908 in the second channel 802, which may facilitate movement of blood from the area around the bearing 330 radially outward to the flushing outlet 356, or create turbulence to improve transfer of heat away from the bearing 330.
  • the vanes 908 may be contiguous with the channel dividers 602. When assembled, a small gap between the vanes 908 and motor housing 540 may prevent contact of these surfaces that move relative to one another.
  • the impeller assembly can include any of the features described herein.
  • the impeller assembly may have a jacket section 904 with a flow diverter 562 as shown in FIG. 12 as well as a second flushing inlet 806 at the base of the blades or vanes 403 as shown in FIG. 14.
  • the impeller assembly may include a first channel 308 that flows between the driven magnets (magnet 444) and drive magnets (magnet array 542) and is diverted to flow over the proximal bearing 330 where it converges with a second channel 802.
  • the second channel 802 may receive a fluid flow from the second flushing inlet 806 at the base of the blades or vanes 403 and may be directed over the proximal bearing 330.
  • the two flow channels can converge around the bearing 330 and flow through radially-oriented channels 560 and exit through a flushing outlet 356.
  • the plurality of radially-oriented channels 560 may include between four and sixteen channels.
  • FIGS. 12 and 14 illustrate an impeller section 902 having eight radially-oriented channels 560.
  • FIG. 13 illustrates an impeller section 902 having four radially-oriented channels 560.
  • the radially-oriented channels 560 may be radially symmetric about the axis of the impeller assembly 900A, 900B to ensure its weight is radially balanced.
  • Each of the radially-oriented channels 560 may have a shape with a width that increases with distance from the axis of rotation in a plane that is transverse (i.e., orthogonal) to the axis of rotation (see FIG.
  • Each of the radially-oriented channels 560 may have a shape that is curved, spiraled, voluted, or angled relative to the radius of the impeller assembly 900A, 900B, for example in a direction away from the direction of rotation 906 when the impeller section 902 is spinning to move blood. Some or all exposed edges or corners of each of the radially-oriented channels 560 that is exposed to blood may be rounded.
  • the radially-oriented channels 560 may be: cylindrical in shape with a constant diameter, curved or straight, a combination of different shapes.
  • the impeller assembly 900A, 900B, 900C may be made from multiple parts such as the impeller section 902 and the jacket section 904 that are joined together.
  • the impeller section 902 and the jacket section 904 may be made of a metal (e.g., titanium) that is machined and optionally surface treated (e.g., electropolished, coated or surface treated to create a hydrophobic nanostructure surface) and joined (e.g., laser welded, adhered) together.
  • the radially-oriented channels 560 may be machined from the impeller section 902 or from the jacket section 904, in which case the channel dividers 602 on the jacket section 904 may have distally-facing axial surfaces that are connected to the transition section of the impeller section 902.
  • the radially-oriented channels 560 may be made by removing material from the base of the impeller section 902 leaving channel dividers 602 that define the radially-oriented channels 560, and the proximal surface of the channel dividers 602 may be joined to a distal surface of the jacket section 904, which may include a distal surface of the flow diverter 562.
  • the radially-oriented channels 560 may be machined from the distal surface of the jacket section 904, and the proximal surface of the impeller section 902 may be a smooth surface (not shown).
  • the impeller assembly 900A, 900B may be 3D printed as multiple parts joined together, or as one single component.
  • the flushing inlet 352to the channel 308 e.g., a circumferential gap between the proximal end of the impeller section 902 and a motor hosusing
  • at least a portion of the impeller section 902 may be positioned in the MCS device adjacent to an outlet window 564 that, when in use, is placed in the patient’s aorta.
  • the radially-oriented channels 560 may have a first width 910 at a first position and a second width 912 at a second position, wherein the first position is more radially distant from the axis of rotation that the second position, and the first width 910 is greater than the second width 912 (see e.g., FIG. 14).
  • the transition from the first width 910 to the second width 912 may be smooth and continuous.
  • the radially-oriented channels 560 may have a first height 914 at a first position and a second height 916 at a second position, wherein the first position is more radially distant from the axis of rotation that the second position, and the first height 914 is less than the second height 916 (see e.g., FIG. 14).
  • the transition from the first height 914 to the second height 916 may be smooth and continuous.
  • the radially-oriented channels 560 may have a consistent width and height along their length (i.e., from the first position to the second position). Corners within the radially-oriented channels 560 may be rounded. At least some and optionally all surfaces in the channel 308 that contact blood may be electropolished.
  • FIG. 15 shows that the second flushing inlet 806 may be circular or radially symmetric and be coaxial with a proximal bearing 330.
  • a process which is depicted as a flowchart, a flow diagram, a structure diagram, or a block diagram. Although a flowchart may describe the operations as a sequential process, many of the operations can be performed in parallel, or concurrently, and the process can be repeated. In addition, the order of the operations may be rearranged.
  • a process is terminated when its operations are completed.
  • a process may correspond to a method, a function, a procedure, a subroutine, a subprogram, etc.
  • a process corresponds to a software function
  • its termination corresponds to a return of the function to the calling function or the main function.
  • An impeller for a heart pump comprising: a first portion comprising: a shaft; and one or more blades extending radially from the shaft; and a second portion extending longitudinally from the first portion, the second portion comprising: a pocket; one or more magnets positioned within the pocket; and an end ring coupled to an end of the second portion.
  • Clause 2 The impeller of Clause 1, wherein the end ring encapsulates the one or more magnets within the pocket.
  • Clause 3 The impeller of any one of Clauses 1-2, further comprising a first circumferential weld-seam at an interface of the end ring and the end of the pocket and a second circumferential weld-seam at an interface of the end ring and the end of the pocket, wherein the first circumferential weld-seam extends around a side wall of the second portion and the second circumferential weld-seam extends along a face of the second portion.
  • Clause 4 The impeller of any one of Clauses 1-3, further comprising an outer wall and an inner wall extending longitudinally away from the first portion, wherein a radial distance between the outer wall and the inner wall defines the pocket.
  • Clause 5 The impeller of Clause 4, further comprising a first circumferential weldseam at an interface of the end ring and the end of the outer wall and a second circumferential weld-seam at an interface of the end ring and the end of the inner wall.
  • Clause 6 The impeller of any one of Clauses 1-5, further comprising one or more alignment recesses within a wall of the pocket opposite the end ring.
  • Clause 7 The impeller of any one of Clauses 1-6, wherein a longitudinal distance between the one or more blades and the one or more magnets is less than 1 mm.
  • Clause 8 The impeller of any one of Clauses 1-7, further comprising a flushing flow inlet positioned in a transition section between the first portion and the second portion.
  • Clause 9 The impeller of any one of Clauses 1 -8, wherein the first portion and the second portion are manufactured separately and assembled together to form the impeller.
  • a mechanical circulatory support system comprising: an elongate flexible catheter shaft, having a proximal end and a distal end; and a circulatory support device carried by the distal end of the elongate flexible catheter shaft, the circulatory support device comprising: a tubular housing; a motor having a shaft that is rotationally fixed with respect to a drive magnet array; an impeller, rotationally fixed with respect to a driven magnet array, the impeller further comprising: a pocket; and an end ring fixedly coupled at an end of a second portion; and a sealed motor housing coupled with the tubular housing, and encasing the motor and the drive magnet array.
  • Clause 12 The mechanical circulatory support system of any one of Clauses 10-11, wherein the end ring encapsulates the driven magnet array within the pocket.
  • Clause 13 The mechanical circulatory support system of any one of Clauses 10-12, further comprising an outer wall and an inner wall extending longitudinally away from a first portion, wherein a radial distance between the outer wall and the inner wall defines the pocket, and wherein a first circumferential weld-seam couples the end ring to an end of the outer wall and a second circumferential weld-seam couples the end ring to an end of the inner wall.
  • Clause 14 The mechanical circulatory support system of any one of Clauses 10-13, the impeller further comprising one or more blades, wherein a longitudinal distance between the driven magnet array and the one or more blades is less than 1 mm.
  • Clause 15 The mechanical circulatory support system of any one of Clauses 10-14, the impeller further comprising one or more alignment recesses at an end of the pocket opposite the end ring.
  • Clause 16 The mechanical circulatory support system of any one of Clauses 10-15, the impeller further comprising a flushing flow inlet positioned upstream of the pocket.
  • Clause 17 The mechanical circulatory support system of any one of Clauses 10-16, wherein the impeller is manufactured as separate components and assembled together.
  • Clause 18 A method of manufacturing an impeller, the method comprising: providing a workpiece; machining a pocket within an end of the workpiece; inserting one or more magnets into the pocket; and encasing the one or more magnets within the pocket with a cover.
  • Clause 19 The method of Clause 18, further comprising machining an impeller body from the workpiece, the impeller body having a first portion and a second portion, wherein the first portion comprises a shaft and one or more blades extending radially from the shaft; and the second portion comprises a cylindrical wall having a thickness.
  • Clause 20 The method of Clause 19, further comprising balancing the impeller.
  • balancing the impeller further comprises mounting the impeller to a balancing device, spinning the balancing device, measuring an amount and a direction of imbalance of the impeller, and removing material from the cover.
  • Clause 22 The method of Clause 21, further comprising aligning the one or more blades.
  • machining the pocket further comprises removing material from the workpiece between an outer dimension and an inner dimension along a longitudinal direction of the workpiece.
  • Clause 24 The method of Clause 23, wherein encasing the one or more magnets within the pocket with the cover further comprises welding the cover to the outer dimension and the inner dimension at an end of the pocket.
  • Clause 25 The method of any one of Clauses 18-24, wherein the pocket encircles a cavity, the method further comprising machinging a flushing flow inlet positioned at an end wall of the cavity.
  • Clause 26 The impeller of any one of Clauses 18-25, wherein the workpiece is a first workpiece, the method further comprising: providing a second workpiece; machining a one or more blades into the second workpiece; and assembling the first workpiece and the second workpiece into the impeller.
  • An impeller for a heart pump comprising: a first portion comprising: a shaft; and one or more blades extending radially from the shaft; a second portion extending longitudinally from the first portion, the second portion comprising one or more magnets; and a flushing inlet extending through a transition section between the first portion and the second portion.
  • Clause 29 The impeller of any one of Clauses 27-28, wherein the flushing inlet provides a purging flow into the second portion.
  • Clause 30 The impeller of any one of Clauses 27-29, wherein the flushing inlet is a first flushing inlet and the impeller comprises a second flushing inlet in an assembled state, wherein the second portion is extends around a motor housing, and wherein the second flushing inlet is a circumferential gap between an end of the second portion and the motor housing.
  • Clause 31 The impeller of any one of Clauses 27-30, wherein the impeller is configured to accommodate a first purging flow and a second purging flow.
  • Clause 32 The impeller of Clause 31, wherein the first purging flow is a proximally directed purging flow and the second purging flow is a distally directed purging flow.
  • Clause 33 The impeller of Clause 31, wherein the first purging flow and the second purging flow exit the impeller through one or more flushing outlets.
  • Clause 34 The impeller of any one of Clauses 27-33, further comprising one or more radially-oriented channels and one or more flushing outlets, wherein the one or more radially- oriented channels extend from a longitudinal axis of the impeller radially outward toward one or more flushing outlets.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Anesthesiology (AREA)
  • Mechanical Engineering (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

L'invention concerne un système de support circulatoire mécanique (MCS) ayant une pompe à sang rotative axiale pourvue d'un boîtier de roue ayant une poche cylindrique permettant de recevoir un aimant et fermé par un anneau d'extrémité, ne nécessitant qu'une seule soudure circonférentielle et une soudure axiale. La roue comprend un arbre et une ou plusieurs pales s'étendant radialement à partir de l'arbre. Une paroi interne et une paroi externe s'étendent longitudinalement à partir de l'arbre définissant la poche entre elles. Un réseau d'aimants est positionné à l'intérieur de la poche et conçu pour être entraîné magnétiquement par un arbre de sortie d'un moteur. L'anneau d'extrémité est couplé à l'extrémité de la poche opposée à l'arbre, encapsulant ainsi le réseau d'aimants à l'intérieur de la poche. Des trous d'alignement peuvent être disposés à l'intérieur d'un plancher de la poche pour orienter et équilibrer la roue.
PCT/US2025/025853 2024-04-24 2025-04-22 Boîtier de roue de pompe cardiaque avec poche magnétique cylindrique, anneau d'extrémité et rinçage de palier de roue Pending WO2025226734A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US202463638154P 2024-04-24 2024-04-24
US63/638,154 2024-04-24
US202463697818P 2024-09-23 2024-09-23
US63/697,818 2024-09-23

Publications (1)

Publication Number Publication Date
WO2025226734A1 true WO2025226734A1 (fr) 2025-10-30

Family

ID=97490862

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2025/025853 Pending WO2025226734A1 (fr) 2024-04-24 2025-04-22 Boîtier de roue de pompe cardiaque avec poche magnétique cylindrique, anneau d'extrémité et rinçage de palier de roue

Country Status (1)

Country Link
WO (1) WO2025226734A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8882477B2 (en) * 2013-03-14 2014-11-11 Circulite, Inc. Magnetically levitated and driven blood pump and method for using the same
US11185678B2 (en) * 2005-06-06 2021-11-30 The Cleveland Clinic Foundation Blood pump
US20220161021A1 (en) * 2020-11-20 2022-05-26 Kardion Gmbh Mechanical circulatory support system with insertion tool
WO2023014742A1 (fr) * 2021-08-04 2023-02-09 Kardion Gmbh Joint pour dispositif de support circulatoire mécanique
US20230079625A1 (en) * 2021-07-01 2023-03-16 Corisma Cardiovascular Devices and methods for transferring power to implanted medical devices

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11185678B2 (en) * 2005-06-06 2021-11-30 The Cleveland Clinic Foundation Blood pump
US8882477B2 (en) * 2013-03-14 2014-11-11 Circulite, Inc. Magnetically levitated and driven blood pump and method for using the same
US20220161021A1 (en) * 2020-11-20 2022-05-26 Kardion Gmbh Mechanical circulatory support system with insertion tool
US20230079625A1 (en) * 2021-07-01 2023-03-16 Corisma Cardiovascular Devices and methods for transferring power to implanted medical devices
WO2023014742A1 (fr) * 2021-08-04 2023-02-09 Kardion Gmbh Joint pour dispositif de support circulatoire mécanique

Similar Documents

Publication Publication Date Title
US20220161021A1 (en) Mechanical circulatory support system with insertion tool
AU2021385091A1 (en) Mechanical circulatory support system with insertion tool
US20230293878A1 (en) Heart pump tips and delivery system couplings for mechanical circulatory support systems
US20230111434A1 (en) Blood pumps
US10251986B2 (en) Intravascular ventricular assist device
CA2841675C (fr) Pompe sanguine
US20250082832A1 (en) Insertion catheter for a circulatory support catheter
WO2022109589A1 (fr) Système mécanique d'aide à la circulation sanguine au moyen d'un fil-guide
EP1931403B1 (fr) Pompe axiale à rotor multi-rainures
WO2024243154A1 (fr) Pointes de pompe cardiaque et couplages de système de distribution pour systèmes de support circulatoire mécanique
AU2013257469B2 (en) Axial flow pump with multi-grooved rotor
WO2025226734A1 (fr) Boîtier de roue de pompe cardiaque avec poche magnétique cylindrique, anneau d'extrémité et rinçage de palier de roue
CN116806163A (zh) 具有插入工具的机械循环支持系统
WO2025128490A1 (fr) Systèmes de palier de rotor et procédés pour systèmes de support circulatoire mécanique