Blood pump system and blood pump drive

Abstract

Blood pump system comprising: - a blood pump (1) comprising a discharge structure (2) which is pneumatically driven for alternately applying suction and pressure in operation, in particular for cyclically driving fluid through a blood pump line (3) discharge, wherein the discharge structure (2) is preferably a membrane; - a pneumatic driver (10) for pneumatically driving the discharge structure (2) of the blood pump (1) via a pneumatic control line (5); wherein the pneumatic driver (10) comprises a piston-cylinder assembly (11, 12), the cylinder (12) having a gas communication port (13) for connection to the pneumatic control line (5), the piston-cylinder assembly (11, 12) being provided with an electromagnetic actuator (14) for moving the piston (11) relative to the cylinder (12). The invention also relates to a pneumatic driver (10) and to a method for driving a blood pump.

Description

Technical Field

[0001] This invention relates to blood pump systems. Background Technology

[0002] Blood pump systems (used for circulating blood) are known in themselves. One known system is the Berlin Heart Pump System, specifically the EXCOR system. ® The Pediatric system is an external pulsatile ventricular assist device, or VAD for short. External means the actual blood pump is located outside the body and is connected to the heart and blood vessels via a cannula. ® Pediatric can be used to support one ventricle (left LVAD) or two ventricles (bilateral LVAD). In known systems, a three-layer membrane is used to separate the blood side and air side of the pump. This membrane is flexible and can be moved by alternating pressure. The pressure originates from the drive system and is introduced into the pump through tubing. If positive pressure is applied to the membrane, blood is expelled from the blood chamber and returned to the patient's circulation. By suction pressure, the pump is refilled with blood. Valves in the inlet and outlet tubing ensure that blood circulates only in one direction. Pumps vary in the size of their stroke volume (i.e., the volume of blood expelled with each stroke). The pump rate setting determines the frequency of the membrane's movement per minute. The rate should be selected to produce a blood flow that meets the patient's requirements.

[0003] Another example is disclosed in WO2005021078. In this example, the blood pump's discharge structure is driven by a commercially available drive system, such as a conventional balloon pump.

[0004] The known drawbacks of blood pump systems are that the corresponding blood pump drivers are bulky (approximately 1 meter in height), relatively expensive, complex, and very heavy (e.g., weighing 75 kg), making them difficult to operate and store. For example, known pump drivers include dedicated vacuum pumps for providing pressures below atmospheric pressure and dedicated compressors for providing pressures above atmospheric pressure. Summary of the Invention

[0005] The present invention aims to provide an improved blood pump system. Specifically, the present invention aims to provide a reliable blood pump system that is user-friendly and can be provided in an economical manner. Furthermore, one aspect of the invention provides a blood pump system with good or even improved manufacturability.

[0006] According to one aspect of the invention, this is achieved by the features of claim 1.

[0007] Advantageously, a blood pump system is provided, comprising: - A blood pump, comprising a pneumatically driven discharge structure for alternately applying suction and pressure during operation, specifically for cyclically driving fluid through a blood pump line to discharge, wherein the discharge structure is preferably a membrane; - A pneumatic actuator for pneumatically driving the discharge structure of the blood pump via a pneumatic control line; The pneumatic actuator includes a piston-cylinder assembly, the cylinder having a gas communication port for connection to the pneumatic control line, and the piston-cylinder assembly being provided with an electromagnetic actuator for moving the piston relative to the cylinder.

[0008] It has been found that this method enables the creation of a relatively reliable and compact blood pump system (e.g., the maximum axial length of the actuator can be, for example, a maximum of 40 cm). The resulting system can be manufactured to be lightweight (the actuator, for example, weighs less than 10 kg, specifically less than 5 kg). Furthermore, the resulting system can be made with relatively few components, thus providing good reliability and durability, and offering user-friendly operation. The piston-cylinder assembly can (alternatingly) deliver both pressures above and below atmospheric pressure, eliminating the need for a dedicated vacuum pump.

[0009] In a preferred embodiment, the system simply uses ambient air as the gas to pneumatically drive the blood pump via a pump driver. Furthermore, in a preferred embodiment, the electromagnetic actuator is a (relatively simple) linear actuator, specifically a linear solenoid or voice coil actuator, which can be directly integrated with the pneumatic piston-cylinder assembly. Additionally, according to a preferred embodiment, ambient air is used by the system as the pneumatic drive gas (i.e., the gas that is alternately pressurized and depressurized by the pneumatic piston-cylinder assembly to cyclically drive the discharge structure of the blood pump).

[0010] Furthermore, one aspect of the present invention provides a pneumatic blood pump driver for pneumatically driving the discharge structure of a blood pump via a pneumatic control line, specifically a blood pump driver according to the system of the present invention, wherein the pump driver is characterized in that it includes a piston-cylinder assembly 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 relative to the cylinder.

[0011] In this way, the above advantages can be achieved.

[0012] Furthermore, a method for driving a blood pump is provided, the blood pump having a pneumatically driven discharge structure, the method utilizing, for example, a system or blood pump driver according to the invention. The method preferably includes: - To move the piston of the piston-cylinder assembly to alternately apply suction and pressure to the gas communication port of the blood pump connected via a pneumatic control line, so as to pneumatically drive the discharge structure of the blood pump. The movement of the piston is caused by an electromagnetic actuator.

[0013] In this way, the aforementioned advantages can also be achieved.

[0014] Further advantageous embodiments are described in the dependent claims. Attached Figure Description

[0015] The invention will now be described in more detail with reference to the accompanying drawings. In the drawings: Figure 1 A partial cross-sectional view of a human chest and an example of a catheter-type blood pump is shown.

[0016] Figure 2 A partially open side view of a non-limiting embodiment of the blood pump system according to the present invention is shown.

[0017] Figure 3 It shows Figure 2 The figure shows a partially opened perspective view of the electromagnetic actuator of the system.

[0018] Figure 4 It shows Figure 2 Details Q.

[0019] Figure 5 The pump driver is shown in its first state. Figure 2 This is part of an example.

[0020] Figure 6 The second state of the pump driver is shown. Figure 2 This is part of an example. Detailed Implementation

[0021] In this application, similar or corresponding features are indicated by similar or corresponding reference numerals.

[0022] The heart pump system itself is well-known. In Figure 1(From WO2005021078) A human chest is shown in a view illustrating the heart H, aorta A, superior vena cava S, inferior vena cava I, right pulmonary vein V, left pulmonary vein W, right pulmonary artery P, left pulmonary artery L, aortic arch AA, left ventricle LV, and right ventricle RV. Arrows indicate the direction of blood flow when the heart H is functioning. In practice, during open-heart surgery on a stopped heart H, blood circulation is typically maintained using a heart-lung machine 112 (shown schematically only), which includes a pump 113 and an oxygenator 114. The heart-lung machine is attached to the body to pump blood from the vena cava to the aorta and maintain blood circulation in the patient.

[0023] The blood flow from the cardiopulmonary bypass machine 113 to the patient is essentially nonpulsatile. This essentially nonpulsatile blood flow enters the aorta A2, which is adjacent to the stopped heart H. Pump 113 is a nonpulsatile pump, which offers advantages in terms of design and compatibility with oxygenator function (see Allen et al., “The importance of Pulsatile and Nonpulsatile Flow in the Design of Blood Pumps”, Artificial Organs 21 (8): 922-928).

[0024] Organ failure following open-heart surgery is a common cause of complications. Different theories exist regarding the causes of this organ failure. One such theory is that the use of a cardiopulmonary bypass machine may have several side effects affecting blood pressure and organ perfusion.

[0025] For example, cardiopulmonary bypass machines induce a non-physiological (non-pulsatile) flow pattern, and when pre-filled fluid from tubing and the oxygenator is introduced into the patient's bloodstream, it results in reduced blood viscosity. Other conditions where lowered blood pressure may interfere with organ function include during toxic shock, potentially caused by an anaphylactic reaction, and long-term cardiac dysfunction that often leads to multiple organ failure.

[0026] Some studies have shown that pulsatile flow is beneficial for obtaining sufficient blood flow to organs. For example, pulsatile flow in the cardiopulmonary bypass has been found to have a positive effect on the blood flow rate in the kidneys of newborn pigs (see 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).

[0027] exist Figure 1 The image shows the clinical application of a catheter pump 1 used to induce blood pressure pulsations in the aorta A. Figure 2 Additional advantageous examples of pump 1 (and corresponding drive 10) are described in more detail in the text.

[0028] Preferably, the pulsating tubular pump 1 has a discharge structure 2 in the form of a rigid housing 2a, which encloses a chamber 9 separated by a flexible membrane 2b. During operation, the tubular pump 1 has a conduit 3 or is connected to a conduit 3, which protrudes from the discharge structure 2 and defines a longitudinally extending channel within the conduit for guiding fluid in the longitudinal direction of the conduit. The channel is located on the distal side of the membrane 2b and in part 9a of the chamber 9 (see [link to relevant documentation]). Figure 2 The discharge structure has a pneumatic actuator port, such as sleeve 2c, for connecting the pneumatic tube 5, which communicates with the pneumatic actuator 10, to a portion 9b of the chamber 9 on the proximal side of the membrane 19. (Refer to below...) Figure 2 - Figure 6 An advantageous embodiment of the pneumatic actuator 10 is described.

[0029] During operation, the discharge structure 2 can be driven (by the actuator 10) via the pneumatic tube 5 to alternately apply suction to discharge fluid from the distal portion of the conduit 3 to the discharge structure 2 via the corresponding channel, and to apply pressure to discharge fluid from the discharge structure 2 to the conduit 3, thereby driving a pulsating backflow through the conduit 3.

[0030] For example, during use, catheter 3 extends from discharge structure 2 through the left subclavian artery leading to the left arm 123 into the aorta A, and is inserted into the patient's aorta A with its distal end positioned in the patient's aorta A.

[0031] According to a non-limiting embodiment, the distal end of the catheter 3 may be provided with an inlet passage 125 disposed in a connector of the catheter 3. Spaced distally from the inlet passage 25, the catheter 3 preferably has an outlet passage 126 (e.g., disposed in a catheter end connector). As those skilled in the art will understand, the catheter 3 may also be constructed differently.

[0032] During use, the discharge structure 2 (i.e., blood pump 1) is preferably connected to the proximal end of the catheter 3 and configured to alternately draw blood from and supply blood to the aorta A via the catheter 3, thereby generating pressure pulsation in the region of the distal end of the catheter 3. The discharge structure 2 preferably has a stroke volume in the range of 40-75 mL and may be made of, for example, optically transparent plastics or polymers such as PC, PMMA, or MABS, as will be apparent to those skilled in the art.

[0033] Preferably, in Figure 1 In the use of the catheter pump 1 shown, pulsation is generated in the blood flow in the aorta A. Blood is pumped into the catheter 3 via the inlet passage 125 (e.g., located in the aortic arch AA) and pumped out of the catheter 3 via the outlet passage 126 in the descending segment of the aorta A, preferably near arteries 130-133 toward the intestine, liver and kidney.

[0034] The pulsation of blood pressure is transmitted to arteries 130–133 toward the intestines, liver, and kidneys. This local pulsation of blood pressure has a positive effect on organ perfusion (e.g., the flow rate per unit mass of organ tissue), which is thought to be caused by an increased effective organ perfusion pressure gradient.

[0035] Therefore, the blood pump 1 and the corresponding pneumatic actuator 10 are arranged for external use.

[0036] This non-limiting example of pump 1 (specifically, catheter pump 1) has a relatively simple construction, thereby providing reliable and sustained blood flow. The corresponding discharge structure 2 is arranged to alternately apply suction and pressure, specifically to cyclically drive fluid through a corresponding catheter 3 (or similar blood flow line) connected to the fluid discharge port 2d of the discharge structure 2.

[0037] Pneumatic tube 5 is configured to communicate with a pneumatic drive system or actuator 10 (see [link]). Figure 2 - Figure 6 ).

[0038] According to a non-limiting embodiment, the system driver 10 is configured to provide corresponding drive pulses in the range of 60–100 BPM (beats per minute) using a corresponding control unit (see below). For example, a selected drive rate (BPM) (e.g., 60, 65, 70, 75, etc.) can be adjusted every 5 beats.

[0039] Figure 2 - Figure 6 An example of the pneumatic actuator 10 is described in more detail.

[0040] The pneumatic actuator 10 is configured to pneumatically drive the discharge structure 2 of the blood pump 1 via a pneumatic (i.e., gas-connected) control line (i.e., the pneumatic tube) 5. During use, the control line / tube 5 can be coupled to the actuator 10, for example via a suitable connector structure 13 such as a Luer lock connector, as will be apparent to those skilled in the art. The pneumatic control line 5 can be, for example, a flexible gas conduit or tube, having a length of at least 10 cm (e.g., at least 1 m).

[0041] According to a highly advantageous embodiment, the actuator 10 includes piston-cylinder assemblies 11, 12, with cylinder 12 having a gas connection port 13 for connection to a gas connection (pneumatic) control line 5.

[0042] For example, the gas connection port 13 of cylinder 12 can have a Luer lock construction, with a tapered Luer lock connector section 13a (such as...). Figure 4 (As shown). In this case, it should be understood that the corresponding pneumatic control line 5 preferably also includes a Luer lock connector at its respective end for detachable connection to the Luer lock connector section 13a of the cylinder 12.

[0043] For example, cylinder 12 (which may be a cylinder barrel) may have a circular cross-section. Cylinder 12 is preferably made of metal or alloy such as stainless steel. Cylinder 12 may have a proximal sidewall 12c including a gas discharge port 13 (see [link to article]). Figure 4 Cylinder 12 may enclose a cylinder chamber that extends axially between the proximal sidewall 12c and the distal sidewall 12d (see...). Figure 2 ).

[0044] The cylinder chamber is divided by piston 11 into a proximal section 12a and a distal section 12b (see...) Figure 4 The volumes of cylinder sections 12a and 12b change during axial piston movement (i.e., during actuator operation). Specifically, the proximal cylinder (chamber) section 12a is in direct gas communication with the gas communication port 13 to provide direct gas communication with the connected pneumatic tube 5 for pneumatically driving the connected blood pump 1.

[0045] According to one embodiment, the stroke volume of the piston-cylinder assemblies 11, 12 (specifically, the maximum volume of the proximal segment 12a of the cylinder chamber) is in the range of approximately 40-75 cc. The stroke volume of the corresponding blood pump 1 driven by the actuator 10 may, for example, be substantially the same as and / or in the range of approximately 40-75 cc as the stroke volume of the piston-cylinder assemblies 11, 12.

[0046] It should be understood that this movable piston 11 is configured to provide a substantially airtight seal between the two cylinder sections 12a, 12b, and both the piston 11 and the inner circumferential side of the cylinder 12 have a circular cross-section. Preferably, the piston 11 is self-lubricating (e.g., it may be made of self-lubricating brass).

[0047] Preferably, the piston 11 is concentrically located within the corresponding cylinder 12. Figure 5 The second position of piston 11 is depicted, in which piston 11 has been axially moved toward a position near gas communication port 13 (to compress the gas in the proximal cylinder section 12a to a pressure higher than atmospheric pressure). Figure 6 The first position of piston 11 is depicted, in which piston 11 has been axially moved away from gas communication port 13 (to depressurize the gas in the proximal cylinder section 12a to a pressure below atmospheric pressure, such as a vacuum).

[0048] Preferably, the distal section of cylinder 12 includes a gas passage 18, thereby allowing gas (preferably ambient air) to enter and exit the second section 12b of the cylinder chamber, specifically maintaining this chamber section substantially at atmospheric pressure during operation. The entry and exit of the gas is controlled by... Figure 5 and Figure 6 The arrow in the diagram indicates "air". It should be understood that one or more such gas passages 18 may be provided, and such gas passages may be located near the distal chamber wall 12d.

[0049] Preferably, cylinder 12 includes a gas inlet port 16 separate from the gas communication port 13 for supplying gas to the proximal section 12a of cylinder 12 (see [link]). Figure 4According to a preferred embodiment, the gas inlet port 16 includes a first valve 16a (e.g., a negative pressure relief valve, a check valve), which is configured to open the gas inlet port 16 when a (predetermined) sub-atmospheric pressure is reached or lowered in the cylinder (i.e., in the proximal chamber section 12a), for example, when the (vacuum) pressure in the proximal chamber section 12a is lower than the pressure outside the gas inlet port (i.e., ambient pressure) by a first predetermined amount. In this way, the first valve 16a can prevent the pressure in the first cylinder section 12a from dropping to a vacuum level that could damage system components. Preferably, the corresponding valve 16a is configured to automatically close the gas inlet port 16 when the pressure in the first cylinder section 12a is at least equal to the ambient pressure, for example, when it is higher than the ambient pressure (i.e., outside the gas inlet port 16) by the first predetermined amount (i.e., during the pressurizing movement of the piston 11 toward the proximal end wall 12c).

[0050] The first valve 16a can be, for example, a spring-biased check valve. Valve 16a can be a valve body 16a engaged by a return spring 16b, which presses the valve body 16a against a valve seat 16f to close the corresponding external gas passage 16e using spring force (see [link to original text]). Figure 4 As will be apparent to those skilled in the art, the configuration of the return spring 16b can be chosen to provide the desired valve operation (i.e., the amount of gas pressure difference at the gas inlet port 16 required to set the valve open, i.e., to move the valve body 16a away from the valve seat 16f and allow ambient air to enter the cylinder 12 via the corresponding gas passages 16e, 12e).

[0051] The gas inlet port 16 can be located substantially outside the cylinder 12, having a valve housing 16d that protrudes (radially) from the cylinder 12. For example, the valve housing 16d can be integrally formed with the cylinder 12.

[0052] Cylinder 12 may be provided with a gas passage 12e leading to a valve space enclosed by a valve housing 16d (which houses the valve body 16a and the valve spring 16b) of gas inlet port 16. In this example, the valve housing 16d of gas inlet port 16 includes a valve seat 16f having a corresponding external gas passage 16e, which can be axially positioned relative to the corresponding gas passage 12e of cylinder 12.

[0053] Similarly, preferably, cylinder 12 includes a gas outlet port 17, which is separate from the gas communication port 13 (and from the gas inlet port 16) for discharging gas from the proximal section 12a of cylinder 12. For example, gas outlet port 17 may include a second valve 17a (e.g., a positive pressure relief valve, a check valve) configured to automatically close gas outlet port 17 when a (predetermined) threshold pressure in cylinder 12 is reached or lowered, for example, when the pressure in the proximal chamber section 12a is a second amount lower than the pressure outside gas outlet port 17 (i.e., ambient pressure) (i.e., during decompression movement of piston 11 away from proximal cylinder wall 12c).

[0054] The second valve 17a is preferably configured to (automatically) open the gas outlet port 17 when the pressure in cylinder 12 is higher than atmospheric pressure by the second amount than the pressure outside gas outlet port 17, thereby allowing ambient air to enter the first cylinder section 12a (to prevent the pressure in the first cylinder section 12a from increasing to a level that could damage system components).

[0055] The second valve 17a can be, for example, a spring-biased check valve. The second valve 17a can be a valve body 17a engaged by a return spring 17b, which uses spring force to press the valve body 17a against a valve seat 17f (to close the corresponding gas passage 17e) (see [link]). Figure 4 As will be apparent to those skilled in the art, the configuration of the return spring 17b can be chosen to provide the desired valve operation (i.e., to set the valve open by the amount of gas pressure difference required at the gas outlet port 17, i.e., to move the valve body 176a away from the valve seat 17f and allow gas to leave via the gas passage 17e).

[0056] In this compact actuator configuration, the gas outlet port 17 is substantially located outside the cylinder 12, having a valve housing 17d projecting (radially) from the cylinder 12. In this case, the valve housing 17d can also be formed as a single piece with the cylinder 12. For example, the cylinder 12 may be provided with a valve seat 17f and a corresponding valve gas passage 12f, the valve gas passage 12f leading to a valve space enclosed by the valve housing 17d of the gas outlet port 17 (a valve housing that accommodates the corresponding valve body 17a and the corresponding valve spring 17b). In this example, the valve housing 17d of the gas outlet port 17 includes a gas passage 17e, which is axially positioned opposite to the corresponding gas passage 12f of the cylinder 12 for discharging gas into the environment (when the valve is already open).

[0057] Preferably, the gas inlet port 16 and the gas outlet port 17 (e.g., the corresponding valves 16a, 17a and valve bodies 16d, 17d) are both located near (or within) the proximal end wall 12c of the cylinder 12. For example, the inlet port 16 and the gas outlet port 17 may be positioned linearly relative to each other (e.g., the opposing gas passages 12e, 12f are positioned radially relative to each other, see...). Figure 4 However, this is not necessary.

[0058] According to one embodiment, the cylinder 12 of the piston-cylinder assembly 11, 12 (and specifically at least a first section 12a of the cylinder and preferably also a second section 12b of the cylinder) contains air.

[0059] Furthermore, advantageously, the piston-cylinder assemblies 11, 12 (integrally) are provided with an electromagnetic actuator 14 for moving the piston 11 relative to the cylinder 12. According to a preferred compact embodiment, the electromagnetic actuator 14 is mounted coaxially relative to the piston-cylinder assembly (see [link]). Figure 2 and Figure 5 According to a preferred embodiment, the electromagnetic actuator 14 is a linear actuator, specifically 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 move in conjunction with the piston 11 of the piston-cylinder assemblies 11, 12.

[0060] For example, the electromagnetic actuator 14 may include a (cylindrical) housing 14c that contains or surrounds a corresponding electromagnet 14b and a permanent magnet 14a (the permanent magnet 14a being, for example, located within the electromagnet 14b and capable of axial movement relative to the electromagnet 14b). It should be understood that the electromagnet 14b can be constructed in various ways, for example provided by a coil of conductive windings for conducting current, thereby generating an electromagnetic force that drives the permanent magnet 14a, such as causing the permanent magnet 14a to move axially. In this example, preferably, the electromagnetic actuator 14 itself does not include an integrated return spring for setting the initial position of the internal permanent magnet 14a. In this example, a single permanent magnet 14a is depicted; it should be understood that the actuator 14 may also include an array of permanent magnets. The permanent magnet 14a can be, for example, a cylindrical magnet, as can the corresponding electromagnet 14b.

[0061] The aforementioned piston 11 preferably includes (e.g., fixed to) a piston rod 11a that extends through substantially the entire electromagnetic actuator 14, specifically through the distal sidewall 14d of the cylinder-facing sidewall 12d of the actuator 14 (see...). Figure 3And extends along the corresponding electromagnet 14b. For example, the piston rod 11a can be axially and movably guided through rod passages located in two opposing sidewalls 12d, 14d. Furthermore, preferably, the piston rod 11a is arranged coaxially with respect to the center of the electromagnet 14b of the actuator. The piston 11 can, for example, be connected to the proximal end of the piston rod 11a, wherein the opposite distal end of the piston rod 11a protrudes axially from the distal sidewall 14d of the actuator 14.

[0062] The piston rod 11a may be made in one piece, for example. Alternatively, the rod 11a may be made of several rod segments, such as a rod segment substantially located in the cylinder 12 and at least one other rod segment substantially located in (and axially guided by) the electromagnetic actuator 14, which are interconnected by suitable connectors or coupling elements.

[0063] The actuator 14 and cylinder 12 of the piston-cylinder assembly can be fixed to or integrated with each other in various ways. For example (see...) Figure 2 The housing 14c of the actuator 14 can partially overlap and connect to the distal portion 12g of the cylinder 12. For this purpose, the distal portion 12g of the cylinder 12 can, for example, be locally widened or reduced in diameter to receive (and engage / attach / assemble) a section of the actuator housing 14c. It should be understood that the axial overlap between the actuator housing 14c and the cylinder 12 can also be achieved in different ways (e.g., by locally varying the diameter of the actuator housing 14c to receive a portion of the cylinder 12).

[0064] The integration of the actuator housing 14c and the pneumatic cylinder 12 can be achieved in various ways, such as by welding or fixing with adhesive, or mechanically by machining threads. Furthermore, according to one embodiment, the electromagnetic actuator housing 14c can be integrally formed with the pneumatic cylinder 12.

[0065] Similarly, the inner wall 12d that separates the interior of the electromagnetic actuator 14 (i.e., the corresponding permanent magnet guiding space) and the distal section 12b of the cylinder space can be integrated with or be part of the electromagnetic actuator 14.

[0066] Therefore, according to one embodiment, the piston 11 of the piston-cylinder assembly 11, 12 is capable of moving through the corresponding cylinder 12 in opposite directions to pneumatically move the discharge structure 2 of the blood pump 1 in opposite directions, wherein the electromagnetic actuator 14 preferably includes a permanent magnet 14a driven by an electromagnet 14b, the permanent magnet 14a being capable of moving together with the piston 11 of the piston-cylinder assembly.

[0067] The resulting actuator 10 can, for example, have a maximum axial length X of 40 cm measured between the outer surface of the distal sidewall 14d and the gas communication port 13 (see...). Figure 2 ).

[0068] In addition, the maximum width Z (e.g., maximum diameter) of the housing of the electromagnetic actuator 14 can be up to 10 cm.

[0069] According to one embodiment, the configuration enables the axial travel distance of the permanent magnet 14a of the electromagnetic actuator 14 to be the same as the axial travel distance of the piston 11 of the piston-cylinder assembly 11, 12, which is preferably in the range of about 1-6 cm.

[0070] According to one embodiment, the electromagnetic actuator 14 includes a controller unit C for controlling actuator movement, specifically for driving the blood pump in a pulsating (BPM) manner. The electromagnet 14b of the actuator can be connected to the controller unit C, for example, via a suitable wire 21 for powering the electromagnet 14b, as will be apparent to those skilled in the art. Furthermore, the controller unit C can include or be connected to a suitable power source (not shown) for powering the controller. The controller unit C can be constructed in various ways, such as including suitable microelectronic hardware, a computer, or a microcontroller, and software code, for example, executed by the appropriate hardware during operation to provide the functionality of the controller unit. Specifically, the controller unit C can be configured to drive (powering) the electromagnetic actuator 14 during operation to achieve pulsating (axial) movement of the piston 11 of the pump driver, resulting in alternating application of suction and pressure to the corresponding gas connection port 13.

[0071] The use of the system and corresponding actuator 10 may include a method for driving a blood pump 1, which has a pneumatically driven discharge structure 2. Therefore, the method preferably includes moving the piston 11 of the piston-cylinder assemblies 11, 12 to alternately apply suction and pressure to a gas communication port 13 of the blood pump 1 connected via a pneumatic control line 5, for pneumatically driving the discharge structure 2 of the blood pump 1. The movement of the piston 11 is caused by an electromagnetic actuator 14 (which, under the control of the control unit C, provides a corresponding current to an electromagnet 14b via a wire 21). Specifically, the electromagnet 14b of the electromagnetic actuator 14 is alternately energized to alternately move a permanent magnet 14a (along two opposite axial directions), thereby moving the piston 11 via an integral piston rod 11a. Specifically, as a result, the piston 11 periodically moves from a first position ( Figure 6 (As shown in the image) Move to the second position (see...) Figure 5The piston is used to pressurize the gas connection port 13 and returns from the second position to the first position to apply suction to the gas connection port 13. The periodic movement of the piston between its first and second positions causes pressurization and suction (vacuum) of the connected pneumatic control line 5, causing the flexible diaphragm 2b to perform a corresponding pumping motion (see...). Figure 5 , Figure 6 This is used to pump liquids (such as blood) toward or away from the blood pump (as indicated by the arrow "Liquid" in the figure). Furthermore, during operation, ambient air can pass through the corresponding gas passage 18 of the cylinder to avoid or reduce overpressure and underpressure in the distal cylinder section 12b.

[0072] During operation, the gas outlet port 17 of cylinder 12 is able to prevent overpressure at the gas connection port 13 (which could, for example, cause rupture of other system components such as membrane 2b or pneumatic tube 5). Similarly, the gas outlet port of cylinder 12 is able to prevent the vacuum or suction pressure at the gas connection port 13 from becoming too low (i.e., to avoid vacuum-induced closure of flexible tube 5, if present, or damage to membrane 5).

[0073] According to one embodiment, during operation, the piston 11 can be moved by the electromagnetic actuator 14 (under the control of the control unit C) to provide approximately 60-120 pressurization steps (i.e., pressurization strokes) per minute (the same number as the corresponding number of intermediate suction steps). In other words, energization can be achieved based on a predetermined time period, specifically based on a set BPM rate.

[0074] In this document, the invention is described with reference to specific examples of embodiments thereof. However, it will be apparent that various modifications and alterations may be made therein without departing from the spirit of the invention as defined in the claims. For clarity and brevity, features are described herein as part of the same or different embodiments; however, alternative embodiments having combinations of all or some of the features described in these different embodiments are also contemplated.

[0075] However, other modifications, variations, and alternatives are also possible. Therefore, the specification, drawings, and embodiments are considered illustrative rather than restrictive.

[0076] In the claims, any reference numerals enclosed in parentheses shall not be construed as limiting the claims. The word “comprising” does not exclude the presence of features or steps other than those listed in the claims. Furthermore, the words “a” and “an” should not be construed as limited to “only one”, but are used to mean “at least one” and do not exclude multiple. The fact that certain measures are described in different claims does not mean that a combination of these measures cannot be used advantageously.

Claims

1. A blood pump system, comprising: - A blood pump (1), the blood pump including a pneumatically driven discharge structure (2) for alternately applying suction and pressure during operation, specifically for cyclically driving fluid through the blood pump line (3) for discharge, wherein the discharge structure (2) is preferably a membrane; - Pneumatic actuator (10), which is used to pneumatically drive the discharge structure (2) of the blood pump (1) via a pneumatic control line (5). The pneumatic actuator (10) is characterized in that the cylinder (12) of the piston-cylinder assembly has a gas communication port (13) for connection to the pneumatic control line (5), and the piston-cylinder assembly is provided with an electromagnetic actuator (14) for moving the piston (11) relative to the cylinder (12).

2. The blood pump system according to claim 1, characterized in that, The cylinder (12) includes a gas inlet port (16) separate from the gas communication port (13) for supplying gas to the proximal section of the cylinder (12).

3. The blood pump system according to claim 2, characterized in that, The gas inlet port (16) includes a first valve (16a) configured to open the gas inlet port when a certain threshold pressure in the cylinder is reached, for example, when the pressure in the cylinder (12) is lower than the pressure outside the gas inlet port by a first amount, and the first valve is configured to close the gas inlet port, for example, when the pressure in the cylinder (12) is higher than the pressure outside the gas inlet port by the first amount.

4. The blood pump according to any one of the preceding claims, characterized in that, The cylinder (12) includes a gas outlet port (17) separate from the gas communication port for discharging gas from the proximal section of the cylinder (12).

5. The blood pump system according to claim 4, characterized in that, The gas outlet port (17) includes a second valve (17a) configured to close the gas outlet port (17) when a certain threshold pressure is reached in the cylinder (12), specifically when the pressure in the cylinder (12) is lower than the pressure outside the gas outlet port (17) by a second amount, and the second valve (17a) is configured, for example, to open the gas outlet port (17) when the pressure in the cylinder (12) is higher than the pressure outside the gas outlet port (17) by the second amount.

6. The blood pump according to any one of the preceding claims, characterized in that, The distal section of the cylinder (12) includes a gas passage (18).

7. The blood pump system according to any one of the preceding claims, characterized in that, The electromagnetic actuator is mounted coaxially with respect to the piston-cylinder assembly.

8. The blood pump system according to any one of the preceding claims, characterized in that, The piston (11) includes a piston rod (11a) that extends through substantially the entire electromagnetic actuator (14), specifically through the sidewall of the actuator (14) facing the cylinder sidewall.

9. The blood pump system according to any one of the preceding claims, characterized in that, The electromagnetic actuator is a linear actuator, specifically a linear solenoid or voice coil actuator.

10. The blood pump system according to any one of the preceding claims, characterized in that, The cylinder (12) of the piston-cylinder assembly contains air.

11. The blood pump system according to any one of the preceding claims, characterized in that, The stroke volume of the piston-cylinder assembly is in the range of approximately 40-75cc, wherein the stroke volume of the corresponding blood pump (1) is preferably approximately the same as and / or in the range of approximately 40-75cc as the stroke volume of the piston-cylinder assembly.

12. The blood pump according to any one of the preceding claims, characterized in that, The electromagnetic actuator (14) includes a controller unit (C) for controlling the actuator movement, specifically for driving the blood pump in a pulsating manner.

13. The blood pump according to any one of the preceding claims, characterized in that, The piston (11) of the piston-cylinder assembly is capable of moving in the opposite direction through the corresponding cylinder (12) to pneumatically move the discharge structure (2) of the blood pump (1) in the opposite direction, wherein the electromagnetic actuator (14) preferably includes a permanent magnet (14a) driven by an electromagnet (14b), the permanent magnet (14a) being capable of moving together with the piston (11) of the piston-cylinder assembly.

14. The blood pump according to any one of the preceding claims, characterized in that, The electromagnetic actuator (14) includes a permanent magnet (14a) driven by an electromagnet (14b), wherein the stroke distance of the permanent magnet (14a) of the electromagnetic actuator (14) is the same as the stroke distance of the piston (11) of the piston-cylinder assembly, and the stroke distance is preferably in the range of about 1-6 cm.

15. A blood pump driver (10) for pneumatically driving the discharge structure (2) of a blood pump (1) via a pneumatic control line (5), specifically a blood pump driver (10) of a blood pump system according to any of the preceding claims, characterized in that, The pneumatic blood pump driver (10) includes a piston-cylinder assembly, the cylinder (12) of the piston-cylinder assembly having a gas communication port (13) for connection to the pneumatic control line (5), the piston-cylinder assembly being provided with an electromagnetic actuator (14) configured to move the piston (11) of the piston-cylinder assembly relative to the cylinder (12).

16. The blood pump actuator according to claim 15, characterized in that, The cylinder (12) includes a gas inlet port (16) separate from the gas communication port (13) for feeding gas into the cylinder (12).

17. The blood pump actuator according to claim 16, characterized in that, The gas inlet port (16) includes a first valve (16a) configured to open the gas inlet port when a certain threshold pressure in the cylinder is reached, for example, when the pressure in the cylinder (12) is lower than the pressure outside the gas inlet port by a first amount, and the first valve is configured to close the gas inlet port, for example, when the pressure in the cylinder (12) is higher than the pressure outside the gas inlet port by the first amount.

18. The blood pump actuator according to any one of claims 15-17, characterized in that, The cylinder (12) includes a gas outlet port (17) separate from the gas communication port for discharging gas from the cylinder (12).

19. The blood pump actuator according to claim 18, characterized in that, The gas outlet port (17) includes a second valve (17a) configured to close the gas outlet port (17) when a certain threshold pressure is reached in the cylinder (12), specifically when the pressure in the cylinder (12) is lower than the pressure outside the gas outlet port (17) by a second amount, and the second valve (17a) is configured, for example, to open the gas outlet port (17) when the pressure in the cylinder (12) is higher than the pressure outside the gas outlet port (17) by the second amount.

20. A method for driving a blood pump, the blood pump having a pneumatically driven discharge structure (2), the method comprising: - Move the piston (11) of the piston-cylinder assembly to alternately apply suction and pressure to the gas communication port (13) of the blood pump connected via a pneumatic control line (5) to pneumatically drive the discharge structure (2) of the blood pump. The movement of the piston (11) is caused by the electromagnetic actuator (14).

21. The method according to claim 20, characterized in that, The piston (11) of the piston-cylinder assembly is connected to or provided with the permanent magnet (14a) of the electromagnetic actuator (14), wherein the electromagnet (14b) of the electromagnetic actuator (14) is AC energized to cause the permanent magnet (14a) to move alternately.

22. The method according to any one of claims 20-21, characterized in that, The piston (11) is moved from a first position to a second position to pressurize the gas communication port (13), wherein the piston is moved from the second position to the first position to apply suction to the gas communication port (13).

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