A system for constructing a non-human animal model of tension pneumothorax and a device thereof

Abstract

The application provides a construction system and device of a non-human animal model of tension pneumothorax, and the system comprises: a fixing unit for fixing the non-human animal; a first processing unit for puncturing a puncture needle to the parietal pleura, making a guide wire pass through the needle cavity of the puncture needle to enter the pleural cavity, and withdrawing the puncture needle; a second processing unit for inserting a catheter along the guide wire to make the catheter enter the pleural cavity, pulling out the guide wire, and fixing the catheter; a third processing unit for unidirectional air injection into the pleural cavity through the catheter; and a fourth processing unit for monitoring the range of pneumothorax, determining that the non-human animal model of tension pneumothorax is obtained when the lung sliding of the injection side chest is greater than or equal to 4 / 6 area and lung points are observed, stopping air injection, and obtaining the non-human animal model of tension pneumothorax. The construction success rate of the application is 100%, the construction process is rapid, repeatable and objective in determination, and the application can provide a rapid and repeatable platform for diagnostic research, decompression technology evaluation and training.

Description

Technical Field

[0001] This invention belongs to the field of intelligent medical technology, specifically relating to a system and apparatus for constructing a non-human animal model of tension pneumothorax. Background Technology

[0002] Tension pneumothorax (TP) is a critical condition in which air enters the pleural cavity in one direction and is difficult to expel, leading to a progressive increase in intrapleural pressure, which in turn causes lung collapse and circulatory failure. Trauma-related TP has a short treatment window, and timely pre-hospital identification and decompression determine the prognosis.

[0003] To elucidate the pathophysiology and optimize treatment procedures, a stable, reproducible, and field-appropriate large animal model is urgently needed. Previous models, including small animal teaching models and large animal puncture / mechanical compression models such as pigs, have proven feasible for hemodynamic studies, but they rely on blind puncture and single-use inflation, which can easily lead to lung injury or subcutaneous emphysema and have insufficient reproducibility. Image guidance can improve localization, but the real-time nature and deployment of X-ray / CT are limited, which is not conducive to dynamic pressure tracking and pre-hospital translation, and the success rate of model construction is low, accompanied by complications.

[0004] Therefore, there is an urgent need for a novel method for constructing a non-human animal model of tension pneumothorax. Summary of the Invention

[0005] In view of this, in order to overcome the shortcomings of the prior art, the present invention is proposed.

[0006] The first aspect of this invention provides a system for constructing a non-human animal model of tension pneumothorax, the system comprising:

[0007] Fixation unit: Used to fix non-human animals;

[0008] First processing unit: used to allow the puncture needle to penetrate the parietal pleura, allow the guide wire to enter the pleural cavity through the puncture needle cavity, and withdraw the puncture needle;

[0009] Second processing unit: used to insert the catheter along the guidewire, so that the catheter enters the pleural cavity, remove the guidewire, and fix the catheter;

[0010] Third processing unit: used for unidirectional air injection into the pleural cavity via catheter;

[0011] The fourth processing unit is used to monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax. Inflation is stopped, and a non-human animal model of tension pneumothorax is obtained.

[0012] In this invention, the term "unit" refers to a software or hardware component that performs a specific function, such as a field-programmable gate array (FPGA), an application-specific integrated circuit (ASIC), an operable medical component, a visualization component, etc. However, the term "unit" is not limited to software or hardware. A "unit" can be configured in an addressable storage medium or can be configured to reproduce one or more processors. Thus, for example, the term "unit" can refer to components such as software components, object-oriented software components, class components, and task components, and can include processes, functions, attributes, procedures, subroutines, program code segments, drivers, firmware, microcode, circuits, data, databases, data structures, tables, arrays, and variables. The functionality provided in components and "units" can be combined into fewer components and "units," or can be further divided into additional components and "units." Furthermore, components and "units" can be implemented to operate one or more central processing units (CPUs) in a device or secure multimedia card.

[0013] In some implementations, the first processing unit further includes a method for clearly identifying intercostal structures using ultrasound to determine the puncture point.

[0014] In some implementations, the first processing unit further includes a method for using ultrasound to confirm that the needle tip of the puncture needle has accurately entered the pleural cavity.

[0015] In some implementations, the first processing unit further includes a method for confirming whether the puncture needle has been successfully inserted.

[0016] In some implementations, the first processing unit further includes a method for removing the needle core and injecting saline solution. If ultrasound shows that the injected fluid diffuses rapidly along the pleural cavity without forming a locally concentrated elliptical hypoechoic area, the puncture is considered successful.

[0017] In some implementations, the puncture point of the puncture needle is the 5th-7th intercostal space along the anterior axillary line.

[0018] In some embodiments, the gas injection rate is 0.5-1.0 L / min.

[0019] In some implementations, the fourth processing unit uses a POCUS instrument to monitor the extent of pneumothorax.

[0020] The aforementioned POCUS stands for Point-of-Care Ultrasound, which has advantages such as being bedside, real-time, radiation-free, and repeatable.

[0021] In this invention, POCUS (point-of-care ultrasound) refers to a portable or handheld color Doppler ultrasound diagnostic device, which is characterized by its small size, ease of operation, and suitability for bedside and field environments.

[0022] In some implementations, the POCUS may include, but is not limited to, the following forms: handheld probe type, tablet or mobile phone connected type, and laptop portable ultrasound device.

[0023] In some implementations, the POCUS is not limited to a specific manufacturer or model, but may be a portable color Doppler ultrasound device manufactured by companies such as Philips, GE, Mindray, and Butterfly Network.

[0024] In some implementation schemes, the required air volume for the left pleural cavity when constructing a left tension pneumothorax model is 80–1020 mL.

[0025] In some implementation schemes, the required air volume for the right pleural cavity when constructing a right-sided tension pneumothorax model is 300–620 mL.

[0026] In some implementations, the construction system also includes an anesthesia unit for inducing anesthesia in non-human animals.

[0027] In some implementations, the anesthesia unit can also be used to maintain anesthesia and / or provide analgesia to non-human animals.

[0028] In some implementations, the non-human animal is selected from pigs.

[0029] A second aspect of the present invention provides an apparatus for constructing a non-human animal model of tension pneumothorax, the apparatus comprising: one or more processors, and a memory for storing one or more computer programs, which, when executed by the one or more processors, implement:

[0030] Operation 1: Fix the non-human animal;

[0031] Procedure 2: Insert the puncture needle into the parietal pleura, allow the guide wire to pass through the puncture needle cavity into the pleural cavity, and then withdraw the puncture needle;

[0032] Procedure 3: Insert the catheter along the guidewire to enter the pleural cavity, remove the guidewire, and fix the catheter.

[0033] Procedure 4: Unidirectional air injection into the pleural cavity via catheter;

[0034] Operation 5: Monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax. Stop inflating and obtain a non-human animal model of tension pneumothorax.

[0035] The term "device" as used in this invention is not limited to one or a specific number of physical objects. As used herein, a device can be any medical or electronic component having multiple parts that can implement at least some portions of this disclosure. Although the term "device" is used in the following description and examples to describe certain aspects of this disclosure, the term "device" is not limited to a particular configuration, type, or number of objects.

[0036] The terms "processor" or "memory" in this invention include computing devices having one processor or one memory, as well as devices having multiple processors or multiple memories, that can be used to perform some or all of the steps described. "Processor" can include more than one processor, for example, a multi-core design or multiple processors each having a multi-core design.

[0037] In some implementations, the device may include, but is not limited to, one or more of the following: a shaving device, a disinfection device, an intercostal structure identification device, a vascular distribution assessment device, a puncture success determination device, a dilation device, a catheter fixation device, an air injection device, an airflow monitoring device, a pleural cavity pressure monitoring device, a pneumothorax range monitoring device, and a hemodynamic monitoring device.

[0038] In some implementations, the shaving component includes, but is not limited to, a razor or surgical scissors.

[0039] In some implementations, the local vascular distribution assessment device is selected from color Doppler.

[0040] In some implementations, decompression resuscitation and catheter removal can be performed after gas injection is stopped.

[0041] The third aspect of the present invention provides any of the following methods:

[0042] (1) A method for constructing a non-human animal model of tension pneumothorax, the method utilizing the construction system described in the first aspect of the present invention and the construction device described in the second aspect of the present invention;

[0043] (2) A method for constructing a non-human animal model of tension pneumothorax, the method being computer-based and comprising the following steps:

[0044] Step 1: Fix the non-human animal;

[0045] Step 2: Insert the puncture needle into the parietal pleura, allow the guide wire to pass through the puncture needle cavity into the pleural cavity, and then withdraw the puncture needle;

[0046] Step 3: Insert the catheter along the guidewire to enter the pleural cavity, remove the guidewire, and fix the catheter.

[0047] Step 4: Inject air unidirectionally into the pleural cavity via catheter;

[0048] Step 5: Monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax. Stop inflating and obtain a non-human animal model of tension pneumothorax.

[0049] (3) A method for screening drugs for the prevention and / or treatment of tension pneumothorax, the method comprising:

[0050] a) A non-human animal model of tension pneumothorax constructed by applying the reagent to be screened to the construction system described in the first aspect of the present invention, the construction device described in the second aspect of the present invention, or the construction method of (1) or (2) in the third aspect of the present invention;

[0051] b) Analyze and evaluate the therapeutic effects of the reagents to be screened, and select the reagents that can significantly improve tension pneumothorax;

[0052] (4) A method for evaluating the efficacy of a drug for treating tension pneumothorax, the method comprising:

[0053] a) A non-human animal model of tension pneumothorax constructed by applying the drug to the construction system described in the first aspect of the present invention, the construction device described in the second aspect of the present invention, or the construction method described in (1) or (2) of the third aspect of the present invention;

[0054] b) Evaluate the therapeutic effect of the drug on the tension pneumothorax;

[0055] (5) A method for studying the pathogenesis of tension pneumothorax, wherein the method is to study the pathogenesis of tension pneumothorax by using a non-human animal model of tension pneumothorax constructed by the construction system described in the first aspect of the present invention, the construction device described in the second aspect of the present invention, or the construction method of (1) or (2) in the third aspect of the present invention.

[0056] The advantages and beneficial effects of this invention are as follows:

[0057] (1) POCUS-guided positioning, “one needle to form a model”, accurate, efficient and short time. During the modeling process, ultrasound clearly identifies the intercostal structures, selects the 5th to 7th intercostal space of the anterior axillary line for puncture, and observes the puncture process in real time to ensure that the needle tip accurately enters the pleural cavity; a small amount of physiological saline is used to construct a “liquid acoustic window” to make the pleural interface clearer;

[0058] (2) High success rate, with a success rate of 100% regardless of whether it is the left or right side;

[0059] (3) POCUS has great real-time assessment value. When the unilateral pneumothorax exceeds 4 / 6, TP is formed, which is confirmed by chest X-ray and hemodynamic parameters.

[0060] (4) The modeling complication rate is low, almost eliminating all serious complications. During the process, POCUS guidance effectively avoids accidental damage to lung tissue and its surrounding important organs and structures.

[0061] (5) The constructed animal model provides a new approach to the puncture decompression method for tension pneumothorax: When performing puncture decompression for tension pneumothorax, the most suitable puncture point can be selected according to the patient's specific situation (such as the injured site, body shape, operating environment, etc.), instead of being bound by the traditional fixed position of "second intercostal space at the midclavicular line". Attached Figure Description

[0062] Figure 1 This is a schematic diagram of a system for constructing a non-human animal model of tension pneumothorax provided in an embodiment of the present invention;

[0063] Figure 2 This is a schematic diagram of the ultrasound-guided right pleural cavity puncture process provided in an embodiment of the present invention;

[0064] Figure 3 This is a schematic diagram of the ultrasound-guided placement of a right pleural duct provided in an embodiment of the present invention;

[0065] Figure 4 This is a four-axis linkage trend diagram of a single experimental pig during the induction of tension pneumothorax provided in this embodiment of the invention;

[0066] Figure 5 This is a distribution diagram of the number of affected POCUS partitions (first event point) under different CO decrease states provided in the embodiments of the present invention;

[0067] Figure 6 This is a graph showing the comparison between pleural pressure and injection volume when CO decreases by ≥50% during left and right side air injection, as provided in an embodiment of the present invention.

[0068] Figure 7 These are typical ultrasound findings during the induction of tension pneumothorax according to an embodiment of the present invention. Figure A: Real-time B-mode ultrasound shows the gradual disappearance of the pleural sliding sign (indicated by the thin arrow), followed by the appearance of the "lung point" sign (indicated by the thick arrow as the borderline between normal lung and pneumothorax), suggesting partial lung collapse and gas accumulation in the pleural cavity; Figure B: M-mode ultrasound of normal pleura shows the typical "sand beach sign," with the pleura rising and falling with respiratory movements (indicated by the thin arrow); Figure C: M-mode ultrasound of pneumothorax shows the disappearance of the "sand beach sign," replaced by the "stratospheric sign," with the pleura not shifting with respiratory movements (indicated by the thick arrow), suggesting the formation of tension pneumothorax.

[0069] Figure 8 These are typical X-ray imaging results of successful tension pneumothorax modeling provided in this embodiment of the invention. Image A: Chest X-ray of the animals in the left modeling group shows: significant air accumulation in the left pleural cavity (red dashed area), loss of lung markings, compression and collapse of the left lung (indicated by the thin arrow), and displacement of the mediastinal structures (trachea and cardiac silhouette) to the right (indicated by the thick arrow), suggesting the formation of left-sided tension pneumothorax. Image B: Chest X-ray of the animals in the right modeling group shows: significant air accumulation in the right pleural cavity (red dashed area), significant inward collapse of the right lung (indicated by the thin arrow), and displacement of the mediastinum to the left (indicated by the thick arrow), consistent with right-sided tension pneumothorax. All of the above imaging features support the successful construction of the model.

[0070] Figure 9 This is a schematic diagram of a device for constructing a non-human animal model of tension pneumothorax provided in an embodiment of the present invention. Detailed Implementation

[0071] The present invention will be further described below with reference to embodiments. The following description is merely a preferred embodiment of the present invention and is not intended to limit the invention in any other way. Any person skilled in the art may make equivalent modifications to the disclosed technical content to create equivalent embodiments. Any simple modifications or equivalent changes made to the following embodiments based on the technical essence of the present invention without departing from the scope of the invention are all within the protection scope of the present invention.

[0072] The present invention describes the operational flow in the specification, drawings, and claims, which includes multiple operational procedures. It should be clearly understood that these operational procedures may not be executed in the order they appear in this document or the drawings, or may be executed in parallel. The labels for the operational steps, such as 101, 102, 103, etc., are only used to distinguish different operations and do not represent any execution order. Furthermore, operations not indicated by the labels may also be added to the operational procedures of the present invention and may be executed sequentially or in parallel. Additionally, all operations mentioned herein may be omitted when necessary. It should be noted that the descriptions such as "first," "second," etc., mentioned in this invention are only used to distinguish different operations, devices, modules, messages, etc., and do not limit the order or specific type.

[0073] Figure 1 This is a schematic diagram of a system for constructing a non-human animal model of tension pneumothorax provided in an embodiment of the present invention.

[0074] In some implementation schemes, such as Figure 1 As shown, the system for constructing a non-human animal model of tension pneumothorax includes: a fixation unit 101, a first treatment unit 102, a second treatment unit 103, a third treatment unit 104, and a fourth treatment unit 105.

[0075] In some implementation schemes, 12 healthy adult miniature Bama pigs, regardless of sex, weighing 38–52 kg (average 45.8 ± 4.4 kg) and aged 17.5 ± 0.5 months, were selected. They were randomly assigned to a right-side modeling group (n=6) and a left-side modeling group (n=6) using a computer-generated randomization method. Each animal underwent unilateral modeling only, and the groups were independent samples. All animals were raised and handled in accordance with relevant Chinese national regulations and the US National Institutes of Health's "Guidelines for the Care and Use of Laboratory Animals" (No: KBSC21-2409-04). Humane endpoints and euthanasia procedures were established, complying with institutional ethics and ARRIVE 2.0 requirements. Animals were acclimatized to the experimental environment for at least 72 hours before the experiment and fasted for 12 hours prior to the experiment.

[0076] In some implementations, the fixing unit 101 is a unit for fixing non-human animals.

[0077] In some implementations, non-human animals are secured to the operating table using a fixing unit.

[0078] In some implementations, the non-human animal is fixed to the operating table in a supine position.

[0079] In some implementations, the first processing unit 102 is a unit for puncturing the puncture needle into the parietal pleura, allowing the guidewire to pass through the puncture needle lumen into the pleural cavity, and withdrawing the puncture needle.

[0080] In some implementations, the puncture point of the puncture needle is the 5th-7th intercostal space along the anterior axillary line.

[0081] In some implementations, the first processing unit further includes methods for using ultrasound to clearly identify intercostal structures and / or assess vascular distribution to determine the puncture point.

[0082] In some implementations, the intercostal structures and / or vascular distribution need to be clearly identified and assessed before puncture, so as to avoid the neurovascular bundle during the puncture.

[0083] In some implementations, under POCUS localization, color Doppler flow imaging (CDFI) is used to identify intercostal structures and assess vascular distribution.

[0084] In some embodiments, the color Doppler ultrasound device is purchased from Philips Ultrasound, Bothell, USA.

[0085] In some implementations, the frequency of the linear array probe is set to 5–12 MHz.

[0086] In some implementations, the convex array / phased array probe frequency is 1–5 MHz.

[0087] In some implementation schemes, 16G, 18G, or 20G puncture needles may be used.

[0088] In one specific implementation plan, an 18G puncture needle is selected.

[0089] In some implementations, the 18G puncture needle was purchased from Bard Japan, Tokyo, Japan.

[0090] In some implementations, the puncture needle passes through the skin, subcutaneous tissue, external intercostal muscles, internal intercostal muscles, and innermost intercostal muscles to puncture the parietal pleura.

[0091] In some implementations, after the puncture needle penetrates the parietal pleura, POCUS is used to confirm that the needle tip has accurately entered the pleural cavity.

[0092] In some implementations, the first processing unit further includes a method for confirming whether the puncture needle has been successfully inserted.

[0093] In some implementation schemes, the puncture needle is inserted into the parietal pleura. When the needle tip breaks through the pleura, the needle is fixed and the needle core is removed. After confirming that there is no blood return, the success of the puncture is determined.

[0094] In some implementation methods, the method for determining whether the puncture was successful includes: removing the needle core and slowly injecting 5-10 mL of normal saline; if the POCUS shows that the injected fluid diffuses rapidly along the pleural cavity without forming a localized oval hypoechoic area, the puncture is considered successful.

[0095] In some implementation schemes, the puncture procedure is as follows: Figure 2 As shown, the puncture point is selected at the 5th-7th intercostal space along the anterior axillary line. Guided by CDFI, the intercostal vascular nerve bundle is avoided, and the puncture needle is accurately placed into the pleural cavity (the needle tip position is indicated by the thick arrow). Normal saline is injected to confirm the positioning (indicated by the thin arrow).

[0096] In some implementations, the guidewire is guided through the puncture needle cavity into the pleural cavity under ultrasound monitoring to confirm that the guidewire tip has entered the pleural cavity and has not returned or mistakenly entered the lung parenchyma.

[0097] In some implementations, the puncture needle is withdrawn after the guidewire position is confirmed.

[0098] In some implementations, the guidewire is a flexible J-shaped guidewire.

[0099] In some implementation schemes, either a left-sided or right-sided tension pneumothorax model can be constructed. If a left-sided tension pneumothorax model is constructed, the puncture point is the 5th-7th intercostal space along the left anterior axillary line. If a right-sided tension pneumothorax model is constructed, the puncture point is the 5th-7th intercostal space along the right anterior axillary line.

[0100] In some embodiments, the second processing unit 103 is a unit for inserting a catheter along a guidewire, allowing the catheter to enter the pleural cavity, removing the guidewire, and fixing the catheter.

[0101] In some implementations, before inserting the catheter along the guidewire, a dilator is used to gently open the channel by rotating it slightly along the guidewire before the catheter is slowly inserted along the guidewire.

[0102] In some implementations, POCUS is used continuously in real time during catheter insertion to monitor the position of the puncture needle tip, guidewire, and catheter tip, ensuring that they enter the pleural cavity rather than blood vessels or lung tissue.

[0103] In some implementations, the guidewire is withdrawn after the catheter enters the pleural cavity.

[0104] In some implementations, the catheter is secured after the guidewire is removed.

[0105] In some implementations, the catheter is secured to the skin.

[0106] In some implementations, sutures are used to secure the catheter.

[0107] In some implementation schemes, such as Figure 3 As shown, the pleural cavity was successfully placed, and the end of the catheter was fixed to the skin for controlling the inflation.

[0108] In some implementations, the catheter is a double-lumen catheter.

[0109] In some implementations, the dual-lumen catheter may serve as one lumen for gradual insufflation and the other lumen connected to a pressure sensor to monitor pleural cavity pressure, and combined with POCUS for real-time assessment of the pneumothorax extent.

[0110] In some implementations, the catheter is a double-lumen central venous catheter.

[0111] In some implementations, the dual-lumen central venous catheter is ABLEFV-2766 (ABLE Medical, China).

[0112] In some implementations, the third processing unit 104 is a unit for unidirectional air injection into the pleural cavity via a catheter.

[0113] In some implementations, the one-way injection of air into the pleural cavity is performed by connecting a one-way valve to an injection module to simulate the state in which gas can only enter and not exit the pleural cavity in tension pneumothorax.

[0114] In some implementations, the one-way valve is selected from Heimlich Valve (Teleflex (USA), VAL-100, VAL-200).

[0115] In some implementations, the gas injection module includes, but is not limited to, a syringe, an air compressor, a gas cylinder, a gas canister, and a peristaltic pump.

[0116] In some implementations, the gas injection module is selected from syringes.

[0117] In some implementations, it is necessary to control the gas injection rate to be 0.5-1.0 L / min.

[0118] In some implementations, the gas injection module is connected to a gas flow monitoring module to monitor the gas flow rate.

[0119] In some implementations, the airflow monitoring module may be a gas flow meter.

[0120] In some implementations, the fourth processing unit 105 is used to monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax, and inflation is stopped to obtain a non-human animal model of tension pneumothorax.

[0121] In some implementations, the fourth processing unit includes a module for monitoring the extent of pneumothorax to determine whether to stop inflatation.

[0122] In some implementations, the module for monitoring the pneumothorax range is selected from POCUS.

[0123] In some implementations, the ≥4 / 6 zone refers to the phenomenon of lung slippage disappearance in ≥4 zones after the six-zone method is used.

[0124] The six-zone method refers to dividing each side of the chest into six zones: the anterior zone (upper and lower), the lateral zone (upper and lower), and the posterior zone (upper and lower).

[0125] In some implementation schemes, such as Figure 4 As shown, during the gas induction process, as the gas volume (goldenrod) gradually accumulates, the pleural pressure (IPP, royalblue) increases stepwise, the number of affected zones of POCUS (seagreen) shows an increasing trend, and the cardiac output (CO, firebrick) decreases synchronously.

[0126] In some implementation schemes, such as Figure 5As shown, the number of POCUS lung slippage areas (out of a total of 6 areas) corresponding to the first occurrence of a ≥50% decrease in cardiac output (CO) in 12 pigs. Box plots show the median and quartile ranges for the two groups (no decrease vs. decreased), with superimposed scatter plots showing individual differences. The gray dashed line marks the recommended threshold of "≥4 / 6", with most of the decreased group located above this line, suggesting its potential value as a trigger point for TP. Ultrasound findings showed that the pleural slippage sign disappeared in the affected lungs of all models. In the supine position, ≥4 pleural zones (anterior superior, anterior inferior, lateral superior, and lateral inferior) were observed on one side of the lung; real-time ultrasound showed the typical "lung point" sign at the junction of pneumothorax and normal areas. M-mode ultrasound showed the disappearance of the "coastline sign," replaced by the "barcode sign" or "stratospheric sign." In 8 experimental animals, the disappearance of the slippage sign first appeared in the anterior inferior zone, then extended to the upper pleural and lateral zones, suggesting gradual gas accumulation in the pleural cavity.

[0127] In some implementation schemes, such as Figure 6 As shown in the figure, the blue bars represent gas volume (mL / kg), and the yellow bars represent pleural pressure (IPP, mmHg), with standard deviation error bars attached. The results showed that the pleural pressure required for a ≥50% decrease in CO2 due to right-sided gas injection was significantly lower than that on the left (12.68 ± 1.60 vs. 16.27 ± 0.56 mmHg), and the corresponding gas volume was also significantly lower (10.08 ± 0.79 vs. 21.30 ± 1.19 mL / kg). Using a 10,000-bounce bootstrap method, the 95% confidence interval for the left-right IPP difference was 2.30–4.53 mmHg, and the gas volume difference was 10.15–12.52 mL / kg, indicating that the difference in side response was significant in physiological response.

[0128] In some implementation schemes, the required air volume for constructing a left-sided tension pneumothorax model is 80–1020 mL.

[0129] In some implementation schemes, the required air volume for constructing a right-sided tension pneumothorax model is 300–620 mL.

[0130] In some implementation schemes, such as Figure 7 As shown in Figure A, real-time ultrasound reveals the gradual disappearance of the pleural sliding sign (indicated by the thin arrow), followed by the appearance of the "lung point" sign (indicated by the thick arrow as the borderline between normal lung and pneumothorax), suggesting partial lung collapse and air accumulation within the pleural cavity. Figure B shows a typical "sand beach sign" observed on M-mode ultrasound of a normal pleura, with the pleura rising and falling with respiratory movements (indicated by the thin arrow). Figure C shows the disappearance of the "sand beach sign" on M-mode ultrasound of a pneumothorax, replaced by a "stratospheric sign," with the pleura not shifting with respiratory movements (indicated by the thick arrow), suggesting the formation of tension pneumothorax.

[0131] In some implementations, the construction system also includes an anesthesia unit for inducing anesthesia in non-human animals.

[0132] In some implementations, anesthetic drugs are administered intravenously to induce anesthesia in non-human animals.

[0133] In some implementations, the anesthetic drugs include, but are not limited to, sodium pentobarbital, midazolam, ketamine, propofol, sevoflurane, fentanyl, succinylcholine, rocuronium bromide, vecuronium bromide, and cisatracurium.

[0134] In some implementation schemes, the anesthetic drug is selected from sodium pentobarbital.

[0135] In some implementation methods, the dosage of sodium pentobarbital is 20-50 mg / kg.

[0136] In some implementation methods, the dosage of sodium pentobarbital is 30 mg / kg.

[0137] In some implementations, the anesthesia unit can also be used to maintain anesthesia and / or provide analgesia to non-human animals.

[0138] In some implementations, intravenous administration of anesthetic drugs maintains anesthesia in non-human animals.

[0139] In some implementations, a central venous catheter is inserted via the right internal jugular vein under ultrasound guidance, through which propofol and 5% glucose solution (1:1 ratio) are infused intravenously at a target rate of 0.05 mg / kg·min to maintain anesthesia in non-human animals.

[0140] In some implementations, the non-human animal is mechanically ventilated to replace the spontaneous breathing suppressed by anesthesia.

[0141] In some implementations, the mechanical ventilation parameters are set to a tidal volume of 6-15 mL / kg.

[0142] In some implementations, the mechanical ventilation parameters are set to a tidal volume of 8 mL / kg.

[0143] In some implementations, the mechanical ventilation parameters are set to PEEP 3–5 cmH2O.

[0144] In some implementations, the mechanical ventilation parameters are set to FiO2 0.4–0.5.

[0145] In some implementations, the parameters of the mechanical ventilation are set to a target EtCO2 of 35–45 mmHg.

[0146] In some implementations, the building system also includes a shaving unit for removing hair from the neck and / or the anterior chest and abdomen area.

[0147] In some implementations, the construction system further includes a positioning unit for locating the operating area.

[0148] In some implementations, the operating area includes the neck, the 5th-7th intercostal space along the anterior axillary line, the parietal pleura, and the pleural cavity.

[0149] In some implementations, the construction system also includes a disinfection unit for disinfecting the animal's operating area and / or the area surrounding the operating area.

[0150] In some embodiments, the non-human animal includes any non-human mammal, including but not limited to rodents (e.g., guinea pigs, hamsters, rats, mice), dogs (e.g., dogs), cats (e.g., cats), pigs (e.g., pigs), horses (e.g., horses), and non-human primates (e.g., monkeys, apes, baboons, gorillas, chimpanzees, orangutans). In a preferred embodiment, the non-human animal is selected from pigs.

[0151] In some implementations, the pigs include, but are not limited to, miniature Bama pigs, Vietnamese big-bellied pigs, Juliani pigs, Ossaba Island pigs, Wuzhishan miniature pigs, Tibetan pigs, and Yunnan small-eared pigs.

[0152] In one specific implementation, the pig is selected from miniature Bama pigs.

[0153] In some implementations, the construction system also includes a verification unit for verifying whether the non-human animal model has been successfully constructed.

[0154] In some implementations, the successful construction of the non-human animal model is verified by chest X-ray, CT imaging, and / or hemodynamic monitoring.

[0155] In some implementation schemes, to ensure safety and data consistency, chest X-rays and PiCCO scans are performed within 2–5 minutes after insufflation is stopped. Decompression and resuscitation are then performed, followed by short-term observation.

[0156] In some implementations, experimental animals were placed in a supine position for chest X-ray examination. A digital imaging system was used with parameters set to 60–70 kV, 5–10 mAs, and a fixed focal length of 1.2 m. A positive validation result was defined as significant ipsilateral lung collapse accompanied by contralateral mediastinal shift. Images were used only for validation / characterization and did not participate in TP trigger determination. All images were archived independently for subsequent analysis. Results are as follows... Figure 8As shown, all 12 pigs exhibited typical TP imaging findings: significant pleural cavity dilation, lung collapse on the affected side, and mediastinal (including trachea and cardiac silhouette) shift to the healthy side. Figure 8 Figure A shows the chest X-ray results of the animals in the left modeling group: significant air accumulation in the left pleural cavity (red dashed line area), loss of lung markings, compression and collapse of the left lung (indicated by the thin arrow), and displacement of the mediastinal structures (trachea and cardiac silhouette) to the right (indicated by the thick arrow), suggesting the formation of left-sided tension pneumothorax; Figure B shows the chest X-ray results of the animals in the right modeling group: significant air accumulation in the right pleural cavity (red dashed line area), significant inward collapse of the right lung (indicated by the thin arrow), and displacement of the mediastinum to the left (indicated by the thick arrow), consistent with the manifestations of right-sided tension pneumothorax. All of the above imaging features support the successful construction of the model.

[0157] In some implementations, hemodynamic monitoring may be performed using, but is not limited to, pulmonary artery catheters, PiCCO (Pulse index Continuous Cardiac Output) monitors, LiDCO, VolumeView / EV1000, FloTrac / Vigileo, and PRAM.

[0158] In some implementations, a PiCCO (Pulse index Continuous Cardiac Output) monitor is used for continuous hemodynamic monitoring.

[0159] In some implementations, the PiCCO monitor is purchased from Pulsion Medical Systems, Feldkirchen, Germany.

[0160] In some implementations, a thermodilution arterial catheter is inserted via puncture of one femoral artery under ultrasound guidance and connected to a PiCCO (Pulse index Continuous Cardiac Output) monitor for continuous hemodynamic monitoring, while simultaneously recording vital signs such as arterial blood pressure and heart rate.

[0161] In some implementation schemes, continuous vital sign monitoring of animals is conducted using the PiCCO system and multi-parameter physiological monitors. Evaluation indicators include: ① mean arterial pressure (MAP); ② heart rate (HR); ③ respiratory rate (RR); ④ arterial oxygen saturation (SpO2); ⑤ central venous pressure (CVP); ⑥ cardiac output index (CI); ⑦ systemic vascular resistance index (SVRI); ⑧ pulsatility variability (SVV); ⑨ global end-diastolic volume index (GEDI) and pulmonary extrapulmonary water index (ELWI). Data are uniformly entered in real-time using recording tables for easy subsequent statistical analysis.

[0162] In some implementations, the hemodynamic abnormalities in the non-human animal model of tension pneumothorax are significant, with marked changes in the animal's vital signs and PICCO hemodynamic parameters, as detailed in Table 1. The table shows that in TP state, mean arterial pressure (MAP), cardiac index (CI), oxygen saturation (SpO2), and global end-diastolic volume index (GEDI) are significantly decreased, while heart rate (HR), respiratory rate (RR), systemic vascular resistance index (SVRI), and pulsatility variability (SVV) are significantly increased (all P < 0.001).

[0163] Table 1. Comparison of vital signs and hemodynamic parameters of animals before and after tension pneumothorax induction.

[0164]

[0165] Note: Data are expressed as mean ± standard deviation (Mean ± SD). TP refers to the tension pneumothorax stage after induction. Differences are expressed as "TP". The "Baseline" is calculated; positive values ​​increase the value, and negative values ​​decrease it. P Values ​​come from pairing t The test (two-sided, α=0.05) and the Wilcoxon signed-rank test results were consistent (both...). P <0.001).

[0166] In some implementations, the present invention uses only the POCUS threshold as the triggering and judgment criterion for tension pneumothorax: if the lung slippage disappears and lung points are seen in ≥4 / 6 of the affected side, it is judged as TP.

[0167] In some implementation schemes, validation criteria are defined as follows: within the validation window following POCUS assessment, X-ray shows lung collapse and contralateral mediastinal shift, with significant decreases in PiCCO (PiCCO), CI (Cardiac Endpoint), MAP (Magnetic Mediastinal Scale), and SpO2 (SpO2). Cases not simultaneously meeting these criteria are still considered "POCUS-TP established, but validation not fully achieved." The confirmation rate (number of cases achieving the composite endpoint / number of cases triggering validation) is calculated for "POCUS-TP composite validation." A description of consistency with the POCUS assessment is also reported.

[0168] In some implementation plans, the occurrence of complications also needs to be observed. Predefined complications include: subcutaneous emphysema, catheter misplacement / dislodgement, intrapleural hemorrhage, significant arrhythmias requiring management, resuscitation failure, and death. Observation window: from modeling to 2 hours after resuscitation (at least 30 minutes if conditions are limited, and noted in the record).

[0169] In some implementations, SPSS 26.0 software was used for data analysis. Quantitative data were described as mean ± standard deviation (mean ± SD) or median [interquartiles]; normality was initially screened using the Shapiro-Wilk method. Hemodynamic parameters were compared using paired t-tests to compare the difference between baseline and the point at which POCUS determined TP (for non-normal data, the Wilcoxon signed-rank test was used), and p-values ​​were reported (two-sided, α = 0.05). Comparison of left and right side insufflation volumes was performed using independent samples t-tests (for non-normal data, the Mann-Whitney U method was used). Modeling time was presented as descriptive statistics (mean ± SD and range). Ultrasound and radiographic findings were described as number of cases / percentage (e.g., presence of lung spots, disappearance of ≥4 / 6 of the lung, mediastinal shift, etc.). Modeling success rate and complication rate were given as number of cases / percentage, with precise 95% confidence intervals (Clopper-Pearson). All tests were two-sided, with p < 0.05 considered statistically significant.

[0170] In some implementations, all non-human animal models of tension pneumothorax were successfully constructed. The modeling success rate was 100.0% (12 / 12; 95% CI 73.5%–100.0%); no complications were observed (0 / 12; bilateral 95% CI 0.0%–26.5%; unilateral 95% upper limit 22.1%). The composite validation endpoint (positive chest X-ray with hemodynamic changes) was achieved in 12 / 12 animals, with a confirmation rate of 100.0% (95% CI 73.5%–100.0%), highly consistent with the POCUS assessment. The modeling time from catheter placement to TP assessment was (4.5±0.3) min. The required inflation volume to achieve TP was higher on the left side than on the right side (range approximately 5–13 mL / kg on the right and 10–18 mL / kg on the left; mean absolute volume difference 403 mL, 95% CI 185–622 mL; P=0.004). POCUS showed disappearance of pleural slippage and presence of lung points (affecting ≥4 / 6 areas); X-ray showed ipsilateral lung collapse and contralateral mediastinal shift. Compared with baseline, MAP decreased from (110.0±5.0) mmHg to (80.0±6.0) mmHg, CI decreased from 4.2±0.3 to 1.5±0.4 L / min / m², and SpO2 decreased from (98.0±1.0)% to (68.0±2.0)% (all P<0.001); SVRI increased (P<0.001), and SVV increased from (12.5±1.8)% to (24.0±2.2)% (P<0.001).

[0171] Figure 9This is a schematic diagram of a device for constructing a non-human animal model of tension pneumothorax according to an embodiment of the present invention. The device includes: one or more processors, and a memory for storing one or more computer programs, which, when executed by the one or more processors, implement the following:

[0172] Operation 1: Fix the non-human animal;

[0173] Procedure 2: Insert the puncture needle into the parietal pleura, allow the guide wire to pass through the puncture needle cavity into the pleural cavity, and then withdraw the puncture needle;

[0174] Procedure 3: Insert the catheter along the guidewire to enter the pleural cavity, remove the guidewire, and fix the catheter.

[0175] Procedure 4: Unidirectional air injection into the pleural cavity via catheter;

[0176] Operation 5: Monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax. Stop inflating and obtain a non-human animal model of tension pneumothorax.

[0177] In some implementations, the constructing device may include, but is not limited to, one or more of the following: a shaving device, a disinfection device, an intercostal structure identification device, a vascular distribution assessment device, a puncture success determination device, a dilation device, a catheter fixation device, an air injection device, an airflow monitoring device, a pleural cavity pressure monitoring device, a pneumothorax range monitoring device, and a hemodynamic monitoring device.

[0178] In some implementations, after stabilizing the non-human animal, hair is shaved off the neck and the front of the chest and abdomen using a shaving tool.

[0179] In some implementations, the shaving component includes, but is not limited to, a razor or surgical scissors.

[0180] In some implementations, after shaving the hair, a disinfectant is used to disinfect the animal's operating area and / or the area surrounding the operating area.

[0181] In some implementations, intercostal structure identification devices and vascular distribution assessment devices are used to avoid vascular nerve bundles during puncture in order to determine the puncture point.

[0182] In some implementations, the intercostal structure identification device and the blood vessel distribution assessment device are selected from color Doppler ultrasound.

[0183] In some implementations, a puncture success determination element is used to determine whether the puncture needle has been successfully inserted.

[0184] In some implementations, after the puncture needle penetrates the parietal pleura, POCUS is used to confirm that the needle tip has accurately entered the pleural cavity.

[0185] In some implementation schemes, the puncture needle is inserted into the parietal pleura. When the needle tip breaks through the pleura, the needle is fixed and the needle core is removed. After confirming that there is no blood return, the success of the puncture is determined.

[0186] In some implementation methods, the method for determining whether the puncture was successful includes: removing the needle core and slowly injecting 5-10 mL of normal saline; if the POCUS shows that the injected fluid diffuses rapidly along the pleural cavity without forming a localized oval hypoechoic area, the puncture is considered successful.

[0187] In some implementations, before inserting the catheter along the guidewire, a dilator is used to gently open the channel by rotating it slightly along the guidewire before the catheter is slowly inserted along the guidewire.

[0188] In some implementations, POCUS is used continuously in real time during catheter insertion to monitor the position of the puncture needle tip, guidewire, and catheter tip, ensuring that they enter the pleural cavity rather than blood vessels or lung tissue.

[0189] In some implementations, catheter fixation devices are used to secure the catheter.

[0190] In some implementations, the catheter fixation element includes sutures.

[0191] In some implementations, an inflator is used to inject air unidirectionally into the pleural cavity via a catheter.

[0192] In some implementations, the gas injection device includes, but is not limited to, a syringe, an air compressor, a gas cylinder, a gas canister, and a peristaltic pump.

[0193] In some implementations, an airflow monitoring device is used to monitor the airflow rate of the injection device.

[0194] In some implementations, the airflow monitoring element may be a gas flow meter.

[0195] In some implementations, a pleural pressure monitoring device is used to monitor pleural pressure.

[0196] In some implementations, a pneumothorax extent monitoring device is used to monitor the extent of pneumothorax.

[0197] In some implementations, hemodynamic monitoring devices are used to monitor hemodynamics.

[0198] In some implementations, hemodynamic monitoring devices include, but are not limited to, pulmonary artery catheters, PiCCO (Pulseindex Continuous Cardiac Output) monitors, LiDCO, VolumeView / EV1000, FloTrac / Vigileo, and PRAM for monitoring hemodynamics.

[0199] In some implementations, the hemodynamic monitoring device is selected from a PiCCO (Pulse index Continuous Cardiac Output) monitor.

[0200] Those skilled in the art will readily understand that, for the sake of convenience and brevity, the specific working processes of the systems, devices, and units described above can be referred to the corresponding processes in the foregoing method embodiments, and will not be repeated here. In the several embodiments provided by this invention, it should be understood that the disclosed systems, devices, and methods can be implemented in other ways. For example, the device embodiments described above are merely illustrative; for instance, the division of units is only a logical functional division, and in actual implementation, there may be other division methods. For example, multiple units or components may be combined or integrated into another system, or some features may be ignored or not executed.

[0201] Furthermore, the functional units in the various embodiments of the present invention can be integrated into one processing unit, or each unit can exist physically separately, or two or more units can be integrated into one unit. The integrated units described above can be implemented in hardware or as software functional units. Those skilled in the art will understand that all or part of the steps in the various methods of the above embodiments can be implemented by a program instructing related hardware. This program can be stored in a computer-readable storage medium, which may include: read-only memory (ROM), random access memory (RAM), a magnetic disk, or an optical disk, etc.

[0202] The computer device provided by the present invention has been described in detail above. For those skilled in the art, there will be changes in the specific implementation and application scope based on the ideas of the embodiments of the present invention. Therefore, the content of this specification should not be construed as a limitation of the present invention.

[0203] The above description of the embodiments is only for understanding the method and core ideas of the present invention. It should be noted that those skilled in the art can make various improvements and modifications to the present invention without departing from the principles of the invention, and these improvements and modifications will also fall within the protection scope of the claims of the present invention.

Claims

1. A system for constructing a non-human animal model of tension pneumothorax, characterized in that, The construction system includes: Fixation unit: Used to fix non-human animals; First processing unit: used to puncture the puncture needle into the parietal pleura, the puncture point of the puncture needle is the 5th-7th intercostal space of the anterior axillary line, to allow the guide wire to enter the pleural cavity through the needle cavity of the puncture needle, and to withdraw the puncture needle; Second processing unit: used to insert the catheter along the guidewire, so that the catheter enters the pleural cavity, remove the guidewire, and fix the catheter; Third processing unit: used for unidirectional air injection into the pleural cavity via catheter; The fourth processing unit is used to monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax. Inflation is stopped, and a non-human animal model of tension pneumothorax is obtained.

2. The construction system according to claim 1, characterized in that, The first processing unit also includes a method for using ultrasound to clearly identify intercostal structures and / or assess vascular distribution in order to determine the puncture point.

3. The construction system according to claim 1, characterized in that, The first processing unit also includes a method for using ultrasound to confirm that the needle tip of the puncture needle has accurately entered the pleural cavity.

4. The construction system according to claim 1, characterized in that, The first processing unit also includes a method for confirming whether the puncture needle has been successfully inserted.

5. The construction system according to claim 1, characterized in that, The first processing unit also includes a tool for removing the needle core and injecting saline. If ultrasound shows that the injected fluid diffuses rapidly along the pleural cavity without forming a locally concentrated elliptical hypoechoic area, it indicates that the puncture was successful.

6. The construction system according to claim 1, characterized in that, The gas injection rate is 0.5-1.0 L / min.

7. The construction system according to claim 1, characterized in that, The fourth processing unit uses POCUS to monitor the extent of pneumothorax.

8. The construction system according to claim 1, characterized in that, When constructing a left-sided tension pneumothorax model, the required air volume for the left pleural cavity is 80–1020 mL.

9. The construction system according to claim 1, characterized in that, When constructing a right-sided tension pneumothorax model, the required air volume for the right pleural cavity is 300–620 mL.

10. The construction system according to claim 1, characterized in that, The constructed system also includes an anesthesia unit for inducing anesthesia in non-human animals.

11. The construction system according to claim 10, characterized in that, The anesthesia unit can also be used to maintain anesthesia in non-human animals and / or to provide analgesia to non-human animals.

12. The construction system according to any one of claims 1-11, characterized in that, The non-human animal in question is selected from pigs.

13. A device for constructing a non-human animal model of tension pneumothorax, characterized in that, The construction apparatus includes: one or more processors, and a memory for storing one or more computer programs, which, when executed by the one or more processors, implement: Operation 1: Fix the non-human animal; Procedure 2: Insert the puncture needle into the parietal pleura. The puncture point of the puncture needle is the 5th-7th intercostal space along the anterior axillary line. Allow the guide wire to pass through the needle cavity of the puncture needle into the pleural cavity, and then withdraw the puncture needle. Procedure 3: Insert the catheter along the guidewire to enter the pleural cavity, remove the guidewire, and fix the catheter. Procedure 4: Unidirectional air injection into the pleural cavity via catheter; Operation 5: Monitor the extent of pneumothorax. When lung slippage disappears in ≥4 / 6 of the chest on the inflated side and lung points are visible, it is determined to be tension pneumothorax. Stop inflating and obtain a non-human animal model of tension pneumothorax.

14. The construction apparatus according to claim 13, characterized in that, The constructing device further includes one or more of the following: a shaving component, a disinfection component, an intercostal structure identification component, a vascular distribution assessment component, a puncture success determination component, a dilation component, a catheter fixation component, an air injection component, an airflow monitoring component, a pleural cavity pressure monitoring component, a pneumothorax range monitoring component, and a hemodynamic monitoring component.

15. The construction apparatus according to claim 14, characterized in that, The shaving equipment includes a razor and surgical scissors.

16. The construction apparatus according to claim 14, characterized in that, The vascular distribution assessment component was selected from color Doppler ultrasound.

17. A method for screening drugs for the prevention and / or treatment of tension pneumothorax, characterized in that, The method includes: a) Applying the reagent to be screened to a non-human animal model of tension pneumothorax constructed by the construction system of any one of claims 1-12 or the construction device of any one of claims 13-16; b) Analyze and evaluate the therapeutic effects of the reagents to be screened, and select the reagents that can significantly improve tension pneumothorax.

18. A method for evaluating the efficacy of a drug for treating tension pneumothorax, characterized in that, The method includes: a) Applying the drug to a non-human animal model of tension pneumothorax constructed using the construction system of any one of claims 1-12 or the construction device of any one of claims 13-16; b) Evaluate the therapeutic effect of the drug on the tension pneumothorax.

Images