Extravasation detection device, extravasation detection system, and program

Abstract

Provided are an extravasation detection device, extravasation detection system, and program, which are capable of more easily detecting extravasation even when detection in a peripheral blood vessel is difficult. An extravasation detection device 1 acquires, from a blood flow measurement device 4, a measurement value related to a blood flow state in the heart H of a patient P with an indwelling needle inserted at a predetermined site 7 of the body before and after administration of an infusion solution trough the indwelling needle, determines whether or not the infusion solution is correctly administered on the basis of the acquired measurement value, and outputs a determination result.

Description

Extravascular Leakage Detection Device, Extravascular Leakage Detection System, and Program

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

[0002] Infusion therapy for patients is the most common medical practice and is thus carried out in many treatments. When performing drip infusion in infusion therapy, it is necessary to appropriately secure an 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, the administration route may shift or come off from the blood vessel where the route has been secured, etc., and an event may occur where the tip of the administration route is located outside the blood vessel and the drug cannot be properly administered into the blood vessel. Such events may, in the worst case, lead to a complication called "extravascular leakage" that necrotizes the surrounding tissue.

[0003] Particularly, when administering an anticancer agent substance, etc. for cancer drug therapy, or in the case of pediatric patients with fragile blood vessels and skin tissue, there are many cases where the condition worsens. Although this is a problem that leads to such serious complications, currently, 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).

[0005] Japanese Unexamined Patent Application Publication No. 2011 - 200429 International Publication No. 2013 / 146696

[0006] Patients under centralized care often undergo multiple punctures to administer fluids, nutrients, and medications. Therefore, healthcare professionals managing these patients need to manage multiple puncture sites, making the process complex. Furthermore, in the case of children, the narrow blood vessels and low blood flow present challenges in detecting punctures in peripheral blood vessels.

[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.

[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.

[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.

[0023] This is an explanatory diagram relating to the use of each device in the extravascular leakage detection system according to the first embodiment. This is a diagram showing the overall configuration of the extravascular leakage detection system and the functional block of the extravascular leakage detection device according to the first embodiment. This is a diagram showing the functional block of the blood flow measuring device according to the first embodiment. This is a flowchart showing the extravascular leakage detection process of the extravascular leakage detection device according to the first embodiment. This is a diagram showing a table of measured values ​​and a graph showing changes over time according to the first embodiment. This is a diagram showing the overall configuration of the extravascular leakage detection system and the functional block of the extravascular leakage detection device according to the second embodiment. This is a diagram showing the functional block of the injection device according to the second embodiment. This is a flowchart showing the extravascular leakage detection process of the extravascular leakage detection device according to the second embodiment. This is a continuation of Figure 8.

[0024] The embodiments of the present invention will be described below 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) Figure 1 is an explanatory diagram of the use of each device in the extravascular leakage detection system 100 according to the first embodiment. Figure 2 is a diagram showing the overall configuration of the extravascular leakage detection system 100 according to the first embodiment and the functional block of the extravascular leakage detection device 1.

[0025] [Extravasation Detection System 100] The extravasation detection system 100 is a system for detecting leakage at the sites where medications or other substances are administered when a patient P, such as a child under centralized management, is punctured in several peripheral blood vessels in the body. In addition to medications, fluid replacement and nutrition may also be administered to the 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 measurement values ​​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 the IV bag 6 and the infusion in the syringe 5. The infusion in the IV bag 6 is mainly intended for the replenishment of water and electrolytes, nutritional support, and treatment of disease conditions. On the other hand, the infusion in the syringe 5 is mainly intended for checking for extravasation. For the above purpose, the infusion in the syringe 5 is administered as a bolus of a prescribed amount at regular intervals. During this bolus administration, the pressure applied to the water generates microbubbles at the peripheral venous insertion site in the circuit (tube or blood vessel). Microbubbles refer to bubbles with a size (diameter) of less than 100 μm, and they are generated in peripheral venous routes and blood vessels during infusion administration performed in daily medical practice. Normally, introducing bubbles into the body is undesirable in medical practice, but it is difficult to prevent the introduction of microbubbles. That is, by applying pressure to the liquid in the tube with the syringe 5 or a pump, dissolved oxygen (O) in the liquid is released. ２ ) and carbon dioxide (CO2) ２ However, due to the subsequent drop in pressure, it is generated as microbubbles. The carbon dioxide gas in the bloodstream is then 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 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 infusion bag 6A, the blood flow state in patient P's heart H changes due to the administration of infusion from syringe 5A. Similarly, if there is no leakage at the puncture sites 7B and 7C, the blood flow state in patient P's heart H changes due to the infusion from syringes 5B and 5C.

[0030] More specifically, when intravenous fluids are administered from the IV bag 6 with the peripheral blood vessels of patient P punctured at various sites 7, the blood containing the intravenous fluids circulates from the peripheral blood vessels to the heart H. Then, when intravenous fluids are administered from the syringe 5, the oxygen (O) dissolved in the liquid at the time of administration is released. ２ ) and carbon dioxide (CO2) ２ The substance becomes microbubbles due to changes in pressure along the administration route or within the blood vessels, and circulates within the patient P's body. Therefore, the blood flow measuring device 4 can, for example, acquire the amount of microbubbles detected as a measured 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 measuring device 4 are connected in a communicative manner. Here, the extravasation detection device 1 and the blood flow measuring device 4 are connected in a communicative manner, for example, via short-range wireless communication. Short-range wireless communication can be used, but is not limited to, Bluetooth® or wireless LAN.

[0032] [Extravascular Leakage Detection Device 1] The extravascular leakage 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 hardware described above to perform various functions by appropriately reading and executing the operating system (OS) and application programs stored in the storage 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 judgment unit 14, and a judgment result output unit 15. The infusion information acquisition unit 11 acquires information related to the administration of infusion fluids using a syringe 5 that administers infusion fluids. Information related to the administration of infusion fluids may include, for example, the timing of administration, and may also include other information such as the amount administered. The infusion information acquisition unit 11 acquires information related to the administration of infusion fluids, for example, when a medical professional inputs information related to the administration of infusion fluids via an input unit 32. In the case of administering infusion fluids to multiple parts 7 of the patient P's body, the infusion information acquisition unit 11 may acquire information related to the administration of infusion fluids in order, corresponding to the administration of infusion fluids using each syringe 5 corresponding to each site 7 with each 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 measured values ​​acquired by the measurement value acquisition unit 12. The determination unit 14 may also determine whether or not intravenous fluid administration is being performed normally based on the change over time of the measured values ​​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 amount of change over time of the measured values ​​acquired by the measurement value acquisition unit 12 is outside the range of the threshold for the change over time of the measured values ​​that has been stored in advance in the threshold storage unit 23. Alternatively, the determination unit 14 may determine whether or not intravenous fluid administration is being performed normally based on the peak value of the measured values ​​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 measured values ​​acquired by the measurement value acquisition unit 12 is outside the range of the threshold for the measured values ​​that has 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 determination result output unit 15 outputs the determination result from the determination unit 14. The determination result output unit 15 outputs the determination result to, for example, the display unit 33. In this case, if the determination result indicates that the intravenous fluid administration is not being performed normally, the determination 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 storage unit 20 stores a program storage unit 21 and a threshold storage unit 23. The program storage unit 21 stores programs for performing the various functions of the control unit 10 described above. The threshold storage unit 23 stores thresholds related to measured values. The thresholds are predetermined. For example, the thresholds may be based on measured values ​​from 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 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 includes an IC (Integrated Circuit) chip and a loop antenna created according to the Bluetooth standard. The communication unit 39 can communicate over a distance of approximately 10m to 100m. Note that 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 Measurement Device 4] Figure 3 is a diagram showing the functional block of the blood flow measurement 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 extravascular 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 surface of the skin by irradiating near-infrared light. When the laser Doppler flowmeter detects a moving object, it measures the blood flow state using 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, which is 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 use sound waves or other types of light.

[0040] The blood flow measurement device 4 shown in FIG. 3 includes a control unit 40, a storage unit 41, an operation unit 42, a display unit 43, a blood flow measurement 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 appropriately reads and executes the OS and application programs stored in the storage unit 41, and cooperates with the above-described hardware to execute various functions. The control unit 40 obtains a measured value quantified based on the detection of the blood flow measurement unit 45.

[0041] The storage unit 41 is a storage area such as a semiconductor memory element for storing programs, data, etc. necessary for the control unit 40 to execute various processes. The operation unit 42 is an input device such as a switch button, for example. The display unit 43 is a display device such as a liquid crystal display, for example. The blood flow measurement unit 45 is attached to the position of the heart H of the patient P, for example, to detect the blood flow of the heart H. The blood flow measurement unit 45 continuously applies a certain amount of light, and utilizes the fact that the amount of light returning changes depending on the amount of microbubbles in the capillaries at the site where the light is applied. The blood flow measurement unit 45 detects the amount of light that has returned. The communication unit 49 is an interface for performing short-range wireless communication with the extravascular leakage detection device 1 by Bluetooth (registered trademark), for example.

[0042] [Syringe 5] The syringe 5 shown in FIG. 1 is a device connected to a tube connecting an infusion bag 6 and an indwelling needle, and for flowing the infusion filled in the syringe 5 through the tube to the indwelling needle. The syringe 5 is filled with an infusion containing microbubbles. Then, medical staff perform an operation for injecting the infusion of the syringe 5 at a desired timing.

[0043] [Explanation of the process] Next, the process in the extravasation detection device 1 will be explained based on a flowchart. Figure 4 is a flowchart of the extravasation detection process of the extravasation detection device 1 according to the first embodiment. Figure 5 is a diagram showing Table 61, which shows 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 the 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 keeps the syringes 5 ready for infusion by operating each syringe 5.

[0044] Subsequently, a medical professional operates the extravasation leakage 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 leakage 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 measurement device 4. In S13, the measurement value output unit 13 starts the process of graphing the acquired measurement values ​​and outputting 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 measurement 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. Here, 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, the medical professional inputs infusion start information to the extravasation detection device 1 via the input unit 32 and starts administering the infusion to one syringe 5, allowing the infusion information acquisition unit 11 to 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 injected. 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 the medical professional can understand the procedure.

[0046] Further, after receiving the input of the infusion start information for the extravascular leakage detection device 1, the control unit 10 may output, to the display unit 33, content instructing to perform an injection operation for one syringe 5 within a predetermined time (for example, within 3 seconds or the like). For example, when receiving the input of the infusion start information, the control unit 10 outputs a countdown display to the display unit 33. Then, simultaneously with the countdown display reaching 0, the medical staff operates the syringe 5 to start the injection. When there is no change in the measured value, the extravascular leakage detection device 1 cannot determine whether the infusion has started or the infusion is leaking. Therefore, after inputting the infusion start information for the extravascular leakage detection device 1, the medical staff needs to perform an injection operation for one syringe 5 within a predetermined time. Alternatively, the medical staff may input the infusion start information for the extravascular leakage detection device 1 immediately after performing the injection operation for one syringe 5.

[0047] In S15, the determination unit 14 performs a determination process of determining whether the infusion administration is being performed normally based on the change over time of the measured value at a predetermined time after the start of the infusion. Here, the data used in the determination process will be described based on FIG. 5. Table 61 showing the change over time of the measured value shown in FIG. 5 shows the measured values obtained every 0.01 seconds with the start of obtaining the measured value in the process of S12 in FIG. 4 as 0 seconds as numerical values. Further, the graph 62 represents Table 61 as a graph. Referring to the graph 62, after about 5 seconds have elapsed since the start of obtaining the measured value, the measured value changes rapidly 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 fluid 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 fluid injection 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 fluid administration is being performed 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. Note that in the case of extravasation, graph 62 would show, for example, no change in the measurement value or 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 determination result output unit 15 performs a warning output process. More specifically, the determination 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 process 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] [Modifications] (1) In the above explanation, the example was given of a case where punctures were made in multiple places on the patient P's body, but it is also possible to use the method even if at least one puncture is made. Furthermore, the extravasation detection process described above may be performed at the start of infusion using the infusion bag 6, or 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 does not have to be a 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 extravasation detection device 1 according to the first embodiment provides the following effects: (1) It comprises 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. As a result, by checking the blood flow state of the heart H, it is possible to check the heart H regardless of where in the body 7 the intravenous fluid is administered, so extravasation can be detected even when detection in peripheral blood vessels is difficult. Furthermore, since the blood flow state of the heart H is determined by measurement values, the possibility of extravasation can be determined automatically. In addition, since the determination result is output, medical personnel can check for extravasation.

[0054] (2) The device includes a measurement value output unit 13 that outputs the measurement values ​​acquired by the measurement value acquisition unit 12, and a 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 judge or detect extravasation in advance from the display of the measurement values. In addition, because a warning is issued based on the judgment result, healthcare professionals can confirm extravasation by the warning.

[0055] (3) The system is equipped with 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. The system is also equipped with a threshold memory unit 23 that stores threshold values ​​for measured values. The determination unit 14 determines that fluid administration is not being performed normally if the peak value of the measured values ​​acquired by the measurement value acquisition unit 12 is outside the threshold range of the threshold memory unit 23. This allows for a determination of whether or not fluid administration is normal based on threshold values, enabling a uniform determination.

[0056] (4) The system is equipped with 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. The judgment unit 14 determines whether or not the infusion fluid is being administered 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 the judgment regarding the administration of infusion fluids to be made in addition to the information related to the administration of infusion fluids. Therefore, it becomes possible to make a more accurate judgment.

[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 in accordance with the sequential administration of infusion fluids by each syringe 5 corresponding to each indwelling needle. As a result, since the infusion fluids are administered sequentially from the syringes 5 and information is acquired from the syringes 5, in the event of extravasation, it becomes possible to determine which syringe 5 the extravasation is from, that is, which indwelling needle is connected to which syringe 5.

[0058] (6) The measurement value acquisition unit 12 is connected to a blood flow measuring device 4 located on the chest of patient P, which measures the blood flow state of patient P's heart H, and 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, the infusion device automatically administers the intravenous fluid based on instructions from the extravasation detection device. In the following description, parts that perform the same functions as those 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 is a diagram showing the overall configuration of the extravascular leakage detection system 200 according to the second embodiment and the functional blocks of the extravascular leakage detection device 201. As shown in Figure 6, the extravascular leakage detection system 200 comprises an extravascular leakage detection device 201, a blood flow measuring device 4, and a plurality of injection devices 205A, 205B, ... The extravascular leakage detection device 201 and the blood flow measuring device 4 are connected in a communicative manner. The extravascular leakage detection device 201 and each injection device 205 are also connected in a communicative manner, for example, via short-range wireless communication, similar to the communication between the extravascular leakage detection device 201 and the blood flow measuring device 4.

[0061] [Extravasation Detection Device 201] The extravasation 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 comprises an infusion information acquisition unit 211, a measurement value acquisition unit 12, a measurement value output unit 13, a judgment unit 14, a judgment 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 in the infusion device 205 that administers the infusion fluids. The infusion information acquisition unit 211 acquires information related to the administration of infusion fluids 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 the 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 memory unit 221 stores programs for executing the various functions of the control unit 210 described above.

[0065] [Infusion Device 205] Figure 7 is a diagram showing the functional block of the infusion device 205 according to the second embodiment. The infusion device 205 is, for example, a syringe device attached to a tube connecting the infusion bag 6 (see Figure 1) and the indwelling needle, and is a device for infusing the infusion fluid filled in the syringe into the indwelling needle via the tube. The infusion 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 infusion device 205. The control unit 250 works in cooperation with the hardware described above to execute various functions by appropriately reading and executing the OS and application programs stored in the storage 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 operation unit 252 is an input device such as a switch button. The display unit 253 is 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 becomes a predetermined value. The communication unit 259 is an interface for short-range wireless communication with the extravasation detection device 201, for example, via Bluetooth®. Although not shown in the figures, the infusion device 205 has various functions for functioning as an infusion device 205 in addition to those described above, but their description is omitted.

[0067] [Explanation of the process] Next, the process in the extravasation detection device 201 will be explained based on a flowchart. Figures 8 and 9 are flowcharts showing the extravasation detection process of the extravasation 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 the patient P's heart H. The medical professional also inserts an indwelling needle into the peripheral blood vessel of patient P, 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 intravenous 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. 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 the infusion fluid. As a result of this process, the control unit 250 of the infusion device 205 controls the pump unit 256 and delivers 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 of the first embodiment (Figure 4). Subsequently, 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 infusion is being administered normally based on the determination process. If it is determined that the infusion is being administered normally (S220: YES), the control unit 210 moves the process to S223. On the other hand, if it is determined that the infusion is not being administered 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. In S222, the determination result output unit 215 performs a warning output process, for example, by outputting a warning sound from the audio output unit 34. The determination result output unit 215 also notifies the display unit 33 so that the target infusion 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 it is normal. At this time, the judgment result output unit 215 may output in a way that allows identification of the target infusion device 205. In S224, the control unit 210 determines whether the operation of all infusion devices 205 has started based on whether or not it has instructed the administration of infusion fluid to the infusion devices 205 that are connected in a communicable manner. If the operation of all infusion devices 205 has started (S224: YES), the control unit 210 terminates this process. On the other hand, if the operation of all infusion devices 205 has not started (S224: NO), the control unit 210 moves the process to S214 in Figure 8 and performs leakage detection of infusion fluid to the one infusion device 205 that has not started administration.

[0071] [Modifications] (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 of the infusion device 205 and the flow rate information in 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. The infusion device control unit 216 sequentially instructs each infusion device 205 to administer infusion fluid. This allows the extravasation detection device 201 to control each infusion device 205 and administer 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 the administration of the infusion fluid to be stopped if extravasation is suspected.

[0076] (3) The judgment result output unit 215 identifies the target infusion device 205 when the judgment result indicates that the infusion is not being administered normally. This allows healthcare professionals to check 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] (Modified Forms) (1) In each embodiment, the extravasation detection device was described as one that acquires measurement values ​​from the blood flow measurement device 4, but is not limited thereto. For example, the extravasation detection device itself may have the functions of the blood flow measurement device. (2) In each embodiment, the devices were described as being connected to each other in a way that enables communication by short-range wireless communication, but is not limited thereto. At least a part of them may be connected in a way that enables communication by wire, for example. (3) In each embodiment, the patient was described as a child, but is not limited thereto. The same can be done with adult patients, etc.

[0079] 1,201 Extravasation detection device 4 Blood flow measurement device 5,5A,5B. 5C Syringe 6, 6A, 6B, 6C Infusion bag 7, 7A, 7B, 7C Part 10, 40, 210, 250 Control unit 11, 211 Infusion information acquisition unit 12 Measurement value acquisition unit 13 Measurement value output unit 14 Judgment unit 15, 215 Judgment result output unit 20, 41, 220, 251 Storage unit 21, 221 Program storage unit 23 Threshold storage unit 32 Input unit 33, 43, 253 Display unit 34 Audio output unit 39, 49, 259 Communication unit 42, 252 Operation unit 45 Blood flow measurement unit 61 Table 62 Graph 100, 200 Extravasation detection system 205, 205A, 205B Infusion device 216 Infusion device control unit 256 Pump unit P Patient H Heart

Claims

1. An extravasation leakage 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 on 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.

2. An extravasation detection device according to claim 1, wherein the determination unit 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. An extravasation leakage detection device according to claim 2, comprising a threshold storage unit that stores in advance a threshold value for the change in the measured value over time, wherein 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 measured value acquisition unit is outside the range of the threshold value in the threshold storage unit.

4. An extravasation detection device according to claim 1, wherein the determination unit determines whether or not intravenous fluid administration is being performed normally based on the peak value of the measured value acquired by the measured value acquisition unit.

5. An extravasation leakage detection device according to claim 4, comprising a threshold storage unit that stores a threshold value of the measured value in advance, wherein 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 of the threshold storage unit.

6. An extravasation leakage detection device according to claim 1, comprising a measurement value output unit that outputs the measurement value acquired by the measurement value acquisition unit, and a judgment result output unit that outputs a warning when the judgment result indicates that the infusion administration is not being performed normally.

7. An extravasation leakage detection device according to claim 1, comprising an infusion information acquisition unit that acquires information relating to the administration of the infusion fluid in an infusion device for administering the infusion fluid into a blood vessel, wherein the determination unit determines whether or not the infusion fluid administration is being performed normally based on the information relating 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.

8. An extravasation detection device according to claim 7, wherein the patient has the indwelling needles inserted into peripheral blood vessels at multiple different locations on the body, and the infusion information acquisition unit acquires information relating 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. An extravasation leakage detection device according to claim 8, comprising an infusion device control unit which is communicably connected to each infusion device and controls the administration of the infusion fluid by each infusion device, wherein the infusion device control unit instructs each infusion device to administer the infusion fluid in sequence.

10. Extravasation detection device according to claim 9, wherein 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.

11. An extravasation leakage detection device according to claim 9 or claim 10, wherein the determination result output unit identifies and notifies the target infusion device when the determination result indicates that the infusion administration is not being performed normally.

12. An extravascular leakage detection device according to claim 1, wherein the extravascular leakage detection device is communicably connected to a blood flow measuring device that measures the blood flow state of the patient's heart, and the measurement value acquisition unit acquires the measurement value from the blood flow measuring device.

13. 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 on the body, before and after administration of intravenous fluid from the indwelling needle; and an extravasation leakage detection device that is communicably 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.

14. A program for causing a computer to function as: a measurement value acquisition 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 part of 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 ​​acquired by the measurement value acquisition means; and a determination result output means for outputting the determination result from the determination means.

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