Extravasation detection device, extravasation detection system, and program

Abstract

Provided are an extravasation detection device, an extravasation detection system, and a program that are capable of more easily detecting extravasation even when detection in peripheral blood vessels is difficult. An extravasation detection device 1 comprises: a first measurement value acquisition unit 11 that acquires a first measurement value related to a blood flow state during administration of an infusion from an indwelling needle 5 at a first measurement position B1 in a blood vessel L of a patient P in the vicinity of an insertion position A1 where the indwelling needle 5 has been inserted; a second measurement value acquisition unit 12 that acquires a second measurement value related to a blood flow state before and after administration of the 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 the infusion is normally administered 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 a determination result by the determination unit 14.

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 one of the most common medical practices and is carried out in many treatments. When performing drip infusion in infusion therapy, it is necessary to appropriately secure the administration route in an arbitrary blood vessel and administer a drug for treatment. Here, due to damage to blood vessel tissue during puncture or an increase in intravascular pressure at the puncture site during infusion administration, etc., an event may occur where the 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 can, in the worst case, lead to a complication called "extravascular leakage" that necrotizes surrounding tissues.

[0003] In particular, when administering anticancer drug substances, etc. for cancer drug therapy, or in the case of pediatric patients with fragile blood vessels and skin tissues, there are many cases where the condition worsens. Although this is a problem leading to such serious complications, currently, as a means for detecting extravascular leakage in clinical practice, 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] JP-A-2011-200429 WO 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 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 preferably 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 the determination unit preferably determines that the infusion administration is not being performed normally when the difference is within the range of the threshold value stored 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.

[0016] 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.

[0017] This is an explanatory diagram relating to the use of each device in the extravasation leakage detection system according to this embodiment. This is a diagram showing the overall configuration of the extravasation leakage detection system and the functional block of the extravasation leakage detection device according to this embodiment. This is a schematic diagram showing the puncture site in a peripheral blood vessel near the site shown in Figure 1 and the measurement site by the blood flow measurement device. This is a diagram showing the functional block of the blood flow measurement device according to this embodiment. This is a flowchart showing the extravasation leakage detection process of the extravasation leakage detection device according to this embodiment. This is a diagram showing a table of measured values ​​and a graph showing changes over time according to this embodiment. This is an explanatory diagram relating to the use of each device in the extravasation leakage detection system according to a modified example. This is a schematic diagram showing the puncture site in a peripheral blood vessel near the site shown in Figure 7 and the measurement site by the blood flow measurement device.

[0018] 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. Figure 1 is an explanatory diagram illustrating the use of each device in the extravascular leakage detection system 100 according to this embodiment. Figure 2 is a diagram showing the overall configuration of the extravascular leakage detection system 100 and the functional blocks of the extravascular leakage detection device 1 according to this embodiment.

[0019] [Extravasation Detection System 100] The extravasation detection system 100 is a system for detecting leakage at the puncture sites when a patient P, such as a child under centralized management, is administered medication or other substances by puncturing several peripheral blood vessels in the body. In addition to medication, replacement fluids and nutrients may also be administered to the patient P's blood vessels, but in the following explanation, all replacement fluids, nutrients, and medications administered to patient P will be described 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 a predetermined part of the patient P's body (for example, the arm) 7A.

[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, described later) was inserted.

[0021] Here, the intravenous fluids filled in the IV bag 6 are primarily intended for the replenishment of water and electrolytes, nutritional support, and treatment of pathological conditions. On the other hand, the intravenous fluids filled in the syringe are primarily intended for checking for extravasation. For the above purposes, the fluids in the syringe are administered as boluses of a specified 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, by applying pressure to the liquid in the tube with a syringe or 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.

[0022] In the following explanation, when individual infusion bags 6A, 6B, etc. are not specified, the designations "A" and "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 measuring units 45 of the blood flow measuring 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 measuring unit 45 of blood flow measuring device 4A, and the second measurement value related to the blood flow state measured by the blood flow measuring unit 45 of blood flow measuring device 4B are transmitted from the blood flow measuring 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 fluid is administered from the IV bag 6 while a peripheral blood vessel at site 7 of patient P is punctured, the blood containing the intravenous fluid circulates from the peripheral blood vessel to site 7. The microbubbles contained in the intravenous fluid are also administered and circulate. Therefore, the blood flow measuring device 4 can, for example, acquire the amount of microbubbles detected as a measured value.

[0025] As shown in Figure 2, the extravasation leakage detection system 100 comprises an extravasation leakage detection device 1, a blood flow measuring device 4A, and a blood flow measuring device 4B. The extravasation leakage detection device 1 and the blood flow measuring devices 4A and 4B are communicated with each other. Here, the extravasation leakage detection device 1 and the blood flow measuring devices 4A and 4B are communicated with each other, for example, via short-range wireless communication. Short-range wireless communication can be, for example, Bluetooth® or wireless LAN, but is not limited to these.

[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 by 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 position 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 the administration of infusion fluid from the indwelling needle 5 at a first measurement position B1 in the blood flow direction D1 within blood vessel L, near insertion position 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 the administration of infusion fluid from the indwelling needle 5 at a second measurement position B2 corresponding to the first measurement position 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 of 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 patient P's blood vessel L. 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 patient P's blood vessel L, 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 value acquisition unit 12 acquires a second measurement value related to the blood flow state before and after administration of infusion from the indwelling needle 5 at the second measurement position B2, which corresponds to the first measurement position B1. More specifically, the second measurement value acquisition unit 12 acquires a second measurement value related to the blood flow state before and after administration of infusion 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 value acquisition 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 the 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. The determination unit 14 may, for example, determine that the 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 patient P's site 7A has not changed much, and that intravenous fluid administration is not being performed normally from the puncture site 7A (for example, the 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 patient P's site 7A has changed by the amount of the intravenous fluid, and therefore the intravenous fluid administration is being performed normally.

[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 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 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 with blood flow measuring devices 4A and 4B, for example, by 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 4 is a diagram showing the functional block of the blood flow measurement 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 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 capillaries flowing near the skin surface 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 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 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 hardware described above 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 storage 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, for example, an input device such as a switch button. The display unit 43 is, for example, a display device such as a liquid crystal display.

[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 being applied. The blood flow measurement unit 45 detects the amount of light returned. The communication unit 49 is, for example, an interface for short-range wireless communication with the extravascular leakage detection device 1 using Bluetooth®.

[0043] [Description of the Process] Next, the process in the extravascular leakage detection device 1 will be described based on a flowchart. FIG. 5 is a flowchart showing the extravascular leakage detection process of the extravascular leakage detection device 1 according to the present embodiment. FIG. 6 is a diagram showing Table 61 indicating the measured values according to the present embodiment and graph 62 indicating the change over time.

[0044] When performing an infusion on patient P, a medical staff member attaches the blood flow measurement unit 45 near the position of part 7A of patient P. Further, the medical staff member punctures an indwelling needle at the puncture position A1 of the peripheral blood vessel L of part 7A of patient P.

[0045] Thereafter, by operating the extravascular leakage detection device 1 and the blood flow measurement devices 4A and 4B by the medical staff member, in step S (hereinafter, "step S" will be simply referred to as "S") 11 of FIG. 5, the control unit 10 of the extravascular leakage 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 the first measurement value from the blood flow measurement device 4A, and the second measurement value acquisition unit 12 starts the process of acquiring the second measurement value from the blood flow measurement device 4B. In S13, the measurement value output unit 13 starts the process of graphing the acquired first measurement value and second measurement value 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 FIG. 6. The control unit 10 continuously performs the process of acquiring and outputting the first measurement value and the second measurement value from the blood flow measurement devices 4A and 4B, which is the process of S12 and S13, until this process ends.

[0046] In S14, the determination unit 14 compares the first measurement value and the second measurement value acquired in S12 to obtain a difference, and performs a determination process of determining whether the obtained difference is within the range of the threshold value in the threshold value storage unit 22 of the storage unit 20. When the difference is within the range of the threshold value (S14: YES), the control unit 10 determines that the infusion administration is not being performed normally and transfers the process to S15. When the difference is outside the range of the threshold value (S14: NO), the control unit 10 determines that the infusion administration is being performed normally and ends this process.

[0047] In S15, the determination result output unit 15 performs warning output processing. More specifically, the determination result output unit 15 may output a warning sound indicating that the infusion administration is not being performed normally from the voice output unit 34 to prompt the medical staff to confirm. Thereafter, the control unit 10 ends this process.

[0048] [Modification Example] In the above description, the case where puncture is performed at one location on the body of the patient P is taken as an example for explanation, but it can also be used even when puncture is performed at two or more locations. Further, the above-described extravasation detection process may be performed at the start of infusion by the infusion bag 6, during the infusion by the infusion bag 6, or at both timings.

[0049] FIG. 7 is an explanatory diagram regarding the use of each device in the extravasation detection system 100 according to the modification example. FIG. 8 is a schematic diagram showing the puncture position A1 where the indwelling needle 5 is punctured into the peripheral blood vessel near the site 7A shown in FIG. 7 and the measurement positions by the blood flow measurement devices 4A and 4B at the site 8 located on the opposite side of the site 7A. Note that the puncture position and the measurement position shown in FIG. 8 are schematic positions and are different from the actual dimensions.

[0050] As shown in FIG. 8, the indwelling needle 5 is punctured into the peripheral blood vessel L1 of the patient P, and the puncture position A1 indicates the position where the indwelling needle 5 is punctured. In the blood vessel L1, the blood is flowing in the blood flow direction D1.

[0051] Furthermore, in the example shown in FIG. 8, the blood vessel L2 to be measured is an artery or vein on the opposite side of the body (for example, if the artery for which infusion is being administered is on the right arm, the opposite side corresponds to the left arm) of the artery or vein L1 for which infusion is being administered with respect to the median plane Q of the body of the patient P, and the artery or vein L2 is the same type of blood vessel as the blood vessel (artery or vein) L1 for which infusion is being administered. That is, in the example shown in FIG. 8, the blood vessel L1, which is the artery or vein for which infusion is being administered, and the blood vessel L2 to be measured are symmetrical with respect to the median plane Q of the body of the patient P. Also, in the blood vessel L2, the blood is flowing in the blood flow direction 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 the 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 the 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 the blood vessel L1.

[0053] The blood flow measuring device 4B measures a second measurement value relating 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 relating 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 relating 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 determination unit 14, and the determination 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 extravasation 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 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 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 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 infusion 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. 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 that is susceptible to the effects of intravenous fluid administration and a second measurement point B2 that is less susceptible to the effects of intravenous fluid administration, and can automatically determine the possibility of extravasation. Furthermore, the device outputs the determination result, allowing healthcare professionals to confirm whether extravasation has occurred.

[0059] (2) The first measurement value acquisition unit 11 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 located upstream of the blood flow direction D1 in the blood vessel L relative to the insertion position A1, and the second measurement value acquisition unit 12 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 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 the patient P, and can automatically determine the possibility of extravasation.

[0060] (3) The extravasation detection device 1 includes a measurement value 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, so that healthcare professionals can determine extravasation from the display. In addition, since 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 storage unit 22 that stores a threshold value for the difference obtained by comparing a first measurement value and a second measurement value, and the judgment unit 14 determines that the infusion is not being administered normally if the difference is within the range of the threshold value stored in the threshold storage 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 that 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 even 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 fluid 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 blood vessel L1 of patient P. 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 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 patient P's body.

[0064] As a result, the extravasation detection device 1 can measure the blood flow status even from a fourth measurement position B4 that 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] (Modified Forms) (1) In each embodiment, the extravascular leakage 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 extravascular leakage 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 it is not limited to this. At least a part of them may be connected in a way that enables communication by, for example, wired.

[0067] 1 Extravasation detection device 4, 4A, 4B Blood flow measurement device 6, 6A, 6B Infusion bag 7, 7A, 7B Part 10, 40 Control unit 11 First measurement value acquisition unit 12 Second measurement value acquisition unit 13 Measurement value output unit 14 Judgment unit 15 Judgment result output unit 20, 41 Storage unit 21 Program storage unit 22 Threshold storage unit 32 Input unit 33, 43 Display unit 34 Audio output unit 39, 49 Communication unit 42 Operation unit 45 Blood flow measurement unit 61 Table 62 Graph 100 Extravasation detection system P Patient Q Midline L, L1, L2, Blood vessel

Claims

1. An extravascular leakage detection device comprising: a first measurement value acquisition unit that acquires a first measurement value relating to the blood flow state during 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 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.

2. An extravasation detection device according to claim 1, wherein the first measurement value acquisition unit acquires the first measurement value relating to the blood flow state during administration of infusion from the indwelling needle at the first measurement position located upstream of the insertion position in the blood flow direction within the blood vessel, and the second measurement value acquisition unit acquires the second measurement value relating to the blood flow state before and after administration of infusion from the indwelling needle at the second measurement position located downstream of the insertion position in the blood flow direction within the blood vessel.

3. An extravasation leakage detection device according to claim 1, comprising 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, wherein the judgment result output unit outputs a warning when the judgment result indicates that the infusion administration is not being performed normally.

4. An extravasation detection device according to claim 1, comprising 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, wherein the determination unit determines that the infusion administration is not being performed normally when the difference is within the range of the threshold value in the threshold storage unit.

5. An extravascular leakage detection device according to claim 1, wherein the extravascular leakage detection device is provided at a predetermined location on the patient's body and is communicably 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, the first measurement value acquisition unit acquires the first measurement value from the first blood flow measuring device, and the second measurement value acquisition unit acquires the second measurement value from the second blood flow measuring device.

6. An extravasation detection device according to claim 1, wherein the first measurement value acquisition unit acquires a first measurement value relating to the blood flow state during 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 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 into which the indwelling needle was punctured with respect to the midline plane of the patient's body.

7. An extravasation leakage detection system comprising: a blood flow measuring device for acquiring measured values ​​relating to the blood flow state before, during, or after administration of intravenous fluid from an indwelling needle inserted into a patient's blood vessel; and an extravasation leakage detection device communicably connected to the blood flow measuring device, wherein the extravasation leakage detection device comprises: a first measurement value acquisition unit for acquiring a first measured 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 was inserted into the patient's blood vessel; a second measurement value acquisition unit for acquiring a second measured 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 for determining whether or not intravenous fluid administration is being performed normally by comparing the first measured value acquired by the first measurement value acquisition unit with the second measured value acquired by the second measurement value acquisition unit; and a determination result output unit for outputting the determination result from the determination unit.

8. A program to cause a computer to function as: a first measurement value acquisition means for acquiring a first measurement value relating to the blood flow state during 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 is inserted into the patient's blood vessel; a second measurement value acquisition means for acquiring 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 means for determining whether or not intravenous fluid administration is being performed normally by comparing the first measurement value acquired by the first measurement value acquisition means with the second measurement value acquired by the second measurement value acquisition means; and a determination result output means for outputting the determination result from the determination means.

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