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WO2017008479A1 - 静脉注射泄漏的检测系统和检测方法 - Google Patents

静脉注射泄漏的检测系统和检测方法 Download PDF

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Publication number
WO2017008479A1
WO2017008479A1 PCT/CN2016/070475 CN2016070475W WO2017008479A1 WO 2017008479 A1 WO2017008479 A1 WO 2017008479A1 CN 2016070475 W CN2016070475 W CN 2016070475W WO 2017008479 A1 WO2017008479 A1 WO 2017008479A1
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Prior art keywords
field parameter
parameter
module
conductivity
temperature
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PCT/CN2016/070475
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English (en)
French (fr)
Inventor
李正龙
张丽杰
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京东方科技集团股份有限公司
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Priority to US15/113,708 priority Critical patent/US11152096B2/en
Priority to EP16734166.8A priority patent/EP3144023B1/en
Publication of WO2017008479A1 publication Critical patent/WO2017008479A1/zh

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    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H20/00—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
    • G16H20/10—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients
    • G16H20/17—ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance relating to drugs or medications, e.g. for ensuring correct administration to patients delivered via infusion or injection
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile
    • G—PHYSICS
    • G06—COMPUTING; CALCULATING OR COUNTING
    • G06F—ELECTRIC DIGITAL DATA PROCESSING
    • G06F17/00—Digital computing or data processing equipment or methods, specially adapted for specific functions
    • G06F17/10—Complex mathematical operations
    • G06F17/16—Matrix or vector computation, e.g. matrix-matrix or matrix-vector multiplication, matrix factorization
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63—ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/13—General characteristics of the apparatus with means for the detection of operative contact with patient, e.g. lip sensor
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/15—Detection of leaks
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/18—General characteristics of the apparatus with alarm
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3306—Optical measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3317—Electromagnetic, inductive or dielectric measuring means
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/33—Controlling, regulating or measuring
    • A61M2205/3368—Temperature
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3553—Range remote, e.g. between patient's home and doctor's office
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/35—Communication
    • A61M2205/3546—Range
    • A61M2205/3569—Range sublocal, e.g. between console and disposable
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/50—General characteristics of the apparatus with microprocessors or computers
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
    • A61M2205/587—Lighting arrangements
    • G—PHYSICS
    • G16—INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16H—HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H50/00—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics
    • G16H50/20—ICT specially adapted for medical diagnosis, medical simulation or medical data mining; ICT specially adapted for detecting, monitoring or modelling epidemics or pandemics for computer-aided diagnosis, e.g. based on medical expert systems

Definitions

  • the invention relates to the technical field of medical instruments, in particular to a detection system and a detection method for intravenous injection leakage.
  • Intravenous injection is a medical technique that uses a catheter to deliver a therapeutic drug directly into a patient.
  • intravenous techniques include common intravenous techniques and central venous catheter techniques.
  • a catheter needle is inserted into a vein of a patient's arm, hand, foot, ankle, or head, and an intravenous infusion is performed by suspending the injection liquid, and the injection liquid is directly delivered into the patient's blood vessel.
  • a central venous catheter needle is inserted into a large vein, such as the internal jugular vein, the subclavian vein or the femoral vein, and a plurality of fluids are introduced into the large vein.
  • the central venous catheter technique also requires frequent fluid administration, and its input liquid is long and large in volume relative to conventional intravenous injection techniques.
  • intravenous injection can only be discovered by humans, that is, after a period of implementation of intravenous puncture, when the patient's acupuncture has a bulge on the skin or a water seepage occurs in the acupuncture, the intravenous injection can be found, due to different people. There are different signs of signs, some people may have obvious bulging skin when the intravenous injection has just occurred, which is easy to observe; and some people may have the above-mentioned skin bulging after a period of intravenous injection. At this time, it can be observed. Therefore, this kind of visual inspection by the human eye finds that the intravenous leak is inaccurate and cannot be found in time.
  • a detection system for an intravenous leak comprising: a detection module for detecting a state parameter of a skin at a needle; and
  • An analysis module configured to acquire the state parameter, and determine a vein according to the state parameter Whether the injection has leaked.
  • a method of detecting an intravenous leak comprising:
  • Whether or not the intravenous injection leaks is determined based on the state parameter.
  • the detection system for intravenous injection provided by the present invention has the above structure, and the state parameter of the skin at the needling point changes rapidly due to the leakage of the intravenous injection, and the present invention determines whether the intravenous injection leaks according to the state parameter of the skin at the acupuncture point.
  • Intravenous leakage can be found in time, so that the leakage liquid does not accumulate in the human body in a large amount, and thus the problem that the leakage of the intravenous liquid cannot be accurately detected in the prior art can be solved.
  • the detection method of the intravenous injection leak has the same advantages as the prior art detection system of the intravenous injection, and will not be described herein.
  • FIG. 1 is a schematic view of a system for detecting an intravenous leak provided by the overall concept of the present invention
  • FIG 2 is a schematic illustration of one specific example of the detection system for intravenous injection shown in Figure 1;
  • FIG 3 is a schematic view of the temperature measuring module shown in Figure 2;
  • FIG. 4 is a schematic view showing another specific example of the detection system of the intravenous injection shown in FIG. 1;
  • FIG. 5 is a schematic illustration of the conductivity module shown in Figure 4.
  • Figure 6 is a schematic view showing still another specific example of the detection system of the intravenous injection shown in Figure 1;
  • FIG. 7 is a flowchart of a method for detecting an intravenous leak according to an embodiment of the present invention.
  • 1-detection module 11-temperature measurement module; 111-visible light emitter;
  • the temperature of the internal tissue of the human body is a constant value that is higher than the normal liquid temperature in the environment in which the human body is located.
  • the temperature of the linear human tissue along the blood flow direction of the vein gradually changes slowly in the human tissue at the acupuncture (within a certain range centered on the needle).
  • the intravenous fluid leaks, the leaked liquid accumulates in the human tissue close to the needle, so that the temperature of the block-shaped human tissue close to the needle in the human tissue at the needling point is rapidly lowered.
  • the temperature field parameters of the skin at the needling point can be determined by detecting the temperature field parameters of the skin at the acupuncture point.
  • the temperature field parameter includes the temperature of a plurality of points in the skin at the needling point, wherein the plurality of points include a point at the needle.
  • the temperature field parameter includes the temperature of a plurality of points in the skin at the needling point, wherein the plurality of points do not include points at the needle.
  • the temperature field parameter may include the skin at the acupuncture point. At least one temperature near the point of the needle.
  • the electrical conductivity of human skin and muscle is within a certain range.
  • an intravenous fluid contains an electrolyte, such as physiological saline
  • the intravenous fluid is a strong conductor of electricity and has a high electrical conductivity; when the intravenous fluid leaks, the leakage liquid accumulates in the body tissue near the intravenous catheter needle, resulting in The conductivity there is increased.
  • the intravenous fluid contains pure water and non-electrolytes, such as pure water and glucose, the intravenous fluid is an insulator or a weak conductor of electricity, and the electrical conductivity is extremely low; when the intravenous injection leaks, the leakage liquid accumulates in the intravenous catheter needle. Within the nearby human tissue, the conductivity is reduced there.
  • the conductivity field distribution at the skin is directly affected by the electrical conductivity of the skin itself or the electrical conductivity of the subcutaneous tissue in the skin. Therefore, it is possible to determine whether the intravenous injection is leaked by detecting the change in the conductivity field of the skin of the needle of the intravenous catheter needle.
  • detecting the electrical conductivity between any two adjacent points in the plurality of points of the skin at the needle as the conductivity field of the skin at the needling, preferably, the plurality of points are evenly distributed in the skin of the needle Distribution; when the intravenous injection leaks, the needle is placed In the skin, the electrical conductivity between the two points closest to the skin at the needle changes, and the electrical conductivity between the two points of the remaining skin does not change, so it can be judged by detecting whether any conductivity in the conductivity field changes. Whether the intravenous injection leaks.
  • Embodiments of the present invention provide a detection system for intravenous leakage.
  • the detection system includes a detection module 1 and an analysis module 2.
  • the detecting module 1 is configured to detect a state parameter of the skin at the needling point;
  • the analyzing module 2 is configured to acquire a state parameter, and determine whether the intravenous injection has a leak according to the state parameter.
  • the skin at the acupuncture may be a certain range of skin centered on the acupuncture, and the skin at the acupuncture may be the epidermis, dermis or subcutaneous tissue of the skin at the acupuncture.
  • the communication mode between the detection module 1 and the analysis module 2 may be communication by wire, or may be performed by wireless.
  • the state parameter can include at least one of a temperature field parameter and a conductivity field parameter.
  • the embodiment of the invention provides a detection system for intravenous injection, and the detection module 1 can detect the state parameter of the skin at the needling point in real time, so that the analysis module 2 can determine whether the intravenous injection leaks according to the state parameter in real time, and because of the acupuncture
  • the state parameter of the skin changes in the early stage of the injection liquid leakage, so that the intravenous fluid leakage can be accurately and timely detected, and the patient can obtain the prescribed dose of the injection liquid to achieve the therapeutic effect.
  • the detecting module 1 can have three structures. To facilitate understanding by those skilled in the art, the following three structures are respectively described in detail.
  • the state parameter includes a temperature field parameter
  • the detecting module 1 includes a temperature measuring module 11
  • the temperature measuring module 11 is configured to detect a temperature field parameter of the skin at the needling point
  • the analyzing module 2 is specifically configured to obtain Temperature field parameters, and based on temperature field parameters to determine whether the injection has leaked.
  • the temperature field parameter can include the temperature of at least one point in the skin at the needling that is near the needle, and the temperature measurement module 11 detects the temperature of at least one of the skin at the needle point near the needle to form a temperature field parameter.
  • the temperature measurement module 11 includes a contact temperature measurement module or a non-contact temperature measurement module, the contact temperature measurement module contacts the skin of the needle, and the non-contact temperature measurement module does not contact the skin of the needle.
  • the contact temperature measuring module may be a pad-shaped thermometer covering the needled skin or a thermometer placed around the skin of the needle, and only the temperature field of the skin at the needling may be detected.
  • the temperature measurement module 11 includes a non-contact temperature measurement module, the non-contact temperature measurement module includes a visible light emitter 111 and a temperature measurement probe 112; and the visible light emitter 111 is used to illuminate a needle.
  • the temperature measuring probe 112 is configured to detect the temperature field parameter of the skin of the needle point B according to the position of the needle point B.
  • the visible light emitter 111 can emit light that is recognizable by the human eye, so that the user (nurse, patient or patient's family) can adjust the irradiation position and direction of the visible light emitter 111, so that the visible light emitter 111 illuminates the needling point B,
  • the position of the needling point B is determined;
  • the temperature measuring probe 112 can be an infrared temperature measuring probe.
  • the visible light emitter 111 and the temperature measuring module 112 may be two separate modules, or may be a module or a component packaged together, which is not specifically limited herein.
  • the temperature measuring module 11 can be fixed around the patient using a bracket, or can be held by the user. Preferably, the temperature measuring module 11 is fixedly disposed without wasting labor.
  • the temperature measuring module 11 is a contact type temperature measuring module or a non-contact type temperature measuring module, the above module can detect the temperature of the skin at the needling point without invading the human tissue, and thus does not cause harm to the patient, and is relatively simple.
  • the analysis module 2 is specifically configured to acquire a temperature field parameter, and determine whether the intravenous injection leaks through the classifier method according to the temperature field parameter; or obtain a temperature field parameter, and calculate by a statistical regression method according to the temperature field parameter.
  • the probability of an intravenous leak when the probability is greater than the first threshold, determines that a leak has occurred in the intravenous injection.
  • the first classifier is a computing tool, which may include a specific classifier such as a decision tree, a neural network, a linear classifier, and a secondary classifier.
  • the classifier includes a plurality of specific classifiers. Since it is a prior art, the present invention is not exhaustive, and only a few common specific classifiers are exemplified, but the present invention is not limited thereto. It should be noted that, since the classifier is an existing common calculation tool, the following only exemplarily describes the working process of a specific classifier, and other specific classifiers not exemplified can be obtained according to the prior art. I won't go into details here.
  • the analyzing module 2 determines, by the classifier method, whether the intravenous injection has a leak according to the temperature field parameter, the analyzing module 2 may calculate the skin area at the acupuncture according to the measured temperature field parameter.
  • the characteristic of the temperature field is used to analyze the change of the temperature field.
  • the temperature field parameter measured in the above-mentioned one time may include the temperature of a plurality of points in the skin at the acupuncture, and the plurality of points include the point at the needle.
  • the temperature field parameter measured at one time may also be the temperature parameter of other positions.
  • the temperature field parameter measured at one time includes the temperature of a plurality of points in the skin of the needle, wherein the plurality of points Does not include the point at the needle.
  • the normal temperature field change and the abnormal temperature field change may be: when the measured temperature field parameter may include the temperature of a plurality of points in the skin at the acupuncture, the plurality of points including the point at the needle, and the other When multiple points are located near the needle, the temperature field changes normally, and the temperature in the direction of blood flow along the vein drops significantly, which is due to intravenous injection.
  • the temperature at the needle is lower due to the lower temperature of the intravenous fluid, and the intravenous fluids at a plurality of points distributed along the direction of the blood flow of the vein are less affected, so that their temperatures are higher, thus
  • the temperature change along the venous blood flow direction is large; and the temperature field change abnormality may be that the temperature along the venous blood flow direction does not decrease significantly, because when the intravenous injection leaks, the leakage liquid covers the needle and the above multiple points, making them The temperature difference between them is small, so the temperature change along the venous blood flow direction is small.
  • the normal temperature field change and the abnormal temperature field change may also be: when the measured temperature field parameter includes the temperature of a plurality of points in the skin area at the acupuncture, the plurality of points do not include the needle. Point, and when the above multiple points are evenly distributed in the acupuncture skin, the temperature field change may be normal, and the temperature change along the non-venous blood flow direction is small, because the needle is in the skin when the intravenous injection is not leaked.
  • the temperature is approximately the same; the abnormal temperature field change may be a large temperature change along the non-venous blood flow direction, because the temperature of the point covered by the intravenous liquid is lower, and the temperature of the point where the intravenous leak liquid is not covered is higher, thus The temperature changes along the direction of non-venous blood flow. It can be seen from the above that when the temperature parameters measured at one time are different, the variation of the temperature field exhibited by the intravenous injection is different. Although the present invention is not exhaustive, it is obvious that the temperature field of the intravenous injection changes. Various situations can be derived from the above disclosure.
  • the following classifier is specifically a linear classifier, and the temperature field parameters measured at one time include the skin at the acupuncture.
  • the classifier method is described by taking the temperature of a plurality of points in the area and the above points including the points at the needle as an example. It should be noted that before inputting the temperature field parameters into the classifier, the linear classifier parameters w, b must be obtained through simulation experiments, that is, by comprehensively considering the various temperature distributions of the non-leakage of the intravenous injection and the leakage, the linearity is obtained.
  • the parameters of the classifier where w is a vector representing the direction of projection and b is a scalar representing the offset. Then, according to the obtained temperature field parameters, a gradient of the temperature field (a specific direction, a change in temperature within a unit distance) and a temperature difference between the temperature of each point in the skin at the needling point and the temperature at the point of the needle are obtained, wherein the needle
  • the temperature difference between each point in the skin area of the thorn and the point at the needle can be represented by t(x, p), where x represents the temperature at a point in the skin area of the needle, and p represents the temperature at the point of the needle;
  • the output of the linear classifier is greater than 0, and it is determined that the intrave
  • statistical regression methods are a method that can include linear regression, logistic regression, and decision-based trees. Regression methods, etc.
  • the statistical regression method is applicable to the case where the temperature field parameter includes the temperature of at least one point in the skin at the acupuncture that is close to the needle.
  • the analyzing module 2 determines whether the intravenous injection leaks by the statistical regression method according to the temperature field parameter: the analysis module 2 analyzes the overall change rate of the temperature field parameter according to the measured temperature field parameters, and further calculates the vein.
  • the probability of an injection occurring when the probability is greater than the first threshold, determines that a leak has occurred in the intravenous injection.
  • the faster the overall variation of the temperature field parameter the higher the probability of an intravenous injection occurring.
  • the first threshold may be determined according to actual needs. Illustratively, if the leakage of the intravenous fluid is harmful to the human body, a smaller first threshold is set, and exemplarily, the first threshold is set to 0.2, when measured If the probability of the intravenous fluid leakage is greater than 0.2, the intravenous fluid leakage is determined; if the intravenous needle is inserted into the patient's vein, the process is complicated, and the leakage of the intravenous fluid is harmless to the human body, then a larger one is set.
  • a threshold exemplarily, sets the first threshold to be 0.5. Since the probability value ranges from 0-1, the range of the first threshold is greater than 0 and less than 1.
  • the above classifier method and statistical regression method may be used alone or in combination.
  • the above embodiment realizes the judgment of the intravenous injection leakage through the analysis module 2, the principle is: whether the temperature field change of the skin flowing along the venous blood in the skin at the acupuncture is abnormal when using the intravenous injection leak, or when using the intravenous injection leak.
  • the rate of change in the temperature field of the skin at the acupuncture achieves a judgment on the leakage of the intravenous injection.
  • the state parameter includes a conductivity field parameter
  • the detecting module 1 includes a conductivity module 12
  • the conductivity module 12 is configured to detect a conductivity field parameter of the skin at the needling point
  • the analysis module 2 is specifically used.
  • the conductivity field parameters are a set of conductivity fields between any two adjacent points of the plurality of points of the skin at the needling point, and preferably, the plurality of points are evenly distributed in the skin at the needling point
  • the conductivity field parameter can also be the electric field rate between two points. It should be noted that when the conductivity field parameter is an electric field between two points, the two points are two points close to the needle.
  • the conductivity module 12 is a contact conductivity module, and the contact conductivity module contacts the skin at the needling point.
  • the conductivity module includes a metal sensing pad 121 that covers the skin of the needle bar B and detects the conductivity field of the subcutaneous tissue at the needle site B.
  • the metal sensing pad 121 can detect the conductivity of the subcutaneous tissue of the needle B at the needle point by positioning two points on the skin at the needle point, thereby obtaining the conductivity field parameter of the skin of the needle B, or by positioning the needle.
  • the electrical conductivity of the subcutaneous tissue at the acupuncture point B between all the adjacent two points is detected, and the conductivity field parameter of the skin of the needle B is obtained.
  • the analyzing module 2 is specifically configured to acquire the conductivity field parameter, and determine whether the intravenous injection leaks through the classifier method according to the conductivity field parameter; or obtain the conductivity field parameter
  • the number, and the probability of intravenous leakage is calculated by statistical regression method according to the conductivity field parameter, and when the probability is greater than the second threshold, it is determined that the intravenous injection leaks.
  • the classifier method is applied to the case where the conductivity field parameter is a set of electrical conductivity between any two adjacent points of the plurality of points of the skin at the acupuncture
  • analysis Module 2 determines whether the intravenous injection leaks according to the conductivity field parameter by the classifier method: the analysis module 2 analyzes the gradient change of the conductivity field parameter according to the measured conductivity field parameter, when the gradient of the conductivity field parameter changes
  • the gradient change abnormality of the conductivity field parameter may be the conductivity between any two points in the conductivity field parameter and the other two points.
  • the conductivity between the two is different; when the gradient of the conductivity field parameter changes normally, it is determined that no leakage occurs in the intravenous injection, and the classifier output is 0 at this time.
  • the gradient change of the conductivity field parameter can be a conductivity field.
  • the conductivity between all two points in the parameter is the same.
  • the statistical regression method is applicable to the case where the conductivity field parameter is a set of conductivity fields between any two adjacent points of the skin at the acupuncture point and in the case of conductivity between the two points.
  • the analyzing module 2 determines whether the intravenous injection leaks by the statistical regression method according to the conductivity field parameter: the analysis module 2 analyzes the change of the overall conductivity field according to the measured conductivity field parameters, and further calculates The probability of an intravenous injection occurring, when the probability is greater than the second threshold, determines that a leak has occurred in the intravenous injection.
  • the setting method of the second threshold refer to the setting method of the first threshold, and details are not described herein again.
  • the above classifier method and statistical regression method may be used alone or in combination.
  • the above embodiment realizes the judgment of the intravenous injection leakage through the analysis module 2, the principle is: whether the conductivity field between any two points in the skin of the acupuncture is abnormal according to the intravenous injection leakage, or according to the intravenous injection leakage Whether the overall conductivity field of the skin at the acupuncture is abnormal, and the judgment of the intravenous injection is realized.
  • the state parameter includes a temperature field parameter and a conductivity field parameter
  • the detecting module 1 includes a temperature measuring module 11 and a conductivity module 12
  • the temperature measuring module 11 is configured to detect the temperature of the skin at the needling point
  • the field parameter the conductivity module 12 is used for detecting the conductivity field parameter of the skin at the needling point
  • the analysis module 2 is specifically configured to obtain the temperature field parameter and the conductivity field parameter, and determine whether the intravenous injection is based on the temperature field parameter and the conductivity field parameter. A leak has occurred.
  • the analysis module 2 may judge according to one or two of the temperature field parameter and the conductivity field parameter. Whether the intravenous injection leaks.
  • the structure and function of the temperature measuring module 11 can be referred to the structure and function of the temperature measuring module 11 in the first structure; the structure and function of the conductivity module 12 can be referred to the conductivity in the second structure.
  • the structure and function of the module 12 will not be described here.
  • the analysis module 2 can be specifically configured to acquire temperature field parameters and conductivity field parameters, and determine whether the intravenous injection leaks through the classifier method according to the temperature field parameter and the conductivity field parameter; or obtain the temperature field Parameters and conductivity field parameters, and the probability of intravenous leakage is calculated by statistical regression method according to temperature field parameters and conductivity field parameters. When the probability is greater than the third threshold, it is determined that the intravenous injection leaks.
  • the classifier method is applicable to the case where one measured temperature field parameter and one measured conductivity field parameter are included in the parameter set, wherein, by way of example, the temperature field parameter includes acupuncture The temperature at a plurality of points in the skin, the conductivity field parameter being a collection of electrical conductivities between any two adjacent points of the plurality of points.
  • the temperature field parameter measured once in the parameter set and the measured conductivity field parameter at one time are simultaneously measured.
  • the analyzing module 2 determines whether the intravenous injection is leaked by the classifier method according to the temperature field parameter and the conductivity field parameter: the analysis module 2 analyzes the temperature field parameter and the conductivity field parameter according to the measured parameter set at one time.
  • the comprehensive gradient change of the two when the integrated gradient changes abnormally, it is determined that the intravenous injection leaks, and the classifier output is greater than 0.
  • the integrated gradient change abnormality may be a plurality of temperatures in the temperature field parameter along the venous blood flow. The direction does not decrease significantly and the conductivity between any two points in the conductivity field parameter is different from the conductivity between the other two points, that is, the comprehensive gradient change anomaly can be the gradient change of the temperature field parameter and the conductivity field.
  • the gradient change of the parameters is abnormal; when the comprehensive gradient changes normally, it is determined that no leakage occurs in the intravenous injection, and the classifier output is less than or equal to 0 at this time.
  • the statistical regression method is applicable to the case where one measured temperature field parameter and one measured conductivity field parameter are included in the parameter set, wherein the temperature field parameter includes at least one point close to the needle in the skin of the needle.
  • the temperature, conductivity field parameter is the set of conductivity fields between any two adjacent points in a plurality of points and the conductivity between the two points.
  • the temperature field parameter measured once in the parameter set and the measured conductivity field parameter at one time are simultaneously measured.
  • the analysis module 2 determines whether the intravenous injection is leaked by the statistical regression method according to the temperature field parameter and the conductivity field parameter: the analysis module 2 analyzes both the temperature field and the conductivity field according to the plurality of measured parameter sets.
  • the comprehensive change calculates the probability of intravenous injection, and when the probability is greater than the third threshold, it is determined that the intravenous injection has leaked.
  • the faster the temperature field parameter changes overall and the faster the overall change in the conductivity field parameter, the higher the probability of intravenous injection.
  • the setting method of the third threshold refer to the setting method of the first threshold, and details are not described herein again.
  • the above classifier method and statistical regression method may be used alone or in combination.
  • the third structure can determine whether the intravenous injection leaks according to the temperature field parameter and the conductivity field parameter, and the vein can be more accurately determined according to the single structure and the second structure. Whether or not the injection is leaked, the detection system having the third structure provided by the embodiment of the present invention is preferable.
  • the detection system may further include an alarm module connected to the analysis module 2.
  • the alarm module determines that a leak occurs in the intravenous injection
  • the alarm module sends an alarm signal to the alarm module to cause the alarm module to perform an alarm.
  • the alarm module and the analysis module 2 can communicate by wire, and can also communicate by wireless; and the alarm module can be disposed in the patient room, so that the patient or the patient's family can pull the catheter out of the patient's skin, or Set in the nurse station to inform the nurse to handle.
  • the detecting system may further include an online module respectively connected to the detecting module 1 and the analyzing module 2; the online module acquires the state parameter detected by the detecting module 1, and the judgment result of the analyzing module 2, and corresponding to the server Send status parameters and judgment results.
  • the online module and the detection module 1 and the online module and the analysis module 2 can communicate by wire or wirelessly.
  • the online module can be placed in the patient's room, receiving relevant parameters, and sending relevant parameters to the server placed in the nurse station for monitoring by the nurse; in addition, the online module can also be set in the server in the nurse station, The relevant parameters are received and displayed through the display module of the server for the nurse to monitor.
  • Another embodiment of the present invention provides a method for detecting an intravenous leak, as shown in FIG. 7, comprising:
  • a state parameter of the skin at the needle is detected.
  • the state parameter of the skin at the needling point can be detected by the detection module 1 .
  • Step 702 Determine whether a leak occurs in the intravenous injection according to the state parameter. Illustratively, with reference to FIG. 1 , it can be determined by the analysis module 2 whether the intravenous injection has a leak according to the state parameter.
  • the embodiment of the invention provides a method for detecting an intravenous leak, which can detect the state parameter of the skin at the acupuncture in real time, and determine whether the intravenous injection leaks according to the state parameter, and the liquid state accumulation does not need to be accumulated due to the change of the state parameter. It can be found for a long time, so that the intravenous leak can be found in time, and the patient can get the prescribed dose of the injection liquid to achieve the therapeutic effect.
  • the state parameter includes a temperature field parameter
  • the step of step 701 specifically includes: detecting a temperature field parameter of the skin at the needling.
  • the temperature measurement module 11 detects the temperature field parameters of the skin at the needling.
  • the step of step 702 specifically includes: determining whether the intravenous injection is vented according to the temperature field parameter leak.
  • the step of detecting the temperature field parameter of the skin at the needling point comprises: illuminating the needling spot with visible light to determine the position of the needling point; and detecting the temperature field parameter of the needling point according to the position of the needling point .
  • the visible light emitter 111 illuminates the needling point with visible light to determine the position of the needling point; the temperature measuring module 112 detects the temperature field parameter at the needling point according to the position of the needling point.
  • the state parameter includes a conductivity field parameter
  • the step of step 701 specifically includes: detecting a conductivity field parameter of the skin at the needle.
  • the conductivity module 12 detects the conductivity field parameters of the skin at the needling.
  • the step of step 702 specifically includes: determining whether a leak occurs in the intravenous injection according to the conductivity field parameter.
  • the state parameter includes a temperature field parameter and a conductivity field parameter
  • the step of step 701 specifically includes: detecting a temperature field parameter and a conductivity field parameter of the skin at the needling.
  • the temperature measurement module 11 detects the temperature field parameters of the skin at the needling point; the conductivity module 12 detects the conductivity field parameters of the skin at the needle point.
  • the step of step 702 specifically includes: determining whether a leak occurs in the intravenous injection according to the temperature field parameter and the conductivity field parameter.
  • the method may further include: sending a status parameter to the server; and determining, in step 702, whether the intravenous injection has a leak, the method further comprising: sending the determination result to the server.
  • it may also include issuing an alarm signal.

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Abstract

一种静脉注射泄露的检测系统和检测方法，所述检测系统包括检测模块(1)和分析模块(2)；所述检测模块(1)用于检测针刺处皮肤的状态参数；所述分析模块(2)用于获取所述状态参数，并根据所述状态参数判断静脉注射是否发生泄漏。

Description

静脉注射泄漏的检测系统和检测方法 技术领域
本发明涉及医疗器械技术领域，尤其涉及一种静脉注射泄漏的检测系统和检测方法。
背景技术
静脉注射技术是一种利用导管将治疗药物直接输送进患者体内的医疗技术。具体地，静脉注射技术包括普通静脉注射技术和中心静脉导管技术。在普通静脉技术中，将导管针头刺入患者的手臂、手、足部、足踝或头部的静脉血管，通过悬挂注射液体进行静脉滴注，将注射液体直接输送到患者血管中。在中心静脉导管技术中，将中心静脉导管针头刺入大静脉中，如颈内静脉、锁骨下静脉或股静脉等，将多种液体输入大静脉中。由此，该中心静脉导管技术还需频繁给液，并且相对于普通静脉注射技术而言，其输入液体时间长且量大。
在上述两种静脉注射技术的操作过程中，都需要将导管针头准确刺入静脉，且在针头刺入静脉之后，要求针头始终处于静脉中。然而，在整个静脉输液的过程中，容易出现针头刺穿静脉或者脱出静脉的现象，导致药物泄露到针头周围的人体组织内。
目前，静脉注射泄漏只能靠人为发现，也即在实施静脉刺穿术一段时间后，患者的针刺处皮肤出现鼓包或者针刺处出现渗水时，才可发现静脉注射泄漏，由于不同的人有不同的体征表象，有的人可能在静脉注射泄漏刚刚发生时皮肤即会出现明显的鼓包，便于观测到；而有的人可能在静脉注射泄漏发生一段时间后会出现上述的皮肤鼓包的现象，这时才可以被观测到，因此，这种靠人眼目测来发现静脉注射泄漏存在不准确和不能及时发现的问题。
发明内容
本发明的目的在于提供一种静脉注射泄漏的检测系统和检测方法，用于至少部分地解决现有技术中不能准确地和无法及时检测到静脉注射液体泄漏的问题。
根据本发明的一个方面，提供了一种静脉注射泄露的检测系统，包括：检测模块，所述检测模块用于检测针刺处皮肤的状态参数；和
分析模块，所述分析模块用于获取所述状态参数，并根据所述状态参数判断静脉 注射是否发生泄漏。
根据本发明的另一方面，还提供了一种静脉注射泄露的检测方法，该方法包括：
检测针刺处皮肤的状态参数；
根据所述状态参数判断静脉注射是否发生泄漏。
本发明提供的静脉注射泄漏的检测系统具有如上结构，由于静脉注射发生泄漏时，针刺处皮肤的状态参数很快发生变化，而本发明根据针刺处皮肤的状态参数判断静脉注射是否发生泄漏，可及时发现静脉注射泄漏，使得泄漏液体不会大量累积在人体组织内，因而可解决现有技术中不能准确地和无法及时检测到静脉注射液体泄漏的问题。因所述静脉注射泄漏的检测方法与上述静脉注射泄漏的检测系统相对于现有技术所具有的优势相同，在此不再赘述。
附图说明
为了更清楚地说明本发明实施例的技术方案，下面将对实施例描述中所需要使用的附图作简单地介绍，显而易见地，下面描述中的附图仅仅是本发明的一些实施例，对于本领域普通技术人员来讲，在不付出创造性劳动的前提下，还可以根据这些附图获得其他的附图。
图1为本发明的整体构思提供的静脉注射泄漏的检测系统的示意图；
图2为图1显示的静脉注射泄漏的检测系统的一个具体示例的示意图；
图3为图2中显示的测温模块的示意图；
图4为图1显示的静脉注射泄漏的检测系统的另一具体示例的示意图；
图5为图4中所显示的电导率模块的示意图；
图6为图1显示的静脉注射泄漏的检测系统的还一具体示例的示意图；
图7为本发明实施例提供的一种静脉注射泄漏的检测方法流程图。
附图标记说明：
1-检测模块；11-测温模块；111-可见光发射器；
112-测温探头；12-电导率模块；121-金属传感垫；
2-分析模块。
具体实施方式
下面将结合本发明实施例中的附图，对本发明实施例中的技术方案进行清楚、 完整地描述，显然，所描述的实施例是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
在描述实施例前，首先对本发明实施例的原理进行说明，也即对静脉注射泄漏与针刺处皮肤的温度和电导率的关系进行说明：
第一、静脉注射泄漏与针刺处皮肤的温度的关系
通常，人体内部组织的温度是一个恒定值，其高于人体所处环境中的普通液体温度。当静脉注射液体持续进入静脉时，会使得针刺处(以针头为中心的一定范围内)的人体组织中，沿静脉血液流动方向的线状人体组织的温度逐渐缓慢变化。而当静脉注射液体泄漏时，由于泄漏液体在接近针头的人体组织内积累，因而会使得针刺处的人体组织中，接近针头的块状人体组织的温度会迅速降低。由于皮肤距离针刺处较近，因而当静脉注射泄露时，示例性的，可通过检测一次针刺处皮肤的温度场参数，判断针刺处皮肤中多个点温度与针头处温度的温度变化。示例性地，温度场参数包括针刺处皮肤中多个点的温度，其中上述多个点包括位于针头处的点。或者可以基于沿静脉血液流动方向的皮肤的温度变化是否规则，从而判断静脉注射是否泄漏。示例性地，温度场参数包括针刺处皮肤中多个点的温度，其中上述多个点不包括位于针头处的点。此外，还可通过检测多次针刺处皮肤的温度场参数，根据针刺处皮肤的温度场的整体变化速率，判断静脉注射是否泄漏，示例性地，温度场参数可以包括针刺处皮肤中至少一个接近针头的点的温度。
第二、静脉注射泄漏与针刺处皮肤的电导率之间的关系
在正常情况下，人体皮肤和肌肉的电导率在一定范围内。当静脉注射液体中含有电解质，如生理盐水时，静脉注射液体为电的强导体，具有高电导率；当静脉注射液体泄漏时，泄漏液体会积累在静脉注射导管针头附近的人体组织内，导致该处的电导率升高。当静脉注射液体中含有纯水和非电解质，如纯水和葡萄糖时，静脉注射液体为绝缘体或者电的弱导体，电导率极低；当静脉注射泄漏时，泄漏液体会积累在静脉注射导管针头附近的人体组织内，导致该处的电导率降低。皮肤处的电导率场分布，直接受到皮肤本身的电导率或者皮肤中的皮下组织的电导率影响，因而可通过检测静脉注射导管针头针刺处皮肤的电导率场变化，判断静脉注射是否泄漏。示例性地，检测针刺处皮肤多个点中任意相邻的两个点之间的电导率，作为针刺处皮肤的电导率场，优选地，上述多个点在针刺处皮肤中均匀分布；当静脉注射泄漏时，针刺处 的皮肤中，最接近针头处皮肤的两点之间的电导率发生变化，其余皮肤的两点之间的电导率不变化，因而可以通过检测电导率场中任意一个电导率是否发生变化，判断静脉注射是否泄漏。还可示例为，检测针刺处皮肤多个点中任意两个点之间的电导率或者检测针刺处皮肤两个点之间的电导率，作为针刺处皮肤的电导率场，当静脉注射泄漏时，根据整体电导率场是否发生变化，判断静脉注射是否泄漏。
本发明实施例提供了一种静脉注射泄露的检测系统。如图1所示，该检测系统包括检测模块1和分析模块2。检测模块1用于检测针刺处皮肤的状态参数；分析模块2用于获取状态参数，并根据状态参数判断静脉注射是否发生泄漏。
需要说明的是，第一，针刺处皮肤可以是以针刺处为中心的一定范围内的皮肤，且针刺处皮肤可以是针刺处皮肤的表皮、真皮或皮下组织。第二、检测模块1与分析模块2之间的通信方式，可以是通过有线方式进行通信，也可以是通过无线方式进行通信。第三，状态参数可包括温度场参数和电导率场参数中的至少一种。
本发明实施例提供了一种静脉注射泄漏的检测系统，检测模块1可实时检测针刺处的皮肤的状态参数，以使分析模块2根据状态参数实时判断静脉注射是否发生泄漏，并且由于针刺处皮肤的状态参数在注射液体泄漏早期即会发生变化，因而，准确地且可及时发现静脉注射液体泄漏，并且，可使病人得到规定剂量的注射液体，达到治疗效果。
在上述实施例中，检测模块1可具有三种结构，为便于本领域技术人员理解，以下对三种结构分别作详细说明。
第一种结构，如图2所示，状态参数包括温度场参数，检测模块1包括测温模块11；测温模块11用于检测针刺处皮肤的温度场参数，分析模块2具体用于获取温度场参数，并根据温度场参数判断静脉注射是否发生泄漏。示例性地，温度场参数可包括针刺处皮肤中至少一个接近针头的点的温度，则测温模块11检测针刺处皮肤中至少一个接近针头的点的温度，形成温度场参数。
在第一种结构中，测温模块11包括接触式测温模块或非接触式测温模块，接触式测温模块接触针刺处皮肤，非接触式测温模块不接触针刺处皮肤。示例性地，接触式测温模块可为覆盖在针刺皮肤上的垫状温度计、或者放置在针刺处皮肤周围的温度计，仅需可检测到针刺处皮肤的温度场即可。
在上述实施例中，如图3所示，测温模块11包括非接触式测温模块，非接触式测温模块包括可见光发射器111和测温探头112；可见光发射器111用于照射针刺处 B，确定针刺处B的位置；测温探头112用于根据针刺处B的位置，检测针刺处B皮肤的温度场参数。其中，可见光发射器111可发出人眼可识别的光线，以使使用者(护士、患者或者患者家属)可调节可见光发射器111的照射位置及方向，使可见光发射器111照射针刺处B，确定针刺处B的位置；测温探头112可为红外测温探头。此外，可见光发射器111和测温模块112可为两个分离的模块，也可为封装在一起的一个模块或一个组件，此处不作具体限定。测温模块11可使用支架固定在患者周围，也可为使用者手持，优选地，测温模块11固定设置，不会浪费劳力。由于测温模块11为接触式测温模块或者非接触式测温模块，上述模块无需侵入人体组织即可检测针刺处皮肤的温度，因而不会对患者造成伤害，且比较简便。
在上述实施例中，分析模块2具体用于，获取温度场参数，并根据温度场参数通过分类器方法判断静脉注射是否发生泄露；或者获取温度场参数，并根据温度场参数通过统计回归方法计算静脉注射泄漏的概率，当概率大于第一阈值时，确定静脉注射发生泄露。
需要说明的是，第一、分类器为一种计算工具，其可包括决策树、神经网络、线性分类器和二次分类器等具体分类器。需注意的是，分类器包括多种具体分类器，由于其为现有技术，因而本发明未作穷举，仅对几个常用具体分类器进行举例，但本发明不限于此。还需注意的是，由于分类器为现有常用计算工具，因而以下仅示例性地对一种具体分类器的工作过程进行详细说明，其他未举例的具体分类器可根据现有技术获得，此处不再赘述。
在上述实施例中，示例性地，分析模块2根据温度场参数通过分类器方法判断静脉注射是否发生泄露的步骤可为：分析模块2根据一次测得的温度场参数，计算针刺处皮肤区域的温度场的特征，用以分析温度场的变化，当温度场变化异常时，确定静脉注射发生泄漏；当温度场变化正常时，确定静脉注射未发生泄漏。其中，上述一次测得的温度场参数可包括针刺处皮肤中多个点的温度，上述多个点包括针头处的点，当然上述一次测得的温度场参数还可为其他位置的温度参数，仅需能说明静脉注射泄漏时与静脉注射未泄漏时的温度区别即可，示例性地，上述一次测得的温度场参数包括针刺处皮肤中多个点的温度，其中上述多个点不包括针头处的点。示例性地，上述温度场变化正常以及温度场变化异常可为：当一次测得的温度场参数可包括针刺处皮肤中多个点的温度，上述多个点包括针头处的点，且其他多个点位于针头附近时，温度场变化正常可为，沿静脉血液流动方向温度显著下降，这是由于当静脉注射 未泄漏时，针头处的温度由于静脉注射液体的温度较低而较低，而沿静脉注射血液流动方向分布的多个点受到的静脉注射液体的影响较小，使得它们的温度较高，因而沿静脉血液流动方向温度变化较大；而温度场变化异常可为，沿静脉血液流动方向温度未显著下降，这是由于当静脉注射泄漏时，由于泄漏液体覆盖针头以及上述多个点，使得它们之间的温度差较小，因而沿静脉血液流动方向温度变化较小。此外，示例性地，上述温度场变化正常以及温度场变化异常还可为：当一次测得的温度场参数包括针刺处皮肤区域中多个点的温度，上述多个点未包括针头处的点，且上述多个点均匀分布于针刺皮肤中时，温度场变化正常可为，沿非静脉血液流动方向温度变化较小，这是由于当静脉注射未泄漏时，针刺处皮肤中的温度大致相同；而温度场变化异常可为沿非静脉血液流动方向温度变化较大，这是由于静脉注射液体覆盖的点的温度较低，静脉注射泄漏液体未覆盖的点的温度较高，因而沿非静脉血液流动方向温度变化较大。由上可知，当一次测得的温度参数不同时，静脉注射泄漏所表现的温度场的变化也不同，虽然本发明未作穷举，但是显而易见的，静脉注射泄漏所表现的温度场的变化的各种情形可根据以上公开内容得出。
由于当一次测得的温度场参数包括的参数不同时，判断得出静脉注射是否泄漏的方法大致相同，因而以下以分类器具体为线性分类器、一次测得的温度场参数包括针刺处皮肤区域中多个点的温度，且上述多个点包括针头处的点为例对分类器方法进行说明。需注意的是，在将温度场参数输入分类器之前，需通过模拟实验得到线性分类器的参数w，b，也即通过综合考虑静脉注射未泄漏以及泄漏时的各种温度分布，得出线性分类器的参数，其中，w为表示投影方向的矢量，b为表示偏移的标量。然后，根据获取的温度场参数，得到温度场的梯度(特定方向、单位距离内温度的变化)以及针刺处皮肤中每点的温度与针头处点的温度之间的温度差，其中，针刺处皮肤区域中每点和针头处点的温度差可用t(x，p)表示，在上式中，x表示针刺处皮肤区域中一点的温度，p表示针头处点的温度；然后，将得到的温度场梯度和每点到针头处的温度差串接为一个矢量υ，计算输出f＝w′·υ+b，其中，′为转秩符号，当温度场变化异常时f＞0、线性分类器的输出大于0，确定静脉注射发生泄露；当温度场变化正常时f≤0、分类器输出小于或等于0，确定静脉注射未发生泄漏。
第二、统计回归方法为一种方法，其可包括线性回归、逻辑回归和基于决策树 的回归方法等。统计回归方法适用于温度场参数包括针刺处皮肤中至少一个接近针头的点的温度的情形。示例性地，分析模块2根据温度场参数通过统计回归方法判断静脉注射是否发生泄露可为：分析模块2根据多次测得的温度场参数，分析温度场参数的整体变化速率，进而计算出静脉注射发生的概率，当概率大于第一阈值时，确定静脉注射发生泄露，示例性地，温度场参数整体变化越快，静脉注射发生的概率越高。
第三，第一阈值可根据实际需求进行确定，示例性地，如果静脉注射液体的泄漏对人体具有伤害，则设置较小的第一阈值，示例性地，设置第一阈值为0.2，当测得的静脉注射液体泄漏的概率大于0.2时，则确定静脉注射液体泄漏；如果静脉注射导管针头刺入患者的静脉过程较复杂，且静脉注射液体的泄漏对人体无伤害，则设置较大的第一阈值，示例性地，设置第一阈值为0.5。由于概率值范围为0-1，因而第一阈值的范围为大于0且小于1。此外，上述分类器方法与统计回归方法可单独使用，也可结合使用。
上述实施例通过分析模块2实现对静脉注射泄漏的判断，其原理为：利用静脉注射泄漏时，针刺处皮肤中沿静脉血液流动的皮肤的温度场变化是否异常，或者，利用静脉注射泄漏时针刺处皮肤的温度场变化的速率，实现对静脉注射泄漏的判断。
第二种结构，如图4所示，状态参数包括电导率场参数，检测模块1包括电导率模块12；电导率模块12用于检测针刺处皮肤的电导率场参数，分析模块2具体用于获取电导率场参数，并根据电导率场参数判断静脉注射发生泄漏。其中，电导率场参数为针刺处皮肤的多个点中任意相邻的两个点之间的电导率场的集合，优选地，上述多个点在针刺处皮肤中均匀分布；此外，电导率场参数也可为两个点之间的电场率。需要说明的是，当电导率场参数为两个点之间的电场时，该两个点为接近针头的两个点。
电导率模块12为接触式电导率模块，接触式电导率模块接触针刺处皮肤。示例性地，如图5所示，电导率模块包括金属传感垫121，金属传感垫121覆盖针刺处B皮肤，检测针刺处B皮下组织的电导率场。金属传感垫121可通过定位针刺处皮肤上两点，检测两点之间针刺处B皮下组织的电导率，从而得到针刺处B皮肤的电导率场参数，也可通过定位针刺处B皮肤上多点中的多个相邻两点，检测所有相邻两点之间针刺处B皮下组织的电导率，得到针刺处B皮肤的电导率场参数。
在上述实施例中，分析模块2具体用于，获取所述电导率场参数，并根据所述电导率场参数通过分类器方法判断静脉注射是否发生泄漏；或者，获取电导率场参 数，并根据电导率场参数通过统计回归方法计算静脉注射泄漏的概率，当概率大于第二阈值时，确定静脉注射发生泄露。
需要说明的是：第一，分类器方法应用于电导率场参数为针刺处皮肤的多个点中任意相邻的两个点之间的电导率的集合的情形中，示例性地，分析模块2根据电导率场参数通过分类器方法判断静脉注射是否发生泄露可为：分析模块2根据一次测得的电导率场参数，分析电导率场参数的梯度变化，当电导率场参数的梯度变化异常时，确定静脉注射发生泄漏，此时分类器输出为1，示例性地，电导率场参数的梯度变化异常可为电导率场参数中任意两个点之间的电导率与其他两个点之间的电导率不同；当电导率场参数的梯度变化正常时，确定静脉注射未发生泄漏，此时分类器输出为0，示例性地，电导率场参数的梯度变化正常可为电导率场参数中所有两个点之间的电导率均相同。
第二，统计回归方法适用于电导率场参数为针刺处皮肤的多个点中任意相邻的两个点之间的电导率场的集合以及为两个点之间的电导率的情形中。示例性地，分析模块2根据电导率场参数通过统计回归方法判断静脉注射是否发生泄露可为：分析模块2根据多次测得的电导率场参数，分析整体电导率场的变化，进而计算出静脉注射发生的概率，当概率大于第二阈值时，确定静脉注射发生泄露。示例性地，电导率场参数整体变化越快，静脉注射发生的概率越大；还可为多个点中两个点之间的电导率发生变化的情况越多，静脉注射发生的概率越高。第二阈值的设置方法请参照第一阈值的设置方法，此处不再赘述。此外，上述分类器方法与统计回归方法可单独使用，也可结合使用。
上述实施例通过分析模块2实现对静脉注射泄漏的判断，其原理为：根据静脉注射泄漏时，针刺处皮肤中任意两点之间的电导率场是否发生异常，或者，根据静脉注射泄漏时针刺处皮肤的整体电导率场是否发生异常，实现对静脉注射泄漏的判断。
第三种结构，如图6所示，状态参数包括温度场参数和电导率场参数，检测模块1包括测温模块11和电导率模块12；测温模块11用于检测针刺处皮肤的温度场参数；电导率模块12用于检测针刺处皮肤的电导率场参数；分析模块2具体用于获取温度场参数和电导率场参数，并根据温度场参数和电导率场参数判断静脉注射是否发生泄漏。
需要说明的是，由于测温模块11或者电导率模块12可能出现未检测到参数的情况，因而，分析模块2可根据温度场参数和电导率场参数中的一种或者两种，判断 静脉注射是否泄漏。
在第三种结构中，测温模块11的结构和功能可参见第一种结构中的测温模块11的结构和功能；电导率模块12的结构和功能可参见第二种结构中的电导率模块12的结构和功能，此处不再赘述。
在第三种结构中，分析模块2可具体用于，获取温度场参数和电导率场参数，并根据温度场参数和电导率场参数通过分类器方法判断静脉注射是否发生泄漏；或者获取温度场参数和电导率场参数，并根据温度场参数和电导率场参数通过统计回归方法计算静脉注射泄漏的概率，当概率大于第三阈值时，确定静脉注射发生泄露。
需要说明的是，第一，分类器方法适用于一次测得的温度场参数和一次测得的电导率场参数均包含在参数集合内的情形，其中，示例性地，温度场参数包括针刺处皮肤中多个点的温度，电导率场参数为多个点中任意相邻的两个点之间的电导率的集合。优选地，为确保判断结果正确，参数集合内一次测得的温度场参数与一次测得的电导率场参数为同时测量得到的。示例性地，分析模块2根据温度场参数和电导率场参数通过分类器方法判断静脉注射是否发生泄露可为：分析模块2根据一次测得的参数集合，分析温度场参数和电导率场参数二者的综合梯度变化，当综合梯度变化异常时，确定静脉注射发生泄漏，此时分类器输出大于0，示例性地，综合梯度变化异常可为温度场参数中的多个温度沿静脉血液流动方向未显著下降以及电导率场参数中任意两个点之间的电导率与其他两个点之间的电导率不同，也即，综合梯度变化异常可为温度场参数的梯度变化和电导率场参数的梯度变化均异常；当其综合梯度变化正常时，确定静脉注射未发生泄漏，此时分类器输出小于或等于0。
第二，统计回归方法适用于一次测得的温度场参数和一次测得的电导率场参数均包含在参数集合内的情形，其中温度场参数包括针刺处皮肤中至少一个接近针头的点的温度，电导率场参数为多个点中任意相邻的两个点之间的电导率场的集合以及为两个点之间的电导率。优选地，为确保判断结果正确，参数集合内一次测得的温度场参数与一次测得的电导率场参数为同时测量得到的。示例性地，分析模块2根据温度场参数和电导率场参数通过统计回归方法判断静脉注射是否发生泄露可为：分析模块2根据多次测得的参数集合，分析温度场和电导率场二者的综合变化，进而计算出静脉注射发生的概率，当概率大于第三阈值时，确定静脉注射发生泄露。示例性地，温度场参数整体变化越快，以及电导率场参数整体变化越快时，静脉注射发生的概率越高。其中，第三阈值的设置方法请参照第一阈值的设置方法，此处不再赘述。此外， 上述分类器方法与统计回归方法可单独使用，也可结合使用。
相对于第一种结构和第二种结构中使用单一参数判断静脉注射是否泄漏，第三种结构可根据温度场参数和电导率场参数共同判断静脉注射是否发生泄漏，因而可更准确地确定静脉注射是否发生泄漏，因此本发明实施例所提供的具有第三种结构的检测系统是优选的。
在上述三种结构中，检测系统还可包括与分析模块2相连的告警模块，当分析模块2确定静脉注射发生泄漏时，向告警模块发送告警信号，以使告警模块进行告警。其中，告警模块与分析模块2之间可通过有线方式通信，还可通过无线方式通信；且告警模块可设置于患者房内，以便于患者或者患者家属将导管从患者的皮肤拔出，也可设置于护士站内，以便于通知护士进行处理。
在上述实施例中，检测系统还可还包括分别与检测模块1和分析模块2相连的在线模块；在线模块获取检测模块1检测的状态参数，以及分析模块2的判断结果，并向服务器相应的发送状态参数和判断结果。需要说明的是，第一，在线模块与检测模块1之间、在线模块与分析模块2之间可通过有线方式通信，也可通过无线方式通信。第二，在线模块可置于患者房内，其接收相关参数，并向置于护士站内的服务器发送相关参数，以便于护士进行监测；此外，在线模块也可设置于护士站内的服务器内，其接收相关参数，并通过服务器的显示模块显示，以便于护士进行监测。
本发明的另一实施例提供了一种静脉注射泄露的检测方法，如图7所示，包括：
步骤701，检测针刺处皮肤的状态参数。示例性地，结合图1进行说明，即可通过检测模块1检测针刺处皮肤的状态参数。
步骤702，根据状态参数判断静脉注射是否发生泄漏。示例性地，结合图1进行说明，即可通过分析模块2根据状态参数判断静脉注射是否发生泄漏。
本发明实施例提供了一种静脉注射泄漏的检测方法，可实时检测针刺处的皮肤的状态参数，以根据状态参数判断静脉注射是否发生泄漏，由于状态参数的变化无需在静脉注射液体积累较多时即可发现，因而可及时发现静脉注射泄漏，并且可使病人得到规定剂量的注射液体，达到治疗效果。
示例性地，状态参数包括温度场参数，步骤701的步骤具体包括：检测针刺处皮肤的温度场参数。示例性地，结合图2进行说明，测温模块11检测针刺处皮肤的温度场参数。步骤702的步骤具体包括：根据温度场参数判断静脉注射是否发生泄 漏。
在上述实施例中，检测针刺处皮肤的温度场参数的步骤，具体包括：利用可见光照射针刺处，确定针刺处的位置；根据针刺处的位置，检测针刺处的温度场参数。示例性地，结合图3进行说明，可见光发射器111利用可见光照射针刺处，确定针刺处的位置；测温模块112根据针刺处的位置，检测针刺处的温度场参数。
示例性地，状态参数包括电导率场参数，步骤701的步骤具体包括：检测针刺处皮肤的电导率场参数。示例性地，结合图4进行说明，电导率模块12检测针刺处皮肤的电导率场参数。步骤702的步骤具体包括：根据电导率场参数判断静脉注射是否发生泄漏。
示例性地，状态参数包括温度场参数和电导率场参数，步骤701的步骤具体包括：检测针刺处皮肤的温度场参数和电导率场参数。示例性地，结合图6进行说明，测温模块11检测针刺处皮肤的温度场参数；电导率模块12检测针刺处皮肤的电导率场参数。步骤702的步骤具体包括：根据温度场参数和电导率场参数判断静脉注射是否发生泄漏。
在上述实施例中，在步骤701之后，还可包括：向服务器发送状态参数；在步骤702判断静脉注射是否发生泄漏之后，还可包括：向服务器发送判断结果。此外，在确定静脉注射发生泄漏之后，还可包括发出告警信号。
本说明书中的各个实施例均采用递进的方式描述，各个实施例之间相同相似的部分互相参见即可，每个实施例重点说明的都是与其他实施例的不同之处。尤其，对于方法实施例而言，由于其基本相似于产品实施例，所以描述得比较简单，相关之处参见产品实施例的部分说明即可。
需说明的是，以上所描述的系统实施例仅仅是示意性的，其中所述作为分离部件说明的单元可以是或者也可以不是物理上分开的，作为单元显示的部件可以是或者也可以不是物理单元，即可以位于一个地方，或者也可以分布到多个单元上。可以根据实际的需要选择其中的部分或者全部模块来实现本实施例方案的目的。本领域普通技术人员在不付出创造性劳动的情况下，即可以理解并实施。
以上所述，仅为本发明的具体实施方式，但本发明的保护范围并不局限于此，任何熟悉本技术领域的技术人员在本发明揭露的技术范围内，可轻易想到变化或替换，都应涵盖在本发明的保护范围之内。因此，本发明的保护范围应以所述权利要求的保护范围为准。

Claims (18)

  1. 一种静脉注射泄露的检测系统，包括：
    检测模块，所述检测模块用于检测针刺处皮肤的状态参数；
    分析模块，所述分析模块用于获取所述状态参数，并根据所述状态参数判断静脉注射是否发生泄漏。
  2. 根据权利要求1所述的检测系统，其中，所述状态参数包括温度场参数，所述检测模块包括测温模块；
    所述测温模块用于检测针刺处皮肤的温度场参数；
    所述分析模块具体用于获取所述温度场参数，并根据所述温度场参数，判断静脉注射是否发生泄漏。
  3. 根据权利要求2所述的检测系统，其中，所述测温模块包括非接触式测温模块，所述非接触式测温模块包括可见光发射器和测温探头；
    所述可见光发射器用于照射针刺处，确定所述针刺处的位置；
    所述测温探头用于获取所述针刺处的位置，并根据所述针刺处的位置，检测所述针刺处皮肤的温度场参数。
  4. 根据权利要求2或3所述的检测系统，其中，所述分析模块在获取所述温度场参数之后根据所述温度场参数通过分类器方法判断静脉注射是否发生泄漏；或者
    在获取所述温度场参数之后根据所述温度场参数通过统计回归方法计算静脉注射泄漏的概率，当所述概率大于第一阈值时，确定静脉注射发生泄露。
  5. 根据权利要求1所述的检测系统，其中，所述状态参数包括电导率场参数，所述检测模块包括电导率模块；
    所述电导率模块用于检测针刺处皮肤的电导率场参数；
    所述分析模块用于在获取所述电导率场参数之后根据所述电导率场参数判断静脉注射是否发生泄露。
  6. 根据权利要求5所述的检测系统，其中，所述电导率模块包括金属传感垫，所述金属传感垫覆盖所述针刺处的皮肤，检测所述针刺处皮下组织的电导率场。
  7. 根据权利要求5或6所述的检测系统，其中，所述分析模块用于：
    在获取所述电导率场参数之后，根据所述电导率场参数通过分类器方法判断静脉注射是否发生泄漏；或者
    在获取所述电导率场参数之后，根据所述电导率场参数通过统计回归方法计算静脉注射泄漏的概率，当所述概率大于第二阈值时，确定静脉注射发生泄露。
  8. 根据权利要求1所述的检测系统，其中，所述状态参数包括温度场参数和电导率场参数，所述检测模块包括测温模块和电导率模块；
    所述测温模块用于检测针刺处皮肤的温度场参数；
    所述电导率模块用于检测所述针刺处皮肤的电导率场参数；
    所述分析模块具体用于获取所述温度场参数和所述电导率场参数，并根据所述温度场参数和所述电导率场参数判断静脉注射是否发生泄漏。
  9. 根据权利要求8所述的检测系统，其中，所述分析模块用于：
    在获取所述温度场参数和所述电导率场参数之后根据所述温度场参数和所述电导率场参数两者通过分类器方法判断静脉注射是否发生泄漏；或者
    在获取所述温度场参数和所述电导率场参数，根据所述温度场参数和所述电导率场参数两者通过统计回归方法判断静脉注射泄漏的概率，当所述概率大于第三阈值时，确定静脉注射发生泄露。
  10. 根据权利要求1所述的检测系统，还包括与所述分析模块相连的告警模块，在分析模块确定静脉注射发生泄漏后，所述分析模块还用于向所述告警模块发送告警信号，以通过所述告警模块进行告警。
  11. 根据权利要求1所述的检测系统，还包括分别与所述检测模块和分析模块相连的在线模块；
    所述在线模块用于获取所述检测模块检测的所述状态参数，以及所述分析模块的判断结果，并向服务器发送所述状态参数和所述判断结果。
  12. 一种静脉注射泄露的检测方法，包括以下步骤：
    检测针刺处皮肤的状态参数；
    根据所述状态参数判断静脉注射是否发生泄漏。
  13. 根据权利要求12所述的检测方法，其中，所述状态参数包括温度场参数；
    所述检测针刺处皮肤的状态参数的步骤包括：检测针刺处皮肤的温度场参数；
    根据所述状态参数判断静脉注射是否发生泄漏的步骤包括：根据所述温度场参数判断静脉注射是否发生泄漏。
  14. 根据权利要求13所述的检测方法，其中，检测针刺处皮肤的温度场参数的步骤包括：
    利用可见光照射针刺处，确定所述针刺处的位置；
    根据所述针刺处的位置，检测所述针刺处的温度场参数。
  15. 根据权利要求12所述的检测方法，其中，所述状态参数包括电导率场参数；
    所述检测针刺处皮肤的状态参数的步骤包括：检测针刺处皮肤的电导率场参数；
    根据所述状态参数判断静脉注射是否发生泄漏的步骤包括：根据所述电导率场参数判断静脉注射是否发生泄漏。
  16. 根据权利要求12所述的检测方法，其中，所述状态参数包括温度场参数和电导率场参数；
    所述检测针刺处皮肤的状态参数的步骤包括：检测针刺处皮肤的温度场参数和电导率场参数；
    根据所述状态参数判断静脉注射是否发生泄漏的步骤包括：根据所述温度场参数和所述电导率场参数判断静脉注射是否发生泄漏。
  17. 根据权利要求12所述的检测方法，其中，
    在检测针刺处皮肤的状态参数之后，所述方法还包括：向服务器发送所述状态参数。
  18. 根据权利要求17所述的检测方法，其中，
    在判断静脉注射是否发生泄漏之后，所述方法还包括：向服务器发送判断结果。
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CN104922755A (zh) 2015-09-23
US11152096B2 (en) 2021-10-19
CN104922755B (zh) 2018-01-09
US20170157339A1 (en) 2017-06-08
EP3144023A1 (en) 2017-03-22
EP3144023A4 (en) 2017-11-22

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