Extravascular leakage detection device, extravascular leakage detection system, and program

Abstract

This invention provides an extravasation detection device, an extravasation detection system, and a program that enable easier detection of extravasation, even in cases where detection in peripheral blood vessels is difficult. [Solution] The extravasation detection device 1 acquires measurements from the blood flow measuring device 4 regarding the blood flow state in the heart H of patient P, in which an indwelling needle has been inserted at a predetermined site 7 in the body, before and after the administration of intravenous fluid from the indwelling needle. Based on the acquired measurements, it determines whether or not the intravenous fluid administration is being performed normally and outputs the determination result.

Description

Technical Field

[0004]

[0001] The present invention relates to an extravascular leakage detection device, an extravascular leakage detection system, and a program.

Background Art

[0002] Infusion treatment for patients is one of the most common medical practices and is carried out in many treatments. When performing drip infusion in infusion treatment, it is necessary to appropriately secure the administration route in an arbitrary blood vessel and administer a drug for treatment. Here, due to damage to blood vessel tissue during puncture or an increase in intravascular pressure at the puncture site during infusion administration, etc., an event may occur where a drug or blood in the blood vessel leaks outside the blood vessel and the tissue is infiltrated. In addition, due to body movement or physical impact, an event may occur where the administration route deviates or detaches from the blood vessel where the route has been secured, and the tip of the administration route is located outside the blood vessel, and appropriate drug administration cannot be performed in the blood vessel. Such events can, in the worst case, cause a complication called "extravascular leakage" that necrotizes surrounding tissues.

[0003] Particularly, when administering an anticancer agent substance or the like for cancer drug therapy, or in the case of pediatric patients with fragile blood vessels and skin tissues, there are many cases where the condition worsens. Although this is a problem leading to such a serious complication, at present, as a means for detecting extravascular leakage clinically, it relies on visual confirmation by medical staff.

[0004] Therefore, for example, in order to improve the detection accuracy of extravascular leakage at the puncture site, a technique that utilizes the noise sound of blood flow having characteristics at the puncture site has been disclosed (see Patent Document 1). Also, for example, a technique for confirming the administration status by detecting microbubbles with a detection device such as ultrasonic waves has been disclosed (see Patent Document 2).

Prior Art Documents

Patent Documents

[0005]

Patent Document 1

[0006] In many cases, patients under centralized care undergo multiple punctures to administer fluids, nutrients, and medications. Therefore, healthcare professionals managing these patients need to manage multiple puncture sites, making the management process complex. Furthermore, in the case of children, there is a problem in that detection in peripheral blood vessels is difficult because the blood vessels are narrow and the blood flow is low.

[0007] Therefore, the present invention aims to provide an extravascular leakage detection device, an extravascular leakage detection system, and a program that can more easily detect extravascular leakage even when detection in peripheral blood vessels is difficult. [Means for solving the problem]

[0008] The present invention relates to an extravasation detection device comprising: a measurement value acquisition unit that acquires measurement values ​​relating to the blood flow state in the heart of a patient in which an indwelling needle has been inserted into a predetermined site in the body, before and after administration of intravenous fluid from the indwelling needle; a determination unit that determines whether or not intravenous fluid administration is being performed normally based on the measurement values ​​acquired by the measurement value acquisition unit; and a determination result output unit that outputs the determination result from the determination unit.

[0009] Furthermore, in an extravasation detection device, it is preferable that the determination unit determines whether or not intravenous fluid administration is being performed normally based on the change over time of the measured value acquired by the measured value acquisition unit.

[0010] Furthermore, in the extravasation detection device, it is preferable to include a threshold storage unit that stores in advance a threshold value for the change in the measured value over time, and the determination unit determines that the infusion is not being administered normally when the amount of change in the measured value over time acquired by the measurement value acquisition unit is outside the range of the threshold value in the threshold storage unit.

[0011] Furthermore, in an extravasation detection device, it is preferable that the determination unit determines whether or not intravenous fluid administration is being performed normally based on the peak value of the measurement value acquired by the measurement value acquisition unit.

[0012] Furthermore, it is preferable that the extravasation detection device includes a threshold storage unit that stores a threshold value for the measured value in advance, and that the determination unit determines that the infusion is not being administered normally when the peak value of the measured value acquired by the measured value acquisition unit is outside the range of the threshold value in the threshold storage unit.

[0013] Furthermore, in the extravasation detection device, it is preferable to include a measurement value output unit that outputs the measurement value acquired by the measurement value acquisition unit, and the judgment result output unit that outputs a warning when the judgment result indicates that the infusion administration is not being performed normally.

[0014] Furthermore, it is preferable that the extravasation detection device includes an infusion information acquisition unit that acquires information related to the administration of the infusion fluid in an infusion device for administering the infusion fluid into a blood vessel, and that the determination unit determines whether or not the infusion fluid administration is being performed normally based on the information related to the administration of the infusion fluid acquired by the infusion information acquisition unit and the measured value acquired by the measured value acquisition unit.

[0015] Furthermore, in the extravasation detection device, it is preferable that the patient has the indwelling needles inserted into peripheral blood vessels at multiple different parts of the body, and that the infusion information acquisition unit acquires information related to the administration of the infusion fluid in accordance with the fact that each infusion device corresponding to each indwelling needle has administered the infusion fluid in sequence.

[0016] Furthermore, the extravasation detection device is preferably equipped with an infusion device control unit that is communicatively connected to each infusion device and controls the administration of the infusion fluid by each infusion device, and the infusion device control unit instructs each infusion device to administer the infusion fluid in sequence.

[0017] Furthermore, in the extravasation detection device, it is preferable that the infusion device control unit instructs the infusion device to stop administering the infusion fluid when the determination unit determines that the infusion fluid administration is not being performed normally.

[0018] Furthermore, in the extravasation detection device, it is preferable that the judgment result output unit notifies the target infusion device in an identifiable manner when the judgment result indicates that the infusion is not being administered normally.

[0019] Furthermore, it is preferable that the extravascular leakage detection device is communicatively connected to a blood flow measuring device that measures the blood flow state of the patient's heart, and that the measurement value acquisition unit acquires the measurement value from the blood flow measuring device.

[0020] The present invention also relates to an extravasation leakage detection system comprising: a blood flow measuring device for measuring blood flow in the heart of a patient in which an indwelling needle has been inserted into a predetermined site in the body, before and after administration of intravenous fluid from the indwelling needle; and an extravasation leakage detection device communicately connected to the blood flow measuring device, wherein the extravasation leakage detection device comprises: a measurement value acquisition unit for acquiring measurement values ​​related to the blood flow state from the blood flow measuring device; a determination unit for determining whether or not intravenous fluid administration is being performed normally based on the measurement values ​​acquired by the measurement value acquisition unit; and a determination result output unit for outputting the determination result from the determination unit.

[0021] Furthermore, the present invention relates to a program for causing a computer to function as the extravascular leakage detection device described above. [Effects of the Invention]

[0022] According to the present invention, it is possible to provide an extravascular leakage detection device, an extravascular leakage detection system, and a program that can more easily detect extravascular leakage even when detection in peripheral blood vessels is difficult.

Brief Description of the Drawings

[0023] [Figure 1] It is an explanatory diagram regarding the use of each device in the extravascular leakage detection system according to the first embodiment. [Figure 2] It is a diagram showing the overall configuration of the extravascular leakage detection system according to the first embodiment and the functional blocks of the extravascular leakage detection device. [Figure 3] It is a diagram showing the functional blocks of the blood flow measurement device according to the first embodiment. [Figure 4] It is a flowchart showing the extravascular leakage detection process of the extravascular leakage detection device according to the first embodiment. [Figure 5] It is a diagram showing a table of measurement values according to the first embodiment and a graph showing changes over time. [Figure 6] It is a diagram showing the overall configuration of the extravascular leakage detection system according to the second embodiment and the functional blocks of the extravascular leakage detection device. [Figure 7] It is a diagram showing the functional blocks of the injection device according to the second embodiment. [Figure 8] It is a flowchart showing the extravascular leakage detection process of the extravascular leakage detection device according to the second embodiment. [Figure 9] It is a continuation of FIG. 8.

Modes for Carrying Out the Invention

[0024] Hereinafter, embodiments of the present invention will be described with reference to the drawings. Note that this is merely an example, and the technical scope of the present invention is not limited thereto. (First Embodiment) FIG. 1 is an explanatory diagram regarding the use of each device in the extravascular leakage detection system 100 according to the first embodiment. Figure 2 shows the overall configuration of the extravascular leakage detection system 100 according to the first embodiment and the functional blocks of the extravascular leakage detection device 1.

[0025] [Extravascular leakage detection system 100] The extravasation detection system 100 is a system for detecting leakage at the sites where medications or other substances are administered, for example, when a patient P, such as a child under intensive care, is administered medications or other substances by puncturing several peripheral blood vessels in the body. In addition to medications, fluid replacement and nutrition may also be administered to patient P's blood vessels, but in the following explanation, all fluid replacement, nutrition, and medications administered to patient P will be referred to as intravenous fluids. In the extravasation detection system 100, the extravasation detection device 1 detects extravasation by acquiring measurements related to the blood flow state at the location of the patient P's heart H.

[0026] In Figure 1, patient P is a child, and infusions from infusion bags 6A to 6C, corresponding to sites 7A to 7C, are being injected into peripheral blood vessels at sites 7A to 7C, where an indwelling needle (not shown) has been inserted. A syringe 5A (infusion device) is connected to the tube connecting the indwelling needle at site 7A to infusion bag 6A. When a doctor or nurse injects the infusion from syringe 5A, the infusion from syringe 5A is injected into the peripheral blood vessel at site 7A. The same applies to syringes 5B and 5C.

[0027] Here, we will explain the difference between the infusion in IV bag 6 and the infusion in syringe 5. The intravenous fluids in IV bag 6 are primarily intended for the replenishment of water and electrolytes, nutrition, and treatment of disease conditions. On the other hand, the intravenous fluids in syringe 5 are primarily intended for checking for extravasation. For the purposes mentioned above, the fluids in syringe 5 are administered as boluses of a predetermined amount at regular intervals. During this bolus administration, the pressure applied to the water generates microbubbles at the peripheral venous insertion site within the circuit (tube or blood vessel). Microbubbles are bubbles with a size (diameter) of less than 100 μm and are generated in peripheral venous routes and blood vessels during intravenous fluid administration in daily clinical practice. Normally, introducing bubbles into the body is undesirable in medical practice, but it is difficult to prevent the introduction of microbubbles. That is, when pressure is applied to the liquid in the tube by syringe 5 or a pump, dissolved oxygen (O2) and carbon dioxide (CO2) in the liquid are generated as microbubbles due to the subsequent decrease in pressure. Furthermore, carbon dioxide gas in the bloodstream is released from the body in the lungs.

[0028] In the following explanation, when individual syringes 5A, 5B, etc. are not specified, the designations "A" and "B" will be omitted, and they will simply be referred to as "Syringe 5" (infusion device). The same applies to "Infusion Bag 6" and "Site 7," etc. Furthermore, those who perform procedures on patient P, such as doctors and nurses, will be referred to as "healthcare professionals" below.

[0029] The blood flow measurement unit 45 of the blood flow measurement device 4 is attached, for example, to the skin of the chest on the right side of the heart H of patient P. The measured values ​​related to the blood flow state measured by the blood flow measurement unit 45 are then transmitted from the blood flow measurement device 4 to the extravasation detection device 1. For example, if there is no leakage from the puncture site 7A during or before infusion using the IV bag 6A, the administration of fluid from syringe 5A will change the blood flow state in patient P's heart H. Similarly, if there is no leakage from the puncture sites 7B and 7C, the administration of fluid from syringes 5B and 5C will change the blood flow state in patient P's heart H.

[0030] More specifically, when intravenous fluids are administered from the IV bag 6 with peripheral blood vessels punctured at various sites 7 in patient P, the blood containing the intravenous fluids circulates from the peripheral blood vessels to the heart H. When intravenous fluids are administered from the syringe 5, the oxygen (O2) and carbon dioxide (CO2) dissolved in the fluid at the time of administration become microbubbles due to changes in pressure along the administration route or within the blood vessels, and these circulate within patient P's body. Therefore, the blood flow measurement device 4 can, for example, obtain the amount of microbubbles detected as a measurement value.

[0031] As shown in Figure 2, the extravasation detection system 100 comprises an extravasation detection device 1, a blood flow measuring device 4, and a plurality of syringes 5A, 5B, ... The extravasation detection device 1 and the blood flow measurement device 4 are connected in a way that allows them to communicate with each other. Here, the extravasation detection device 1 and the blood flow measurement device 4 are connected in a way that allows them to communicate with each other, for example, via short-range wireless communication. Examples of short-range wireless communication include, but are not limited to, Bluetooth® or Wi-Fi.

[0032] [Extravascular leakage detection device 1] The extravasation detection device 1 may be, for example, a general personal computer (PC) or a dedicated device. The extravascular leakage detection device 1 shown in Figure 2 comprises a control unit 10, a storage unit 20, an input unit 32, a display unit 33, an audio output unit 34, and a communication unit 39. The control unit 10 is a central processing unit (CPU) that controls the entire extravascular leakage detection device 1. The control unit 10 works in cooperation with the aforementioned hardware to perform various functions by appropriately reading and executing the operating system (OS) and application programs stored in the memory unit 20.

[0033] The control unit 10 includes an infusion information acquisition unit 11, a measurement value acquisition unit 12, a measurement value output unit 13, a determination unit 14, and a determination result output unit 15. The infusion information acquisition unit 11 acquires information related to the administration of infusion fluids using the syringe 5 that administers the infusion fluids. This information may include, for example, the timing of administration, as well as other information such as the dosage. The infusion information acquisition unit 11 acquires this information, for example, when a healthcare professional inputs the information related to the administration of infusion fluids via the input unit 32. If infusion fluids are administered to multiple body parts 7 of the patient P, the infusion information acquisition unit 11 may acquire information related to the administration of infusion fluids in a sequence corresponding to the administration of infusion fluids using each syringe 5 that corresponds to each body part 7 via an indwelling needle.

[0034] The measurement value acquisition unit 12 acquires measurement values ​​related to the blood flow state in the heart H of patient P, where an indwelling needle has been inserted into a body part 7, before and after the administration of intravenous fluids via the indwelling needle. The measurement values ​​may be, for example, detection values ​​that change depending on the content of the microbubbles per predetermined time, or detection values ​​of sound waves or light waves of a predetermined wavelength that change depending on the blood flow state. The measurement value acquisition unit 12 can acquire measurement values ​​related to the blood flow state measured by the blood flow measuring device 4. The measurement value output unit 13 outputs the measurement values ​​acquired by the measurement value acquisition unit 12. The measurement value output unit 13 may, for example, graph the measurement values ​​and output them to the display unit 33.

[0035] The determination unit 14 determines whether or not intravenous fluid administration is being performed normally based on the measurement values ​​obtained by the measurement value acquisition unit 12. The determination unit 14 may determine whether or not intravenous fluid administration is being performed normally based on the change over time of the measured value acquired by the measured value acquisition unit 12. More specifically, the determination unit 14 may determine that intravenous fluid administration is not being performed normally if, for example, the amount of change over time of the measured value acquired by the measured value acquisition unit 12 is outside the range of a threshold for the change over time of the measured value that has been stored in advance in the threshold storage unit 23. Furthermore, the determination unit 14 may determine whether or not intravenous fluid administration is being performed normally based on the peak value of the measurement value acquired by the measurement value acquisition unit 12. More specifically, the determination unit 14 may determine that intravenous fluid administration is not being performed normally if, for example, the peak value of the measurement value acquired by the measurement value acquisition unit 12 is outside the range of the threshold values ​​of the measurement values ​​that have been stored in advance in the threshold storage unit 23.

[0036] Furthermore, the determination unit 14 may determine whether or not the intravenous fluid administration is being performed normally based on the information related to the administration of intravenous fluids acquired by the intravenous fluid information acquisition unit 11 and the measured values ​​acquired by the measured value acquisition unit 12. The judgment result output unit 15 outputs the judgment result from the judgment unit 14. The judgment result output unit 15 outputs the judgment result to, for example, the display unit 33. In this case, if the judgment result determines that the intravenous fluid administration is not being performed normally, the judgment result output unit 15 may output a warning from, for example, the audio output unit 34.

[0037] The storage unit 20 is a storage area such as a hard disk or semiconductor memory element for storing programs, data, etc., necessary for the control unit 10 to perform various processes. The memory unit 20 stores the program memory unit 21 and the threshold memory unit 23. The program storage unit 21 stores programs for executing the various functions of the control unit 10 described above. The threshold memory unit 23 stores threshold values ​​related to the measured values. The threshold values ​​are predetermined. For example, the threshold values ​​may be based on measurements taken by a blood flow measuring device such as a blood flow meter when past extravasation events occurred.

[0038] The input unit 32 is, for example, an input device such as a keyboard or mouse. The display unit 33 is, for example, a display device such as a liquid crystal display. Alternatively, the input unit 32 and the display unit 33 may be integrated into a single touch panel display. The audio output unit 34 is an output device, such as a speaker, that transmits audio to the outside. The communication unit 39 is an interface for short-range wireless communication with the blood flow measuring device 4, for example, using Bluetooth®. The communication unit 39 is equipped with an IC (Integrated Circuit) chip and a loop antenna created according to the Bluetooth standard. The communication unit 39 can communicate over a range of approximately 10m to 100m. Furthermore, a computer refers to an information processing device equipped with a control unit, memory device, etc., and the extravascular leakage detection device 1 is an information processing device equipped with a control unit 10, a memory unit 20, etc., and is included in the concept of a computer.

[0039] [Blood flow measuring device 4] Figure 3 shows the functional block of the blood flow measuring device 4 according to the first embodiment. The blood flow measurement device 4 is a device that measures the blood flow state and transmits the measured values ​​obtained to the extravasation leakage detection device 1. The blood flow measurement device 4 may be, for example, a laser Doppler flowmeter. A laser Doppler flowmeter measures the blood flow state in the capillaries flowing near the skin surface by irradiating with near-infrared light. When a laser Doppler flowmeter detects a moving object, it measures the blood flow state through a phenomenon called the "Doppler effect," in which the frequency of scattered light changes in response to the speed of movement. The laser Doppler flowmeter expresses the blood flow state of the heart H, the area to which the laser is applied, as a numerical value. Note that the blood flow measurement device 4 is not limited to the laser Doppler flowmeter described above, and may also use sound waves or other types of light.

[0040] The blood flow measuring device 4 shown in Figure 3 comprises a control unit 40, a storage unit 41, an operation unit 42, a display unit 43, a blood flow measuring unit 45, and a communication unit 49. The control unit 40 is a CPU that controls the entire blood flow measurement device 4. The control unit 40 works in cooperation with the aforementioned hardware to perform various functions by appropriately reading and executing the OS and application programs stored in the memory unit 41. The control unit 40 obtains a numerical value based on the detection by the blood flow measurement unit 45.

[0041] The memory unit 41 is a storage area such as a semiconductor memory element for storing programs, data, etc., necessary for the control unit 40 to perform various processes. The operating unit 42 is, for example, an input device such as a switch button. The display unit 43 is, for example, a display device such as a liquid crystal display. The blood flow measurement unit 45 is attached, for example, to the heart H of patient P to detect blood flow in the heart H. The blood flow measurement unit 45 continuously applies a constant amount of light and utilizes the fact that the amount of light returned changes depending on the amount of microbubbles in the capillaries of the area being illuminated. The blood flow measurement unit 45 detects the amount of light returned. The communication unit 49 is, for example, an interface for short-range wireless communication with the extravascular leakage detection device 1 using Bluetooth®.

[0042] [Syringe 5] The syringe 5 shown in Figure 1 is connected to a tube that connects the infusion bag 6 and the indwelling needle, and is a device for delivering the infusion fluid filled in the syringe 5 to the indwelling needle via the tube. Syringe 5 is filled with an infusion solution containing microbubbles. The healthcare professional then performs the procedure to inject the infusion solution from syringe 5 at the desired time.

[0043] [Explanation of the process] Next, the processing in the extravascular leakage detection device 1 will be explained based on a flowchart. Figure 4 is a flowchart showing the extravascular leakage detection process of the extravascular leakage detection device 1 according to the first embodiment. Figure 5 shows Table 61, which displays the measured values ​​according to the first embodiment, and Graph 62, which shows the changes over time. When administering intravenous fluids to patient P, the medical professional attaches the blood flow measurement unit 45 near the location of patient P's heart H. The medical professional also inserts an indwelling needle into a peripheral blood vessel at site 7 of patient P, and ensures that the infusion fluids contained in each syringe 5 can be injected by manipulating the syringes 5.

[0044] Subsequently, a medical professional operates the extravasation detection device 1 and the blood flow measurement device 4, and in step S 11 of Figure 4 (hereinafter, "step S" will be simply referred to as "S"), the control unit 10 of the extravasation detection device 1 establishes communication with the blood flow measurement device 4. In S12, the measurement value acquisition unit 12 starts the process of acquiring measurement values ​​from the blood flow measuring device 4. In S13, the measurement value output unit 13 starts processing to graph the acquired measurement values ​​and output them to the display unit 33. The graph output to the display unit 33 may be, for example, the graph 62 shown in Figure 5. Graph 62 will be described later. The control unit 10 continues the process of acquiring and outputting measurement values ​​from the blood flow measuring device 4, which is the process in S12 and S13, until this process is completed.

[0045] In S14, the infusion information acquisition unit 11 acquires infusion start information for one syringe 5. When administering infusion to patient P using multiple syringes 5, the infusion is administered by sequentially operating each syringe 5 corresponding to each indwelling needle. Therefore, when a healthcare worker inputs infusion start information to the extravasation detection device 1 via the input unit 32 and starts administering infusion to one syringe 5, the infusion information acquisition unit 11 can acquire infusion start information for one syringe 5. The infusion start information may include information regarding the start of infusion, as well as the amount of infusion, etc. Here, the control unit 10 may output the procedure for inputting to the extravasation detection device 1 and starting the operation of one syringe 5 to the display unit 33 so that medical personnel can understand the procedure.

[0046] Furthermore, after receiving the infusion start information input to the extravasation leakage detection device 1, the control unit 10 may output to the display unit 33 an instruction to perform an injection operation on one syringe 5 within a predetermined time (for example, within 3 seconds). For example, when the control unit 10 receives the infusion start information input, it outputs a countdown display to the display unit 33. Then, as soon as the countdown display reaches 0, the medical professional operates the syringe 5 to start the injection. If there is no change in the measured value, the extravasation leakage detection device 1 cannot determine whether the infusion has started or whether the infusion is leaking. Therefore, after receiving the infusion start information input to the extravasation leakage detection device 1, the medical professional needs to perform an injection operation on one syringe 5 within a predetermined time. Alternatively, the healthcare professional may immediately input the infusion start information into the extravasation detection device 1 after performing the infusion procedure with one syringe 5.

[0047] In S15, the determination unit 14 performs a determination process to determine whether or not the infusion is being administered normally based on the change in the measured value over a predetermined period of time after the start of the infusion. Here, we will explain the data used in the decision-making process based on Figure 5. Table 61, which shows the change in measured values ​​over time as shown in Figure 5, displays the measured values ​​obtained every 0.01 seconds, with the start of measurement acquisition by processing S12 in Figure 4 set to 0 seconds. Graph 62 is a graphical representation of Table 61. Referring to Graph 62, approximately 5 seconds after the start of measurement acquisition, the measured value changes sharply to a high value, and then shows a downward trend.

[0048] From this graph 62, it can be seen that approximately 5 seconds after the start of measurement acquisition, the infusion from syringe 5 was injected, and the amount of microbubbles detected in the blood increased. Furthermore, it can be seen that the amount of change in the measurement value over time is within the threshold range of the threshold memory unit 23. The control unit 10 detects the start of infusion from syringe 5 through the process in S14 of Figure 4, and in the case of the measurement value shown in Figure 5, the judgment unit 14 determines that the infusion is being administered normally based on the change in the measurement value over a predetermined time after the start of infusion. In other words, it can be seen that there is no extravasation from the site 7 connected to syringe 5. In the case of extravasation, Graph 62 will show, for example, no change in the measured value or only a small change.

[0049] In S16 of Figure 4, the determination unit 14 determines whether or not the intravenous fluid administration is being performed normally based on the determination process. If it is determined that the intravenous fluid administration is being performed normally (S16: YES), the control unit 10 moves the process to S18. On the other hand, if it is determined that the intravenous fluid administration is not being performed normally (S16: NO), the control unit 10 moves the process to S17. In S17, the judgment result output unit 15 performs a warning output process. More specifically, the judgment result output unit 15 may output a warning sound from the audio output unit 34 to prompt medical personnel to confirm. After that, the control unit 10 terminates this process.

[0050] On the other hand, in S18, the control unit 10 determines whether administration has started in all syringes 5, for example, based on input from a medical professional to the input unit 32. The determination result output unit 15 may, for example, if it determines in the processing of S16 that infusion administration is being performed normally, output a screen to the display unit 33 asking whether to check the other syringes 5, allowing the medical professional to make a selection. If administration has started in all syringes 5 (S18: YES), the control unit 10 terminates this process. On the other hand, if administration has not started in all syringes 5 (S18: NO), the control unit 10 moves the process to S14 and detects extravasation by administering infusion to the syringes 5 that have not started administration.

[0051] [Differentiation] (1) The above explanation uses the example of a patient P having punctures in multiple locations on their body, but it can also be used even if there is at least one puncture. Furthermore, the extravasation detection process described above may be performed at the start of infusion using the infusion bag 6, during infusion using the infusion bag 6, or at both times.

[0052] (2) In the above explanation, the decision process was described using the change in the measured value over time at a predetermined time after the start of intravenous fluid administration as an example, but it is not necessary to use the change in the measured value over time. For example, the decision process may be based on the peak value of the measured value at a predetermined time after the start of intravenous fluid administration.

[0053] As described above, the extravascular leakage detection device 1 according to the first embodiment provides the following effects. (1) The system includes a measurement value acquisition unit 12 that acquires measurement values ​​related to the blood flow state in the heart H of a patient P in which an indwelling needle has been inserted at a predetermined site 7 of the body, before and after administration of intravenous fluid from the indwelling needle; a determination unit 14 that determines whether or not intravenous fluid administration is being performed normally based on the measurement values ​​acquired by the measurement value acquisition unit 12; and a determination result output unit 15 that outputs the determination result from the determination unit 14. This allows for monitoring the blood flow status of the heart (H), enabling detection at the heart regardless of where infusion is administered (7), thus allowing for the detection of extravasation even when detection in peripheral blood vessels is difficult. Furthermore, because the blood flow status of the heart (H) is determined by measurement, the possibility of extravasation can be automatically assessed. In addition, the assessment results are output, allowing healthcare professionals to confirm the presence of extravasation.

[0054] (2) The measurement value acquisition unit 12 has a measurement value output unit 13 that outputs the measurement value acquired by the unit, and the judgment result output unit 15 outputs a warning if the judgment result indicates that the intravenous fluid administration is not being performed normally. This allows healthcare professionals to determine or detect extravasation based on the displayed measurement values. Furthermore, the system issues warnings based on the results, enabling healthcare professionals to confirm extravasation.

[0055] (3) The system includes a threshold memory unit 23 that stores threshold values ​​for changes in measured values ​​over time. The determination unit 14 determines that fluid administration is not being performed normally if the amount of change in measured values ​​over time acquired by the measurement value acquisition unit 12 is outside the threshold range of the threshold memory unit 23. Furthermore, the system includes a threshold storage unit 23 that stores threshold values ​​for measured values. The determination unit 14 determines that fluid administration is not being performed correctly if the peak value of the measured value acquired by the measured value acquisition unit 12 is outside the threshold range of the threshold storage unit 23. This allows for a standardized assessment of whether or not intravenous fluid administration is normal, based on a threshold.

[0056] (4) The system includes an infusion information acquisition unit 11 that acquires information related to the administration of infusion fluids in a syringe 5 for intravenous administration of infusion fluids, and the determination unit 14 determines whether or not the infusion fluid administration is being performed normally based on the information related to the administration of infusion fluids acquired by the infusion information acquisition unit 11 and the measured values ​​acquired by the measured value acquisition unit 12. This allows for decisions regarding the administration of intravenous fluids to be made while taking into account information related to the administration of intravenous fluids. Therefore, it becomes possible to make more accurate decisions.

[0057] (5) Patient P has indwelling needles inserted into multiple different body parts 7, and the infusion information acquisition unit 11 acquires information related to the administration of infusion fluids corresponding to each syringe 5 that has administered infusion fluids in sequence to each indwelling needle. This allows for sequential administration of infusion fluids from syringe 5 and acquisition of information from syringe 5, making it possible to determine which syringe 5, or in other words, which indwelling needle, is responsible for extravasation in the event of leakage.

[0058] (6) The measurement value acquisition unit 12 is located on the chest of patient P and is communicatively connected to a blood flow measuring device 4 that measures the blood flow state of patient P's heart H. The measurement value acquisition unit 12 acquires measurement values ​​from the blood flow measuring device 4. Therefore, the extravasation detection device 1 can be implemented using a general-purpose computer.

[0059] (Second Embodiment) Next, a second embodiment of the present invention will be described. In the second embodiment, we describe a system in which the infusion device automatically administers intravenous fluids based on instructions from an extravasation detection device. In the following description, parts that perform the same functions as in the first embodiment described above will be denoted by the same reference numerals or the same reference numerals at the end, and redundant explanations will be omitted as appropriate.

[0060] [Extravascular leakage detection system 200] Figure 6 shows the overall configuration of the extravascular leakage detection system 200 and the functional blocks of the extravascular leakage detection device 201 according to the second embodiment. As shown in Figure 6, the extravasation detection system 200 comprises an extravasation detection device 201, a blood flow measuring device 4, and a plurality of injection devices 205A, 205B, ... The extravasation detection device 201 and the blood flow measurement device 4 are connected in a communication manner. Furthermore, the extravasation detection device 201 and each injection device 205 are connected in a communication manner. The extravasation detection device 201 and each injection device 205 are connected in a way that allows communication, for example, via short-range wireless communication, similar to the communication between the extravasation detection device 201 and the blood flow measurement device 4.

[0061] [Extravascular leakage detection device 201] The extravascular leakage detection device 201 comprises a control unit 210, a storage unit 220, an input unit 32, a display unit 33, an audio output unit 34, and a communication unit 39. The control unit 210 includes an infusion information acquisition unit 211, a measurement value acquisition unit 12, a measurement value output unit 13, a determination unit 14, a determination result output unit 215, and an infusion device control unit 216. The infusion information acquisition unit 211 acquires information related to the administration of infusion fluids from the infusion device 205 that administers the infusion fluids. The infusion information acquisition unit 211 acquires this information by receiving it from the infusion device 205.

[0062] The judgment result output unit 215 outputs the judgment result from the judgment unit 14. The judgment result output unit 215 outputs the judgment result to, for example, the display unit 33. In this case, if the judgment result determines that the infusion is not being administered normally, the judgment result output unit 215 may output a warning from, for example, the voice output unit 34. Also, if the judgment result determines that the infusion is not being administered normally, the judgment result output unit 215 may, for example, provide information that identifies the target infusion device 205. The target infusion device 205 is the infusion device 205 that has been determined not to be administering infusion normally, and the information to be provided may be, for example, the serial number of the infusion device 205.

[0063] The infusion device control unit 216 controls the administration of intravenous fluids by each infusion device 205. Furthermore, if the judgment unit 14 determines that intravenous fluid administration is not being performed normally, the infusion device control unit 216 instructs the infusion device 205 to stop administering the intravenous fluid.

[0064] The memory unit 220 stores the program memory unit 221 and the threshold memory unit 23. The program storage unit 221 stores programs for executing the various functions of the control unit 210 described above.

[0065] [Injection device 205] Figure 7 shows the functional block of the injection device 205 according to the second embodiment. The infusion device 205 is, for example, a syringe device attached to the tube connecting the infusion bag 6 (see Figure 1) and the indwelling needle, and is a device for delivering the infusion fluid filled in the syringe to the indwelling needle via the tube. The injection device 205 comprises a control unit 250, a storage unit 251, an operation unit 252, a display unit 253, a pump unit 256, and a communication unit 259. The control unit 250 is a CPU that controls the entire injection device 205. The control unit 250 works in cooperation with the aforementioned hardware to perform various functions by appropriately reading and executing the OS and application programs stored in the memory unit 251.

[0066] The memory unit 251 is a memory area such as a semiconductor memory element for storing programs, data, etc., necessary for the control unit 250 to perform various processes. The operating unit 252 is, for example, an input device such as a switch button. The display unit 253 is, for example, a display device such as a liquid crystal display. The pump unit 256 is a device for dispensing infusion fluid from a syringe, and is controlled so that the flow rate per unit time is set to a predetermined value. The communication unit 259 is an interface for short-range wireless communication with the extravascular leakage detection device 201, for example, using Bluetooth®. Although not shown in the diagram, the injection device 205 has various functions necessary to function as an injection device 205 in addition to those described above, but their explanation will be omitted.

[0067] [Explanation of the process] Next, the processing in the extravascular leakage detection device 201 will be explained based on a flowchart. Figures 8 and 9 are flowcharts illustrating the extravascular leakage detection process of the extravascular leakage detection device 201 according to the second embodiment. When administering intravenous fluids to patient P, the medical professional attaches the blood flow measurement unit 45 near the location of patient P's heart H. The medical professional also inserts an indwelling needle into patient P's peripheral blood vessel, attaches the infusion device 205 to the tube connecting the infusion bag 6 (see Figure 1) and the indwelling needle, and prepares the device to allow infusion of fluids from the infusion device 205.

[0068] Subsequently, medical personnel operate the extravasation detection device 201, the blood flow measurement device 4, and each infusion device 205, so that in S211 of Figure 8, the control unit 210 of the extravasation detection device 201 establishes communication with the blood flow measurement device 4 and with each infusion device 205. The processes in S212 and S213 are the same as those in S12 and S13 of the first embodiment (Figure 4). In S214, the infusion device control unit 216 instructs one infusion device 205 to administer an infusion fluid. Through this process, the control unit 250 of the infusion device 205 controls the pump unit 256 to deliver the infusion fluid. In S215, the infusion information acquisition unit 211 acquires infusion start information from one infusion device 205. The process in S216 is the same as the process in S15 in the first embodiment (Figure 4). After that, the control unit 210 moves the process to S220 in Figure 9.

[0069] In S220 of Figure 9, the determination unit 14 determines whether or not the intravenous fluid administration is being performed normally based on the determination process. If it is determined that the intravenous fluid administration is being performed normally (S220: YES), the control unit 210 moves the process to S223. On the other hand, if it is determined that the intravenous fluid administration is not being performed normally (S220: NO), the control unit 210 moves the process to S221. In S221, the infusion device control unit 216 instructs the infusion device 205 to stop administering the infusion fluid. In S222, the judgment result output unit 215 performs a warning output process, for example, by outputting a warning sound from the audio output unit 34. The judgment result output unit 215 also notifies the display unit 33 so that the target injection device 205 can be identified. After that, the control unit 210 terminates this process.

[0070] On the other hand, in S223, the judgment result output unit 215 outputs to the display unit 33 that the operation is normal. At that time, the judgment result output unit 215 may output in a way that allows identification of the target injection device 205. In S224, the control unit 210 determines whether all infusion devices 205 have started operating based on whether or not it has instructed the infusion device 205 to administer infusion fluid. If all infusion devices 205 have started operating (S224: YES), the control unit 210 terminates this process. On the other hand, if all infusion devices 205 have not started operating (S224: NO), the control unit 210 moves the process to S214 in Figure 8 and performs leakage detection of infusion fluid for the one infusion device 205 that has not started administration.

[0071] [Differentiation] (1) In the above description, the infusion device 205 was described using a syringe device as an example, but it is not limited to this. It may also be a device attached to a tube connecting the infusion bag 6 (see Figure 1) and the indwelling needle, for flowing the infusion fluid filled in the infusion bag 6 through the tube to the indwelling needle.

[0072] (2) In the above explanation, the decision process was described using the change in measured values ​​over time at a predetermined time after the start of infusion as an example, but it does not have to be a change in measured values ​​over time. For example, the decision process may be based on information related to the administration of infusion in the infusion device 205 and measured values ​​at a predetermined time after the start of infusion. Here, the information related to the administration of infusion may include, for example, the timing of administration and the amount administered, as well as flow rate information. The control unit 210 may then determine whether or not infusion is being administered normally based on the difference between the flow rate information from the infusion device 205 and the flow rate information from the patient P's heart H obtained from the measured values. In this way, the control unit 210 can also determine whether or not infusion is being administered normally by monitoring both flow rate information in real time.

[0073] As described above, the extravascular leakage detection device 201 according to the second embodiment provides the following effects.

[0074] (1) Each infusion device 205 is connected to an infusion device control unit 216 which controls the administration of infusion fluid by each infusion device 205, and the infusion device control unit 216 instructs each infusion device 205 to administer infusion fluid in sequence. This allows the extravasation detection device 201 to control each infusion device 205 to administer the infusion fluid.

[0075] (2) If the judgment unit 14 determines that the infusion device control unit 216 is not administering the infusion fluid properly, it instructs the infusion device 205 to stop administering the infusion fluid. This allows for the cessation of intravenous fluid administration if extravasation is suspected.

[0076] (3) The judgment result output unit 215 will notify the target infusion device 205 in an identifiable manner if the judgment result indicates that the infusion is not being administered normally. This allows healthcare professionals to identify which infusion device 205 is causing extravasation by looking at the display unit 33.

[0077] It should be noted that the present invention is not limited to the embodiments described herein, and any modifications, improvements, etc., that can achieve the objectives of the present invention are included within the scope of the present invention. Furthermore, the embodiments described above and the modified forms described later can be used in combination as appropriate, but a detailed explanation will be omitted.

[0078] (Transformed form) (1) In each embodiment, the extravasation detection device was described as one that acquires measurement values ​​from the blood flow measurement device 4, but it is not limited to this. For example, the extravasation detection device itself may have the functions of the blood flow measurement device. (2) In each embodiment, the devices have been described as being connected to each other in a way that enables communication by short-range wireless communication, but the invention is not limited to this. At least a part of the devices may be connected to each other in a way that enables communication by, for example, wired connections. (3) In each embodiment, the description was given using pediatric patients as examples, but the method is not limited to these. The same can be done with adult patients, etc. [Explanation of Symbols]

[0079] 1,201 Extravascular leakage detection device 4 Blood flow measuring device 5, 5A, 5B, 5C Syringes 6, 6A, 6B, 6C Infusion Bags 7,7A,7B,7C parts 10, 40, 210, 250 Control Unit 11,211 Infusion information acquisition department 12 Measurement value acquisition unit 13 Measurement value output section 14 Judgment Department 15,215 Decision Result Output Unit 20,41,220,251 Storage section 21,221 Program Storage Unit 23 Threshold memory unit 32 Input section 33,43,253 Display section 34 Audio output section 39,49,259 Communications Department 42,252 Operation unit 45 Blood flow measurement section 61 table 62 Graphs 100,200 Extravascular Leakage Detection System 205,205A,205B Injection device 216 Injection device control unit 256 Pump section P patient H Heart

Claims

1. A measurement value acquisition unit that acquires measurement values ​​related to the blood flow state in the heart of a patient in whom an indwelling needle has been inserted into a predetermined site on the body, before and after administration of intravenous fluid from the indwelling needle, A determination unit determines whether or not intravenous fluid administration is being performed normally based on the measurement values ​​obtained by the measurement value acquisition unit, A determination result output unit that outputs the determination result from the aforementioned determination unit, An extravascular leakage detection device equipped with the following features.

2. In the extravascular leakage detection device according to claim 1, The determination unit is an extravasation detection device that determines whether or not intravenous fluid administration is being performed normally based on the change in the measured value acquired by the measurement value acquisition unit over time.

3. In the extravascular leakage detection device according to claim 2, The system includes a threshold memory unit that stores in advance the threshold value for the change in the measured value over time, The determination unit determines that the intravenous fluid administration is not being performed normally when the amount of change in the measured value over time acquired by the measured value acquisition unit is outside the range of the threshold in the threshold storage unit.

4. In the extravascular leakage detection device according to claim 1, The determination unit determines whether or not intravenous fluid administration is being performed normally based on the peak value of the measurement value acquired by the measurement value acquisition unit, and is an extravasation detection device.

5. In the extravascular leakage detection device according to claim 4, It includes a threshold storage unit that stores the threshold values ​​of the measured values ​​in advance, The determination unit determines that the intravenous fluid administration is not being performed normally when the peak value of the measurement value acquired by the measurement value acquisition unit is outside the range of the threshold in the threshold storage unit. This is an extravasation detection device.

6. In the extravascular leakage detection device according to claim 1, The measurement value acquisition unit includes a measurement value output unit that outputs the measurement value acquired by the measurement value acquisition unit, The judgment result output unit is an extravasation leakage detection device that outputs a warning when the judgment result indicates that the intravenous fluid administration is not being performed normally.

7. In the extravascular leakage detection device according to claim 1, The infusion device for administering the aforementioned infusion fluid into a blood vessel is equipped with an infusion fluid information acquisition unit that acquires information related to the administration of the aforementioned infusion fluid. The determination unit determines whether or not the intravenous fluid administration is being performed normally based on the information related to the administration of the intravenous fluid acquired by the intravenous fluid information acquisition unit and the measured value acquired by the measured value acquisition unit, and is an extravasation detection device.

8. In the extravascular leakage detection device according to claim 7, The patient had the indwelling needles inserted into peripheral blood vessels in multiple different parts of his body. The infusion information acquisition unit is an extravasation leakage detection device that acquires information related to the administration of the infusion fluid in accordance with the fact that each infusion device corresponding to each indwelling needle has administered the infusion fluid in sequence.

9. In the extravascular leakage detection device according to claim 8, Each injection device is connected in a communication-enabled manner. Each infusion device includes an infusion device control unit that controls the administration of the infusion fluid by the respective infusion device. The infusion device control unit is an extravasation detection device that sequentially instructs each infusion device to administer the infusion fluid.

10. In the extravascular leakage detection device according to claim 9, The infusion device control unit is an extravasation detection device that, when the determination unit determines that the infusion fluid administration is not being performed normally, instructs the infusion device to stop the administration of the infusion fluid.

11. In the extravascular leakage detection device according to claim 9 or claim 10, The judgment result output unit is an extravasation leakage detection device that identifies and notifies the target infusion device when the judgment result indicates that the infusion administration is not being performed normally.

12. In the extravascular leakage detection device according to claim 1, It is communicated to a blood flow measuring device that measures the blood flow state of the patient's heart, The measurement value acquisition unit is an extravascular leakage detection device that acquires the measurement value from the blood flow measuring device.

13. A blood flow measuring device that measures blood flow in the heart of a patient in whom an indwelling needle has been inserted into a designated site on the body, before and after administration of intravenous fluid from the indwelling needle, An extravascular leakage detection device, which is connected to the blood flow measuring device in a communication manner, An extravasation detection system equipped with, The extravascular leakage detection device is, A measurement value acquisition unit that acquires measurement values ​​related to the blood flow state from the blood flow measuring device, A determination unit determines whether or not intravenous fluid administration is being performed normally based on the measurement values ​​obtained by the measurement value acquisition unit, A determination result output unit that outputs the determination result from the aforementioned determination unit, An extravasation detection system equipped with the following features.

14. Computers, A means for acquiring measurement values ​​related to the blood flow state in the heart of a patient in whom an indwelling needle has been inserted into a predetermined site on the body, before and after administration of intravenous fluid from the indwelling needle, A determination means for determining whether or not intravenous fluid administration is being performed normally based on the measurement values ​​obtained by the measurement value acquisition means, A determination result output means that outputs the determination result obtained by the aforementioned determination means, A program to make it work.

Images