Detention catheter, detention catheter system, determination device, determination method, and computer program

Abstract

To provide a detention catheter, etc. capable of outputting information for determining a catheter insertion state.SOLUTION: A detention catheter includes a catheter shaft, an electrostatic capacity sensor provided at the tip of the catheter shaft, and a transmission part for transmitting electrostatic capacity detected by the electrostatic capacity sensor.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] The present invention relates to an indwelling catheter, an indwelling catheter system, a determination device, a determination method, and a computer program. [Background technology]

[0002] Medical catheters are used for insertion into hollow organs such as blood vessels and vasculature to perform treatment, diagnosis, etc. Patent Document 1 discloses a catheter assembly that detects physiological conditions of a patient using sensors included in the branched hub, extension legs, and proximal end of the catheter tube. [Prior art documents] [Patent documents]

[0003] [Patent Document 1] Patent No. 7091240 Summary of the Invention [Problem to be solved by the invention]

[0004] The technology described in Patent Document 1 does not output information for determining the insertion state of the catheter.

[0005] An object of one aspect of the present disclosure is to provide an indwelling catheter or the like that can output information for determining the insertion state of the catheter. [Means for solving the problem]

[0006] (1) An indwelling catheter according to one aspect of the present disclosure includes a catheter shaft, a capacitance sensor provided at the tip of the catheter shaft, and a transmitter that transmits the capacitance detected by the capacitance sensor.

[0007] (2) In the indwelling catheter described in (1) above, the transmitter may be a short-range wireless communication tag, and the capacitance sensor may be provided in the short-range wireless communication tag.

[0008] (3) In the indwelling catheter described in (1) or (2) above, the capacitance sensor may be provided on the surface of the tip of the catheter shaft.

[0009] (4) In the indwelling catheter according to any one of (1) to (3) above, the capacitance sensor may be provided inside the tip of the catheter shaft.

[0010] (5) An indwelling catheter system according to one aspect of the present disclosure comprises an indwelling catheter described in any one of (1) to (4) above and a determination device having a control unit, wherein the control unit acquires the capacitance detected by the capacitance sensor and determines the insertion state of the indwelling catheter in the living body based on the acquired capacitance.

[0011] (6) In the indwelling catheter system described in (5) above, the control unit may determine that the indwelling catheter is inserted into the living body if the capacitance is greater than or equal to a predetermined value, and may determine that the indwelling catheter is not inserted into the living body if the capacitance is less than the predetermined value.

[0012] (7) In the indwelling catheter system described in (5) or (6) above, when the control unit determines that the indwelling catheter is not inserted into the living body, the control unit may output notification information indicating that the indwelling catheter is not inserted into the living body.

[0013] (8) In the indwelling catheter system described in any one of (5) to (7) above, when the capacitance is equal to or greater than a predetermined value, the control unit may store the time point at which the capacitance was detected in association with identification information that identifies the capacitance sensor or the indwelling catheter.

[0014] (9) In the indwelling catheter system described in any one of (5) to (8) above, the control unit may output replacement information for the indwelling catheter when the elapsed time from the time the capacitance was detected is equal to or greater than a predetermined value.

[0015] (10) In the indwelling catheter system described in any one of (5) to (9) above, identification information for identifying the capacitance sensor or the indwelling catheter may be stored in association with identification information for the living body.

[0016] (11) The indwelling catheter system according to any one of (5) to (10) above may further include a reading unit that reads the capacitance detected by the capacitance sensor.

[0017] (12) A determination device according to one aspect of the present disclosure includes a control unit that acquires capacitance detected by a capacitance sensor provided at the tip of an indwelling catheter inserted into a living body, and executes a process to determine the insertion state of the indwelling catheter in the living body based on the acquired capacitance.

[0018] (13) A determination method according to one aspect of the present disclosure includes a computer that acquires capacitance detected by a capacitance sensor provided at the tip of an indwelling catheter inserted into a living body, and determines the insertion state of the indwelling catheter in the living body based on the acquired capacitance.

[0019] (14) A computer program according to one aspect of the present disclosure acquires capacitance detected by a capacitance sensor provided at the tip of an indwelling catheter inserted into a living body, and determines the insertion state of the indwelling catheter in the living body based on the acquired capacitance. [Effects of the Invention]

[0020] According to the present disclosure, information for determining the insertion state of a catheter can be output. [Brief explanation of the drawings]

[0021] [Figure 1] FIG. 1 is a schematic diagram of an indwelling catheter system. [Figure 2] FIG. 2 is an explanatory diagram illustrating an example of the configuration of a catheter assembly. [Figure 3] FIG. 2 is a block diagram showing an example of the configuration of a determination device. [Figure 4] FIG. 2 is a block diagram illustrating an example of the configuration of a reading device. [Figure 5] FIG. 10 is a diagram illustrating an example of information stored in a detection DB. [Figure 6] 10 is a flowchart illustrating an example of a processing procedure executed by the indwelling catheter system. [Figure 7] 10 is a flowchart illustrating an example of a processing procedure executed by a determination device according to a second embodiment. DETAILED DESCRIPTION OF THE INVENTION

[0022] The present disclosure will be specifically described with reference to the drawings showing embodiments thereof.

[0023] (First embodiment) 1 is a schematic diagram of an indwelling catheter system 100. The indwelling catheter system 100 of this embodiment comprises a catheter assembly 1, a determination device 2, and a reading device 3. The determination device 2 and the reading device 3 are communicatively connected via a network N such as a LAN (Local Area Network) or the Internet.

[0024] The catheter assembly 1 is configured as an indwelling needle (peripheral venous indwelling catheter) for administering a drug (infusion) into the blood vessel of a patient (living body). The catheter assembly 1 includes an indwelling catheter 12 equipped with a capacitance sensor 11.

[0025] The determination device 2 is an information processing device capable of various information processing and information transmission and reception, such as a smartphone, tablet terminal, personal computer, or server computer. The determination device 2 may be a medical staff terminal used by a medical staff member such as a nurse or doctor, or may be an information processing device installed in a medical institution to which the medical staff member belongs. A medical staff member is an example of a user of this system. The reading device (reading unit) 3 is a device for reading the detection value of the capacitance detected by the capacitance sensor.

[0026] Figure 2 is an explanatory diagram illustrating an example configuration of the catheter assembly 1. In the following, various configurations will be described with the direction along the axis of the catheter assembly 1 as the axial direction, the left side in Figure 2 as the "tip side," and the right side as the "base side."

[0027] The catheter assembly 1 includes an indwelling catheter 12 and an inner needle 15. The indwelling catheter 12 includes a catheter shaft 13 and a catheter hub 14 connected to the proximal end of the catheter shaft 13.

[0028] The catheter shaft 13 is a flexible tubular member. The catheter shaft 13 is configured to be continuously insertable into a patient's blood vessel. The catheter shaft 13 has a lumen 13a extending along the axial direction over its entire length. An opening communicating with the lumen 13a is formed at the distal end surface of the catheter shaft 13.

[0029] The material of the catheter shaft 13 is not particularly limited, but may be, for example, a transparent resin material, preferably a soft resin material, etc. Examples of materials for the catheter shaft 13 include fluororesins such as polytetrafluoroethylene (PTFE), ethylene-tetrafluoroethylene copolymer (ETFE), and perfluoroalkoxy fluororesin (PFA), olefin resins such as polyethylene and polypropylene, mixtures of these, polyurethane, polyester, polyamide, polyether nylon resin, and mixtures of olefin resins and ethylene-vinyl acetate copolymer.

[0030] The catheter hub 14 is formed in a hollow (cylindrical) shape. The catheter hub 14 is preferably made of a material harder than the catheter shaft 13, and more preferably a thermoplastic resin. Examples of materials that can be used to make the catheter hub 14 include polypropylene, polycarbonate, polyamide, polysulfone, polyarylate, methacrylate-butylene-styrene copolymer, polyurethane, acrylic resin, and ABS resin.

[0031] The inner needle 15 includes a needle body 16 and a needle hub 17 connected to the base end of the needle body 16. The needle body 16 is a rigid tubular member. The needle body 16 is configured to be able to puncture the skin of a patient. In the initial state (assembled state) of the catheter assembly 1, the needle body 16 is inserted through the lumen 13a of the catheter shaft 13 and the lumen 14a of the catheter hub 14.

[0032] Examples of materials that can be used to form the needle body 16 include metal materials such as stainless steel, aluminum, aluminum alloy, titanium, and titanium alloy. The needle body 16 is formed to be sufficiently longer than the catheter shaft 13, and in the initial state of the catheter assembly 1, the tip of the needle body 16 is exposed (protrudes) from the tip of the catheter shaft 13. A blade surface 16a that is inclined relative to the axis of the needle body 16 is formed at the tip of the needle body 16.

[0033] The needle hub 17 is formed to be hollow (cylindrical). The needle hub 17 may be made of the same material as the above-mentioned catheter hub 14. The needle hub 17 functions as an operating part of the catheter assembly 1.

[0034] A capacitance sensor 11 is provided at the tip of the catheter shaft 13. In this embodiment, the capacitance sensor 11 is provided in a short-range wireless communication tag 19 and is integrated into the short-range wireless communication tag 19. The short-range wireless communication tag 19 including the capacitance sensor 11 is provided at the tip of the catheter shaft 13.

[0035] The capacitance sensor 11 detects the magnitude of capacitance (capacitance value) that changes depending on whether the catheter shaft 13 is in contact with or not in contact with biological tissue (for example, subcutaneous tissue, blood vessels, etc.).

[0036] The short-range wireless communication tag 19 is a communication tag for communicating with the reader 3 according to predetermined short-range wireless communication. The short-range wireless communication tag 19 further includes, for example, an antenna for transmitting and receiving radio waves and an IC chip for controlling communication and storing information (neither of which is shown). The short-range wireless communication tag 19 transmits a signal indicating the capacitance detected by the capacitance sensor 11 to the reader 3. The short-range wireless communication tag 19 functions as a transmitter for transmitting the capacitance.

[0037] In this embodiment, the short-range wireless communication tag 19 is an NFC (Near Field Communication) tag, and performs NFC communication with the reader 3. The NFC tag performs electromagnetic coupling by receiving electromagnetic waves radiated from the reader 3, and can operate by receiving power from electromotive force generated by this electromagnetic coupling.

[0038] 1 and 2, the short-range wireless communication tag 19 is provided on the outer peripheral surface at the tip of the catheter shaft 13. There are no particular restrictions on the method of attaching the short-range wireless communication tag 19. For example, the short-range wireless communication tag 19 may be placed on the surface of the catheter shaft 13, and then a certain amount of coating agent may be applied to form a coating film on the short-range wireless communication tag 19, thereby adhering the short-range wireless communication tag 19 to the catheter shaft 13. Examples of materials for the coating agent include the same materials as those used to form the catheter shaft 13 described above.

[0039] The short-range wireless communication tag 19 is not limited to being provided on the outer circumferential surface of the catheter shaft 13, but may be provided at an appropriate position at the tip of the catheter shaft 13. The short-range wireless communication tag 19 may be provided, for example, on the inner circumferential surface at the tip of the catheter shaft 13, or may be embedded inside the catheter shaft 13.

[0040] The catheter shaft 13 may be provided with a plurality of capacitance sensors 11. When a plurality of capacitance sensors 11 are provided, the catheter shaft 13 may be provided with one short-range wireless communication tag 19 equipped with a plurality of capacitance sensors 11, or may be provided with a plurality of short-range wireless communication tags 19 equipped with one or a plurality of capacitance sensors 11. When a plurality of short-range wireless communication tags 19 are provided, the short-range wireless communication tags 19 are preferably arranged at equal intervals around the circumference of the catheter shaft 13. Note that the capacitance sensor 11 is not limited to being mounted on the short-range wireless communication tag 19. For example, the capacitance sensor 11 itself may be configured to have a communication function.

[0041] The procedure for administering a drug using the catheter assembly 1 will be described. The surgeon grasps the catheter assembly 1 in its initial state and inserts it from the surface of the living body (skin surface) toward a blood vessel, gradually inserting the inner needle 15 toward the desired site. As a result, the tip of the inner needle 15 advances while cutting through the subcutaneous tissue. After the inner needle 15 has punctured the target blood vessel, the catheter shaft 13 and catheter hub 14 are moved to their distal ends, and the catheter shaft 13 is inserted into the blood vessel. After insertion, the inner needle 15 is removed from the indwelling catheter 12 with the distal end of the catheter shaft 13 remaining in the blood vessel. Thereafter, a drug supply device (not shown) is connected to the proximal end of the catheter hub 14, and a drug is supplied into the lumen 13a of the catheter shaft 13. The indwelling catheter 12 placed in the blood vessel is usually used continuously for a certain period of time and then removed from the blood vessel when it is time to replace it.

[0042] 3 is a block diagram showing an example of the configuration of the determination device 2. The determination device 2 is a computer, and includes a control unit 21, a storage unit 22, a communication unit 23, a display unit 24, and an operation unit 25. The determination device 2 may be configured to perform distributed processing using multiple computers, may be realized by multiple virtual machines provided in a single server, or may be realized using a cloud server.

[0043] The control unit 21 includes one or more arithmetic processing devices such as a central processing unit (CPU), a micro-processing unit (MPU), a graphics processing unit (GPU), etc. The control unit 21 controls each component unit and executes processing using built-in memories such as a read-only memory (ROM) or a random access memory (RAM), a clock, a counter, etc. Each functional unit of the control unit 21 may be realized by software, by hardware (for example, an FPGA or an ASIC), or by a combination thereof.

[0044] The storage unit 22 includes a nonvolatile memory such as a hard disk, flash memory, or SSD (Solid State Drive). The storage unit 22 may be an external storage device connected to the determination device 2. The storage unit 22 stores various computer programs and data referenced by the control unit 21. The storage unit 22 stores a program 2P for causing a computer to execute processing related to determining the insertion state of the indwelling catheter 12, and a detection DB (Data Base) 221.

[0045] A computer program (program product) including the program 2P may be provided by a non-transitory recording medium 2A on which the computer program is readably recorded. The storage unit 22 stores the computer program read from the recording medium 2A by a reading device (not shown). The recording medium 2A may be, for example, a magnetic disk, an optical disk, or a semiconductor memory. Alternatively, the computer program may be downloaded from an external server connected to a communications network and stored in the storage unit 22. The program 2P may be a single computer program or may be composed of multiple computer programs, and may be executed on a single computer or on multiple computers interconnected by a communications network.

[0046] The communication unit 23 includes a communication device for performing processing related to communication via the network N. The control unit 21 transmits and receives information to and from the reading device 3 via the communication unit 23.

[0047] The display unit 24 includes a display device such as a liquid crystal display, an organic EL (Electro Luminescence) display, etc. The display unit 24 displays various information including the result of the insertion state determination in accordance with instructions from the control unit 21. The display unit 24 may be interpreted as a notification unit and configured to notify information by other means such as sound or lighting.

[0048] The operation unit 25 is an interface that accepts user operations. The operation unit 25 includes, for example, a keyboard, a mouse, a touch panel device with a built-in display, a speaker, a microphone, etc. The operation unit 25 accepts operation input from the user and sends a control signal according to the operation content to the control unit 21.

[0049] 4 is a block diagram showing an example of the configuration of the reading device 3. The reading device 3 is a computer, and includes a control unit 31, a storage unit 32, a first communication unit 33, and a second communication unit 34. The reading device 3 functions as a tag reader (for example, an NFC reader) for reading the near field communication tag 19. The reading device 3 may also have a writer function for writing information to the near field communication tag 19.

[0050] The control unit 31 includes one or more arithmetic processing units such as a CPU or an MPU. The control unit 31 controls each component unit and executes processing using built-in memory such as a ROM or RAM, a clock, a counter, etc. The storage unit 32 includes a non-volatile memory such as a flash memory. The storage unit 32 stores various computer programs and data referenced by the control unit 31. The storage unit 32 stores identification information of the near field communication tag 19.

[0051] The first communication unit 33 includes a communication device for performing processing related to communication via the network N. The control unit 31 transmits and receives information to and from the determination device 2 through the first communication unit 33.

[0052] The second communication unit 34 includes a communication device for performing processing related to short-range wireless communication. In this embodiment, the second communication unit 34 performs NFC communication. The control unit 31 transmits and receives information to and from the short-range wireless communication tag 19 through the second communication unit 34.

[0053] The reader 3 and the near field communication tag 19 may perform near field communication according to a communication standard other than NFC. The reader 3 and the near field communication tag 19 may communicate using a communication protocol such as Bluetooth (registered trademark) or WiFi (registered trademark).

[0054] The determination device 2 and the reading device 3 are not limited to transmitting and receiving data via the network N. The determination device 2 may, for example, be provided with an input interface for connecting the reading device 3 and receive information output from the reading device 3 via a signal line. The determination device 2 and the reading device 3 are not limited to being separate devices, but may be a single common processing device.

[0055] 5 is a diagram showing an example of the contents of information stored in the detection DB 221. The detection DB 221 is a database that stores information related to the capacitance detected by the capacitance sensor 11. The detection DB 221 stores tag information and detection value information.

[0056] The tag information stores records that link together information such as tag identification information for identifying the short-range wireless communication tag 19, catheter identification information for identifying the indwelling catheter 12, patient identification information for identifying the patient, and the period of use.

[0057] The catheter identification information may be a catheter lot number. The patient identification information may be a patient ID assigned to each medical institution. The usage period is the usage period of the indwelling catheter 12 identified by the catheter identification information. The usage period may be determined from a recommended replacement interval set for the indwelling catheter 12. The tag information may be collected by accepting a user's registration operation using a registration screen provided by the determination device 2 before starting a procedure using the catheter assembly 1.

[0058] The detection value information stores records that link information such as the time of capacitance detection, the detection value, and tag identification information, using a detection ID that identifies the detection value as a key, for example. The detection time may include the detection date or detection date and time when the capacitance was detected. The tag identification information represents the tag identification information of the near field communication tag 19 equipped with the capacitance sensor 11 that detected the capacitance. The detection value information may also store sensor identification information for identifying the capacitance sensor 11. The information in the detection DB 221 is updated as needed. The contents stored in the detection DB 221 are not limited to the example shown in FIG. 4.

[0059] When using the indwelling catheter 12, the indwelling catheter 12 may become dislodged from the living body due to factors such as the patient's body movement after placement. Dislodgment of the indwelling catheter 12 can lead to interruption of treatment or leakage of medicinal solution, so it is important to accurately grasp the insertion state of the indwelling catheter 12. However, dislodgment of the indwelling catheter 12 is difficult to detect unless a medical professional visually checks it or the patient senses pain or discomfort. In this embodiment, the determination device 2 automatically determines the insertion state of the indwelling catheter 12 based on the capacitance measured by the capacitance sensor 11.

[0060] The capacitance detected by capacitance sensor 11 changes depending on the insertion state of indwelling catheter 12. The capacitance of the human body is normally about 80 pF to 200 pF. For example, when indwelling catheter 12 is not inserted (placed) in the living body, such as before being inserted into the living body, the capacitance is almost zero. When indwelling catheter 12 is inserted (placed) in the living body, the capacitance value increases from before insertion to about 80 pF or more.

[0061] If the capacitance detected by the capacitance sensor 11 is equal to or greater than a preset threshold, the determination device 2 determines that the indwelling catheter 12 is inserted (placed) in the living body. If the capacitance is less than the preset threshold, the determination device 2 determines that the indwelling catheter 12 is not inserted (placed) in the living body and has come loose. The capacitance threshold used for the determination can be set based on the standard capacitance of the human body. The capacitance threshold used for the determination may be a capacitance range defined by an upper limit and a lower limit.

[0062] A plurality of the thresholds may be set according to the biological tissue into which the indwelling catheter 12 is inserted. For example, the following determinations are made by previously setting a first threshold based on the capacitance of the subcutaneous tissue and a second threshold based on the capacitance of the blood. The first threshold is smaller than the second threshold. If the capacitance detected by the capacitance sensor 11 is less than the first threshold, it can be determined that the indwelling catheter 12 is not inserted into the living body. If the capacitance is equal to or greater than the first threshold and less than the second threshold, it can be determined that the indwelling catheter 12 is inserted into the living body, but the tip of the catheter shaft 13 is not located in a blood vessel (the blood vessel is not secured). If the capacitance is equal to or greater than the preset second threshold, it can be determined that the indwelling catheter 12 is inserted into the living body, but the tip of the catheter shaft 13 is located in a blood vessel (the blood vessel is secured).

[0063] 6 is a flowchart showing an example of a processing procedure executed by the indwelling catheter system 100. The control unit 21 of the determination device 2 executes the following processing in accordance with a program 2P stored in the memory unit 22. The control unit 31 of the reading device 3 executes the following processing in accordance with a program stored in the memory unit 32.

[0064] When performing a procedure using the catheter assembly 1, the user brings the reading device 3 close enough to the catheter assembly 1 to enable short-range wireless communication. This establishes short-range wireless communication between the reading device 3 and the short-range wireless communication tag 19, and pairs the reading device 3 with the short-range wireless communication tag 19. While the system is performing a determination process, the reading device 3 is always installed near the catheter assembly 1.

[0065] The short-range wireless communication tag 19 acquires the capacitance detected by the capacitance sensor 11, associates the acquired capacitance with the tag identification information of the short-range wireless communication tag 19 stored in advance, and transmits it to the reading device 3 (step S11).

[0066] The control unit 31 of the reading device 3 receives the capacitance and the tag identification information (step S12), and transmits the received capacitance and tag identification information to the determination device 2 (step S13).

[0067] The control unit 21 of the determination device 2 receives the capacitance and tag identification information (step S14). Based on the received capacitance, the control unit 21 determines whether the received capacitance is equal to or greater than a preset threshold value, thereby determining the insertion state of the indwelling catheter 12 (step S15).

[0068] In step S15, the determination device 2 may determine the insertion state of the indwelling catheter 12 based on a plurality of preset thresholds. The determination device 2 may determine the insertion state including blood vessel access based on, for example, a first threshold and a second threshold.

[0069] If the capacitance is less than the preset threshold value (S15: NO), the control unit 21 determines that the indwelling catheter 12 is not inserted into the living body (step S16). The control unit 21 generates notification information indicating that the indwelling catheter 12 is not indwelling in the living body, displays the generated notification information on the display unit 24 (step S17), and proceeds to step S19. The notification information displayed on the display unit 24 includes, for example, a message notifying the user that the indwelling catheter has been removed and information indicating the tag identification information of the short-range wireless communication tag 19. The control unit 21 may output the notification information in a predetermined manner, such as by outputting a sound or by lighting up.

[0070] If the capacitance is equal to or greater than the preset threshold value (S15: YES), the control unit 21 determines that the indwelling catheter 12 is inserted into the living body (step S18).

[0071] The control unit 21 stores the received detection time of the capacitance in the detection DB 221 (step S19), and ends the process. The control unit 21 may store the received capacitance and tag identification information in association with the detection time of the capacitance.

[0072] Each device in the indwelling catheter system 100 repeatedly executes the series of processes shown in FIG. 6 at predetermined intervals while the pairing between the reading device 3 and the short-range wireless communication tag 19 continues. The control unit 21 of the determination device 2 determines the insertion state of the indwelling catheter 12 based on the capacitance detected at predetermined intervals. The insertion state determination process is not limited to being performed only during the procedure, but may also be performed before the procedure begins or after the procedure ends. The user can recognize that the indwelling catheter 12 has come loose from the notification information output from the determination device 2.

[0073] In the above-described processing, the determination device 2 may omit the output processing of the notification information in step S17 until the capacitance first exceeds the threshold value after starting to monitor the capacitance, i.e., until the indwelling catheter 12 is once inserted into the living body.

[0074] The determination device 2 is not limited to a configuration in which the received capacitance is stored in the detection DB 221 every time the capacitance is received, but may store the capacitance only when a predetermined condition set in advance is satisfied in the detection DB 221. Examples of the predetermined condition include the capacitance being equal to or greater than a threshold, the capacitance being equal to or greater than a threshold for the first time, and the capacitance being acquired within a predetermined period after the start of detection.

[0075] The determination device 2 may output catheter identification information or patient identification information as the notification information instead of or in addition to the tag identification information. In this case, the determination device 2 identifies the catheter identification information or patient identification information corresponding to the received tag identification information based on the tag information stored in the memory unit 22, and generates notification information including the identified catheter identification information or patient identification information.

[0076] The information output from the short-range wireless communication tag 19 may be information that allows the capacitance and tag identification information to be grasped. For example, the determination device 2 may receive a URL for displaying the capacitance and tag identification information from the short-range wireless communication tag 19 and acquire the capacitance and tag identification information through a web page.

[0077] The determination device 2 may write part of the information stored in the detection DB 221 to the short-range wireless communication tag 19. The determination device 2, for example, refers to tag information and transmits at least one of catheter identification information, patient identification information, and usable period corresponding to the indwelling catheter 12 to be determined to the short-range wireless communication tag 19, thereby writing this information to the short-range wireless communication tag 19. Writing of information to the short-range wireless communication tag 19 may be performed via the reading device 3. When outputting data, the short-range wireless communication tag 19 can transmit at least one of the catheter identification information, patient identification information, and usable period in association with capacitance, instead of or in addition to the tag identification information.

[0078] According to this embodiment, the indwelling catheter 12 can output information for determining the insertion state of the indwelling catheter 12. The insertion state of the indwelling catheter 12 can be determined based on the information output from the indwelling catheter 12, thereby providing appropriate support for the use of the indwelling catheter 12. The insertion state can be automatically determined by the determination device 2 based on the detection results of the capacitance sensor 11, improving the accuracy of determining the insertion state. This reduces the burden on the person involved in checking the insertion state, and also reduces the burden on the patient.

[0079] By using a short-range wireless communication tag 19 equipped with a capacitance sensor 11, capacitance can be easily detected. By using short-range wireless communication, the detected value of the capacitance sensor 11 can be transmitted easily, quickly, and reliably. By providing the short-range wireless communication tag 19 on the surface of the tip of the catheter shaft 13, capacitance at the tip of the catheter shaft 13 can be detected with high accuracy. By providing the short-range wireless communication tag 19 inside the tip of the catheter shaft 13, the diameter of the catheter shaft 13 can be reduced.

[0080] The insertion state of the indwelling catheter 12 can be determined by threshold judgment, which reduces the burden of the judgment process, speeds up the process, and improves real-time performance. If the indwelling catheter is not inserted into the living body, notification information can be output to reliably notify the user that the indwelling catheter has fallen out.

[0081] By storing tag identification information, catheter identification information, patient identification information, and the period of use related to capacitance detection in association with each other, this information can be managed efficiently. For example, by storing this information in the short-range wireless communication tag 19 and outputting it together with the capacitance, the user can efficiently grasp more information regarding the use of the indwelling catheter 12.

[0082] (Second embodiment) The second embodiment describes a configuration for outputting replacement information for the indwelling catheter 12. In the following embodiment, differences from the first embodiment will be mainly described, and components common to the first embodiment will be assigned the same reference numerals and detailed description thereof will be omitted.

[0083] It is recommended that the indwelling catheter 12 placed in the patient's body be replaced periodically. Catheter replacement timing is often managed manually, which can lead to forgetting to replace the catheter. In this embodiment, the period of use of the indwelling catheter 12 is managed based on the capacitance detection results, and the timing for replacement is automatically indicated.

[0084] 7 is a flowchart showing an example of a processing procedure executed by the determination device 2 of the second embodiment. After the end of the flowchart shown in FIG. 6, for example, the determination device 2 starts the following processing.

[0085] The control unit 21 of the determination device 2 calculates the period (e.g., the number of days elapsed, the elapsed time, etc.) from the reference time to the present, using the time when the capacitance was detected when it first became equal to or greater than the threshold value as the reference time (step S21). The time when the capacitance was detected when it first became equal to or greater than the threshold value can be identified by referring to the detection DB 221.

[0086] The control unit 21 determines whether the calculated elapsed period is equal to or greater than a preset threshold, thereby determining whether the indwelling catheter 12 needs to be replaced (step S22). The time threshold used for the determination may be the usage period associated with the indwelling catheter 12. Based on the information stored in the tag information, the control unit 21 reads out the usage period linked to the tag identification information corresponding to the capacitance, and sets the read usage period as the time threshold.

[0087] If the calculated elapsed period is less than the preset threshold (S22: NO), the control unit 21 determines that replacement is not necessary and ends the series of processes.

[0088] If the calculated elapsed period is equal to or greater than a preset threshold (S22: YES), the control unit 21 determines that replacement is necessary and causes the display unit 24 to display replacement information indicating that it is time to replace the indwelling catheter 12 (step S23). The control unit 21 may output the replacement information by a predetermined voice output, lighting, etc.

[0089] The replacement information displayed on display unit 24 includes, for example, a message urging replacement of indwelling catheter 12 and information indicating the tag identification information of short-range wireless communication tag 19. Based on the information stored in detection DB 221, control unit 21 identifies the tag identification information corresponding to indwelling catheter 12 to be replaced, and generates replacement information including the identified tag identification information and a predetermined message. The replacement information may include at least one of the calculated elapsed period, the catheter identification information stored in detection DB 221, the patient identification information, and the usable period.

[0090] In the above-described process, the reference time for calculating the elapsed period is not limited to the time when the capacitance was detected when it first exceeded the threshold. The reference time can be appropriately selected from the time when the capacitance was detected corresponding to the indwelling catheter 12 to be observed. The reference time may be, for example, any time when the capacitance was detected when it exceeded the threshold, or the time when the capacitance was first detected after detection began. Setting the reference time to the time when the capacitance was detected when it exceeded the threshold, particularly the time when the capacitance was detected when it first exceeded the threshold, is preferable because it allows the calculation of the elapsed period from when the indwelling catheter 12 was inserted into the blood vessel or immediately after insertion.

[0091] In the above-described process, the control unit 21 may vary the time threshold based on attribute information of the patient for whom the indwelling catheter 12 is to be used. The patient attribute information includes at least one of age, sex, height, weight, etc. For example, the control unit 21 decreases the time threshold as the patient becomes taller or heavier.

[0092] The control unit 21 may also output predetermined notification information not only when the elapsed period is equal to or greater than a predetermined threshold, but also when the elapsed period is less than a predetermined threshold, i.e., when it is determined that replacement is unnecessary. When the elapsed period is less than the predetermined threshold, the control unit 21 may calculate the remaining usable time by, for example, subtracting the calculated elapsed period from the predetermined threshold, and cause the display unit 24 to display the calculated remaining time.

[0093] According to this embodiment, the detection results of the capacitance sensor 11 can be used to present information on replacing the indwelling catheter 12, thereby increasing the usefulness of the capacitance detected by the capacitance sensor 11 and improving the convenience of the system.

[0094] In the above-described embodiments, examples have been described in which an indwelling catheter is used as an indwelling needle, but the indwelling catheter can be generally used as a catheter that is indwelled in a living body. The indwelling catheter may be, for example, a urinary catheter, a thoracic drainage catheter, a central venous catheter, etc.

[0095] The embodiments disclosed herein should be considered to be illustrative in all respects and not restrictive. The technical features described in each embodiment can be combined with each other, and the scope of the present invention is intended to include all modifications within the scope of the claims and the scope equivalent to the claims. The sequences shown in each embodiment are not limited, and the order of each process may be changed within a range consistent with the present invention, and multiple processes may be executed in parallel. The entity that performs each process is not limited, and the process of each device may be executed by another device within a range consistent with the present invention.

[0096] The matters described in each embodiment can be combined with each other. In addition, the independent claims and dependent claims described in the claims can be combined with each other in any combination, regardless of the reference format. Furthermore, although the claims use a format in which a claim references two or more other claims (multiple claim format), this is not limited to this format. A multiple claim (multi-multi claim) that references at least one other multiple claim may also be used. [Explanation of symbols]

[0097] 100 Indwelling catheter system 1. Catheter assembly 11 Capacitive Sensor 12 Indwelling catheter 13 Catheter shaft 14 Catheter Hub 15 Inner needle 16 Needle body 17 needle hub 19. Near Field Communication Tags 2 Judgment device 21 Control section 22 Memory section 23 Communications Department 24 Display section 25 Control section 2P Program 2A Recording Media 221 Detection DB 3 Reading device 31 Control Unit 32 Storage section 33 First Communications Department 34 Second Communications Department

Claims

1. A catheter shaft; a capacitance sensor provided at the tip of the catheter shaft; a transmitter that transmits the capacitance detected by the capacitance sensor; Equipped with Indwelling catheter.

2. the transmitter is a short-range wireless communication tag, The capacitance sensor is provided in the short-range wireless communication tag. The indwelling catheter of claim 1.

3. The capacitance sensor is provided on the distal end surface of the catheter shaft. The indwelling catheter according to claim 1 or 2.

4. The capacitance sensor is provided inside the tip of the catheter shaft. The indwelling catheter according to claim 1 or 2.

5. The indwelling catheter according to claim 1; a determination device having a control unit, The control unit acquiring the capacitance detected by the capacitance sensor; The insertion state of the indwelling catheter in the living body is determined based on the acquired capacitance. Indwelling catheter system.

6. The control unit If the capacitance is equal to or greater than a predetermined value, it is determined that the indwelling catheter is inserted into the living body; If the capacitance is less than a predetermined value, it is determined that the indwelling catheter is not inserted into the living body. The indwelling catheter system of claim 5 .

7. The control unit When it is determined that the indwelling catheter is not inserted into the living body, notification information indicating that the indwelling catheter is not inserted into the living body is output. The indwelling catheter system of claim 5 .

8. The control unit If the capacitance is equal to or greater than a predetermined value, the time point at which the capacitance was detected is stored in association with identification information for identifying the capacitance sensor or the indwelling catheter. The indwelling catheter system of claim 5 .

9. The control unit If the time period elapsed since the capacitance was detected is equal to or greater than a predetermined value, information on replacing the indwelling catheter is output. The indwelling catheter system of claim 5 .

10. Identification information for identifying the capacitance sensor or the indwelling catheter is stored in association with identification information for the living body. The indwelling catheter system of claim 5 .

11. a reading unit that reads the capacitance detected by the capacitance sensor; The indwelling catheter system of claim 5 .

12. The capacitance detected by the capacitance sensor provided at the tip of the indwelling catheter inserted into the living body is acquired, The insertion state of the indwelling catheter in the living body is determined based on the acquired capacitance. Equipped with a control unit that executes processing Judgment device.

13. The capacitance detected by the capacitance sensor provided at the tip of the indwelling catheter inserted into the living body is acquired, The insertion state of the indwelling catheter in the living body is determined based on the acquired capacitance. A method for determining whether a process is executed by a computer.

14. The capacitance detected by the capacitance sensor provided at the tip of the indwelling catheter inserted into the living body is acquired, The insertion state of the indwelling catheter in the living body is determined based on the acquired capacitance. A computer program that causes a computer to perform a process.

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