System for Treating Heart Failure with Preserved Ejection Fraction (HFpEF)

Abstract

To provide a "system for treating Heart Failure with preserved Ejection Fraction (HFpEF)." A system for treating Heart Failure with preserved Ejection Fraction (HFpEF) is described that includes a blood pump device configured for implantation in a left ventricle of a subject's heart, a fixation assembly for fixing the blood pump device to a wall of the left ventricle, and a controller configured to modify output parameters of the blood pump device to activate and deactivate the blood pump device in a pattern coordinated with the subject's cardiac cycle, including activation during ventricular diastole and deactivation during ventricular systole.

Description

[Technical field]

[0001] The present invention relates to a system for treating heart failure with preserved ejection fraction (HFpEF). The present invention also relates to a method for treating heart failure with preserved ejection fraction (HFpEF) and to a method for reducing or preventing secondary pulmonary hypertension. [Background technology]

[0002] Heart failure is defined as the inability of the heart to adequately supply blood to the body. As demographics suggest, the prevalence of heart failure is increasing as the population ages. The main symptoms of HF include dyspnea and fatigue, which can limit exercise tolerance, and fluid retention, which can cause pulmonary and / or visceral congestion and / or peripheral edema.

[0003] The cardiac cycle has two phases: contraction, during which the heart pumps blood to the body, and relaxation, during which the heart fills with blood. Heart failure associated with the contraction phase (systole) includes HF with reduced ejection fraction (HFrEF), a condition commonly caused by ischemic heart disease, resulting in reduced stroke volume and cardiac output, which results in a neurohormonal response to restore normal cardiac output. Left ventricular assist devices have been developed to assist the heart during the contraction phase, including pump devices designed to assist pumping blood into the aorta during diastole (systole), and contractile devices designed to be implanted between the two walls of the left ventricle, reciprocating in a pattern that cooperates with the cardiac rhythm to assist the contraction of the left ventricle during systole. Pump devices for the treatment of HFrEF are described in US2016 / 000983 and US7942804.

[0004] Cardiac diseases associated with the relaxation phase (diastole) of the cardiac cycle include heart failure with preserved ejection fraction (HFpEF). HFpEF is a clinical syndrome in which patients have symptoms and signs of HF with a normal or near normal left ventricular ejection fraction (LVEF>50 percent). During the early diastolic phase of the cardiac cycle, a healthy left ventricle (LV) acts as a "vacuum cleaner," increasing suction, especially during exercise. In HFpEF, this relaxation-promoting effect is lost due to stiffening of the myocardial cells, so normal LV filling depends on high left atrial (LA) pressure to push blood into the LV. This increased pressure may further lead to atrial remodeling and secondary pulmonary hypertension, predisposing patients to atrial fibrillation and right ventricular (RV) dysfunction. Each 10 mmHg increase in pulmonary artery pressure in HFpEF patients has been found to be associated with a 28% increase in 3-year mortality. Therefore, there is a need to effectively control mortality due to HFpEF.

[0005] To date, no pharmacological treatment has yet been proven to reduce morbidity and mortality in patients with HFpEF in randomized clinical trials, mainly due to the pathophysiological heterogeneity of the disease. Current treatment strategies according to the American Heart Association (AHA) and European Society of Cardiology (ESC) focus on treating comorbidities and relieving congestion using diuretics.

[0006] Transcatheter left atrial-right atrial shunt devices (REDUCE LAP-HF-I) have previously been proposed as a possible treatment for HFpEF, but right ventricular (RV) volume overload and subsequent RV failure, as well as worsening secondary pulmonary hypertension, can be problems with these shunt devices.

[0007] A left ventricular implantable device (CORolla), which directly applies an internal distending force to increase LV volume, has also been proposed as a possible treatment for HFpEF. In theory, the expansion elements of the CORolla device could be used for the treatment of all forms of HFpEF, but the performance of such a device is highly dependent on the degree of cardiac remodeling, which varies significantly with HFpEF phenotype.

[0008] WO2020 / 081481 describes an implantable device for treating HFpEF, which includes a pump connected to the mitral valve and controlled to pump blood from the left atrium to the left ventricle during the cardiac cycle, where the pump operates continuously between a low pumping speed (first flow) during myocardial perfusion during diastole and a high pumping speed (second flow) during the resting phase of the cardiac cycle. Because the pump is connected to the mitral valve, it must be operated at all times, which prevents the mitral valve from closing completely. Therefore, during ventricular systole, when the mitral valve normally closes completely, the pump must be operated at a high speed to prevent backflow of blood from the left ventricle to the left atrium. In order to prevent compression of the left ventricle during diastole, the pumping speed during diastole must be reduced. Connecting the pump to the mitral valve through a sewing cuff is a complex procedure. In addition, the device cannot be delivered percutaneously due to its large internal diameter, which means that cardiac surgery is required. [Prior art documents] [Patent documents]

[0009] [Patent Document 1] US Patent Application Publication No. 2016 / 000983 [Patent Document 2] U.S. Patent No. 7,942,804 [Patent Document 3] International Publication No. 2020 / 081481 Summary of the Invention [Problem to be solved by the invention]

[0010] SUMMARY OF THE PRESENT EMBODIMENT An object of the present invention is to overcome at least one of the above problems.

[0011] This object is met by providing a system and method for the treatment of HFpEF using a blood pump device implanted in the left ventricle, configured to be sequentially activated during diastole (to assist the left ventricle to draw blood from the right atrium into the left ventricle through the open mitral valve) and stopped during systole when the left ventricle empties. Thus, unlike the system of WO2020 / 081481, which operates continuously, including during systole (to prevent blood from flowing back), the system of the present invention activates the blood pump device only during ventricular diastole. This is made possible by implanting the blood pump device in the left ventricle. The controller is operably coupled to the blood pump device and is configured to activate and stop the blood pump device in a pattern that cooperates with the subject's cardiac cycle, including activation during ventricular diastole and stopping during ventricular systole. The controller may receive signals from a sensor that may form part of the blood pump device or may be a separate sensor, such as an ECG or atrial sensor. The blood pump device generally includes an impeller and is ideally an axial pump. In use, the blood pump device is secured to the wall of the left ventricle and is positioned such that, when activated, pressure in the upper part of the left ventricle adjacent the mitral valve is sufficiently reduced to assist in the flow of blood from the right atrium to the left ventricle. [Means for solving the problem]

[0012] In a first aspect, the present invention provides a method for producing a composition comprising the steps of: a blood pump device configured for implantation in a left ventricle of a subject's heart; a fixation assembly for fixing the blood pump device to a wall of the left ventricle; a controller configured to vary output parameters of the blood pump to activate and deactivate the blood pump in a pattern that cooperates with a subject's cardiac cycle, including activating during ventricular diastole and deactivating during ventricular systole; The present invention provides a system including:

[0013] In any embodiment, the system is for treating heart failure with preserved ejection fraction (HFpEF).

[0014] In any embodiment, the system is for treating, reducing, or preventing secondary pulmonary hypertension.

[0015] In any embodiment, the system is for treating a condition associated with impaired filling of the left ventricle during ventricular diastole.

[0016] In any embodiment, the system includes at least one sensor in communication with the controller for detecting one or more parameters associated with the heart, wherein the controller is configured to alter an output parameter of the blood pump device based on the one or more detected parameters received from the sensor.

[0017] In any embodiment, the controller is configured to vary the pump flow rate and / or frequency of operation of the blood pump device.

[0018] In any embodiment, the controller is configured to vary the amplitude of the voltage of the power supply to the blood pump device. If the pump includes a rotor, varying the amplitude of the voltage varies the rotational speed of the rotor.

[0019] In an optional embodiment, the controller is configured to vary the frequency of a voltage duty cycle of the blood pump device's power supply. Varying the frequency of the voltage controls the activation and deactivation of the pump.

[0020] In any embodiment, the at least one sensor is selected from the group consisting of a pressure sensor, a wireless pressure sensor, a microelectromechanical pressure sensor, an arterial pressure sensor, a Cardiac Output (CO) sensor, a blood pressure sensor, a left ventricular ejection fraction, a heart rate sensor, a motion sensor, an accelerometer, an ECG (electrocardiogram) sensor, an O2 saturation sensor, a microaccelerometer, and an ultrasonic micrometer. The pressure sensor can be a ventricular and / or atrial pressure sensor.

[0021] In any embodiment, the sensor is a cardiac pacing sensor.

[0022] In any embodiment, the sensor is an atrial or ventricular pressure sensor.

[0023] In any embodiment, the system includes a cardiac pacing sensor and an atrial or ventricular pressure sensor.

[0024] In any embodiment, the sensor is integral to the blood pump device.

[0025] In any embodiment, the sensor is coupled to cardiac tissue.

[0026] In any embodiment, the blood pump device includes an impeller.

[0027] In any embodiment, the blood pump device includes an axial pump.

[0028] In any embodiment, the blood pump device further comprises: a housing including a fluid inlet, a fluid outlet, and a lumen extending through the housing from the fluid inlet to the fluid outlet; A rotor disposed within the housing; An impeller disposed on the rotor; a motor operatively coupled to the rotor for rotating the rotor upon actuation; The blood pump is configured to, upon operation, cause fluid to flow through the housing from the inlet to the outlet.

[0029] In any embodiment, the fluid inlet of the housing extends through the mitral valve into the left atrium. In this embodiment, the blood pump is configured to fit completely within the left ventricle with only a portion of the fluid inlet extending into the left atrium.

[0030] In any embodiment, the blood pump apparatus includes a fluid extension conduit configured to provide fluid communication from the interior of the left atrium to the fluid inlet of the housing.

[0031] In any embodiment, the fluid extension conduit is removably coupled to the fluid inlet of the housing.

[0032] In any embodiment, the fluid extension conduit is flexible.

[0033] In any embodiment, the impeller is disposed on the rotor on the fluid outlet side of the housing.

[0034] In any embodiment, the housing is a tubular housing.

[0035] In any embodiment, the tubular housing includes a first cylindrical portion connected to a second cylindrical portion by a plurality of struts.

[0036] In any embodiment, the inlet and the outlet are aligned along a common axis.

[0037] In any embodiment, the blood pump device further comprises: a first cylindrical portion including a motor; a second cylindrical portion including an impeller; a central portion connecting the first cylindrical portion and the second cylindrical portion, the central portion including a fluid inlet; a fluid outlet disposed in the first cylindrical portion or the second cylindrical portion; The rotor extends from the motor through a central portion toward the impeller.

[0038] In any embodiment, the fluid inlet includes one or more openings in a central portion of the housing.

[0039] In an optional embodiment, the second portion includes a fluid outlet. In this embodiment, rotation of the impeller draws blood through the fluid inlet, through the second portion and out of the fluid outlet.

[0040] In any embodiment, the second portion of the housing has a diameter D1 that is greater than the diameter D2 of the first portion of the housing, in any embodiment, the ratio of D1 to D2 ranges from 3:2 to 5:2.

[0041] In any embodiment, the central portion of the housing has a frusto-conical shape.

[0042] In any embodiment, the central portion of the housing includes a plurality of posts connecting the first and second portions of the housing.

[0043] In an optional embodiment, the fluid outlet is disposed in the first portion. In this embodiment, the first portion has a lumen for fluid that allows the fluid to pass through the motor and exit through the fluid outlet.

[0044] In any embodiment, the motor is an electromagnetic motor that includes a stator disposed within a housing that surrounds at least a portion of a rotor.

[0045] In any embodiment, the impeller includes an axle hub and at least two blades attached to the hub, where each blade has an elongated swept shape.

[0046] In any embodiment, each vane has a hub-to-tip ratio (v) of 0.20 to 0.30.

[0047] In any embodiment, the impeller includes two blades disposed on opposite sides of the hub.

[0048] In any embodiment, each vane has an axial length of from 5 to 20 mm, preferably from 10 to 15 mm, and more ideally from about 12 to about 13 mm.

[0049] In any embodiment, each vane has a radial width of from 1 to 10 mm, 3 to 7 mm, 4 to 6 mm, or ideally, about 5 mm.

[0050] In any embodiment, each vane extends at a sweep angle about the hub of 70° to 140°, 80° to 120°, 90° to 120°, or about 100° to about 120°. The sweep angle refers to the angle that the vane sweeps about the hub. This can be seen from the end view shown in FIG. 6B, where it can be seen that the vane extends at about 100° about the hub.

[0051] In any embodiment, the gap between the radial tip of each vane and the hub housing is between 0.1 mm and 1.5 mm, between 0.3 mm and 0.7 mm, between 0.4 mm and 0.6 mm, and ideally is about 0.5 mm.

[0052] In any embodiment, the controller is configured to receive heart rate data from the sensor and alter an output parameter of the blood pump in real time based on the received heart rate data.

[0053] In any embodiment, the controller is configured to compare the heart rate data with reference impeller rotational speed data, calculate an impeller rotational speed based on the comparison, and operate the blood pump device during the diastolic phase to rotate the impeller at the calculated impeller rotational speed.

[0054] In any embodiment, the blood pump device is sized to be delivered percutaneously into the left ventricle of the heart within a delivery catheter up to 32 Fr, typically over a guidewire.

[0055] In any embodiment, the blood pump device is configured to be attached to a guidewire.

[0056] In any embodiment, the fixation assembly includes one or more anchor elements (eg, arms) coupled to the blood pump device.

[0057] In any embodiment, the fixation assembly is configured to be attached to the left ventricular septum, the apex of the left ventricle, or the left ventricular septum and the apex of the left ventricle.

[0058] In any embodiment, the fixation assembly includes a plurality of fixation arms configured to be adjusted from a stowed position suitable for percutaneous delivery to a deployed position in which the plurality of fixation arms face the ventricular wall, hi any embodiment, the fixation arms are configured to spread radially outward after deployment.

[0059] In any embodiment, each fixation arm includes a distal tissue engaging anchor, such as, for example, a barb.

[0060] In any embodiment, the stationary arm is connected to a distal end of the housing.

[0061] In any embodiment, the fixation arms are configured to self-deploy, for example, each arm may be biased toward a deployed position to self-deploy when the device is advanced beyond the distal end of the delivery sheath.

[0062] In any embodiment, the fixation assembly is configured for connection to a blood pump device in vivo.

[0063] In any embodiment, the fixation assembly includes a fixation hub configured to couple to the blood pump and a number of fixation arms extending from the hub.

[0064] In any embodiment, the system further includes an electronic circuit for setting an output parameter of the blood pump device, wherein the electronic circuit is coupled between the controller and the blood pump device, and the controller is configured to send a control signal to the electronic circuit to change the output parameter of the blood pump device.

[0065] In any embodiment, the controller is configured for implantation.

[0066] In any embodiment, the controller is configured to be implanted under the skin, typically subdermally, in the subject's chest.

[0067] In any embodiment, the system further includes a power unit associated with the blood pump device.

[0068] In any embodiment, the power unit is associated with the electronic circuit.

[0069] In any embodiment, the power unit is configured for implantation.

[0070] In any embodiment, the power unit is configured to be implanted subcutaneously, typically subdermally, in the subject's chest.

[0071] In any embodiment, the controller and power unit (and optionally the electronic circuitry) are contained within a single implantable housing.

[0072] In any embodiment, the system includes power leads that provide electrical communication between the power unit and the blood pump device, typically via a controller and electronic circuitry.

[0073] In any embodiment, the blood pump includes a chamber and a power lead disposed (e.g., fully disposed) within the chamber in a spooled or coiled configuration. In this embodiment, the blood pump is delivered to the left ventricle with the power lead wound on a spool within the chamber. Once the blood pump is deployed, the proximal end of the power lead is retrieved using a medical device and delivered (typically via a controller) to an implantable power unit that may be implanted under the skin in the subject's chest.

[0074] In any embodiment, the system includes an access sheath having a lumen configured to percutaneously deliver the blood pump device to the left ventricle.

[0075] In any embodiment, the system includes a delivery shaft for the blood pump for advancing the blood pump through the lumen of the access sheath.

[0076] In any embodiment, the delivery shaft and blood pump are configured to be releasably coupled together, allowing the blood pump to be connected to the delivery shaft, the shaft to be advanced through the access sheath to deliver the device, and then the delivery shaft to be removed from the blood pump.

[0077] In any embodiment, the system includes a handle connected to the proximal end of the access sheath, typically via a first hemostasis valve.

[0078] In any embodiment, the proximal end of the delivery shaft is connected to a handle, typically via a second hemostasis valve.

[0079] In any embodiment, the handle includes a first actuator that adjusts the axial position of the delivery shaft relative to the access sheath.

[0080] In any embodiment, the handle includes a second actuator that rotates the delivery shaft relative to the access sheath.

[0081] In any embodiment, the controller is configured to be implanted within the left ventricle of the heart. In any embodiment, the controller is integral with or operably connected to the blood pump device.

[0082] In another aspect, the invention provides a method, e.g., a method of treating or preventing heart failure, e.g., treating a subject suffering from a cardiac condition such as HFpEF, the method comprising: delivering a blood pump device within the subject's heart and positioning the blood pump device to pump blood from the left atrium to the left ventricle; activating and deactivating the blood pump device in a pattern that cooperates with the subject's cardiac cycle, including activating during ventricular diastole and deactivating during ventricular systole.

[0083] In any embodiment, the method includes securing the blood pump device to a wall of the left ventricle of the subject's heart.

[0084] In any embodiment, the method is a method of treating heart failure with preserved ejection fraction (HFpEF).

[0085] In any embodiment, the method is a method of reducing or preventing secondary pulmonary hypertension. In any embodiment, the method further comprises: Detecting a heart rate of a subject using a sensor; Activating and deactivating the blood pump device in a pattern (eg, at a frequency) that is synchronous with the subject's sensed heart rate.

[0086] In any embodiment, the method includes adjusting the frequency of turning on and off the blood pump according to changes in the detected heart rate over time.

[0087] In any embodiment, adjusting the frequency of turning the blood pump on and off includes adjusting the frequency of a voltage duty cycle to the blood pump.

[0088] In any embodiment, the method further comprises: sensing a blood pressure parameter of the subject's heart, typically a blood pressure parameter of the left side of the heart, preferably a left atrial or left ventricular blood pressure parameter, with a sensor; During operation of the blood pump, operating the blood pump at a pumping speed appropriate to the sensed blood pressure parameter (eg, adjusting the rotational speed of an impeller of the blood pump).

[0089] In any embodiment, the method includes adjusting the pumping speed of the blood pump according to changes in the sensed blood pressure parameter over time.

[0090] In any embodiment, adjusting the pumping speed of the blood pump comprises adjusting the amplitude of a voltage supply to the blood pump.

[0091] In any embodiment, the method includes operating the impeller of the blood pump at an impeller rotational speed of between 5,000 rpm and 50,000 rpm.

[0092] In any embodiment, the method includes operating the impeller of the blood pump at an impeller rotational speed of between 10,000 rpm and 40,000 rpm.

[0093] In any embodiment, the method comprises reducing pressure in the left ventricle by at least 5 to 10 mmHg during ventricular diastole.

[0094] In any embodiment, the method includes percutaneously delivering a blood pump device to the left ventricle.

[0095] In any embodiment, the blood pump device is delivered percutaneously via the femoral vein → iliac vein → inferior vena cava → right atrium → atrial septum → left atrium → left ventricle to the left ventricle.

[0096] In any embodiment, the method includes implanting a sensor in communication with or within the subject's heart. Typically, the sensor is a blood pressure parameter sensor. In one embodiment, the sensor is a cardiac pacing device.

[0097] In any embodiment, the method includes implanting a controller for the blood pressure device in the subject, typically subdermally implanted.

[0098] In any embodiment, the method includes implanting in the subject, typically subdermally, a power unit for the blood pressure device.

[0099] In any embodiment, the power unit and the controller (and optionally the circuitry) are contained within a single implantable unit, where the method includes implanting the single unit, typically subdermally.

[0100] In any embodiment, the method further comprises: Detecting a heart rate of a subject with a heart rate sensor; activating and deactivating the blood pump device based on the sensed heart rate data received from the heart rate sensor, by the controller.

[0101] In any embodiment, the method further comprises: sensing a cardiac blood pressure parameter of a subject with a blood pressure parameter sensor; and adjusting, by the controller, a pumping speed of the blood pump device based on the sensed blood pressure parameter data received from the blood pressure sensor.

[0102] In any embodiment, the method includes connecting the power unit to the blood pump device with a power lead.

[0103] In any embodiment, the method further comprises: percutaneously delivering a blood pump device to the left ventricle; capturing a proximal end of a power lead that is packaged in the blood pump device, typically in a spooled or coiled configuration; Delivering the proximal end of the power lead to a power unit.

[0104] In any embodiment, the method includes retracting the proximal end of the power lead into the right atrium, which may be performed by an access sheath or another form of catheter device.

[0105] In any embodiment, the proximal end of the power lead is delivered to the power unit at least partially percutaneously.

[0106] In any embodiment, the power leads are delivered via the right atrium, the superior vena cava, and the internal jugular / subclavian veins.

[0107] In any embodiment, the method includes coupling a sensor and a controller (or a single unit) with the sensor leads.

[0108] In any embodiment, the method further comprises: percutaneously advancing an access sheath over the guidewire such that a distal end of the access sheath is positioned within the left ventricle; advancing a blood pump along a lumen of the access sheath and beyond a distal end of the access sheath; and deploying an anchoring module to anchor the blood pump device to the wall of the left ventricle.

[0109] In any embodiment, the method includes the step of the fixturing module self-deploying.

[0110] In any embodiment, the method includes delivering a fixation module to the left ventricle and coupling a blood pump device to the fixation module within the left ventricle.

[0111] In any embodiment, the method includes deploying the fixation module to secure the fixation module to a wall of the left ventricle and coupling a blood pressure device to the fixation module.

[0112] Further aspects and preferred embodiments of the present invention are defined and described in the remaining claims set forth below. [Brief description of the drawings]

[0113] [Figure 1] FIG. 2 is a perspective view of a blood pump device forming part of the system of the present invention, viewed from the blood inlet side of the device housing. [Diagram 2] 2 is a perspective view of the heart pump device of FIG. 1 as viewed from the blood outlet side of the device housing. [Diagram 3] FIG. 2 is a cross-sectional view of the blood pump device of FIG. [Figure 4] FIG. 2 is a cross-sectional view of the blood pump device of FIG. [Diagram 5] FIG. 2 is a perspective view of a rotor forming part of the blood pump apparatus of FIG. 1; [Figure 6A] FIG. 6 is a perspective view of a swept-blade impeller forming part of the rotor of FIG. [Figure 6B] FIG. 6 is an end view of a swept-blade impeller forming part of the rotor of FIG. 5. [Figure 6C] FIG. 6 is a side view of a swept-blade impeller forming part of the rotor of FIG. 5. [Figure 7] 1 is a diagram of a human heart with the system of the present invention implanted in the left ventricle and secured to the apex of the left ventricle. [Figure 8] FIG. 8 is an exploded view of the left ventricle of FIG. 7 showing the blood pump device in its position within the left ventricle with its inlet facing the mitral valve, illustrating how the device draws blood from the RA into the LV when actuated during diastole. [Figure 9] FIG. 1 is a diagram of one embodiment of the system of the present invention in which a controller is placed outside the heart and electrically connected to a blood pump device by control wires and also electrically connected to an ECG sensor placed on the subject's chest. [Figure 10] FIG. 13 is a diagram of another embodiment of the system of the present invention in which the controller is placed outside the heart and electrically connected to the blood pump device by control wires and also electrically connected to a heart rate sensor implanted in the outer wall of the left ventricle. [Figure 11] FIG. 13 is a diagram of another embodiment of the system of the present invention, in which the controller is located outside the heart and electrically connected to the blood pump device by a wireless transmitter / receiver, and the sensor is coupled to the blood pump device and in contact with the inner wall of the left ventricle. [Figure 12] FIG. 1 is a block diagram of one embodiment of the major components of the system of the present invention deployed for use within the heart. [Figure 13] FIG. 2 is a block diagram of another embodiment of the major components of the system of the present invention deployed for use within the heart. [Figure 14] 1 is a graph of impeller tip diameter versus rotor speed. The speed at the smallest impeller diameter that fits within the maximum diameter range is shown at 38348 rpm. [Figure 15] 1 is a semi-log plot of pump flow parameters versus rotor speed. The minimum rotor speed required based on the maximum impeller diameter is shown at 38,348 rpm. [Figure 16] 1 is a graph of pump coefficient against specific speed. The minimum specific speed based on maximum diameter is shown as 1398.5. [Figure 17] 1 is a graph of specific speed (u=13.272 m min-1) versus assumed impeller tip speed for NPSHR and pump head. [Figure 18] 2 shows a second embodiment of a blood pump device forming part of the system of the present invention. [Figure 19] 19 shows the blood pump apparatus of FIG. 18 secured to the left ventricle of a subject's heart. [Figure 20] 1 shows a second embodiment of a blood pump device forming part of the system of the present invention, the device having a fluid conduit providing fluid communication between the left atrium and a fluid inlet of the blood pump device. [Figure 21]21 shows the blood pump apparatus of FIG. 20 secured to the left ventricle of a subject's heart. [Figure 22A] 1 shows the distal end of a blood pump device forming part of the present invention, showing the power / control leads wound within a chamber at the proximal end of the device. [Figure 22B] A retrieval catheter is shown capturing the loop at the proximal end of the power / control lead and withdrawing the lead. [Figure 22C] 1 shows the power / control leads fully retracted from the chamber of the blood pump and the proximal ends of the leads operably connected to the controller / power unit. [Diagram 23] 1 shows a system of the present invention including a catheter delivery system that delivers a blood pump device via a femoral artery to the left ventricle of a subject's heart. [Figure 24] 13 shows a retrieval catheter deployed to retrieve the proximal end of the power lead via the subclavian vein and superior vena cava. [Diagram 25] FIG. 1 shows a blood pump device in the left ventricle connected to a power unit / controller implanted subcutaneously in the chest via power leads that extend through the subclavian vein, superior vena cava, right atrium, atrial septum, left atrium, and into the left ventricle. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0114] All publications, patents, patent applications, and other references mentioned herein are incorporated by reference in their entirety for all purposes as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference and was set forth in its entirety.

[0115] As used herein, and unless otherwise specified, the following terms are intended to have the following meanings, in addition to any broader (or narrower) meaning that such terms may enjoy in the art.

[0116] As used herein, the use of the singular includes the plural and vice versa, unless the context requires otherwise. The terms "a" or "an" when used in reference to an entity are intended to refer to one or more of that entity. As such, the terms "a" (or "an"), "one or more," and "at least one" are used interchangeably herein.

[0117] As used herein, the term "comprise" or variations thereof, such as "comprises" or "comprising," are understood to indicate the inclusion of any recited item (e.g., a property, element, feature, property, method / processing step, or limitation) or group of items (e.g., a property, element, feature, property, method / processing step, or limitation) and not the exclusion of other items or groups of items. Thus, as used herein, the term "comprising" is inclusive or open-ended and does not exclude additional, unrecited items or method / processing steps.

[0118] As used herein, the term "disease" is used to define an abnormal condition in which physiological function is impaired and is accompanied by certain symptoms. The term is used broadly to include any disease, illness, disorder, condition, illness, pathology, or symptom in which physiological function is impaired, regardless of the nature of the etiology (or whether or not the pathological basis of the disease has actually been established). Thus, conditions resulting from infection, trauma, injury, surgery, radioablation, poisoning, or nutritional deficiency are also included.

[0119] In addition, the term "treatment" or "treating" refers to an intervention (e.g., supporting left ventricular contraction using a device of the invention) that prevents or delays the onset or progression of a disease, or reduces its incidence (or eradicates) in a treated population. In this context, the term treatment is used synonymously with the term "prophylactic treatment."

[0120] In the context of the above-mentioned treatment and effective amount, the term subject (which shall include "individual", "animal", "patient" or "mammal" as the context allows) defines any subject for which treatment is indicated, particularly a mammalian subject. Mammalian subjects include, but are not limited to, humans, farm animals, livestock, zoo animals, sports animals, pet animals such as dogs, cats, guinea pigs, rabbits, rats, mice, horses, cows, cows, primates such as apes, monkeys, orangutans and chimpanzees, canines such as dogs and wolves, felines such as cats, lions and tigers, equines such as horses, donkeys and zebras, food animals such as cows, pigs and sheep, ungulates such as deer and giraffes, and rodents such as mice, rats, hamsters and guinea pigs. In a preferred embodiment, the subject is a human.

[0121] By "blood drawing device" is meant a device configured to be implanted in a cardiac ventricle, particularly the left ventricle, and which, in operation, can draw blood from the right atrium to the left ventricle through the mitral valve during diastole, thus assisting the left ventricle to fill with blood. The device generally includes an impeller. The impeller typically includes a rotor having blades disposed within a housing having a blood inlet and a blood outlet. The housing is generally tubular and elongated in shape, where the blood inlet is disposed at one end or in the center of the housing, and the blood outlet is disposed at one end of the housing. The impeller is mounted for rotation within the housing with the blades disposed toward the blood outlet of the housing. In use, the device is typically secured to the wall of the left ventricle such that the blood inlet of the housing is located closer to the mitral valve than the blood outlet of the housing. The housing typically has a longitudinal axis that, in use, is directed toward the mitral valve. The device generally includes a motor, which may be an electromagnetic motor including a stator. The device may also include a controller and a sensor. The device may include or be operably coupled to an inductive charging device.

[0122] "Output parameters" as applied to the blood drawing device include the frequency of operation of the device and the pump flow pressure (e.g., impeller rotation speed during operation. It will be understood that during the rest phase of the blood drawing device, the impeller rotation may be maintained, but the rotation speed is significantly reduced compared to the operating phase. Thus, for example, the impeller may rotate at a rotation speed that is 50% or less than the rotation speed of the operating phase.

[0123] "Activated during ventricular diastole and deactivated during ventricular systole" means that the blood pump is activated during at least a portion of ventricular diastole (usually at least 50%, 60%, 70%, 80%, 90%, or 100% of ventricular diastole) and the blood pump is deactivated during ventricular systole. For example, the blood pump may be deactivated (during ventricular systole) when the system detects the aortic valve closing and activated (during ventricular filling and subsequent atrial contraction) when the system detects the aortic valve opening. The blood pump may be activated and deactivated at a frequency based on the frequency of the heartbeat detected, for example, by a cardiac pacing sensor.

[0124] By "anchor" is meant an element configured to engage tissue, for example, the wall, septum, or apex of the left ventricle of the heart. The fixation assembly may include one, two, three, or more anchors. One may be connected to the left ventricular septum and another may be connected to the apex of the left ventricle. The fixation assembly includes an anchor configured to be deployed and embedded in tissue of the wall of the left ventricle to ensure a firm connection of the blood suction device. Fixation is usually performed at a minimum of two locations in the wall. The anchors are adapted to withstand the repeated loads caused by the cardiac suction device as well as the loads caused by the tissue in which they are embedded. In addition, the anchors are designed to minimize damage to the surrounding tissue by design to minimize damage caused by the penetration of the anchors through muscle tissue as well as any subsequent damage to the tissue caused by repeated and successive contraction cycles. The anchors may be formed of any suitable structure. The anchors are selected according to the type of tissue and the condition of the tissue. In one embodiment, the anchor is encapsulated by a resilient polymeric membrane that expands circumferentially when the fixation assembly is compressed in the deployed configuration.

[0125] In one embodiment, the connection between at least one of the anchors and the blood suction device includes a magnet or magnetizable element, which facilitates connection of the anchors to the blood suction device at a target location in vivo. In one embodiment, the anchors are configured to releasably connect to the cardiac suction device, which allows one or both of the anchors to be delivered to the target location separately from the cardiac suction device. In one embodiment, the device is delivered in two parts, a first part including the first anchor and a second part including the cardiac suction device connected to the second anchor.

[0126] The systems of the present invention may include an inductive charging device. By "inductive charging device" is meant a device or any device of the system that wirelessly charges the system using any one of electromagnetic fields, radio waves, or magnetic resonance charging to transfer energy to charge the device. For example, a blood suction device may include an inductive charging device.

[0127] The system of the present invention is designed to deliver clinically effective functional support to the left ventricle of the heart during the filling phase (diastole). The system increases blood flow to the left ventricle of the implanted heart during diastole and then stops during systole. In one embodiment, the blood pump is stopped for the entire period of ventricular systole. The controller is programmable so that the system can operate as an auto-adaptive system that responds to physiological cues. The system can be continuously adapted to specific user requirements. The blood suction device is configured by the controller to operate in a pattern that cooperates with the natural cycle of the heart, for example, the blood suction device is activated during diastole and deactivated during systole. Thus, when the subject's heart rate increases, the frequency of activation and deactivation of the blood suction device changes in synchrony with the heart rate based on the signal received from the sensor. In addition, the controller can change the impeller rotation speed based on the physiological cues received from the sensor, for example, increasing the impeller rotation speed during periods when the heart rate is increasing and decreasing the impeller rotation speed during periods when the heart rate is decreasing. The controller may include a computing device configured to receive data from the sensor, compare the stored data to stored reference data, and alter an output parameter of the blood drawing device based on the comparison.

[0128] The controller may be configured for use outside the heart. Thus, the system may include a control lead operatively connecting the cardiac suction device implanted inside the heart with a controller located outside the body. The control lead may extend through the wall of the heart through the chest to the external controller. In another embodiment, the control lead may extend percutaneously from the left ventricle through a portion of the vascular system to the outside of the body at a suitable location. The controller may be configured to be worn by the subject. The controller may be connected to a power source, e.g., a battery. In another embodiment, the controller may be configured to be implanted inside the heart as part of the blood suction device and configured to receive data from the sensor.

[0129] The sensor may be part of the system of the present invention, or the system of the present invention may be configured to be used with a separate sensor.For example, the system may include a sensor configured to be implanted in the left ventricle of the heart, where the sensor is operatively connected or coupled to a blood suction device.This may be a wire / sensor element configured to extend in contact with the wall of the heart to sense the parameters of cardiac contraction / relaxation, or to contact the blood in the left ventricle or another ventricle to detect the parameters of blood (e.g., pressure or flow).

[0130] In another embodiment, the sensor is configured to be implanted in the outer wall of the heart and operably coupled to a controller that may be attached outside the subject's body.

[0131] In any embodiment, the system includes a graphical user interface that may form part of a controller that may be configured to display GUI data related to the functioning of the system, such as heart rate, blood pressure, frequency of impeller actuation, and impeller rotational speed.

[0132] In any embodiment, the sensor is configured to detect the ejection fraction of the left ventricle. In any embodiment, the controller is configured to compare the detected ejection fraction of the left ventricle with one or more ejection fraction reference values ​​and modify an output parameter of the blood drawer based on the comparison. In any embodiment, the controller is configured to switch off the blood drawer for a period of time if it is detected that the ejection fraction is decreasing. In any embodiment, the controller is configured to resume operation of the blood drawer if it is detected that the ejection fraction is maintained.

[0133] The system may further include a telemetry component for transmitting or receiving signals related to the left ventricle, the activity of the heart, or the activity of the system. The telemetry component may include a wireless medical telemetry element that uses radio frequency to relay data such as pulse, heart rate, and cardiac electrical activity to the controller.

[0134] The controller may be configured to control the operation of the blood drawing device either by automatic execution of program instructions in the memory and / or by receiving external input from a user. The memory components of the system may include ROM and RAM memory. The controller may take the form of a microprocessor. Examples

[0135] The present invention will now be described with reference to specific examples, which are merely exemplary and for purposes of illustration only. They are not intended to limit in any way the scope of the claimed exclusivity or the invention described. These examples constitute the best modes currently contemplated for carrying out the invention.

[0136] Referring now to the drawings, and initially to Figures 1 to 6, a blood aspiration device forming part of the system of the present invention is illustrated and generally designated by the reference numeral 1. The device 1 includes an outer tubular housing 2 with a blood inlet 3, a blood outlet 4, and an internal lumen 6 extending between the inlet 3 and the outlet 4. The housing has a length of 30 mm and a diameter of 7.6 mm. A rotor 5 is mounted on spaced bearings 7 and extends axially through the internal lumen 6 for rotation therein. A stator 8 is mounted within the housing adjacent the blood inlet 3 surrounding the proximal end of the rotor, and in use functions to rotate the rotor during operation of the blood pump device. A PCB 9 containing the electronic circuitry for rotating the device is located in a central portion of the housing surrounding the rotor 5.

[0137] 3, the housing 2 has a proximal portion 10 and a distal portion 11 separated from a central annular portion 13 by a partition wall 12. The proximal portion of the housing contains an annular compartment 14 which houses the stator 8 and PCB 9, as well as a central lumen 15 with a passage for blood during operation of the device. The PCB 9 contains the following components: resistors, diodes, transistors, a microprocessor, a pressure sensor.

[0138] Specifically, referring to Figures 4 to 6, impeller apparatus 20 is attached to the distal end of rotor 5 and includes a tubular hub 21 having a diameter of 1.665 mm and elongated swept vanes 22 mounted symmetrically on opposite sides of the hub. Each vane has an axial length of 13 mm, a radial width of 4.995 mm, and sweeps about the hub along its length from distal to proximal end at an angle (sweep angle) of approximately 100°, shown as O in Figure 6B. The gap between each vane and the surrounding outer housing is 0.5 mm.

[0139] 7 and 8 show a human heart including the left atrium 30, left ventricle 31, aorta 32, and aortic valve cusps 33, mitral valve 34, right atrium 35, right ventricle 36, left ventricular septum 37, and left ventricular apex 38. A blood suction device 1 is shown implanted in the left ventricle with two fixation arms, a first fixation arm 39A fixed to the lower part of the left ventricular septum 37, and a second fixation arm 39B fixed to the apex 38. The device is positioned such that the blood inlet 3 of the device 1 faces towards the mitral valve 34 and left atrium, and the blood outlet 4 faces the apex of the left ventricle. During actuation of the device during diastole, blood is flowed into the device through the inlet 3 and ejected through the outlet 4, as shown by arrow A, which helps to transfer blood from the right atrium to the left ventricle. At the end of diastole, the device is shut off as the mitral valve closes, the aortic valve cusps open, and the left ventricle contracts and pumps blood into the aorta on its own.

[0140] Figures 9 to 11 show several embodiments of the system of the present invention, where parts described with reference to the previous embodiments have been assigned the same reference numerals.

[0141] In FIG. 9, the system 40 of the present invention includes the blood draw device 1 shown implanted in the LV of the heart as previously described, and a controller device 41 external to the subject's body, housing a power module 42 and a controller / processing device 43. A control lead 44 extends from the LV through the wall of the LV and operably connects with the controller device 41. A sensing lead 45 operably connects the controller device to an ECG sensor 46 attached to the subject's chest. The ECG array has one or more leads placed on the user's skin, as shown in FIG. 12. The ECG leads may be placed subcutaneously or implanted in the body, such as in the left parasternal region. In this embodiment, the ECG monitors electrical parameters of the subject's heart, and the controller receives the electrical parameters and activates and stops the blood pump device 1 in a pattern that cooperates with the electrical parameters to activate the blood draw device during diastole and stop the blood draw device during systole to help the LV ventricle fill with blood during diastole. The controller also controls other parameters of the blood suction device based on the data received from the sensors, including increasing the impeller rotational speed during diastole during periods of activity (e.g., when the heart rate is above the resting heart rate) and decreasing the impeller rotational speed during diastole during periods of rest.

[0142] Figure 10 shows an alternative embodiment of the system of the present invention, designated by reference numeral 50, with parts described with reference to the previous embodiment being assigned the same reference numerals. In this embodiment, a sensor 51 for detecting left ventricular contraction parameters is implanted in the subject's chest by keyhole surgery and fixed to the outer wall of the left ventricle using suitable fixation means. A sensor lead 55 extends between the sensor 51 and the controller device 41 and provides data including the left ventricular contraction parameters to the controller. Use of this system for enhancing filling of the left ventricle during diastole is the same as previously described with reference to Figure 9.

[0143] FIG. 11 shows an alternative embodiment of the system of the invention, designated by reference number 60, where parts described with reference to the previous embodiment are assigned the same reference numbers. In this embodiment, a sensor 61 is provided in the form of a wire connected to the housing of a blood drawing device 1 configured to be deployed in contact with the wall of the left ventricle upon deployment of the device in the left ventricle. The wire is configured to detect an electrical parameter of the heart and relay the detected electrical parameter to a wireless transmitter / receiver mounted on the housing of the blood drawing device. A controller includes a wireless receiver / transmitter that receives data from the sensor 61 and relates the output parameter to the blood drawing device. The use of this system to enhance filling of the left ventricle during diastole is the same as previously described with reference to FIG. 9.

[0144] Figure 12 shows a block diagram of one embodiment of the main components of the system of the present invention. In the embodiment shown in this figure, a blood suction device 1 including an impeller pump is fixed to the left ventricle 31 of the subject's heart. A sensor 70 configured to detect a heart rate parameter is placed outside the heart. The sensor may be an ECG sensor including ECG leads placed on the subject's chest, or another type of heart rate parameter sensor placed outside the subject's heart. The sensor 70 is configured to detect a heart rate parameter 47, in this case a left ventricular contraction parameter.

[0145] The sensor data output from the sensor 70 is communicated, either by wired or wireless communication, to the microprocessor / control unit 81. The microprocessor / control unit 81 is configured to continuously evaluate the diastolic and systolic times based on the received sensor data and optimally synchronize the activation and deactivation of the blood suction device 1 to be synchronized with the diastolic and systolic phases of the cardiac cycle.

[0146] In use, the sensor 70 detects heart rate parameters and transmits sensor data to the microprocessor / control unit 82. The received sensor data is analyzed by the microprocessor / control unit 82 according to instructions stored in memory 84. The microprocessor / control unit 82 then delivers control signals to the power unit 85 and electronic circuitry 83 to appropriately alter the output parameters of the cardiac suction device 1 based on the sensor data to operate the cardiac suction device 1 in a pattern that cooperates with the heart's natural contraction cycle, activating the device during diastole and deactivating the device during systole.

[0147] Figure 13 shows a block diagram of another embodiment of the main components of the system of the present invention. In this embodiment, which is substantially the same as the system described with reference to Figure 11, a sensor 70 for sensing a heart rate parameter is placed in the left ventricle of the heart and transmits the sensed data to an external microprocessor / control unit 81 by wired or wireless communication. The use of the system of this embodiment is substantially the same as that described above with reference to Figure 11. Delivery of blood suction device to the LV

[0148] The device may be delivered percutaneously via the femoral / subclavian arteries or vein. The device may also be delivered via a transapical route, whereby an incision is made in the intercostal space and the device is delivered through the apex of the heart. Support Data

[0149] Figure 4 shows a blood suction device according to one embodiment of the present invention. The embodiment of Figure 4 is designed to be suitable for delivery with a 29Fr (9.66mm OD) catheter to allow more space for internal components such as printed circuit boards and stator coils. The wall thickness can be customized to some extent, but we assume a wall thickness of 1mm. Thus, the internal diameter is 7.66mm. Assuming a clearance and wall thickness of 0.5mm, the impeller tip diameter of the present invention cannot exceed 6.6mm.

[0150] The pump parameters are based on a set of relevant equations given in Gulich (2020-Page.455) [Gulich, J., 2020. Centrifugal Pumps. 4th ed. Springer International Publishing, p.455].

[0151] The known quantities include flow rate (Qopt), head (Hopt), available net suction head (NPSHA), cavitation safety factor (FNPSH), and pump efficiency (ηh). The values ​​listed and any calculations are contained in the MATLAB script Pump_graph.m.

[0152] The flow rate required by a pump is the volume of blood the pump needs to move per heartbeat multiplied by the heart rate, m 3 s -1 Assuming that 20 ml of blood needs to be moved and the worst case heart rate is 200 bpm, then Qopt = 6.66 × 10 -5 m 3 s -1 It is.

[0153] The required head is the reduced pressure required to alleviate LA hypertension in HFpEF. This is estimated to be 10 mmHg in a worst case scenario. This pressure can be expressed in meters by dividing by the specific weight of the fluid (assumed to be the same as water), Hopt = 0.1359 m.

[0154] The available net suction head is the net pressure at the pump inlet minus the vapor pressure of the fluid expressed in meters. The total pressure in the LA is the sum of the LAP at diastole (20 mmHg, which is when the pump is on), the LA height (3 cm), and the atmospheric pressure (760 mmHg). The vapor pressure of blood is assumed to be the same as the vapor pressure of water (47 mmHg). NPSHA = 9.995 m.

[0155] The cavitation safety factor is estimated to limit the amount of cavitation by ensuring that the pressure does not fall below the blood vapor pressure, which is estimated to be FNPSH=0.8*NPSHA.

[0156] Pump efficiency cannot be calculated but must be derived experimentally. For axial flow pumps, typically ηh=85%.

[0157] Here, the desired quantities are the rotor speed (n), impeller tip diameter (d2), hub ratio (v), specific speed (nq), pressure coefficient (ψ), flow coefficient (φ), and cavitation coefficient (σ).

[0158] The quantities can be calculated iteratively, but in practice it is easier to use a MATLAB script to plot the quantities with increasing rotor speed and determine possible pump characteristics based on the graph of these parameters generated. Figure 14 shows the minimum impeller diameter calculated for a range of rotor speeds. By choosing a diameter value below the maximum impeller diameter (6.66 mm), the minimum rotor speed required for the pump can be determined to be 38348 rpm.

[0159] Figure 15 is a semi-logarithmic graph of flow parameters against rotor speed. Again, the minimum rotor speed required is shown to be 38348 rpm. This graph shows that at the required rotor speed, NPSHR=1.5322 m and circumferential speed u=13.272 m / min -1 and the approach flow angle is β=0.1455°.

[0160] Figure 16 shows the pump coefficients versus specific speed, where the minimum rotor speed required has been converted to specific speed, shown on the graph as 1398.5. The values ​​of the coefficients can be evaluated at this point on the graph as follows: Ψ=0.0151, φ=0.1465, v=0.0608, and σ=0.1708.

[0161] FIG. 17 shows the NPSHR and pump head vs. specific speed when the impeller tip speed is set to the calculated circumferential speed evaluated above (u=13.272 m min -1 ). The required specific speed is shown to be 1398.5, and the NPSHR and head at this value are evaluated to be 1.5332 m and 0.1360 m, respectively. This value of NPSHR is the same as that evaluated from Figure 4, and the value of head is the same as that specified as the pump requirement.

[0162] Figure 7 shows a table taken from Gulich (2020) pg. 456 outlining the number of impeller blades and diffuser vanes required for a range of specific speeds. From this table, it can be seen that for specific speeds > 290, the number of impeller blades should be 2 and the number of diffuser vanes should be 5 / 7 / 9.

[0163] Rather than performing the calculations of the blade characteristics by hand, the blade design was finalized using a software tool called CFTurbo (CFturbo GmbH, Germany). This tool takes the information calculated in the previous section and semi-automates the process of the impeller design. The inputs selected were calculated for the HFpEF condition of 200 bpm as described above. However, the hub ratio calculated for this condition was too small to be practical. Therefore, the code was re-run with a range of different heart rates and a hub ratio of 0.25 was selected as a compromise. The final impeller design was output and prepared for inclusion in a complete CAD file.

[0164] 18 and 19, an alternative blood pump device forming part of the system of the present invention is illustrated, where parts described with reference to the previous embodiment are assigned the same reference numerals. The blood pump device, generally designated by reference numeral 90, includes a housing 2 with a blood inlet 3, a blood outlet 4, and a rotor 5. In this embodiment, the housing includes a cylindrical proximal portion 91 including a motor 92 operably connected to a proximal end of the rotor 5, a cylindrical distal portion 93 including an impeller 20 mounted to a distal portion of the rotor 5 and a distal blood outlet 4, and a central portion 94 including the blood inlet 3. The cylindrical distal portion 93 has a diameter approximately two times larger than that of the cylindrical proximal portion 91. The central portion 94 includes a number of struts 95 connecting the proximal portion 91 to the distal portion 93, the struts defining a number of large triangular blood inlet openings 96 that function as blood inlets. The device has a length of approximately 20 to 30 m, a diameter at the proximal end of 1.5 to 3 mm, and a diameter at the distal end of 3 to 7 mm, and is therefore suitable for percutaneous delivery to the left ventricle. A power / control lead 97 is coupled to the motor and extends proximally from the device 90 toward the left atrium. The distal end of the power / control lead 97 is operably coupled to a power unit implanted subdermally in the subject's chest (not shown). Three fixation arms 39A, 39B, and 39C are attached to the cylindrical distal portion 93 of the housing and are pivotally adjustable from a stowed delivery configuration shown in FIG. 18 to an outwardly flared deployed configuration shown in FIG. 19. The arms are formed of Nitinol and are resiliently biased to self-deploy into the outwardly flared configuration once the device 90 is moved beyond the distal end of the access / delivery sheath (not shown). The tip of each arm includes an anchoring barb 98 that engages tissue in the wall of the left ventricle.

[0165] In use, the device 90 is loaded into the proximal end of the access sheath with the fixation arms constrained in a stowed delivery configuration. The device 90 is then advanced through the lumen of the sheath into the left ventricle, whereupon it is deployed out of the distal end of the sheath, causing the fixation arms to self-deploy and anchor the device to the wall of the left ventricle. The device is positioned such that the blood inlet 3 of the device 1 faces toward the mitral valve 34 and the left atrium, and the blood outlet 4 faces the apex of the left ventricle 31. Delivery of the device through the access sheath may employ an elongated delivery shaft having a distal end removably coupled to the proximal end of the device, where the device is advanced through the access sheath by advancing the delivery shaft into the access sheath. The access sheath and delivery shaft may be associated with a handle having an actuator that axially moves the delivery shaft relative to the access sheath. Once in situ and the power / control lead 97 is coupled to the controller and power unit, the motor will activate and deactivate in a pattern that cooperates with the cardiac cycle, including activation of the motor during ventricular diastole to help fill the left ventricle with blood, and then deactivation during ventricular systole when the left ventricle contracts to eject blood, based on cardiac cycle data received from the sensor by the controller. The frequency of activation / deactivation is adjusted in real time based on changes in the subject's heart rate detected by the sensor. The sensor may also provide blood pressure parameter data to the controller, which may be used to control the rotational speed of the motor during the activation phase. In this way, the system of the present invention may set the rotational speed of the impeller according to blood pressure detected at the heart, and adjust the impeller speed according to changes in blood pressure, for example, when the subject's heart needs to work harder due to exercise or physical activity.

[0166] 20 and 21, an alternative blood pump device forming part of the system of the present invention is illustrated, where parts described with reference to the previous embodiment are assigned the same reference numerals. The blood pump device, generally designated by reference numeral 100, is the same as device 90 previously described, but additionally includes a fluid extension conduit 101 configured to provide fluid communication from the interior of the left atrium 30 to the blood inlet opening 96 of device 90. Conduit 101 is generally flexible and includes an open distal end 102 that fluidly mates with the proximal end of the cylindrical distal portion 93 of the device housing, and an open proximal end 103 that receives blood from the left atrium. Conduit 101 is dimensioned to extend partially into the interior of the left atrium 30 such that the open proximal end 103 is disposed within the left atrium. The distal end of the conduit may be configured to be secured to the mitral valve 34. Conduit 101 may be integrally formed with device 100 or may be removably connected thereto. The use of this embodiment is the same as that described for the embodiment of Figure 18, except that blood is flowed through conduit 101 to device 100 directly from the left atrium.

[0167] 22A, 22B and 22C, an alternative blood pump device forming part of the system of the present invention is illustrated, where parts described with reference to the previous embodiment are assigned the same reference numerals. The blood pump device, generally designated by reference numeral 110, is the same as device 90 previously described, except that the cylindrical proximal portion 91 of the device housing includes a chamber 111 and a power / control lead 97 packed inside the chamber 111 proximally of the motor 92. The distal end of the power / control lead 97 includes a loop 112. A retrieval catheter 113 with a distal hook 114 is also illustrated. In use, the blood pump device 110 is delivered to the left ventricle with the power / control lead 97 wound on a spool inside the chamber 111 as previously described (FIG. 22A). Once the device is secured to the left ventricle and the delivery shaft is detached from the device and withdrawn, the recovery catheter 113 is advanced through a second access sheath (not shown) that extends from an entry point in the subclavian vein, through the superior vena cava, through the right atrium, and into the left atrium. The recovery catheter is advanced through the second access sheath until the distal hook 114 hooks the loop 112 of the power / control lead 97 (FIG. 22B), and the recovery catheter is then retracted to retract the lead 97 proximally through the right atrium, the superior vena cava, and the subclavian vein, from where it can be electrically coupled to a controller 41 including a power unit 42 implanted subdermally in the subject's chest (FIG. 22C). Use of the device of this embodiment is the same as previously described.

[0168] 23-25 ​​show a system of the present invention used to deliver a blood pump device to the left ventricle of the heart via a femoral artery route (FIG. 23), a retrieval catheter advanced into the left ventricle via the subclavian vein to "hook" the proximal end of the power lead (FIG. 24), and the device in the left ventricle coupled to a power unit / controller implanted subcutaneously in the subject's chest via a power lead that extends through the subclavian vein, superior vena cava, right atrium, atrial septum, left atrium, and into the left ventricle (FIG. 25). The system of the present invention may be configured such that the delivery device of the blood pump device retracts the proximal end of the power lead toward the right atrium as the delivery device is withdrawn. The retrieval catheter may then be advanced toward the right atrium, hooking the proximal end of the power lead and retrieving it toward the subclavian vein, where it is coupled to the implanted power unit / controller. Equivalent

[0169] The foregoing description details presently preferred embodiments of the invention. Numerous modifications and variations in its practice are anticipated by those skilled in the art in light of these descriptions. Such modifications and variations are intended to be encompassed within the scope of the appended claims. [Explanation of symbols]

[0170] 1. Blood pump device 2 Outer tubular housing 3. Blood inlet 4 blood outlet 5 Rotor 6 Internal lumen 7 Spaced Bearings 8 Stator 9 PCB (electronic circuit) 10. Proximal housing portion 11 Housing Distal Portion 12 Housing Partition Wall 13 Central Circular Section 15 Central lumen 20 Impeller device 21 Tubular hub 22 Extended sweep blade 30 left atrium 31 Left ventricle 32 Aorta 33 Aortic valve cusp 34 Mitral Valve 35 Right atrium 36 Right ventricle 37 Left ventricular septum 38 Left ventricular apex 39A First Fixed Arm 39B Second fixed arm 39C 3rd fixed arm 40 First system of the present invention 41 Controller device 42 Power Modules / Units 43 Controller / Processing Unit 44 Control Lead 45 Detection lead wire 46 ECG sensors 50 Second system of the present invention 51 Sensors 55 Sensor lead wire 60 The third system of the present invention 61 Sensors 70 Sensors 81 Microprocessor / Control Unit 83 Electronic circuit 84 Memory 90 Blood Pump Device 91 Cylindrical proximal part 92 Motor 93 Cylindrical Distal Section 94 Central part 95 Post 96 Blood inlet opening 97 Power / Control Leads 98 Fixed Barb 100 Blood pump device 101 Fluid extension conduit 102 Open Distal End 103 Open proximal end 110 Blood pump device 111 Chamber 112 Loop 113 Retrieval Catheter 114 Distal Hook

Claims

1. A system (40, 50, 60) for treating heart failure with preserved ejection fraction (HFpEF), comprising: a blood pump device (1, 90, 100, 110) configured for implantation in a left ventricle (31) of a subject's heart, the blood pump device being configured, upon operation, to pump blood from a left atrium (30) to the left ventricle (31) of the heart via a mitral valve (34); a fixation assembly (39A, 39B, 39C) for fixing the blood pump device to the wall of the left ventricle; a controller (41, 43) configured to vary output parameters of the blood pump to activate and deactivate the blood pump in a pattern coordinated with the subject's cardiac cycle, including activation during ventricular diastole and deactivation during ventricular systole; Including, the system.

2. 2. The system of claim 1, further comprising at least one sensor (46, 51, 61, 70) in communication with the controller for detecting one or more parameters associated with the heart, the controller being configured to modify the output parameters of the blood pump device (1) based on the one or more detected parameters received from the at least one sensor.

3. 3. The system of claim 2, wherein the at least one sensor is configured to detect one or more parameters selected from heart rate, aortic valve closure, aortic valve opening, mitral valve closure, and mitral valve opening, and the controller is configured to adjust a frequency of activation and deactivation of the blood pump device based on the one or more parameters sensed by the sensor.

4. 5. The system of claim 4, wherein the controller (41, 43) is configured to regulate the frequency of activation and deactivation of the blood pump device by adjusting the frequency of a voltage supply to the blood pump device.

5. 5. The system of claim 2, wherein the at least one sensor (46, 51, 61, 70) is configured to detect a blood pressure parameter of the subject's heart, and the controller is configured to adjust the pump flow rate of the blood pump device in response to the blood pressure parameter detected by the sensor.

6. The system of claim 5 , wherein the sensor is an atrial pressure sensor.

7. 7. The system according to claim 5 or 6, wherein the controller (41, 43) is configured to regulate the pumping flow rate of the blood pump device by adjusting the amplitude of a voltage supply to the blood pump device.

8. 8. The system of claim 1, wherein the blood pump device (100) includes a fluid extension conduit (101) configured to provide fluid communication from an interior of the left atrium (30) to the blood inlet (3) of the housing (2).

9. The system of claim 8, wherein the fluid extension conduit (101) is removably connected to the housing (2).

10. The system of any of claims 1 to 9, wherein the fluid extension conduit (101) is flexible.

11. The blood pump device (90, 100) comprises: a first cylindrical portion (91) containing said motor (92); a second cylindrical portion (93) containing said impeller (20); a central portion (94) connecting said first cylindrical portion and said second cylindrical portion and including said fluid inlet (3); a fluid outlet (4) disposed in the first cylindrical portion or the second cylindrical portion, 11. The system of claim 1, wherein the rotor (5) extends from the motor through the central portion towards the impeller.

12. The system according to claim 11, wherein the fluid outlet (4) is arranged at a free end of the second cylindrical portion (93).

13. 13. The system of claim 11 or 12, wherein the central portion (94) of the blood pump device includes a plurality of struts (95) connecting the first cylindrical portion (91) and the second cylindrical portion (93), and the blood inlet (3) includes a plurality of openings (96) defined by the plurality of struts (95).

14. A system according to any of claims 2 to 13, including cardiac pacing sensors, such as ECG and atrial pressure sensors.

15. 14. A system according to any one of claims 2 to 13, including cardiac pacing sensors, such as ECG and ventricular pressure sensors.

16. The system of any of claims 11 to 15, wherein the controller (41, 43) is implantable.

17. 17. The system of any of claims 11 to 16, including a power unit (42) associated with the blood pump device, the power unit being implantable.

18. 18. The system of claim 16 or 17, wherein the controller (41, 43) and the power unit (42) are contained within a single implantable unit.

19. 19. The system of claim 17 or 18, wherein the power unit (42) is configured for contactless inductive charging.

20. 18. The system of claim 16 or 17, comprising a power lead (97) configured to operatively connect the power unit (42) and / or the controller (41, 43) to the blood pump device.

21. 21. The system of claim 20, wherein the blood pump device includes a chamber (111), and the power leads are disposed within the chamber in a spooled or coiled configuration.

22. 22. The system of claim 21, comprising a retrieval catheter (113) configured to capture a proximal end of the power lead (97) and retract the power lead from the chamber (111).

23. 23. The system of any of claims 11 to 22, comprising an access sheath having a lumen configured to percutaneously deliver the blood pump device to the left ventricle.

24. 24. The system of claim 1, further comprising a delivery shaft for the blood pump device for advancing the blood pump device through the lumen of the access sheath.

25. The system of claim 24 , wherein the delivery shaft and the blood pump are configured to be removably coupled together.

26. 26. The system of any of claims 11 to 25, wherein the fixation assembly includes a plurality of fixation arms (38A, 39B, 39C) configured to be adjusted from a stowed position suitable for percutaneous delivery to a deployed position in which the plurality of fixation arms face the ventricular wall.

27. 27. The system of claim 26, wherein the fixation arms are configured to self-deploy.

28. 28. The system of any of claims 11 to 27, wherein the fixation assembly is configured to couple to the blood pump device in vivo.

29. 30. The system of claim 29, wherein the fixation assembly includes a fixation hub configured to couple to the blood pump and a plurality of fixation arms extending from the hub.

30. 12. The system of claim 11, wherein the impeller (20) includes an axle hub (21) and at least two blades (22) attached to the hub, each blade having an elongated swept profile.

31. 31. The system of claim 30, wherein each vane (22) includes a hub-to-tip ratio (v) of 0.20 to 0.

30.

32. 32. The system of claim 30 or 31, wherein the impeller (20) includes two blades (22) disposed on opposite sides of the hub.

33. 33. A system as claimed in any of claims 30 to 32, wherein each vane (22) has an axial length of 10 to 15 mm and a radial width of 3 to 7 mm.

34. 34. A system as claimed in any of claims 30 to 33, wherein each vane (22) extends along a sweep angle of between 80° and 120° about the hub.

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