Central venous catheter assembly

Abstract

The invention provides a central venous catheter assembly, which comprises a puncture needle, a central venous catheter, a central venous catheter and a central venous catheter, the puncture needle is sleeved with the catheter, and the needle tip of the puncture needle is exposed out of the front end of the catheter; the blood stop valve is arranged at the rear end of the catheter, the blood stop valve is connected with a branch pipe, the branch pipe is provided with a Robert clamp, and a three-way connector is arranged at the tail end of the branch pipe; the standard Luer taper is connected to the tail end of the puncture needle, the standard Luer taper is connected with the blood stop valve, and the standard Luer taper is connected with an external injector or a plug; the needle holder is arranged on the catheter and used for clamping the catheter in the catheter pushing process; and the sensor module is arranged on the catheter and is used for monitoring the physical sign data, processing the physical sign data, comparing the processed physical sign data with a standard threshold value, and generating a warning signal when a preset threshold value is reached. Whether the catheter displaces or leaks liquid or not can be monitored in real time, and therefore a clinician can find complications caused by catheter displacement as soon as possible.

Description

Technical Field

[0001] The present invention relates to the technical field of medical equipment, and in particular to a central venous catheter assembly. Background Art

[0002] The basic configuration of the existing central venous catheter kit generally includes a central venous catheter, a puncture needle, a guide wire and a dilator. When in use, the puncture needle is first inserted into the central vein, then the guide wire is inserted, and then the central venous catheter is inserted with the help of a dilator. The existing method requires four steps, including puncture-guidewire placement-skin dilation-infusion catheter placement, to complete the insertion of the central venous catheter. The operation process is complicated and difficult to operate. It is easy to make operational errors, resulting in the risk of surgical failure and even risks to the patient's life safety.

[0003] During surgery, it is crucial to regulate and monitor the patient's body temperature. In particular, hypothermia is a common phenomenon in patients during surgery. Hypothermia can cause serious harm to the body, leading to serious postoperative complications and adversely affecting the patient's recovery. Therefore, during central venous catheter surgery, correct and effective temperature regulation and monitoring are essential. Clinically, rectal temperature, tongue temperature, axillary temperature, bladder temperature, and nasopharyngeal temperature are commonly used to measure human body temperature, but these temperature measurement methods cannot accurately reflect the patient's body temperature.

[0004] In addition, during the operation, problems such as catheter displacement or leakage may occur, which may lead to serious complications such as pleural effusion. Summary of the invention

[0005] In view of the problems existing in the background technology, the purpose of the present invention is to provide a central venous catheter assembly, which can be inserted into the central venous catheter once and simplifies the operation process. It can accurately monitor the patient's intraoperative body temperature in real time, accurately monitor the displacement or leakage of the catheter, and reduce the risk of surgical complications.

[0006] In order to achieve the above-mentioned purpose, the present invention provides a central venous catheter assembly, which includes: a puncture needle, which is a hollow needle; a catheter, which is sleeved on the puncture needle, and the needle tip of the puncture needle is exposed at the front end of the catheter; a blood stop valve, which is arranged at the rear end of the catheter, and the blood stop valve is connected to a branch pipe, and the branch pipe is provided with a Robert clamp, and the end of the branch pipe is provided with a three-way connector; a standard Luer connector, which is connected to the end of the puncture needle, and the standard Luer connector is connected to the blood stop valve, and the standard Luer connector is connected to an external syringe or a plug; a needle holder, which is arranged on the catheter and is used to clamp the catheter during the process of pushing the catheter; and a sensor module, which is arranged on the catheter, monitors vital sign data, and compares each vital sign data with a standard threshold after processing, and generates a warning signal when the predetermined threshold is reached.

[0007] In one embodiment, the sensor module includes: a sensor for detecting various vital sign parameters; a transmission line arranged in a catheter and connected to the sensor, the transmission line being sealed and connected to the catheter; a signal processor arranged in a blood stop valve, connected to the transmission line, and receiving and processing the detected signals.

[0008] In one embodiment, the sensor is disposed inside or outside the catheter, preferably outside the catheter.

[0009] In one embodiment, the sensors are a temperature sensor and a pressure sensor.

[0010] In one embodiment, the temperature sensor is 2-120 mm away from the front end of the catheter.

[0011] In one embodiment, three pressure sensors are provided, namely a first pressure sensor, a second pressure sensor, and a third pressure sensor. The first pressure sensor is 10 mm away from the front end of the catheter, the second pressure sensor is 30 mm away from the first pressure sensor, and the third pressure sensor is 30 mm away from the second pressure sensor.

[0012] In one embodiment, the signal processor is connected to a remote smart device.

[0013] In one embodiment, the remote smart device is a monitor and / or a mobile device of a medical staff and / or a smart phone of a patient.

[0014] In one embodiment, data transmission is wired transmission and / or wireless transmission, and the wireless transmission includes one of Bluetooth, radio frequency, RFID, and radar signal.

[0015] In one embodiment, the catheter is pushed into the central vein under visualization technology, and puncture injuries can be avoided with visual assistance.

[0016] The beneficial effects of the present invention are as follows:

[0017] 1. The present invention has a simple structure and can insert the central venous catheter at one time, thus simplifying the operation process.

[0018] 2. The present invention is provided with a sensor module, which can accurately monitor the central body temperature during surgery, which has more medical guidance significance than rectal temperature, tongue temperature, axillary temperature, bladder temperature, nasopharyngeal temperature and other temperatures.

[0019] 3. The present invention can monitor in real time whether the catheter is displaced or leaking, so that clinicians can detect complications caused by catheter displacement early. BRIEF DESCRIPTION OF THE DRAWINGS

[0020] In order to more clearly illustrate the technical solution of the present invention, the drawings required for use in the embodiments are briefly introduced below. Obviously, for ordinary technicians in this field, other drawings can be obtained based on these drawings without creative work.

[0021] Figure 1 1 is a front view of a central venous catheter assembly according to the present invention (the needle holder is not shown).

[0022] Figure 2 1 is a rear view of a central venous catheter assembly according to the present invention (the needle holder is not shown).

[0023] Figure 3 It is a right side view of a central venous catheter assembly according to the present invention (the needle holder is not shown).

[0024] Figure 4 It is a perspective view of a central venous catheter assembly according to the present invention (the needle holder is not shown).

[0025] Figure 5 1 is a top view of a central venous catheter assembly according to the present invention (the needle holder is not shown).

[0026] Figure 6 for Figure 5 An enlarged view of the local position A (puncture needle not shown).

[0027] Figure 7 It is a perspective view of a central venous catheter assembly according to the present invention (the puncture needle is not shown).

[0028] Figure 8 FIG. 4 is a front view of an embodiment of a central venous catheter assembly according to the present invention.

[0029] Fig. 9 for Figure 8 A right side view of an embodiment of the present invention.

[0030] Fig.10 for Figure 8 A perspective view of an embodiment of the present invention.

[0031] Fig.11 FIG. 4 is a front view of another embodiment of a central venous catheter assembly according to the present invention.

[0032] Fig.12 for Fig.11 A right side view of an embodiment of the present invention.

[0033] Fig.13 for Fig.11 A perspective view of an embodiment of the present invention.

[0034] Fig.14It is a front perspective view of yet another embodiment of a central venous catheter assembly according to the present invention.

[0035] Fig.15 for Fig.14 A perspective view of an embodiment of the present invention.

[0036] Illustration Description:

[0037] 1 puncture needle, 2 catheter, 3 blood stop valve, 31 branch tube, 32 Robert clamp, 33 three-way connector, 4 standard Luer connector, 41 external syringe, 42 plug, 5 needle holder, 6 sensor module, 61 temperature sensor, 62 pressure sensor, 63 transmission line, 64 signal processor DETAILED DESCRIPTION

[0038] The preferred embodiments of the present invention will be described in more detail below with reference to the accompanying drawings. Although the preferred embodiments of the present invention are shown in the accompanying drawings, it should be understood that the present invention can be implemented in various forms and should not be limited to the embodiments set forth herein.

[0039] Reference Figures 1 to 15 The central venous catheter assembly according to the present invention comprises: a puncture needle 1, which is a hollow needle; a catheter 2, which is sleeved on the puncture needle 1, and the needle tip of the puncture needle 1 is exposed at the front end of the catheter 2; a blood stop valve 3, which is arranged at the rear end of the catheter 2, and the blood stop valve 3 is connected to a branch pipe 31, and the branch pipe 31 is provided with a Robert clamp 32, and the end of the branch pipe 31 is provided with a three-way connector 33; a standard Luer connector 4, which is connected to the end of the puncture needle 1, and the standard Luer connector 4 is connected to the blood stop valve 3, and the standard Luer connector 4 is connected to an external syringe 41 or a plug 42; a needle holder 5, which is arranged on the catheter 2 and is used to clamp the catheter 2 during the process of pushing the catheter 2; and a sensor module 6, which is arranged on the catheter 2, monitors vital sign data, and compares each vital sign data with a standard threshold after processing, and generates a warning signal when the predetermined threshold is reached.

[0040] In the central venous catheter assembly according to the present invention, the puncture needle 1 can be a hollow needle made of medical stainless steel or other materials. The end of the puncture needle 1 is provided with a beveled surface, the distal end of which forms a sharp tip for penetrating body tissues. The interior of the puncture needle 1 has a hollow channel for liquid circulation. When the puncture needle 1 successfully punctures into the central vein, blood will pass through the hollow channel of the puncture needle 1 due to the negative pressure of the liquid extraction and the blood pressure in the central vein. The catheter 2 is provided with a blood stop valve 3, and a standard Luer connector 4 is connected to the blood stop valve 3. The standard Luer connector 4 is connected to an external syringe 41. Fig.14 and Fig.15 At this time, it can be judged whether the puncture needle 1 has been successfully punctured by visual inspection or blood pressure data detected by the sensor module 6.

[0041] In the central venous catheter assembly according to the present invention, the puncture needle 1 enters the catheter 2 and extends in the catheter 2, and the proximal end of the beveled surface of the puncture needle 1 extends beyond the tip of the front end of the catheter 2, and the range of the excess is less than 1mm. The outer diameter of the front end of the catheter 2 gradually shrinks and intersects with the inner surface of the catheter 2 at the tip, that is, its outer diameter gradually decreases to the same as its inner diameter, and the inner diameter of the catheter 2 can be set to be not less than the outer diameter of the puncture needle 1. It should be noted that the inner diameter of the front end of the catheter 2 and the outer diameter of the puncture needle 1 remain constant along their length. After the puncture needle 1 enters the catheter 2 and the proximal end of its distal beveled surface exceeds the tip of the catheter 2, since the outer diameter of the front end of the catheter 2 gradually shrinks to the same as its inner diameter, the outer surface of the assembly composed of the puncture needle 1 and the catheter 2 is a continuous surface, which is convenient for both to penetrate the central vein together. After the puncture needle 1 enters the central vein, the catheter 2 is also entered into the skin. After the puncture is completed, the catheter 2 is manually and slowly pushed forward for a certain distance, and the puncture needle 1 is withdrawn. This operation does not cause the catheter 2 to be withdrawn together. At this time, the catheter 2 stays in the central vein, so that the subsequent injection operation can continue. With such a structure, it is possible to effectively prevent the puncture needle 1 from moving relative to the catheter 2 during the process of entering the central vein, and at the same time, the catheter 2 is taken out during the reverse withdrawal from the central vein. The structure is simple and easy to operate.

[0042] When the user operates the central venous catheter assembly, after successfully puncturing the puncture needle 1 into the central vein, the front section of the catheter 2 is slowly sent to the distal side into the central vein for a short distance, and then the puncture needle 1 is slowly withdrawn toward the proximal side while the catheter 2 is continued to be sent into the central vein. The external syringe 41 connected to the standard Luer connector 4 can be removed, and the standard Luer connector 4 can be connected to the plug 42. Multiple operations can be performed through the three-way connector 33, including injection operations, or it is often necessary to obtain blood from the proximal end during surgery to accurately detect the blood drug concentration. Blood can be quickly obtained through the three-way connector without the need for additional blood drawing, which is convenient for intraoperative operations. Sampling and drug administration can be performed at the same time, and insertion and removal can be performed at any time as needed. The central venous catheter assembly of the present invention simplifies the puncture process, and simplifies the steps of puncture-wire placement-skin expansion-insertion catheter placement in the prior art into puncture-push catheter, avoiding the undesirable conditions such as puncture point displacement, guide wire dislocation, and skin expansion too deep that may occur during the operation, while improving the puncture success rate and effectively reducing the operation time.

[0043] In one embodiment of the sensor module 6, refer to Figure 1 , Figure 5 and Figure 6The sensor module 6 may include: a sensor for detecting various vital sign parameters; a transmission line 63, which is arranged in the catheter 2 and connected to the sensor, and the transmission line 63 is sealed and connected to the catheter 2; a signal processor 64, which is arranged in the blood stop valve 3, connected to the transmission line 63, and receives and processes the detected signal. The transmission line 63 is a metal wire with a plastic wrapped on the outer surface. The transmission line 63 does not affect the infusion of the catheter 2. The sealed connection can be sealed by UV glue curing. The sensor may include a temperature sensor 61 and a pressure sensor 62. The sensor may be arranged inside the catheter or outside the catheter, preferably outside the catheter.

[0044] In the central venous catheter assembly of the present invention, the total length of the catheter 2 can be 10-30 cm, preferably 18-25 cm. Figure 5 In the illustrated embodiment, the length of the catheter 2 is 204 mm, but the present invention is not limited thereto. Generally, the length of the catheter 2 inserted into the blood vessel is about 12-15 cm, which is determined clinically according to the patient's physical condition, such as the patient's height and weight.

[0045] In one embodiment, the temperature sensor 61 may be 2-120 mm away from the front end of the catheter 2. Preferably, it is 5-80 mm. In clinical practice, the temperature sensor 61 is selected according to the patient's condition. When the catheter 2 is inserted into the vein, it is preferred that the temperature sensor 61 is located inside the blood vessel to ensure that the measured data are all blood temperature data. This setting can ensure that the measured temperature data will not be affected by the injected liquid in the inner cavity of the catheter 2. For example, after exceeding 120 mm, the temperature sensor 61 may be buried in the subcutaneous tissue, outside the blood vessel, and the temperature data monitored by the temperature sensor 61 outside the blood vessel cannot accurately reflect the patient's core body temperature. Figure 6 The temperature sensor 61 of the illustrated embodiment is disposed inside the conduit 2 , but the present invention is not limited thereto. The temperature sensor 61 of the present invention is preferably disposed outside the conduit 2 .

[0046] The temperature monitored by the temperature sensor 61 provided in the present invention is the patient's central blood temperature (central body temperature). Those skilled in the art will know that the blood temperature represents the central body temperature of the body. It is more accurate than the body temperature measured by traditional methods, more representative of the body's central temperature, and more meaningful for clinical diagnosis. Body temperature regulation and monitoring are of great significance in surgical operations. Correct and effective body temperature regulation and monitoring can reduce surgical risks and promote patient recovery. A suitable body temperature monitoring method can help medical staff understand the patient's body temperature in real time, make timely adjustments, and ensure that the operation is safe and smooth. The present invention can accurately measure the intraoperative body temperature with high accuracy, thereby improving the quality of surgery and ensuring the safety and health of patients.

[0047] In the central venous catheter assembly of the present invention, the signal processor 64 of the sensor module 6 compares the temperature data detected by the temperature sensor 61 with the set temperature threshold (generally the central temperature is 36.5-37.5 degrees), determines the difference, and generates a warning signal when the difference reaches the predetermined threshold. Monitor whether the patient has hypothermia or hyperthermia during surgery.

[0048] In the central venous catheter assembly of the present invention, the pressure sensor 62 of the sensor module 6 can be set to multiple, and the signal processor 64 of the sensor module 6 can compare the pressure data monitored by each pressure sensor 62 with the threshold to determine the difference, and generate a warning signal when the difference reaches the predetermined threshold. Multi-point monitoring of central venous pressure can make clinical evaluation more accurate. In addition, the present invention is provided with multiple pressure sensors 62. If the pressure data of multiple pressure sensors 62 are monitored to be different and the difference exceeds a predetermined threshold, the patient can be diagnosed as displacement or leakage. In one embodiment, the pressure sensor 62 can be set to two or three. Preferably, the pressure sensor 62 is set at a position 1-8 cm away from the front end of the catheter 2.

[0049] In a preferred embodiment, referring to Figure 5 and Figure 6 , the pressure sensor 62 is set to three, namely the first pressure sensor, the second pressure sensor, and the third pressure sensor. The first pressure sensor is 10mm away from the front end of the catheter 2, the second pressure sensor is 30mm away from the first pressure sensor, and the third pressure sensor is 30mm away from the second pressure sensor. If the signal processor 64 of the sensor module 6 receives different pressure data detected by the three pressure sensors 62, the patient can be diagnosed as displacement or leakage. For example, when the pressure of the first pressure sensor 62 is monitored to be 0 or negative, it can be diagnosed that the front end of the catheter 2 breaks through the heart and shifts outside the heart, which is a serious medical problem. Through this device, it can be automatically detected as soon as possible to avoid causing serious complications such as pleural effusion and infusion of liquid into the chest cavity in patients. The present invention determines the position of the catheter tip (puncturing the heart, piercing the heart, entering the chest cavity, etc.) by setting multiple points of pressure detection. The catheter is not limited to the central venous catheter described in the present invention, but also includes other infusion catheters such as PICC catheters and infusion tubes.

[0050] In the central venous catheter assembly of the present invention, the signal processor 64 of the sensor module 6 is connected to a remote smart device. The signal processor 64 transmits the monitored data to the remote smart device. The remote smart device outputs the relevant output data to the doctor or patient, outputs a warning signal and records the results. The output data includes: the vital sign data detected by the sensor, and other data and warning signals based on calculation and processing, for example, a warning signal of displacement of the catheter 2. In one embodiment, the remote smart device can be a monitor and / or a mobile device of medical staff and / or a patient's smart phone. The data can be transmitted to the APP of the monitor or the doctor's mobile phone, which is convenient for real-time monitoring and remote monitoring by the doctor.

[0051] In the central venous catheter assembly of the present invention, data transmission between the sensor module 6 and the remote smart device can be through a wired or wireless connection, preferably a wireless connection. The wireless connection includes one of Bluetooth, radio frequency, RFID, and radar signals. For example: after the wireless connection is completed, the doctor or nurse begins to monitor the patient's central venous temperature, venous pressure, the position of the catheter 2, etc. through the mobile application on the remote smart device. It is also possible to receive auditory and visual notifications directly from the smart device.

[0052] The central venous catheter assembly according to the present invention pushes the catheter 2 into the central vein under visualization technology, and puncture damage can be avoided under visual assistance. The visualization technology can be ultrasound guidance. The present invention can push the catheter 2 into the central vein under ultrasound guidance, and puncture damage can be avoided under visual assistance. The development of the puncture needle 1 can accurately locate the puncture position. The puncture needle 1 can also be enhanced for more accurate positioning. In one embodiment, the puncture needle 1 is enhanced and developed, and the puncture needle 1 is set with a developer.

[0053] In one embodiment, the needle holder 5 may be a clamp-type needle holder (see Figures 8 to 10 ) or clip-on needle holder (refer to Figures 11 to 13 The material of the part where the needle holder 5 contacts the catheter 2 is silicone rubber. Silicon rubber has a good anti-slip effect.

[0054] In one embodiment, the material of the catheter may be one of PP, PE, TPU, and TPE soft materials.

[0055] In one embodiment, the surface of the catheter and the puncture needle may be provided with a super-slip coating. The super-slip coating can reduce the puncture resistance, so there is no need for traditional vasodilation. In one embodiment, the super-slip coating is one of a parylene coating, a Teflon coating, and a hydrophilic coating.

[0056] In one embodiment, the surfaces of the catheter and the puncture needle are provided with an antibacterial coating.

[0057] In one embodiment, the surfaces of the catheter and the puncture needle are provided with an anticoagulant coating.

[0058] In one embodiment, the catheter is configured as a single lumen or a multi-lumen. One lumen may be provided in the catheter, but in some embodiments, two lumens may be provided in the catheter. For example, the two lumens may be separated by a partition extending longitudinally along the length of the catheter, and the puncture needle enters the first lumen through a blood stop valve without puncturing into the second lumen. The first lumen and the second lumen may be connected to two infusion tubes, respectively, and the two infusion tubes are respectively connected to, for example, corresponding infusion sources. However, it is understandable that three or more lumens may also be provided in the catheter, which is not limited here. By providing multiple lumens in the catheter 2 and connecting them to multiple infusion tubes, respectively, various application scenarios can be applied, making multi-threaded operations more convenient.

[0059] In a preferred embodiment, the external syringe connected to the standard Luer connector is a syringe that automatically maintains negative pressure.

[0060] The sensor module of the present invention can be configured to monitor the patient's vital signs data, which may include not only body temperature but also blood pressure, blood sugar, blood oxygen saturation, etc.

[0061] Those skilled in the art will readily appreciate other embodiments of the present invention after considering the specification and practicing the invention disclosed herein. The present invention is intended to cover any variations, uses or adaptations of the present invention that follow the general principles of the present invention and include common knowledge or customary techniques in the art that are not disclosed by the present invention. The description and examples are to be considered exemplary only, and the true scope and spirit of the present invention are defined by the claims.

Claims

1. A central venous catheter assembly, characterized in that: include: A puncture needle, wherein the puncture needle is a hollow needle; A catheter is sleeved on the puncture needle, and the needle tip of the puncture needle is exposed at the front end of the catheter; A blood stop valve is arranged at the rear end of the catheter, the blood stop valve is connected to a branch pipe, the branch pipe is provided with a Robert clamp, and the end of the branch pipe is provided with a three-way connector; A standard Luer connector connected to the end of the puncture needle, the standard Luer connector connected to a blood stop valve, and the standard Luer connector connected to an external syringe or a plug; A needle gripper, which is arranged on the catheter and is used to clamp the catheter during the process of pushing the catheter; as well as The sensor module is installed in the catheter to monitor the vital sign data, and compares the processed vital sign data with the standard threshold value, and generates a warning signal when the predetermined threshold value is reached.

2. The central venous catheter assembly according to claim 1, characterized in that The sensor module includes: a sensor for detecting various vital sign parameters; a transmission line arranged in the catheter, connected to the sensor, and sealedly connected to the catheter; a signal processor arranged in the blood stop valve, connected to the transmission line, and receiving and processing the detected signal.

3. The central venous catheter assembly according to claim 1, characterized in that: The sensor is arranged inside or outside the catheter, preferably outside the catheter.

4. The central venous catheter assembly according to claim 1, characterized in that: The sensors are temperature sensors and pressure sensors.

5. The central venous catheter assembly according to claim 1, characterized in that: The temperature sensor is 2-120 mm away from the front end of the catheter.

6. The central venous catheter assembly according to claim 1, characterized in that: There are three pressure sensors, namely a first pressure sensor, a second pressure sensor and a third pressure sensor. The first pressure sensor is 10 mm away from the front end of the catheter, the second pressure sensor is 30 mm away from the first pressure sensor, and the third pressure sensor is 30 mm away from the second pressure sensor.

7. The central venous catheter assembly according to claim 1, characterized in that: The signal processor is connected to a remote smart device.

8. The central venous catheter assembly according to claim 1, characterized in that: The remote smart device is a monitor and / or a medical staff's mobile device and / or a patient's smartphone.

9. The central venous catheter assembly according to claim 1, characterized in that: The data transmission is wired transmission and / or wireless transmission, and the wireless transmission includes one of Bluetooth, radio frequency, RFID, and radar signal.

10. The central venous catheter assembly according to claim 1, characterized in that: The catheter is pushed into the central vein under visualization technology, and puncture injury can be avoided with visual assistance.

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