Microballoon device for modeling primary injury of cerebral hemorrhage in basal section and modeling method

Abstract

The invention relates to the technical field of basal node cerebral hemorrhage, and particularly discloses a microsphere device for basal node cerebral hemorrhage primary injury modeling and a modeling method. The micro-balloon device is composed of an expandable balloon, a catheter assembly, a liquid injection interlayer, a needle core, a connecting port, a hose and an injection port. The method comprises the steps that after the expandable balloon is placed in a basal joint area, normal saline is injected to enable the expandable balloon to expand rapidly, cortical spinal bundles are pressed in a targeted mode, and the acute mechanical primary injury of clinical cerebral hemorrhage is simulated. According to the micro-balloon device and the modeling method, the modeling process is rapid, parameters can be quantitatively controlled, the characteristics of pure injury mechanism, high modeling success rate and excellent repeatability are achieved, and a special tool is provided for cerebral hemorrhage primary injury mechanism research and drug screening.

Description

Technical Field

[0001] This invention relates to the field of basal ganglia brain hemorrhage modeling technology, specifically to a microballoon device and modeling method for modeling primary injury in basal ganglia brain hemorrhage. Background Technology

[0002] Current modeling of primary basal ganglia hemorrhage mainly relies on non-balloon modeling methods, with autologous blood injection being the core technical approach.

[0003] Autologous blood injection involves drawing autologous blood from an animal (such as tail vein blood in rats) and directly injecting it into the basal ganglia region to form a hematoma, using a microinjection pump. However, microinjection pumps have the following problems during use: the hematoma morphology is greatly affected by the injection speed and blood coagulation state (e.g., too fast an injection can easily cause blood to spill out, while too slow an injection can easily form a thrombus), and the modeling reproducibility is poor. Summary of the Invention

[0004] To develop a modeling device specifically for primary injury in basal ganglia hemorrhage, this invention provides a microballoon device and modeling method for modeling primary injury in basal ganglia hemorrhage. The microballoon device and modeling method provided by this invention offer a rapid modeling process with quantifiable parameter control, exhibiting characteristics of pure injury mechanism, high modeling success rate, and excellent reproducibility. This provides a dedicated tool for research on the primary injury mechanism of cerebral hemorrhage and drug screening.

[0005] This invention provides a microballoon device for modeling primary lesions caused by basal ganglia hemorrhage, comprising: The catheter assembly and the needle core are detachably inserted into the inner cavity of the catheter assembly; the catheter assembly includes an inner tube and an outer tube arranged coaxially, and an injection jacket is formed between the inner tube and the outer tube; An expandable balloon is fitted over the distal end of the catheter assembly; The fluid infusion passage connects the fluid infusion jacket to the internal space of the expandable balloon and is configured to deliver fluid from the proximal end of the catheter assembly to the expandable balloon for expansion, or to aspirate fluid from the expandable balloon for contraction. The expandable balloon fits tightly against the outer surface of the catheter assembly when in a contracted state, allowing the device to pass through brain tissue non-invasively when withdrawn. The device simulates primary mechanical injury caused by cerebral hemorrhage by generating mechanical pressure without leaving a foreign object in place.

[0006] The microballoon device provided by this invention has quantifiable controllable parameters and features a pure damage mechanism, high modeling success rate, and excellent repeatability, providing a dedicated tool for the study of the primary damage mechanism of cerebral hemorrhage and drug screening.

[0007] Furthermore, the injection passage includes a connector, a hose, and an injection port connected in sequence, with the connector communicating with the injection jacket.

[0008] Furthermore, the inner diameter of the hose is 0.2 mm to 0.3 mm.

[0009] Furthermore, the needle core fits tightly against the catheter assembly.

[0010] Furthermore, the volume of the expandable balloon in the expanded state is 90 μL to 110 μL.

[0011] Furthermore, the diameter of the expandable balloon in the expanded state is 5 mm to 6 mm.

[0012] Furthermore, the compressive pressure generated by the expandable balloon in its expanded state is 8 atm to 12 atm.

[0013] The present invention also provides a method for modeling primary basal ganglia hemorrhage using the microballoon device, comprising the following steps: The needle core is inserted into the catheter assembly, and the expandable balloon is placed in the target area of ​​the basal ganglia region of the brain through the catheter assembly. The air in the lumen is evacuated through the injection port, and then normal saline is injected. The expandable balloon is then injected through the tubing, connector, and injection splint, causing the expandable balloon to bulge out from the bottom of the catheter assembly and directly compress the corticospinal tract in the basal ganglia region. After compression, normal saline is aspirated using a microsyringe, causing the expandable balloon to contract and adhere tightly to the inner wall of the catheter assembly. The catheter assembly is then withdrawn, completing the modeling of the primary injury of the basal ganglia region brain hemorrhage.

[0014] Furthermore, the compression time is 8 min to 12 min.

[0015] Compared with the prior art, the beneficial effects of the present invention are as follows: The microballoon device provided by this invention, through precise structural design, ensures that the balloon's expanded size (5.76 mm in diameter) is adapted to the anatomical space of the rat basal ganglia, avoiding damage to unrelated brain regions. After stereotactic placement, the balloon can be expanded within 1 to 2 minutes by injecting saline, and stable primary injury can be formed within 10 minutes of compression, without waiting for the natural process. This perfectly matches the pathological timeline of "acute mechanical compression" in clinical cerebral hemorrhage. At the same time, the compression intensity (0.5 atm to 2 atm) can be precisely controlled by adjusting the injection volume, thereby improving the injury efficiency.

[0016] The modeling method provided by this invention requires no special equipment and can be completed using only a conventional stereotactic instrument and a precision syringe. Key parameters such as injection volume and compression time can be quantitatively controlled, and ordinary experimental personnel can master it after short-term training. Compared with the collagenase injection method, which requires precise control of enzyme concentration and incubation time, the promotion threshold is lower. The balloon can be reused by replacing the injection catheter, reducing the cost of a single experiment. It can be adapted to the anatomical characteristics of the basal ganglia of different species such as mice and rabbits, breaking the limitation of some existing methods that are only applicable to a single species. The balloon is made of medical-grade silicone rubber, with no exogenous enzymes, blood, or other foreign matter residues, which can reduce non-compression damage to brain tissue, reduce the probability of abnormal reactions in experimental animals, and improve the stability and repeatability of the modeling process. Attached Figure Description

[0017] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0018] Figure 1 This is a schematic diagram of the microsphere structure.

[0019] Explanation of reference numerals in the attached diagram: 1-Expandable balloon, 2-Catheter assembly, 201-Injection jacket, 3-Needle core, 4-Connecting port, 5-Tube, 6-Injection port. Detailed Implementation

[0020] The specific embodiments of the present invention are described in detail below, but it should be understood that the scope of protection of the present invention is not limited to the specific embodiments. 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. Unless otherwise specified, the experimental methods described in the embodiments of the present invention are conventional methods, and the materials and reagents used in the following embodiments are commercially available unless otherwise specified.

[0021] Example 1: A microballoon device and modeling method for modeling primary lesions caused by basal ganglia hemorrhage.

[0022] 1. Components of the microballoon device The expandable balloon 1 is made of medical-grade silicone rubber and is used to simulate primary injury. After expansion, its volume is 100 μL (5.76 mm in diameter).

[0023] The catheter assembly 2 is 8 cm long and made of medical-grade polyimide, with an internal infusion jacket 201. The expandable balloon 1 is connected to the infusion jacket 201. When it contracts, it fits tightly against the inner tube of the catheter assembly 2, so that it will not cause additional damage to brain tissue during puncture. When it expands, it bulges out from around the front end of the catheter assembly 2.

[0024] The needle core 3 is made of 304 stainless steel. The needle core 3 is inserted into the catheter assembly 2 (the diameter of the needle core 3 is the same as the inner diameter of the catheter 2, fitting tightly without the need for other fixation), which reduces damage to brain tissue during puncture and increases the rigidity of the catheter.

[0025] Connection port 4 is located on the outer tube of conduit 2 and is used to connect the injection jacket 201 and the hose 5.

[0026] Hose 5, made of PTFE, with an inner diameter of 0.25 mm, is used for conducting saline solution.

[0027] Injection port 6 allows for the precise control of balloon inflation volume by injecting physiological saline through a micro-syringe.

[0028] 2. Establish a primary injury model of basal ganglia brain hemorrhage. Ninety SD rats were selected for model construction. The rats' heads were fixed to a stereotactic apparatus, and the target coordinates of the basal ganglia region were determined based on imaging data. After ensuring the expandable balloon 1 was tightly attached to the inner cannula of the catheter assembly 2, the needle core 3 was inserted into the catheter assembly 2. One end of the tubing 5 was connected to the connector 4, and the other end to the injection port 6. Guided by the coordinates of the stereotactic apparatus, the catheter assembly 2 was placed inside the brain along a predetermined path until the expandable balloon 1 was located at the target position in the basal ganglia region. Using a microsyringe connected to the injection port 6, air was first aspirated from the lumen, and then 100 μL of physiological saline was injected. This saline was then injected into the expandable balloon 1 through the tubing 5, connector 4, and injection jacket 201, causing the expandable balloon 1 to bulge out from the front end of the catheter assembly 2. After expansion, the expandable balloon 1 directly compressed the corticospinal tract in the basal ganglia region at a pressure of 10 atm, achieving controlled local injury. After applying pressure for 10 minutes, use a microsyringe to aspirate saline solution, causing the expandable balloon 1 to contract tightly against the inner tube of the catheter assembly 2. Then, remove the catheter assembly 2 to complete the modeling of primary basal ganglia hemorrhage injury.

[0029] 3. Modeling success rate assessment The cylinder test was used to analyze limb asymmetry in rats after surgery, thereby assessing the success rate of establishing a primary injury model of basal ganglia hemorrhage. One day after modeling, rats were placed inside a transparent cylinder (15 cm high, 9 cm in diameter), and their activities were recorded using a camera for 10 minutes. The number of times the left forelimb, right forelimb, and both forelimbs simultaneously contacted the sidewall of the cylinder while the rat was upright was counted. The number of forelimb contacts on the same side as the primary injury of basal ganglia hemorrhage was recorded as A, the number of contacts on the opposite side of the primary injury of basal ganglia hemorrhage was recorded as B, and the number of contacts on both forelimbs simultaneously was recorded as C. The limb asymmetry index was calculated using the formula: (AB) / (A+B+C)×100%. The results showed that only one rat did not show obvious limb asymmetry due to balloon placement deviation. The remaining 89 rats were significantly dependent on the forelimb on the same side as the primary cerebral hemorrhage injury, resulting in a significant increase in the limb asymmetry index compared with normal rats (the limb asymmetry index of normal rats is close to 0). Therefore, the modeling success rate was 98.9% (89 / 90 rats).

[0030] Although preferred embodiments of the invention have been described, those skilled in the art, once they have learned the basic inventive concept, can make other changes and modifications to these embodiments.

[0031] Obviously, those skilled in the art can make various modifications and variations to this invention without departing from its spirit and scope. Therefore, if these modifications and variations fall within the scope of the claims of this invention and their equivalents, this invention also intends to include these modifications and variations.

Claims

1. A microballoon device for modeling primary lesions caused by basal ganglia hemorrhage, characterized in that, include: The catheter assembly (2) and the needle core (3) are detachably inserted into the inner cavity of the catheter assembly (2); the catheter assembly (2) includes an inner tube and an outer tube arranged coaxially, and an injection jacket (201) is formed between the inner tube and the outer tube. An expandable balloon (1) is fitted over the distal end of the catheter assembly (2); The fluid infusion passage connects the fluid infusion jacket (201) to the internal space of the expandable balloon (1) and is configured to deliver fluid from the proximal end of the catheter assembly (2) to the expandable balloon (1) to expand it, or to aspirate fluid from the expandable balloon (1) to contract it. The expandable balloon (1) fits tightly against the outer surface of the catheter assembly (2) in the contracted state, so that the device can pass through the brain tissue non-invasively when withdrawn. The device simulates primary mechanical injury caused by cerebral hemorrhage by generating mechanical pressure without leaving a foreign object in place.

2. The microsphere device according to claim 1, characterized in that, The injection passage includes a connector (4), a hose (5) and an injection port (6) connected in sequence, and the connector (4) is connected to the injection jacket (201).

3. The microballoon device according to claim 2, characterized in that, The inner diameter of the hose (5) is 0.2 mm to 0.3 mm.

4. The microballoon device according to claim 1, characterized in that, The needle core (3) is tightly fitted to the catheter assembly (2).

5. The microsphere device according to claim 1, characterized in that, The expandable balloon (1) has a volume of 90 μL to 110 μL in the expanded state.

6. The microsphere device according to claim 5, characterized in that, The expandable balloon (1) has a diameter of 5 mm to 6 mm in the expanded state.

7. The microsphere device according to claim 5, characterized in that, The expandable balloon (1) generates an external pressure of 8 atm to 12 atm when it is in the expanded state.

8. A method for modeling primary basal ganglia hemorrhage using the microballoon device of claim 1, characterized in that, Includes the following steps: Insert the needle core (3) into the catheter assembly (2), and place the expandable balloon (1) in the target area of ​​the basal ganglia region of the brain through the catheter assembly (2); aspirate the air in the lumen through the injection port (6), and then inject saline. Inject the expandable balloon (1) through the tubing (5), the connecting port (4) and the injection splint (201) so that the expandable balloon (1) bulges out from the bottom of the catheter assembly (2) and directly compresses the corticospinal tract of the basal ganglia region; after the compression is completed, use a micro-syringe to aspirate the saline so that the expandable balloon (1) contracts to fit tightly against the inner wall of the catheter assembly (2), and then remove the catheter assembly (2) to complete the modeling of the primary injury of the basal ganglia region brain hemorrhage.

9. The method according to claim 8, characterized in that, The compression time is 8 min to 12 min.

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