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WO2025042270A1 - Système et pilote de pompe d'assistance circulatoire - Google Patents

Système et pilote de pompe d'assistance circulatoire Download PDF

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Publication number
WO2025042270A1
WO2025042270A1 PCT/NL2023/050435 NL2023050435W WO2025042270A1 WO 2025042270 A1 WO2025042270 A1 WO 2025042270A1 NL 2023050435 W NL2023050435 W NL 2023050435W WO 2025042270 A1 WO2025042270 A1 WO 2025042270A1
Authority
WO
WIPO (PCT)
Prior art keywords
cylinder
blood pump
piston
gas
pressure
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/NL2023/050435
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English (en)
Inventor
Oren Malkin
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.)
PulseCath BV
Original Assignee
PulseCath BV
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 PulseCath BV filed Critical PulseCath BV
Priority to PCT/NL2023/050435 priority Critical patent/WO2025042270A1/fr
Publication of WO2025042270A1 publication Critical patent/WO2025042270A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61M60/104—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body
    • A61M60/117—Extracorporeal pumps, i.e. the blood being pumped outside the patient's body for assisting the heart, e.g. transcutaneous or external 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
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders
    • A61M60/274—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders the inlet and outlet being the same, e.g. para-aortic counter-pulsation blood 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
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic

Definitions

  • the invention relates to a blood pump system.
  • Blood pump systems for circulating blood are known as such.
  • a known system is the Berlin heart pump system, in particular the EXCOR® Pediatric system which is a paracorporeal, pulsatile ventricular assist device, or VAD for short.
  • Paracorporeal means that the actual blood pumps are located outside of the body, and are connected to the heart and blood vessels via cannulas.
  • EXCOR® Pediatric can be used to support one ventricle (left-sided I LVAD) or both ventricles (bilateral I BVAD).
  • a triple-layer membrane serves to separate the blood and air sides of the blood pump. The membrane is curved and can be set in motion through alternating pressures. The pressures originate from a driving system and are channeled into the pump via a tube.
  • the membrane If positive pressure is applied on the membrane, it ejects the blood out of the blood chamber and back into the patient's circulation. With a suction pressure, the blood pump fills again with blood. Valves in the inflow and outflow stubs ensure that the blood can only circulate in one direction.
  • the blood pumps differ in the size of their stroke volumes, i.e. the volume of blood displaced with each stroke.
  • the pump rate setting determines how often the membrane moves in one minute. The rate should be chosen in such a way that the resulting blood flow meets the patient's requirements.
  • known blood pump drivers are bulky (having a height of about 1 m), relatively expensive, complex and very heavy (e.g. weighing 75 kg), which can be cumbersome to handle and store.
  • known pump drivers include a dedicated vacuum pump for providing subatmospheric pressures and a dedicated compressor for providing superatmospheric pressures.
  • the present invention aims to provide an improved blood pump system.
  • the invention aims to provide a reliable blood pump system that is user friendly and can be provided in an economical manner.
  • an aspect of the invention is to provide a blood pump system that has good or even improved manufacturability.
  • a blood pump system including: -a blood pump including a pneumatically driven displacement structure for, while in operation, alternatingly applying suction and pressure, in particular for cyclically driving fluid displacement through a blood pump line, wherein the displacement structure is preferably a membrane;
  • the pneumatic driver includes a piston -cylinder assembly, the cylinder having a gas communication port for connection to the pneumatic control line, the piston-cylinder assembly being provided with an electromagnetic actuator for moving the piston with respect to the cylinder.
  • a relatively reliable, and relatively compact blood pump system can be achieved (for example, a maximum axial length of the driver can e.g. be at most 40 cm.
  • the resulting system can be made lightweight (the driver e.g. having a weight less than 10 kg, in particular less than 5 kg). Also, the resulting system can be made of relatively little components, providing good reliability and good durability, and can provide user-friendly operation.
  • the piston-cylinder assembly can deliver both super- and subatmospheric pressures (in alternating manner), so that use of a dedicated vacuum pump is not required anymore.
  • the system simply uses (ambient) air as a gas, for pneumatically driving the blood pump via the pump driver.
  • the electromagnetic actuator is a (relatively simple) a linear actuator, in particular a linear solenoid or voice coil actuator, that can be integrated in a straight-forward manner with the pneumatic piston-cylinder assembly.
  • (ambient) air is used by the system as a pneumatic driving gas (i.e. the gas that is alternatingly pressurized and depressurized by the pneumatic piston-cylinder assembly for cyclically driving the blood pump’s displacement structure).
  • an aspect of the invention provides a pneumatic blood pump driver, for pneumatically driving a displacement structure of a blood pump via a pneumatic control line, in particular a blood pump driver of a system according to the invention, wherein the pump driver is characterized in that it includes a piston-cylinder assembly, the cylinder having a gas communication port for connection to the pneumatic control line, the pistoncylinder assembly being provided with an electromagnetic actuator for moving the piston with respect to the cylinder.
  • a method for driving a blood pump the blood pump having a pneumatically drivable displacement structure, the method for example utilizing a system or a blood pump driver according to the invention.
  • the method preferably includes:
  • a piston of a piston-cylinder assembly for alternatingly applying suction and pressure to a gas communication port that is connected to the blood pump via a pneumatic control line, for pneumatically driving the displacement structure of the blood pump; wherein the movement of the piston is being induced by an electromagnetic actuator.
  • Figure 1 a partially cut-away view of a human thorax and an example of a catheter blood pump
  • Figure 2 a partially opened side view of a non-limiting embodiment of a blood pump system according to the invention
  • Figure 3 a partially opened perspective view of an electromagnetic actuator of the system shown in Fig. 2;
  • Figure 4 a detail Q of Fig. 2;
  • Figure 6 part of the example of Fig. 2, at a second state of the pump driver.
  • FIG. 1 a human thorax is illustrated in a view showing the heart H, the aorta A, the superior vena cava S, the inferior vena cava I, the right pulmonary veins V, the left pulmonary veins W, right pulmonary arteries P, the left pulmonary arteries L, the aortic arch AA, the left ventricle LV and the right ventricle RV.
  • Arrows indicate blood flow directions when the heart H is in operation.
  • a heart lung machine 112 shown schematically only
  • the heart lung machine is connected to the human body for pumping blood from the vena cava to the aorta and maintains the blood circulation in the patient.
  • the blood flow from the heart lung machine 113 to the patient is essentially non -pulsatile.
  • This essentially non-pulsatile blood flow enters the aorta A2 closely adjacent the heart H, which has been deactivated.
  • the pump 113 is a non-pulsatile pump, which provides advantages in terms of design and compatibility with the function of the oxygenator (Allen et al.;"The importance of Pulsatile and Nonpulsatile Flow in the Design of Blood Pumps” ; Artificial Organs 21 (8): 922-928).
  • Organ failure after open-heart surgery is a frequent cause of complications.
  • One of these theories is, that the use of a heart -lung machine has several side effects that may influence blood pressure and organ perfusion.
  • the heart-lung machine causes a non-physiological (nonpulsatile flow pattern and a decreased blood viscosity when the priming liquid from the tubing and the oxygenator is introduced into the patient's blood circulation.
  • Other instances when reduced blood pressure may disturb organ functions are during toxic shock, which may for instance be caused by an allergic reaction and, prolonged cardiac malfunction, which frequently entails multi-organ failure.
  • pulsatile flow in a cardio pulmonary bypass has been found to have a positive effect on the blood flow rate to the kidneys of neonate pigs (Lodge et al.; "Regional Blood Flow During Pulsatile Cardiopulmonary Bypass and After Circulatory Arrest in an Infant Model” ; Ann Thorac Surg 1997; 63: 1243-50).
  • FIG. 1 clinical use of a catheter pump 1 for causing the blood pressure pulsations in the aorta A is illustrated.
  • the pulsatile catheter pump 1 has a displacement structure 2 in the form of a rigid housing 2a enclosing a chamber 9 divided by a flexible membrane 2b.
  • the catheter pump 1 has or is connected to a catheter 3 projecting from that displacement structure 2 and bounding a channel that extends longitudinally inside the catheter for leading fluid on longitudinal direction of the catheter.
  • the channel communicates with a portion 9a of the chamber 9 (see Figure 2) on a distal side of the membrane 2b.
  • the displacement structure has a pneumatic driver port, for example a sleeve 2c, for connection of a pneumatic conduit 5 communicating with a pneumatic driver 10 to a portion 9b of the chamber 9 on a proximal side of the membrane 19.
  • An advantageous embodiment of the pneumatic driver 10 which will be described below, with reference to Figures 2-6.
  • the displacement structure 2 can be driven (by the driver 10) via the pneumatic conduit 5 for alternatingly applying suction for displacing fluid from the distal portion of the catheter 3 to the displacement structure 2 via the respective channel and for applying pressure for displacing fluid from the displacement structure 2 to the catheter 3, thus driving a flow through the catheter 3 which reverses in a pulsating manner.
  • the catheter 3 projects from the displacement structure 2 into the aorta A via the left subclavian artery leading to the left arm 123 and is inserted into the aorta A of a patient in a position having its distal end portion in the aorta A of the patient.
  • the distal end portion of the catheter 3 can be provided with inlet passages 125 arranged in a fitting of the catheter 3. Spaced in distal direction from the inlet passages 25, the catheter 3 preferably has an outlet passage 126 (for example arranged in a catheter tip fitting).
  • the catheter 3 can also be configured differently, as will be appreciated by the skilled person.
  • the displacement structure 2 (i.e. the blood pump 1) is preferably connected to a proximal end of the catheter 3 and is configured to alternatingly withdraw blood from the aorta A and feed blood to the aorta A via the catheter 3, such that pressure pulsations are generated in the area of the distal end portion of the catheter 3.
  • the displacement structure 2 preferably has a stroke in the range of 40-75 ml and can e.g. be constructed from an optically transparent plastic or polymer such as PC, PMMA or MABS, as will be clear to the skilled person.
  • pulsations are generated in the blood flow in the aorta A.
  • Blood is pumped into the catheter 3 via the inlet passages 125 (e.g. located in the aortic arch AA) and pumped out of the catheter 3 via the outlet passage 126 in a descending section of the aorta A, preferably in close proximity of arteries 130-133 towards the bowels, the liver and the kidneys.
  • the pulsations in the blood pressure pass into the arteries 130-133 towards the bowels, the liver and the kidneys.
  • Such local blood pressure pulsations have a positive effect on the organ perfusion (for instance expressed as a flow rate per unit of mass of organ tissue), which is believed to be caused by increased effective organ perfusion pressure differentials.
  • the present non-limiting example of the pump 1 (in particular a catheter pump 1) has a relatively simple configuration, providing reliable and durable blood flow action.
  • the respective displacement structure 2 is arranged for alternatingly applying suction and pressure, in particular for cyclically driving fluid displacement through a respective catheter 3 (or similar blood flow line) connected to a fluid displacement port 2d of the displacement structure 2.
  • the pneumatic conduit 5 is configured for communicating with a pneumatic drive system or driver 10 (see Figures 2-6).
  • the driver 10 of the system is configured to provide respective drive pulses in the range of 60- 100 BPM (beats per minute) with a respective control unit (see below).
  • BPM beats per minute
  • a selected drive rate (BPM) can be adjusted, for example every 5 beats (for example 60, 65, 70 ,75 etc.).
  • FIGS 2-6 depict an example of the pneumatic driver 10 in more detail.
  • the pneumatic driver 10 is configured for pneumatically driving the displacement structure 2 of the blood pump 1 via a pneumatic (i.e. gas communication) control line (i.e. said pneumatic conduit) 5.
  • a pneumatic (i.e. gas communication) control line i.e. said pneumatic conduit
  • the control line/conduit 5 can e.g. be coupled to the driver 10 via a suitable connector structure 13, for example a Luer-lock connector or the-like, as will be clear to the skilled person.
  • the pneumatic control line 5 can e.g. be a flexible gas duct or tube, e.g. having a length of at least 10 cm (e.g. a length of at least 1 m).
  • the driver 10 includes a piston-cylinder assembly 11, 12, the cylinder 12 having a gas communication port 13 for connection to the gas communication (pneumatic) control line 5.
  • the gas communication port 13 of the cylinder 12 may have a Luer-lock configuration, having a tapered Luer-lock connector section 13a (as shown in Figure 4)
  • the respective pneumatic control line 5 preferably also includes a Luer-lock connector at its respective end for detachably connecting to the Luer-lock connector section 13a of the cylinder 12.
  • the cylinder 12 (which can be a cylinder barrel) can have a circular cross-section.
  • the cylinder 12 is preferably made of metal or an alloy, e.g. stainless steel.
  • the cylinder 12 can have a proximal side wall 12 c (see Figure 4) that includes the gas discharge port 13.
  • the cylinder 12 can enclose a cylinder chamber that axially extends between said proximal side wall 12 c and a distal side wall 12 d (see Figure 2).
  • the cylinder chamber is divided by a piston 11 in a proximal section 12a and a distal section 12b (see Figure 4), wherein the volume of the cylinder sections 12a, 12b changes during axial piston movement (i.e. during driver operation).
  • the proximal cylinder (chamber) section 12a is in direct gas communication with the gas communication port 13, to provide direct gas communication to a connected pneumatic conduit 5, for pneumatically driving a connected blood pump 1.
  • a stroke volume of the piston-cylinder assembly 11, 12 (in particular a maximum volume of said proximal section 12a of the cylinder chamber) is in the range of about 40-75 cc.
  • a stroke volume of the respective blood pump 1, to be driven by the driver 10 can e.g. be about the same as the stroke volume of the piston-cylinder assembly 11, 12 and/or in the range of about 40-75 cc.
  • the movable piston 11 as such is configured to provide a substantially gas-tight seal between the two cylinder sections 12a, 12b, and that the piston 11 and a surrounding inner side of the cylinder 12 both have a circular cross-section.
  • the piston 11 is self-lubricating (e.g. it can be made of self-lubricating brass).
  • the piston 11 is located concentrically within the respective cylinder 12.
  • Figure 5 depicts a second position of the piston 11, wherein it has been axially moved towards a position near the gas communication port 13 (for compressing gas in the proximal cylinder section 12a to a superatmospheric pressure).
  • Figure 6 depicts a first position of the piston 11, wherein it has been axially moved away from the gas communication port 13 (for decompressing gas in the proximal cylinder section 12a to a sub atmospheric pressure, e.g. a vacuum).
  • a sub atmospheric pressure e.g. a vacuum
  • a distal section of the cylinder 12 includes a gas passage 18, allowing entry and exit of gas (preferably ambient air) into the second section 12b of the cylinder chamber, in particular to keep that chamber section substantially at atmospheric pressure during operation. Entry and exit of gas is indicated by arrows ‘air’ in Figures 5 and 6. It will be appreciated that one or more such gas passages 18, can be provided, and that such a gas passage can be located near the distal chamber wall 12d.
  • gas preferably ambient air
  • the cylinder 12 includes a gas inlet port 16, separate from the gas communication port 13, for feeding gas into the proximal section 12a of the cylinder 12 (see Fig. 4).
  • the gas inlet port 16 includes a first valve 16a (e.g. a negative pressure release valve, a check-valve), configured to open the gas inlet port 16 at/below a certain (predetermined) subatmospheric threshold pressure in the cylinder (i.e. in the a proximal chamber section 12a), for example in case a (vacuum) pressure in the proximal chamber section 12a is lower than a pressure outside the gas inlet port (i.e. an ambient pressure) by a first predetermined amount.
  • a first valve 16a e.g. a negative pressure release valve, a check-valve
  • the first valve 16a can prevent that a pressure in the first cylinder section 12a drops to a vacuum level that might damage system components.
  • the respective valve 16a is configured to automatically close the gas inlet port 16 in case the pressure in the first cylinder section 12a is at least equal to ambient pressure, e.g. higher than an ambient pressure (i.e. outside the gas inlet port 16) by said first amount (i.e. during a pressurizing movement of the piston 11, towards the proximal end wall 12c).
  • the first valve 16a can e.g. be a spring biased check-valve.
  • the valve 16a can be a valve body 16a that is engaged by a return spring 16b for forcing the valve body 16a on a valve seat 16f, for closing a respective outer gas passage 16e, using spring force (see Fig. 4).
  • the configuration of the return spring 16b can be selected for providing a desired valve operation (i.e. for setting the amount of gas pressure difference over the gas inlet port 16 required for opening the valve, i.e. for moving the valve body 16a away from the seat 16f and allowing entry of ambient air via respective gas passages 16e, 12e into the cylinder 12), as will be clear to the skilled person.
  • the gas inlet port 16 can be substantially located outside the cylinder 12, having a valve housing 16d protruding (radially) from the cylinder 12.
  • the valve housing 16d can be made in one piece with the cylinder 12.
  • the cylinder 12 can be provided with a gas passage 12e, leading into a valve space that is enclosed by the valve housing 16d of the gas inlet port 16 (the valve housing containing the valve body 16a and valve spring 16b).
  • the valve housing 16d of the gas inlet port 16 includes the valve seat 16f having the respective outer gas passage 16e, which can be located axially opposite the respective gas passage 12e of the cylinder 12.
  • the cylinder 12 includes a gas outlet port 17, separate from the gas communication port 13 (and separate from the gas inlet port 16), for discharging gas from the proximal 12a section of the cylinder 12.
  • the gas outlet port 17 can include a second valve 17a (e.g. a positive pressure release valve, a check-valve), configured to automatically close the gas outlet port 17 at/below a certain (predetermined) threshold pressure in the cylinder 12, e.g. in case a pressure in the proximal chamber section 12a is lower than a pressure outside the gas outlet port 17 (i.e. an ambient pressure) by a second amount (i.e. during a depressurizing movement of the piston 11, away from the proximal cylinder wall 12c).
  • a second valve 17a e.g. a positive pressure release valve, a check-valve
  • the second valve 17a is preferably configured to (automatically) open the gas outlet port 17 in case a superatmospheric pressure in the cylinder 12 is higher than a pressure outside the gas outlet port 17 by said second amount, allowing ambient air to enter the first cylinder section 12a (to prevent that a pressure in the first cylinder section 12a increases to a level that might damage system components).
  • the second valve 17a can e.g. be a spring biased check-valve.
  • the second valve 17a can be a valve body 17a that is engaged by a return spring 17b for forcing the valve body 17a on a valve seat 17f (for closing a respective gas passage 17e) using spring force (see Fig. 4).
  • the configuration of the return spring 17b can be selected for providing a desired valve operation (i.e. for setting the amount of gas pressure difference over the gas outlet port 17 required for opening the valve, i.e. for moving the valve body 176a away from the seat 17f and allowing exit of gas via the gas passage 17e), as will be clear to the skilled person.
  • the gas outlet port 17 is substantially located outside the cylinder 12, having a valve housing 17d protruding (radially) from the cylinder 12.
  • the valve housing 17d can be made in one piece with the cylinder 12.
  • the cylinder 12 can be provided with the valve seat 17f and respective valve gas passage 12f, leading into a valve space that is enclosed by the valve housing 17d of the gas outlet port 17 (the valve housing containing a respective valve body 17a and respective valve spring 17b).
  • the valve housing 17d of the gas outlet port 17 includes a gas passage 17e, located axially opposite the respective gas passage 12f of the cylinder 12, for discharging gas to an environment (in case the valve has opened).
  • both the gas inlet port 16 and gas outlet port 17 are located near the proximal end wall 12c (or in that end wall) of the cylinder 12.
  • the inlet port 16 and gas outlet port 17 can be located in-line with each other (e.g. opposite gas passages 12e, 12f being located radially opposite each other, see Figure 4), but that is not required.
  • the cylinder 12 of the piston-cylinder assembly 11, 12 contains air.
  • the piston-cylinder assembly 11, 12 is (integrally) provided with an electromagnetic actuator 14 for moving the piston 11 with respect to the cylinder 12.
  • the electromagnetic actuator 14 is mounted coaxially with respect to the piston-cylinder assembly (see Figures 2, 5).
  • the electromagnetic actuator 14 is a linear actuator, in particular a linear solenoid or voice coil actuator (known per se).
  • the electromagnetic actuator 14 preferably includes a permanent magnet 14a, driven by an electromagnet 14b.
  • the permanent magnet 14a can be arranged to be jointly movably with the piston 11 of the piston-cylinder assembly 11, 12.
  • the electromagnetic actuator 14 can include a (cylindrical) housing 14c that contains or surrounds the respective electromagnet 14b as well as the permanent magnet 14a (the permanent magnet 14a e.g. being located in and axially moveably with respect to the electromagnet 14b).
  • the electromagnet 14b can be configured in various ways, e.g. being provided by a coil of electrically conducting windings for conducing electric current, leading to a resulting electromagnetic force to drive c.q. axially move the permanent magnet 14a.
  • the electromagnetic actuator 14 as such does not include an integrated return spring for setting an initial position of the internal permanent magnet 14a.
  • a single permanent magnet 14a is depicted, it will be appreciated that the actuator 14 can also include an array of permanent magnets.
  • the permanent magnet 14a can e.g. be a circular cylindrical magnet, the same hold for the respective electromagnet 14b.
  • the afore-mentioned piston 11 preferably includes (e.g. is fixed to) a piston rod Ila that extends through substantially the entire electromagnetic actuator 14, in particular through a distal side wall 14d of the actuator 14 that faces a side wall 12d of the cylinder (see Figure 3), and along the respective electromagnet 14b.
  • the piston rod Ila can be axially, movably, guided through rod passages located in the two opposite side walls 12d, 14.
  • the piston rod Ila is arranged coaxially with respect to a center of the electromagnet 14b of the actuator.
  • piston rod Ila can e.g. be connected to a proximal end of the piston rod Ila, wherein an opposite distal end of the piston rod Ila axially protrudes from the distal side wall 14d of the actuator 14.
  • the piston rod 1 la can e.g. be made in one piece.
  • the rod Ila can be made of several rod sections, for example a rod section that is substantially located in the cylinder 12 and at least a further rod section that is substantially located in (and axially guided by) the electromagnetic actuator 14, the rod sections being interconnected by a suitable connector or coupling element.
  • the actuator 14 and cylinder 12 of the piston-cylinder assembly can be mutually fixed or integrated in various ways.
  • the housing 14c of the actuator 14 can partially overlap with and connected to a distal part 12 g of the cylinder 12. To that aim, the distal part
  • the cylinder 12 g of the cylinder 12 can e.g. be locally widened or reduced in diameter, for receiving (and engaging/attaching/fitting to) a section of the actuator housing 14c. It will be appreciated that axial overlap between the actuator housing 14c and the cylinder 12 can also be achieved differently (e.g. by a local change of a diameter of the actuator housing 14c for receiving part of the cylinder 12 ).
  • the actuator housing 14c and the pneumatic cylinder 12 can be achieved in various ways, e.g. via welding or fixation using adhesive, or mechanically with machined threads.
  • the electromagnetic actuator housing 14c can be made in one- piece with the pneumatic cylinder 12.
  • an internal wall 12 d dividing an interior of the electromagnetic actuator 14 (i.e. a respective permanent magnet guiding space) and the distal section 12b of the cylinder space, can be integrated with or part of the electromagnetic actuator 14.
  • the piston 11 of the piston-cylinder assembly 11, 12 is movable in opposite directions through the respective cylinder 12 for pneumatically moving the displacement structure 2 of the blood pump 1 in opposite directions, wherein the electromagnetic actuator 14 preferably includes the permanent magnet 14a, driven by the electromagnet 14b, the permanent magnet 14a being jointly movably with the piston 11 of the piston-cylinder assembly.
  • the resulting driver 10 can e.g. have an axial length X (see Figure 2), measured between an outer surface of a distal side wall 14d and the gas communication port 13 of at most 40 cm.
  • a maximum width Z of a housing of electromagnetic actuator 14, e.g. a maximum diameter, can be at most 10 cm.
  • the configuration can be such that an axial stroke distance of the permanent magnet 14a of the electromagnetic actuator 14 is the same as an axial stroke distance of the piston 11 of the piston-cylinder assembly 11, 12, the stroke distance preferably being in the range of about 1-6 cm.
  • the electromagnetic actuator 14 includes a controller unit C for controlling actuator movement, in particular for driving the blood pump in a pulsatile (BPM) manner.
  • the electromagnet 14b of the actuator can e.g. be connected to the controller unit C via suitable electric wiring 21 for powering the electromagnet 14b, as will be clear to the skilled person.
  • the controller unit C can include or be connectable to a suitable power source (not shown) for electrically powering the controller.
  • the controller unit C can be configured in various ways, e.g. including suitable microelectronic hardware, a computer or microcontroller and/or the- like, and e.g. software code that is executed by the respective hardware during operation to provide controller unit function(s).
  • the controller unit C can be configured to drive (power) the electromagnetic actuator 14 during operation to achieve a pulsating (axial) movement of the piston 11 of the pump driver, leading to alternatingly applying suction and pressure to the respective gas communication port 13.
  • Use of the system and respective driver 10 can include a method for driving a blood pump 1, the blood pump 1 having a pneumatically drivable displacement structure 2. It follows that the method preferably includes moving the piston 11 of the piston-cylinder assembly 11, 12 for alternatingly applying suction and pressure to a gas communication port 13 that is connected to the blood pump 1 via the pneumatic control line 5, for pneumatically driving the displacement structure 2 of the blood pump 1. The movement of the piston 11 is being induced by the electromagnetic actuator 14 (under control of the control unit C, providing respective electric current to the electromagnet 14b via the electric wiring 21).
  • the electromagnet 14b of the electromagnetic actuator 14 is alternatingly energized for alternatingly moving the permanent magnet 14a (in two opposite axial directions, and thus moving the piston 11 via the integrated piston rod Ila.
  • the piston 11 is moved periodically, from a first position (shown in Figure 6) to a second position (see Figure 5) for pressurizing the gas communication port 13, and from the second position back to the first position for applying suction to the gas communication port 13.
  • the periodic piston movements between its first and second position leads to pressurizing and suction (vacuum) of the connected pneumatic control line 5 such that the flexible membrane 2b performs respective pumping movements (see Figures 5, 6) for pumping liquid (e.g.
  • the gas outlet port 17 of the cylinder 12 can prevent overpressure at the gas communication port 13 (which might e.g. lead to rupture of other system components, e.g. a membrane 2b or pneumatic conduit 5).
  • the gas outlet port of the cylinder 12 can prevent that a vacuum or suction pressure at the gas communication port 13 becomes too low (i.e. to avoid vacuum induced closing of a flexible conduit 5 - if any- or damage to a membrane 5).
  • the piston 11 can be moved by the electromagnetic actuator 14 (under control of the control unit C), to provide about 60 - 120 pressurization steps (i.e. pressurization strokes) per minute (idem the respective number of intermediate suction steps).
  • energizing can be achieved based on a predetermined time period, in particular on a set BPM rate.
  • any reference signs placed between parentheses shall not be construed as limiting the claim.
  • the word ‘comprising’ does not exclude the presence of other features or steps than those listed in a claim.
  • the words ‘a’ and ‘an’ shall not be construed as limited to ‘only one’, but instead are used to mean ‘at least one’, and do not exclude a plurality.
  • the mere fact that certain measures are recited in mutually different claims does not indicate that a combination of these measures cannot be used to an advantage.

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Abstract

L'invention concerne un système de pompe d'assistance circulatoire comprenant : une pompe d'assistance circulatoire (1) comprenant une structure de déplacement à entraînement pneumatique (2) pour, pendant le fonctionnement, appliquer alternativement une aspiration et une pression, en particulier pour entraîner cycliquement un déplacement de fluide à travers une conduite de pompe d'assistance circulatoire (3), la structure de déplacement (2) étant de préférence une membrane ; un dispositif d'entraînement pneumatique (10) pour entraîner par voie pneumatique la structure de déplacement (2) de la pompe d'assistance circulatoire (1) par l'intermédiaire d'une conduite de commande pneumatique (5) ; le dispositif d'entraînement pneumatique (10) comprend un ensemble piston-cylindre (11, 12), le cylindre (12) comportant un orifice de communication de gaz (13) pour le raccordement à la conduite de commande pneumatique (5), l'ensemble piston-cylindre (11, 12) étant pourvu d'un actionneur électromagnétique (14) pour déplacer le piston (11) par rapport au cylindre (12). L'invention concerne également un dispositif d'entraînement pneumatique (10), ainsi qu'un procédé d'entraînement d'une pompe d'assistance circulatoire.
PCT/NL2023/050435 2023-08-24 2023-08-24 Système et pilote de pompe d'assistance circulatoire Pending WO2025042270A1 (fr)

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PCT/NL2023/050435 WO2025042270A1 (fr) 2023-08-24 2023-08-24 Système et pilote de pompe d'assistance circulatoire

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PCT/NL2023/050435 WO2025042270A1 (fr) 2023-08-24 2023-08-24 Système et pilote de pompe d'assistance circulatoire

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WO2025042270A1 true WO2025042270A1 (fr) 2025-02-27

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Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997002850A1 (fr) * 1995-07-10 1997-01-30 Medicard Ltd. Systeme d'assistance cardiaque
WO2005021078A1 (fr) 2003-09-02 2005-03-10 Intra-Vasc.Nl B.V. Pompe a catheter, catheter et fixations, et procede permettant d'utiliser une pompe a catheter.
US20090118568A1 (en) * 2000-03-28 2009-05-07 Pptt Llc Implantable counterpulsation cardiac assist device
US20190275223A1 (en) * 2018-03-08 2019-09-12 Berlin Heart Gmbh Drive device for a membrane fluid pump and operating method
WO2022197716A1 (fr) * 2021-03-17 2022-09-22 3R Life Sciences Corporation Dispositif de pompe à sang para-aortique

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997002850A1 (fr) * 1995-07-10 1997-01-30 Medicard Ltd. Systeme d'assistance cardiaque
US20090118568A1 (en) * 2000-03-28 2009-05-07 Pptt Llc Implantable counterpulsation cardiac assist device
WO2005021078A1 (fr) 2003-09-02 2005-03-10 Intra-Vasc.Nl B.V. Pompe a catheter, catheter et fixations, et procede permettant d'utiliser une pompe a catheter.
US20190275223A1 (en) * 2018-03-08 2019-09-12 Berlin Heart Gmbh Drive device for a membrane fluid pump and operating method
WO2022197716A1 (fr) * 2021-03-17 2022-09-22 3R Life Sciences Corporation Dispositif de pompe à sang para-aortique

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
ALLEN ET AL.: "The importance of Pulsatile and Nonpulsatile Flow in the Design of Blood Pumps", ARTIFICIAL ORGANS, vol. 21, no. 8, pages 922 - 928, XP071481072, DOI: 10.1111/j.1525-1594.1997.tb00252.x
LODGE ET AL.: "Regional Blood Flow During Pulsatile Cardiopulmonary Bypass and After Circulatory Arrest in an Infant Model", ANN THORAC SURG, vol. 63, 1997, pages 1243 - 50, XP022283457, DOI: 10.1016/S0003-4975(97)00238-5

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