Circulatory support devices, systems, and methods

Abstract

A circulatory support system can include a blood pump, one or more sensors, and a controller in communication with the one or more sensors. The blood pump can include a driven component and a motor in communication with the driven component to drive the driven component to pump a blood flow through the blood pump. A sensor of the one or more sensors can be configured to sense a value related to a speed of the motor. The controller can be configured to provide a command signal to the motor to drive the driven component and determine a hemolysis rate during operation of the blood pump based on an operating parameter of the blood pump.

Description

Cross-reference to related applications

[0001] This application claims priority to U.S. Provisional Application No. 63 / 539,242, filed September 19, 2023, the entire disclosure of which is incorporated herein by reference. Technical Field

[0002] This disclosure relates to mechanical circulatory support devices. More specifically, this disclosure relates to the operation of percutaneous ventricular assist devices (PVADs). Background Technology

[0003] A wide variety of in vivo and extracorporeal medical devices and systems have been developed for medical applications, such as use in cardiac surgery and / or for cardiac treatment. Some of these devices and systems include guidewires, catheters, catheter systems, pump devices, cardiac assist devices, etc. These devices and systems are manufactured using any of a variety of different manufacturing methods and can be used according to any of these methods. Each of the known medical devices, systems, and methods has certain advantages and disadvantages. There is a continued need for alternative medical devices and systems, as well as alternative methods for manufacturing and using them. Summary of the Invention

[0004] This disclosure provides alternatives for the design, materials, manufacturing methods, and uses of medical devices, including ventricular assist devices.

[0005] A first example may include a circulatory support system comprising: a blood pump including a driven component and a motor, the motor communicating with the driven component and configured to drive the driven component to pump blood flow through the blood pump; one or more sensors configured to sense a measure related to the speed of the motor; and a controller communicating with the motor and the one or more sensors configured to sense a measure related to the speed of the motor, wherein the controller may be configured to send command signals to the motor and determine the hemolysis rate during operation of the blood pump based on the speed of the motor.

[0006] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to: determine a measure related to the blood flow rate through the blood pump based on the speed of the motor; determine a measure related to the patient's left ventricular pressure based on the speed of the motor; and determine the hemolysis rate based on the measure related to the flow rate through the blood pump and the measure related to the patient's left ventricular pressure.

[0007] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to: receive hemolysis test results for a patient, the hemolysis test results including the time taken to obtain a blood sample from the patient; and determine the hemolysis rate based on the speed of the motor, the hemolysis test results, and the time taken to obtain the blood sample from the patient.

[0008] In another example, replacing or supplementing any of the examples above, the hemolysis test result may include the value of plasma free hemoglobin in the blood sample or the value of lactate dehydrogenase (LDH) in the blood sample.

[0009] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to integrate the hemolysis rate determined during the operation period of the blood pump to determine the amount of hemolysis that has occurred during the operation period.

[0010] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to automatically adjust the command signal based on the hemolysis rate determined during the operation of the blood pump.

[0011] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to automatically adjust the command signal to reduce the blood flow rate through the blood pump based on the hemolysis rate determined during operation of the blood pump.

[0012] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to: determine the amount of hemolysis based on the hemolysis rate determined during operation of the pump; and output a signal indicating that a hemolysis test is recommended when the amount of hemolysis reaches or exceeds a threshold level.

[0013] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to: receive input from a user; determine the expected hemolysis rate during operation of the blood pump based on the received input from the user; and output an indication recommending changes to the blood pump based on the determined expected hemolysis rate being higher than a threshold.

[0014] In a different example, alternative to or in addition to any of the examples above, the controller may be configured to output an indication to the user interface based on the hemolysis rate determined during the operation of the blood pump.

[0015] Further examples may include a non-transitory computer-readable medium storing instructions executable by a circulatory support device for a patient's heart, the instructions causing the circulatory support device to perform methods including: sending a command signal from a controller to a motor of a blood pump to cause the motor of the blood pump to drive a driven component to pump blood from the ventricles of the patient's heart through the blood pump to the patient's vascular system; receiving a measurement related to the speed of the motor from one or more sensors in communication with the controller; and determining the rate of hemolysis during operation of the blood pump based on the speed of the motor.

[0016] In a different example, in addition to or in addition to any of the examples above, determining the hemolysis rate during operation of the blood pump further includes: determining the blood flow rate through the blood pump based on the speed of the motor; determining a measure related to the patient's ventricular pressure based on the speed of the motor; and determining the hemolysis rate based on the flow rate-related measure and the measure related to the patient's ventricular pressure.

[0017] In a different example, in addition to or supplementing any of the examples above, the method may further include receiving hemolysis test results at a specified time when the blood sample being tested is acquired, wherein the hemolysis rate during operation of the blood pump can be determined based on the hemolysis test results and the specified time.

[0018] In a different example, or in addition to any of the examples above, the method may further include integrating the hemolysis rate determined during the operation period of the blood pump to determine the amount of hemolysis during the operation period of the blood pump.

[0019] In a different example, in addition to or supplementing any of the examples above, the method may further include outputting a signal indicating that a hemolysis test is recommended when the amount of hemolysis reaches or exceeds a threshold level.

[0020] In a different example, in addition to or supplementing any of the examples above, the method may further include automatically adjusting the command signal based on the hemolysis rate determined during operation of the blood pump.

[0021] Further examples may include a method of operating a blood circulation support system for a patient's heart, the method comprising: sending a command signal from a controller to a motor of a blood pump to cause the motor of the blood pump to drive a driven component to pump blood from the ventricles of the patient's heart through the blood pump to the patient's vascular system; receiving a measurement related to the speed of the motor from one or more sensors in communication with the controller; and determining the rate of hemolysis during operation of the blood pump based on the speed of the motor.

[0022] In a different example, or in addition to any of the examples above, determining the hemolysis rate during operation of the blood pump may further include: determining the blood flow rate through the blood pump based on the speed of the motor; determining a measure related to the patient's ventricular pressure based on the speed of the motor; and determining the hemolysis rate based on the flow rate-related measure and the measure related to the patient's ventricular pressure.

[0023] In a different example, or in addition to any of the examples above, the method may further include: determining the amount of hemolysis during the operation period of the blood pump based on the hemolysis rate determined during the operation period of the blood pump; and outputting a signal indicating that a hemolysis test is recommended when the amount of hemolysis reaches or exceeds a threshold level.

[0024] In a different example, in addition to or supplementing any of the examples above, the method may further include automatically adjusting the command signal based on the hemolysis rate determined during operation of the blood pump.

[0025] The above overview of some embodiments is not intended to describe every disclosed embodiment or every implementation thereof. The following drawings and detailed description illustrate some of these embodiments in more detail. Attached Figure Description

[0026] This disclosure can be more fully understood by considering the following specific embodiments in conjunction with the accompanying drawings, in which:

[0027] Figure 1 It is a schematic partial cross-section of the anatomical structure and a schematic side view of an illustrative percutaneous ventricular assist device (PVAD) within the anatomical structure;

[0028] Figure 2 This is a schematic cross-sectional view of an illustrative PVAD;

[0029] Figure 3 yes Figure 2 The illustrative PVAD line 3-3 depicts a schematic detailed view.

[0030] Figure 4This is a schematic diagram of an illustrative loop support system;

[0031] Figure 5 It is an illustrative diagram of a computing device or controller and a user interface;

[0032] Figure 6 This is a schematic diagram of an illustrative loop support system;

[0033] Figure 7 This is a schematic diagram of an illustrative loop support system;

[0034] Figure 8 This is a schematic diagram illustrating the controller configuration;

[0035] Figure 9 This is a schematic diagram illustrating the controller configuration;

[0036] Figure 10 This is a schematic diagram illustrating the controller configuration;

[0037] Figure 11 This is a schematic diagram illustrating the controller configuration;

[0038] Figure 12 This is a schematic diagram illustrating the controller configuration;

[0039] Figure 13 This is a schematic diagram illustrating the controller configuration; and

[0040] Figure 14 This is a schematic diagram illustrating the operational loop support system.

[0041] While this disclosure can be modified and alternatively made in various forms, its details have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that this disclosure is not intended to be limited to the specific embodiments described. Rather, it is intended to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of this disclosure. Detailed Implementation

[0042] For terms defined below, those definitions shall apply unless otherwise specified in the claims or elsewhere in this specification.

[0043] All numerical values ​​in this document are assumed to be modified by the word “approximately”, whether explicitly stated or not. The term “approximately” generally refers to a range of numbers that a person skilled in the art would consider equivalent to the listed values ​​(i.e., having the same function or result). In many cases, the term “approximately” may include numbers rounded to the nearest significant figure.

[0044] The range of numbers listed by endpoints includes all numbers in that range (for example, 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, and 5).

[0045] As used in this specification and the appended claims, the singular forms “a” and “the” include plural references unless the context clearly indicates otherwise. As used in this specification and the appended claims, the term “or” is generally used in its sense that it includes “and / or” unless the context clearly indicates otherwise.

[0046] It should be noted that references to "embodiments," "some embodiments," and "other embodiments" in the specification refer to the fact that the described embodiments may include one or more specific features, structures, and / or characteristics. However, such enumeration does not necessarily mean that all embodiments include the specific features, structures, and / or characteristics. Furthermore, when a specific feature, structure, and / or characteristic is described in conjunction with an embodiment, it should be understood that, unless expressly stated to the contrary, such feature, structure, or characteristic may also be used in conjunction with other embodiments, whether or not it is explicitly described.

[0047] The following detailed description should be read with reference to the accompanying drawings, in which similar structures in different drawings are numbered the same. The drawings (not necessarily drawn to scale) depict illustrative embodiments and are not intended to limit the scope of this disclosure. Furthermore, it should be noted that in any given drawing, some features may not be shown or may be shown schematically for clarity and / or simplicity. 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 provide several desired features and benefits as described in more detail below.

[0048] Various circulatory support devices are known to assist or replace the pumping function of the heart in patients with severe heart failure and / or other cardiac conditions. Circulatory support devices can be configured to treat patients with cardiogenic shock, myocardial infarction, acute decompensated heart failure, and / or other heart-related conditions. Additionally or alternatively, circulatory support devices can support patients during percutaneous coronary interventions and / or other procedures.

[0049] Examples of cardiac circulatory assist devices include, but are not limited to, ventricular assist devices (VADs), total artificial hearts, intra-aortic balloon pump (IABP), and extracorporeal membrane oxygenation (ECMO). Example VADs include left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), and biventricular assist devices (BiVADs). A further illustrative VAD is a percutaneous ventricular assist device (PVAD), which can be inserted into the ventricle of the patient's heart (e.g., the left or right ventricle) via delivery through the femoral artery or vein and / or other suitable vascular systems. PVADs can be placed at the desired location on the patient's anatomy via percutaneous access and delivery, enabling their use in emergency medicine, catheterization labs, and / or other surgical and / or non-surgical settings.

[0050] Figure 1 Illustrative positioning of the blood pump 100 (e.g., a percutaneous circulatory support device, such as a PVAD in an LVAD configuration) within the patient's anatomy is depicted. Figure 1 In this configuration, the blood pump 100 is positioned such that its distal end 103 is located in the left ventricle 16 of the heart 18 and its proximal end 107 is located in the aorta 20, such 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 can be configured to pump blood from the left ventricle 16 into the aorta 20 to assist blood circulation. Other suitable locations of the blood pump relative to the anatomical structures are contemplated, and these locations include, but are not limited to, the distal end 103 of the blood pump being positioned in the right ventricle of the heart 18, with the proximal end positioned in the pulmonary artery.

[0051] Figure 2 A schematic cross-sectional view depicting an illustrative configuration of the blood pump 100 is shown. In some cases, the blood pump 100 may be integrated with a guidewire, guide sheath, controller, user interface, one or more sensors, and / or other suitable components to form part of a percutaneous or circulatory support system.

[0052] 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 constructed integrally or in a single unit, but this is not required, and the impeller housing 102 and the motor housing 104 may be separate components configured to be removably 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 integrally constructed with the motor 105.

[0053] Impeller housing 102 may house impeller assembly 106 and driven magnet 124, which may be part of or separate from impeller assembly 106. Impeller assembly 106 may include impeller shaft 108, which is rotatably supported by at least one bearing (e.g., bearing 110 and / or other suitable bearing). Impeller assembly 106 may further include impeller 112, which rotates relative to impeller housing 102 to drive blood through blood pump 100. In some configurations, and as shown, impeller shaft 108 and impeller 112 may be separate components, and in other configurations, impeller shaft 108 and impeller 112 may be integral. Impeller assembly 106 as a whole may be considered a driven component, and / or rotating components of impeller assembly 106 (e.g., impeller shaft 108 and / or impeller 112) may be driven components individually or in combination.

[0054] Impeller 112 may be configured within impeller housing 102 such that, when impeller 112 rotates, blood flows through impeller housing 102 from blood inlet 114 formed on or at impeller housing 102 and out of impeller housing 116 formed on or at impeller housing 102. In some configurations, impeller housing 102 may be coupled to or include a distally extending conduit (not shown), and the conduit may receive blood and deliver blood to inlet 114 (e.g., from left ventricle 16 of heart 18 and / or from other suitable locations).

[0055] Inlet 114 and outlet 116 may each have any suitable number of orifices configured to facilitate the reception of blood at blood pump 100 and the discharge of blood from blood pump 100, respectively. In some examples, inlet 114 and / or outlet 116 may each include multiple orifices, and in other examples, one or both of inlet 114 and outlet 116 may each include a single orifice.

[0056] The inlet and outlet 116 can each be formed at any suitable location along the impeller housing 102 or at other suitable locations along the blood pump 100. In some examples, and as... Figure 2 As depicted, inlet 114 may be formed on an end portion (e.g., a distal portion) of impeller housing 102, and outlet 116 may be formed on a side portion of impeller housing 102 (e.g., near the location of inlet 114). Other suitable positioning configurations of inlet 114 and / or outlet 116 on impeller housing 102 are conceivable.

[0057] The motor housing 104 can accommodate the motor 105 and other suitable components. In some examples, and such as... Figure 2 As depicted, the motor housing 104 can at least accommodate the motor 105, the drive shaft 120, and the drive magnet 122.

[0058] Motor 105 can be any suitable type of motor. In one example, motor 105 can be a brushless DC (BLDC) motor, but other suitable motor types are also conceivable.

[0059] In operation, motor 105 can be configured to rotatably drive impeller 112 relative to impeller housing 102. In some example configurations, motor 105 can rotate drive shaft 120, which is coupled to drive magnet 122. Rotation of drive magnet 122 can cause rotation of driven magnet 124, which is part of or connected to impeller assembly 106 and rotates with impeller assembly. That is, when impeller shaft 108 is included in impeller assembly 106, impeller shaft 108 and impeller 112 are configured to rotate together with driven magnet 124. Additionally or alternatively, motor 105 can be coupled to impeller assembly 106 via other components.

[0060] As discussed in more detail below, the controller ( Figure 2 (Not shown) can be operatively coupled to motor 105 and configured to control motor 105 via one or more command signals sent from the controller to motor 105. The controller may be located within motor housing 104 and / or may be located outside motor housing 104 (e.g., within a blood pump 100 housing separate from motor housing 104, outside the patient's body, etc.). In some embodiments, the controller may include multiple components, one or more of which may be located within motor housing 104 and / or configured to be separate from motor housing 104.

[0061] The motor housing 104 can be connected to the conduit 126 at a position opposite to the impeller housing 102. The conduit 126 can be connected to the motor housing 104 in various ways (such as laser welding, brazing, etc.). The conduit 126 can extend proximally away from the motor housing 104.

[0062] The catheter 126 may include one or more lumens for receiving one or more components of a circulatory support system (including the blood pump 100). In some cases, the catheter 126 may be configured to carry a motor cable 128 (e.g., one or more cables configured to facilitate operation of a motor 105) within the main lumen 130, and the motor cable 128 may operatively connect the motor 105 to a controller (not shown) and / or an external power source (not shown).

[0063] The catheter 126 may carry a sensor assembly 132 for measuring pressure within a patient's vascular system (e.g., within the aorta or pulmonary artery). The sensor assembly 132 may be positioned relative to other components of the blood pump 100 to obtain highly accurate pressure data. For example, a proximal position of the sensor assembly 132 relative to the motor housing 104 and the motor 105 can reduce and / or eliminate sensing inaccuracies related to motor speed or dynamic pressure. Such inaccuracies are typical for other percutaneous circulation support devices employing pressure sensors located more distal to the motor or impeller assembly (e.g., devices employing pressure sensors located near outlet 116).

[0064] Figure 3 Depicting Figure 2 A schematic detailed view of the interior of line 3-3. (See also...) Figure 3 As depicted, sensor assembly 132 may include sensor housing 134 having an internal chamber 136. In some examples, internal chamber 136 may have a countersunk shape, but other suitable shapes and / or configurations of internal chamber 136 are also contemplated. 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 sensor, may be disposed within internal chamber 136 and configured to sense pressure in aorta 20 when blood pump 100 is extended into left ventricle 16 of heart 18. Sensor housing 134 may protect pressure sensor 138 during deployment of blood pump 100. Sensor housing 134 may also include a distally facing orifice 140 of internal chamber 136 or include a distally facing orifice coupled to internal chamber 136. Orifice 140 may allow blood to enter internal chamber 136, and orifice 140 thereby allows pressure sensor 138 to sense blood pressure in the vicinity of internal chamber 136.

[0065] The sensor housing 134 can take various forms. For example, the sensor housing 134 can be a tube or sleeve made of, for example, one or more metals, one or more plastics, composite materials, and / or other suitable materials. The sensor housing 134 can be coupled to the conduit 126 via one or more welds (not shown), one or more adhesives 142, and / or an outer sheath 144 surrounding at least a portion of the sensor housing 134 and the conduit 126. The sensor housing 134 may also include a sensor mount 145 within the internal chamber 136. The sensor mount 145 can facilitate supporting the pressure sensor 138 separately from the wall of the sensor housing 134 (e.g., the sensor mount 145 can center the pressure sensor 138 within the internal chamber 136), which in turn facilitates highly accurate pressure sensing. Other suitable configurations of the sensor housing 134 are also contemplated.

[0066] Sensor assembly 132 may include a sensor cable 147 coupled to pressure sensor 138. Sensor cable 147 operatively couples pressure sensor 138 to a controller (not shown). As shown, sensor cable 147 may extend through sensor mount 145 and support pressure sensor 138, separating it from the wall of sensor housing 134. Sensor cable 147 may extend proximally, through adhesive 142, and through or to a cable lumen 149 of conduit 126. In some examples, cable lumen 149 may be coupled to conduit 126 via one or more solder joints (not shown), adhesive (not shown), and / or outer sheath 144. In other examples, cable lumen 149 may be omitted, and sensor cable 147 may extend through main lumen 130 of conduit 126 or directly beneath outer sheath 144. An example suitable sensor assembly 132 is disclosed in U.S. Patent Application Publication No. 2023 / 0149699 A1, entitled “Percutaneous Circulatory Support Device Including Proximal Pressure Sensor,” filed November 16, 2022, which is hereby incorporated herein by reference in its entirety.

[0067] Figure 4 A schematic diagram of an illustrative circulatory support system 10 is depicted. Among other additional and / or alternative components, the circulatory support system 10 may also include a blood pump 100, a pressure sensor 138, a controller 146, and a user interface 148. As discussed, the blood pump 100 may include a motor 105 communicating with the controller 146 and an impeller 112 communicating with the motor 105.

[0068] 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 sense the speed of the motor 105 and / or a quantity related to the speed of the motor 105. When one or more sensors 150 are included, they may be coupled to the controller 146 via one or more cables extending through and / or along the conduit 126. In some cases, the speed or position of the motor 105 may be sensed directly from the electrical signals used by the controller 146 to drive the motor 105. In such cases, the motor 105 may be an implicit sensor used with explicit sensors 150, or an implicit sensor that eliminates the need for explicit sensors.

[0069] The one or more sensors 150 can be any suitable type of sensor for sensing the speed of the motor 105. Exemplary 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.

[0070] Figure 5 A schematic diagram depicts an illustrative configuration of a controller 146 (e.g., a computing device) and a user interface 148 for a circulatory support system 10. The controller 146 can be and / or may include any suitable computing device configured to process data from the circulatory support system 10 or data for the circulatory support system (e.g., data from or derived from motor 105, pressure sensor 138, sensor 150, patient test results, user input, patient monitors, etc.). In some cases, one or more components of the circulatory support system 10 may be integrated into the controller 146 and / or the user interface 148. Further, one or more components of the circulatory support system 10 may be integrated with one or more computing devices similar to or having components similar to the controller 146 and / or the user interface 148.

[0071] The controller 146 can be configured to facilitate the operation of the cyclic support system 10. In some cases, the controller 146 can be configured to control the operation of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150 by establishing control signals and / or outputting control signals to components of the motor 105, pressure sensor 138, user interface 148, and / or sensor 150 to control and / or monitor the operation of these units and devices.

[0072] Controller 146 can communicate with a remote server or other suitable computing device. When controller 146, or at least a portion thereof, is a component structurally separate from motor 105, pressure sensor 138, user interface 148, and / or sensor 150, controller 146 can communicate with the electronics of the circulation support system 10 via one or more wired or wireless connections or networks (e.g., LAN and / or WAN).

[0073] 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 complex PLDs (CPLDs), one or more custom application-specific integrated circuits (ASICs), one or more special-purpose processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components. Although controller 146 may be referred to herein in the singular, controller 146 may be implemented in multiple instances, distributed across multiple computing devices, instantiated within multiple virtual machines, etc.

[0074] In addition to other suitable components, the illustrative controller 146 may also include one or more processors 152, memory 154, and / or one or more I / O units 156. The controller 146 is not described in... Figure 2 Other suitable components specifically depicted may include, but are not limited to, communication components, touchscreens, selection buttons, housings, and / or other suitable components of the controller. As discussed above, one or more components of the controller 146 may be detachable from and / or integrated into the components of the circulation support system 10.

[0075] Controller 146 may include and / or communicate with a variety of sub-controllers. Examples of sub-controllers that may be included in or communicate with controller 146 may include, but are not limited to, motor sub-controllers, flow rate sub-controllers, pressure sub-controllers, motor torque sub-controllers, motor mechanical loss sub-controllers, stall pressure sub-controllers, pressure loss sub-controllers, and / or other suitable sub-controllers.

[0076] The processor 152 of the controller 146 may include a single processor, or more than one processor that operates independently 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 memories. Examples of components of the processor 152 may include, but are not limited to, a central processing unit, a microprocessor, a microcontroller, a multi-core processor, a graphics processing unit, a digital signal processor, an application-specific integrated circuit (ASIC), an artificial intelligence accelerator, a field-programmable gate array (FPGA), discrete circuitry, and / or other suitable types of data processing devices.

[0077] The memory 154 of controller 146 may include a single memory component, or more than one memory component that operates independently or in conjunction with each other. Example types of memory 154 may include random access memory (RAM), EEPROM, flash memory, suitable volatile storage devices, suitable non-volatile storage devices, persistent memory (e.g., read-only memory (ROM), hard disk drive, flash memory, optical disk drive, and / or other suitable persistent memory), and / or other suitable types of memory. Memory 154 may be or may include non-transitory computer-readable media. Memory 154 may include instructions stored in a transient and / or non-transitory state on a computer-readable medium, which may be executable by processor 152 to cause the processor to implement one or more of the methods and / or techniques described herein.

[0078] The I / O unit 156 of the controller 146 may include a single I / O component, or more than one I / O component that operates independently or in conjunction with each other. Example I / O unit 156 may be or may include any suitable type of communication hardware and / or software, including but not limited to communication ports configured to communicate with the electronics of the loop support system 10 and / or with other suitable computing devices or systems. Example types of I / O unit 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, Bluetooth Low Energy 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.

[0079] User interface 148 may be configured to communicate with controller 146 via one or more wired or wireless connections. In some cases, user interface 148 may be configured to receive sensed and / or calculated or determined data from controller 146. 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 features.

[0080] Display device 158 can be any suitable display. Exemplary suitable displays include, but are not limited to, touch screen displays, non-touch screen 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.

[0081] Input device 160 may be and / or may include any suitable components and / or features for receiving user input via a user interface. Example input device 160 includes, but is not limited to, touchscreen, keypad, mouse, touchpad, microphone, selection button, selection knob, optical input device, camera, gesture sensor, eye tracker, voice recognition control (e.g., a microphone coupled to an appropriate natural language processing component), and / or other suitable input devices.

[0082] Output device 162 may be and / or may include any suitable components and / or features for providing information and / or data to a user and / or other computing components. Example output devices 162 include, but are not limited to, displays, speakers, vibration systems, haptic feedback systems, optical outputs, cables, lamps, and / or other suitable output devices.

[0083] Mechanical circulatory support (MCS) devices, such as PVADs, can provide temporary support for up to several weeks in patients with impaired cardiac function and / or cardiac output. However, due to the nature of the interaction between the MCS device and the blood passing through it, operation of such an MCS device can result in some amount of hemolysis. Hemolysis is the rupture of red blood cells and the release of their contents into the surrounding fluid.

[0084] Hemolysis is a problem with MCS devices on the market because the incidence of adverse reactions to hemolysis is high. Exemplary adverse reactions caused by hemolysis in patients include, but are not limited to, thrombosis, fatigue, dizziness, pallor, palpitations (tachycardia), tachypnea, jaundice, scleral icterus, splenomegaly, and / or other adverse reactions.

[0085] The amount of hemolysis is proportional to the level of support provided by the MCS device (e.g., flow rate can be proportional to hemolysis). Therefore, physicians can reduce blood flow support from the MCS device to decrease hemolysis caused by the MCS device. However, the management of hemolysis caused by the operation of the MCS device can be difficult and may not begin until the hemolytic problem or adverse reaction is identified. The concepts discussed in this article improve the operation of the MCS device and its application to patients by providing active control techniques for operating the MCS device to address the possibility of hemolysis caused by the operation of the MCS device before adverse reactions occur and to mitigate hemolysis caused by the operation of the MCS device and / or adverse reactions resulting from hemolysis.

[0086] Various operating parameters of, through, or near the blood pump 100 (e.g., motor speed, pressure, flow rate, etc.) can be operation-related and / or clinically relevant performance parameters used to control the operation of the blood pump 100 to address hemolysis. For example, users (e.g., clinicians, internists, etc.) may be interested in obtaining data such as: circulatory parameter data, ventricular pressure data, vascular system pressure data (e.g., aortic pressure data, pulmonary artery pressure data, etc.), differential pressure data across the blood pump 100 (e.g., differential pressure data between the ventricle and the aorta, etc.), flow rate data related to blood flowing through the blood pump 100, hemolysis test results data, and / or other data related to the operation of the blood pump 100 to make operational decisions to address hemolysis associated with the operation of the blood pump 100. Furthermore, data relating to and / or for the pressure and flow rate of the blood flowing through the blood pump 100, other blood pump data relating to the operation of the blood pump 100, and / or calculations based on data relating to the blood flowing through the blood pump 100 can be used by the controller 146 to automatically and / or in response to user input to control the operation of the blood pump 100 (e.g., adjust command signals, etc.) to resolve hemolysis problems.

[0087] Figure 6 A schematic diagram of the control system of the cyclic support system 10 is depicted. (For example...) Figure 6 As depicted, controller 146 can communicate with motor 105 of blood pump 100 via converter plate 164 to drive or otherwise rotate impeller shaft 108 and impeller 112. Converter plate 164 and / or components thereof may be incorporated into controller 146, may be incorporated into motor 105, and / or may be components separate from one or both of controller 146 and motor 105. In some examples, converter plate 164 may be omitted.

[0088] In operation, the conversion block 166 of the conversion board 164 can be configured to receive a command signal 168 and the output of a sensor 150, which senses the speed of the motor 105 and / or a speed-related measure. The conversion block 166 can use the output of the sensor 150 to synchronize the command signal 168 with the operation of the motor 105, and provide a control signal 170 to the motor 105 based on the command signal 168 and the output of the sensor 150.

[0089] Furthermore, the high-pass filter (HPF) 172 of the conversion board 164 can be configured to receive the output of the sensor 150. The HPF 172 can be configured to differentiate the position signal and filter noise in the resulting velocity signal from the sensor 150, providing the filtered signal as output to the controller 146. In some examples, the HPF 172 can be omitted; if a velocity sensor is used, an LPF (low-pass filter) can be used instead, and / or other suitable filters can be utilized.

[0090] Controller 146 may be and / or may include any suitable type of controller. For example, controller 146 may be and / or may include one or more proportional controllers, proportional-integral (PI) controllers, proportional-integral-derivative (PID) controllers, lead-lag controllers, nonlinear table controllers, linear table controllers, and / or other suitable types of controllers. In some examples, controller 146 may be or may include one or more PI controllers having a proportional component 174 and an integral component 176, such as... Figure 6 As depicted, but not required. Furthermore, although not required, controller 146 may include multiple control loops and / or may be configured to regulate intermediate states.

[0091] In operation, controller 146 can be configured to receive the value of reference parameter 178, which is input from user interface 148 or automatically generated by controller 146, and send it to motor sub-controller 180. Motor sub-controller 180 may include a proportional component 174 and an integral component 176 of a PI controller, which are configured to: process the value of reference parameter 178, values ​​related to the value of reference parameter 178, and / or other suitable data; and output a command signal 168.

[0092] The value of reference parameter 178 can be any suitable type of input from a user, a component communicating with controller 146, or a system. In some cases, the value of reference parameter 178 can be a setpoint provided by the user via user interface 148, hemolysis test results, etc., but this is not required. The value of reference parameter 178 can be a setpoint related to any parameter concerning the operation of blood pump 100, including but not limited to motor speed, blood flow rate across blood pump 100, pressure in the ventricles of heart 18 (e.g., left ventricular pressure and / or right ventricular pressure), differential pressure across blood pump 100 (e.g., the pressure difference between the pressure in the ventricles and the pressure in the aorta), and / or other suitable values. In some examples, the value of reference parameter 178 can be the speed of motor 105, but this is not required.

[0093] When the value of reference parameter 178 is the setpoint for the speed of motor 105, the value of reference parameter 178 can be configured to be added at adder 182 (e.g., a summing unit) to the output from sensor 150 (e.g., which may or may not pass through HPF 172) and / or the output of hemolysis analyzer 181. When the value of reference parameter 178 is not the setpoint for the speed of motor 105, the value of a parameter obtained based on the value of reference parameter 178 (e.g., the speed determined based on the value of reference parameter 178) can be added at adder 182 to the outputs of sensor 150 and / or hemolysis analyzer 181. Alternatively or additionally, when the value of reference parameter 178 is not the setpoint for the speed of motor 105, the value of reference parameter 178 can be added to the value of a parameter obtained based on the output of sensor 150 (e.g., pressure, flow rate, etc.) and / or the output of hemolysis analyzer 181. In some examples, the difference between these values ​​can be identified at adder 182 and / or other adders discussed herein, and this difference can be indicated by a "-" sign near the adder.

[0094] Although the PI controller is Figure 6 The controller type described is between adder 182 and adder 183, but additional and / or alternative controller types may also be used. When the motor sub-controller 180 includes a proportional component 174 and an integral component 176 of controller 146, the output of adder 182 can be processed using the proportional component 174 and the integral component 176. The outputs of the proportional component 174 and the integral component 176 can be added together at adder 183, which can output a command signal 168. The command signal 168 can be generated by adding the values ​​received at adder 183, but this is not necessary. Other suitable configurations of the motor sub-controller 180 are also conceivable.

[0095] The controller 146 may use outputs and / or signals (e.g., command signal 168, sensed motor speed, sensed aortic pressure, etc.) from the control and / or operation of the blood pump 100, including the motor 105 and impeller 112, to determine or calculate one or more parameters. Additionally or alternatively, the controller 146 may use outputs from the blood pump 100 or the circulatory support system 10, or from one or more other sensors in communication with the blood pump or circulatory support system, to determine or calculate the one or more parameters, wherein the outputs from the one or more sensors may include, but are not limited to, the output from the pressure sensor 138, which is configured to sense pressure in the patient's vascular system (e.g., the aorta 20, pulmonary artery, etc.).

[0096] The parameters determined or calculated by controller 146 may include one or more values ​​of parameters related to the blood flow pumped through blood pump 100. In some examples, controller 146 may be configured to: determine or calculate one or more values ​​of blood flow velocity across blood pump 100; one or more values ​​of one or more pressures near blood pump 100 (e.g., left ventricular pressure, right ventricular pressure, differential pressure across blood pump 100, etc.); one or more measures of hemolysis caused by operation of blood pump 100 or one or more measures related to hemolysis; and / or other suitable values ​​of parameters related to the blood flow pumped through blood pump 100.

[0097] To facilitate the determination or calculation of one or more values ​​of parameters related to the blood flow pumped through blood pump 100 and / or otherwise related to the operation of blood pump 100, controller 146 may include a status observer 177. Status observer 177 may be configured to receive outputs and / or signals (e.g., command signal 168, sensed motor speed, sensed pressure, sensed flow rate, etc.) from controller 146 and / or from the operation of motor 105 and impeller 112. In some examples and as... Figure 6 As depicted, the state observer 177 can be configured to receive command signal 168 and sensed motor speed from motor speed sensor 150. Other configurations are also conceivable, and additional or alternative inputs can be received at the state observer 177.

[0098] The status observer 177 can be configured to monitor inputs received at the status observer and determine or calculate values ​​of one or more parameters related to the operation of the blood pump 100 based on the inputs. For example, the status observer 177 can be configured to use the values ​​of the received parameters (e.g., the value of command signal 168, the value related to the speed of motor 105, and / or other suitable values) to calculate or determine the blood flow velocity through the blood pump 100, the pressure provided by the blood pump 100, ventricular pressure, differential pressure across the blood pump 100, arterial pressure (e.g., mean arterial pressure (MAP)), stall pressure of motor 105, theoretical head pressure of the blood pump 100, pressure loss across the blood pump 100, motor mechanical losses, motor torque, and / or other parameters related to the operation of the blood pump 100.

[0099] Once the values ​​of the parameters have been calculated or determined at the state observer 177 and / or other locations on the controller 146, some or all of these values ​​can be provided to the storage unit 179 and / or the hemolysis analyzer 181. The storage unit 179 may be and / or may include the memory 154 and / or other suitable memory. Although the storage unit 179 is depicted as part of the controller 146, it may be physically separate from other parts of the controller 146, but this is not required.

[0100] Storage component 179 can be configured in any suitable manner. In some examples, storage component 179 may be or may include a sample-by-sample storage system, wherein each received value is stored individually in memory. Additionally or alternatively, in some examples, storage component 179 may be or may include a filter (e.g., a low-pass filter, a high-pass filter with a long time constant, etc.) configured to allow sufficient values ​​of the calculated or determined parameters to be collected for analysis of those values ​​and detection of hemolysis trends. In some cases, storage component 179 may be configured to store received values ​​from or received from command signal 168, motor sensor 150 (e.g., optionally via HPF 172), status observer 177, hemolysis analyzer 181, and / or values ​​of other parameters sensed or determined within system 10 (e.g., the value of motor speed 179d and the value of voltage in command signal 179e, such as...). Figure 7 (as depicted) and / or other suitable parameter values), but this is not required. Furthermore, the storage unit 179 can output data to the correlator unit 185, the hemolysis analyzer 181, the user interface 148, the motor sub-controller 180, and / or other suitable components of the system 10.

[0101] The controller 146 includes a hemolysis analyzer 181 (which can communicate with the motor sub-controller 180 and / or the user interface 148, such as...). Figure 6 The described hemolysis analyzer 181 can be configured to analyze data from the status observer 177, data stored in the storage unit 179, and / or other suitable data. In some examples, the hemolysis analyzer 181 can be configured to receive information and / or data from one or more sensors, motor sub-controller 180, user interface 148, status observer 177, storage unit 179, correlator 185, and / or other suitable sources. Exemplary information and / or data received at the hemolysis analyzer 181 may include, but is not limited to, motor speed (e.g., from sensor 150), vascular system pressure (e.g., from pressure sensor 138), command signal 168, value of reference parameter 178, hemolysis test result data (e.g., via user interface 148), time of acquiring blood samples associated with the hemolysis test result data, and / or other suitable information and / or data.

[0102] The hemolysis analyzer 181 can be configured to output information and / or data to the motor sub-controller 180, user interface 148, storage unit 179, and / or other components of system 10 or other components communicating with the system. In some examples, the hemolysis analyzer 181 can be configured to output the hemolysis rate, the total amount of hemolysis over a time period, the hemolysis trend, hemolysis alarms or warnings relative to a threshold, hemolysis test recommendations, control signals (e.g., setpoints, etc.), hemolysis-related pump recommendations, and / or other suitable information, data, and / or control signals. In some cases, the hemolysis analyzer 181 can be configured to determine the hemolysis rate during operation of the blood pump 100 based on the speed of the motor 105 and / or the voltage value from the command signal 168, but this is not required.

[0103] The hemolysis analyzer 181 can utilize any suitable statistical analysis (e.g., linear analysis and / or other suitable statistical analysis) to determine or predict the hemolysis rate and / or hemolysis amount based on data from the state observer 177 and / or other data. In some examples, the hemolysis analyzer 181 can be configured to process the received data into output using lookup tables (e.g., multidimensional lookup tables and / or other suitable types of lookup tables), feedback loops, models, algorithms, and / or via other suitable techniques.

[0104] The correlator component 185 of controller 146 can be configured to receive hemolysis measurement or test data via manual input through a user interface and / or communication with the system performing the hemolysis test. In some examples, the hemolysis measurement or test data may include, but is not limited to, hemolysis blood test results, the time of obtaining a blood sample from a patient for the hemolysis blood test, and / or other suitable hemolysis measurement data. In operation, the correlator component 185 can utilize the hemolysis measurement data received from the time the blood sample was obtained for the hemolysis blood test (when the result of the test was received) (e.g., directly or via storage component 179) and data from a status observer, and determine a new and / or updated set of coefficients (e.g., lookup table coefficients, polynomial coefficients, etc.) for the hemolysis analyzer 181 to determine the hemolysis rate and / or hemolysis amount based on the output of the status observer 177. The new and / or updated set of coefficients can be output to the hemolysis analyzer 181, and / or other components of controller 146 or other components communicating with the controller.

[0105] Figure 7 This is a schematic diagram of a system 10 with additional structures including a state observer 177, a storage unit 179, a hemolysis analyzer 181, and a correlator 185. Although the state observer 177, storage unit 179, hemolysis analyzer 181, and correlator 185 are... Figure 7The component is depicted as part of controller 146, but one or more functions of state observer 177, storage component 179, hemolysis analyzer 181, and correlator 185 may be associated with it. Figure 7 One or more of the state observer 177, storage unit 179, hemolysis analyzer 181, and correlator 185 depicted are separately incorporated into the controller 146. In this way, one or more components of the state observer 177, storage unit 179, hemolysis analyzer 181, and correlator 185, and / or the state observer 177, storage unit 179, hemolysis analyzer 181, and correlator 185, can be omitted, and the controller 146 can continue to perform the functions of the state observer 177, storage unit 179, hemolysis analyzer 181, and correlator 185 and / or their components. Additionally or alternatively, one or more of the components of the status observer 177, storage unit 179, hemolysis analyzer 181 and correlator 185, and / or one or more of the components of the status observer 177, storage unit 179, hemolysis analyzer 181 and correlator 185, or one or more portions thereof, may be separate from the controller 146 (e.g., on the same or different computing devices) and communicate with the controller 146 (e.g., via a high-speed and / or reliable communication platform, which may include wired and / or wireless connections).

[0106] like Figure 7 As depicted, the status observer 177 may include: a flow rate observer 184 (e.g., a sub-controller or other suitable observer) configured to calculate or determine one or more values ​​of blood flow rate across the blood pump 100; and a pressure observer 186 (e.g., a sub-controller or other suitable observer) configured to calculate or determine one or more values ​​of left ventricular pressure and / or other suitable pressure values. Flow rate data from the flow rate observer 184, pressure data from the pressure observer 186, and / or calculations based on the flow rate and / or pressure data may be used to control the operation of the blood pump 100 and / or for other suitable purposes other than for the hemolysis analyzer 181. The status observer 177 may include other suitable observers of the controller 146 or other suitable observers in communication with the controller to calculate or determine values ​​of parameters related to the operation of the blood pump 100.

[0107] The flow rate observer 184 can be configured to calculate or determine the blood flow rate across the blood pump 100, entirely or at least partially, based on the value of the command signal 168 or values ​​in that command signal, the sensed motor speed, and / or other data or information regarding the operation of the blood pump 100. Alternatively or additionally, the flow rate can be sensed directly and filtered or calibrated as needed. The calculated or determined flow rate can then be stored in the flow rate partition 179a of the storage unit 179.

[0108] Pressure observer 186 may be configured to receive flow rate data and / or determine the blood flow rate through blood pump 100. In some examples, one or more pressure sensors may be part of or communicate with system 10 and transmit sensed values ​​to controller 146 and pressure observer 186, wherein pressure sensors may be configured to sense or be associated with the following: pressure in the left ventricle, differential pressure across blood pump 100 (e.g., differential pressure between left ventricle 16 and aorta 20), pressure in the vascular system (e.g., sensing a measure associated with pressure in aorta 20 via pressure sensor 138), and / or other suitable pressures associated with the operation of blood pump 100. Additionally or alternatively, in some examples, pressure observer 186 may be configured to determine or calculate intraventricular pressure, differential pressure across blood pump 100, pressure in the vascular system, and / or appropriate pressure related to the operation of blood pump 100 based on data and / or signals received from or in communication with one or more components of system 10, including but not limited to the value of command signal 168 or a value in that command signal, sensed motor speed, values ​​from pressure sensor 138, and / or other data or information regarding the operation of blood pump 100. The calculated or determined pressure may then be stored in pressure partition 179b of storage component 179.

[0109] The flow rate and / or pressure at or near the blood pump 100 can be calculated and / or determined in any suitable manner. In some examples, the flow rate and / or pressure at or near the blood pump 100 can be based on Bernoulli's principle:

[0110]

[0111] in Let g be the fluid density, g be the acceleration of the fluid due to gravity, P be the pressure at a point in the fluid, v be the velocity of the fluid at that point, h be the height at that point, and C be a constant based on the physical properties of the working fluid.

[0112] The flow rate and / or pressure at or near the blood pump can be calculated using Newton's force balance equations; specifically:

[0113]

[0114] Where F is the force applied by the motor, m is the mass of the moving fluid, and a is the acceleration applied to the working fluid. In some examples, the flow rate can be calculated or determined based on the following function:

[0115]

[0116] in, For motor torque, For motor mechanical losses, The value of the command signal (e.g., the voltage or level sent to motor 105), and This refers to the sensed motor speed. As discussed in this article, regarding... Figures 8 to 10 A more detailed illustrative configuration for calculating or determining the blood flow rate across the blood pump 100 is described. In some examples, pressure (e.g., distal or left ventricular pressure) can be calculated or determined based on the following functions:

[0117]

[0118] in, For pressure loss, For stall pressure, and The pressure sensed (e.g., via pressure sensor 138). As discussed herein, regarding Figures 9 to 13 The illustrative configuration for calculating or determining left ventricular pressure is described in more detail.

[0119] The hemolysis analyzer 181 can be configured to calculate or determine the hemolysis rate and / or hemolysis volume using one or more calculated or determined values ​​of flow rate and pressure (e.g., one or more values, two or more values ​​over time, etc.) and / or other suitable data. Figure 7 The hemolysis analyzer 181 depicted may include a hemolysis rate component 195 and a hemolysis volume component 197, as well as other suitable components. Although the hemolysis rate component 195 and the hemolysis volume component 197 are... Figure 7 These components are depicted as part of the hemolysis analyzer 181, but one or more of these components may be separate from the hemolysis analyzer 181.

[0120] The hemolysis rate component 195 and / or hemolysis volume component 197 can determine the hemolysis rate and / or hemolysis volume using one or more lookup tables (e.g., multidimensional lookup tables, algorithms, etc.) that include coefficients that can be updated over time. The calculated or determined hemolysis rate and / or hemolysis volume can then be stored in the hemolysis partition 179c of the storage component 179, provided to the user interface 148 for display and / or analysis, and / or provided to the motor sub-controller 180 for controlling the operation of the blood pump.

[0121] The hemolysis rate component 195 can be configured to calculate or determine the current hemolysis rate due to the operation of the blood pump 100 in the patient's body, provide trend analysis of the hemolysis rate over time, provide results comparing the hemolysis rate to a threshold, make determinations based on the hemolysis rate, and / or make other hemolysis-related determinations. The hemolysis rate can be or can indicate the number of ruptured red blood cells per unit time (e.g., one second, one minute, one hour, etc.) or per revolution of the impeller 112.

[0122] The hemolysis rate component 195 can be configured to use a hemolysis rate algorithm, lookup table, or function to determine the current hemolysis rate due to the operation of the blood pump 100. In some examples, the hemolysis rate algorithm, lookup table, or function can be configured to determine the hemolysis rate based on one or more factors, including but not limited to: the results of a hemolysis test on a patient's blood sample (e.g., the amount of hemolysis in the blood sample and the time when the blood sample was obtained from the patient). The value derived from command signal 168 (e.g., voltage value). Motor speed 105 The vascular system pressure sensed by pressure sensor 138 ventricular pressure ; Differential pressure across the blood pump 100, The blood flow rate through the blood pump, And / or other suitable factors. In some examples, the hemolysis rate can be determined based on the following algorithm: (4)

[0123] In one example, the hemolysis rate can be calculated based on a determined or calculated measure related to the flow rate across the blood pump 100 (e.g., the value of the flow rate) and a determined or calculated measure related to the left ventricular pressure (e.g., the value of the left ventricular pressure), wherein the measure related to the flow rate across the blood pump 100 and the measure related to the left ventricular pressure can be determined or calculated based on a measure related to the motor speed (e.g., command signal 168, sensed motor speed, etc.) and / or other suitable parameters.

[0124] The hemolysis volume component 197 can be configured to calculate the hemolysis volume over a specified time period based on a determined hemolysis rate. In some examples, the hemolysis volume component 197 can be configured to integrate the hemolysis rate over the specified time period to obtain the total hemolysis volume over the specified time period. The specified time period may include, but is not limited to, a time period set by the user via a user interface, the total time period during which the blood pump has operated, and / or other suitable time periods. In one example, the hemolysis volume component 197 can be configured to integrate the hemolysis rate over at least the instantaneous fluid flow rate through the blood pump 100 and the ventricular pressure over the total time the pump operates, but this is not required. Further, when the hemolysis analyzer 181 receives the hemolysis test results for a blood sample acquired before the current time, the hemolysis volume component 197 can be configured to update the hemolysis volume since the time the sample was acquired, taking into account the incorporation of the hemolysis test results into the hemolysis rate algorithm.

[0125] Although not strictly necessary, the hemolysis analyzer 181 of controller 146 can be configured to analyze the determined or calculated hemolysis rate and / or hemolysis volume and provide output to the user interface 148, motor sub-controller 180, correlator 185, and / or components of system 10 or components communicating with the system. In some cases, the hemolysis analyzer 181 can compare the determined or calculated hemolysis rate, hemolysis volume, and / or values ​​based on the hemolysis rate and / or hemolysis volume (e.g., average, rolling average, median, etc.) with one or more thresholds and provide output based on the comparison. These thresholds can be preset and / or adjustable by a physician or clinician based on patient needs, response to the use of blood pump 100, and / or other factors. The output obtained based on the comparison can be sent to motor sub-controller 180, user interface 148, one or more remote patient monitoring systems, and / or other components communicating with controller 146 of system 10.

[0126] The hemolysis analyzer 181 can be configured to compare a determined or calculated hemolysis rate, hemolysis volume, and / or values ​​based on the hemolysis rate and / or hemolysis volume (e.g., average, rolling average, median, etc.) with one or more warning thresholds and output signals to the user interface 148 based on the comparison. These signals can trigger the user interface to provide one or more alarms based on the signals received from the hemolysis analyzer 181. In some examples, the warning thresholds may include one or more thresholds at which a physician or clinician might want to take action or at least understand the level of the hemolysis rate and / or hemolysis volume. In some cases, there may be two additional warning thresholds of progressively increasing severity, which can be indicated at the user interface 148 using increasingly prominent warning signals (e.g., lights, sounds, tactile feedback, etc.) associated with these progressively increasing severity thresholds, but this is not required.

[0127] The hemolysis analyzer 181 can be configured to compare a calculated or determined hemolysis rate and / or hemolysis volume with a hemolysis test threshold, at which the analyzer 181 can output a signal to a user interface 148 and / or other components in communication with the controller 146, indicating that a hemolysis test is recommended to determine the actual hemolysis in the vicinity of the blood pump 100. In one example, when the hemolysis volume during pump operation has reached or exceeded the hemolysis test threshold, the analyzer 181 can output a signal indicating that a hemolysis test is recommended. Utilizing the hemolysis test threshold can facilitate obtaining the actual hemolysis count and taking necessary actions to avoid adverse hemolysis reactions before identifying or observing any adverse reactions in the patient.

[0128] The hemolysis test threshold can be a threshold among the warning thresholds or a threshold associated with these warning thresholds. In some examples, the hemolysis test threshold can be the middle threshold of the three warning thresholds, but this is not required, and the hemolysis test threshold can be a different threshold from the warning thresholds.

[0129] The hemolysis test threshold and / or other thresholds used by the hemolysis analyzer 181 can be dynamic. In some examples, the hemolysis test threshold can change automatically over time, such that the hemolysis test threshold may be higher closer to the last sample collection time associated with the hemolysis test result and lower further away from the last sample collection time associated with the hemolysis test result.

[0130] The hemolysis analyzer 181 can be configured to compare the calculated or determined hemolysis rate and / or hemolysis volume with one or more blood pump upgrade thresholds. The blood pump upgrade thresholds may be thresholds within or associated with warning thresholds, but this is not required. Other dynamic thresholds are also conceivable.

[0131] Comparing the calculated or determined hemolysis rate and / or hemolysis volume with a device upgrade threshold can cause the hemolysis analyzer 181 to output the following indication: It is recommended to use a blood pump 100 with different characteristics (e.g., impeller size, flow rate capability, etc.) for the patient to reduce hemolysis when the blood pump 100 pumps the patient's blood. For example, a physician may increase the speed of the motor 105 of the blood pump 100 to increase the flow rate across the blood pump 100; however, doing so may increase the calculated or determined hemolysis rate or expected hemolysis volume, moving it forward above the threshold of the implanted blood pump 100. This could cause the hemolysis analyzer 181 to recommend positioning a more powerful blood pump 100 in the patient's body that can pump at a higher rate without causing too much hemolysis (e.g., a larger diameter impeller 112 is configured to pump more blood at a lower rotation rate, etc.).

[0132] Hemolysis analyzer 181 can be configured to compare a calculated or determined hemolysis rate and / or hemolysis amount with one or more control thresholds. The control thresholds can be thresholds in or associated with warning thresholds, such that when a warning threshold with an associated control threshold is reached or exceeded, hemolysis analyzer 181 can output a signal to motor sub-controller 180 (e.g., adder 182) to adjust the operation of motor 105 (e.g., increase or decrease rotation), but this is not required. In some examples, controller 146 can automatically adjust command signal 168 based on the calculated or determined hemolysis rate and / or hemolysis amount during operation of blood pump 100. When the hemolysis rate and / or hemolysis amount is higher than a threshold, controller 146 can automatically adjust command signal 168 to reduce the blood flow rate through blood pump 100.

[0133] Comparing the calculated or determined hemolysis rate and / or hemolysis amount with control thresholds allows for automatic control of the motor 105 of the blood pump 100 to mitigate the possibility of adverse reactions due to hemolysis caused by the blood pump. In some cases, when the calculated or determined hemolysis rate and / or hemolysis amount reaches or exceeds each of one or more control thresholds, the hemolysis analyzer 181 may output a signal to the motor sub-controller 180 and / or the user interface 148, which adjusts the value of the reference parameter 178 such that the motor 105 and impeller 112 are adjusted to achieve a desired hemolysis rate and / or hemolysis amount over time or per unit time.

[0134] The hemolysis analyzer 181 can be configured (e.g., via communication with a user interface 148) to receive a value of a reference parameter 178 or a value associated with the reference parameter 178 (e.g., motor speed or a value associated with motor speed) input at the user interface 148. The hemolysis analyzer 181 can use the received value of the reference parameter 178 to determine or calculate the expected hemolysis rate or expected hemolysis amount over a time period and compare the expected hemolysis rate or expected hemolysis amount with one or more of the thresholds discussed herein or otherwise. In one example, the expected hemolysis rate or expected hemolysis amount determined or calculated based on the value of the reference parameter 178 can be compared with a device upgrade threshold, and if the determined or calculated expected hemolysis rate or expected hemolysis amount reaches or exceeds the device upgrade threshold, the hemolysis analyzer 181 can output an indication recommending a blood pump change.

[0135] The correlator 185 can be configured (e.g., manually or automatically from the testing system) to populate hemolysis test result data and / or to analyze hemolysis test result data, wherein the hemolysis test result data can provide a measure of the amount of hemolysis occurring in the patient near the blood pump 100. The hemolysis test result data can be stored in the hemolysis test result component 199, and the time of obtaining the blood sample used in the hemolysis test from the patient can be stored in the test blood collection time component 201, but this data can also be stored at other suitable locations. Hemolysis-related test results can be manually entered by the user via the user interface 148 and / or automatically fed to the controller 146 from one or more test components and / or databases communicating with the controller 146.

[0136] The hemolysis rate can be calculated in any suitable manner using the hemolysis test results of a specific patient. While the hemolysis rate algorithm can be population-specific, it can also be tuned, calibrated, or made patient-specific using correlator 185, the results of one or more hemolysis tests on blood samples from one or more patients acquired over time (e.g., measurements of hemolysis in the blood samples and the time of sample acquisition), patient medication information, information from the IV pump, and / or information from the user and / or one or more other suitable devices or systems communicating with the user interface 148, controller 146, and / or other components of system 10. In some examples, hemolysis test result data, state observer data acquired or calculated at or before and after acquiring the test blood sample from the patient, and / or other suitable data can be used as variable parameters, allowing the variables of the hemolysis rate algorithm to change as the hemolysis test results are received at controller 146. Additionally or alternatively, correlator 185 may be configured to use time-organized hemolysis test result data, state observer data obtained or calculated at or before and after obtaining test blood samples from the patient, and / or other suitable data to determine and / or update the coefficients of the lookup table and / or algorithm used by hemolysis analyzer 181 to calculate or determine (e.g., within a specified time period) the hemolysis rate and / or hemolysis volume. In some examples, hemolysis test results may be used to calculate one or more variables used in the hemolysis rate algorithm (e.g., one or more of the following: values ​​from command signal 168 (e.g., voltage values)). Motor speed 105 The vascular system pressure sensed by pressure sensor 138 ventricular pressure ; Differential pressure across the blood pump 100, The blood flow rate through the blood pump, The coefficients of (and / or other suitable variables) can be provided to the hemolysis analyzer 181 and / or storage unit 179 once determined.

[0137] The level of hemolysis measured at a given time can be determined using any suitable test, where a suitable test can check whether the red blood cell count is low. Exemplary suitable tests that produce a value for the measured level of hemolysis or are used to determine the measured level of hemolysis include, but are not limited to, serum free hemoglobin tests, complete blood cell count (CBC) tests, reticulocyte count tests, peripheral blood smear tests, lactate dehydrogenase (LDH) tests, measurements of plasma free hemoglobin in blood samples, haptoglobin tests, direct antiglobulin tests, urinalysis tests, and / or other suitable tests.

[0138] The hemolysis test results can be used to treat the patient and / or control the operation of the blood pump 100. For example, the hemolysis test results can be used for hemolysis trend analysis to determine the control operations used to operate the blood pump 100; to update the coefficients of the algorithm or lookup table used to calculate or determine the hemolysis rate based on the blood flow rate through the blood pump 100 and / or the pressure near the blood pump 100; and so on. In one example, the measured hemolysis value identified during the hemolysis test and the time of sample acquisition from the patient for testing can be entered into a database at correlator 185 and used to develop, calibrate, and / or update the algorithm used to determine or calculate the hemolysis rate. Using both the measured hemolysis value and the time of sample acquisition from the patient to develop, calibrate, and / or update the algorithm used to determine or calculate the hemolysis rate allows for a more accurate determination or calculation of hemolysis at the current time relative to when the algorithm has not received updated hemolysis test results over time, because the patient's hemolysis may change over time, and this change is not necessarily linearly proportional to the speed of the motor 105 or the time since the last test.

[0139] Figures 8 to 13 A schematic diagram illustrating a controller configuration used to calculate or determine parameter values ​​is provided. September 25, 2023 The U.S. patent application filed under the title "Cyclic Support Devices, Systems, and Methods" 63 / 540,346 The U.S. Patent Application describes exemplary suitable techniques for calculating or determining the value of a parameter, which are hereby incorporated herein by reference in their entirety for any and all purposes.

[0140] Flow rate observer 184 and pressure observer 186 can utilize command signal 168 output from motor sub-controller 180 as parameter values ​​representing the operation of motor 105. In some cases, command signal 168 may include a voltage level or value or voltage signal configured to achieve a desired motor rotation or speed. Parameter values ​​can be determined using the voltage level or value in command signal 168, rather than using sensed current at motor 105, and may be more advantageous than using such sensed current at motor 105 to determine parameter values ​​related to the operation of blood pump 100. For example, using command signal 168 can allow for faster flow rate and / or pressure determination or calculation time compared to using sensed current values ​​at motor 105 to determine parameter values, because it does not require waiting for the motor to implement command signal 168 and for the sensors to sense the current used by motor 105 in response to the implemented command signal 168. Using command signal 168 as input to determine parameter values ​​allows for determination based on how motor 105 will operate, rather than how motor 105 has operated in the past. How it will operate is identified using sensed current or voltage at motor 105, because it takes time to move the sensed current or voltage value to controller 146, which may include passing the sensed current or voltage value through one or more filters (e.g., HPF 172 and / or other suitable filters). Furthermore, using the voltage level or value of command signal 168 reduces the amount of noise when determining parameter values ​​compared to using sensed current and / or voltage values ​​at motor 105, thus reducing the complexity of determining or calculating flow rate and / or pressure.

[0141] Figure 8 A diagram schematically depicting the illustrative operation of a flow rate observer 184 configured to determine or calculate the flow rate of blood flowing across blood pump 100 is provided. The flow rate observer 184 may be configured to receive values ​​from command signal 168 (e.g., voltage level or value and / or other suitable values) and sensed motor speed 187 or related values. Based on the received signals or values, the flow rate observer 184 may determine or calculate the motor torque output 188 of motor 105 and the mechanical losses 190 of motor 105 (e.g., the amount of torque or energy required to rotate motor 105).

[0142] The motor torque output 188 and mechanical losses 190 can be determined in any suitable manner. Regarding... Figure 9 An illustrative configuration for determining the motor torque output 188 is discussed. Regarding... Figure 10 An illustrative configuration for determining mechanical loss 190 is discussed.

[0143] Once the motor torque output 188 and the mechanical losses 190 of motor 105 are determined or calculated, one or more values ​​of the determined motor torque output 188 can be added to one or more values ​​of the mechanical losses 190 of motor 105 at adder 192. In some examples, the difference between these values ​​can be identified at adder 192. The difference between the motor torque output 188 (e.g., the total torque produced by motor 105) and the mechanical losses 190 of motor 105 (e.g., the amount of torque required to rotate motor 105) represents the amount of torque that motor 105 uses to pump blood through blood pump 100.

[0144] Once the difference between the motor torque output 188 and the mechanical loss 190 is identified, one or more pump coefficients (e.g., torque-flow rate pump coefficients) can be applied to that difference to correlate the determined motor 105 torque available for pumping fluid through the blood pump 100 with the flow rate of the fluid through the blood pump 100. In some examples, these one or more coefficients can be determined experimentally and are specific to the configuration of the blood pump 100.

[0145] exist Figure 8 In the illustrated example configuration, two pump coefficients can be applied, each relating to a value related to the difference between the determined motor torque output 188 and the mechanical loss 190 of the motor 105. The first pump coefficient K can be... FR0 194 is applied to the difference between the motor torque output 188 and the mechanical loss 190. First pump coefficient K FR0 194 can be a value obtained experimentally for blood pump 100 (e.g., a value determined for the configuration of blood pump 100), which correlates the motor torque of blood pump 100 with the flow rate through blood pump 100. Furthermore, the square root 196 of the difference between the motor torque output 188 and the mechanical loss 190 can be determined, and the second torque-flow rate coefficient K can be... FR1 198 is applied to the value of the square root 196. Second torque-velocity coefficient K FR1 198 can be an experimental value for blood pump 100, which correlates the square root of the motor torque of blood pump 100 with the flow rate through blood pump 100.

[0146] At adder 200, the first torque-flow coefficient K will be passed through. FR0 194 is a value determined by applying the difference between the motor torque output 188 and the mechanical loss 190, and by using the second torque-flow rate coefficient K. FR1198 is the sum of values ​​determined by the square root of the difference between the motor torque output 188 and the mechanical loss 190. This sum can be a determined or calculated value of the flow rate 202 through the blood pump 100, or a value associated with that flow rate. The flow rate 202 can be output to the user interface 148 or other user interfaces for use by practitioners when treating patients with the blood pump 100 and / or to automatically control the operation of the blood pump 100 by providing the determined or calculated flow rate to the motor sub-controller 180, and / or can be output in one or more other suitable ways.

[0147] Figure 9 A diagram schematically depicts the illustrative operation of a motor torque output observer 204 (e.g., a sub-controller or other suitable 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 can be configured to receive values ​​from a command signal 168 (e.g., a voltage value and / or other suitable value) and sensed motor speed 187 or related values. Based on the received signals or values, the motor torque output observer 204 can determine or calculate the motor torque output 188 of the motor 105.

[0148] Once command signal 168 and sensed motor speed 187 are received, one or more coefficients can be applied to the values ​​of command signal 168 and sensed motor speed 187, or values ​​related to the command signal and sensed motor speed. In some examples, these one or more coefficients can be determined experimentally and / or specific to the configuration of motor 105, and the voltage value can be correlated with the torque output of motor 105. In some cases, one or more of the coefficients for correlating voltage with torque output can be provided on the datasheet of motor 105.

[0149] exist Figure 9 In the illustrated example configuration, two coefficients can be applied to the received voltage command signal 168 and the sensed motor speed 187, respectively. The torque-voltage coefficient K can be... T 206 is applied to the value of the sensed motor speed 187 or a value related to the sensed motor speed to generate a voltage value (e.g., the inverse EMF value of motor 105 and / or other suitable value), which can be added to the value of command signal 168 at adder 208. Torque-voltage coefficient K T 206 can be the motor torque constant, which can be a parameter value found in the motor datasheet.

[0150] At adder 208, it can be determined that by controlling the torque-voltage coefficient K... T206 is the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168. This is achieved by using the torque-voltage coefficient K... T The value determined by 206 based on the sensed motor speed 187 can be the amount of voltage generated inside the motor 105 based on the speed of the motor 105, or an amount that can represent that voltage. To determine the accurate value of the motor torque output 188, the torque-voltage coefficient K can be subtracted from the command voltage in the command signal 168. T 206 is the value determined by applying the sensed motor speed 187.

[0151] The ratio factor 210 can be applied by using the torque-voltage coefficient K T 206 is the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168. The ratio coefficient 210 can be adjusted by using the torque-voltage coefficient K. T The value is determined by dividing 206 by the winding resistance of motor 105. The winding (or terminal) resistance R of motor 105 is... w 212 can be determined experimentally for motor 105, and / or the winding resistance R of motor 105. w 212 can be a value found in the datasheet for motor 105.

[0152] It is applied to the torque-voltage coefficient K T The output of the ratio factor 210, which is the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168, can represent the motor torque output 188. In some cases, such as... Figure 9 As depicted, the low-pass filter 214 can be applied to the ratio factor 210 applied to the torque-voltage coefficient K. T The output value is obtained by applying the difference between the value determined by the sensed motor speed 187 and the value of the command signal 168. The low-pass filter 214 can be configured to filter out all values ​​with frequencies higher than a predetermined frequency threshold to filter out noise.

[0153] Figure 10 A diagram schematically depicts the illustrative operation of a motor mechanical loss observer 216 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the mechanical loss 190 of the motor 105 of the blood pump 100 based on force balance equations. The motor mechanical loss observer 216 can be configured to receive sensed motor speed 187 or values ​​associated with it. Based on the received signal or value, the motor mechanical loss observer 216 can determine or calculate the motor mechanical loss 190 of the motor 105.

[0154] Once the sensed motor speed 187 is received, a low-pass filter 218 can be applied to the sensed motor speed 187. The low-pass filter 218 can be the same as a low-pass filter 214 with the same frequency threshold or a different low-pass filter with different frequency thresholds, to filter noise from the received sensed motor speed 187. The output of the low-pass filter 218 can be processed and summed in several separate steps to obtain the determined or calculated motor mechanical loss 190.

[0155] In the step, the derivative 220 of the output of the low-pass filter 218 can provide the acceleration of the motor 105. The inertial equation J 222 can be applied to the determined or calculated acceleration of the motor 105, wherein the output obtained by applying the inertial equation J 222 to the acceleration of the motor 105 can represent or can be the calculated or determined force required to overcome the inertia of the motor 105.

[0156] In the additional processing steps, the output of the low-pass filter 218 can be squared (224), and the nonlinear drag coefficient C can be... N 226 is applied to the square of the output of the low-pass filter 218. Nonlinear resistance coefficient C. N 226 can correspond to nonlinear force and / or power lost to the environment as heat due to low efficiency in motor 105, and the nonlinear drag coefficient C N The output obtained by applying 226 to the output of the low-pass filter 218 can represent or may be the calculated or determined force required to overcome the nonlinear resistance on the motor 105.

[0157] The calculated or determined force required to overcome the inertia of motor 105 can be added at adder 228 to the calculated or determined force used to overcome the resistance on motor 105. The output of adder 228 can be or may represent the calculated or determined net inertial and nonlinear forces acting on motor 105.

[0158] In further processing steps, the linear drag coefficient C can be... L 230 is applied to the output of the low-pass filter 218. Linear resistance coefficient C L 230 can correspond to linear force and / or power lost to the environment as heat due to low efficiency in motor 105, and the linear drag coefficient C L The output obtained by applying 230 to the output of low-pass filter 218 can represent or may be the calculated or determined force required to overcome the linear resistance on motor 105.

[0159] The calculated or determined net inertial and nonlinear forces acting on motor 105 can be added at adder 232 to the calculated or determined force required to overcome the linear resistance on motor 105. The output of adder 232 can be or may represent the calculated or determined net forces acting on motor 105 (e.g., inertial force, nonlinear resistance, and linear resistance). In other words, the output of adder 232 can be the motor mechanical loss 190.

[0160] Figure 11 A diagram schematically depicts the illustrative operation of a pressure observer 186 configured to determine or calculate pressure (e.g., ventricular pressure, such as left ventricular pressure and / or right ventricular pressure, depending on which ventricle the blood pump 100 extends into) distal to impeller 112 (or proximal to the direction of blood flow). The distal end of the impeller may be located in a ventricle (e.g., the left or right ventricle of a patient's heart). The pressure observer 186 may be configured to receive values ​​from command signal 168 (e.g., voltage values ​​or levels and / or other suitable values), sensed motor speed 187 or values ​​associated therewith, and values ​​from pressure sensor 138 (e.g., a pressure sensor that senses pressure proximal to impeller 112 or distal to the direction of blood flow (e.g., pressure in a patient's aorta)). Based on the received signals or values, the pressure observer 186 can determine or calculate the motor torque output 188 of the motor 105, the mechanical losses 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 can be the pressure at which blood no longer moves through the blood pump 100.

[0161] The motor torque output 188 and mechanical losses 190 can be determined in any suitable manner, including but not limited to those described herein. Figure 9 and Figure 10 As described. Furthermore, the stall pressure 234 can be determined in any suitable manner. Regarding... Figure 12 An illustrative configuration for determining stall pressure 234 is discussed.

[0162] Once the motor torque output 188 and the mechanical loss 190 of the motor 105 are determined or calculated, one or more values ​​of the determined motor torque output 188 can be added to one or more values ​​of the mechanical loss 190 of the motor 105 at adder 236. In some examples, the difference between these values ​​can be identified at adder 236, which can represent the amount of torque used by the motor 105 to pump blood through the blood pump 100, similar to the above regarding... Figure 9 The subject of discussion.

[0163] Once the difference between the motor torque output 188 and the mechanical loss 190 is identified, the pressure observer 186 can use this difference, along with the sensed motor speed 187, to calculate or determine the pressure loss 238 caused by blood flow through the blood pump 100. Regarding Figure 13 An illustrative configuration for determining pressure loss 238 is discussed.

[0164] exist Figure 11 In the example configuration depicted, the calculated or determined pressure loss 238 can be added to the calculated or determined stall pressure 234 at adder 240. The difference between the stall pressure 234 and the pressure loss 238 can be and / or can represent the instantaneous pressure drop across the pump for a given blood flow through the pump 100. In some examples, the pressure drop represents the difference between the ventricular pressure of the ventricle (e.g., the left or right ventricle) in which the pump 100 is located and the arterial pressure of the artery (e.g., the aorta or left pulmonary artery) in which the pump 100 is located.

[0165] The determined pressure drop across the blood pump 100 can be added at adder 242 to the pressure value sensed by pressure sensor 138 and / or a pressure value based on a measurement sensed by that pressure sensor (e.g., pressure at a location proximal to impeller 112, such as the patient's aorta). At adder 242, the determined pressure drop across the blood pump 100 can be subtracted to determine a distal pressure value 244 of the pressure distal to impeller 112 (e.g., ventricular pressure, such as left ventricular pressure or right ventricular pressure). The distal pressure value 244 can be output to user interface 148 or other user interfaces for use by practitioners when treating patients with blood pump 100 and / or to automatically control the operation of blood pump 100 by providing the determined or calculated distal pressure value 244 to motor sub-controller 180 and / or can be output in one or more other suitable ways.

[0166] Figure 12 A schematic diagram illustrates the illustrative operation of a motor stall pressure observer 246 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the stall pressure 234 of the motor 105 of the blood pump 100. The stall pressure observer 246 can be configured to receive sensed motor speed 187 or a value associated with it. Based on the received signal or value, the stall pressure observer 246 can determine or calculate the stall pressure 234 of the motor 105.

[0167] Once the sensed motor speed 187 is received, a low-pass filter 248 can be applied to the sensed motor speed 187. The low-pass filter 248 can be the same as one or both of low-pass filters 214, 218 with the same frequency threshold or different low-pass filters with different frequency thresholds, to filter noise from the received sensed motor speed 187 value. The output of the low-pass filter 218 can be processed in several separate steps to obtain the determined or calculated stall pressure 234 of the motor 105.

[0168] In this step, the derivative 220 of the output of the low-pass filter 248 can provide the acceleration of the motor 105. In an additional processing step, the output 224 of the low-pass filter 248 can be squared.

[0169] Once the acceleration of motor 105 is determined and squared by the output of low-pass filter 248, one or more coefficients (e.g., speed-pressure loss pump coefficients) can be applied to correlate the sensed motor speed 187 with the stall pressure 234. In some examples, these one or more pump coefficients can be determined experimentally and are specific to the configuration of blood pump 100. In some examples, a second pump coefficient K can be used. SP1 221 is applied to the acceleration of motor 105, and the first pump coefficient K can be used. SP0 225 is applied to the square of the motor speed output from the low-pass filter 248. Second pump coefficient K SP1 221 can be a value obtained experimentally for blood pump 100 (e.g., a value determined for the configuration of blood pump 100), which correlates the acceleration of the motor 105 of blood pump 100 with the stall pressure of blood pump 100. First pump coefficient K SP0 225 could be an experimental value for the blood pump 100, which correlates the square of the sensed motor speed 187 with the stall pressure of the blood pump 100.

[0170] The second pump coefficient K can be obtained from adder 250. SP1 Subtract the first pump coefficient K from the output obtained by applying the acceleration of motor 105. SP0 The output obtained by applying it to the output of low-pass filter 248. The first pumping coefficient K, determined at adder 250. SP0 The output obtained by applying the square of the output of the low-pass filter 248 and applying the second pump coefficient K SP1 The difference in output obtained by applying acceleration to motor 105 can be stall pressure 234, where stall pressure 234 can be the maximum pressure that blood pump 100 may be able to generate.

[0171] Figure 13A diagram schematically depicts the illustrative operation of a pressure loss observer 252 (e.g., a sub-controller or other suitable observer) configured to determine or calculate the pressure loss 238 of the motor 105 of the blood pump 100. The pressure loss observer 252 may be configured to receive a sensed motor speed 187 or a value associated therewith, and a residual motor torque 254 or a value associated therewith. 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 observer 252 can determine or calculate the pressure loss 238 of the motor 105.

[0172] Once the sensed motor speed 187 and residual motor torque 254 values ​​are received, a low-pass filter 256 can be applied to the sensed motor speed(s) values ​​187. The low-pass filter 256 can be the same as one or both of low-pass filters 214, 218, 248 with the same frequency threshold or different low-pass filters with different frequency thresholds, to filter noise from the received sensed motor speed 187 values. The output of the low-pass filter 218 can be provided to the multiplier 258.

[0173] The residual motor torque 254 can be processed using one or more coefficients in multiple steps, which can correlate the residual motor torque 254 and / or the sensed motor speed 187 with the pressure loss 238. In some examples, one or more of these coefficients can be determined experimentally and are specific to the configuration of the blood pump 100.

[0174] In one step, the first pump coefficient K can be... PL0 255 is applied to residual motor torque. First pump coefficient K PL0 255 can be a value obtained experimentally for blood pump 100 (e.g., a value determined for the configuration of blood pump 100), which correlates the residual motor torque of blood pump 100 with the pressure loss 238. A first pump coefficient K can be applied. PL0 The result obtained is provided to adder 260.

[0175] Furthermore, the square root 196 of the residual motor torque 254 can be calculated or determined and applied to the multiplier 258. The values ​​received at the multiplier 258 can then be multiplied.

[0176] Once the values ​​received at multiplier 258 are multiplied, the second pump coefficient K can be obtained. PL1 259 is applied to the product of the values ​​provided to multiplier 258. Second pump coefficient K PL1259 can be an experimentally derived value for blood pump 100, which correlates the product of residual motor torque 254 and sensed motor speed 187 with pressure loss 238. The second pump coefficient K... PL1 259 is applied to the product of the values ​​provided to multiplier 258, and the result can be provided to adder 260.

[0177] At adder 260, the first pump coefficient K can be used to... PL0 The value of 194, applied to the residual motor torque of 254, is obtained by combining the second pump coefficient K. PL1 259 is applied to the sum of the values ​​generated from the output of multiplier 258 to determine or calculate the value of pressure loss 238. The determined value of pressure loss 238 can be used to determine distal pressure or ventricular pressure 244 and / or other suitable parameters.

[0178] Figures 8 to 13 The constants or coefficients depicted and discussed in these graphs can be based on the values ​​of one or more parameters. In some examples, Figures 7 to 12 The constants or coefficients in the equation can be values ​​planned based on motor or pump speed, motor or pump temperature, motor or pump power, motor or pump operating time, combinations of these parameters, and / or values ​​of additional or alternative parameters used to compensate for changes in pump performance when pump operating conditions change.

[0179] Figure 14 A schematic method or technique 300 for operating a circulatory support system for a patient's heart is depicted. Method 300 may include sending a command signal 302 to a motor of a blood pump located within the patient's body. In some examples, the command signal may be sent from a controller to the motor, and the command signal may include a voltage value or level for controlling the speed of the motor in a desired manner. In some examples, the command signal may be based on a value (e.g., a setpoint) of a reference parameter 178 received by a practitioner, a hemolysis analyzer 181, and / or other components of the circulatory support system or other components communicating with the circulatory support system, as discussed herein or otherwise. The command signal may cause the motor to drive drive components (e.g., an impeller) to pump blood from the patient's ventricles (e.g., the left or right ventricle) through the blood pump to the patient's arterial vascular system (e.g., the aorta or pulmonary artery).

[0180] During the operation of the blood pump, the speed of the motor can be sensed by one or more sensors that sense the motor speed or a quantity related to the motor speed. The sensed motor speed can be transmitted from the one or more sensors that sense the motor speed or a quantity related to the motor speed to the controller, so that the controller can receive the sensed motor speed or the quantity related to the motor speed and use the value in the operation of the blood pump.

[0181] Further, method 300 may include determining the hemolysis rate 306 during operation of the blood pump based on a received value of motor speed or a measure associated with motor speed. In some examples, the hemolysis rate during operation of the blood pump may be determined or calculated using only the motor speed or a measure associated with that motor speed and / or one or more additional or alternative parameters, including but not limited to pressure near the blood pump, flow rate through the blood pump, hemolysis test results, and / or other suitable parameters or variables. The determined and calculated values ​​of the hemolysis rate and / or amount of hemolysis may be used in the value determinations or calculations discussed herein, which may be used (e.g., via configuration and / or adjustment of command signals from the controller) to control the operation of the blood pump, evaluate the operation of the blood pump, treat a patient, and / or monitor the patient's needs regarding the blood pump (e.g., determining and / or indicating that the blood pump output is sufficient to meet the patient's needs (e.g., pumping blood from the left ventricle to the aorta).

[0182] It should be understood that this disclosure is illustrative in many respects only. Changes in detail, particularly in shape, size, and arrangement of steps, may be made without departing from the scope of this disclosure. To the appropriate extent, this may include using any feature of one example embodiment in other embodiments. Of course, the scope of this disclosure is defined by the language of the appended claims.

Claims

1. A loop support system, comprising: Blood pump, the blood pump comprising: Driven component; and A motor, which communicates with the driven component and is configured to drive the driven component to pump blood flow through the blood pump; One or more sensors configured to sense a measure related to the speed of the motor; and A controller that communicates with the motor and one or more sensors configured to sense quantities related to the speed of the motor, and The controller is configured to send command signals to the motor and determine the hemolysis rate during operation of the blood pump based on the speed of the motor.

2. The cyclic support system as described in claim 1, wherein, The controller is configured to: The speed of the motor is used to determine a measure related to the blood flow rate through the blood pump. The speed of the motor is used to determine a measure related to the patient's left ventricular pressure, and The hemolysis rate is determined based on a measure related to the flow rate through the blood pump and a measure related to the patient's left ventricular pressure.

3. The cyclic support system as described in claim 1 or claim 2, wherein, The controller is configured to receive hemolysis test results for a patient, the hemolysis test results including the time of obtaining a blood sample from the patient; The hemolysis rate is determined based on the speed of the motor, the results of the hemolysis test, and the time it takes to obtain the blood sample from the patient.

4. The cyclic support system as described in claim 3, wherein, The hemolysis test results include the value of plasma free hemoglobin in the blood sample or the value of lactate dehydrogenase (LDH) in the blood sample.

5. The cyclic support system as described in any one of claims 1 to 4, wherein, The controller is configured to integrate the hemolysis rate determined during the operation period of the blood pump to determine the amount of hemolysis that has occurred during the operation period.

6. The cyclic support system as described in any one of claims 1 to 5, wherein, The controller is configured to automatically adjust the command signal based on the hemolysis rate determined during the operation of the blood pump.

7. The cyclic support system as described in claim 6, wherein, The controller is configured to automatically adjust the command signal to reduce the blood flow rate through the blood pump based on the hemolysis rate determined during operation of the blood pump.

8. The cyclic support system as described in any one of claims 1 to 7, wherein, The controller is configured to: The amount of hemolysis is determined based on the hemolysis rate determined during the operation of the pump, and When the amount of hemolysis reaches or exceeds a threshold level, a signal indicating that a hemolysis test is recommended is output.

9. The cyclic support system as described in any one of claims 1 to 8, wherein, The controller is configured to: Receive input from the user; The expected hemolysis rate during operation of the blood pump is determined based on the input received from the user. as well as Based on the determined expected hemolysis rate being higher than a threshold, an indication is output recommending changes to the blood pump.

10. The cyclic support system as described in any one of claims 1 to 9, wherein, The controller is configured to output instructions to the user interface based on the hemolysis rate determined during the operation of the blood pump.

11. A non-transitory computer-readable medium storing instructions executable by a circulatory support device for a patient's heart, the instructions causing the circulatory support device to perform methods including: A command signal is sent from the controller to the motor of the blood pump, so that the motor of the blood pump drives the driven component to pump blood from the ventricles of the patient's heart through the blood pump to the patient's vascular system; Receive a measure related to the speed of the motor from one or more sensors that communicate with the controller; as well as The rate of hemolysis during the operation of the blood pump is determined based on the speed of the motor.

12. The non-transitory computer-readable medium of claim 11, wherein, Determining the hemolysis rate during operation of the blood pump further includes: The blood flow rate through the blood pump is determined based on the speed of the motor. The speed of the motor is used to determine a measure related to the patient's ventricular pressure, and The hemolysis rate is determined based on the flow rate-related measures and the patient's ventricular pressure-related measures.

13. The non-transitory computer-readable medium as claimed in claim 11 or claim 12, wherein, The method further includes: Receive the hemolysis test results at the specified time after obtaining the blood sample being tested, and The hemolysis rate during the operation of the blood pump is determined based on the hemolysis test results and the specified time.

14. The non-transitory computer-readable medium as claimed in any one of claims 11 to 13, wherein, The method further includes: Integrate the hemolysis rate determined during the operation period of the blood pump to determine the amount of hemolysis during the operation period of the blood pump; and When the amount of hemolysis reaches or exceeds a threshold level, a signal indicating that a hemolysis test is recommended is output.

15. The non-transitory computer-readable medium as claimed in any one of claims 11 to 14, wherein, The method further includes: The command signal is automatically adjusted based on the hemolysis rate determined during the operation of the blood pump.

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