CN117282018A - Abnormality detection method and device - Google Patents
Abnormality detection method and device Download PDFInfo
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- CN117282018A CN117282018A CN202311576639.XA CN202311576639A CN117282018A CN 117282018 A CN117282018 A CN 117282018A CN 202311576639 A CN202311576639 A CN 202311576639A CN 117282018 A CN117282018 A CN 117282018A
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Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/205—Non-positive displacement blood pumps
- A61M60/216—Non-positive displacement blood pumps including a rotating member acting on the blood, e.g. impeller
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/403—Details relating to driving for non-positive displacement blood pumps
- A61M60/408—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable
- A61M60/411—Details relating to driving for non-positive displacement blood pumps the force acting on the blood contacting member being mechanical, e.g. transmitted by a shaft or cable generated by an electromotor
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/50—Details relating to control
- A61M60/508—Electronic control means, e.g. for feedback regulation
- A61M60/538—Regulation using real-time blood pump operational parameter data, e.g. motor current
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/802—Constructional details other than related to driving of non-positive displacement blood pumps
- A61M60/804—Impellers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
Abstract
The application provides an anomaly detection method and device, wherein the method comprises the following steps: acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when the ventricular assist device runs at a target rotating speed, and the target information is body information of a target user using the ventricular assist device; estimating a target flow range of a target user according to the target flow curve and the target information; and judging whether the current ventricular assist device has an abnormal event according to the target flow range. According to the method and the device, the flow range required by the user is determined through the body information of the user and the flow change pumped by the ventricular assist device, whether the target user has the left ventricular suction problem or the unloading deficiency problem due to the abnormal rotation speed of the ventricular assist device is judged according to the required flow range, the irrecoverable damage to the user can be prevented, and the user safety is improved.
Description
Technical Field
The application relates to the technical field of medical equipment, in particular to an abnormality detection method and device.
Background
Ventricular assist devices (Ventricular Assist Device, VAD) are mainly used for the protection of high-risk percutaneous coronary intervention PCI procedures. By adding power and pressure to the patient's blood flow, the VAD may partially or completely replace the pumping function of the heart. For example, a VAD is placed in the left ventricle of a patient, and the heart is assisted to achieve a pumping function by pumping blood in the left ventricle into the aorta.
The patient may need different blood flow under different activity conditions, e.g. less blood flow in sleep than in exercise. If the VAD is operated at a flow rate exceeding the flow of blood into the ventricle, the VAD will produce a pumping state within the ventricle that affects clinical outcome and may in extreme cases lead to serious adverse events, so detection and prevention of abnormal events of the VAD is critical to the patient.
Disclosure of Invention
The embodiment of the application provides an abnormality detection method and device, which can detect whether an abnormal event exists in a ventricular assist device so as to prevent irrecoverable damage to a user.
In a first aspect, an embodiment of the present application provides an anomaly detection method, including:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when a ventricular assist device runs at a target rotating speed, the target information is body information of a target user using the ventricular assist device, and the target information comprises weight and height;
estimating a target flow range of the target user according to the target flow curve and the target information;
judging whether the target rotating speed is abnormal or not according to the target flow range;
Wherein said estimating a target flow range of the target user from the target flow curve and the target information comprises: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
In a second aspect, embodiments of the present application provide a control unit, where the control unit includes one or more processors configured to:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when a ventricular assist device runs at a target rotating speed, the target information is body information of a target user using the ventricular assist device, and the target information comprises weight and height;
estimating a target flow range of the target user according to the target flow curve and the target information;
judging whether the target rotating speed is abnormal or not according to the target flow range;
wherein, in terms of estimating a target flow range of the target user according to the target flow curve and the target information, the control unit is specifically configured to: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
In a third aspect, embodiments of the present application provide a ventricular assist device comprising:
a housing;
an impeller disposed within the housing;
a control unit for controlling the suspension rotation of the impeller, wherein the control unit is used for:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when the ventricular assist device runs at a target rotating speed, the target information is body information of a target user using the ventricular assist device, and the target information comprises weight and height;
estimating a target flow range of the target user according to the target flow curve and the target information;
judging whether the target rotating speed is abnormal or not according to the target flow range;
wherein, in terms of estimating a target flow range of the target user according to the target flow curve and the target information, the control unit is specifically configured to: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
In a fourth aspect, embodiments of the present application provide a medical device comprising a processor, a memory, a communication interface, and one or more programs stored in the memory and configured to be executed by the processor, the programs comprising instructions for performing part or all of the steps described in the method of the first aspect above.
In a fifth aspect, embodiments of the present application provide a computer-readable storage medium storing a computer program for electronic data exchange, where the computer program causes a computer to perform some or all of the steps described in the method of the first aspect.
In a sixth aspect, embodiments of the present application provide a computer program product, wherein the computer program product comprises a non-transitory computer readable storage medium storing a computer program, the computer program being operable to cause a computer to perform some or all of the steps described in the method according to the first aspect of the embodiments of the present application. The computer program product may be a software installation package.
According to the technical scheme, a target flow curve and target information are obtained, wherein the target flow curve is a flow curve when the ventricular assist device runs at a target rotating speed, and the target information is body information of a target user using the ventricular assist device; estimating a target flow range of a target user according to the target flow curve and the target information; and judging whether the current ventricular assist device has an abnormal event according to the target flow range. According to the method and the device, the flow range required by the user is determined through the body information of the user and the flow change pumped by the ventricular assist device, whether the target user has the left ventricular suction problem or the unloading deficiency problem due to the abnormal rotation speed of the ventricular assist device is judged according to the required flow range, the irrecoverable damage to the user can be prevented, and the user safety is improved.
Drawings
In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings that are needed in the embodiments will be briefly described below, and it is obvious that the drawings in the following description are some embodiments of the present application, and other drawings may be obtained according to these drawings without inventive effort for a person skilled in the art.
FIG. 1 is a schematic diagram of a ventricular assist device according to an embodiment of the present disclosure;
FIG. 2 is a schematic illustration of a ventricular assist device according to an embodiment of the present application in a normal position of a patient's heart;
fig. 3 is a schematic flow chart of an anomaly detection method according to an embodiment of the present application;
fig. 4 is a schematic structural diagram of a medical device according to an embodiment of the present application.
Detailed Description
For better understanding of the technical solutions of the present application by those skilled in the art, the technical solutions of the embodiments of the present application are clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application, and it is apparent that the described embodiments are only some embodiments of the present application, but not all embodiments. All other embodiments, which can be made by those skilled in the art without the exercise of inventive faculty, are intended to be within the scope of protection of the present application based on the description of the embodiments herein.
The terms first, second and the like in the description and in the claims of the present application and in the above-described figures, are used for distinguishing between different objects and not for describing a particular sequential order. Furthermore, the terms "comprise" and "have," as well as any variations thereof, are intended to cover a non-exclusive inclusion. For example, a process, method, software, article, or apparatus that comprises a list of steps or elements is not limited to only those listed steps or elements but may include other steps or elements not listed or inherent to such process, method, article, or apparatus.
Reference herein to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the present application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Those of skill in the art will explicitly and implicitly appreciate that the embodiments described herein may be combined with other embodiments.
It should be noted that, in the present application, the term "proximal" or "proximal" refers to an end or side closer to the operator; "distal" or "distal" refers to the end or side that is farther from the operator.
Referring to fig. 1-2, fig. 1 is a schematic structural diagram of a ventricular assist device 100 according to an embodiment of the present application, and fig. 2 is a schematic diagram of a ventricular assist device 100 according to an embodiment of the present application in a normal position of a heart 120 of a patient. Ventricular assist device 100 may operate within a left heart, within a right heart, outside a heart, partially outside a vascular system, or in any other suitable location in the vascular system of a patient. The present application illustrates ventricular assist device 100 placement with a left heart, for example.
The ventricular assist device 100 may be percutaneously inserted through the femoral artery 122 into the aorta 124 and through the aorta 124 into the left ventricle 128. For example, the ventricular assist device may be percutaneously inserted into the aorta 124 via the axillary artery 123 and passed through the aorta 124 into the left ventricle. In other embodiments, the ventricular assist device may also be inserted directly into the aorta 124 and through the aorta 124 into the left ventricle 128. During operational operation, ventricular assist device 100 pumps blood in left ventricle 128 into aorta 124.
The ventricular assist device 100 includes a cannula 10. The cannula 10 has a proximal end and a distal end, the distal end of the cannula 10 having a fluid inlet 101, the proximal end of the cannula 10 having a fluid outlet 102, blood flowing in from the fluid inlet 101 and out from the fluid outlet 102 via the cannula 10.
Ventricular assist device 100 includes an impeller (not shown). The impeller is at least partially located at the distal end of the cannula 10, such as at the fluid inlet 101 of the cannula 10, such that the impeller is driven in rotation to pump blood from the left ventricle 128 to the aorta 124 when the ventricular assist device 100 is in operation.
Ventricular assist device 100 may include a motor (not shown) that may be disposed inside ventricular assist device 100 or may be disposed outside ventricular assist device 100. In this embodiment, the motor is disposed inside the ventricular assist device 100, for example, the motor is disposed in the motor housing 201, the distal end of the motor housing 201 is connected to the proximal end of the sleeve 10, and the motor drives the impeller to rotate by driving the driving shaft to rotate, so as to realize the blood pumping function of the ventricular assist device 100.
Ventricular assist device 100 includes a catheter 30, a distal end of catheter 30 being connected to a proximal end of motor housing 201, and a drive cable extending through catheter 30. By way of example, catheter 30 may house electrical connections connecting ventricular assist device 100 to an external controller. Illustratively, the ventricular assist device 100 further includes a distal member 110, such as a pigtail, extending distally away from the distal end of the cannula 10.
Ventricular assist device 100 also includes a control unit that may be used to perform any of the embodiments, aspects, and methods herein. The control unit may be provided inside the ventricular assist device 100 or may be provided outside the ventricular assist device 100. The control unit is used for detecting relevant parameters of the ventricular assist device 100 and the patient and controlling the operation of the ventricular assist device 100, for example, the control unit supplies current to the motor via one or more wires and detects the current via a current detection circuit (e.g., a phase current detection circuit); estimating a present pumping flow rate from the received current, controlling a rotational speed of the ventricular assist device 100 according to the received command; and further detects whether there is an abnormal event such as suction or not, etc., based on the pump speed flow rate and the rotational speed.
The ventricular assist device 100 is positioned such that the cannula 10 extends across the aortic valve 126 of the patient, the distal end of the cannula 10 being located in the left ventricle 128 of the patient, and the proximal end of the cannula 10 being located in the aorta 124 of the patient.
In connection with the above description, the present application is described below from the viewpoint of a method example.
Referring to fig. 3, fig. 3 is a flowchart of an abnormality detection method according to an embodiment of the present application, which is applied to the ventricular assist device 100 shown in fig. 1-2. As shown in fig. 3, the method includes the following steps.
S310, acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when the ventricular assist device operates at a target rotating speed, and the target information is body information of a target user using the ventricular assist device.
During operation of the ventricular assist device 100 in a patient, the flow rate of pumping through the ventricular assist device 100 is dependent upon the resistance of the ventricular assist device 100 to perform work to pump blood from the left ventricle 128 to the aorta 124. The amount of work done by ventricular assist device 100 can be quantified as the amount of current that needs to be provided to the motor, i.e., the motor current corresponds to the amount of current delivered to the motor of ventricular assist device 100 when ventricular assist device 100 is operating in a patient. The load of the motor may vary during different phases of the cardiac cycle of the patient's heart. When the pressure differential in the patient's heart changes, the motor current will also change to keep the rotor speed constant. For example, as the flow rate of blood into the aorta 124 increases (e.g., during systole), the current required by the motor will increase. The change in motor current can therefore help characterize cardiac performance. That is, during operation of ventricular assist device 100, ventricular assist device 100 has a current-flow characteristic, wherein the greater the current, the more ventricular assist device 100 performs, i.e., the greater the pumping flow of ventricular assist device 100.
The current of ventricular assist device 100 may be measured by a phase current detection circuit provided or by any other suitable means, such as a current sensor. The current-flow characteristic curve may be stored in the control unit in advance, and before the ventricular assist device 100 leaves the factory, it may be placed in a test system to test the relationship curve of the pumping flow of the ventricular assist device 100 with the current change at different rotational speeds, respectively, so as to store the current-flow characteristic curve in the control unit. The control unit may store the detected current in real time.
Specifically, when the ventricular assist device 100 operates at the target rotational speed, the control unit obtains a current curve within a preset time period, and then estimates a target flow curve within the preset time period corresponding to the current curve using a pre-stored current-flow characteristic curve. The preset time period is longer than the cardiac cycle of a normal person.
The target information may include weight and height. For an adult patient, the ventricular assist device 100 may be configured to pump blood at a rate of about 1-10L/min at a pump pressure differential of about 10-110mmHg, as desired by the patient, with the patient's desired blood change as the patient's weight and height change. The present application can determine the level of demand for cardiac output by a patient by taking the patient's weight and height.
Specifically, the medical staff may store the measured height and weight information of the patient in the control unit through the external controller or directly before the target user does not implant the ventricular assist device 100, and the control unit may directly obtain the target information of the target user from the storage unit when the ventricular assist device 100 operates at the target rotation speed.
S320, estimating a target flow range of the target user according to the target flow curve and the target information.
In the present application, the target information may determine the level of demand for cardiac output of the target user, i.e. the minimum and maximum demands of the target user on cardiac output. The change of the target flow curve can show the state of the current user, for example, the demand on the cardiac output is less in the static state than in the motion state, the demand on the cardiac output is less in the sleep state than in the static state, the adjustment range of the current cardiac output of the target user can be determined through the change of the target flow curve, and then the current required target flow range of the target user can be estimated by adjusting the demand level of the cardiac output according to the adjustment range.
Optionally, the estimating the target flow range of the target user according to the target flow curve and the target information includes: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
Wherein, the cardiac output of the user in a static or relative static state is not proportional to the body weight, but is proportional to the body surface area as the basal metabolic rate. The body surface area of the target user is calculated by substituting the weight and height of the target user into a formula, which can be expressed as:wherein the body surface area has a unit of m 2 The unit of height is cm and the unit of weight is kg.
The pulsation index, which is the relationship between the number of beats per minute and each beat of the heart, is an index reflecting the function of the heart and can be used to evaluate the heart's load. When the heart is overloaded, the pulsation index increases; as the heart load decreases, the pulsation index decreases, so the pulsation index can be used to monitor changes in cardiac output. The greater the pulsatile blood flow, the more pulsatile components and the greater the pulsatile index. The pulsation index may be calculated from a target flow curve of a target user. And detecting a flow pulsation period of one minute and the amplitude of each pulsation of one minute from the target flow curve, and further calculating the pulsation index of the target user according to the ratio of the amplitude to the period.
For example, the control unit may collect and store the flow pumped by the ventricular assist device in real time, wherein the flow within each time window may be used to calculate the pulsation index, which time window may vary.
In the present application, the control unit may store in advance a mapping table or a relational expression between different body surface areas and flow ranges corresponding to the pulsation indexes, and further determine a target flow range required by the target user by searching the mapping table or the relational expression after calculating the pulsation indexes according to the target flow curve and calculating the body surface areas according to the target information.
S330, judging whether the target rotating speed is abnormal according to the target flow range.
After estimating the target flow range required by the target user, the control unit may compare the current instantaneous flow of the ventricular assist device 100 with the target flow range in real time to determine whether the current flow of the target user meets the required flow range, and further determine whether the target rotational speed is abnormal to affect the heart pumping of the target user. For example, when the flow rate of the target user is above its desired flow rate range, i.e., ventricular assist device 100 is operating at a flow rate exceeding the inflow of blood, ventricular assist device 100 will generate a pumping event within left ventricle 128, causing left ventricle 128 to collapse and be substantially free of blood, thereby failing to provide adequate blood circulation to the target user; when the flow rate of the target user is below its desired flow rate range, i.e., the ventricular assist device 100 is operated at a flow rate below the inflow of blood, the left ventricle load can gradually increase, even exceeding the load capacity of the left ventricle 128, affecting the life safety of the target user.
Optionally, the determining whether the target rotation speed is abnormal according to the target flow range includes: acquiring a target instantaneous flow, wherein the target instantaneous flow is the instantaneous flow of the ventricular assist device running at the target rotating speed at present; if the target instantaneous flow is in the target flow range, determining that the target rotating speed is normal; otherwise, acquiring a target flow parameter of the target user in a first time period according to the target flow curve, and determining that the target rotating speed is abnormal when the target flow parameter and/or the target instantaneous flow meet a target condition.
The target rotational speed anomaly may include: the high target rotating speed causes serious suction problems of the current target user, the high target rotating speed causes slight suction problems of the current target user, the high target rotating speed causes no abnormal problems of the current target user, the low target rotating speed causes insufficient unloading problems of the current target user, and the low target rotating speed causes no abnormal problems of the current target user.
Wherein the target flow parameter comprises a pulsation index period and a maximum flow amplitude difference; the target condition includes any one of the following: the pulsation index period is smaller than a preset period; the maximum flow magnitude difference is less than a first threshold; the pulsation index is smaller than a preset index, the maximum flow amplitude difference is smaller than a second threshold, and the second threshold is larger than the first threshold; the target instantaneous flow is less than a third threshold that is less than the first threshold.
The control unit compares the instantaneous flow rate of the ventricular assist device 100 acquired in real time with the target flow rate range to determine whether the target rotational speed is abnormal. The method comprises the following steps: when the target instantaneous flow is within the target flow range, it indicates that the current rotation speed of the ventricular assist device 100 is normal; when the target instantaneous flow exceeds the target flow range, the rotational speed of the ventricular assist device 100 may be too high resulting in insufficient left ventricular blood flow, or too low of the rotational speed of the ventricular assist device 100 resulting in an abnormal problem of insufficient left ventricular 128 unloading.
Further, to ensure user safety, the control unit may acquire flow related parameters to first determine if operation of the ventricular assist device 100 causes a serious pumping problem in the left ventricle 128 of the target user. Wherein the flow related parameter may include a pulsation index period and a maximum flow magnitude difference, the pulsation index period and the maximum flow magnitude difference being detectable from a target flow curve.
When the target instantaneous flow is lower than the target flow range, the control unit respectively compares the target flow parameter and the target instantaneous flow with the corresponding threshold values, and further determines that the target rotating speed is too high when the pulsation index period, the maximum flow amplitude difference and the target instantaneous flow meet the target conditions, so that the left ventricle of the target user has serious suction or over-suction problems.
Specifically, the pulsation index period is compared with a preset period, the maximum flow amplitude difference is compared with a first threshold value and a second threshold value respectively, the target instantaneous flow is compared with a third threshold value, and the pulsation index is compared with the preset index. If the pulsation index period is smaller than the preset period, determining that the target rotating speed is too high and serious suction or over-suction problems exist; if the maximum flow amplitude difference is smaller than the first threshold value, determining that the target rotating speed is too high and serious suction or over-suction problems exist; if the pulsation index is smaller than the preset index and the maximum flow amplitude difference is smaller than the second threshold, determining that the target rotating speed is too high and serious suction or over-suction problems exist; if the target instantaneous flow is less than the third threshold, determining that the target rotating speed is too high and serious suction or over-suction problems exist.
For example, the first threshold may be set to 1LPM, the second threshold may be set to 2 LPM, and the third threshold may be set to 0. The preset period may be 30 and the preset index may be 40.
Optionally, after determining that the target rotation speed is abnormal, the method further includes: if the ith instantaneous flow is smaller than the third threshold, stepping the ith rotating speed down to a target speed, wherein the ith instantaneous flow is the instantaneous flow when the ventricular assist device operates at the ith rotating speed, and the i is a positive integer; repeating the steps until the ith rotating speed is less than or equal to k times of the target rotating speed, wherein k is greater than 0 and less than 1; and when i=1, the ith rotating speed is the target rotating speed, and the ith instantaneous flow is the target instantaneous flow.
When the control unit determines that there is a serious pumping problem for the target user, the control unit may periodically decrease the rotational speed of the ventricular assist device 100 until the instantaneous flow rate of the ventricular assist device 100 is greater than the third threshold. The method comprises the following steps: the target rotational speed is reduced by a target speed step and then a check is made to see if the instantaneous flow rate of the ventricular assist device 100 after the rotational speed reduction by the target speed step is greater than a third threshold during the cycle time. If the instantaneous flow rate is greater than the third threshold value during the cycle time, determining the rotational speed of the ventricular assist device 100 as the rotational speed after the step of decreasing the target speed; otherwise, the rotational speed of the ventricular assist device 100 is continuously reduced by the target rotational speed step in the next cycle until the rotational speed of the ventricular assist device 100 is reduced by k times the target rotational speed.
Where k may be set according to the body surface area of the target user and the degree of heart failure, for example, k may be set to values of 0.7, 0.8, 0.85, 0.9, etc. By way of example, k is 0.7.
In one possible example, the method further comprises: increasing the j-th rotating speed by a target speed step, wherein j is a positive integer; if the j+1th instantaneous flow is greater than the j-th instantaneous flow, the j+1th instantaneous flow is the instantaneous flow of the ventricular assist device in step operation by increasing the target speed by the j-th rotating speed, determining that the ventricular assist device is normal in operation, and repeating the steps until the j+1th rotating speed is less than or equal to n times the target rotating speed, wherein n is greater than 1; if the j+1th instantaneous flow is smaller than or equal to the j instantaneous flow, determining that the target rotating speed is abnormal; and when j=1, the j-th rotating speed is the target rotating speed, and the j-th instantaneous flow is the target instantaneous flow.
When the target instantaneous flow exceeds the target flow range, the control unit may first determine whether there is a serious aspiration or overspray problem in the left ventricle 128 of the target user. After the target user's left ventricle 128 does not have a serious pumping or overspray problem, it is further determined whether the target user's left ventricle 128 has a slight pumping or underspray problem.
Judging that there is a slight pumping problem for the target user duration, the control unit may periodically increase the target rotational speed by a target speed step and then look at the change in pumping flow rate after increasing the rotational speed of the ventricular assist device 100 by the target speed step. If the pumping flow rate after the increase of the target speed step increases with the increase of the rotation speed, it may be determined that the target user does not have a slight pumping problem at present, and the rotation speed of the ventricular assist device 100 is continuously increased by the target rotation speed step in the next period until the rotation speed of the ventricular assist device 100 is increased by n times the target rotation speed; if the pumping flow rate after increasing the target speed step does not increase with increasing rotational speed, it can be determined that the target user is currently experiencing a slight pumping problem.
Further, during the gradual increase of the rotational speed of the ventricular assist device 100, the control unit may also compare the amount of change in the average flow rate of the ventricular assist device 100 after each increase in the target rotational speed step, which may be an average of the instantaneous flow rates over the cycle time. If the average flow rate after the j-th increase target rotational speed step is less than the average flow rate after the j-1 th increase target rotational speed step, ventricular assist device 100 may be determined as the rotational speed after the j-1 th increase target rotational speed step.
In the event of a slight pumping problem in the left ventricle of the target user, the control unit may periodically decrease the rotational speed of the ventricular assist device 100 to avoid serious pumping problems in the target user. The control unit may control the current rotation speed of the ventricular assist device 100 to decrease the target rotation speed step, and if the flow rate pumped by the ventricular assist device 100 increases with an increase in the rotation speed after the target rotation speed step is decreased, determine the rotation speed of the ventricular assist device 100 as the rotation speed after the target rotation speed step is decreased; if the flow rate pumped by the ventricular assist device 100 does not increase with an increase in rotational speed after the target rotational speed step is decreased, the rotational speed of the ventricular assist device 100 is continuously decreased by the target rotational speed step in the next cycle until the rotational speed of the ventricular assist device 100 is decreased to k times the target rotational speed.
In the present application, the control unit may detect whether the rotation speed of the ventricular assist device 100 is abnormal according to the flow range required by the body information of the target user in different active states, and may improve the accuracy of the abnormality detection. When the rotation speed of the ventricular assist device 100 is abnormal, whether the target user has a serious suction problem or a slight suction problem is further judged, and then under the suction problems of different degrees, the flow rate of the ventricular assist device is regulated by regulating the rotation speed of the ventricular assist device 100, so that the target user is prevented from serious accidents, and the abnormal risk is reduced.
Wherein, n and the target rotational speed step can be set according to the body surface area and heart failure degree of the target user, for example, n can be set to values of 1.1, 1.3, 1.5, 1.8 and the like, and the target rotational speed step can be set to 10rpm/min, 15rpm/min, 20rpm/min, 30rpm/min. Illustratively, n is 1.2 and the target rpm step is 20rpm/min.
For example, when the rotational speed of the ventricular assist device is adjusted by the control unit beyond a preset time while the left ventricle of the target user is still experiencing a gentle pumping problem, the control unit may alert to alert the healthcare worker that the current target user is experiencing a gentle pumping problem. In the application, different lamplight colors and/or sound sizes can be used for respectively giving alarm prompts for light pumping problems, serious pumping problems and out-of-range flow of target users.
In this application, the control unit may fine tune the flow rate of the ventricular assist device 100 when it is determined that the flow rate pumped by the ventricular assist device 100 when it is operated at the target rotational speed exceeds the flow rate required by the target user, but the target user has not suffered an abnormal problem temporarily, or the flow rate pumped by the ventricular assist device 100 when it is operated at the target rotational speed is lower than the flow rate required by the target user, resulting in overload of the left ventricle 128 of the target user. When the target instantaneous flow rate is below the target flow rate range, the rotational speed of the ventricular assist device 100 may be increased to increase the flow rate; when the target instantaneous flow rate is higher than the target flow rate range, then decreasing the rotational speed of the ventricular assist device 100 to decrease the flow rate; when the target instantaneous flow is within the target flow range, the regulation is stopped. The fine tuning means that the step of increasing or decreasing the rotational speed of the ventricular assist device 100 is less than the target rotational speed step, such as 3rpm/min, 5rpm/min, 7 rpm/min, etc.
Further, when the control unit fine-adjusts the rotation speed of the ventricular assist device 100, it increases the rotation speed of the ventricular assist device 100 by n times the target rotation speed, and decreases the rotation speed of the ventricular assist device 100 by k times the target rotation speed. And when the control unit fine-adjusts the ventricular assist device 100 for more than 5min and the flow rate of the ventricular assist device 100 is still within the target flow rate range, the control unit can alarm to the medical staff to prompt that the current flow rate of the ventricular assist device 100 is not within the normal range.
According to the method and the device, when the pumping flow of the ventricular assist device 100 exceeds the flow range required by the target user, the rotating speed of the ventricular assist device 100 can be automatically adjusted to adjust the pumping flow to the flow range required by the target user, the occurrence of insufficient pumping or unloading problems can be prevented while the flow accuracy is improved, and the safety of the user is improved.
In one possible example, the method further comprises: acquiring a target pressure flow curve, wherein the target pressure flow curve is a pressure flow curve when the ventricular assist device operates at the target rotating speed; determining a maximum differential pressure according to the target pressure flow curve and the target flow curve; and if the maximum pressure difference is smaller than a preset pressure difference, continuously reducing the target rotating speed until the maximum pressure difference is larger than or equal to the preset pressure difference.
In this application, the control unit may also detect the pulse pressure difference amplitude of the target user in real time to determine whether the aortic valve 126 of the target user is open during the systolic period, where the pulse pressure difference is the difference between the left ventricular pressure and the aortic pressure.
Before the ventricular assist device 100 leaves the factory, the ventricular assist device 100 can be put into a test system for testing, a relationship curve of a pressure difference between an outlet pressure and an inlet pressure of the ventricular assist device 100 and a pumping flow rate at different rotational speeds is measured, that is, a plurality of pressure flow rate curves of the ventricular assist device 100 are measured in advance, and the pressure flow rate curves at different rotational speeds are stored in the control unit. When the ventricular assist device 100 is operated, the control unit may search a target pressure flow rate curve corresponding to the target rotational speed from the stored plurality of pressure flow rate curves according to the target rotational speed, and further determine a differential pressure curve at the target rotational speed according to the target flow rate curve.
The control unit may look for a maximum pressure difference from the pressure difference curve, and if the maximum pressure difference is smaller than the preset pressure difference, it indicates that the aortic valve 126 is not opened during the systole of the cardiac cycle by the target user, and also indicates that the rotational speed of the ventricular assist device 100 is too high, resulting in that the left ventricular pressure does not rise above the aortic pressure during the systole, so that the aortic valve 126 is also closed all the time during the systole. Therefore, when the control unit detects that the maximum pressure difference is smaller than the preset pressure difference, the rotation speed or the flow rate of the ventricular assist device 100 can be periodically reduced until the maximum pressure difference is greater than or equal to the preset pressure difference.
The preset pressure difference can be the average pressure difference value between the left ventricular pressure and the aortic pressure of a normal person during contraction.
Further, if the control unit adjusts the rotational speed and the flow rate of the ventricular assist device 100 within the preset time period, and the maximum differential pressure is not greater than or equal to the preset differential pressure, the control unit may alert the medical staff to prompt the target user that the current aortic valve 126 is not opened, which may cause a risk of thrombus.
It can be seen that the present application proposes an anomaly detection method, in which a target flow rate curve and target information are obtained, the target flow rate curve being a flow rate curve when the ventricular assist device is operated at a target rotational speed, the target information being body information of a target user who uses the ventricular assist device; estimating a target flow range of a target user according to the target flow curve and the target information; and judging whether the current ventricular assist device has an abnormal event according to the target flow range. According to the method and the device, the flow range required by the user is determined through the body information of the user and the flow change pumped by the ventricular assist device, whether the target user has the left ventricular suction problem or the unloading deficiency problem due to the abnormal rotation speed of the ventricular assist device is judged according to the required flow range, the irrecoverable damage to the user can be prevented, and the user safety is improved.
The foregoing description of the embodiments of the present application has been presented primarily in terms of a method-side implementation. It will be appreciated that the network device, in order to implement the above-described functions, includes corresponding hardware structures and/or software modules that perform the respective functions. Those of skill in the art will readily appreciate that the elements and algorithm steps described in connection with the embodiments disclosed herein may be embodied as hardware or a combination of hardware and computer software. Whether a function is implemented as hardware or computer software driven hardware depends upon the particular application and design constraints imposed on the solution. Skilled artisans may implement the described functionality in varying ways for each particular application, but such implementation decisions should not be interpreted as causing a departure from the scope of the present application.
By way of example, the present application provides a control circuit comprising a circuit having one or more processors configured to: acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when a ventricular assist device runs at a target rotating speed, and the target information is body information of a target user using the ventricular assist device; estimating a target flow range of the target user according to the target flow curve and the target information; and judging whether the target rotating speed is abnormal according to the target flow range.
Optionally, the target information includes weight and height; the estimating the target flow range of the target user according to the target flow curve and the target information comprises the following steps: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
Optionally, the determining whether the target rotation speed is abnormal according to the target flow range includes: acquiring a target instantaneous flow, wherein the target instantaneous flow is the instantaneous flow of the ventricular assist device running at the target rotating speed at present; if the target instantaneous flow is in the target flow range, determining that the target rotating speed is normal; otherwise, acquiring a target flow parameter of the target user in a first time period according to the target flow curve, and determining that the target rotating speed is abnormal when the target flow parameter and/or the target instantaneous flow meet a target condition.
Optionally, the target flow parameter includes a pulsation index period and a maximum flow amplitude difference; the target condition includes any one of the following: the pulsation index period is smaller than a preset period; the maximum flow magnitude difference is less than a first threshold; the pulsation index is smaller than a preset index, the maximum flow amplitude difference is smaller than a second threshold, and the second threshold is larger than the first threshold; the target instantaneous flow is less than a third threshold that is less than the first threshold.
Optionally, the method further comprises: increasing the j-th rotating speed by a target speed step, wherein j is a positive integer; if the j+1th instantaneous flow is greater than the j-th instantaneous flow, the j+1th instantaneous flow is the instantaneous flow of the ventricular assist device in step operation by increasing the target speed by the j-th rotating speed, determining that the ventricular assist device is normal in operation, and repeating the steps until the j+1th rotating speed is less than or equal to n times the target rotating speed, wherein n is greater than 1; if the j+1th instantaneous flow is smaller than or equal to the j instantaneous flow, determining that the target rotating speed is abnormal; and when j=1, the j-th rotating speed is the target rotating speed, and the j-th instantaneous flow is the target instantaneous flow.
Optionally, after determining that the target rotation speed is abnormal, the method further includes: if the ith instantaneous flow is smaller than the third threshold, stepping the ith rotating speed down to a target speed, wherein the ith instantaneous flow is the instantaneous flow when the ventricular assist device operates at the ith rotating speed, and the i is a positive integer; repeating the steps until the ith rotating speed is less than or equal to k times of the target rotating speed, wherein k is greater than 0 and less than 1; and when i=1, the ith rotating speed is the target rotating speed, and the ith instantaneous flow is the target instantaneous flow.
Optionally, the method further comprises: acquiring a target pressure flow curve, wherein the target pressure flow curve is a pressure flow curve when the ventricular assist device operates at the target rotating speed; determining a maximum differential pressure according to the target pressure flow curve and the target flow curve; and if the maximum pressure difference is smaller than a preset pressure difference, continuously reducing the target rotating speed until the maximum pressure difference is larger than or equal to the preset pressure difference.
By way of example, the present application also provides a ventricular assist device comprising:
a housing;
an impeller disposed within the housing;
a control unit for controlling the suspension rotation of the impeller, wherein the control unit is used for:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when the ventricular assist device runs at a target rotating speed, and the target information is body information of a target user using the ventricular assist device;
estimating a target flow range of the target user according to the target flow curve and the target information;
and judging whether the target rotating speed is abnormal according to the target flow range.
The present application also provides, for example, a medical device comprising the control unit or the ventricular assist device described above.
The control circuit of each scheme has the function of realizing the corresponding steps executed by the medical equipment in the method; the functions may be implemented by hardware, or may be implemented by hardware executing corresponding software.
In the embodiments of the present application, the control circuit may also be a chip or a chip system, for example: system on chip (SoC).
Referring to fig. 4, fig. 4 is a schematic structural diagram of a medical device according to an embodiment of the present application, where the medical device includes: one or more processors, one or more memories, one or more communication interfaces, and one or more programs; the one or more programs are stored in the memory and configured to be executed by the one or more processors.
The program includes instructions for performing the steps of:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when a ventricular assist device runs at a target rotating speed, and the target information is body information of a target user using the ventricular assist device; estimating a target flow range of the target user according to the target flow curve and the target information; and judging whether the target rotating speed is abnormal according to the target flow range.
All relevant contents of each scenario related to the above method embodiment may be cited to the functional description of the corresponding functional module, which is not described herein.
It should be appreciated that the memory described above may include read only memory and random access memory and provide instructions and data to the processor. A portion of the memory may also include non-volatile random access memory. For example, the memory may also store information of the device type.
In an embodiment of the present application, the processor of the above apparatus may be a central processing unit (Central Processing Unit, CPU), which may also be other general purpose processors, digital Signal Processors (DSPs), application Specific Integrated Circuits (ASICs), field Programmable Gate Arrays (FPGAs) or other programmable logic devices, discrete gate or transistor logic devices, discrete hardware components, etc. A general purpose processor may be a microprocessor or the processor may be any conventional processor or the like.
It should be understood that references to "at least one" in embodiments of the present application mean one or more, and "a plurality" means two or more. "and/or", describes an association relationship of an association object, and indicates that there may be three relationships, for example, a and/or B, and may indicate: a alone, a and B together, and B alone, wherein a, B may be singular or plural. The character "/" generally indicates that the context-dependent object is an "or" relationship. "at least one of" or the like means any combination of these items, including any combination of single item(s) or plural items(s). For example, at least one (one) of a, b, or c may represent: a, b, c, a-b, a-c, b-c, or a-b-c, wherein a, b, c may be single or plural.
In implementation, the steps of the above method may be performed by integrated logic circuits of hardware in a processor or by instructions in the form of software. The steps of a method disclosed in connection with the embodiments of the present application may be embodied directly in a hardware processor for execution, or in a combination of hardware and software elements in the processor for execution. The software elements may be located in a random access memory, flash memory, read-only memory, programmable read-only memory or electrically erasable programmable memory, registers, etc. as well known in the art. The storage medium is located in a memory, and the processor executes instructions in the memory to perform the steps of the method described above in conjunction with its hardware. To avoid repetition, a detailed description is not provided herein.
The present application also provides a computer storage medium storing a computer program for electronic data exchange, the computer program causing a computer to execute some or all of the steps of any one of the methods described in the method embodiments above.
Embodiments of the present application also provide a computer program product comprising a non-transitory computer-readable storage medium storing a computer program operable to cause a computer to perform some or all of the steps of any one of the methods described in the method embodiments above. The computer program product may be a software installation package.
It should be noted that, for simplicity of description, the foregoing method embodiments are all expressed as a series of action combinations, but it should be understood by those skilled in the art that the present application is not limited by the order of actions described, as some steps may be performed in other order or simultaneously in accordance with the present application. Further, those skilled in the art will also appreciate that the embodiments described in the specification are all preferred embodiments, and that the acts and modules referred to are not necessarily required in the present application.
In the foregoing embodiments, the descriptions of the embodiments are emphasized, and for parts of one embodiment that are not described in detail, reference may be made to related descriptions of other embodiments.
The integrated units described above, if implemented in the form of software functional units and sold or used as stand-alone products, may be stored in a computer readable memory. Based on such understanding, the technical solution of the present application may be embodied essentially or in part or all of the technical solution contributing to the prior art or in the form of a software product stored in a memory, comprising several instructions for causing a computer device (which may be a personal computer, a server or TRP, etc.) to perform all or part of the steps of the methods of the various embodiments of the present application. And the aforementioned memory includes: a U-disk, a Read-Only Memory (ROM), a random access Memory (RAM, random Access Memory), a removable hard disk, a magnetic disk, or an optical disk, or other various media capable of storing program codes.
Those of ordinary skill in the art will appreciate that all or a portion of the steps in the various methods of the above embodiments may be implemented by a program that instructs associated hardware, and the program may be stored in a computer readable memory, which may include: flash disk, ROM, RAM, magnetic or optical disk, etc.
The foregoing has outlined rather broadly the more detailed description of embodiments of the present application, wherein specific examples are provided herein to illustrate the principles and embodiments of the present application, the above examples being provided solely to assist in the understanding of the methods of the present application and the core ideas thereof; meanwhile, as those skilled in the art will have modifications in the specific embodiments and application scope in accordance with the ideas of the present application, the present description should not be construed as limiting the present application in view of the above.
Claims (10)
1. An anomaly detection method, the method comprising:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when a ventricular assist device runs at a target rotating speed, the target information is body information of a target user using the ventricular assist device, and the target information comprises weight and height;
Estimating a target flow range of the target user according to the target flow curve and the target information;
judging whether the target rotating speed is abnormal or not according to the target flow range;
wherein the estimating the target flow range of the target user according to the target flow curve and the target information includes: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
2. The method of claim 1, wherein said determining whether the target rotational speed is abnormal based on the target flow range comprises:
acquiring a target instantaneous flow, wherein the target instantaneous flow is the instantaneous flow of the ventricular assist device running at the target rotating speed at present;
if the target instantaneous flow is in the target flow range, determining that the target rotating speed is normal;
otherwise, acquiring a target flow parameter of the target user in a first time period according to the target flow curve, and determining that the target rotating speed is abnormal when the target flow parameter and/or the target instantaneous flow meet a target condition.
3. The method of claim 2, wherein the target flow parameter comprises a pulsation index period and a maximum flow magnitude difference; the target condition includes any one of the following:
the pulsation index period is smaller than a preset period;
the maximum flow magnitude difference is less than a first threshold;
the pulsation index is smaller than a preset index, the maximum flow amplitude difference is smaller than a second threshold, and the second threshold is larger than the first threshold;
the target instantaneous flow is less than a third threshold that is less than the first threshold.
4. A method according to claim 3, characterized in that the method further comprises:
increasing the j-th rotating speed by a target speed step, wherein j is a positive integer;
if the j+1th instantaneous flow is greater than the j-th instantaneous flow, the j+1th instantaneous flow is the instantaneous flow of the ventricular assist device in step operation by increasing the target speed by the j-th rotating speed, determining that the ventricular assist device is normal in operation, and repeating the steps until the j+1th rotating speed is less than or equal to n times the target rotating speed, wherein n is greater than 1;
if the j+1th instantaneous flow is smaller than or equal to the j instantaneous flow, determining that the target rotating speed is abnormal;
And when j=1, the j-th rotating speed is the target rotating speed, and the j-th instantaneous flow is the target instantaneous flow.
5. The method according to claim 3 or 4, characterized in that after determining the target rotation speed abnormality, the method further comprises:
if the ith instantaneous flow is smaller than the third threshold, stepping the ith rotating speed down to a target speed, wherein the ith instantaneous flow is the instantaneous flow when the ventricular assist device operates at the ith rotating speed, and the i is a positive integer;
repeating the steps until the ith rotating speed is less than or equal to k times of the target rotating speed, wherein k is greater than 0 and less than 1;
and when i=1, the ith rotating speed is the target rotating speed, and the ith instantaneous flow is the target instantaneous flow.
6. The method according to claim 1, wherein the method further comprises:
acquiring a target pressure flow curve, wherein the target pressure flow curve is a pressure flow curve when the ventricular assist device operates at the target rotating speed;
determining a maximum differential pressure according to the target pressure flow curve and the target flow curve;
and if the maximum pressure difference is smaller than a preset pressure difference, continuously reducing the target rotating speed until the maximum pressure difference is larger than or equal to the preset pressure difference.
7. A control unit comprising one or more processors configured to:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when a ventricular assist device runs at a target rotating speed, the target information is body information of a target user using the ventricular assist device, and the target information comprises weight and height;
estimating a target flow range of the target user according to the target flow curve and the target information;
judging whether the target rotating speed is abnormal or not according to the target flow range;
wherein, in terms of estimating a target flow range of the target user according to the target flow curve and the target information, the control unit is specifically configured to: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
8. A ventricular assist device, the ventricular assist device comprising:
a housing;
An impeller disposed within the housing;
a control unit for controlling the suspension rotation of the impeller, wherein the control unit is used for:
acquiring a target flow curve and target information, wherein the target flow curve is a flow curve when the ventricular assist device runs at a target rotating speed, the target information is body information of a target user using the ventricular assist device, and the target information comprises weight and height;
estimating a target flow range of the target user according to the target flow curve and the target information;
judging whether the target rotating speed is abnormal or not according to the target flow range;
wherein, in terms of estimating a target flow range of the target user according to the target flow curve and the target information, the control unit is specifically configured to: calculating the pulsation index of the target user according to the target flow curve; calculating the body surface area of the target user according to the weight and the height; and estimating the target flow range according to the pulsation index and the body surface area.
9. A medical device comprising a processor, a memory and a communication interface, the memory storing one or more programs, and the one or more programs being executed by the processor, the one or more programs comprising instructions for performing the steps in the method of any of claims 1-6.
10. A computer readable storage medium storing a computer program for electronic data exchange, wherein the computer program causes a computer to perform the steps of the method according to any one of claims 1-6.
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