Circulation support device, circulation support system, and circulation support method

Abstract

A circulatory support system may include a blood pump and a controller. The blood pump may include a driven component and a motor that works in conjunction with the driven component and communicates with the controller to drive the driven component to pump blood through the blood pump. The controller may be configured to receive values ​​of circulatory parameters related to the blood flow through the patient, determine a value of a command signal based on the received value, and output the command signal to the motor to drive the driven component at a set speed to achieve the value of the circulatory parameters related to the blood flow through the patient.

Description

[Technical Field]

[0001] This disclosure relates to mechanical circulatory support devices. More specifically, this disclosure relates to the operation of percutaneous ventricular assist devices (PVADs). [Background technology]

[0002] A wide variety of in-vivo and in-vitro medical devices and systems have been developed for medical applications, for example, in cardiac procedures and / or cardiac treatments. Some of these devices and systems include guidewires, catheters, catheter systems, pumps, cardiac assist devices, and the like. These devices and systems can be manufactured by any of several different manufacturing methods and used in any of several different ways. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is an ongoing need to provide alternative medical devices and systems, as well as alternative methods for manufacturing and using medical devices and systems. [Overview of the project]

[0003] This disclosure provides alternatives for the design, materials, manufacturing methods, and use of medical devices, including ventricular assist devices. In the first example, the circulatory support system may include a blood pump comprising a driven component and a motor configured to work in conjunction with the driven component to drive the driven component and pump blood flow through the blood pump; and a controller communicating with the motor, configured to receive one or more values ​​of one or more circulatory parameters relating to blood flow in the patient, determine a value of a command signal based on one or more values ​​of the one or more circulatory parameters relating to blood flow in the patient, and output the determined command signal to the motor to drive the driven component at a speed set to achieve one or more values ​​of the one or more circulatory parameters relating to blood flow in the patient.

[0004] Alternatively, or in addition to any of the above examples, in another example, one or more circulatory parameters related to blood flow in a patient may be selected from the group consisting of the flow rate of blood passing through the blood pump, mean arterial pressure, and cardiac output.

[0005] In an alternative or additional example to any of the above examples, the controller may be configured to determine a value for the flow rate of blood passing through the blood pump and to determine a value for a command signal based on one or more received values ​​of one or more circulatory parameters related to blood flow in the patient and the determined value for the flow rate of blood passing through the blood pump.

[0006] In an alternative or additional example to any of the above examples, the controller may be configured to determine the value of the patient's left ventricular pressure and to determine the value of a command signal based on one or more values ​​of one or more circulatory parameters related to blood flow in the patient, a determined value of the flow rate of blood passing through the blood pump, and the determined value of the left ventricular pressure.

[0007] Alternatively, or in addition to, any of the above examples, another example includes one or more sensors configured to detect a value related to the motor speed and one or more sensors configured to detect a value related to the patient's aortic pressure, wherein the controller is configured to determine a value for the flow rate of blood passing through the blood pump based on the value related to the motor speed and to determine a value for the patient's left ventricular pressure based on the value related to the patient's aortic pressure.

[0008] Alternatively, or in addition to any of the above examples, in another example, one or more values ​​of one or more circulatory parameters related to blood flow in a patient may include one or more values ​​of the flow rate of blood passing through the blood pump.

[0009] In an alternative or additional example to any of the above examples, the controller may be configured to determine a value for the flow rate of blood passing through the blood pump and to determine a value for a command signal based on the received value of the flow rate of blood passing through the blood pump and the determined value of the flow rate of blood passing through the blood pump.

[0010] Alternatively, or in addition to any of the above examples, in another example, one or more values ​​of one or more circulatory parameters related to blood flow in a patient may include one or more values ​​of the patient's mean arterial pressure.

[0011] Alternatively, or in addition to any of the above examples, in another example, the controller may be configured to determine the value of the blood flow rate through the blood pump, determine the value of the patient's left ventricular pressure, and determine the value of the command signal based on the received value of the blood flow rate through the blood pump, the received value of the patient's mean arterial pressure, the determined value of the blood flow rate through the blood pump, and the determined value of the patient's left ventricular pressure.

[0012] Alternatively, or in addition to, any of the above examples, in another example, one or more received values ​​of the blood flow rate through the blood pump may include a minimum flow rate threshold. Alternatively, or in addition to any of the above examples, in another example, the controller may be configured to adjust the value of a command signal to reduce the speed of one or more driven components over a predetermined period of time.

[0013] Alternatively, or in addition to any of the above examples, in another example, the controller may be configured to adjust the value of a command signal to reduce the speed of a driven component based on the value of one or more circulatory parameters related to blood flow in the patient.

[0014] In a further example, there is provided a non-transitory computer-readable medium storing instructions executable by a circulatory assist device for use in a patient's heart, the instructions causing the circulatory assist device to execute a method comprising: receiving one or more values of one or more circulation parameters associated with blood flow in a patient; determining a value of a command signal based on the one or more values of the one or more circulation parameters associated with blood flow in the patient; and transmitting the command signal from a controller of the circulatory assist device to a motor of a blood pump of the circulatory assist device, causing the motor to pump fluid from the patient's left ventricle through the blood pump into the patient's aorta, and driving a driven component of the blood pump at a speed configured to achieve the one or more values of the one or more circulation parameters.

[0015] Alternatively or additionally to any of the above examples, in another example, the method may further comprise the steps of: determining a value of a flow rate of blood passing through the blood pump; and determining the value of the command signal based on the received one or more values of the one or more circulation parameters associated with blood flow in the patient and the determined value of the flow rate of blood passing through the blood pump.

[0016] Alternatively or additionally to any of the above examples, in another example, the method may further comprise the steps of: determining a value of left ventricular pressure of the patient; and determining the value of the command signal based on the received one or more values of the one or more circulation parameters associated with blood flow in the patient and the determined value of the left ventricular pressure.

[0017] Alternatively or additionally to any of the above examples, in another example, the one or more values of the one or more circulation parameters associated with blood flow in the patient include one or more values of a flow rate of blood passing through the blood pump, and the method further comprises the steps of: determining a value of the flow rate of blood passing through the blood pump; and determining the value of the command signal based on the received one or more values of the flow rate of blood passing through the blood pump and the determined value of the flow rate of blood passing through the blood pump.

[0018] Alternatively, or in addition to any of the above examples, in another example, one or more values ​​of one or more circulatory parameters related to blood flow in a patient may include one or both of the minimum and maximum thresholds.

[0019] In an alternative or additional example to any of the above examples, the method may further include the step of adjusting the value of a command signal to reduce the speed of the driven component over one or more predetermined time intervals.

[0020] Alternatively, or in addition to any of the above examples, in another example, the method may further include adjusting the value of the command signal to reduce the speed of the driven component based on a determined value of one or more circulatory parameters related to blood flow in the patient.

[0021] In a further example, a method for operating a blood circulation support system for use in a patient's heart may include the steps of: receiving one or more values ​​of one or more circulatory parameters relating to blood flow in the patient; determining a value of a command signal based on one or more values ​​of one or more circulatory parameters relating to blood flow in the patient; and sending a command signal from the controller of the blood circulation support system to the motor of the blood pump of the blood circulation support system to drive the motor to drive a driven component of the blood pump to pump fluid from the patient's left ventricle through the blood pump into the patient's aorta, thereby achieving one or more values ​​of one or more circulatory parameters.

[0022] The above summary of some embodiments is not intended to describe each disclosed embodiment or all implementations of this disclosure. The following drawings and detailed description illustrate these embodiments more specifically. [Brief explanation of the drawing]

[0023] This disclosure can be better understood by referring to the following detailed description in relation to the attached drawings. [Figure 1]This is a schematic partial cross-sectional view of an anatomical structure, and a schematic side view of an exemplary percutaneous ventricular assist device (PVAD) within the anatomical structure. [Figure 2] This is a schematic cross-sectional view of an exemplary PVAD. [Figure 3] This is a schematic detail diagram along line 3-3 of the PVAD shown in Figure 2. [Figure 4] This is a schematic diagram of an exemplary circulatory support system. [Figure 5] This is a schematic diagram of an exemplary computing device or controller and user interface. [Figure 6] This is a schematic diagram of an exemplary circulatory support system. [Figure 7] This is a schematic diagram of an exemplary circulatory support system. [Figure 8] This is a schematic diagram of an exemplary circulatory support system. [Figure 9] This is a schematic diagram of an exemplary circulatory support system. [Figure 10] This is a schematic diagram of an exemplary controller configuration. [Figure 11] This is a schematic diagram of an exemplary controller configuration. [Figure 12] This is a schematic diagram of an exemplary controller configuration. [Figure 13] This is a schematic diagram of an exemplary controller configuration. [Figure 14] This is a schematic diagram of an exemplary controller configuration. [Figure 15] This is a schematic diagram of an exemplary controller configuration. [Figure 16] This is a schematic diagram illustrating an exemplary method for operating a circulatory support system. [Modes for carrying out the invention]

[0024] This disclosure follows various modifications and alternative forms, the details of which are shown in the drawings as examples and described in detail. However, it should be understood that the intent is not to limit the invention to any particular embodiment described. On the contrary, this disclosure encompasses all modifications, equivalents, and alternative forms that fall within the technical concept and scope of this disclosure.

[0025] The terms defined below shall apply unless otherwise given in the claims or elsewhere in this specification. All numerical values ​​herein are assumed to be modified by the term “approximately,” whether expressly indicated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to (i.e., having the same function or result as) the stated value. In many cases, the term “approximately” may include numbers rounded to the nearest significant figure.

[0026] Numerical ranges specified by endpoints include all numbers within that range (for example, 1-5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5). As used herein and in the appended claims, the singular forms “a,” “an,” and “the” refer to multiple subjects unless the context clearly indicates otherwise. As used herein and in the appended claims, the term “or” is used generally to mean “and / or” unless the context clearly indicates otherwise.

[0027] Please note that references in this specification to “one embodiment,” “several embodiments,” and “other embodiments” indicate that the embodiments described may include one or more specific features, structures, and / or characteristics. However, such descriptions do not necessarily mean that all embodiments include specific features, structures, and / or characteristics. In addition, if specific features, structures, and / or characteristics are described in relation to one embodiment, please understand that such features, structures, and / or characteristics may be used in relation to other embodiments, whether explicitly described or not, unless explicitly stated otherwise.

[0028] The following detailed description should be read with reference to the drawings, where similar structures are numbered identically in different drawings. The drawings are not necessarily to a fixed scale and illustrate exemplary embodiments; they are not intended to limit the scope of this disclosure. In addition, note that in any drawing, some features may be omitted or shown schematically for clarity and / or simplification. Additional details regarding some components and / or method steps may be shown in more detail in other drawings. The apparatus and / or methods disclosed herein may offer many desirable features and advantages, as will be described in more detail below.

[0029] Various circulatory support devices are known to assist or replace the heart's pumping function in patients with severe heart failure and / or other cardiac-related diseases. These devices may be configured to treat patients with cardiogenic shock, myocardial infarction, acute decompensated heart failure, and / or other cardiac-related conditions. Additionally, or alternatively, circulatory support devices may assist patients during percutaneous coronary intervention and / or other procedures.

[0030] Examples of cardiovascular support devices include, but are not limited to, ventricular assist devices (VADs), total prosthetic hearts, intra-aortic balloon pumps (IABPs), and extracorporeal membrane oxygenation (ECMO). Examples of VADs include left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), and biventricular assist devices (BiVADs). A further exemplary VAD is the percutaneous ventricular assist device (PVAD), which can be inserted into the ventricle of a patient's heart (e.g., the left or right ventricle) via delivery to the ventricle through the femoral artery or femoral vein and / or other suitable vascular system. PVADs can be positioned at a desired location in the patient's anatomical structure via percutaneous access and delivery, which may allow PVADs to be used in emergency medicine, catheterization laboratories, and / or other surgical and / or non-surgical settings.

[0031] Figure 1 shows an exemplary placement of the blood pump 100 (e.g., a percutaneous circulatory support device such as a PVAD in an LVAD configuration) in the anatomical structure of a patient. In Figure 1, the blood pump 100 is positioned with its distal end 103 located in the left ventricle 16 of the heart 18 and its proximal end 107 located in the aorta 20, so that the blood pump 100 extends across the aortic valve 22 between the left ventricle 16 and the aorta 20. With the blood pump 100 extending from the left ventricle 16 to the aorta 20, the blood pump 100 may be configured to pump blood from the left ventricle 16 to the aorta 20 to assist in hemodynamic circulation. Other appropriate placements of the blood pump in anatomical structures are also envisioned, including, but not limited to, a configuration in which the distal end 103 of the blood pump is located in the right ventricle of the heart 18 and the proximal end is located in the pulmonary artery.

[0032] Figure 2 shows a schematic cross-sectional view of an exemplary configuration of the blood pump 100. In some cases, the blood pump 100 may constitute part of a percutaneous circulatory system or circulatory support system, together with a guidewire, introducer sheath, controller, user interface, one or more sensors, and / or other appropriate components.

[0033] The blood pump 100 may include a housing 101 having an impeller housing 102 and a motor housing 104. The impeller housing 102 and the motor housing 104 may be configured as a single unit or integrated structure, but this is not required, and the impeller housing 102 and the motor housing 104 may be separate components configured to be detachable or permanently coupled. In some configurations, the blood pump 100 may lack a motor housing 104 separate from the impeller housing 102, and the impeller housing 102 may be directly coupled to the motor 105, or the motor housing 104 may be configured integrally with the motor 105.

[0034] The impeller housing 102 may house an impeller assembly 106 and a driven magnet 124, which may be part of the impeller assembly 106 or separate from it. The impeller assembly 106 may include an impeller shaft 108 rotatably supported by at least one bearing, such as a bearing 110 and / or other suitable bearings. The impeller assembly 106 may further include an impeller 112 that rotates relative to the impeller housing 102 to allow blood to flow through the blood pump 100. In some configurations, for example as shown, the impeller shaft 108 and the impeller 112 may be separate components, and in other configurations, the impeller shaft 108 and the impeller 112 may be integrated. The impeller assembly 106 as a whole may be considered a driven component, and / or the rotating components of the impeller assembly 106 (e.g., the impeller shaft 108 and / or the impeller 112) may be driven components individually or in combination.

[0035] The impeller 112 is located within the impeller housing 102, and as the impeller 112 rotates, blood may be configured to flow in through a blood inlet 114 formed on or at the location of the impeller housing 102, and to flow out through the impeller housing 102 through a blood outlet 116 formed on or at the location of the impeller housing 102. In some configurations, the impeller housing 102 may be coupled to or include a distally extending cannula (not shown), the cannula which can receive blood (e.g., from the left ventricle 16 of the heart 18 and / or other suitable location) and deliver it to the inlet 114.

[0036] The inlet 114 and outlet 116 may each have any suitable number of openings configured to allow blood to be received into the blood pump 100 and blood to be discharged from the blood pump 100, respectively. In some examples, the inlet 114 and / or outlet 116 may each include multiple openings, and in other examples, one or both of the inlet 114 and outlet 116 may each include a single opening.

[0037] The inlet and outlet 116 may be formed at any suitable location along the impeller housing 102 or at other suitable locations along the blood pump 100, respectively. In some examples, as shown in Figure 2, the inlet 114 may be formed at the end of the impeller housing 102 (e.g., the distal end), and the outlet 116 may be formed on the side of the impeller housing 102 (e.g., proximal to the location of the inlet 114). Other suitable arrangements of the inlet 114 and / or outlet 116 on the impeller housing 102 are also conceivable.

[0038] The motor housing 104 may house the motor 105 along with other suitable components. In some examples, as shown in Figure 2, the motor housing 104 may house at least the motor 105, the drive shaft 120, and the drive magnet 122.

[0039] Motor 105 can be any suitable type of motor. For example, motor 105 may be a brushless direct current (DC) motor (BLDC), but other suitable types of motors are also possible.

[0040] During operation, the motor 105 may be configured to rotationally drive the impeller 112 relative to the impeller housing 102. In some exemplary configurations, the motor 105 may rotate a drive shaft 120 coupled to a drive magnet 122. The rotation of the drive magnet 122 may cause the rotation of a driven magnet 124, which is part of the impeller assembly 106 or is connected to the impeller assembly 106 and rotates together with it. That is, if the impeller shaft 108 is included in the impeller assembly 106, the impeller shaft 108 and the impeller 112 are configured to rotate together with the driven magnet 124. Additionally or alternatively, the motor 105 may be coupled to the impeller assembly 106 via other components.

[0041] As will be described in more detail below, a controller (not shown in Figure 2) may be operably coupled to the motor 105 and configured to control the motor 105 by one or more command signals transmitted from the controller to the motor 105. The controller may be located inside the motor housing 104 and / or outside the motor housing 104 (e.g., inside the housing of the blood pump 100, which is independent of the motor housing 104, outside the patient, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located inside the motor housing 104 and / or separately therefrom.

[0042] The motor housing 104 may be coupled to the catheter 126 at a position on the motor housing 104 opposite to the impeller housing 102. The catheter 126 may be coupled to the motor housing 104 by laser welding, soldering, or various equivalent methods. The catheter 126 may extend proximal to the motor housing 104.

[0043] The catheter 126 may include one or more lumens for housing one or more components of a circulatory support system, including a blood pump 100. In some cases, the catheter 126 may be configured to house a motor cable 128 (e.g., one or more cables configured to enable the operation of a motor 105) within the main lumen 130, and the motor cable 128 may be operably coupled to a controller (not shown) and / or an external power supply (not shown).

[0044] The catheter 126 may include a sensor assembly 132 for measuring pressure within the patient's vascular structure, for example, within the aorta or pulmonary artery. The sensor assembly 132 may be positioned relative to other components of the blood pump 100 to obtain high-precision pressure data. For example, the proximal position of the sensor assembly 132 relative to the motor housing 104 and motor 105 can reduce and / or eliminate measurement errors related to motor speed or dynamic pressure. Such errors are typically seen in other percutaneous circulatory support devices that employ pressure sensors located more distally to the motor or impeller assembly, for example, devices that employ pressure sensors located near the outlet 116.

[0045] Figure 3 shows a schematic detail of the interior of line 3-3 in Figure 2. As shown in Figure 3, the sensor assembly 132 may include a sensor housing 134 having an internal chamber 136. In some examples, the internal chamber 136 may have a counterbore shape, but other suitable shapes and / or configurations of the internal chamber 136 are also conceivable. A pressure sensor 138, such as an optical pressure sensor (e.g., an optical pressure sensor using one or more optical fibers and / or other suitable optical pressure sensors), an electrical pressure sensor, and / or other suitable pressure sensors, may be placed within the internal chamber 136 and configured to detect pressure in the aorta 20 as the blood pump 100 extends into the left ventricle 16 of the heart 18. The sensor housing 134 may protect the pressure sensor 138 when the blood pump 100 is deployed. The sensor housing 134 may also include a distally facing opening 140 of, or coupled to, the internal chamber 136. The opening 140 may allow blood to flow into the internal chamber 136, thereby enabling the pressure sensor 138 to detect the pressure of the blood in the vicinity of the internal chamber 136.

[0046] The sensor housing 134 can take various forms. For example, the sensor housing 134 may be a tube or ferrule manufactured from, for example, one or more metals, one or more plastics, composite materials, and / or other suitable materials. The sensor housing 134 may be coupled to the catheter 126 via one or more welds (not shown), one or more adhesives 142, and / or an outer jacket 144 enclosing at least a portion of the sensor housing 134 and the catheter 126. The sensor housing 134 may also include a sensor mount 145 within an internal chamber 136. The sensor mount 145 allows the pressure sensor 138 to be supported away from the walls of the sensor housing 134 (for example, the sensor mount 145 may be centered on the pressure sensor 138 within the internal chamber 136), thereby enabling high-precision pressure sensing. Other suitable configurations of the sensor housing 134 are also conceivable.

[0047] The sensor assembly 132 may include a sensor cable 147 coupled to a pressure sensor 138. The sensor cable 147 may operably couple the pressure sensor 138 to a controller (not shown). As shown, the sensor cable 147 may extend through a sensor mount 145 and support the pressure sensor 138 away from the wall of the sensor housing 134. The sensor cable 147 may extend proximal through an adhesive 142 and through a cable lumen 149 of the catheter 126 or a cable lumen 149 coupled to the catheter 126. In some examples, the cable lumen 149 may be coupled to the catheter 126 via one or more welds (not shown), adhesive (not shown), and / or an outer jacket 144. In other examples, the cable lumen 149 may be omitted, and the sensor cable 147 may extend through the main lumen 130 of the catheter 126 or be located directly beneath the outer jacket 144. An exemplary suitable sensor assembly 132 is disclosed in U.S. Patent Application Publication No. 2022 / 0149699, filed November 16, 2023, entitled “Percutaneous Circulation Support Device Including Proximal Pressure Sensor,” which is incorporated herein by reference in its entirety.

[0048] Figure 4 shows a schematic diagram of an exemplary circulatory support system 10. Along with other additional and / or alternative components, the circulatory support system 10 may include a blood pump 100, a pressure sensor 138, a controller 146, and a user interface 148. As described, the blood pump 100 may include a motor 105 that is communicatively connected to the controller 146, and an impeller 112 that works in conjunction with the motor 105.

[0049] In some examples, the blood pump 100 may include, or be coupled to, one or more sensors 150 (e.g., one or more position sensors and / or other suitable speed sensors configured to detect speed or speed-related values) configured to detect the speed and / or position of the motor 105. If one or more of the sensors 150 are included, one or more of the sensors 150 may be connected to the controller 146 through the catheter 126 and / or via one or more cables extending along the catheter 126. In some cases, the speed or position of the motor 105 may be detected directly from the electrical signals used by the controller 146 to drive the motor 105. In these cases, the motor 105 may be an implicit sensor used with an explicit sensor 150, or an implicit sensor that eliminates the need for an explicit sensor.

[0050] One or more sensors 150 may be any suitable type of sensor for detecting the speed or position of the motor. Examples of suitable types of sensors 150 include, but are not limited to, position sensors, Hall effect sensors, magnetic induction sensors, optical encoders, eddy current sensors, Doppler effect sensors, tachometers, and / or other suitable types of sensors.

[0051] Figure 5 shows a schematic diagram of an exemplary configuration of the controller 146 (e.g., a computing device) and user interface 148 of the circulatory support system 10. The controller 146 may be any suitable computing device configured to process data from or for the circulatory support system 10 (e.g., motor 105, pressure sensor 138, sensor 150, patient examination results, user input, patient monitor, etc.). In some cases, one or more components of the circulatory support system 10 may be incorporated into the controller 146 and / or user interface 148. Furthermore, one or more components of the circulatory support system 10 may incorporate one or more computing devices having similar or identical components to the controller 146 and / or user interface 148.

[0052] The controller 146 may be configured to enable the operation of the circulation assistance system 10. In some cases, the controller 146 may be configured to control the operation of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150 by establishing and / or outputting control signals to the components of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150, and by controlling and / or monitoring the operation of these units and devices.

[0053] The controller 146 may communicate with a remote server or other suitable computing device. If the controller 146, or at least a part of the controller 146, is a component separate from the structure of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150, the controller 146 may communicate with the electronic components of the circulation assistance system 10 via one or more wired connections, wireless connections, or networks (e.g., LAN and / or WAN).

[0054] The controller 146 may be, may include, or may be included in, one or more field-programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more composite PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs) or system-on-chips (SOCs), software, hardware, firmware, or any combination thereof and / or other components. Although the controller 146 may be referred to in the singular form herein, the controller 146 may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, and / or similarly.

[0055] The exemplary controller 146 may include one or more processors 152, memory 154, and / or one or more I / O units 156, in addition to other suitable components. Other exemplary components of the controller 146 not specifically shown in Figure 2 may include, but are not limited to, communication components, touchscreens, selectable buttons, housings, and / or other suitable components of the controller. As described above, one or more components of the controller 146 may be separate from and / or incorporated into the components of the circulation assistance system 10.

[0056] The controller 146 may include and / or communicate with various subcontrollers. Exemplary subcontrollers that may be included in or communicate with the controller 146 may include, but are not limited to, motor subcontrollers, flow subcontrollers, pressure subcontrollers, motor torque subcontrollers, motor mechanical loss subcontrollers, stall pressure subcontrollers, pressure loss subcontrollers, and / or other suitable subcontrollers.

[0057] The processor 152 of the controller 146 may include a single processor or two or more processors operating individually or in conjunction with each other. The processor 152 may be configured to receive and execute instructions, including instructions that can be loaded into memory 154 and / or other suitable memory. Exemplary components of the processor 152 may include, but are not limited to, a central processing unit, a microprocessor, a microcontroller, a multicore processor, a graphical processing unit, a digital signal processor, an application-specific integrated circuit (ASIC), an artificial intelligence accelerator, a field-programmable gate array (FPGA), discrete circuits, and / or other suitable types of data processing devices.

[0058] The memory 154 of the controller 146 may include a single memory component or two or more memory components, each operating individually or in conjunction with one another. Exemplary types of memory 154 may include random access memory (RAM), EEPROM, flash, a suitable volatile storage device, a suitable non-volatile storage device, persistent memory (e.g., read-only memory (ROM), a hard drive, flash memory, optical disc memory, and / or other suitable types of memory), and / or other suitable types of memory. Memory 154 may be or include a non-temporary computer-readable medium. Memory 154 may include instructions stored on the computer-readable medium in a temporary and / or non-temporary state, which may be executed by the processor 152 to cause the processor to perform one or more of the methods and / or techniques described herein.

[0059] The I / O unit 156 of the controller 146 may include a single I / O component, or two or more I / O components that operate individually or in conjunction with each other. The exemplary I / O unit 156 may be, or include, any suitable type of communication hardware and / or software, including, but not limited to, a communication port configured to communicate with the electronic components and / or other suitable computing devices or systems of the circulation support system 10. Exemplary types of I / O units 156 may include, but are not limited to, wired communication components (e.g., HDMI® components, Ethernet® components, VGA components, serial communication components, parallel communication components, component video ports, S-Video components, composite audio / video components, DVI components, USB components, optical communication components, and / or other suitable wired communication components), wireless communication components (e.g., radio frequency (RF) components, low energy Bluetooth® protocol components, Bluetooth® protocol components, near-field communication (NFC) protocol components, Wi-Fi protocol components, optical communication components, Zigbee® protocol components, and / or other suitable wireless communication components), and / or other suitable I / O units 156.

[0060] The user interface 148 may be configured to communicate with the controller 146 via one or more wired or wireless connections. The user interface 148 may include one or more display devices 158, one or more input devices 160, one or more output devices 162, and / or one or more other suitable functions.

[0061] The display device 158 may be any suitable display. Examples of suitable displays include, but are not limited to, touchscreen displays, non-touchscreen displays, liquid crystal display (LCD) screens, light-emitting diode (LED) displays, head-mounted displays, virtual reality displays, augmented reality displays, and / or other suitable display types.

[0062] Input device(s) 160 may be and / or include any suitable components and / or functions for receiving user input via a user interface. Exemplary input device(s) 160 may include, but are not limited to, a touchscreen, keypad, mouse, touchpad, microphone, selectable button, selectable knob, optical input, camera, gesture sensor, eye tracker, voice recognition control (e.g., a microphone connected to a suitable natural language processing component), and / or other suitable input device(s).

[0063] Output devices(s) 162 may be any suitable components and / or functions for providing information and / or data to the user and / or other computing components, and / or may include such components. Exemplary output devices(s) 162 may include, but are not limited to, displays, speakers, vibration systems, haptic feedback systems, optical outputs, cables, lights, and / or other suitable output devices.

[0064] Various parameters of the blood pump 100, the blood passing through the blood pump 100, or the vicinity of the blood pump 100 (e.g., pressure, flow rate, etc.) may be operational and / or clinically relevant performance parameters of the blood pump 100 or related to the blood pump 100 placed in a patient. For example, a user (physician, clinician, etc.) may be interested in ventricular pressure data, vascular pressure data (e.g., aortic pressure data, pulmonary artery pressure data, etc.), differential pressure data at both ends of the blood pump 100 (e.g., between the ventricle and the aorta, etc.), flow rate data related to the blood flowing through the blood pump 100, impeller speed data, motor speed data, and / or other data related to the operation of the blood pump 100 for making decisions regarding additional or alternative therapies, assessing the patient's condition, assessing the condition of the blood pump, assessing the operation of the blood pump, assessing the effectiveness of the blood pump, and controlling the operation of the blood pump. Furthermore, calculation results based on pressure and flow rate data related to and / or for the blood flowing through the blood pump 100, other blood pump data related to the operation of the blood pump 100, and / or data related to the blood flowing through the blood pump 100 may be used by the controller 146 to control the operation of the blood pump 100 automatically and / or in response to user input (e.g., by adjusting command signals).

[0065] The management of a patient with an MCS device (e.g., a PVAD such as a blood flow pump 100 and / or other suitable blood flow pumps) placed inside the patient's heart may depend on one or more variables. When setting the speed of the blood pump 100 (e.g., motor or impeller speed), the user may consider, but is not limited to, the capacity of the blood pump 100 (e.g., maximum flow rate) as well as variability including the patient's current and / or evolving hemodynamics (e.g., blood flow rate through the blood pump 100, left ventricular pressure, arterial pressure, mean arterial pressure (MAP), differential pressure at both ends of the blood pump 100, cardiac output (CO), hemolysis, etc.). However, the patient's hemodynamics are usually more closely related to the pressure and flow rate around the blood pump 100 placed inside the patient's heart than to the speed of the motor 105 or impeller 112 of the blood pump 100, which is typically used as the setting point for the blood pump. Therefore, in order for a user to predict how the blood pump speed setting will affect the patient's hemodynamics, the user needs to convert the speed to pressure or flow rate, which can be difficult because different patients or different patient conditions may respond differently to the set speed of the blood pump 100. Furthermore, due to variations between pumps (e.g., due to manufacturing tolerances, process changes, design changes, design differences between different models, etc.), the effect on the patient's hemodynamics may differ even with the same speed setting on two different pumps.

[0066] Given the predictable variability in how the patient responds to the speed setting of the blood pump 100, the blood pump is often set to the maximum permissible speed setting, and then the patient's hemodynamics are continuously monitored, and the speed of the blood pump 100 can be adjusted when the measured or calculated patient hemodynamics indicate the need for a speed adjustment. The concept described herein improves the operation of the MCS device and its application to the patient by enabling predictive control of the blood pump 100 based on the patient's hemodynamics rather than the speed of the blood pump 100, thereby enabling rapid adjustment of the blood pump to the patient's needs and potentially simplifying the control of the blood pump for the user.

[0067] A flow control function for the blood pump 100 may be available in the circulatory support system 10. If a flow control function is included, it may be enabled at all times or selectively to facilitate patient treatment. In some examples, the flow control function for the blood pump 100 may be enabled as a mode with various settings available to the user for setting operating parameters, thresholds, etc. Exemplary modes may include, but are not limited to, a flow-based control mode, a MAP-based threshold mode, a total cardiac output (TCO)-based threshold mode, a flow-based threshold mode, an automatic withdrawal mode, and / or other appropriate flow control modes. The flow control modes for the blood pump 100 may be used in combination and / or individually.

[0068] The flow-based control mode may allow the user to set the setpoint of the blood pump 100 based on the flow rate passing through the blood pump 100, rather than the speed of the motor 105 or impeller 112. Such a setpoint allows the user to easily predict how the patient will respond to the operation of the blood pump 100 without having to guess or estimate how the patient will respond (e.g., what the flow rate passing through the pump will be) based on a speed level setpoint, thereby simplifying the control and operation of the blood pump 100 for the user, even in patient-specific circumstances.

[0069] The MAP-based threshold mode may be configured to facilitate the operation of the blood pump 100 by automatically controlling the speed of the motor 105 and / or impeller 112 to maintain the patient's MAP above a user-defined threshold or otherwise predetermined MAP threshold. Additionally or alternatively, the MAP-based threshold mode may include an upper limit on the MAP to avoid operating the blood pump 100 at a speed that could cause excessive and / or dangerous arterial pressure.

[0070] The TCO-based threshold mode may be configured to facilitate the operation of the blood pump 100 by automatically controlling the speed of the motor 105 and / or impeller 112 to maintain the patient's TCO above a user-defined threshold or otherwise predetermined TCO threshold. Additionally or alternatively, the TCO-based threshold mode may include an upper limit on TCO to avoid operating the blood pump 100 at a speed that could cause excessive arterial pressure. In some cases, the use of the MAP-based threshold mode may require the user and / or the system to provide the system 10 with periodically measured cardiac output values.

[0071] The flow-based threshold mode may be configured to facilitate the operation of the blood pump 100 by automatically controlling the speed of the motor 105 and / or impeller 112 to maintain the flow rate of blood passing through the blood pump 100 above a minimum threshold, below a maximum threshold, and / or within a desired range of flow rate. In some cases, the flow-based threshold mode may be used in combination with one or both of the MAP-based threshold mode and the TCO-based threshold mode to ensure that the flow rate of blood passing through the blood pump is maintained within a desired range while maintaining desired values ​​of MAP and / or TCO.

[0072] The automatic weaning mode may include a function in which the system 10 gradually reduces the output of the blood pump 100 (e.g., the flow rate of blood passing through the blood pump 100, the speed of the motor 105, the speed of the impeller 112) until a user-set or other predetermined final blood pump output is reached. This function may allow the patient to gradually reduce their dependence on the blood pump 100. In some examples, the weaning or reduction of the output of the blood pump 100 may be configured to occur at predetermined time intervals. In some examples, the weaning mode may be configured to test the patient's ability to tolerate lower speeds and adjust the speed if patient variables (e.g., circulatory parameters and / or other patient variables) indicate that the patient can tolerate a reduced speed or reduced output from the blood pump 100. In some cases, the withdrawal mode can function well with the MAP-based threshold mode and / or TCO-based threshold mode, because the system 10 can automatically reduce the speed of the motor 105 and / or impeller 112 of the blood pump 100 if the test is or relates to the patient's MAP and / or TCO, and the values ​​of MAP and / or TCO suggest that the rate reduction is well tolerated by the patient. The test may also relate to other parameters, including flow rate, pressure, etc.

[0073] Figure 6 shows a schematic diagram of an exemplary control system for the circulation support system 10. In some cases, the control system may be a closed-loop or partially closed-loop control system, but this is not mandatory.

[0074] As shown in Figure 6, the controller 146 communicates with the motor 105 of the blood pump 100 via the commutation board 164 to drive or otherwise rotate the impeller shaft 108 and the impeller 112. The commutation board 164 and / or its components may be incorporated into the controller 146, incorporated into the motor 105, and / or may be components separate from either or both of the controller 146 and the motor 105. In some examples, the commutation board 164 may be omitted.

[0075] During operation, the commutation block 166 of the commutation board 164 may be configured to receive a command signal 168 and the output of a sensor 150 that detects the speed of the motor 105 and / or a speed-related measure. The commutation block 166 may use the output of the sensor 150 to synchronize the command signal 168 with the operation of the motor 105 and supply a control signal 170 to the motor 105 based on the command signal 168 and the output of the sensor 150.

[0076] Furthermore, the high-pass filter (HPF) 172 of the commutation board 164 may be configured to receive the output of the sensor 150. The HPF 172 may be configured to acquire the derivative of the position signal, filter out noise in the velocity signal obtained from the position sensor 150, and supply the filtered signal as an output to the controller 146. In some examples, the HPF 172 may be omitted, and if a velocity sensor is used, the HPF 172 may be replaced with an LPF (low-pass filter), and / or other suitable filters may be used.

[0077] Controller 146 may be and / or include any suitable type of controller. For example, controller 146 may be and / or include one or more proportional controllers, proportional-integral (PI) controllers, proportional-integral-derivative (PID) controllers, read-lag controllers, nonlinear table controllers, linear table controllers, and / or other suitable types of controllers. In some examples, controller 146 may be and / or include one or more PI controllers having proportional components 174 and integral components 176, as shown in Figure 6. Furthermore, although not required, controller 146 may include multiple control loops and / or be configured to adjust intermediate states.

[0078] During operation, the controller 146 may be configured to receive values ​​of reference parameters 178, which are input to the motor subcontroller 180 for processing into a command signal 168. In some examples, the motor subcontroller 180 may include proportional and integral components 174 and 176 of a PI controller configured to process the values ​​of the reference parameters 178, values ​​related to the received values ​​of the reference parameters 178, and / or other appropriate data to determine and output the command signal 168.

[0079] The value of the reference parameter 178 may be any appropriate type of input from a user, component, or system communicating with the controller 146. In some cases, the value of the reference parameter 178 may be a setpoint and / or one or more thresholds provided by the user via the user interface 148, but this is not required. The reference parameter 178 may be any parameter related to the operation of the blood pump 100, including, but not limited to, the motor speed, the flow rate of blood passing through the blood pump 100, the intraventricular pressure of the heart 18 (e.g., left ventricular pressure and / or right ventricular pressure), the blood at both ends of the blood pump 100 (e.g., the pressure difference between intraventricular pressure and aortic pressure), mean arterial pressure (MAP), total cardiac output (TCO), and / or other appropriate values. In some examples, the reference parameter 178 may be, but is not required, circulatory parameters such as the flow rate of blood passing through the blood pump 100, intraventricular pressure of the heart 18 (e.g., left ventricular pressure and / or right ventricular pressure), differential pressure at both ends of the blood pump 100 (e.g., pressure difference between intraventricular pressure and intra-aortic pressure), mean arterial pressure (MAP), total cardiac output (TCO), and / or other appropriate circulatory parameters.

[0080] If the value of reference parameter 178 is a setpoint and / or one or more thresholds for the patient's circulatory parameters, the motor subcontroller 180 may utilize two PI controllers and / or other suitable controllers, as shown in Figure 6. In some examples, the first PI controller or other suitable controller may be configured to convert the value of reference parameter 178 for circulatory parameters to a value related to the motor speed setting, and the second PI controller or other suitable controller may be configured to convert the value related to the motor speed setting to a command signal 168, but this is not mandatory, and other suitable configurations are assumed.

[0081] In the configuration shown in Figure 6, the value of the reference parameter 178 related to the cyclic parameter can be combined in the adder 181 with the output from the cyclic parameter observer 184 (e.g., a subcontroller and / or other suitable observer). In some examples, the difference between these values ​​may be identified in the adder 181 and / or other adders described herein, and this difference may be represented by a "-" sign in the vicinity of the adder.

[0082] The circulatory parameter monitor 184 may be configured to receive circulatory parameter data and / or determine circulatory parameter values. In some examples, one or more circulatory parameter sensors (e.g., flow sensors, pressure sensors, etc.) may be provided as part of the system 10 or in a manner that allows them to communicate with the system 10, and may transmit detected values ​​to the controller 146 and the circulatory parameter monitor 184. Additionally or alternatively, in some examples, the circulatory parameter monitor 184 may be configured to determine or calculate circulatory parameters based on data and / or signals received from one or more components of the system 10 or communicating with the system 10, including but not limited to the value of command signal 168 or values ​​within command signal 168, detected motor speed, pressure detected near the blood pump 100, and / or other data or information relating to the operation of the blood pump 100. In some examples, instead of, or in addition to, utilizing the value of command signal 168, the circulatory parameter monitor 184 may be configured to utilize the output of a first PI controller that processes received values ​​relating to circulatory parameters.

[0083] The output of adder 181 is processed by the proportional component 174 and integral component 176 of the first PI controller and can be added in adder 182 to the speed setpoint value of motor 105 or a related value. Figure 6 shows the PI controller as a type of controller placed between adder 181 and adder 182, but additional and / or alternative types of controllers may be used. For example, read-lag based controllers (e.g., for slowly changing parameters), nonlinear table-based controllers (e.g., for highly nonlinear parameters), and / or other suitable types of controllers may be used between adder 181 and adder 182.

[0084] The speed setpoint value of motor 105 or a value related thereto can be added in adder 182 to the speed of motor 105 from sensor 150 (e.g., whether or not it passes through HPF 172) (for example, the outputs of the proportional component 174 and integral component 176 of the first PI controller may be added, and the difference between the added value and the speed of motor 105 may be identified, although this is not mandatory). If the output of the first PI controller is not the speed setpoint value of motor 105 or a value related thereto, the value of a parameter based on the output of the first PI controller (e.g., speed determined based on a reference value) may be added in adder 182 to the output of sensor 150. Alternatively or additionally, if the output of the first PI controller is not the speed setpoint value of motor 105 or a value related to the speed setpoint, the output of the first PI controller may be compared in adder 182 to the value of a parameter based on the output of sensor 150 (e.g., pressure, flow rate, etc.).

[0085] The output of adder 182 may be processed by the proportional component 174 and integral component 176 of a second PI controller. In Figure 6, the PI controller is shown as a type of controller placed between adder 182 and adder 183, but additional and / or alternative types of controllers may be available.

[0086] The outputs of the proportional component 174 and integral component 176 of the second PI controller may be added together in the adder 183, which may output a command signal 168. The values ​​added in the adder 183 may be added to generate the command signal 168, but this is not required. In some cases, the command signal 168 may be configured to operate the motor 105 at a speed that achieves the value of the received reference parameter 178. Other suitable configurations of the motor subcontroller 180 are also conceivable.

[0087] Figure 7 shows a schematic diagram of an exemplary control system for a circulatory support system 10, similar to the control system shown in Figure 6, where the value received as reference parameter 178 includes one or more flow rate values ​​of blood passing through the blood pump 100, and the circulatory parameter monitor 184 is replaced by a flow monitor 185 (e.g., a flow subcontroller or other suitable monitor). In some cases, the control system may be a closed-loop or partially closed-loop control system, but this is not mandatory.

[0088] The values ​​received as flow rate values ​​for one or more blood flowing through the blood pump 100 may include any appropriate values. Exemplary appropriate values ​​include one or more of the flow rate setpoint value, maximum flow rate value, minimum flow rate value, a desired range of values ​​for which the controller 146 should maintain the flow rate through the blood pump 100, and / or other appropriate values.

[0089] During operation, the controller 146 may be configured to receive one or more values ​​relating to the flow rate of blood passing through the blood pump 100, and these values ​​are input to the motor subcontroller 180. In such a configuration, the flow rate one or more values ​​may be configured to be added in the adder 181 with the output from the flow rate monitor 185.

[0090] The flow meter 185 may be configured to receive flow data and / or determine flow values. In some examples, one or more sensors (e.g., a flow sensor, a pressure sensor, and / or other suitable sensors configured to detect flow parameters or flow-related parameters of the fluid passing through the blood pump 100) may be provided as part of the system 10 or communicatively with the system 10 to transmit detected values ​​to the controller 146 and the flow meter 185. Additionally or alternatively, in some examples, the flow meter 185 may be configured to determine or calculate the flow rate based on data and / or signals received from or communicating with one or more components of the system 10, including but not limited to the value of the command signal 168 or a value within the command signal 168, the detected motor speed, and / or other data or information relating to the operation of the blood pump 100. In some examples, instead of using the value of command signal 168 or a value within command signal 168, or in addition to using it, the flow meter 185 may be configured to calculate or determine the predicted flow rate of blood passing through the blood pump 100 by utilizing the output of a first PI controller that processes the received value(s) related to the flow rate.

[0091] The output of adder 181 can be processed by the proportional component 174 and integral component 176 of the first PI controller into a value or a value related to the speed setpoint of motor 105. The value or a value related to the speed setpoint of motor 105 can be added in adder 182 to the speed of motor 105 from sensor 150 (for example, whether or not it has passed through HPF 172).

[0092] The output of adder 182 may be processed by the proportional component 174 and integral component 176 of the second PI controller. The outputs of the proportional component 174 and integral component 176 of the second PI controller may be added together in adder 183, which may output a command signal 168. The values ​​added in adder 183 may be added in order to generate the command signal 168, but this is not required.

[0093] Figure 8 shows a schematic diagram of an exemplary control system for a circulating support system 10, similar to the control system shown in Figure 6, in which case reference values ​​may be received for two or more different parameters. As shown in Figure 8, the value of the first reference parameter 178a may be received along with the values ​​of up to the Nth reference parameter 178n, where "Nth" reference parameter means that the controller 146 may receive and process the values ​​of any appropriate number of reference parameters. In some cases, the control system may be a closed-loop or partially closed-loop control system, but this is not required.

[0094] As described above, the values ​​of the reference parameters 178a to n can be any appropriate type of input from a user, component, or system communicating with the controller 146. In some examples, the value of the first reference parameter 178a may be one or more setpoints or ranges of setpoints of the blood flow rate through the blood pump 100, and the nth reference parameter may be a minimum MAP threshold or a minimum TCO threshold. Other appropriate combinations of received reference parameters are assumed.

[0095] The values ​​of one or more reference parameters 178a~n may include any suitable values. Exemplary suitable values ​​include one or more of the setpoint, maximum value, minimum value, desired operating value range, and / or other suitable values.

[0096] During operation, the controller 146 may be configured to receive values ​​from the first reference parameter 178a to the Nth reference parameter 178n, which can be input to the motor subcontroller 180. In such a configuration, the values ​​of the reference parameters 178a to n can be added together with the outputs from the cyclic parameter observers 184a to n associated with each reference parameter 178a to n in the adders 181a to n.

[0097] Similar to the circulatory parameter observer 184 described above, circulatory parameter observers 184a to n may be configured to receive circulatory parameter data and / or determine or calculate circulatory parameter values. For example, the first circulatory parameter observer 184a may be configured to receive values ​​from command signal 168, values ​​of the detected motor 105 speed, and values ​​from pressure sensor 138, and the nth circulatory parameter observer 184n may be configured to receive values ​​from command signal 168 and values ​​of the detected motor 105 speed. However, circulatory parameter observers 184a to n may be configured to receive additional and / or alternative circulatory parameter data and / or other data to determine or calculate circulatory parameter values, as described herein or otherwise.

[0098] The motor subcontroller 180 may provide the outputs from adders 181a to 189 to an integrated PI controller or to individual PI controllers corresponding to each of the reference parameters 178a to 179. The outputs of adders 181a to 189 may be processed by the proportional component 174 and integral component 176 of the associated PI controller and output to adders 189a to 189, where the values ​​may be added to the motor 105 speed setpoint value or a value associated with the speed setpoint for each received reference parameter 178a to 179. The motor 105 speed setpoint value or a value associated with the speed setpoint for each received reference parameter 178a to 179 is compared, and the motor speed setpoint value or a value associated with the speed setpoint may be selected in the value selection component 191. The selected value of the motor 105 speed setpoint or a selected value associated with the speed setpoint may be added in adder 182 to the motor 105 speed from sensor 150 (for example, whether or not it is passing through HPF 172).

[0099] The value selection component 191 may be configured to make one or more selections of the following: selection of a minimum value, selection of a maximum value, and / or selection of one or more other suitable values ​​(e.g., selection over time). In some examples, the value selection component 191 may be configured to select the maximum value. In some examples, the value selection component 191 may be configured to select the minimum value. In some examples, the value selection component 191 may be configured to select the minimum value first, then the maximum value, and to sequentially alternate between selecting the minimum and maximum values ​​over time. The value selection component 191 may additionally, alternatively, be configured to perform a majority vote among multiple inputs or to implement an intermediate value selection scheme.

[0100] The output of adder 182 may be further processed by proportional component 174 and integral component 176 of another PI controller. The outputs of proportional component 174 and integral component 176 of the second PI controller may be added together in adder 183, which may output command signal 168. The values ​​added in adder 183 may be added to generate command signal 168, but this is not mandatory. Other suitable configurations of the motor subcontroller 180 are also conceivable.

[0101] Figure 9 shows a schematic diagram of an exemplary control system for a circulatory support system 10, similar to the control system shown in Figure 8, where the received values ​​relate to a first reference parameter 178a, such as the flow rate of blood flowing through the blood pump 100, and a second reference parameter 178b, such as MAP, and the first and Nth circulatory monitors 184a-n are replaced by a flow monitor 185 and a pressure monitor 186 (e.g., a pressure subcontroller and / or other suitable pressure monitor). In such a control system configuration, the commanded pump speed may be sufficient to maintain a desired flow rate of blood flowing through the blood pump 100 and to maintain a minimum MAP. In another example, an exemplary control system similar to that shown in Figure 9 may be used when the value of TCO is received as the second reference parameter 178b, but this is not mandatory. In some cases, the control system shown in Figure 9 may be a closed-loop or partially closed-loop control system, but this is not mandatory.

[0102] During operation, the controller 146 may be configured to receive values ​​of a first reference parameter 178a, such as one or more values ​​of the blood flow rate through the blood pump 100, and values ​​of a second reference parameter 178b, such as one or more values ​​of the MAP. The values ​​of one or both of the first and second reference parameters 178a, 178b may include any appropriate values. Exemplary appropriate values ​​include one or more of setpoints, maximum values, minimum values, desired operating ranges, and / or other appropriate values. As an example, the controller 146 may receive a setpoint value of the first reference parameter 178a, such as a setpoint value of the blood flow rate through the blood pump 100, and a minimum threshold value of the second reference parameter 178b, such as a minimum threshold value of the MAP.

[0103] In such a configuration, the received values ​​of the first reference parameter 178a and the second reference parameter 178b can be added to the output from the circulation parameter subcontroller. In the exemplary control configuration shown in Figure 9, the received value of the first reference parameter 178a can be added to the output of the flow rate monitor 185 in adder 181a, and the value of the second reference parameter 178b can be added to the output of the pressure subcontroller in adder 181b. In some cases, a comparison between the received value and the output of monitors 185 and 186 can provide a determination of how much the received value differs from the current value of the reference parameter 178.

[0104] As described above with respect to Figure 7, the flow meter 185 may be configured to receive flow data and / or determine flow values ​​related to the operation of the blood pump 100. For example, the flow meter 185 may be configured to receive detected values ​​and transmit the received detected values ​​to the controller 146, and / or the flow meter 185 may be configured to determine or calculate flow based on data and / or signals received from one or more components of the system 10 or from one or more components communicating with the system 10, including but not limited to the value of the command signal 168 or a value within the command signal 168, detected motor speed, and / or other data or information related to the operation of the blood pump 100.

[0105] The pressure meter 186 may be configured to receive pressure data and / or determine pressure values ​​related to the operation of the blood pump 100. In some examples, one or more pressure sensors (e.g., pressure sensor 138 and / or other suitable sensors configured to detect parameters of pressure near the blood pump 100 or parameters related to that pressure) may be provided as part of the system 10 or communicatively with the system 10 to transmit detected values ​​to the controller 146 and the pressure meter 186. Additionally or alternatively, in some examples, the pressure meter 186 may be configured to determine or calculate the pressure near the blood pump 100 based on data and / or signals received from one or more components of the system 10 or communicating with the system 10, including but not limited to the value of command signal 168 or a value within command signal 168, detected motor speed, detected value from pressure sensor 138, and / or other data or information related to the operation of the blood pump 100. In some examples, instead of using the value of command signal 168 or a value within command signal 168, or in addition to using it, the pressure meter 186 may be configured to calculate or determine a predicted pressure in the vicinity of the blood pump 100 by utilizing the output of the maximum value selection component 191.

[0106] The pressure monitor 186 may be configured to calculate or determine any appropriate pressure in the vicinity of the blood pump 100. Examples of appropriate pressures include, but are not limited to, ventricular pressure, MAP, arterial pressure, aortic pressure, pulmonary artery pressure, differential pressure at both ends of the blood pump 100 (e.g., transvalvular pressure as the difference between ventricular pressure and arterial pressure when the blood pump 100 extends across the valve between the ventricles of the patient's heart and the arteries extending from the patient's heart), and / or other appropriate pressures in the vicinity of the blood pump.

[0107] In some examples, the pressure meter 186 may be configured to output a MAP calculated based on the input for comparison with the received MAP value(s). The MAP can be determined by the pressure meter 186 in any suitable way. For example, the MAP may be determined by taking the incoming aortic pressure and averaging a buffer (e.g., a relatively large buffer) containing multiple aortic pressure samples, and / or fitting the maximum and / or minimum values ​​into a formula, using a low-pass filter (LPF). The determined MAP can be compared to a reference MAP, such as the received MAP value(s).

[0108] The motor subcontroller 180 may provide the outputs from adders 181a and 181b to PI controllers specific to each reference parameter 178a and 178b. The outputs of adders 181a and 181b are processed by the proportional component 174 and integral component 176 of the associated PI controllers and output to adders 189a and 189b, respectively, where the values ​​may be added to the speed setpoint value or a value associated with the speed setpoint of the motor 105 for each received reference parameter 178a and 178b (e.g., flow rate and MAP). The speed setpoint values ​​or values ​​associated with the speed setpoint of the motor 105 for each of the first and second reference parameters 178a and 178b are compared with each other, and the maximum value of the speed setpoint or a maximum value associated with the speed setpoint of the motor 105 may be selected in the maximum value selection component 191. The selected value of the speed setpoint of motor 105, or a selected value associated with the speed setpoint, can be compared in the adder 182 with the speed of motor 105 from sensor 150 (for example, whether or not it is passing through HPF 172).

[0109] The output of adder 182 may be further processed by the proportional component 174 and integral component 176 of another PI controller. The outputs of the proportional component 174 and integral component 176 of the second PI controller are added together in adder 183, which may output command signal 168. The values ​​added in adder 183 may be added to generate command signal 168, but this is not mandatory. Other suitable configurations of the motor subcontroller 180 are also conceivable.

[0110] As described above, the controller 146 may use outputs and / or signals from the control and / or operation of the motor 105 and impeller 112 (e.g., command signal 168, detected motor speed, aortic pressure, etc.) to determine or calculate one or more parameters (e.g., circulatory parameters). Additionally or alternatively, the controller 146 may use outputs from one or more other sensors provided with or communicating with the blood pump 100 or the circulatory support system 10 to determine or calculate one or more parameters, where outputs from one or more sensors may include, but are not limited to, outputs from a pressure sensor 138 configured to detect pressure in the patient's vascular system (e.g., aorta 20, pulmonary artery, etc.), outputs from one or more other pressure sensors, and / or outputs from one or more flow sensors.

[0111] Over time, the patient may no longer require the use of the circulatory support system 10, or the patient's need for assistance from the circulatory support system 10 may decrease. Therefore, the circulatory support system 10 may transition to a weaning mode, and the patient may be weaned from the blood pump 100 of the circulatory support system 10. In one example, the weaning mode may be configured to decrease the value of a received reference parameter by a predetermined amount at predetermined intervals. The predetermined interval may be a preset time and / or when a specific current value of the circulatory parameter is calculated or determined by the circulatory parameter monitor 184. Once the value of the reference parameter is adjusted, a command signal may be adjusted to reduce the speed of the motor 105 and impeller 112 to achieve the adjusted value of the reference parameter, and it may be determined whether the patient can stand on their own with reduced power from the motor 105.

[0112] The parameters determined or calculated by the controller 146 to control the operation of the blood pump 100 may include one or more values ​​of parameters related to the blood flow pumped through the blood pump 100. In some examples, the controller 146 may be configured to determine or calculate one or more values ​​of the blood flow rate through the blood pump 100 at the flow meter 185, one or more pressures near the blood pump 100 at the pressure meter 186 (e.g., left ventricular pressure, right ventricular pressure, differential pressure at both ends of the blood pump 100, etc.), and / or other appropriate parameters related to the blood flow pumped through the blood pump 100.

[0113] The flow rate and / or pressure in or near the blood pump 100 can be calculated by any suitable method. In some examples, the flow rate and / or pressure in or near the blood pump 100 can be calculated based on the law of conservation of energy, more specifically Bernoulli's principle.

[0114]

number

[0115] Here, ρ is the density of the fluid, g is the acceleration due to gravity, P is the pressure at a point in the fluid, v is the velocity of the fluid at that point, h is the height at that point, and C is a constant based on the physical properties of the working fluid.

[0116] The flow rate and / or pressure in or near the blood pump 100 can also be calculated using Newton's force equilibrium equations.

[0117]

number

[0118] Here, F is the force applied by the motor, m is the mass of the fluid in motion, and a is the acceleration applied to the working fluid. Figures 10–15 show schematic diagrams of exemplary controller configurations for calculating or determining the parameter values. Exemplary suitable techniques for calculating or determining the parameter values ​​are described in U.S. Patent Application No. 63 / 540,346, filed September 25, 2023, entitled "Circulation Support Devices, System, and Methods," which is incorporated herein by reference in its entirety for all purposes.

[0119] The flow rate monitor 185 and the pressure monitor 186 may utilize the command signal 168 output from the motor subcontroller 180 as a parameter value representing the operation of the motor 105. In some cases, the command signal 168 may include a voltage level or value, or a voltage signal, configured to achieve a desired motor rotation or speed. The voltage level or value in the command signal 168 may be used to determine the parameter value instead of using the current detected in the motor 105, which may offer advantages over using the current detected in the motor 105 when determining the parameter value related to the operation of the blood pump 100. For example, by using the command signal 168, there is no need to wait for the motor to execute the command signal 168 and for the sensor to detect the current used by the motor 105 operating in response to the executed command signal 168, which may allow for faster determination or calculation of flow rate and / or pressure compared to determining the parameter value using the value of the current detected in the motor 105. By using command signal 168 as input for determining parameter values, it becomes possible to determine parameter values ​​based on how motor 105 will operate, rather than how motor 105 was operating, which is identified using the current or voltage detected in motor 105. This is because transmitting the detected current or voltage values ​​to controller 146 takes time, which may involve passing the detected current or voltage values ​​through one or more filters (e.g., HPF 172 and / or other suitable filters). Furthermore, by using the voltage level or value of command signal 168, the amount of noise in determining parameter values ​​can be reduced compared to the noise level when using detected current and / or voltage values ​​in motor 105 to determine parameter values, thereby reducing the complexity in determining or calculating flow rate and / or pressure.

[0120] Figure 10 schematically illustrates the operation of a flow meter 185 configured to determine or calculate the flow rate of blood flowing across the blood pump 100. The flow meter 185 may be configured to receive values ​​from a command signal 168 (e.g., voltage level or value and / or other appropriate values) and the detected motor speed 187 or related values. Based on the received signals or values, the flow meter 185 may determine or calculate the motor torque output 188 of the motor 105 and the mechanical losses 190 of the motor 105 (e.g., the amount of torque or energy required to rotate the motor 105 (and pump)).

[0121] The motor torque output 188 and the mechanical loss 190 can be determined by any suitable method. An exemplary configuration for determining the motor torque output 188 is described with reference to Figure 11. An exemplary configuration for determining the mechanical loss 190 is described with reference to Figure 12.

[0122] Once the motor torque output 188 and mechanical loss 190 of motor 105 are determined or calculated, one or more of the determined values ​​of motor torque output 188 and one or more of the mechanical loss 190 of motor 105 may be added together in adder 192. In some examples, the difference between these values ​​may be identified in adder 192. The difference between motor torque output 188 (e.g., the total torque generated by motor 105) and mechanical loss 190 of motor 105 (e.g., the amount of torque required to rotate motor 105) represents the amount of torque used by motor 105 to pump blood through the blood pump 100.

[0123] Once the difference between the motor torque output 188 and the mechanical loss 190 is determined, one or more coefficients may be applied to the difference so that the determined torque of the motor 105 available for pumping fluid through the blood pump 100 and the flow rate of fluid through the blood pump 100 can be associated. In some examples, one or more coefficients may be determined experimentally and be specific to the configuration of the blood pump 100.

[0124] In the exemplary configuration shown in Figure 10, two pump coefficients can be applied separately to values ​​related to the determined difference between the motor torque output 188 of the motor 105 and the mechanical loss 190. The first pump coefficient K FR0 (194) can be applied to the difference between the motor torque output 188 and the mechanical loss 190. First pump coefficient K FR0 (194) may be an experimentally determined value for the blood pump 100 (for example, a value determined for the configuration of the blood pump 100) that correlates the motor torque of the blood pump 100 with the flow rate through the blood pump 100. Furthermore, the square root 196 of the difference between the motor torque output 188 and the mechanical loss 190 is determined, and the second torque-flow coefficient K FR1 (198) can be applied to the value of the square root 196. Second torque-flow coefficient K FR1 (198) may be an experimentally determined value for the blood pump 100, which correlates the square root of the motor torque of the blood pump 100 with the flow rate through the blood pump 100.

[0125] In the adder 200, the first torque-flow coefficient K FR0 The value obtained by applying (194) to the difference between the motor torque output 188 and the mechanical loss 190 is the second torque-flow coefficient K FR1 (198) is added to the value obtained by applying (198) to the square root of the difference between the motor torque output 188 and the mechanical loss 190. This sum may be or may be the value of the determined or calculated flow rate 202 passing through the blood pump 100. The flow rate 202 may be output to the user interface 148 or other user interface and used by healthcare professionals when treating a patient with the blood pump 100, and / or may be used to automatically control the operation of the blood pump 100 by providing the determined or calculated flow rate to the motor subcontroller 180, and / or in one or more other suitable ways.

[0126] FIG. 11 schematically illustrates a diagram of an exemplary operation of a motor torque output observer 204 (e.g., a motor torque output sub-controller and / or any other suitable type of motor torque output observer) configured to determine or calculate the motor torque 188 of the motor 105 of the blood pump 100. The motor torque output observer 204 may be configured to receive a value from the command signal 168 (e.g., a voltage value and / or any other suitable value) and the detected motor speed 187 or a value associated therewith. The motor torque output observer 204 may determine or calculate the motor torque output 188 of the motor 105 based on the received signals or values.

[0127] Once the command signal 168 and the detected motor speed 187 are received, one or more coefficients may be applied to the values of the command signal 168 and the detected motor speed 187 or values associated therewith. In some examples, the one or more coefficients may be determined experimentally and / or are specific to the configuration of the motor 105, and may correlate voltage values with the torque output of the motor 105. In some cases, one or more of the coefficients that relate voltage to torque output may be provided on a data sheet for the motor 105.

[0128] In the exemplary configuration shown in FIG. 11, two coefficients may be separately applied to the received voltage command signal 168 and the detected motor speed 187, respectively. Torque-voltage coefficient K T (206) is applied to the value of the detected motor speed 187 or a value associated therewith, and may generate a voltage value (e.g., a value of the back EMF of the motor 105 and / or any other suitable value) that is added to the value of the command signal 168 in the adder 208. Torque-voltage coefficient K T (206) may be a motor torque constant and may be a parameter value found on a motor data sheet.

[0129] In the adder 208, the difference between the value determined by applying torque-voltage coefficient K T (206) to the detected motor speed 187 and the value of the command signal 168 may be determined. Torque-voltage coefficient KT The value obtained by applying (206) to the detected motor speed 187 may be the amount of voltage internally generated for the motor 105 based on the speed of the motor 105, or may represent the amount of voltage. To determine the exact value of the motor torque output 188, the torque-voltage coefficient K T The value obtained by applying (206) to the detected motor speed 187 can be subtracted from the command voltage in the command signal 168.

[0130] The ratio coefficient 210 is the torque-voltage coefficient K T (206) can be applied to the difference between the value obtained by applying it to the detected motor speed 187 and the value of the command signal 168. The ratio coefficient 210 is the torque voltage coefficient K T (206) can be determined by dividing it by the winding resistance of motor 105. Winding (or terminal) resistance R of motor 105 w (212) can be experimentally determined for motor 105 and / or the winding resistance R of motor 105. w (212) may be a value found in the datasheet for motor 105.

[0131] Torque-voltage coefficient K T The output obtained by applying the ratio coefficient 210 to the difference between the value obtained by applying (206) to the detected motor speed 187 and the value of the command signal 168 may represent the motor torque output 188. In some cases, as shown in Figure 11, for example, the low-pass filter 214 has a torque-voltage coefficient K T The output value obtained by applying (206) to the detected motor speed 187 and applying the ratio coefficient 210 to the difference between that value and the value of the command signal 168 can be applied. The low-pass filter 214 may be configured to filter out noise by filtering out all values ​​with frequencies higher than a predetermined frequency threshold.

[0132] Figure 12 schematically illustrates the operation of an exemplary motor mechanical loss meter 216 (e.g., a motor mechanical loss subcontroller or other suitable type of motor mechanical loss meter) configured to determine or calculate the mechanical loss 190 of the motor 105 of the blood pump 100 based on a force equilibrium equation. The motor mechanical loss meter 216 may be configured to receive a detected motor speed 187 or a related value. Based on the received signal or value, the motor mechanical loss meter 216 may determine or calculate the motor mechanical loss 190 of the motor 105.

[0133] When a value(s) of the detected motor speed 187 is received, a low-pass filter 218 may be applied to the value(s) of the detected motor speed 187. The low-pass filter 218 may be the same as the low-pass filter 214 having the same frequency threshold, or it may be a different low-pass filter having a different frequency threshold, and it filters out noise from the received value(s) of the detected motor speed 187. The output of the low-pass filter 218 may be processed in several separate steps and added to obtain the determined or calculated motor mechanical loss 190.

[0134] In one step, the derivative 220 of the output of the low-pass filter 218 may provide the acceleration of the motor 105. The equation of inertia J(222) may be applied to the determined or calculated acceleration of the motor 105, and the output of applying the equation of inertia J(222) to the acceleration of the motor 105 may represent, or may be, the calculated or determined force required to overcome the inertial force of the motor 105.

[0135] In the additional processing step, the output of the low-pass filter 218 is squared (224), and the nonlinear drag coefficient C N (226) can be applied to the square of the output of the low-pass filter 218. Nonlinear drag coefficient C N (226) corresponds to the nonlinear force and / or power lost to the environment as heat due to the inefficiency of the motor 105, and the nonlinear drag coefficient C NThe output obtained by applying (226) to the output of the low-pass filter 218 may represent, or may be, a calculated or determined force necessary to overcome the nonlinear drag acting on the motor 105.

[0136] The calculated or determined force required to overcome the inertia of motor 105 and the calculated or determined force to overcome the drag of motor 105 can be added together in adder 228. The output of adder 228 may be, or represent, the calculated or determined net inertia and nonlinear force acting on motor 105.

[0137] In yet another processing step, the linear drag coefficient C L (230) can be applied to the output of the low-pass filter 218. Linear drag coefficient C L (230) corresponds to the linear force and / or power lost to the environment as heat due to the inefficiency of the motor 105, and the linear drag coefficient C L The output obtained by applying (230) to the output of the low-pass filter 218 may represent, or may be, a calculated or determined force required to overcome the linear drag acting on the motor 105.

[0138] The calculated or determined net inertial and nonlinear forces acting on motor 105, and the calculated or determined forces required to overcome the linear drag of motor 105, can be added in adder 232. The output of adder 232 may be the calculated or determined net forces acting on motor 105 (e.g., inertial force, nonlinear drag, and linear drag), or may represent the calculated or determined net forces. In other words, the output of adder 232 may be the motor mechanical loss 190.

[0139] Figure 13 schematically illustrates the exemplary operation of a pressure monitor 186 configured to determine or calculate the pressure distal to (or proximal to the direction of blood flow) the impeller 112 (e.g., ventricular pressure such as left ventricular pressure and / or right ventricular pressure, depending on which ventricle the blood pump 100 extends into), where the distal end of the impeller may be located in a ventricle (e.g., the left or right ventricle of the patient's heart). The pressure monitor 186 may be configured to receive values ​​from a command signal 168 (e.g., a voltage value or level and / or other appropriate value), a detected motor speed 187 or a related value, and values ​​from a pressure sensor 138 (e.g., a pressure sensor that detects pressure proximal to the impeller 112 or distal to the direction of blood flow, such as pressure in the patient's aorta). Based on the received signal or value, the pressure meter 186 may determine or calculate the motor torque output 188 of the motor 105, the mechanical loss 190 of the motor 105 (e.g., the amount of torque or energy required to rotate the motor 105), and the stall pressure (e.g., head pressure or zero flow pressure), which may be the pressure at which blood is no longer moving through the blood pump 100.

[0140] The motor torque output 188 and mechanical losses 190 can be determined by any suitable method, including, but not limited to, those described herein with respect to Figures 11 and 12. Furthermore, the stall pressure 234 can be determined by any suitable method. An exemplary configuration for determining the stall pressure 234 is described with respect to Figure 14.

[0141] Once the motor torque output 188 and mechanical loss 190 of motor 105 are determined or calculated, one or more values ​​of the determined motor torque output 188 and one or more values ​​of the mechanical loss 190 of motor 105 may be added together in adder 236. In some examples, the difference between these values ​​may be identified in adder 236, and this difference may represent the amount of torque used by motor 105 to pump blood through the blood pump 100, as described above with respect to Figure 10.

[0142] Once the difference between the motor torque output 188 and the mechanical loss 190 is determined, the pressure gauge 186 may use the difference between the motor torque output 188 and the mechanical loss 190 and the detected motor speed 187 to calculate or determine the pressure loss 238 caused by the blood flow passing through the blood pump 100. An exemplary configuration for determining the pressure loss 238 is described with reference to Figure 15.

[0143] In the exemplary configuration shown in Figure 13, the calculated or determined pressure loss 238 can be added to the stall pressure 234 calculated or determined in the adder 240. The difference between the stall pressure 234 and the pressure loss 238 may be and / or represent the instantaneous pressure drop across the entire pump for a particular blood flow passing through the blood pump 100. In some examples, the pressure drop represents the difference between the ventricular pressure in the ventricle where the blood pump is located (e.g., the left or right ventricle) and the arterial pressure in the artery where the blood pump 100 is located (e.g., the aorta or the left pulmonary artery).

[0144] The determined pressure drop passing through the blood pump 100 can be added in the adder 242 to a pressure value based on the pressure sensor 138 and / or an index detected by the pressure sensor 138 (e.g., the pressure at a location proximal to the impeller 112, such as the patient's aorta). In the adder 242, the pressure value can be subtracted from the determined pressure drop passing through the blood pump 100 to determine a distal pressure value 244, which is the distal pressure of the impeller 112 (e.g., ventricular pressure such as left ventricular pressure or right ventricular pressure). The distal pressure value 244 can be output to the user interface 148 or other user interfaces and used by healthcare professionals when treating a patient with the blood pump 100, and / or used to automatically control the operation of the blood pump 100 by providing the determined or calculated distal pressure value 244 to the motor subcontroller 180, and / or can be output in one or more other appropriate forms.

[0145] Figure 14 schematically illustrates the operation of an exemplary motor stall pressure meter 246 (e.g., a motor stall pressure subcontroller and / or other suitable type of motor stall pressure meter) configured to determine or calculate the stall pressure 234 of the motor 105 of the blood pump 100. The stall pressure meter 246 may be configured to receive the detected motor speed 187 or a related value. Based on the received signal or value, the stall pressure meter 246 may determine or calculate the stall pressure 234 of the motor 105.

[0146] When a value(s) of the detected motor speed 187 is received, a low-pass filter 248 may be applied to the value(s) of the detected motor speed 187. The low-pass filter 248 may be the same as one or both of the low-pass filters 214, 218 having the same frequency threshold, or it may be a different low-pass filter having a different frequency threshold, and is used to filter out noise from the received value(s) of the detected motor speed 187. The output of the low-pass filter 218 may be processed in several separate steps to determine the motor 105 or to obtain a calculated stall pressure 234.

[0147] In one step, the derivative 220 of the output of the low-pass filter 248 may provide the acceleration of the motor 105. In an additional processing step, the output of the low-pass filter 248 may be squared (224).

[0148] Once the acceleration of motor 105 is determined and the output of low-pass filter 248 is squared, one or more coefficients (e.g., speed-pressure loss pump coefficients) can be applied to relate the detected motor speed 187 to the stall pressure 234. In some examples, one or more pump coefficients may be experimentally determined and specific to the configuration of blood pump 100. In some examples, a second pump coefficient K SP1 (221) can be applied to the acceleration of motor 105, and the first pump coefficient K SP0 (225) can be applied to the squared motor speed output from the low-pass filter 248. Second pump coefficient K SP1(221) may be an experimentally determined value for the blood pump 100 (for example, a value determined for the configuration of the blood pump 100) that correlates the acceleration of the motor 105 of the blood pump 100 with the stall pressure of the blood pump 100. First pump coefficient K SP0 (225) may be an experimentally determined value for the blood pump 100 that correlates the square of the detected motor speed 187 with the stall pressure of the blood pump 100.

[0149] First pump coefficient K SP0 The output obtained by applying this to the output of the low-pass filter 248 is used in the adder 250 to obtain the second pump coefficient K SP1 The first pump coefficient K can be subtracted from the output obtained by applying it to the acceleration of motor 105. SP0 The output obtained by applying this to the squared output of the low-pass filter 248, and the second pump coefficient K SP1 The difference determined in the adder 250 between the output obtained by applying this to the acceleration of motor 105 may be the stall pressure 234, which may be the maximum pressure that the blood pump 100 can generate.

[0150] Figure 15 schematically illustrates the operation of an exemplary pressure loss meter 252 (e.g., a pressure loss subcontroller and / or other suitable type of pressure loss meter) configured to determine or calculate the pressure loss 238 of the motor 105 of the blood pump 100. The pressure loss meter 252 may be configured to receive a detected motor speed 187 or a related value and a residual motor torque 254 or a related value. The residual motor torque 254 may be the difference between the motor torque output 188 and the motor mechanical loss 190. Based on the received signals or values, the pressure loss meter 252 may determine or calculate the pressure loss 238 of the motor 105.

[0151] When the detected motor speed 187 and residual motor torque 254 values ​​(multiple values) are received, a low-pass filter 256 may be applied to the detected motor speed 187 value (multiple values). The low-pass filter 256 may be the same as one or both of the low-pass filters 214, 218, and 248 having the same frequency threshold, or it may be a different low-pass filter having a different frequency threshold, and may be used to filter out noise from the received detected motor speed 187 value. The output of the low-pass filter 218 may be provided to a multiplier 258.

[0152] The residual motor torque 254 may be processed in several steps using one or more coefficients relating the residual motor torque 254 and / or the detected motor speed 187 to the pressure loss 238. In some examples, one or more coefficients may be experimentally determined and specific to the configuration of the blood pump 100.

[0153] In one step, the first pump coefficient K PL0 (255) can be applied to the residual motor torque. First pump coefficient K PL0 (255) may be an experimentally determined value for the blood pump 100 (for example, a value determined for the configuration of the blood pump 100) that correlates the residual motor torque of the blood pump 100 with the pressure loss 238. First pump coefficient K PL0 The result obtained by applying (255) may be provided to the adder 260.

[0154] Furthermore, the square root 196 of the residual motor torque 254 can be calculated or determined and applied to the multiplier 258. The value received in the multiplier 258 can be multiplied. After the value received by the multiplier 258 is multiplied, the second pump coefficient K is applied to the product of the values ​​provided to the multiplier 258. PL1 (259) may be applicable. Second pump coefficient K PL1(259) may be an experimentally determined value for the blood pump 100, which correlates the product of the residual motor torque 254 and the detected motor speed 187 with the pressure loss 238. The second pump coefficient K is added to the product of the values ​​supplied to the multiplier 258. PL1 The result obtained by applying (259) can be supplied to adder 260.

[0155] In the adder 260, the first pump coefficient K PL0 The value obtained by applying (194) to the residual motor torque 254 and the value output from the multiplier 258 are given by the second pump coefficient K PL1 The value of the pressure loss 238 can be determined or calculated by adding the value obtained by applying (259). The determined value of the pressure loss 238 can be used in determining the distal pressure or ventricular pressure 244 and / or other appropriate parameters.

[0156] The constants or coefficients shown and described in Figures 10 to 15 may be values ​​based on one or more parameters. In some examples, the constants or coefficients in Figures 10 to 15 may be scheduled values ​​based on the motor or pump speed, motor or pump temperature, motor or pump power, motor or pump operating time, combinations of these parameter values, and / or additional or alternative parameter values ​​used to compensate for changes in pump performance due to changes in pump operating conditions.

[0157] Figure 16 shows a schematic method or technique 300 for operating a blood circulation support system for use with a patient's heart. Method 300 may include a step (302) of receiving one or more values ​​of one or more reference parameters (e.g., circulatory parameters) related to blood flow in the patient. As described herein, these values ​​may be setpoint values, maximum thresholds and / or minimum thresholds, a range of appropriate operating values, and / or other appropriate values. Exemplary reference parameters include, but are not limited to, the flow rate of blood passing through the blood pump 100, intraventricular pressure of the heart 18 (e.g., left ventricular pressure and / or right ventricular pressure), differential pressure at both ends of the blood pump 100 (e.g., pressure difference between intraventricular pressure and intra-aortic pressure), mean arterial pressure (MAP), total cardiac output (TCO), and / or other appropriate circulatory parameters.

[0158] The value of a command signal may be determined based on the value of a received reference parameter (304). The command signal may be determined based on the value of a received reference parameter by a controller of a circulatory support system and / or other suitable controller, as described herein with respect to Figures 6 to 15, and / or by one or more other suitable methods. In some examples, the command signal may be based on the value of a received reference parameter and the current value of a circulatory parameter (e.g., blood flow rate through the blood pump, left ventricular pressure, etc.) added together, but this is not required.

[0159] The determined command signal may be transmitted from the controller on which the command signal was determined to the motor of the blood pump of the circulatory support system (306). In some examples, the command signal may be configured to drive the motor to a driven component (e.g., an impeller) of the blood pump to pump fluid from the ventricle of the patient's heart (e.g., the left ventricle) through the blood pump to the patient's arteries (e.g., the aorta) to achieve one or more received values ​​of one or more circulatory parameters. For example, the command signal may set the motor to a speed configured to achieve one or more received values ​​of one or more circulatory parameters.

[0160] As mentioned above, by using one or more circulatory parameters as reference parameters instead of, for example, motor speed, it may be possible to link the user's interaction with the circulatory support system to the patient's outcome. The use of such circulatory parameters allows for more precise initial control of the pump and can reduce the trial and error typically used when adjusting the use of the circulatory support system for a patient.

[0161] It should be understood that this disclosure is illustrative in many respects. Modifications can be made without exceeding the scope of this disclosure, particularly with respect to details, shape, size, and step arrangement. This may include, to a reasonable extent, the use of any feature of one exemplary embodiment used in other embodiments. The scope of this disclosure is, of course, defined in the language in which the appended claims are expressed.

Claims

1. A circulatory support system It is a blood pump, Driven components and, The blood pump comprises a motor configured to cooperate with the driven component and drive the driven component to pump blood through the blood pump, A controller that communicates with the motor, Receive one or more values ​​of one or more circulatory parameters related to blood flow in a patient, The value of the command signal is determined based on the one or more values ​​of the one or more circulatory parameters related to blood flow in the patient. A circulatory assistance system comprising: a controller that outputs the determined command signal to the motor to drive the driven component at a speed set to achieve the one or more values ​​of the one or more circulatory parameters related to blood flow in the patient.

2. The system according to claim 1, wherein the one or more circulatory parameters related to blood flow in the patient are selected from the group consisting of the flow rate of blood passing through the blood pump, mean arterial pressure, and cardiac output.

3. One or more sensors configured to detect a value related to the speed of the motor, The system further comprises one or more sensors configured to detect values ​​related to the patient's aortic pressure, The aforementioned controller, Based on the value related to the speed of the motor, the value of the flow rate of blood passing through the blood pump is determined. Based on the aforementioned values ​​related to the patient's aortic pressure, the value of the patient's left ventricular pressure is determined. The system according to claim 1 or 2, configured to determine the value of the command signal based on the one or more values ​​of the one or more circulatory parameters relating to blood flow in a patient, the determined value of the flow rate of blood passing through the blood pump, and the determined value of the left ventricular pressure.

4. The system according to any one of claims 1 to 3, wherein the one or more values ​​of the one or more circulatory parameters related to blood flow in a patient include one or more values ​​of the flow rate of blood passing through the blood pump.

5. The aforementioned controller, Determine the value of the blood flow rate passing through the blood pump, The system according to claim 4, configured to determine the value of the command signal based on the received value of the flow rate of blood passing through the blood pump and the determined value of the flow rate of blood passing through the blood pump.

6. The one or more values ​​of the one or more circulatory parameters related to blood flow in the patient include one or more values ​​of the patient's mean arterial pressure. The aforementioned controller, Determine the value of the blood flow rate passing through the blood pump, Determine the value of the patient's left ventricular pressure, The system is configured to determine the value of the command signal based on the received value of the blood flow rate through the blood pump, the received value of the patient's mean arterial pressure, the determined value of the blood flow rate through the blood pump, and the determined value of the patient's left ventricular pressure. The system according to claim 4 or 5, wherein one or more received values ​​of the flow rate of blood passing through the blood pump include a minimum flow rate threshold.

7. The system according to any one of claims 1 to 6, wherein the controller is configured to adjust the value of the command signal to reduce the speed of the driven component over one or more predetermined time periods.

8. The system according to any one of claims 1 to 7, wherein the controller is configured to adjust the value of the command signal to reduce the speed of the driven component based on the value of one or more circulatory parameters related to blood flow in the patient.

9. A non-temporary computer-readable medium containing instructions that can be executed by a circulatory support device for use in a patient's heart, wherein the instructions are to be executed by the circulatory support device. A step of receiving one or more values ​​of one or more circulatory parameters related to blood flow in a patient, A step of determining the value of a command signal based on the one or more values ​​of the one or more circulatory parameters related to blood flow in the patient, A non-temporary computer-readable medium that performs a method including transmitting the command signal from the controller of the circulatory support device to the motor of the blood pump of the circulatory support device, causing the motor to drive the driven components of the blood pump at a speed set to achieve the one or more values ​​of the one or more circulatory parameters, thereby pumping fluid from the patient's left ventricle through the blood pump to the patient's aorta.

10. The above method further, The steps include determining the value of the blood flow rate passing through the blood pump, The non-temporary computer-readable medium according to claim 9, comprising the step of determining the value of the command signal based on the received one or more values ​​of the one or more circulatory parameters relating to blood flow in a patient and the determined value of the flow rate of blood passing through the blood pump.

11. The above method further, The steps include determining the value of the patient's left ventricular pressure, A non-temporary computer-readable medium according to claim 9 or 10, comprising the step of determining the value of the command signal based on the received one or more values ​​of the one or more circulatory parameters relating to blood flow in a patient and the determined value of the left ventricular pressure.

12. The one or more values ​​of the one or more circulatory parameters related to blood flow in the patient include one or more values ​​of the flow rate of blood passing through the blood pump, and the method further, The steps include determining the value of the blood flow rate passing through the blood pump, A non-temporary computer-readable medium according to any one of claims 9 to 11, comprising the steps of: determining the value of the command signal based on the received one or more values ​​of the flow rate of blood passing through the blood pump and the determined value of the flow rate of blood passing through the blood pump.

13. The non-temporary computer-readable medium according to any one of claims 9 to 12, wherein the one or more values ​​of the one or more circulatory parameters relating to blood flow in a patient include one or both of a minimum threshold and a maximum threshold.

14. The above method further, A non-temporary computer-readable medium according to any one of claims 9 to 13, comprising the step of adjusting the value of the command signal to reduce the speed of the driven component over one or more predetermined time periods.

15. The above method further, A non-temporary computer-readable medium according to any one of claims 9 to 14, comprising the step of adjusting the value of the command signal to reduce the speed of the driven component based on a determined value of one or more circulatory parameters relating to blood flow in a patient.

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