Load-improving blood pump system and its blood pump

Abstract

One aspect of the present invention relates to a load-improving blood pump (40, 40') comprising a casing (400) suitable for incorporation into a human body (6), a turbine rotated by a rotor, a pumping chamber body (402) attached to the casing (400) housing the turbine, an inlet port (401) for drawing blood from an aspiration cannula (41) into the pumping chamber body (402), and an outlet port (403) for expelling blood from the pumping chamber (402) to a reinfusion cannula (43), the pump (40, 40') being configured to allow a nominal constant continuous flow of between 0.05 L / min and 0.5 L / min, depending on its power source, to reduce capillary pressure in the lungs and / or left atrium and / or left ventricle.

Description

Technical Field

[0001] The technical field of the present invention generally relates to the field of blood pumps. More precisely, the present invention relates to a blood pump configured for transplantation into a human and for improving the ventricular load in order to reduce the risk of heart failure with preserved ejection fraction (HFpEF).

[0002] The present invention also relates to a blood pump system and its blood pump for improving the load on the heart region in order to reduce heart failure with preserved ejection fraction (HFpEF).

Background Art

[0003] Heart failure (HF) is known as a disease in which the ejection fraction (HFpEF) is preserved or the ejection fraction (HFrEF) is decreased or reduced. The distinction between heart failure with reduced or decreased ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF) is based particularly on Doppler echocardiography, which gives a numerical value of the left ventricular ejection fraction (LVEF). An ejection fraction EF < 40 - 50% indicates HF with a decrease or reduction in the ejection fraction (HFrEF). Otherwise, EF > 40 - 50% suggests heart failure with preserved ejection fraction (HFpEF). The diagnosis can be confirmed by specific criteria for relaxation disorder and diastolic dysfunction.

[0004] Pharmacological and non - pharmacological or surgical treatments using intracardiac devices (biventricular pacing) for heart failure are known, but ventricular assist devices for the most important cases of heart failure with reduced or decreased ejection fraction (HFrEF) are also known. A ventricular assist device includes a pump for assisting the heart by pumping blood at a flow rate according to the needs of the heart. Its useful nominal flow rate is about 5 L / min at rest and during exercise for an adult, and can increase to 35 - 40 L / min for an athlete. These pumps can assist the heart between 2 L and 10 L / min when the heart is unable to obtain a sufficient cardiac output. These pumps are very large due to the power required to pump blood flow from the left ventricle to the aorta.

[0005] A rotary blood pump can be either centrifugal or axial flow. In a centrifugal blood pump, blood enters the pump along its axis of rotation and exits perpendicular to the axis of rotation. In an axial flow blood pump, blood enters the pump along its axis of rotation and exits along the axis of rotation.

[0006] In particular, there are axial-assisted pumps with extremely high rotational speeds; for example, their rotors rotate at 32,000 rpm, providing a flow rate of 2.5 L / min. This high speed can cause thrombosis. Even if such pumps can be set to lower flow rates, for example 0.3 L / min, their rotational speeds are still very high, around 17,000 rpm, which can lead to a significant risk of hemolysis and thrombosis.

[0007] Axial flow pumps are more difficult to handle than constant flow centrifugal pumps, but centrifugal pumps allow for higher flow rates at constant rotational speed, thereby reducing the problems of thrombosis and hemolysis.

[0008] However, despite numerous trials, treatments that are neither pharmacological nor surgical have been proven effective in heart failure with preserved ejection fraction (HFpEF). As a result, heart failure with preserved ejection fraction leads to many deaths; in France, 30–50% of cases of heart failure (HF) are heart failure with preserved ejection fraction (HFpEF), and according to a US study, the mortality rate is approximately 29% at one year and approximately 65% ​​at five years. [Overview of the project] [Problems that the invention aims to solve]

[0009] Therefore, treatment for heart failure with preserved ejection fraction (HFpEF) is necessary. [Means for solving the problem]

[0010] This invention provides a solution to the aforementioned problem by enabling a reduction in atrioventricular pressure without increasing pulmonary flow compared to interatrial formation. In fact, the effects of HFpEF on the lungs are directly related to increased pressure and passive dilation of the pulmonary vessels. Increased pressure leads to an increase in pulmonary artery diameter and a decrease in endothelial shear, which has detrimental effects on endothelial function. If pressure stimulation persists, functional and structural remodeling occurs in the pulmonary circulation, leading to pulmonary hypertension and, consequently, right heart failure. Therefore, by reducing pulmonary capillary pressure, the symptoms of heart failure with preserved ejection fraction (HFpEF) are alleviated.

[0011] One aspect of the present invention relates to a load-improving blood pump system, The load-improving blood pump system is A suction cannula having a suction inlet and outlet end configured to connect to the atrium or ventricle, A fluid reinjection cannula comprising an inlet end and a return end connected to the aorta or an artery downstream of the aorta, particularly for example, the left subclavian artery, A blood pump that improves load, The pressurized chamber body for pumping blood during operation, It is connected to the outlet end of the suction cannula and has an inlet port for aspirating blood from the suction cannula to the main body of the pressure chamber, To drain blood from the pressure chamber into the reinfusion cannula, it is equipped with an outlet port connected to the inlet end of the flux reinfusion cannula, The pump is configured to allow a nominal constant continuous flow rate of 0.05 L / min to 0.5 L / min to reduce the capillary pressure in the lungs and / or left atrium and / or left ventricle, depending on its power supply. A blood pump that improves load, A ligation clip configured to ligate the subclavian artery upstream of the perfusion end of the reinjection cannula, It is equipped with.

[0012] According to the present invention, the pump can pump blood to reduce the pressure in the left atrium and / or left ventricle by improving the load through pumped blood circulating in the left atrium, i.e., some of the blood coming from the pulmonary veins proceeds to the arteries without passing through the aortic valve. In particular, when blood is drawn from the left atrium to the pump, this collected blood flows from the left atrium to the arteries downstream of the aorta without passing through the mitral valve, left ventricle, and aortic valve. A low, constant continuous flow rate, e.g., 0.5 L / min, allows for the pumping of blood to the left portion of the heart to reduce atrioventricular pressure without increasing cardiac output as much as an auxiliary pump. In fact, the resting pressure in the left atrium during HFpEF is between 20 mmHg and 30 mmHg, and therefore, when using the pump, it is set to a rotational speed to obtain the desired (calculated) constant flow rate to reduce the patient's atrioventricular pressure as needed. Such pumping of blood into the left atrium or left ventricle allows for a reduction in capillary pressure or capillary pressure within the left ventricle or left atrium. For example, clinical and ultrasound parameters can be used to determine whether the continuous flow rate of the pump is sufficient to adequately or excessively improve the load on the heart. For instance, if the pressure inside the heart is still too high (left ventricular end-diastolic pressure), the pump can be rotated to pump 0.05 L / min at 2000 rpm, and the rotation speed and flow rate can be increased until the desired pressure is achieved, and vice versa. Furthermore, such a pump is not as powerful as an assisted pump, and therefore much less bulky, and also requires less energy. In fact, the lower the flow rate, the lower the pump's output, and the smaller the pump's size and energy consumption, such as electricity. This makes it possible, for example, to have a battery storage system in the case of power consumption, or to have a smaller power supply cable (pneumatic or electric) than conventional pumps, thus reducing the risk of infection. In addition, the fact that the flow rate is continuous (without acceleration and deceleration) reduces wear and tear and increases energy efficiency. Another advantage is that the inlet and outlet cross-sections of the pump portion connected to the cannula can be smaller due to the lower flow rate compared to an electric assisted pump.Therefore, such pumps do not need to be oversized compared to conventional pumps sized to produce a flow rate of at least 2 L / min. The clips allow for ligation to avoid flux competition with the heart and to enable improved cardiac load. In fact, the clips ligate 90% of the artery upstream of the outlet port to avoid the risk of thrombosis and thromboembolism. This avoids thromboembolism, which can occur due to flux competition between cardiac output in the subclavian artery and the flow rate of the load-improving blood pump. Thus, these flux competitions are avoided by clipping the subclavian artery upstream of the implantation zone of the reinfusion cannula.

[0013] In addition to the features described in the preceding paragraph, according to one aspect of the present invention, the load-improving blood pump system may have one or more of the following additional features, which are considered individually or in any technically possible combination:

[0014] According to one embodiment, the pump comprises a casing configured to be incorporated into the human body.

[0015] In the field of implantable devices, such pumps can be as small as pacemakers, significantly reducing the size of the energy battery (pneumatic or electric) and making them easier to carry, as well as reducing the overall size of the energy battery. Finally, the lower the power consumption (electric or pneumatic), the smaller the cross-section of the power supply cable (electric or pneumatic) for the motor part of the pump can be.

[0016] According to one embodiment, the rotor is configured to rotate at a continuous speed of 2000 to 5000 revolutions per minute, particularly at 2000 revolutions per minute to 5000 revolutions per minute at a flow rate of 0.05 L / min and 0.5 L / min. Such a pump meets the needs of the majority of patients and allows for large-scale implementation of the pump. Therefore, such a pump can be made even smaller.

[0017] According to one embodiment, the pump has a maximum flow rate of 0.7 L / min. Thus, such a load improvement pump has a much smaller size, power, and consumption than an assist pump.

[0018] According to one embodiment, the load improvement blood pump includes a casing configured to be incorporated into the human body, at least one stator integral with the casing and having a winding coil, a rotor rotatably mounted centrally with respect to the stator, a turbine rotated by the rotor, a power connector electrically connected to the winding coil, a pumping chamber body mounted in the casing housing the turbine, and when the rotor rotates the turbine, the inlet port enables blood to be suctioned from the suction cannula into the pumping chamber body, and the outlet port enables blood to be discharged from the pumping chamber into the reinfusion cannula.

[0019] According to an example of this embodiment, the pump is a centrifugal pump. Thereby, hemolysis is reduced compared to an axial flow pump, and wear and breakage of the pump are reduced. Further, an axial flow pump causes more thromboembolism than a centrifugal pump.

[0020] According to an example of this embodiment, the rotor is a magnet rotor and the stator includes an electric winding. Such a rotor avoids the need for bulky non-permanent brushes as opposed to magnets.

[0021] According to an example of this embodiment, the pump section is directly coupled to the rotor shaft. Direct coupling means that one rotation of the rotor is equal to one rotation of the pump section.

[0022] According to an example of this embodiment, the rotor forms a centrifugal pump rotor turbine housed in the main body of the pumping chamber to pump blood at a flow rate of 0.05 L / min to 0.5 L / min. The rotor turbine, also known as an impeller, when rotated, enables sucking and discharging the flow of a liquid, in this case blood, into the main body of the pumping chamber, and the pumping chamber discharges this liquid through an outlet port.

[0023] For example, the rotor an axial port on the opposite side of the inlet port arranged axially with respect to the rotation axis of the rotor, magnets angularly and evenly distributed around the axial port, and notches respectively arranged between two magnets, each notch longitudinally opening and extending from the inlet port to the outer periphery of the rotor, having an inclined ramp increasing the axial depth of the notch from the inlet port to the outer periphery of the rotor, each notch opening into the volume of the pumping chamber surrounding at least the notch of the rotor a rotor forming a rotating impeller arranged in the main body of the pumping chamber, configured to pressurize the blood entering axially through the inlet port and exiting radially through the spiral part through the outlet port is provided.

[0024] According to an example of this embodiment, the pump includes a drive part having a plurality of magnetic motor stators, the rotor has a plurality of magnetic regions, and is levitated rotatably in the axial and radial directions by passive and active magnetic flux sources acting on the rotor and magnetic forces generated by one or more hydrodynamic thrust bearings provided on the upper surface of the impeller.

[0025] According to one example of this embodiment, the pump is a levitation centrifugal pump equipped with a passive permanent magnet bearing. For example, the passive permanent magnet bearing comprises a stack of magnets around an axis mounted on a stator, stacked in alternating N / S polarities, and another stack of magnets mounted on a rotor, the bearing surrounding the first stack on the stator and together applying a first axial force to the rotor. Such a bearing reduces friction and reduces the size of the levitation bearing.

[0026] In one example of this embodiment, the pump is equipped with a battery electrically connected to the drive unit. This allows the pump to operate without being permanently connected to an external power source.

[0027] For example, the pump is equipped with a wireless induction charger for charging the battery. Such a pump avoids the need for a power cable that passes through the skin to connect to the battery or charger. According to this example, the pump is equipped with a control unit for controlling the power supply to the drive unit, particularly the stator. Such a pump avoids the problem of infection at the exit of a power cable that passes through the skin. Due to its low power consumption, such a pump avoids the need for a power cable that passes through the skin, which could lead to infection.

[0028] According to an alternative example of the embodiment described above, the pump comprises a power cable connected to a connector, the cable configured to pass through the intercostal space, or the abdominal wall, or behind the auricle.

[0029] In one example of this embodiment, the pump is suspended magnetically and hydrodynamically.

[0030] According to one example of this embodiment, the pump casing has a diameter of 3 cm to 5 cm and an axial length of 1.5 cm to 4 cm, particularly a size of 4 cm (diameter) × 3 cm (axial length). Such a pump size allows it to be embedded, for example, in the subclavian region above or below the pectoralis major muscle, in a pocket made in the subclavian region. Thus, such a pump has a casing with an outer diameter smaller than that of an assist pump, which has an axial length of 45 mm and a centrifugal rotor diameter of about 65 mm. Furthermore, such a load-relieving pump is considerably smaller than an assist pump.

[0031] According to one embodiment, the pump is a positive displacement pump, also known as a positive displacement pump, and for example, the turbine has two lobes for blood transport.

[0032] For example, positive displacement pumps are either pneumatic or electric pumps.

[0033] According to one embodiment, the suction cannula comprises at least a portion of polyethylene terephthalate (PET) in textile form or polytetrafluoroethylene (ePTFE) in microporous form, with a proximal port or another biocompatible material.

[0034] In one example of this embodiment, the suction cannula comprises a treated biocompatible titanium component with a suction end, and an ePTFE or PET component connects the titanium component to the inlet port of the pump unit.

[0035] According to one embodiment, the reinjection cannula comprises at least a portion of PET or ePTFE or other biocompatible material with a proximal port.

[0036] In one example of this embodiment, the reinfusion cannula comprises a treated biocompatible titanium component with an inlet end, and a PTFE component connects the titanium component to the outlet port of the pump unit.

[0037] According to one embodiment, the reinjection cannula and the suction cannula have a diameter of 5 mm to 10 mm.

[0038] According to one embodiment, the clip extends from a portion of the reinjection cannula near the exit port. This allows the clip to be brought closer to the cannula during surgery, thus assisting the surgeon during the procedure.

[0039] According to one embodiment, the pump is an electric pump, and the system comprises a control and power supply device which includes a battery and a control unit for controlling the supply of power to the pump at a predetermined continuous flow rate.

[0040] According to one embodiment, the control unit is intended to control the pump continuously (without interruption). This avoids the risk of thrombosis and thromboembolism. If the battery charge is low, the system may include a warning device, such as an audible or visual warning device, controlled by the control unit according to the battery voltage measured by the control unit, to warn the user.

[0041] According to one embodiment, the system includes a pump connector and a power cable connected to a control unit, the power cable being configured to pass through the skin of a human body.

[0042] According to one embodiment, the casing comprises a shell that extends similarly from portions of the reinjection cannula and the suction cannula.

[0043] Another aspect of the present invention relates to a method for implanting a load-improving blood pump system (for example, according to the aforementioned aspects of the present invention, with or without the various characteristics of the embodiments described above), the method being: The procedure involves either of the following steps: first, clamping the left atrium, then directly anastomosing the suction end of the suction cannula to the left atrium, and then removing the clamp from the left atrium; or, placing the left ventricle under ventricular fibrillation, and then anastomosing the suction end of the suction cannula to the tip of the left ventricle under ventricular fibrillation. The steps include degassing the load-relieving pump and To ligate 85-100% of the artery, for example, by clipping the subclavian artery, The steps involve clamping the subclavian artery in two regions, The steps include anastomosing the reinjection cannula by inserting the reinjection end of the reinjection cannula between the two clamps and downstream of the clip fastener, The steps include removing the clamp from the subclavian artery, A step to calculate the flow rate that should be drained from the left atrium in order to avoid HFpEF, The steps include setting the pump control unit according to the calculated flow rate, The control unit starts the pump, It is equipped with.

[0044] Another aspect of the present invention relates to a method for implanting a load-improving blood pump system (for example, according to the aforementioned aspects of the present invention, with or without the various characteristics of the embodiments described above), the method being: The procedure involves inserting the suction end of the suction cannula into the left atrium by inserting the suction cannula into the blood vessel so that it first enters the internal jugular vein, then the right atrium, and finally the left atrium through the interatrial septum. The steps include degassing the load-relieving pump and To ligate 85-100% of the artery, for example, by clipping the subclavian artery, The steps involve clamping the subclavian artery in two regions, The steps include anastomosing the reinjection cannula by inserting the reinjection end of the reinjection cannula between the two clamps and downstream of the clip fastener, The steps include removing the clamp from the subclavian artery, A step to calculate the flow rate that should be drained from the left atrium in order to avoid HFpEF, The steps include setting the pump control unit according to the calculated flow rate, The control unit starts the pump, It is equipped with.

[0045] Another aspect of the present invention not claimed relates to a load-improving blood pump, the load-improving blood pump is A casing designed to be incorporated into the human body, A stator comprising a winding coil and integrated with a casing, A rotor that is mounted in the center and is rotatably movable relative to the stator, A turbine rotated by a rotor, A power connector electrically connected to the winding coil, The pressurized chamber body is installed inside the casing that houses the turbine, An inlet port for drawing blood from the suction cannula into the main body of the pressure chamber when the rotor rotates the turbine, and an outlet port for discharging blood from the pressure chamber to the reinjection cannula, Equipped with, The pump is characterized by being configured to enable a nominally constant continuous flow rate of 0.05 L / min to 0.5 L / min in order to reduce the capillary pressure in the lungs and / or the left atrium and / or left ventricle, depending on its power supply.

[0046] The pump may have features described in the examples of embodiments of a pump system according to the above-mentioned aspects of the present invention, which includes such a blood pump.

[0047] Another aspect of the present invention not claimed relates to a load-improving blood pump, the load-improving blood pump is A casing designed to be incorporated into the human body, membrane and A pneumatic power connector for moving the membrane, A pressure chamber body is installed inside a casing that houses the membrane, An inlet port for drawing blood from the suction cannula into the main body of the pressure chamber when the rotor rotates the turbine, and an outlet port for discharging blood from the pressure chamber to the reinjection cannula, Equipped with, The pump is characterized by being configured to enable a nominally constant continuous flow rate of 0.05 L / min to 0.5 L / min in order to reduce the capillary pressure in the lungs and / or the left atrium and / or left ventricle, depending on its power supply.

[0048] The present invention and its various applications will be better understood by reading the following description and examining the accompanying drawings.

[0049] The drawings are provided for illustrative purposes only and are not intended to limit the scope of this invention. [Brief explanation of the drawing]

[0050] [Figure 1] This is a schematic diagram of the load-improving blood pump system according to the present invention, which is embedded to reduce capillary pressure in the first use. [Figure 2] This is a schematic diagram of a load-improving blood pump system according to the first embodiment of the present invention. [Figure 3] This is a schematic diagram of the load-improving blood pump system according to the present invention, which is embedded to reduce capillary pressure in a second use. [Modes for carrying out the invention]

[0051] The drawings are provided to illustrate the purpose of the present invention and are not intended to limit it in any way.

[0052] Continuous flow rate refers to a +10% or -10% increase in the flow rate through the pump.

[0053] Figure 1 is a schematic diagram of the load-improving blood pump system according to the present invention, which is embedded to reduce capillary pressure during first use.

[0054] The patient has a heart 1 which includes a left portion A and a right portion B. Blood vessels 2A supply blood to the left portion of the heart, and the left portion of the heart draws blood into the aorta 3A. Left portion A includes a left atrium 10A, a left ventricle 11A, a left atrioventricular valve also called the mitral valve 12A between the left atrium 10A and the left ventricle 11A, and an aortic valve 13A between the left ventricle 11A and the aorta 3A. The aorta 3A distributes blood to various arteries, including the left subclavian artery 30A. Right portion B also includes a right atrium 10B, a right ventricle 11B, and a right atrioventricular valve also called the tricuspid valve 12B between the right atrium 10B and the right ventricle 11B. The arrows represent the circulation of blood 3A into heart 1, starting from blood vessel 2A, first passing through the left atrium 10A, then through the atrioventricular valve 12A to enter the left ventricle 11A, and finally through the aortic valve 13A to enter the aorta 3A.

[0055] The load-improving blood pump system 4 is attached during this initial use and pumps blood from the left atrium 10A to the left subclavian artery 30A.

[0056] The load-relieving blood pump system 4 comprises a suction cannula 41, a reinfusion cannula 43, and a load-relieving blood pump 40, which in this embodiment comprises a ligation member, in this case a clip 430 which can be replaced by a lasso. The blood pump 40 comprises an inlet port 401 connected to the outlet end 412 (referenced in Figure 2) of the suction cannula 41 and an outlet port 403 connected to the inlet end 432 (referenced in Figure 2) of the reinfusion cannula 43. In this embodiment, the suction cannula 41 has a suction end 411 opposite to the outlet end 412 located in the left atrium 11A, and the reinfusion cannula 43 has a return end 433 opposite to the inlet end 434 located in the left subclavian artery. The clip 430 is clipped to the left subclavian artery upstream of the return end 433 to ligate the artery. In the lasso example, the lasso is wrapped around the left subclavian artery upstream of the perfusion end 433. The clip 430 or lasso may be configured to ligate 85% to 100% of the left subclavian artery. The clip 430 or lasso is in this case connected to a reinfusion cannula 43, thus improving the surgical procedure. The reinfusion cannula 43 and the suction cannula 41 have an inner diameter of 5 mm to 10 mm, for example, 5 mm for the suction cannula 41 and 8 mm for the reinfusion cannula 43. The cannulas 41, 43 are made of polyethylene terephthalate in textile form (PET), or polytetrafluoroethylene in microporous form (ePTFE), or another biocompatible material.

[0057] Therefore, the load-relieving blood pump 40 allows blood to be drawn into the left atrium 10A through the suction end 411 of the suction cannula 41 and discharged into the subclavian artery 30A through the return end 433 of the reinfusion cannula 43. The load-relieving blood pump 40 is configured to absorb a blood flow rate between 0.05 liters per minute and 0.5 liters per minute. This flow rate allows for the relief of pressure in the left atrium, and therefore the capillary pressure in the lungs.

[0058] Figure 2 shows a schematic diagram of the load-relieving blood pump 40 connected to the outlet end 412 of the suction cannula 41 and the inlet end 432 of the delivery cannula 43.

[0059] The load-relieving blood pump 40 comprises a casing 400 configured to be incorporated into a human body 6 in which a sealed, spiral-shaped pressure chamber body 402 is located.

[0060] In this example, the pressure chamber body 402 has a volume of 4 to 10 milliliters and opens to an inlet port 401 having an inner diameter larger than the inner diameter of the outlet end 412 of the suction cannula 41, for example, 1 mm larger than the diameter of the outlet end 412, in this example 6 mm in diameter. The pressure chamber body 402 further opens to an outlet port 403 at one end of its spiral shape, having an inner diameter 1 mm larger than the inner diameter of the reinfusion cannula 43, in this example 9 mm larger. In this case, the pressure chamber body 402 is made of biocompatible titanium.

[0061] The load-improving blood pump 40 includes a turbine impeller housed within the pumping chamber body 402.

[0062] The load-improving blood pump 40 includes an electric motor that forms the drive unit of the load-improving blood pump 40. In this case, the load-improving blood pump 40 is an electric centrifugal pump. In particular, the turbine impeller is also the rotor of the electric motor having a rotation axis X.

[0063] Therefore, the turbine impeller in this example is a rotor turbine 405 comprising a turbine body and ferromagnetic permanent magnets 405m housed within the body. The magnets may be made of, for example, neodymium or alnico alloy or cobalt-platinum alloy. Furthermore, the rotor turbine 405 comprises, for example, polymer layers (parylene and silicone), polymers to be overmolded onto the magnets. The layers may be further biocompatiblely treated with chromium nitride and / or titanium nitride. Thus, the turbine impeller 405 may comprise, for example, four magnets angularly distributed in four housings of the body around the rotation axis X, with their polarities being angularly alternating. The rotor turbine comprises notches, each located between two magnets, each notch extending longitudinally from an inlet port 412 to the outer circumference of the rotor turbine. The notches may comprise inclined ramps that increase the axial depth of the notch from the inlet port to the outer circumference of the rotor, and each notch opens into the volume of a pressurized chamber surrounding at least the notch of the rotor turbine. Therefore, the arrows in the diagram represent the flow rate of blood through the rotor turbine.

[0064] The body of the rotor turbine 405 has an outer diameter of 15 to 30 mm and an axial length, also called an axial height, of 5 to 20 mm, and the casing 400 has a size of approximately 40 x 30 mm to house the stator of the electric motor in addition to the pump chamber body in this example. Therefore, due to the low flow rate, the load-improving blood pump 40 is much smaller than conventional auxiliary pumps, with a diameter of 30 mm to 50 mm and an axial length of 15 mm to 40 mm, for example, in this example, a diameter of 40 mm and an axial length of 30 mm.

[0065] The turbine body is made of biocompatible titanium, such as titanium nitrite, or ceramic material.

[0066] Therefore, such a pumping chamber body 402 having such a rotor turbine 405 can enable the pump to deliver 0.05 L / min to 0.5 L / min of blood while rotating at a rotational speed of 2000 to 5000 rpm.

[0067] The electric motor of the load-relieving blood pump 40 comprises one or more stators housed within a casing, at least one wound stator 47 comprising a wound coil 470 that, when powered, generates a magnetic field to produce rotational torque in a rotor turbine 405. Other stators may comprise permanent magnets. The load-relieving blood pump 40 further comprises a power connector 471 electrically connected to the wound coil 470, and the system further comprises a power cable 7 connected to the pump connector 471 and a control and power supply unit 8. The connector 471 may comprise an electrical connector made of a conductive material such as platinum or copper, the conductive material being covered with an insulator such as polyetherketone (PEEK) or polysulfone (PSU) or medical-grade epoxy.

[0068] In this example, the control and power supply unit 8 is located outside the body. Therefore, the power cable 7 is configured to pass through the skin of the human body 6, and in particular here, through the intercostal space, or through the abdominal wall, or behind the auricle. The power cable 7 may also be made of platinum and covered with medical insulators such as a cannula or connector 471.

[0069] The control and power supply unit 8 includes a control unit 80 for controlling the power transmitted to the pump motor, and therefore the rotational speed and flow rate of the blood pump. The control and power supply unit 8 further includes a battery 81 for supplying power to the winding coil 470 of the stator 47 of the blood pump 40.

[0070] In this example, the electric motor has two stators: a first lower stator 48 surrounding the inlet port, which has magnets 480, for example, four magnets evenly (regularly) distributed around the axis of rotation; and the other upper coiled stator 47, which faces the lower stator axially relative to the rotor turbine 405. The coiled stator 47 is closer to the axis than the lower stator 48 and therefore exerts a greater axial force. Both stators have a diameter of 15 mm with a height of 8 mm.

[0071] In particular, in this example, the load-relieving blood pump 40 is an electric levitation centrifugal pump equipped with a passive permanent magnet bearing 46. The levitation bearing 46 has a shaft extending axially from the upper stator 47 into the pump chamber body 402 and comprises a plurality of internal permanent magnets 460 integrated with the shaft, for example, two identically repeating poles NS / NS / NS and three magnets stacked axially. The levitation bearing is an external permanent magnet 461 attached to the body of the rotor turbine 405, further comprising a plurality of hollow cylindrical external permanent magnets 461 that surround the internal permanent magnets 460 and are stacked axially with two identically repeating poles NS / NS / NS. This levitation bearing allows the radial pump to be centered by magnetic repulsion and further by the axial attractive force of the upper stator 47.

[0072] Such load-reducing blood pumps 40 enable continuous operation with minimal wear and tear while maintaining a blood flow rate of 0.05 L / min to 0.5 L / min. Therefore, depending on the patient's cardiac structure, the blood pump may be configured to have a flow rate of 0.05 L / min to 0.3 L / min, and thus even smaller, for example, comprising a casing with a diameter of 3 cm and an axial length of 1.5 cm, and a rotor turbine body with a diameter of 15 mm and an axial length of 5 mm. The continuous flow rate of the pump is set according to the cardiac and vacuum characteristics to be achieved.

[0073] Figure 3 shows a second use of another example of the load-improving blood pump system 4' according to the first embodiment.

[0074] This load-improving blood pump system 4' is identical to the first example, except that the suction cannula 41 and discharge cannula 43 are made of a single material and surround the casing of the pump 40, and the control and power supply unit 8' is configured to be inside the body and includes an induction charger 82 for charging the battery 81. The control and power supply unit 8' may be located in another body space, for example, in the chest wall, under the pectoralis major muscle, or under the dorsi major muscle. The second use is identical to the first use, except that the suction cannula 41 has its suction end 411 in the left ventricle so that it passes through the left ventricle 11A and thus aspirates blood and discharges it into the left subclavian artery 30A.

[0075] The method for implanting the load-improving blood pump system 4 comprises two embodiments in a first use. In the first embodiment, the method comprises a first step of clamping the left atrium 10A, then anastomosing the suction end 411 of the suction cannula 41 to the left atrium 10A, and then removing the clamp from the left atrium.

[0076] In a second embodiment of the first use, the method comprises a first step of inserting the suction end 411 of the suction cannula 41 into the left atrium 10A, first through the internal jugular vein and then through the right atrium into the blood vessel, and then passing the end of the suction cannula 411 through the atrial septum to insert it into the left atrium 10A.

[0077] The step of anastomosing the cannula to a part of the heart means inserting the end of the cannula into a part of the heart in order to connect it to the volume of that part of the heart.

[0078] A method for implanting the load-improving blood pump system 4, in a second use, comprises the steps of placing the left ventricle into ventricular fibrillation, and then directly anastomosing the suction end 411 of the suction cannula 41 into the left ventricle 11A.

[0079] In the step of placing the left ventricle into ventricular fibrillation, the contraction is stopped for several seconds while inserting the suction cannula. The step of placing the left ventricle into ventricular fibrillation may include a substep of placing a stitch and collar in the left ventricle of the beating heart before the contraction is stopped.

[0080] Next, in both uses, this method includes the step of degassing the load relief pump.

[0081] Next, in both uses, the method comprises the step of ligating the subclavian artery 30A by, for example, clipping clip 430, thereby ligating 85-100% of the artery according to the calculated flow rate.

[0082] Next, the method includes the step of clamping two regions of the subclavian artery 30A.

[0083] Next, the method involves the step of anastomosing the reinjection cannula 43 by inserting its reflux end 433 downstream of the clip fastener 430 between two clamps, The steps include removing the clamp from the subclavian artery, A step to calculate the flow rate that should be drained from the left atrium in order to avoid HFpEF, The steps include setting the pump control unit according to the calculated flow rate, The control unit starts the pump, It is equipped with.

[0084] Unless otherwise specified, the same element appearing in different figures shall have a single symbol.

Claims

1. A load-improved blood pump system (4, 4'), comprising: an aspiration cannula (41) having an aspiration inlet (411) and an outlet end (412) configured to connect to the atrium (10A, 10B) or ventricle (11A, 11B); a re-infusion cannula (43) having an inlet end (432) and a return end (433) connected to the aorta or an artery downstream of the aorta, in particular the left subclavian artery; A load-improved blood pump (40, 40'), comprising: a pumping chamber body (402) for pumping blood upon actuation; an inlet port (401) connected to the outlet end (412) of the aspiration cannula (41) for drawing blood from the aspiration cannula (41) into the pumping chamber body (402); an outlet port (403) connected to the inlet end (432) of the flow reinfusion cannula (43) for draining blood from the pumping chamber (402) to the reinfusion cannula (43); a load-improving blood pump (40, 40') configured to allow a nominal constant continuous flow rate of between 0.05 L / min and 0.5 L / min to reduce capillary pressure in the lungs and / or the left atrium and / or the left ventricle, depending on its power source; a ligation clip (430) configured to ligate the subclavian artery (30A) upstream relative to the return end (433) of the reinfusion cannula (43); A load-improved blood pump system (4, 4') comprising:

2. The load-improving blood pump (40, 40') comprises: a casing (400) configured to be incorporated into a human body (6); At least one stator (47, 48) fixed to the casing and having a winding coil (470); a rotor rotatably mounted centrally relative to the stator (47, 48); a turbine rotated by the rotor; a power connector (471) electrically connected to the winding coil (470); a pump chamber body (402) mounted within a casing (400) containing a turbine; Equipped with 2. The load-improved blood pump system (4, 4') of claim 1, wherein when the rotor rotates the turbine, the inlet port (401) allows blood to be drawn from the suction cannula (41) into the pumping chamber body (402), and the outlet port (403) allows blood to be discharged from the pumping chamber (402) to the reinfusion cannula (43).

3. 3. The load-improved blood pump system (4, 4') according to claim 2, wherein the rotor of the blood pump (40, 40') is configured to rotate at a continuous speed of 2000 to 5000 rpm, in particular from 2000 rpm with a flow rate of 0.05 L / min to 5000 rpm with a flow rate of 0.5 L / min.

4. 4. The load-improved blood pump system (4, 4') according to claim 2 or 3, wherein the pump is a centrifugal pump.

5. The load-improved blood pump system (4, 4') according to any one of claims 2 to 4, wherein the rotor forms a centrifugal pump rotor turbine (405) housed within a pumping chamber body (402) for pumping blood at a flow rate of 0.05 L / min to 0.5 L / min.

6. 6. The load-improved blood pump system (4, 4') according to claim 5, wherein the blood pump has a maximum flow rate of 0.7 L / min.

7. The load-improved blood pump system (4, 4') according to claim 6, wherein the reinfusion cannula (43) and the suction cannula (41) have a diameter of 5 to 10 mm.

8. The load-improved blood pump system (4, 4') according to any one of claims 1 to 7, wherein the clip extends from a portion of the reinfusion cannula close to the outlet port.

9. 1. A method for implanting a load-improved blood pump system, the method comprising: a first step of first clamping the left atrium, then directly anastomosing the suction end of the suction cannula to the left atrium, and then removing the clamp from the left atrium; or a step of placing the left ventricle under ventricular fibrillation, and then anastomosing the suction end of the suction cannula to the tip of the left ventricle under ventricular fibrillation; venting the load improvement pump; ligating the subclavian artery, e.g., by clipping, to ligate 85-100% of the artery; clamping the subclavian artery in two regions; anastomosing the reinfusion cannula by inserting the return end of the reinfusion cannula between the two clamps and downstream of the clip; removing the clamp from the subclavian artery; calculating the flow rate that should be ejected from the left atrium to avoid HFpEF; setting a control unit of the pump according to the calculated flow rate; starting the pump with the control unit; A method for providing the above.

10. 1. A method for implanting a load-improved blood pump system, the method comprising: inserting an aspiration end of the aspiration cannula into the left atrium by intravascularly inserting the aspiration cannula first through the internal jugular vein, then through the right atrium, and finally through the atrial septum into the left atrium; venting the load improvement pump; ligating the subclavian artery, e.g., by clipping, to ligate 85-100% of the artery; clamping the subclavian artery in two regions; anastomosing the reinfusion cannula by inserting the return end of the reinfusion cannula between the two clamps and downstream of the clip; removing the clamp from the subclavian artery; calculating the flow rate that should be ejected from the left atrium to avoid HFpEF; setting a control unit of the pump according to the calculated flow rate; starting the pump with the control unit; A method for providing the above.

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