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 includes: a first measurement value acquisition unit 11 that acquires a first measurement value related to the blood flow state during the administration of intravenous fluid from the indwelling needle 5 at a first measurement position B1 in the blood vessel L near the insertion position A1 where the indwelling needle 5 is inserted into the blood vessel L of patient P; a second measurement value acquisition unit 12 that acquires a second measurement value related to the blood flow state before and after the administration of intravenous fluid from the indwelling needle 5 at a second measurement position B2 corresponding to the first measurement position B1; a determination unit 14 that determines whether or not intravenous fluid administration is being performed normally by comparing the first measurement value acquired by the first measurement value acquisition unit 11 and the second measurement value acquired by the second measurement value acquisition unit 12; and a determination result output unit 15 that outputs the determination result from the determination unit 14.

Description

Technical Field

[0005] ,

[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 the most common medical practice and is thus carried out in many treatments. When performing drip infusion in infusion treatment, 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., there may occur an event in which the drug or blood in the blood vessel leaks outside the blood vessel and the tissue becomes infiltrated. Further, due to body movement or physical impact, etc., there may occur an event in which the administration route deviates or detaches from the blood vessel in which the route has been secured, such that the tip of the administration route is located outside the blood vessel and proper drug administration into the blood vessel cannot be performed. Such events may, in the worst case, result in a complication called "extravascular leakage" that necrotizes surrounding tissues.

[0003] In particular, 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. Despite being a problem leading to such serious complications, at present, as a means for detecting extravascular leakage clinically, reliance is placed 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). Further, 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] 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. [Means for solving the problem]

[0008] The present invention relates to an extravasation detection device comprising: a first measurement value acquisition unit that acquires a first measurement value relating to the blood flow state during the administration of intravenous fluid from an indwelling needle at a first measurement position in the blood flow direction within a blood vessel near the insertion site where an indwelling needle is inserted into a patient's blood vessel; a second measurement value acquisition unit that acquires a second measurement value relating to the blood flow state before and after the administration of intravenous fluid from an indwelling needle at a second measurement position corresponding to the first measurement position; a determination unit that determines whether or not intravenous fluid administration is being performed normally by comparing the first measurement value acquired by the first measurement value acquisition unit with the second measurement value acquired by the second measurement value acquisition unit; and a determination result output unit that outputs the determination result from the determination unit.

[0009] Furthermore, it is preferable that the first measurement value acquisition unit acquires the first measurement value relating to the blood flow state during the administration of infusion fluid from the indwelling needle at the first measurement position located upstream in the blood flow direction within the blood vessel relative to the insertion position, and the second measurement value acquisition unit acquires the second measurement value relating to the blood flow state before and after the administration of infusion fluid from the indwelling needle at the second measurement position located downstream in the blood flow direction within the blood vessel relative to the insertion position.

[0010] Furthermore, the extravasation detection device preferably includes a measurement output unit that outputs the first measurement value acquired by the first measurement value acquisition unit and the second measurement value acquired by the second measurement value acquisition unit in a time series, and the judgment result output unit preferably outputs a warning when the judgment result indicates that the infusion administration is not being performed normally.

[0011] Furthermore, the extravasation detection device is equipped with a threshold storage unit that stores a threshold value relating to the difference obtained by comparing the first measurement value and the second measurement value, and it is preferable that the determination unit determines that the infusion is not being administered normally when the difference is within the range of the threshold value in the threshold storage unit.

[0012] Furthermore, it is preferable that the extravascular leakage detection device is provided at a predetermined location on the patient's body and is communicatively connected to a first blood flow measuring device and a second blood flow measuring device that measure the blood flow state at the predetermined location on the patient, with the first measurement value acquisition unit acquiring the first measurement value from the first blood flow measuring device and the second measurement value acquisition unit acquiring the second measurement value from the second blood flow measuring device.

[0013] Furthermore, it is preferable that the first measurement value acquisition unit acquires a first measurement value related to the blood flow state during the administration of intravenous fluid from the indwelling needle at the first measurement position, and the second measurement value acquisition unit acquires a second measurement value related to the blood flow state at a second measurement position which is symmetrical to the first measurement position with respect to the midline plane of the patient's body, in a blood vessel on the opposite side which is symmetrical to the blood vessel in which the indwelling needle was punctured with respect to the midline plane of the patient's body.

[0014] The present invention also relates to an extravasation leakage detection system comprising: a blood flow measuring device that acquires measured values ​​relating to the blood flow state during or before / after administration of intravenous fluid from an indwelling needle inserted into a patient's blood vessel; and an extravasation leakage detection device that is communicably connected to the blood flow measuring device, wherein the extravasation leakage detection device comprises: a first measurement value acquisition unit that acquires a first measurement value relating to the blood flow state during intravenous fluid administration from the indwelling needle at a first measurement position in the blood flow direction within the blood vessel near the insertion site where the indwelling needle is inserted into the patient's blood vessel; a second measurement value acquisition unit that acquires a second measurement value relating to the blood flow state before and after administration of intravenous fluid from the indwelling needle at a second measurement position corresponding to the first measurement position; a determination unit that determines whether or not intravenous fluid administration is being performed normally by comparing the first measurement value acquired by the first measurement value acquisition unit with the second measurement value acquired by the second measurement value acquisition unit; and a determination result output unit that outputs the determination result from the determination unit.

[0015] 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]

[0016] According to the present invention, it is possible to provide an extravasation detection device, an extravasation detection system, and a program that can more easily detect extravasation even when detection in peripheral blood vessels is difficult. [Brief explanation of the drawing]

[0017] [Figure 1] This diagram illustrates the use of each device in the extravascular leakage detection system according to this embodiment. [Figure 2] This figure shows the overall configuration of the extravascular leakage detection system and the functional block of the extravascular leakage detection device according to this embodiment. [Figure 3] This is a schematic diagram showing the puncture site in the peripheral blood vessel near the area shown in Figure 1, and the measurement site by the blood flow measurement device. [Figure 4]It is a diagram showing the functional blocks of the blood flow measurement device according to the present embodiment. [Figure 5] It is a flowchart showing the extravasation detection process of the extravasation detection device according to the present embodiment. [Figure 6] It is a diagram showing a table of measurement values according to the present embodiment and a graph showing changes over time. [Figure 7] It is an explanatory diagram regarding the use of each device in the extravasation detection system according to the modified example. [Figure 8] It is a schematic diagram showing the puncture position punctured into the peripheral blood vessels near the site shown in FIG. 7 and the measurement position by the blood flow measurement device.

Mode for Carrying Out the Invention

[0018] 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. FIG. 1 is an explanatory diagram regarding the use of each device in the extravasation detection system 100 according to the present embodiment. FIG. 2 is a diagram showing the overall configuration of the extravasation detection system 100 according to the present embodiment and the functional blocks of the extravasation detection device 1.

[0019] [Extravasation Detection System 100] The extravasation detection system 100 is, for example, a system for detecting leakage at the punctured site when a patient P such as a pediatric patient subject to centralized management is punctured in several peripheral blood vessels of the body and a chemical solution or the like is administered. In addition to the chemical solution, fluids, nutrients, etc. can also be administered to the blood vessels of the patient P. In the following description, all of the fluids, nutrients, drugs, etc. administered to the patient P are described as infusions. In the extravasation detection system 100, the extravasation detection device 1 detects extravasation by acquiring measurement values related to the blood flow state at a predetermined site (for example, the arm) 7A of the patient P's body.

[0020] Patient P, illustrated in Figure 1, is an adult, and the infusions from infusion bags 6A and 6B, corresponding to sites 7A and 7B, are being injected into the peripheral blood vessels at sites 7A and 7B where the indwelling needle 5 (see Figure 3 below) was inserted.

[0021] Here, the intravenous fluids filled in IV bag 6 are primarily intended for the replenishment of water and electrolytes, nutritional support, and treatment of disease conditions. On the other hand, the intravenous fluids filled in syringes are primarily intended for checking for extravasation. For the aforementioned purposes, the fluids in syringes 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 tract insertion site within 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 intravenous fluid administration performed 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 a syringe or pump, the oxygen (O2) and carbon dioxide (CO2) dissolved 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.

[0022] In the following explanation, when individual infusion bags 6A, 6B, etc. are not specified, the designations "A" or "B" will be omitted, and the bag will simply be referred to as "infusion bag 6." The same applies to "blood flow measurement device 4," "site 7," etc. Furthermore, those who perform procedures on patient P, such as doctors and nurses, will be referred to as "healthcare professionals" below.

[0023] The blood flow measurement units 45 of the blood flow measurement devices 4A and 4B are attached, for example, to the skin of the right arm near site 7B of patient P. The first measurement value related to the blood flow state measured by the blood flow measurement unit 45 of blood flow measurement device 4A, and the second measurement value related to the blood flow state measured by the blood flow measurement unit 45 of blood flow measurement device 4B are transmitted from the blood flow measurement devices 4A and 4B to the extravasation detection device 1. For example, if there is no leakage from the puncture site 7A during or after infusion using the infusion bag 6A, the blood flow state near site 7A of patient P changes.

[0024] More specifically, when intravenous fluids are administered from the IV bag 6 while a peripheral blood vessel at site 7 of patient P is punctured, the blood containing the intravenous fluids circulates from the peripheral blood vessels to site 7. The microbubbles contained in the intravenous fluids are also administered and circulate. Therefore, the blood flow measuring device 4 can, for example, obtain the amount of microbubbles detected as a measurement value.

[0025] As shown in Figure 2, the extravasation detection system 100 comprises an extravasation detection device 1, a blood flow measuring device 4A, and a blood flow measuring device 4B. The extravasation detection device 1 and the blood flow measuring devices 4A and 4B are connected in a communicative manner. Here, the extravasation detection device 1 and the blood flow measuring devices 4A and 4B 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 Wi-Fi.

[0026] [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.

[0027] The control unit 10 includes a first measurement value acquisition unit 11, a second measurement value acquisition unit 12, a measurement value output unit 13, a determination unit 14, and a determination result output unit 15.

[0028] Figure 3 is a schematic diagram showing the puncture site in the peripheral blood vessel near site 7A shown in Figure 1, and the measurement sites of the blood flow measuring devices 4A and 4B. Note that the puncture site and measurement sites shown in Figure 3 are approximate and do not represent the actual dimensions.

[0029] As shown in Figure 3, an indwelling needle 5 is inserted into a peripheral blood vessel L of patient P, and insertion site A1 indicates the position where the indwelling needle 5 was inserted. Within blood vessel L, blood flows in the blood flow direction D1. The blood flow measuring device 4A measures a first measurement value related to the blood flow state during infusion administration from the indwelling needle 5 at a first measurement site B1 in the blood flow direction D1 within blood vessel L, near insertion site A1 where the indwelling needle 5 was inserted into patient P's blood vessel L. The blood flow measuring device 4B measures a second measurement value related to the blood flow state before and after infusion administration from the indwelling needle 5 at a second measurement site B2 corresponding to the first measurement site B1.

[0030] More specifically, the blood flow measuring device 4A measures a first measurement value related to the blood flow state during the administration of infusion from the indwelling needle 5 at a first measurement position B1 located upstream of the blood flow direction D1 within the blood vessel L relative to the insertion position A1. The blood flow measuring device 4B measures a second measurement value related to the blood flow state before and after the administration of infusion from the indwelling needle 5 at a second measurement position B2 located downstream of the blood flow direction D1 within the blood vessel L relative to the insertion position A1. The blood vessel L corresponding to the insertion position A1 may be the same blood vessel L from which the infusion is being administered, or it may be the same artery or vein on the opposite side from the artery or vein from which the infusion is being administered.

[0031] The first measurement value acquisition unit 11 acquires a first measurement value relating to the blood flow state during the administration of infusion fluid from the indwelling needle 5 at a first measurement position B1 in the blood flow direction D1 within the blood vessel L, near the insertion position A1 where the indwelling needle 5 was inserted into the blood vessel L of patient P. More specifically, the first measurement value acquisition unit 11 acquires a first measurement value relating to the blood flow state before and after the administration of infusion fluid from the indwelling needle 5 at a first measurement position B1 located upstream of the insertion position A1 where the indwelling needle 5 was inserted into the blood vessel L of patient P, in the blood flow direction D1 within the blood vessel L. The first measurement value may be, for example, a detected value that changes depending on the content of the microbubbles per predetermined time, or a detected value of sound waves or light waves of a predetermined wavelength that changes depending on the blood flow state. The first measurement value acquisition unit 11 can acquire a first measurement value relating to the blood flow state measured by the blood flow measuring device 4A.

[0032] The second measurement unit 12 acquires a second measurement value related to the blood flow state before and after the administration of infusion fluid from the indwelling needle 5 at the second measurement position B2, which corresponds to the first measurement position B1. More specifically, the second measurement unit 12 acquires a second measurement value related to the blood flow state before and after the administration of infusion fluid from the indwelling needle 5 at the second measurement position B2, which is located downstream in the blood flow direction D1 within the blood vessel L of patient P, relative to the insertion position A1 where the indwelling needle 5 is punctured. The second measurement value may be, for example, a detected value that changes depending on the content of the microbubbles per predetermined time, or a detected value of sound waves or light waves of a predetermined wavelength that changes depending on the blood flow state. The second measurement unit 12 can acquire a second measurement value related to the blood flow state measured by the blood flow measuring device 4B.

[0033] The measurement value output unit 13 outputs the first measurement value and the second measurement value acquired by the first measurement value acquisition unit 11 and the second measurement value acquisition unit 12, respectively, in a time series. The measurement value output unit 13 may, for example, graph the first measurement value and the second measurement value and output them to the display unit 33.

[0034] The determination unit 14 determines whether or not intravenous fluid administration is being performed normally by comparing the first measurement value obtained by the first measurement value acquisition unit 11 with the second measurement value obtained by the second measurement value acquisition unit 12. For example, the determination unit 14 may determine that intravenous fluid administration is not being performed normally if the difference obtained by comparing the first measurement value and the second measurement value is within the range of the threshold value of the threshold storage unit 22 of the storage unit 20.

[0035] If the difference between the first and second measurements is small (i.e., the difference is within the threshold range), it is considered that the blood flow state around site 7A of patient P has not changed much, and that fluid administration from the puncture site 7A is not being performed properly (for example, fluid is leaking). On the other hand, if the difference is large (i.e., the difference is outside the threshold range), it is considered that the blood flow state around site 7A of patient P has changed by the amount of fluid being administered, and therefore fluid administration is being performed properly.

[0036] 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 memory 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 a program storage unit 21 and a threshold storage unit 22. The program storage unit 21 stores programs for performing the various functions of the control unit 10 described above. The threshold storage unit 22 stores thresholds related to the difference obtained by comparing a first measurement value and a second measurement value. The thresholds may be predetermined, for example, derived from changes over time in 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 between the blood flow measuring devices 4A and 4B, 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. 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 measuring device 4] Figure 4 shows the functional block of the blood flow measuring device 4 according to this 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 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 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 area 7A 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 4 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 measuring 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 storage unit 41. The control unit 40 obtains numerically calculated measurements based on the detection by the blood flow measuring unit 45.

[0041] The memory unit 41 is a memory area such as a semiconductor memory element for storing programs, data, etc., necessary for the control unit 40 to perform various processes. The operation unit 42 is an input device such as a switch button. The display unit 43 is a display device such as a liquid crystal display.

[0042] The blood flow measurement unit 45 is attached, for example, near the location of area 7A of patient P (first measurement position B1 and second measurement position B2 shown in Figure 3) to detect blood flow at area 7A. 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 to which the light is applied. The blood flow measurement unit 45 detects the amount of light returned. The communication unit 49 is an interface for short-range wireless communication with the extravascular leakage detection device 1, for example, using Bluetooth®.

[0043] [Explanation of the process] Next, the processing in the extravascular leakage detection device 1 will be explained based on a flowchart. Figure 5 is a flowchart of the extravascular leakage detection process of the extravascular leakage detection device 1 according to this embodiment. Figure 6 is a diagram showing Table 61, which shows the measured values ​​according to this embodiment, and Graph 62, which shows the changes over time.

[0044] When administering intravenous fluids to patient P, the medical professional attaches the blood flow measurement unit 45 near location 7A on patient P. The medical professional also inserts an indwelling needle at insertion site A1 of the peripheral blood vessel L at location 7A on patient P.

[0045] Subsequently, a medical professional operates the extravasation detection device 1 and the blood flow measurement devices 4A and 4B, and in step S (hereinafter referred to simply as "S") 11 of Figure 5, the control unit 10 of the extravasation detection device 1 establishes communication with the blood flow measurement devices 4A and 4B. In S12, the first measurement value acquisition unit 11 starts the process of acquiring a first measurement value from the blood flow measuring device 4A, and the second measurement value acquisition unit 12 starts the process of acquiring a second measurement value from the blood flow measuring device 4B. In S13, the measurement value output unit 13 starts the process of graphing the acquired first measurement value and second measurement value, respectively, 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 6. The control unit 10 continues the process of acquiring and outputting the first and second measurement values ​​from the blood flow measuring devices 4A and 4B, which is the process in S12 and S13, until this process is completed.

[0046] In S14, the determination unit 14 compares the first measurement value and the second measurement value obtained in S12 to determine the difference, and performs a determination process to determine whether the determined difference is within the threshold range of the threshold storage unit 22 of the storage unit 20. If the difference is within the threshold range (S14: YES), the control unit 10 determines that the infusion is not being administered normally and moves the process to S15. If the difference is outside the threshold range (S14: NO), the control unit 10 determines that the infusion is being administered normally and terminates this process.

[0047] In S15, 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 indicating that the intravenous fluid administration is not being performed correctly, prompting medical personnel to check. After that, the control unit 10 terminates this process.

[0048] [Differentiation] The above explanation uses the example of a single puncture site on patient P's body, but it can also be used when there are two or more puncture sites. Furthermore, the extravasation detection process described above may be performed at the start of infusion using the IV bag 6, during infusion using the IV bag 6, or at both times.

[0049] Figure 7 is an explanatory diagram illustrating the use of each device in the modified extravasation detection system 100. Figure 8 is a schematic diagram showing the insertion site A1, where a peripheral blood vessel near site 7A shown in Figure 7 is punctured, and the measurement sites by blood flow measuring devices 4A and 4B at site 8, located on the opposite side of site 7A. Note that the insertion and measurement sites shown in Figure 8 are approximate and do not represent the actual dimensions.

[0050] As shown in Figure 8, an indwelling needle 5 is inserted into peripheral blood vessel L1 of patient P, and insertion site A1 indicates the position where the indwelling needle 5 was inserted. Within blood vessel L1, blood is flowing in the direction of blood flow D1.

[0051] Furthermore, in the example shown in Figure 8, the blood vessel L2 being measured is on the opposite side of the patient P's body from the artery or vein L1 to which the intravenous fluid is being administered, relative to the midline plane Q of the patient P's body (for example, if the artery administering the fluid is in the right arm, the opposite side is the left arm), and the artery or vein L2 is of the same type as the blood vessel (artery or vein) L1 to which the intravenous fluid is being administered. In other words, in the example shown in Figure 8, the blood vessel L1, which is the artery or vein to which the intravenous fluid is being administered, and the blood vessel L2 being measured are symmetrical with respect to the midline plane Q of the patient P's body. Also, within blood vessel L2, blood flows in the direction of blood flow D2.

[0052] In the examples shown in Figures 7 and 8, the blood flow measuring device 4A measures a first measurement value related to the blood flow state before and after the administration of infusion fluid from the indwelling needle 5 at a third measurement position B3 in the blood flow direction D1 within blood vessel L1, near the insertion point A1 where the indwelling needle 5 is inserted into the patient P's blood vessel L1. In the examples shown in Figures 7 and 8, the third measurement position B3 is downstream of the insertion point A1 in the blood flow direction D1 within blood vessel L1, but is not limited to this, and the third measurement position B3 may be upstream of the insertion point A1 in the blood flow direction D1 within blood vessel L1.

[0053] The blood flow measuring device 4B measures a second measurement value related to the blood flow state at a fourth measurement position B4 that is symmetrical to the third measurement position B3 with respect to the midline plane Q of patient P's body, in a blood vessel L2 that is symmetrical to the blood vessel L1 in which the indwelling needle 5 is inserted with respect to the midline plane Q of patient P's body. The first measurement value acquisition unit 11 acquires a first measurement value related to the blood flow state at the third measurement position B3 during the administration of infusion fluid from the indwelling needle 5. The second measurement value acquisition unit 12 acquires a second measurement value related to the blood flow state before and after the administration of infusion fluid from the indwelling needle 5 at the fourth measurement position B4.

[0054] Subsequently, the measurement value output unit 13, the judgment unit 14, and the judgment result output unit 15 of the control unit 10 perform the same processing as in the embodiments shown in Figures 1 to 6. In the examples shown in Figures 7 and 8, the blood vessel L1 into which the indwelling needle 5 is inserted relative to the midline plane Q of patient P's body is in patient P's right arm, and the blood vessel L2 on the opposite, symmetrical side is in patient P's left arm. However, the example is not limited to this, and for example, a blood vessel in the leg may be used instead of the arm, and blood vessel L may be in patient P's right leg and blood vessel L2 may be in patient P's left leg.

[0055] In the embodiments described above, blood flow status was measured in areas that are easy to measure, such as the arms and legs. However, the method is not limited to these areas. For example, blood flow status can be measured in any area other than around the heart where blood flow is stable.

[0056] Furthermore, in the embodiment described above, the extravasation detection device 1 acquired measurement values ​​related to the blood flow state at two measurement locations, but it is not limited to this, and may acquire measurement values ​​related to the blood flow state at three or more measurement locations. This enables the extravasation detection device 1 to perform measurements with higher accuracy.

[0057] For example, in patients with impaired blood flow in the lower extremities, such as dialysis patients, it is preferable to perform measurements at sites other than the lower extremities. Furthermore, by performing measurements at other sites with stable blood flow in addition to the lower extremities, extravasation can be confirmed with high accuracy.

[0058] As described above, the extravascular leakage detection device 1 according to this embodiment provides the following effects. (1) The extravasation detection device 1 includes: a first measurement value acquisition unit 11 that acquires a first measurement value relating to the blood flow state during administration of infusion from the indwelling needle 5 at a first measurement position B1 in the blood flow direction D1 within the blood vessel L near the insertion position A1 where the indwelling needle 5 is inserted into the blood vessel L of patient P; a second measurement value acquisition unit 12 that acquires a second measurement value relating to the blood flow state before and after administration of infusion from the indwelling needle 5 at a second measurement position B2 corresponding to the first measurement position B1; a determination unit 14 that determines whether or not infusion is being administered normally by comparing the first measurement value acquired by the first measurement value acquisition unit 11 with the second measurement value acquired by the second 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, the extravasation detection device 1 can detect extravasation from measurements taken between two points in the peripheral blood vessel L of patient P: a first measurement point B1, which is susceptible to the effects of intravenous fluid administration, and a second measurement point B2, which is less susceptible to the effects of intravenous fluid administration. It can automatically determine the possibility of extravasation. Furthermore, it outputs the determination result, allowing healthcare professionals to confirm whether extravasation has occurred.

[0059] (2) The first measurement unit 11 acquires a first measurement value related to the blood flow state during the administration of infusion from the indwelling needle 5 at a first measurement position B1 located upstream of the blood flow direction D1 in the blood vessel L relative to the insertion position A1, and the second measurement unit 12 acquires a second measurement value related to the blood flow state before and after the administration of infusion from the indwelling needle 5 at a second measurement position B2 located downstream of the blood flow direction D1 in the blood vessel L relative to the insertion position A1. As a result, the extravasation detection device 1 can detect extravasation from measurement values ​​between two points, upstream and downstream of the peripheral blood vessel L of patient P, and can automatically determine the possibility of extravasation.

[0060] (3) The extravasation detection device 1 includes a measurement output unit 13 that outputs the first measurement value acquired by the first measurement value acquisition unit 11 and the second measurement value acquired by the second measurement value acquisition unit 12 in a time series, and the judgment result output unit 15 outputs a warning when the judgment result is determined to be that the infusion is not being administered normally. As a result, the extravasation detection device 1 displays the time series of measurement values, allowing healthcare professionals to determine extravasation from the display. In addition, because a warning is issued based on the judgment result, healthcare professionals can confirm extravasation by the warning.

[0061] (4) The extravasation detection device 1 includes a threshold memory unit 22 that stores a threshold value for the difference obtained by comparing a first measurement value and a second measurement value, and the determination unit 14 determines that the infusion is not being administered normally if the difference is within the threshold range of the threshold memory unit 22. As a result, the extravasation detection device 1 can make a determination of whether or not it is normal based on the threshold value, and can make a uniform determination.

[0062] (5) The extravasation detection device 1 is installed on predetermined parts 7A and 7B of the patient P's body and is communicatively connected to blood flow measuring devices 4A and 4B, which measure the blood flow state of predetermined parts 7A and 7B of the patient P. The first measurement value acquisition unit 11 acquires a first measurement value from the blood flow measuring device 4A, and the second measurement value acquisition unit 12 acquires a second measurement value from the blood flow measuring device 4B. Thus, the extravasation detection device 1 can be realized using a general-purpose computer.

[0063] (6) The first measurement unit 11 acquires a first measurement value relating to the blood flow state during the administration of infusion from the indwelling needle 5 at a third measurement position B3 located in the blood flow direction D1 within the blood vessel L1 near the insertion position A1 where the indwelling needle 5 was inserted into the patient P's blood vessel L1. The second measurement unit 12 acquires a second measurement value relating to the blood flow state at a fourth measurement position B4 which is symmetrical to the third measurement position B3 with respect to the midline plane Q of the patient P's body, in the opposite blood vessel L2 which is symmetrical to the blood vessel L1 where the indwelling needle 5 was inserted with respect to the midline plane Q of the patient P's body.

[0064] As a result, the extravasation detection device 1 can measure the blood flow status even from the fourth measurement position B4, which is far from the insertion position A1, and automatically determine the possibility of extravasation.

[0065] 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.

[0066] (Transformed form) (1) In each embodiment, the extravasation detection device 1 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. [Explanation of Symbols]

[0067] 1. Extravascular leakage detection device 4,4A,4B Blood flow measuring device 6, 6A, 6B Infusion Bags 7,7A,7B part 10,40 Control Unit 11. First measurement value acquisition unit 12. Second measurement value acquisition unit 13 Measurement value output section 14 Judgment Department 15. Output unit for judgment results 20,41 Storage part 21 Program Storage Unit 22 Threshold storage unit 32 Input section 33,43 Display section 34 Audio output section 39,49 Communications Department 42 Operation section 45 Blood flow measurement section 61 table 62 Graphs 100 Extravascular Leakage Detection System P patient Q Median plane L,L1,L2, blood vessels

Claims

1. A first measurement value acquisition unit acquires a first measurement value related to the blood flow state during the administration of intravenous fluid from the indwelling needle at a first measurement position in the direction of blood flow within the blood vessel near the insertion site where the indwelling needle was punctured in the patient's blood vessel, A second measurement value acquisition unit acquires a second measurement value related to the blood flow state before and after administration of intravenous fluid from the indwelling needle at a second measurement position corresponding to the first measurement position, A determination unit that determines whether or not intravenous fluid administration is being performed normally by comparing the first measurement value obtained by the first measurement value acquisition unit with the second measurement value obtained by the second 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 first measurement value acquisition unit acquires the first measurement value relating to the blood flow state during the administration of infusion from the indwelling needle at the first measurement position located upstream in the blood flow direction within the blood vessel relative to the insertion position. The second measurement value acquisition unit is an extravasation leakage detection device that acquires the second measurement value relating to the blood flow state before and after administration of infusion fluid from the indwelling needle at the second measurement position located downstream in the blood flow direction within the blood vessel relative to the insertion position.

3. In the extravascular leakage detection device according to claim 1, The system includes a measurement value output unit that outputs the first measurement value acquired by the first measurement value acquisition unit and the second measurement value acquired by the second measurement value acquisition unit in a time series. 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.

4. In the extravascular leakage detection device according to claim 1, The system includes a threshold storage unit that stores a threshold value relating to the difference obtained by comparing the first measurement value and the second measurement value, The determination unit determines that the intravenous fluid administration is not being performed normally when the difference is within the range of the threshold in the threshold storage unit, and is an extravasation detection device.

5. In the extravascular leakage detection device according to claim 1, The extravascular leakage detection device is installed at a predetermined location on the patient's body and is communicated with a first blood flow measuring device and a second blood flow measuring device that measure the blood flow state at the predetermined location on the patient. The first measurement value acquisition unit acquires the first measurement value from the first blood flow measuring device. The second measurement value acquisition unit is an extravascular leakage detection device that acquires the second measurement value from the second blood flow measuring device.

6. In the extravascular leakage detection device according to claim 1, The first measurement value acquisition unit acquires a first measurement value related to the blood flow state during the administration of infusion from the indwelling needle at the first measurement position. The second measurement unit is an extravascular leakage detection device that acquires a second measurement value relating to the blood flow state at a second measurement position which is symmetrical to the first measurement position with respect to the midline plane of the patient's body, in a blood vessel on the opposite side which is symmetrical to the blood vessel in which the indwelling needle was punctured with respect to the midline plane of the patient's body.

7. A blood flow measuring device that acquires measurements related to the blood flow status before, during, or after administration of intravenous fluids from an indwelling needle inserted into a patient's blood vessel, 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 first measurement value acquisition unit acquires a first measurement value related to the blood flow state during the administration of intravenous fluid from the indwelling needle at a first measurement position in the blood vessel in the direction of blood flow within the blood vessel, near the insertion site where the indwelling needle was punctured in the blood vessel of the patient. A second measurement value acquisition unit acquires a second measurement value related to the blood flow state before and after administration of intravenous fluid from the indwelling needle at a second measurement position corresponding to the first measurement position, A determination unit that determines whether or not intravenous fluid administration is being performed normally by comparing the first measurement value obtained by the first measurement value acquisition unit with the second measurement value obtained by the second 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.

8. Computers, A first measurement value acquisition means for acquiring a first measurement value related to the blood flow state during the administration of intravenous fluid from the indwelling needle, at a first measurement position in the direction of blood flow within the blood vessel near the insertion site where the indwelling needle was inserted into the patient's blood vessel. A second measurement value acquisition means for acquiring a second measurement value related to the blood flow state before and after administration of intravenous fluid from the indwelling needle at a second measurement position corresponding to the first measurement position, A determination means for determining whether or not intravenous fluid administration is being performed normally by comparing the first measurement value obtained by the first measurement value acquisition means with the second measurement value obtained by the second measurement value acquisition means, and Decision result output means for outputting the decision result obtained by the aforementioned decision means A program designed to function as such.

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