Method and device for detecting wear condition of cardiac support system and for operating the same, and cardiac support system

Abstract

To provide a method for detecting a state of wear of a cardiac support system.SOLUTION: The method comprises a read-in step and a determination step. During the read-in step, a sensor signal (315) representing an operating state of the cardiac support system is read in. During the determination step, a wear signal (325) is determined using the sensor signal (315) and a comparison rule (320). The wear signal (325) represents the wear condition.SELECTED DRAWING: Figure 3

Description

[Technical field]

[0001] The present invention relates to an apparatus or a method of the type described in the independent patent claims. [Background technology]

[0002] U.S. Pat. No. 5,904,708 discloses an implantable barometric pressure sensor, an external barometric pressure sensor, and The system has an embedded processing unit that receives and processes the external pressure to detect changes in blood pressure. The present invention describes a system for detecting pressure changes in a patient, comprising an implanted pressure sensor and an external pressure sensor. Data from the device may be used to set or control functions of an implantable medical device. To perform.

[0003] Based on this, the underlying objective of the present invention is to determine not only the status of the cardiac assist system, but also the To operate, and in particular to monitor, the cardiac assist system itself, methods known in the state of the art are used. To further improve the method and the device, and to ensure high functional reliability and ideal The aim is to avoid serious system failure.

[0004] With this in mind, the approach presented here aims to reduce the wear and tear of cardiac assist systems. The present invention relates to a method for detecting a cardiac condition, a method for operating a cardiac assist system, and the like. The present invention relates to a method and an apparatus for using and / or controlling a cardiac assist system according to the main claim. Advantageous further developments and improvements of the devices specified in the independent patent claims are incorporated herein by reference in the dependent patent claims. This is possible using the means specified in paragraph 1.

[0005] Using the approach presented herein, a sensor representative of the operating state of a cardiac assist system The signals can be read and processed. The operating state can be determined, for example, by the physical state of the cardiac assist system. The sensor may be a target condition or a condition of the environment in which the cardiac assist system is operating. The signal and processing specifications can be used, for example, to translate sensor signals into specific operating conditions of the cardiac assist system. and determining a wear signal indicative of a wear status of the cardiac assist system by comparing the wear signal with the This can be advantageously used to prevent, for example, damage or deterioration of the cardiac assist system. or to detect the wear process of the cardiac assist system, This allows for continuous monitoring, which can help avoid failure of the cardiac assist system. or to enable rapid action to be taken in the event of such wear conditions. By monitoring the condition and detecting the wear condition, Together, this can improve the safety and reliability of cardiac assist systems. Summary of the Invention

[0006] The present invention provides a method for detecting a state of wear in a cardiac assist system, the method comprising: The method includes the steps of: reading and determining the operating status of the cardiac assist system. In the step of determining, a sensor signal representative of the wear state is read. The wear signal is indicative of the wear state, as determined using comparison rules.

[0007] Wear conditions may affect the condition of the cardiac assist system or its function. Components of the cardiac assist system (rotors, plain bearings, impellers, or cables) that may be In the case of an impeller, for example, this can be understood as the current state of The impeller may be unbalanced. Also, wear conditions may occur, for example, in cardiac assist systems. Characteristics such as the location or location of the system or components of the cardiac assist system (e.g., pump inlet) For example, the pump inlet may be configured to suck itself into the blood vessel. The cardiac assist system may be, for example, an apical cardiac assist system. Can be designed as a stem or as a cardiac assist system for the aortic valve position The sensor signal may be an electrical signal. The signal may be a signal or a radio signal, for example, sent by a sensor device of a cardiac assist system. The sensor device may be, for example, a temperature sensor, a pressure sensor, or an electric A pressure sensor may be provided, and the sensor signal may correspond to the operating condition such as temperature, pressure, etc. The sensor signal may represent a pressure change, or a voltage. The determining step may include, for example, using a sensor signal. The sensor parameter set can be extracted by using the A wear signal can be determined using a set of sensor parameters to The signal may be stored as a state of wear, for example in the form of a processing specification, to indicate a predicted time course of the cardiac assist system. The wear indicator may be an electrical signal indicative of a deviation of the state of wear from an initial state defined for the purpose.

[0008] According to one embodiment, at least one wear parameter is determined in the determining step. The wear signal may include a wear parameter. The wear parameter may include a cardiac It may contain technical data about the components of the auxiliary system, e.g. The operating state reflected by the sensor signal can be, for example, Wear parameters can be advantageously used to distinguish the state of wear. For example, the present invention can be used to analyze cardiac assist systems or Time to failure for components can be predicted, which increases safety. For example, instead of replacing the entire cardiac assist system, it is possible to replace related components. It is also possible to check the wear status of certain components to enable This advantageously results in resource savings and cost savings.

[0009] Additionally or alternatively, according to one embodiment, at least one signal representative of the functionality of the cardiac assist system is At least one functional parameter may be determined in the determining step. In this case, wear The signal may include a functional parameter, for example a function of a cardiac assist system. Whether the system can operate more reliably or whether replacement or maintenance is required. The functionality of the cardiac assist system can therefore be advantageously and particularly simply Thus, for example, maintenance of an implantable cardiac assist system can be avoided. or to be able to plan such maintenance in advance. It is possible to detect a malfunction or a disturbance in the desired functionality of the cardiac assist system, which may include: Advantageously, this increases the safety and reliability of cardiac assist systems.

[0010] According to one embodiment, the method further comprises: The external processing device may include providing a signal to an interface with the external processing device. The device may be, for example, an external control device, or a portable device such as a smartphone, or a cardiac It can be a server for auxiliary systems or an alarm device. Therefore, the operating status and and additionally or alternatively the state of wear may advantageously be monitored, e.g. for further evaluation. , can be stored externally. Interface with the warning device or to a smartphone For the provision of the wear signal, the wear signal can include, for example, a functional parameter, and the wear signal can be controlled by an external control device. For provision to an interface with a device or server, the wear signal may be, for example, The wear signal may also include, for example, an interface with a smartphone. In order to provide a user interface, functional and wear parameters may also be included, e.g. For example, the wear signal may be displayed visually or audibly. For example, as a warning signal using predefined limits as processing specifications and A wear signal may be determined to be provided as a function of the comparison with the limit value.

[0011] According to one embodiment, the method may also include a step of sensing. An operating condition is sensed and a sensor signal representative of the operating condition is provided. Certain components or areas of the cardiac assist system may be monitored to determine their operational status, e.g. For example, the sensor signal can be sensed by a defined sensor area. The sensor device for obtaining the above information can advantageously detect, for example, wear of components of a cardiac assist system. To determine the condition of the can be done.

[0012] According to one embodiment, the sensor signal may also be sensed using a sensor device. The sensor device measures electrical quantities, temperatures, pressures, volumetric flows, movements, optical signals, etc. of the cardiac assist system. The sensor may be configured to sense a change in electrical or acoustic signal, force, or position. Pressure can be sensed, for example, as an electrical quantity. For example, vibrations in components of the cardiac assist system can be sensed as pressure. As a result of movement or a fall by the wearer of the implantable cardiac assist system or an object hitting the wearer It can sense sudden movements in the form of physical shocks. It senses pressure and volume flow. What is done is to check, for example, whether the pump inlet of the cardiac assist system is aspirating itself into the blood vessel. It is advantageous to check whether the impeller is out of balance or whether the cardiac assist system is displaced. or malfunctions can be detected, for example, by laser interferometers, microphones or structure-borne sound sensors. The identification can be achieved with the aid of optical or acoustic signals that can be acquired by the detection of the target object. To sense the quantities mentioned above, the sensor device may be, for example, a voltage sensor, an electrical resistance sensor, a temperature sensor, degree sensor, pressure sensor, ultrasonic flow sensor, optical reflection coefficient sensor, movement sensor, acceleration sensor Sensors, magnetic sensors, microphones, force sensors, distance sensors, or inductive rotor bearings sensors and / or capacitive rotor bearing sensors, or a combination of the aforementioned sensors At least one of the sensors may be, for example, a sensor self-regulating device. For diagnostic purposes, it may be additionally configured to be redundant. The integrated sensor can be advantageously used to provide a sensor signal. This is cost-saving and compact for the equipment to carry out this embodiment of the method. This enables fast design.

[0013] According to one embodiment, the sensor signal is also analyzed in the time domain, and additionally or alternatively To this end, the sensor signals can be used to represent the operating state in the frequency domain. For example, to determine the average or standard deviation of a performance status within a certain period of time If the sensor signal represents the operating condition in the frequency domain, e.g. The characteristic frequency of the spectrum, the integrated band energy in the defined frequency band, The magnitude or absolute amplitude at the location of a known damage frequency can also be determined. In addition, further analysis of the sensor signal is advantageously possible, which allows for an accurate determination of the wear state. This is advantageous for determination.

[0014] Further, according to one embodiment, further sensors representing further operational states of the cardiac assist system are provided. In the reading step, the sensor signal can be read. In the determining step, the wear signal can be The determination can be made using the sensor signal, the further sensor signal, and a comparison rule. This is to enable the wear state to be determined using multiple sensor signals. It is advantageous.

[0015] In this case, according to one embodiment, the sensor signal and the further sensor signal are used to The wear signal can be extracted by determining a set of sensor parameters. The sensor parameter set can be determined using a meter set and comparison rules. It may be advantageous to transform the sensor data into the time domain or the frequency domain. be.

[0016] According to one embodiment, the method includes using the sensor signal to define a comparison rule. For example, a sensor parameter set can be used to do this. The sensor signals can be used, for example, to create a profile of the operating conditions or to This embodiment has the advantage that it is possible to generate a so-called fingerprint of the system. In addition, it is possible to define a comparison rule using already read sensor signals, e.g. A comparison rule is used to determine the operating state of the device (e.g., the implanted state of a cardiac assist system). This allows you to set the rule.

[0017] This approach further introduces a method for operating a cardiac assist system. a method for detecting a wear condition of a cardiac assist system, comprising: and providing a control signal for controlling a component of the cardiac assist system. The signal is output using a sensor signal or a wear signal. To detect and optionally evaluate wear, the cardiac assist system must already have a set of protective devices in place for normal operation. The sensor signals required for performing the cardiac assist function of the cardiac assist system are According to this design example, for example, Depending on the operating conditions or wear conditions, it may reduce or eliminate damage to the mechanical elements of the cardiac assist system. To prevent this, the sensor signal and additionally or alternatively the wear signal may be used to monitor cardiac function. The components and resulting functions of the auxiliary systems can be advantageously adapted. For example: When an impact such as a fall is detected by the acceleration sensor or movement sensor, For example, the sensor signal may be used to slow down a pump in a cardiac assist system to prevent damage. It can be done.

[0018] The approach presented herein reduces the wear status of the cardiac assist system presented herein. for detecting a cardiac condition or for operating a cardiac assist system in a corresponding device - Patents.com The present invention further provides an apparatus configured to perform, control or implement the steps of the method variations. This design variation of the present invention in the form of a device also achieves the underlying objective of the present invention in a fast and efficient manner. This enables us to achieve the following:

[0019] For this purpose, the device comprises at least one processor for processing signals or data. at least one memory unit for storing a unit, a signal or data, a sensor To input sensor signals from or output data or control signals to actuators an interface to at least one sensor or actuator for detecting the and / or at least one device for inputting or outputting data embedded within a communication protocol. The computing unit may comprise, for example, a signal processor. may be a processor, microcontroller, or the like, while The memory unit can be a flash memory, an EEPROM, or a magnetic memory unit. The communication interface can input data wirelessly and / or via wired communication. or output, thereby inputting or outputting wired data. The communication interface can transmit the above-mentioned data electrically or optically, for example. In effect, the corresponding data transmission line can be input or output. Cut.

[0020] In this case, the device processes the sensor signal and generates a control signal as a function of said sensor signal. and / or a data signal. Interfaces that can be hardware and / or software based In the case of a hardware-based configuration, the interface may be, for example, For example, it may be part of a so-called system ASIC, which contains various functions of the device. However, the interface may be implemented as a separate integrated circuit or at least partially In the case of a software-based configuration, the interface may be provided, for example, on a microcontroller together with other software modules. It may be a software module.

[0021] Such a device may advantageously be part of a cardiac assist system or may be used to For example, one embodiment of the device can be integrated into a cardiac assist system. The sensor signals, which will be acquired anyway during operation of the system, are used to To be able to monitor the wear status of the support system, It can be incorporated into a cardiac assist system.

[0022] Design examples of the approach presented herein are shown diagrammatically in the drawings and described below. This is explained in more detail in [Brief description of the drawings]

[0023] [Figure 1] FIG. 1 is a schematic diagram of a cardiac assist system in the aortic valve position according to one design example. [Diagram 2] FIG. 2 is a schematic diagram of an apical cardiac assist system according to one design example. [Diagram 3]FIG. 3 is a schematic diagram of an apparatus for detecting a wear condition of a cardiac assist system according to one design example. [Figure 4] FIG. 4 is a schematic diagram of an apparatus for operating a cardiac assist system according to one design example. [Diagram 5] FIG. 5 is a schematic diagram of a sensor arrangement in a cardiac assist system having an apparatus for detecting a wear condition of the cardiac assist system according to one design example. [Figure 6] FIG. 6 is a flowchart of a method for detecting a wear condition of a cardiac assist system and a method for operating the cardiac assist system according to one design. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0024] In the following description of the preferred design of the present invention, identical or similar reference numbers refer to various figures. is used for the elements shown in, which has a similar effect, thereby Repeated listing of elements is omitted.

[0025] FIG. 1 shows a schematic diagram of a cardiac assist system 100 in the aortic valve position according to one design example. 1 shows a simplified schematic of a cardiac assist system 100 implanted within a heart 105. The cardiac assist system 100 shown in FIG. 1 has an inlet cannula 110 in the aortic valve position. A section of the cardiac assist system 100 is disposed in the left ventricle 115 of the heart 105, and Another section of the assist system 100 is disposed in the aorta 120 in the region of the aortic valve 125. The pump volume flow 130 is received at the tip of the inlet cannula 110 within the ventricle 115, The aorta 120 is then drained into the area of ​​the aorta 120. An example is shown with reference to Figures 3 and 4 described below, which is a method for detecting a state of wear. The present invention provides an apparatus for performing a cardiac assist function, such as a cardiac assist valve, a cardiac assist device, or a cardiac assist system.

[0026] FIG. 2 shows a schematic diagram of an apical cardiac assist system 100 according to one design example. FIG. 1 shows a simplified schematic of the apical cardiac assist system 100 in an apical position. 0 has an inlet for introducing blood flow, which runs along the outside of the heart 105. The left ventricle 115 of the heart is connected to the aorta 120 via a drain cannula 205 led through the aorta 120. To this end, the pump volume flow 130 is 0 pump, e.g., a rotary pump, into the drain cannula 205. Rain cannula 205 delivers pump volume flow 130 to aorta 120. One design example of the apical cardiac assist system 100 shown is also shown in FIGS. 3 and 4 described below. 1 to detect a wear condition or to detect a wear condition in the cardiac assist system 100. The present invention includes an apparatus for operating the

[0027] FIG. 3 illustrates an apparatus 300 for detecting a wear condition in a cardiac assist system according to one design example. A schematic diagram is shown. The device 300 comprises a reading device 305 and a determining device 310. The acquisition device 305 is adapted to read a sensor signal 315 representative of the operating condition of the cardiac assist system. The decision device 310 uses the sensor signal 315 and the comparison rule 320 to The wear signal 325 is configured to determine the wear state by represent.

[0028] The device 300 shown in this specification is a two-core device as shown in the embodiment of Figures 1 and 2 above. The device may be used in conjunction with a cardiac assist system, such as one of the cardiac assist systems.

[0029] According to one design example, the determining device 310 determines at least one wear parameter, and providing a wear signal 325 including the wear parameter. Alternatively, the determination unit 310 may determine at least one functional parameter indicative of the functionality of the cardiac assist system. and configured to determine a wear parameter and provide a wear signal 325 including the functional parameter. It is being done.

[0030] According to the design example shown herein, the decision device 310 also has an interface with the external processing device 335. The sensor signal 315 is configured to provide a wear signal 325 to the interface. An interface with an external processing device 335 is also optionally provided. The service can be wireless or wired.

[0031] According to the design example shown herein, the reader 305 also serves as a further The system is also configured to read at least one further sensor signal 330 representative of a different operating condition. The decision device 310 receives the sensor signal 315, at least one further sensor signal 316, and 330, and configured to use the comparison rule 320 to determine the wear signal 325. The decision device 310 also optionally determines whether the sensor signal 315 and at least one The additional sensor signal 330 is used to extract a sensor parameter set and The parameter set and comparison rules 320 are used to determine the wear signal 325. According to the design example shown in this specification, the comparison rules are pre-stored in the decision device. The comparison rules 320 are optionally defined using the sensor signals 315.

[0032] According to the design example shown here, the sensor signal 315 and the further sensor signal 330 are , provided by the sensor device 340. The sensor device 340 senses the operating conditions and Optionally, the device is configured to provide a sensor signal 315 representative of an operating condition. By way of example, the sensor device 340 may also include a cardiac assist device to provide the sensor signal 315. System electrical quantities, temperatures, pressures, volume flows, movements, optical or acoustic signals, forces, According to one design example, the sensor signal 31 is configured to sense a change in position. 5 represents operating conditions in the time domain and additionally or alternatively in the frequency domain. The system is configured to:

[0033] In combination with a cardiac assist system, the device 300 shown herein may be used to treat first symptoms or deep The cardiac assist system is designed to allow for maintenance interventions to be performed before a critical emergency occurs. The sensor device 3 can be used to monitor at least one of the functional groups. 40 may be, for example, a sensor device incorporated in a cardiac assist system, and may also be a current, voltage, temperature, vibration, pressure and pressure changes, sound, optical reflection coefficient, force, and position. The system may be configured to determine operational parameters such as changes in temperature, humidity, and the like. The sensor parameters can be, for example, in the time domain and additionally or alternatively in the frequency domain. In the region, a decision unit 310 is used to extract from the sensor data.

[0034] The fingerprint of the system is, so to speak, the result of determining the set of sensor parameters. Alternatively, the sensor parameter set can be generated from the fingerprint itself. Using the decision unit 310, the fingerprint can be compared with the comparison rule 3 It can be continuously compared with the definition of a healthy fingerprint in 20 forms. The deviation of the fingerprint from the healthy fingerprint of the cardiovascular system It is an indication of an ongoing aging or damage process of the stem. The time progression allows the evaluation of the wear process of the cardiac assist system and, in some cases, the time to failure. Optionally, a decision unit 310 is employed to predict the According to a design example, the decision device 310 is configured to interface with an external processing device 335. A wear signal 325 is configured to provide a wear signal 325, e.g., a wear signal including a wear parameter. 325 in the form of a wear signal 325 from a normal fingerprint. In the event of a deviation, for example, a patient wearing an implantable cardiac assist system having the device 300 , or to a physician via a wear signal 325 indicative of the wear status.

[0035] Such monitoring of the status of a cardiac assist system using variations of the device 300 shown herein This advantageously allows for the reduction or even prevention of serious system failures to be achieved. Early detection of system degradation provides a time advantage, resulting in, for example, Surgical appointments for element replacement can be planned early. Predictive maintenance interventions are Improve the quality of life for patients by not exposing them to medical emergency scenarios The device 300 shown herein may also be referred to as a condition monitoring system, and is particularly For subsystems that cannot be configured to be redundant, such as pump motors, By incorporating the device 300 as a condition monitoring system, Patients can have greater confidence in their support system, which provides peace of mind .

[0036] A wear signal 325 may be used to communicate the determined wear state to a wireless modem or wired interface. An interface with an external processing device 335 in the form of a communication interface such as an The external processing device 335 may transmit the signal via, for example, an external control device or So-called "wearable" display devices in the form of screens of portable devices (external processing device 33 5. Connected via Bluetooth Low Energy In the case where the wear signal 325 is provided in the wear-out state, e.g., For example, the condition of wear may be displayed on a display device in the form of a status scale.

[0037] By providing a wear signal 325 to interface with an external processor 335, The wear state and / or the underlying sensor values ​​or parameters may be further analyzed using additional or Alternatively, the device may be connected to a computer (such as a cable, wireless, or inductively coupled communication interface) for later extraction. via a USB port) in an external control device or in a control device implanted with the cardiac assist system. and / or a wide area network (e.g., WLAN, LTE, or GPR) S) to a central server. Use of the central server is enabled by Wear Signal 3. 25, the fingerprint of the system transmitted by the The progression of the data parameters' trends can be compared to a large population of systems; As a result, it is possible to make robust statements about the system state of the cardiac assist system. This has the advantage that

[0038] FIG. 4 shows a schematic diagram of an apparatus 400 for operating a cardiac assist system according to one design example. The device 400 shown herein is a cardiac assist device as shown by way of example with reference to FIG. and configured to operate and additionally or alternatively control a cardiac assist system such as a cardiac assist system. For this purpose, the device 400 comprises a reading device 305 and a determining device 306. 10, which corresponds substantially to the reading device and the determination device shown in FIG. The sensor device 305 is adapted to read a sensor signal 315 provided by a sensor device 340. The decision device 310 is configured to correspond to the sensor signal 315 and the comparison rule 320. The wear signal 325 is configured to determine and provide a wear signal 325 using the

[0039] According to the design example shown herein, the device 400 also includes a controller 405. 405 uses the sensor signal 315 or the wear signal 325 to configure the cardiac assist system. It is configured to provide a control signal 410 for controlling an element 415 .

[0040] The cardiac assist system components 415 may be, for example, a control unit or a As shown in the figure, the pump or impeller or drive is a structural element. By signal 315 and additionally or alternatively by a wear signal using a determination device 310 The device 400 detects a fall or other physical impact on the patient, as determined by 325. In this case, the device 400 uses a control device 405 to control a pump, etc., by a control signal 410. 415 of the cardiac assist system to prevent damage to mechanical elements. The pump is configured to temporarily slow down or stop the pump to reduce .

[0041] FIG. 5 illustrates an apparatus 3 for detecting a state of wear in a cardiac assist system 100 according to one design example. 1 shows a schematic diagram of the arrangement of sensors in the cardiac assist system 100 relative to the cardiac assist system shown in FIG. The sensor incorporation into the cardiac assist system 100 also serves to operate the cardiac assist system 100. The cardiac assist system may be implemented in conjunction with the device 400 for performing the cardiac assist function. an apparatus 300, which is similar or identical to the variant of the apparatus described with reference to Figures 3 and 4 of 400. By way of example, the cardiac assist system 100 shown in FIG. A cardiac assist system for the aortic valve position, such as the cardiac assist system described with reference to It is shown as follows.

[0042] The cardiac assist system 100 includes a tip 505 and an inlet cage 506 for receiving a volumetric flow of blood. 10, an inlet cannula 515 for delivering a volumetric blood flow to the micro axial pump, The impeller 520 of the microaxial flow pump is magnetically or mechanically coupled to an electric drive unit 52. 5, a supply cable 530, and a control unit 535. The control unit 535 includes: For example, the cardiac assist system 100 may include devices 300 and 400. In one embodiment, the sensor device includes various sensors. The cardiac assist system 100 includes three temperature sensors 542, two of which are electrically driven. One of them is located in the region of the movable portion 525, and the other is located in the region of the tip 505. The cardiac assist system 100 also includes three pressure sensors 544, one of which is one located in the region of the tip 505, one located in the region of the inlet cannula 515, and One is located in the area of ​​the electric drive 525. The area between the tip 505 and the inlet cage 510. In the region, the cardiac assist system also includes an ultrasonic flow sensor 546. At the end facing away, the inlet cannula 515 is coupled to a force, bend, or distance sensor 54. 8 and an optical reflection coefficient sensor 550. The air drive 525 includes an impeller position sensor 552 in the form of a magnetic sensor or a Hall sensor. , optical distance sensors such as laser interferometers, or inductive rotor sensors and additional or Alternatively, the rotor position sensor may be a capacitive rotor position sensor. The system 100 may include a vibration sensor, a structure-borne sound sensor, a microphone, and additional or alternative Alternatively, a further impeller position sensor 554 may be, for example, a microphone in the form of a sensor hub. In the area of ​​the contact points of the control unit 535 with the supply cable 530, The cardiac assist system may include a sensor in the form of a voltage, current, power, electrical resistance and / or back EMF sensor. The control unit 535 includes a microphone, pressure, acceleration sensor 556. and / or a control device sensor 558 in the form of a rotational speed sensor, or a temperature sensor. Prepare for the future.

[0043] The sensors 542, 544, 546, 548, 550, 552, 554 shown herein , 556, and 558 are redundantly designed to reduce the difference between the individual sensor values ​​of the sensor 542. , 544, 546, 548, 550, 552, 554, 556, and 558 self-diagnosis The sensors 542, 544, 546, 548, 550 shown herein are advantageous for The incorporation of 552, 554, 556, and 558 all makes sense for all uses. may not be practical for all applications due to space or cost reasons. The most relevant sensors can be selected according to the specific application, e.g. Based on mode and effect analysis (FMEA analysis) or observed during long-term or stress testing Selection can be made in a targeted manner based on the perceived fault.

[0044] The following is a description of a method for detecting a wear condition of the cardiac assist system 100 and / or for detecting a wear condition of the cardiac assist system 100. To operate the cardiac assist system 100, the cardiac assist system 100 and the cardiac assist system 100 shown herein Sensors 542, 544, 546, 548, 550, 552, 554, 556 and 558 1 is a list of application examples of the devices 300, 400 in conjunction with a sensor device such as one or more of the devices shown in FIG.

[0045] An impeller sensor 554 in the form of a microphone or structure-borne sound sensor, and additional or alternatively, a control device sensor 5 in the form of a microphone and / or an acceleration sensor. 58 allows for analysis of bearing wear by determining the state of wear.

[0046] In the case of a magnetically coupled and magnetically mounted impeller 520, aging and Deposits, as well as the development of pump thrombosis, can lead to imbalance of the impeller 520. This is due to the microphones of the impeller sensor 554 and / or the control device sensor 558. , can be detected through acceleration sensors, rotational speed sensors, and structure-borne sound sensors. do.

[0047] For example, the sliding bearings of the cardiac assist system 100 as a result of wear or deposit buildup. Changes in friction can be detected by changes in power consumption, which can be current, voltage or A voltage sensor 556 in the form of a power sensor in combination with the actual pressure rise or volumetric flow rise The actual pressure rise or volumetric flow rate rise can be sensed by the inlet cannula 51. 5 or one of the pressure sensors 544 in the region of the electrical actuator 525 or ultrasonic flow This error pattern can be further characterized by a characteristic vibration. This is also connected to the impeller sensor 554 and / or the controller sensor 558. Detected by microphones, acceleration sensors, rotational speed sensors, and structure-borne sound sensors It is possible.

[0048] The measurement of slip between the magnetically coupled drive 525 and impeller 520 is The slippage of the bearings of the impeller 520 is measured by, for example, can be sensed via an optical, magnetic, or capacitive impeller position sensor 552, or Electric drive current and back-induced electric field energy in the currentless rotation of a polyphase electric motor 525 ( The phase relationship of the back EMF is determined, for example, by the voltage sensor in the control device 535 or the electric drive unit 525. For this purpose, the voltage sensor 556 is Temperature sensor 542 or pressure sensor 554 located at or in the position shown in the specification The actuator 525 may be located in the region of the electrical actuator 525 in position.

[0049] The load on the bearings and the resulting pressure rise in the impeller 520 can be expressed as forces, strains, or It can also be sensed at the impeller bearing by distance sensor 548.

[0050] The development of sedimentation and pump thrombosis is caused by the presence of deposits in the inlet hose in the form of the inlet cannula 515. For example, the pressure gradient between the aorta and the inlet cannula 515 or the ventricle can be reduced through a pressure drop in the The power consumption can be detected through the power supply 552, but can also be detected by the voltage sensor 556. , compared to the actual flow detectable by the ultrasonic flow sensor 546 and the pressure sensor It can also be detected via the pump pressure rise detectable by 544.

[0051] Symptoms of the aging process of the stator of the electric drive 525 can be, for example, The winding temperature can be detected by a temperature sensor 542 located in the region of or the winding impedance, which can be detected by a voltage sensor 556. However, a temperature sensor 542 or a pressure sensor 544 arranged in the area of ​​the electric drive 525 Optical motor air gap measured by impeller position sensor 552 at position 4 The dimensions may also be provided by dimensions measured objectively, inductively, or capacitively.

[0052] Deposits on the rotor, as well as imbalances, can also be detected using the reflection coefficient sensor 550. It can be determined via optical measurements.

[0053] The quality of the supply cable 530 is monitored via electrical resistance measurements by a voltage sensor 556. In addition to detecting cable breaks (series measurement), resistance measurements can also be Between adjacent wire strands to evaluate the condition of the edge jacket and / or dielectric It can also be implemented as a complex-valued impedance measurement.

[0054] Failure of the power and signal electronics of the control unit 535 measures the temperature of the individual assemblies. , and can be detected by monitoring selected voltage levels.

[0055] The pump inlet suction to the aortic ventricular wall in the cardiac assist system 100 at the aortic valve position Pull, or "aspiration," can also be detected by the devices 300, 400 shown herein. When the cardiac assist system 100 is aspirating, auxiliary blood volume flow is no longer possible. The cardiac assist system 100 then (automatically) reduces pumping power until the aortic wall is released. Suction should be reduced in the area of ​​the tip 505 and in the area of ​​the inlet cannula 515. The pressure gradient of the pressure sensor in the Partial closure of the inlet cage 510 can also reduce the flow conditions in the inlet cage 510. The flow rate is changed, which is detected via the Doppler spectrum of the ultrasonic flow sensor 546. It is possible.

[0056] The sensor data processing by the decision unit of the device 300, 400 may be performed, for example, using a relative threshold or an absolute threshold. via thresholds, mean values, standard deviations, minimum and maximum values ​​over a time frame or the entire observation period; Based on the analysis of the sensor signal in the time domain. The sensor data processing by the determination device of 0 is, for example, a feature frequency, a median frequency of a spectrum, number, integrated band energy in a defined frequency band, or location of known damage frequencies It is based on the analysis of the sensor signal in the frequency domain via the determination of the absolute amplitude at The sensor parameters of the stated operating conditions are used as condition parameters (i.e., wear parameters, for example). parameter) based on predefined thresholds of the comparison rules. Alternatively, the fingerprint of the system parameters may be defined as a comparison rule. Often, for example, the threshold is chosen as a healthy one (e.g., a threshold super-average in a multi-dimensional parameter space). It can be defined as a mathematical distance measure on the fingerprint, which is defined as a surface.

[0057] The processing of the sensor values ​​is done by the pump's integrated microcontroller or control device, such as a sensor hub. The sensor hub may also pre-process the sensor data and It can only be used to transfer extracted sensor parameters, which is This reduces the communication bandwidth required along the bus 530.

[0058] FIG. 6 illustrates a method 600 for detecting a wear condition in a cardiac assist system according to one design example. 7 shows a flow chart of a method 700 for operating a cardiac assist system.

[0059] The method 600 includes a reading step 601 and a determining step 603. In step 01, a sensor signal representative of an operating state of the cardiac assist system is read. At 603, the wear signal is determined using the sensor signal and a comparison rule. indicates the state of wear.

[0060] According to one design example, at least one wear parameter is determined in determining step 603. In this case, the wear signal includes at least one wear parameter. In 3, at least one functional parameter that represents the functionality of the cardiac assist system is also optional. The wear signal then includes at least one functional parameter.

[0061] The method 600 also optionally communicates the sensor signal and / or the wear signal with an external processing device. The providing step 605 optionally includes: This is performed after the determining step 603. In the providing step 605, only the sensor signal is provided. In that case, the providing step 605 can also be performed after the reading step 601 .

[0062] According to one design example, the method 600 further includes a step of sensing 607, where the operating condition is The sensing step 607 optionally includes: , before the reading step 601. The sensing step 607 may additionally or alternatively include: This is performed before the providing step 605.

[0063] In step 601, further sensors indicative of further operating conditions of the cardiac assist system are read. In this case, the wear signal is read in from the sensor signal, the further sensor signal, Using the signal and a comparison rule, the sensor is determined in a determining step 603. The parameter set is also optionally determined using the sensor signal and the further sensor signal. , is extracted in step 603. The wear signal is then calculated based on the sensor parameter set and comparison rules are used to determine.

[0064] According to one design example, the method 600 includes a step 6 of defining a comparison rule using the sensor signal. 09. The defining step 609 optionally includes, after the reading step 601, This is performed before the determining step 603 .

[0065] The method 700 for operating a cardiac assist system may include at least some of the features of the method 600, as described above. At least steps 601 and 603, and optionally steps 605, 607, and The method 700 includes one or more of the following: The control signal may be a sensor signal or a friction signal. The signal is provided using a wear signal.

[0066] If the design example includes an "and / or" conjunction between a first feature and a second feature, This is because, according to one embodiment, the design example includes both the first feature and the second feature, and According to another embodiment, the present invention includes either the first feature only or the second feature only. should be read as meaning this.

Claims

1. 1. A cardiac assist system comprising: The impeller, a sensor associated with the impeller; 1. A condition monitoring system, comprising: storing a current fingerprint associated with an operating state of an impeller of the cardiac assist system implanted in the heart based at least in part on the sensor signal from the sensor of the cardiac assist system; comparing the current fingerprint to a predetermined fingerprint based at least in part on a comparison rule; determining a wear signal based at least in part on said comparison of said current fingerprint and said predetermined fingerprint; determining a failure prognosis associated with the cardiac assist system based on the wear signal; and causing an interface to provide an alert related to the failure prediction.

2. The cardiac assist system of claim 1 , wherein the failure prediction comprises a predicted time of failure of the cardiac assist system.

3. The cardiac assist system of claim 1 , wherein the sensor signal is related to deposits on the impeller or an imbalance of the impeller.

4. 2. The cardiac assist system of claim 1, wherein the sensor signal relates to at least one of position, vibration, acceleration, pressure, rotational speed, temperature, voltage, current, power, light reflection, or electrical resistance associated with the impeller.

5. The cardiac assist system of claim 1 , wherein the sensor signal represents the operating condition of the cardiac assist system in the time domain or the frequency domain.

6. The cardiac assist system of claim 1 , wherein the condition monitoring system is configured to provide the sensor signal or the wear signal to an external processing device.

7. A control device, generating a control signal based at least in part on the wear signal, the control signal being configured to control a component of the cardiac assist system; 2. The cardiac assist system of claim 1, further comprising a controller configured to: transmit the control signal to control components of the cardiac assist system.

8. 1. A method for monitoring a cardiac assist system, comprising: storing a current fingerprint associated with an operating state of an impeller of the cardiac assist system implanted in the heart based at least in part on a sensor signal from a sensor of the cardiac assist system; comparing the current fingerprint to a predetermined fingerprint based at least in part on a comparison rule; determining a wear signal based at least in part on said comparison of said current fingerprint and said predetermined fingerprint; determining a failure prognosis associated with the cardiac assist system based on the wear signal; and causing an interface to provide an alert related to the fault prediction.

9. The method of monitoring a cardiac assist system of claim 8 , wherein the failure prediction comprises a predicted time of failure of the cardiac assist system.

10. The method of monitoring a cardiac assist system of claim 8 , wherein the sensor signal is related to deposits on the impeller or an imbalance of the impeller.

11. 9. The method of monitoring a cardiac assist system of claim 8, wherein the sensor signal relates to at least one of position, vibration, acceleration, pressure, rotational speed, temperature, voltage, current, power, light reflection, or electrical resistance associated with the impeller.

12. The method of monitoring a cardiac assist system of claim 8 , wherein the sensor signal represents the operating condition of the cardiac assist system in the time domain or the frequency domain.

13. The method of monitoring a cardiac assist system of claim 8 , further comprising the step of providing the sensor signal or the wear signal to an external processing device.

14. generating a control signal based at least in part on the wear signal, the control signal being configured to control a component of the cardiac assist system; 9. The method of claim 8, further comprising transmitting the control signal to control a component of the cardiac assist system.

15. 1. A cardiac assist system comprising: an inlet cannula for supplying a volumetric flow of blood to the flow pump; an impeller of the flow pump; 1. An apparatus configured to monitor a wear condition of a cardiac assist system, comprising: a reader configured to receive a sensor signal associated with a first operating condition of the impeller of the cardiac assist system; 1. A condition monitoring system, comprising: storing a current fingerprint based at least in part on the sensor signal and comparing the current fingerprint to a predetermined fingerprint based at least in part on a comparison rule; determining a wear signal based at least in part on said comparison; determining a failure prognosis associated with the cardiac assist system based on the wear signal; and an apparatus including a condition monitoring system that performs the step of causing an interface to provide an alert related to the failure prediction.

16. The cardiac assist system of claim 15 , wherein the failure prediction comprises a predicted time of failure of the cardiac assist system.

17. The cardiac assist system of claim 15 , wherein the sensor signal is related to deposits on the impeller or an imbalance of the impeller.

18. 16. The cardiac assist system of claim 15, wherein the sensor signal relates to at least one of position, vibration, acceleration, pressure, rotational speed, temperature, voltage, current, power, light reflection, or electrical resistance associated with the impeller.

19. The cardiac assist system of claim 15 , wherein the sensor signal represents the operating condition of the cardiac assist system in the time domain or the frequency domain.

20. The cardiac assist system of claim 15, wherein the condition monitoring system further comprises providing the sensor signal or the wear signal to an external processing device.

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