Chemotherapy outpatient anti-extravasation chemotherapy dosing device

Abstract

The present application relates to the technical field of medical devices, in particular to a chemotherapy outpatient anti-extravasation chemotherapy dosing device, comprising a transfusion tube, a hydraulic collection assembly is arranged on the transfusion tube, a drip speed collection assembly is arranged outside the drip tube, the hydraulic collection assembly is signal connected with a controller, the controller is electrically connected with a strain collection assembly, whether the current transfusion process is abnormal is comprehensively judged through the hydraulic change information of the drug solution delivery and the drip speed change information in the drip tube, and whether there is drug solution extravasation is judged in combination with the tension change of the patient's puncture point; a valve assembly is arranged on the transfusion tube, and a drug solution recovery assembly is further arranged below the valve assembly, when drug solution extravasation occurs in the patient's transfusion process, the valve assembly is driven to block the drug solution delivery, and the drug solution recovery assembly recovers the residual drug solution in the transfusion tube. The present application integrates hydraulic, drip speed and skin tension multi-dimensional data monitoring, when chemotherapy drug delivery extravasation is detected, the drug solution delivery is blocked, and the residual drug solution is cleaned and recovered, so that the defect of continuous drug delivery after existing drug delivery extravasation is solved.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a chemotherapy outpatient anti-extravasation chemotherapy delivery device. Background Technology

[0002] Chemotherapy administration in outpatient clinics typically refers to the intravenous delivery of chemotherapy drugs (cytotoxic drugs, targeted drugs, etc.) to the patient to inhibit or kill cancer cells and control tumor growth. Chemotherapy extravasation, however, refers to the accidental leakage of chemotherapy drugs into surrounding tissues outside the veins during administration. This can lead to local tissue necrosis, inflammatory reactions, and in severe cases, even affect the patient's treatment outcome and quality of life.

[0003] A conventional infusion set typically includes a stopper needle with a vent valve, which connects to an infusion tubing. The tubing is equipped with a drip chamber and a flow regulator (roller clamp). A connector is attached to the end of the tubing furthest from the stopper needle, used to connect a needle or indwelling needle assembly. Based on this conventional infusion set, Chinese Patent Publication No. CN118718163B discloses an extravasation-preventing chemotherapy delivery device for oncology, comprising a holder and a vial. The lower end of the vial is equipped with a transmission mechanism and an automatic infusion rate control mechanism to prevent extravasation. Combined with a liquid detection mechanism to monitor the remaining medication in the vial, the device automatically adjusts the injection rate based on the patient's venous pressure to prevent extravasation.

[0004] While existing chemotherapy delivery devices can reduce the incidence of extravasation and mitigate acute damage caused by high-pressure infusion by adjusting the infusion rate, they continue to administer medication even after extravasation is detected, making it difficult to avoid the ongoing harm caused by extravasation to patients. Therefore, there is an urgent need to develop a chemotherapy delivery device for outpatient use that prevents extravasation. This device should integrate real-time extravasation monitoring and dynamic control of the drug delivery process to enable immediate interruption of drug administration when extravasation occurs, thereby minimizing the risk of tissue damage to patients. Summary of the Invention

[0005] To address the aforementioned issues, this invention provides a chemotherapy outpatient extravasation prevention chemotherapy delivery device that integrates multi-dimensional data monitoring of hydraulic pressure, drip rate, and skin tension. When extravasation of chemotherapy is detected, it blocks the delivery of the drug solution and removes and recovers the residual drug solution, thus overcoming the shortcomings of existing technologies that allow for continuous drug delivery after extravasation.

[0006] To achieve the above objectives, the technical solution of the present invention is as follows: a chemotherapy outpatient extravasation prevention chemotherapy delivery device, comprising an infusion tube, one end of which is connected to a puncture device, and the other end of the infusion tube away from the puncture device is connected to a connector. A transparent dropper is provided on the infusion tube, and a hydraulic acquisition component for detecting hydraulic pressure changes within the infusion tube is provided on the infusion tube. A drip rate acquisition component for real-time counting of drip rate is provided outside the dropper. The hydraulic acquisition component is signal-connected to a controller, and the drip rate acquisition component is signal-connected to the controller. The controller is electrically connected to a strain acquisition component applied to the patient's skin surface. The strain acquisition component is used to acquire changes in skin tension near the patient's puncture point. By comprehensively judging whether the current infusion process is abnormal through the hydraulic pressure change information of the drug delivery and the drip rate change information within the dropper, and further combining the tension change at the patient's puncture point, it is determined whether there is drug extravasation.

[0007] The infusion tubing is equipped with a valve assembly for controlling the flow of the medication. Below the valve assembly is a medication recovery assembly for recovering the remaining medication in the infusion tubing. Both the valve assembly and the medication recovery assembly are connected to the controller. When extravasation of medication occurs during the patient's infusion, the controller immediately drives the valve assembly to block the medication delivery and then drives the medication recovery assembly to recover the remaining medication in the infusion tubing to prevent further extravasation.

[0008] The technical principle of the above solution is as follows: Based on a conventional infusion set, a hydraulic acquisition component, a drip rate acquisition component, and a strain acquisition component are integrated into the infusion tubing to collect real-time data on hydraulic changes within the infusion tubing, drug drip rate, and changes in skin tension at the patient's puncture point. A controller is designed to receive and comprehensively analyze the above multi-dimensional data to determine whether the infusion process is abnormal. The accuracy of drug extravasation detection is improved by combining abnormal infusion process with abnormal skin tension at the patient's puncture point. When extravasation is detected, the controller immediately drives the valve component to block drug delivery and activates the drug recovery component to recover the remaining drug in the infusion tubing, forming a multi-control process design of monitoring, judgment, blocking, and recovery.

[0009] The above approach has the following beneficial effects:

[0010] 1. Existing technologies continue to administer medication even after extravasation is detected. This solution uses a controller to link valve components to immediately block the delivery of the medication when extravasation occurs, thus preventing further damage to the patient's tissues from continuous extravasation and solving the problem of continuous medication administration after extravasation.

[0011] 2. This solution combines three-dimensional data from hydraulic pressure detection, drip rate detection, and skin tension detection for comprehensive judgment. Compared with single-parameter detection, it effectively eliminates interference factors such as pipeline blockage and changes in patient position, improves the accuracy of extravasation judgment, and reduces the false extravasation rate.

[0012] 3. This solution actively removes residual fluid from the infusion tubing through a drug recovery component, solving the problem of potential leakage of residual medication after the infusion set is blocked, reducing the risk of residual medication extravasation, and further ensuring patient safety.

[0013] Furthermore, the hydraulic acquisition component includes an annular outer shell that is sleeved and fixed to the outside of the infusion tube. Several pressure sensors are uniformly fixed to the inner wall of the annular outer shell, and several through grooves corresponding to the positions of the pressure sensors are opened on the wall of the infusion tube.

[0014] Beneficial effects: By installing an annular shell with a pressure sensor on the outside of the infusion tube, the sensor can directly contact the drug solution through the groove in the tube wall to collect hydraulic data inside the infusion tube; the circumferential distribution design of multiple sensors improves the comprehensiveness of hydraulic detection and ensures that pressure abnormalities caused by leakage are accurately captured.

[0015] Furthermore, the annular outer shell is located on the tube wall near the connector end of the infusion tube, and the bottom of the annular outer shell fits against the top of the connector.

[0016] Beneficial effects: This design places the annular outer shell near the connector end and fits the top of the connector, shortening the hydraulic transmission path, reducing the attenuation of pressure signals by long pipelines, making the collected data closer to the actual subcutaneous pressure changes of the patient, and improving the real-time monitoring.

[0017] Furthermore, the drip rate acquisition component includes a support frame fitted onto the outside of the drip irrigation system, on which an infrared sensor is fixedly connected.

[0018] Beneficial effects: This design uses an infrared sensor on the outer support frame of the droplet to detect the frequency of droplets blocking the infrared beam and count the droplet rate; non-contact infrared detection avoids interference with the flow of the medicine and realizes real-time and continuous monitoring of the droplet rate, providing dynamic flow rate basis for extravasation judgment.

[0019] Furthermore, the strain acquisition component includes an adhesive patch with an embedded tension sensor for acquiring the deformation tension of the patch applied to the surface of the patient's puncture site.

[0020] Beneficial effects: By collecting changes in skin tension at the puncture point through the tension sensor embedded in the adhesive patch, subcutaneous tissue swelling caused by extravasation can be directly captured; the patch design ensures close contact between the sensor and the skin, improving the sensitivity of tension change detection.

[0021] Furthermore, the valve assembly includes two electrically controlled clamp valves, the output ends of which are attached to the outer wall of the infusion tube. The electrically controlled clamp valves are controlled by a controller signal to control the clamping degree of their output ends, thereby adjusting the flow diameter of the infusion tube.

[0022] Beneficial effects: The clamping degree of the clamping valve output end is controlled by an electrical signal sent by the controller, thereby adjusting the flow diameter of the infusion tube; in addition, during routine drug administration, the infusion flow rate can be automatically controlled by adjusting the clamping degree, and the drug delivery path can be cut off by increasing the clamping degree when extravasation occurs; this design features an electrically controlled clamping valve with a faster response speed than traditional manual roller clamps, which can quickly block drug delivery when extravasation occurs, reducing the risk of tissue damage; at the same time, it realizes automated and precise adjustment of the infusion flow rate, replacing manual mechanical adjustment, and improving the convenience of operation and the accuracy of drip rate control.

[0023] Furthermore, two electrically controlled clamp valves are located at the bottom of the dropper and the top of the connector, respectively.

[0024] Beneficial effects: The design of the two electrically controlled clamp valves can work together to form a dual blocking mechanism that blocks the infusion source and the infusion end. The upper electrically controlled clamp valve cuts off the entry of new medication into the tubing to avoid continuous infusion, while the lower electrically controlled clamp valve directly blocks the delivery of medication near the puncture point to reduce residual medication extravasation. This not only prevents the blocking failure caused by the failure of a single electrically controlled clamp valve and shortens the response distance on the medication delivery path, but also further reduces the tissue damage to the patient caused by extravasation.

[0025] Furthermore, the drug recovery assembly includes a recovery tube connected to the infusion tube, and a negative pressure pump assembly and a collection bottle are sequentially connected to the end of the recovery tube away from the infusion tube.

[0026] A one-way liquid valve is fixedly connected inside the recovery tube. The one-way liquid valve only allows liquid to flow unidirectionally from the infusion tube to the collection bottle.

[0027] Beneficial effects: After extravasation is stopped, the controller activates the negative pressure pump assembly, using the negative pressure effect to draw residual medication from the infusion tubing to the collection bottle through the recovery tube. The one-way valve prevents backflow of the recovered medication from causing pipeline contamination or incomplete recovery. The negative pressure pump actively removes residual medication, solving the problem of potential leakage of residual medication after the infusion set is stopped, significantly reducing the risk of extravasation and improving medication safety.

[0028] Furthermore, the recovery tube extends obliquely towards the drip tube along its connection point with the infusion tube.

[0029] Beneficial effects: The angled extension of the recovery tube design allows the inlet of the recovery tube to be closer to the high residue area below the drip tube, shortening the negative pressure conduction distance to improve the suction response speed; at the same time, it avoids local eddy current loss caused by right-angle turns, allowing the negative pressure to act more directly on the remaining medicine, further reducing the amount of medicine residue in the infusion tube and improving the recovery efficiency.

[0030] Furthermore, the controller integrates a control system, which includes a data acquisition module, an analysis module, an infusion interruption module, and a drug recovery module.

[0031] The data acquisition module is used to collect hydraulic data in the infusion tube through several pressure sensors to generate hydraulic change graph data, collect drug drip rate through infrared sensors to generate drug drip rate change graph data, and collect skin tension change graph data near the patient's puncture site through tension sensors.

[0032] The analysis module first receives hydraulic pressure change data and drip rate change data, and detects whether there are abrupt changes in either to identify abnormal flow within the infusion tubing. Once an abnormal flow of the medication within the infusion tubing is determined, it combines this data with skin tension change data. If the tension increases and matches the abrupt change trends in hydraulic pressure and drip rate, it is determined to be extravasation of chemotherapy medication, and an extravasation confirmation signal is sent to the infusion blocking module. Otherwise, it is determined to be a general infusion abnormality.

[0033] The infusion interruption module receives the extravasation confirmation signal sent by the analysis module and immediately transmits an adjustment signal to the electrically controlled clamp valve to drive it to close, thus blocking the continuous delivery of chemotherapy drugs; after the electrically controlled clamp valve closes, it sends a recovery signal to the drug recovery module.

[0034] The drug recovery module is used to receive the recovery signal transmitted by the infusion interruption module and transmit the drive signal to the negative pressure pump assembly to drive the negative pressure pump assembly to perform negative pressure suction on the residual drug in the infusion tube through the recovery tube and collect the residual liquid into the collection bottle.

[0035] Beneficial effects: The controller integrates data acquisition, analysis, infusion blocking, and drug recovery modules. Through the collaboration of these modules, it achieves real-time data acquisition and analysis, and automatically executes blocking and recovery commands. This forms an intelligent control process that replaces manual intervention, improving the timeliness and accuracy of extravasation treatment.

[0036] Additional aspects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of the overall structure of an embodiment of the chemotherapy outpatient anti-extravasation chemotherapy drug delivery device of the present invention;

[0038] Figure 2 This is a detailed exploded view of the hydraulic acquisition component in an embodiment of the chemotherapy outpatient anti-extravasation chemotherapy drug delivery device of the present invention;

[0039] Figure 3 This is an isometric schematic diagram of the drip rate acquisition component in an embodiment of the chemotherapy outpatient anti-extravasation chemotherapy drug delivery device of the present invention;

[0040] Figure 4 This is an isometric schematic diagram of the drug recovery component in an embodiment of the chemotherapy outpatient anti-extravasation chemotherapy drug delivery device of the present invention;

[0041] Figure 5 This is a schematic diagram of the operation of the control system in an embodiment of the chemotherapy outpatient anti-extravasation chemotherapy drug delivery device of the present invention.

[0042] The reference numerals in the accompanying drawings of the instruction manual include: 1. Infusion stand; 2. Infusion tube; 3. Connector; 4. Dropper; 5. Hydraulic acquisition assembly; 51. Annular outer shell; 52. Pressure sensor; 53. Through groove; 6. Drip rate acquisition assembly; 61. Support frame; 62. Infrared sensor; 7. Electrically controlled clamp valve; 8. Drug recovery assembly; 81. Recovery tube; 82. Negative pressure pump assembly; 83. Collection bottle. Detailed Implementation

[0043] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0044] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0045] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0046] The following detailed description illustrates the specific implementation method:

[0047] Example 1:

[0048] This embodiment provides a chemotherapy outpatient extravasation prevention chemotherapy delivery device, specifically as follows: Figure 1As shown (illustrated with the medication dispenser hanging on the infusion stand 1), it includes an infusion tube 2. One end of the infusion tube 2 is sealed and connected to a puncture device for inserting into the infusion bottle to connect the infusion bottle and the infusion tube 2. The end of the infusion tube 2 away from the puncture device is connected to a connector 3 for connecting a needle, indwelling needle or extension tube. A transparent dropper 4 is connected to the body of the infusion tube 2.

[0049] Because extravasation increases the pressure in the patient's subcutaneous tissue, it can cause abnormal back pressure within the infusion tubing 2. Therefore, this embodiment includes a hydraulic data acquisition component 5 on the infusion tubing 2 to detect changes in hydraulic pressure within it. Specifically, in conjunction with… Figure 1 and Figure 2 As shown, the hydraulic acquisition component 5 includes an annular outer shell 51 that is sleeved and fixed to the outside of the infusion tube 2. Sealing rings are fitted at the connection points between the two sides of the annular outer shell 51 and the infusion tube 2. Several pressure sensors 52 are uniformly embedded in the inner wall of the annular outer shell 51. Several through grooves 53 corresponding to the positions of the pressure sensors 52 are opened in the wall of the infusion tube 2. The pressure sensors 52 are designed to collect hydraulic data in real time. When extravasation of medication causes an increase in subcutaneous pressure, abnormal back pressure in the infusion tube 2 will trigger changes in the signals of the pressure sensors 52, enabling dynamic monitoring of the medication delivery pressure and providing crucial data support for extravasation detection and medication interruption.

[0050] In addition, the annular outer shell 51 is located on the wall of the infusion tube 2 near the connector 3, and the bottom of the annular outer shell 51 fits against the top of the connector 3. This design allows the pressure sensor 52 to collect data closer to the patient's infusion site, shortens the hydraulic transmission path, and reduces the impact of the long infusion tube 2 on the attenuation or delay of the pressure signal, thereby allowing the detection data to more accurately reflect the changes in the patient's subcutaneous pressure and improving the effectiveness of hydraulic monitoring.

[0051] However, simply detecting the hydraulic pressure during chemotherapy administration is insufficient to accurately determine whether extravasation of chemotherapy drugs has occurred. Therefore, based on the acquisition of the hydraulic pressure during chemotherapy administration, this embodiment designs a drip rate acquisition component 6 external to the dropper 4 for real-time drip rate counting, specifically combined with… Figure 1 and Figure 3 As shown, the drip rate acquisition component 6 includes a support frame 61 sleeved on the outside of the drip irrigation tube, and an infrared sensor 62 is fixedly connected to the support frame 61. The infrared sensor 62 is designed to count the drip rate of the medicine in real time by detecting the number of times the droplet blocks the infrared beam when it passes through the drip tube 4.

[0052] Infrared sensor 62 is connected to a controller, and several pressure sensors 52 are also connected to the controller. The controller receives hydraulic data collected by pressure sensor 52 and drip rate data collected by infrared sensor 62 in real time. Combining the hydraulic data and drip rate data, the controller establishes a hydraulic and drip rate linkage analysis model: During normal drug administration, hydraulic pressure and drip rate have a stable matching relationship; when the patient's infusion is abnormal, the subcutaneous pressure increases, causing the hydraulic pressure to rise abnormally. At the same time, the back pressure increases, causing the drip rate to drop significantly or be interrupted. The controller accurately judges the patient's infusion abnormality by identifying the characteristic changes of high hydraulic pressure and low drip rate. If only a single parameter is abnormal (e.g., the hydraulic pressure rises but the drip rate is normal, which may be due to blockage of infusion tubing 2; the drip rate is abnormal but the hydraulic pressure is stable, which may be due to abnormal infusion pump / infusion bottle), the corresponding type of abnormality warning is triggered, realizing differentiated identification of different infusion abnormality scenarios.

[0053] To enhance the specificity of chemotherapy extravasation detection, a unique feature is the controller's electrical connection to a strain acquisition component applied to the patient's skin. This component includes an adhesive patch with an embedded tension sensor for collecting the deformation tension of the patch applied to the patient's puncture site. Given that a key differentiating feature of chemotherapy extravasation from other infusion abnormalities (such as coughing, sneezing, or tubing blockage) is puncture site tissue swelling accompanied by skin expansion, the adhesive patch design and tension sensor collect real-time changes in skin tension at the puncture site, using this as the core indicator for extravasation determination. The controller combines three-dimensional parameters—hydraulic pressure changes, drip rate changes, and skin tension—to confirm chemotherapy extravasation only when all three parameters—high pressure, low drip rate, and high skin tension—are synergistically abnormal. This effectively eliminates misjudgments caused by fluctuations in a single parameter, significantly improving the accuracy of extravasation identification and providing highly specific diagnostic evidence for clinical intervention.

[0054] When it is determined that extravasation has occurred during chemotherapy administration, this embodiment includes a valve assembly on the infusion tubing 2 to control the flow rate of the medication, specifically as follows: Figure 1 As shown, the valve assembly includes two electrically controlled clamp valves 7 fixedly connected to the infusion stand 1 via connecting rods. Both electrically controlled clamp valves 7 are preferably SMC LPV series electromagnetically driven clamp valves. The output ends of both electrically controlled clamp valves 7 are in contact with the outer wall of the infusion tube 2. Both electrically controlled clamp valves 7 are connected to the controller signal and are controlled by the controller signal to control the clamping degree of their output ends, thereby adjusting the flow diameter of the infusion tube 2. When the controller determines that extravasation has occurred, it immediately sends a shut-off signal to each electrically controlled clamp valve 7, causing it to quickly adjust the flow diameter to cut off the infusion pathway, terminate the continuous extravasation of the drug solution, and reduce tissue damage. Furthermore, during routine drug administration, the controller can automatically and precisely control the infusion flow rate by adjusting the clamping degree of the electrically controlled clamp valves 7 according to preset drip rate parameters or real-time adjustments, replacing the traditional manual roller clamp mechanical adjustment method and improving the convenience and accuracy of drip rate control. In addition, as... Figure 1As shown, two electrically controlled clamp valves 7 are located at the bottom of the drip tube 4 and the top of the connector 3, respectively (hereinafter referred to as the upper and lower electrically controlled clamp valves 7). The upper electrically controlled clamp valve 7 is fused to the bottom wall of the drip tube 4, and the lower electrically controlled clamp valve 7 is fused to the top wall of the connector 3. The upper electrically controlled clamp valve 7 is used to block the flow of medication from the infusion bottle into the infusion tube, while the lower electrically controlled clamp valve 7 is used to block the continuous infusion of medication from the infusion tube into the patient's body. The two electrically controlled clamp valves 7 work together to achieve dual blocking at both the source and end of the infusion. The upper electrically controlled clamp valve 7 cuts off the entry of new medication into the tubing, preventing continuous infusion after extravasation; the lower electrically controlled clamp valve 7 directly blocks the delivery of medication near the puncture point, reducing the risk of residual medication extravasation. This tiered blocking improves safety, prevents blocking failure caused by the malfunction of any electrically controlled clamp valve 7, and shortens the blocking response distance along the medication delivery path, further reducing tissue damage to the patient caused by extravasation.

[0055] To improve the convenience of intravenous infusion, the infusion tubing 2 is generally designed as a flexible, long tube. Blocking the medication only stops the medication from entering the infusion tubing 2 from the infusion bottle; any residual medication in the tubing 2 can still be continuously infused into the patient's puncture site. Therefore, based on this infusion blocking design, a medication recovery component 8 is also provided below the electrically controlled clamp valve 7 for recovering residual medication in the infusion tubing 2, as detailed below... Figure 1 and Figure 4 As shown, the drug solution recovery assembly 8 includes a recovery tube 81 integrally formed and connected with the infusion tube 2. The end of the recovery tube 81 away from the infusion tube 2 is sequentially fitted with a negative pressure pump assembly 82 and a collection bottle 83. The negative pressure pump assembly 82 is connected to the controller via a signal. The negative pressure pump assembly 82 is preferably a Qilinbell GL-810 miniature benchtop vacuum pump. After the drug solution delivery is cut off by the controller, the vacuum pump is started simultaneously. The negative pressure generated by the pump is used to draw the residual drug solution in the infusion tube 2 into the collection bottle 83 through the recovery tube 81, thereby achieving rapid removal of residual liquid.

[0056] A one-way liquid valve is welded and fixed inside the recovery tube 81. The one-way liquid valve only allows liquid to flow unidirectionally from the infusion tube 2 to the collection bottle 83. The one-way liquid valve is designed to prevent residual liquid backflow from causing secondary contamination or incomplete recovery in the infusion tube 2.

[0057] Based on the principle of two electrically controlled clamping valves 7 clamping the infusion tube 2, the vacuum pump recovers the medication from the infusion tube 2. When an external leakage occurs, the controller first drives the upper electrically controlled clamping valve 7 to close rapidly, cutting off the continuous infusion of medication from the infusion bottle into the infusion tube 2. At the same time, the lower electrically controlled clamping valve 7 gradually closes to prevent a sudden increase in pressure within the infusion tube 2, which could lead to accelerated leakage of residual medication. Simultaneously, the vacuum pump starts to perform negative pressure suction on the section of infusion tube 2 between the upper and lower electrically controlled clamping valves 7. After the upper and lower electrically controlled clamping valves 7 are completely closed, the vacuum pump continues to extract the residual medication from this section of the tube until a stable negative pressure state is formed (pressure within the tube ≤ -15kPa), after which the vacuum pump stops operating.

[0058] Based on the above-mentioned procedures for handling extravasation, medical staff can quickly perform re-infusion preparation using this principle: First, open the upper electrically controlled clamp valve 7, using the negative pressure inside the infusion tubing 2 to quickly draw in the new medication from the infusion bottle and fill the tubing area where the medication might have been contaminated, thus achieving self-cleaning of the infusion tubing 2; then open the lower electrically controlled clamp valve 7, briefly expelling a small amount of air from the tubing before re-puncturing to administer medication; this process does not require replacing the entire infusion tubing, and re-infusion preparation can be completed in two steps: negative pressure filling and rapid air venting. Compared with the traditional method (replacing the infusion set and then re-venting), this saves operation time, avoids the risk of contaminated medication residue, and significantly improves the efficiency of extravasation treatment and re-infusion.

[0059] The following experiments were conducted based on the drug delivery device proposed in this embodiment:

[0060] Experimental objective: To verify the effectiveness of the proposed anti-extravasation drug delivery device in reducing the amount of extravasated drug solution and tissue damage compared to traditional drug delivery devices.

[0061] Experimental steps:

[0062] 1. Experimental Materials

[0063] Experimental group: The extravasation-proof drug delivery device described in this document (including hydraulic acquisition, drip rate acquisition, strain acquisition components, and electrically controlled clamp valve 7 and negative pressure pump recovery module);

[0064] Control group: Traditional chemotherapy administration device (containing only manual roller clamp, without extravasation detection and automatic blocking function);

[0065] Simulated extravasation model: porcine ex vivo skin (3-5 mm thick) + subcutaneous tissue simulated gel (simulating the human subcutaneous environment);

[0066] Drug solution: methylene blue stained physiological saline (simulating chemotherapy drug solution, to facilitate observation of extravasation range);

[0067] Monitoring equipment: high-speed camera (to record the blocking time), electronic balance (to weigh the amount of recovered drug solution), and image analysis software (to measure the extravasation area).

[0068] 2. Experimental Procedure

[0069] (1) Model preparation: Pig skin was fixed on the experimental table, and 5 mL of simulated gel was injected subcutaneously to construct the "subcutaneous space". The puncture needle was inserted into the gel layer through the skin and connected to the drug delivery device (experimental group / control group). The infusion rate was set to 50 drops / minute.

[0070] (2) Extravasation simulation: 3 minutes after the start of drug administration, 2 mL of air was injected into the gel layer through the side of the puncture needle to simulate the increase in subcutaneous pressure caused by extravasation (triggering abnormal signals of hydraulic pressure / drip rate / tension in the experimental group).

[0071] (3) Experimental group operation: Start the drug delivery device control system and record the following data:

[0072] Residual liquid recovery volume: The weight (converted to volume) of the liquid in the collection bottle after the negative pressure pump is started for recovery.

[0073] Extravasation area: After 30 minutes, the skin was peeled off, and the area of ​​the methylene blue stained region was measured using image analysis software.

[0074] (4) Control group operation: After the extravasation simulation, the experimenter observed the extravasation of the drug solution with the naked eye (such as skin swelling), manually closed the roller clamp, and recorded the manual blocking time and the amount of residual drug solution that naturally leaked out (the staining area was measured after 30 minutes).

[0075] (5) Repeat the experiment: Each group of experiments was repeated 5 times and the average value was taken.

[0076] Experimental data: Table 1:

[0077]

[0078] Experimental conclusion: The extravasation area of ​​the experimental group (1.8 cm²) was only 34.6% of that of the control group (5.2 cm²), which verifies that the synergistic effect of blocking and recovery can effectively reduce the extravasation range and reduce the risk of tissue damage.

[0079] Example 2:

[0080] As attached Figure 1 As shown, the difference from Embodiment 1 is that the recovery tube 81 extends obliquely towards the drip tube 4 along its connection with the infusion tube 2. By extending the recovery tube 81 and the infusion tube 2 obliquely towards the drip tube 4, the path of residual liquid recovery flow is optimized. The oblique arrangement design makes the inlet of the recovery tube 81 closer to the residual area below the drip tube 4, which helps to shorten the negative pressure conduction distance, so that the liquid in the infusion tube 2 is drawn in the direction of negative pressure, improving the suction response speed. At the same time, it avoids the local eddy current loss caused by right-angle turns, so that the negative pressure can act more directly on the remaining medicine, further reducing the amount of medicine residue in the infusion tube 2.

[0081] Example 3:

[0082] As attached Figure 5 As shown, the difference from Embodiment 2 is that the controller integrates a control system, which includes a data acquisition module, an analysis module, an infusion interruption module, and a drug recovery module.

[0083] The data acquisition module collects hydraulic data in the infusion tube 2 through several pressure sensors 52 to generate hydraulic change graph data, collects drug drip rate through infrared sensor 62 to generate drug drip rate change graph data, and collects skin tension change graph data near the puncture site through tension sensor.

[0084] The analysis module receives the hydraulic pressure change curve and the drip rate change curve, and detects whether there are sudden changes in either (such as abnormal increase in hydraulic pressure, sudden drop in drip rate or interruption) to identify abnormal flow in infusion tubing 2. When abnormal flow of drug solution in infusion tubing 2 is determined, the module combines the skin tension change curve. If the tension increases and matches the sudden change trend of hydraulic pressure and drip rate, it is determined to be extravasation of chemotherapy drug solution, and an extravasation confirmation signal is sent to the infusion blocking module. Otherwise, it is determined to be a general infusion abnormality (i.e., patient cough or body position adjustment, etc.).

[0085] The infusion blocking module receives the extravasation confirmation signal sent by the analysis module and immediately transmits the adjustment signal to the electrically controlled clamp valve 7 to drive the electrically controlled clamp valve 7 to close, blocking the continuous delivery of chemotherapy drugs and preventing further extravasation; after the electrically controlled clamp valve 7 is closed, a recovery signal is sent to the drug recovery module.

[0086] The drug recovery module receives the recovery signal transmitted by the infusion blocking module and transmits the drive signal to the vacuum pump to drive the vacuum pump to perform negative pressure suction on the residual drug in the infusion tube 2 through the recovery tube 81, and collect the remaining liquid into the collection bottle 83.

[0087] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A chemotherapy outpatient extravasation prevention chemotherapy administration device, comprising an infusion tube (2), one end of the infusion tube (2) being connected to a puncture device, the other end of the infusion tube (2) away from the puncture device being connected to a connector (3), and a transparent dropper (4) provided on the infusion tube (2), characterized in that, The infusion tube (2) is equipped with a hydraulic acquisition component (5) for detecting hydraulic changes in the infusion tube (2), and the drip rate acquisition component (6) for real-time counting of drip rate is provided outside the drip tube (4). The hydraulic acquisition component (5) is connected to a controller, and the drip rate acquisition component (6) is connected to the controller. The controller is electrically connected to a strain acquisition component that is applied to the surface of the patient's skin. The strain acquisition component is used to collect changes in skin tension near the puncture point of the patient. By combining the hydraulic change information of drug delivery and the drip rate change information in the drip tube (4), it is determined whether the current infusion process is abnormal. Then, combined with the tension change of the puncture point of the patient, it is determined whether there is drug extravasation in the infusion. The infusion tube (2) is equipped with a valve assembly for controlling the flow of the drug solution. Below the valve assembly is a drug solution recovery assembly (8) for recovering the residual liquid in the infusion tube (2). Both the valve assembly and the drug solution recovery assembly (8) are connected to the controller signal. When extravasation of the drug solution occurs during the patient's infusion, the controller immediately drives the valve assembly to block the drug solution delivery, and then drives the drug solution recovery assembly (8) to recover the remaining drug solution in the infusion tube (2) to prevent continuous extravasation from causing harm to the patient.

2. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 1, characterized in that, The hydraulic acquisition component (5) includes an annular shell (51) that is sleeved and fixed to the outside of the infusion tube (2). Several pressure sensors (52) are uniformly fixed to the inner wall of the annular shell (51). Several through grooves (53) corresponding to the positions of the pressure sensors (52) are opened on the wall of the infusion tube (2).

3. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 2, characterized in that, The annular outer shell (51) is located on the tube wall of the infusion tube (2) near the connector (3), and the bottom of the annular outer shell (51) fits against the top of the connector (3).

4. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 3, characterized in that, The drip rate acquisition component (6) includes a support frame (61) sleeved on the outside of the drip irrigation system, and an infrared sensor (62) is fixedly connected to the support frame (61).

5. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 4, characterized in that, The strain acquisition component includes an adhesive patch with an embedded tension sensor for acquiring the deformation tension of the patch applied to the surface of the patient's puncture site.

6. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 5, characterized in that, The valve assembly includes two electrically controlled clamp valves (7). The output ends of the two electrically controlled clamp valves (7) are attached to the outer wall of the infusion tube (2). The electrically controlled clamp valves (7) are controlled by the controller signal to control the clamping degree of their output ends in order to adjust the flow diameter of the infusion tube (2).

7. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 6, characterized in that, Two electrically controlled clamp valves (7) are located at the bottom of the dropper (4) and the top of the connector (3), respectively.

8. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 7, characterized in that, The drug recovery assembly (8) includes a recovery tube (81) connected to the infusion tube (2), and a negative pressure pump assembly (82) and a collection bottle (83) are connected in sequence at the end of the recovery tube (81) away from the infusion tube (2). A one-way liquid valve is fixedly connected inside the recovery tube (81). The one-way liquid valve only allows liquid to flow unidirectionally from the infusion tube (2) to the collection bottle (83).

9. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 8, characterized in that, The recovery tube (81) extends obliquely towards the dropper (4) along its connection point with the infusion tube (2).

10. The chemotherapy outpatient extravasation prevention chemotherapy delivery device according to claim 9, characterized in that, The controller integrates a control system, which includes a data acquisition module, an analysis module, an infusion interruption module, and a drug recovery module. The data acquisition module is used to acquire hydraulic data in the infusion tube (2) through several pressure sensors (52) to generate hydraulic change graph data, acquire drug drip rate through infrared sensor (62) to generate drug drip rate change graph data, and acquire skin tension change graph data near the puncture hole of the patient through tension sensor. The analysis module is used to first receive hydraulic pressure change data and drip rate change data, and detect whether there is a sudden change in either, so as to identify abnormal flow in the infusion tube (2); when it is determined that the drug flow in the infusion tube (2) is abnormal, it combines the skin tension change data. If the tension increases and matches the sudden change trend of hydraulic pressure and drip rate, it is determined to be extravasation of chemotherapy drug and an extravasation confirmation signal is sent to the infusion blocking module; otherwise, it is determined to be a general infusion abnormality. The infusion blocking module is used to receive the extravasation confirmation signal sent by the analysis module and immediately transmit the adjustment signal to the electrically controlled clamp valve (7) to drive the electrically controlled clamp valve (7) to close and block the continuous delivery of chemotherapy drugs; When the electrically controlled clamp valve (7) is closed, a recovery signal is sent to the liquid recovery module; The drug recovery module is used to receive the recovery signal transmitted by the infusion blocking module and transmit the drive signal to the negative pressure pump assembly (82) to drive the negative pressure pump assembly (82) to perform negative pressure suction on the residual drug in the infusion tube (2) through the recovery tube (81) and collect the remaining liquid into the collection bottle (83).

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