Blood sampling and timing needle for clinical drug test

Abstract

The application provides a blood sampling and timing indwelling needle for a drug clinical test, which comprises a puncture steel needle and an indwelling hose, an extension pipeline and a terminal connector. The puncture steel needle is used for puncturing into a blood vessel of a subject together with the indwelling hose. After the puncture is completed, the puncture steel needle is withdrawn, and only the indwelling hose is kept in the blood vessel of the test participant. The extension pipeline is used for guiding blood from the indwelling hose to the terminal connector. The terminal connector is a Y-shaped structure, which comprises a first connector and a second connector. The first connector is used for connecting a blood sampling and puncture needle, and the second connector is a spare connector. A blood flow detection unit is arranged on the first connector of the terminal connector. The blood flow detection unit is used for detecting blood flow in the first connector, so as to record the start and end time of the blood flow. The blood sampling and timing indwelling needle for the drug clinical test automatically records the start and end time of each blood sampling through the blood flow sensor arranged on the terminal connector, and effectively avoids the occurrence of missed recording and wrong recording of manual recording.

Description

Technical Field

[0001] This application relates to an indwelling needle, and more particularly to an indwelling needle capable of automatic timing for use in drug clinical trials. Background Technology

[0002] According to the National Medical Products Administration's Announcement on Issuing the "Measures for Supervision and Inspection of Drug Clinical Trial Institutions (Trial)" (No. 56 of 2023) (https: / / www.nmpa.gov.cn / xxgk / ggtg / ypggtg / ypqtggtg / 20231103175749117.html) and the 2025 revised draft of GCP, all clinical trials should have traceability. Source records should be attributable, readable, synchronic, original, accurate, and complete. Blood collection procedures in drug clinical trials require accurate recording of blood collection time. Drug clinical trials often involve multiple blood collections; therefore, indwelling needles are frequently used to avoid repeated punctures of subjects. Currently, when using indwelling needles for blood collection, the start and end times of each blood collection need to be manually recorded, which is cumbersome and often results in omissions or errors.

[0003] Existing indwelling needles mainly consist of three parts: a puncture needle and an indwelling tubing, an extension tubing, and a terminal connector. The puncture needle is used to insert into the subject's blood vessel along with the indwelling tubing. After puncture, the puncture needle is withdrawn, leaving only the indwelling tubing in the subject's blood vessel. The extension tubing is used to guide blood from the indwelling tubing to the terminal connector. The terminal connector is generally a Y-shaped structure, including a first connector and a second connector. The first connector is used to connect the blood collection tube puncture needle, and the second connector is a spare connector for injecting medication into the subject in emergency situations. Summary of the Invention

[0004] In view of the above problems, this application aims to provide a timing indwelling needle for blood collection in drug clinical trials, which can automatically record the start and end time of each blood flow through it.

[0005] The indwelling needle for blood collection timing in clinical trials of this application includes: a puncture needle and an indwelling tubing, an extension tubing, and a terminal connector; the puncture needle is used to insert into the subject's blood vessel along with the indwelling tubing; after puncture, the puncture needle is withdrawn, leaving only the indwelling tubing in the subject's blood vessel; the extension tubing is used to guide blood from the indwelling tubing to the terminal connector; the terminal connector has a Y-shaped structure, including a first connector and a second connector; the first connector is used to connect the blood collection tube puncture needle, and the second connector is a spare connector; A blood flow detection unit is included on the first connector of the end connector; The blood flow detection unit is used to detect blood flow in the first connector to record the start and end times of blood flow.

[0006] Preferably, the blood flow detection unit includes: a control unit, an infrared sensor, and a clock unit; An infrared sensor is installed on the first connector to detect blood flow through it; the infrared sensor is connected to the control unit; the control unit is connected to the clock unit. When the infrared sensor detects that blood has started to flow through the first connector, it sends a signal to the control unit. The control unit reads the time from the clock unit and records the blood collection start time. When the infrared sensor detects that the blood flow through the first connector has stopped, it sends a signal to the control unit. The control unit reads the time from the clock unit and records the blood collection end time.

[0007] Preferably, the blood flow detection unit further includes a display unit; the display unit is connected to the control unit and is used to display the start time and end time.

[0008] Preferably, the blood flow detection unit further includes a wireless communication unit to send the blood collection start time and blood collection end time to an external system.

[0009] The indwelling needle for timing blood collection in this application for drug clinical trials automatically records the start and end times of each blood collection by setting a blood flow sensor on the terminal connector, effectively avoiding omissions and errors in manual recording. Attached Figure Description

[0010] Figure 1 This is a schematic diagram of the end connector of the indwelling needle for timing blood collection in the drug clinical trial of this application.

[0011] Figure 2 This is a schematic diagram of the circuit portion contained in the terminal connector of the indwelling needle for timing blood collection in the drug clinical trial of this application.

[0012] Figure 3 for Figure 2 The circuit connection diagram shown is for the circuit section. Detailed Implementation

[0013] The present application will now be described in detail with reference to the accompanying drawings.

[0014] The indwelling needle for timing blood collection in clinical trials of this application is an improvement on the existing indwelling needle for blood collection.

[0015] The parts identical to those in existing blood collection catheters are: a puncture needle and an indwelling tubing, an extension tubing, and a terminal connector; the puncture needle is used to insert into the subject's blood vessel along with the indwelling tubing; after puncture, the puncture needle is withdrawn, leaving only the indwelling tubing in the subject's blood vessel; the extension tubing is used to guide blood from the indwelling tubing to the terminal connector 30; the terminal connector 30 has a Y-shaped structure, including a first connector 32 and a second connector 31; the first connector 32 is used to connect the blood collection tube puncture needle 33, and the second connector 31 is a spare connector.

[0016] The difference in this application is that a blood flow detection unit 40 is included on the first connector 32 of the end connector 30.

[0017] The blood flow detection unit 40 is used to detect blood flow in the first connector 32 to record the start and end times of blood flow.

[0018] The blood flow detection unit 40 includes: a control unit 41, an infrared sensor 42, and a clock unit 43.

[0019] An infrared sensor 41 is installed on the first connector 32 to detect the flow of blood through the first connector 32; the infrared sensor 42 is connected to the control unit 41; the control unit 41 is connected to the clock unit 43.

[0020] When the infrared sensor 42 detects that blood has started to flow through the first connector 32, it sends a signal to the control unit 41. The control unit 41 reads the time from the clock unit 43 and records the blood collection start time. When the infrared sensor 42 detects that the blood flow through the first connector 32 has stopped, it sends a signal to the control unit 41. The control unit 41 reads the time from the clock unit 43 and records the blood collection end time.

[0021] The blood flow detection unit 40 also includes a display unit 44; the display unit 44 is connected to the control unit 41 and is used to display the start time and the end time.

[0022] The blood flow detection unit 40 also includes a wireless communication unit, such as a Bluetooth communication module or a WIFI communication module, to send the blood collection start time and blood collection end time to an external system, such as an HIS system.

[0023] by Figure 3 Using the circuit diagram shown as an example, the specific working steps of the blood flow detection unit 40 are explained.

[0024] Figure 3In this circuit, control unit 40 is implemented using an AT89C51 chip. The AT89C51 is an MCU with an 8051 core, 4KB Flash, and 128B RAM. Clock unit 42 is implemented using a DS1302 chip. The DS1302 is a real-time clock chip that provides accurate Beijing time. Display unit 44 is implemented using an LCD1602; the LCD1602 is a 16x2 character LCD that displays Beijing time / status. An S8050 is an NPN transistor that drives a buzzer.

[0025] 1. Infrared sensor 42 detected blood flow signals; 2. The blood flow signal is input to the P1.0 pin of the MCU via pull-up resistor R3 and filter capacitor C6; 3. The MCU starts its internal timer and reads Beijing time from the DS1302; 4. The MCU's P2.0 pin outputs a high level, which, after passing through R4, lights up LED2 for timing indication; 5. When blood flow stops, the voltage level of the P1.0 pin of the MCU changes, and the MCU stops timing; 6. Record the end time (Beijing time), and LED2 will turn off.

[0026] The indwelling needle for timing blood collection in drug clinical trials proposed in this application can reduce the number of personnel required during blood collection operations in drug clinical trials, eliminating the need for assistants to record the time; avoiding errors and omissions in recording; enabling real-time recording of blood collection time for easy traceability; and ensuring the authenticity and reliability of clinical trial data.

Claims

1. A timing catheter for blood collection in a drug clinical trial, comprising: Puncture needle, indwelling tubing, extension tubing, and end connector; the puncture needle is used to insert into the subject's blood vessel along with the indwelling tubing. After the puncture is completed, the puncture needle is withdrawn, leaving only the indwelling tubing in the subject's blood vessel; the extension tubing is used to guide blood from the indwelling tubing to the terminal connector; the terminal connector has a Y-shaped structure, including a first connector and a second connector; the first connector is used to connect the blood collection tube puncture needle, and the second connector is a spare connector; the feature is that a blood flow detection unit is included on the first connector of the terminal connector; The blood flow detection unit is used to detect blood flow in the first connector to record the start and end times of blood flow.

2. The indwelling needle for timing blood collection in clinical trials according to claim 1, characterized in that: The blood flow detection unit includes: a control unit, an infrared sensor, and a clock unit; An infrared sensor is installed on the first connector to detect blood flow through it; the infrared sensor is connected to the control unit; the control unit is connected to the clock unit. When the infrared sensor detects that blood has started to flow through the first connector, it sends a signal to the control unit. The control unit reads the time from the clock unit and records the blood collection start time. When the infrared sensor detects that the blood flow through the first connector has stopped, it sends a signal to the control unit. The control unit reads the time from the clock unit and records the blood collection end time.

3. The indwelling needle for timing blood collection in clinical trials according to claim 2, characterized in that: The blood flow detection unit also includes a display unit; the display unit is connected to the control unit and is used to display the start time and end time.

4. The indwelling needle for timing blood collection in clinical trials according to claim 2, characterized in that: The blood flow detection unit also includes a wireless communication unit to send the blood collection start time and blood collection end time to an external system.

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