Medical double-core-layer pressure-resistant sensing balloon and preparation method thereof

Abstract

The invention discloses a medical double-core-layer pressure-resistant sensing balloon and a preparation method thereof.The medical double-core-layer pressure-resistant sensing balloon comprises a balloon body connected with a catheter, the balloon body is of a double-core-layer shell layer structure, and a core layer comprises a developing and pressure sensing double-core structure; a developing agent is loaded in the inner core layer balloon, the position of the balloon is effectively displayed, it can be guaranteed that the core layer is not affected after the outer layer is damaged, the inner layer and the other core layer balloon can synchronously conduct pressure sensing, and the shell layer is a compression layer with toughness and bursting pressure and can be coated with a medicine coating. According to the medical double-core-layer high-pressure-resistant balloon provided by the invention, through the design of the internal double core layers, accurate control of pressure is effectively realized, and the problem that a developing agent leaks out of the brain after the outer layer of the balloon is broken in a trigeminal nerve minimally invasive puncture balloon compression operation is prevented; and by controlling the surface roughness of the outer layer, medicine coating can be carried out, so that vagus nerve reflex is prevented, and the problem of high risks of sudden blood pressure rise and sudden heartbeat arrest caused by compression in the operation process is solved.

Description

Technical Field

[0001] The present invention relates to the technical field of material forming, and particularly relates to a medical double-core layer pressure-resistant and sensorable balloon and a preparation method thereof. Background Art

[0002] Trigeminal neuralgia is a common neurological disease with a large number of patients. Females are slightly more than males, and the incidence rate can increase with age, with a population prevalence of 0.3%. During an attack, the pain is in the head and face, starting and stopping suddenly, presenting excruciating pain such as knife-like, burning-like, and needle-like. It generally lasts for several seconds to several minutes and occurs irregularly, seriously affecting the quality of life of patients. The treatment of trigeminal neuralgia mainly includes drug treatment, microvascular decompression surgery, and balloon compression. In recent years, more and more patients who cannot tolerate drug treatment or have recurrence after microvascular decompression surgery are looking for a minimally invasive and effective method to treat the disease. Therefore, balloon compression for trigeminal neuralgia has been accepted by more patients and doctors. A disposable minimally invasive balloon catheter kit is one of the key links related to the success or failure of the surgical treatment of trigeminal neuralgia. The shape of the balloon and its susceptibility to breakage during balloon compression are the keys to the success of the surgery. The balloon compression time, the volume of the balloon, and the pressure inside the balloon during the operation are closely related to the postoperative efficacy and complications. If the balloon breaks during the operation and the contrast agent flows out, it will cause fluid retention in the brain and may lead to various adverse consequences. Therefore, extremely high requirements are imposed on the balloon for balloon compression.

[0003] The invention patent with application number CN116849776A provides a medical device and a puncture device that are convenient for exhaust. The technical problem to be solved is to discharge gas from the catheter and the balloon, with a fast and good air discharge speed, thereby improving the treatment effect. Compared with the prior art, this invention adopts a double-layer balloon technology. A developing metal part that can deform following the balloon is arranged between the first-layer balloon body and the second-layer balloon body, or it can be a developing coating and is coated on the outer surface of the first-layer balloon body or the inner surface of the second-layer balloon body. It can also be a gas or liquid developing material. During the treatment process, no contrast agent is injected, and the developing layer can independently display the expanded shape under X-ray. The two-layer balloon bodies protect each other and play a protective role for the developing layer. This technical solution is significantly different from the present invention. Although adding a developing layer can independently display the expanded shape and save treatment steps, the pressure during balloon compression in percutaneous trigeminal ganglion microballoon compression is a key factor that will affect the "pear-shaped" state of the balloon and the judgment of the subsequent compression time. In addition, the drug coating layer design on the sphere surface can be coated with an atropine coating for anti-vagal reflex to avoid the risk of sudden increase in patient blood pressure and cardiac arrest caused by pressure. Summary of the Invention

[0004] In view of the deficiencies in the prior art, the object of the present invention is to provide a preparation method of a medical double-core layer pressure-resistant and sensorable balloon, which overcomes the easy breakage of a single-layer balloon and the pressure caused by the expansion and extrusion of the monitoring imaging layer due to the injection of a contrast agent during percutaneous trigeminal ganglion microballoon compression. The prepared balloon can ensure that the inner layer is not affected after the outer layer is damaged. The two inner layers of the balloon can effectively cope with the corrosion of the contrast agent and real-time monitor the pressure value when the balloon is compressed. In addition, the surface of the outer sphere has nano-level concave layers for coating drugs. To achieve the above object and other advantages of the present invention, a medical double-core layer pressure-resistant and sensorable balloon is provided, including: The balloon includes an outer balloon layer and a plurality of inner layer structures arranged inside the outer balloon layer, and the plurality of inner layer structures include an imaging layer and a sensing layer; A plurality of concave layers are provided on the surface of the outer balloon layer; A micro pressure sensor is attached to the sensing layer; The sensing layer is located between the outer balloon layer and the imaging layer. When the inside of the balloon is filled and the inner layer structure expands, the imaging layer and the sensing layer come into contact, causing a pressure change in the sensing layer by the imaging layer. The piezoelectric material in the micro pressure sensor on the sensing layer generates a voltage change, and the voltage change is detected by the micro pressure sensor and converted into an electrical signal; One end of the outer balloon layer is provided with a plurality of ports, and the plurality of ports include a first connection port and a second connection port. The first connection port is communicated with the sensing layer, and the second connection port is communicated with the imaging layer. Through the setting of the plurality of ports of the outer balloon layer, the respective operations between the sensing layer and the imaging layer are not affected, and it is ensured that the contrast liquid in the imaging layer will not leak onto the sensing layer to contaminate the sensing layer and also avoid affecting the operation of the micro pressure sensor. Moreover, the balloon will be in an expanded state during operation, and the balloon will present a pear-shaped structure after expansion. Through the plurality of ports on the outer balloon layer, it is more conducive to the formation of the pear-shaped structure after the balloon expands.

[0005] A preparation method of a medical double-core layer pressure-resistant and sensorable balloon includes the following steps: S1. Prepare the outer balloon layer with a blend material, and the outer balloon layer is a pressure-resistant layer for coating drugs; S2. Prepare the imaging layer and the sensing layer; S3. Form a double-core layer and three-chamber structure by a material forming process with the outer balloon layer, the imaging layer and the sensing layer; S4. Perform heating and expansion treatment on the double-core layer and three-chamber structure, and then stretch and shape the double-core layer and three-chamber structure; S5. Perform corrosion spraying treatment on the surface of the outer balloon layer to achieve surface concave layers; S6. Place a micro pressure sensor on the sensing layer through a catheter.

[0006] Preferably, the materials of the outer balloon layer and the multiple inner balloon layers in step S1 are any one or a combination of several materials among nylon, thermoplastic polyurethane, polyether block amide, polyester elastomer, latex Pebax, polyethylene terephthalate, polyethylene, polypropylene, polyamide, polyvinyl chloride or silicone material.

[0007] Preferably, the surface of the outer balloon layer is subjected to roughness treatment so that the surface of the outer balloon layer has multiple nano-level concave layers.

[0008] Preferably, the micro pressure sensor in the sensing layer in step S6 is used to monitor the pressure of the developing layer expanded and extruded by injecting the developer.

[0009] Preferably, step S5 specifically includes the following steps: S51. Perform surface acetone cleaning treatment on the material of the outer balloon layer for 20 - 60 min; S52. After cleaning, use an oxidation system atomizing spraying device to uniformly spray on the surface of the outer balloon layer. The number of nozzles can be at least one, and the nozzles can move along the mandrel or be fixed on the mandrel. The spraying time is 1 - 10 min; S53. Commonly used oxidation systems include: any one of chloric acid, sulfuric acid, permanganic acid, tetrachloroethane, nitric acid; S54. After the spraying treatment, the surface of the outer balloon layer is cleaned successively with water, ethanol, and acetone.

[0010] Preferably, the thickness of the outer balloon layer is 0.5 - 1.5 mm, the diameter is 7.5 - 8.5 mm, and the hardness is 91 - 130 D.

[0011] Preferably, the thickness of the developing layer is 0.1 - 1 mm, the diameter is 6.5 - 7.5 mm, and the hardness is 40 - 90 D.

[0012] Preferably, the thickness of the sensing layer is 0.1 - 0.5 mm, the diameter is 4 - 5 mm, and the hardness is 30 - 60 D.

[0013] Compared with the prior art, the beneficial effects of the present invention are as follows: The provided medical double-layer triple-chamber high-pressure-resistant balloon is made of a double-layer composite material, effectively increasing the balloon burst pressure while enabling the balloon itself to have a certain flexibility. When used as a trigeminal ganglion balloon, it can effectively cope with the corrosive effect of the contrast agent and monitor the pressure value of the balloon under compression in real time. The double-layer triple-chamber balloon has patient tolerance, is convenient for doctors to use, has high burst pressure resistance, adjustable size and inner diameter, good balloon compliance, and a special imaging mark and sensing device are designed at the balloon head end, and it also has excellent biocompatibility. In particular, the micro-pressure sensor in the sensing layer can monitor the pressure of the imaging layer expanded and extruded by injecting the contrast agent, optimizing the clinical operation. At the same time, for the optimized double-layer triple-chamber balloon, even if the outer layer or the inner layer ruptures after the imaging layer is loaded with the contrast agent, the overall rupture of the balloon can still be effectively avoided, making it not easy to leak into the cerebrospinal fluid. By controlling the surface roughness of the outer layer, drug coating is carried out to achieve anti-vagal reflex, preventing the problem of high risk of sudden increase in blood pressure and cardiac arrest caused by compression during the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Figure 1 FIG. is a schematic structural diagram of the modified balloon after assembly in the preparation method of the medical double-core layer high-pressure-resistant and sensorable balloon according to the present invention; Figure 2 FIG. is a schematic structural diagram of the modified balloon in the preparation method of the medical double-core layer high-pressure-resistant and sensorable balloon according to the present invention; Figure 3 FIG. is a schematic structural diagram of the balloon during inflation in the preparation method of the medical double-core layer high-pressure-resistant and sensorable balloon according to the present invention; Figure 4 FIG. is a schematic diagram of the concave layer on the balloon surface in the preparation method of the medical double-core layer high-pressure-resistant and sensorable balloon according to the present invention; DETAILED DESCRIPTION OF THE INVENTION

[0015] The technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present invention. Obviously, the described embodiments are only a part of the embodiments of the present invention, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments of the present invention without creative efforts shall fall within the protection scope of the present invention.

[0016] The present invention provides a preparation method of a medical double-core layer high-pressure-resistant and sensorable balloon, and the steps are as follows: (1) Blending 1 wt% - 5 wt% of nylon 6 and polyurethane by an injection molding process to produce a thermoplastic polyurethane elastomer rubber (TPU) / nylon 6 blend as the outer layer material; (2) Clean the original jute fibers and cut them into lengths of approximately 3 mm, followed by air drying and oven drying (at 105 °C for 5 h); (3) Immerse the jute fibers from step (2) in a 0.06 M sodium periodate solution at a fiber-to-liquid ratio of 1:16; (4) Conduct the oxidation reaction of the solution from step (3) at 70 °C for 5 h, then cool and separate the oxidized jute fibers; (5) Thoroughly wash the oxidized jute fibers from step (4) with tap water and then with distilled water; (6) Air-dry the oxidized fibers from step (5) outdoors and then dry them in an oven at 105 °C for 6 h; (7) Thoroughly mix the oxidized and dried jute fibers from step (6) (20 - 35 wt%) with polypropylene granules as the developing layer material; (8) Prepare a solution with a molar ratio of triol / diol of (1:0 to 1:6); (9) Premix the solution obtained in step (8) using a hand-held stirrer at a speed of 1000 - 1500 RPM for 200 - 400 seconds to obtain a mixture called Component A; (10) Add a predetermined amount (150 - 195 g) of Component B, diphenylmethane diisocyanate (MDI), to the mixture from step (9) and stir at 1000 - 1500 RPM for 12 - 18 seconds. Then, immediately transfer the A - B mixture to a closed mold coated with a release agent; (11) Pour the mixture obtained in step (10) into a mold with dimensions of 38.1 × 38.1 × 6.5 cm 3 Set the temperature to 65 - 80 °C. Conduct foaming, forming, and curing in the mold for 8 - 10 minutes, then post-cure in a ventilation oven at 65 - 80 °C for 2 hours; (12) Demold the polyurethane foam (PUF) obtained in step (11) and condition it at room temperature for 24 - 48 hours; (13) Appropriately fill the PUF obtained in step (12) into a mold pre-coated with a release agent and conduct hot pressing. Set the temperature of the hot press to 100 - 150 °C and gradually increase the compression pressure to a constant pressure of 15 MPa within 10 minutes; (14) After hot pressing the sample obtained in step (13) under a constant pressure for 20 - 30 minutes, transfer the mold and the sample together to a cold press and repress at a pressure of 1 MPa at room temperature for 10 - 15 minutes; (15) Cut and punch the polyurethane sheet (PUS) obtained in step (14) to obtain the sensing layer material; (16) Ensure that the extrusion temperature is 135 ± 5 °C for the outer layer in step (1), the developer layer material in step (7), and the sensing layer material in step (13). Set the extrusion speed to 3 - 15 Hz. Using the double-layer co-extrusion method, simultaneously extrude the inner layer, the developer layer, and the sensing layer to form a three-chamber structure; (17) Seal and inflate the extrusion tube in step (16). Seal one end and fill high-pressure gas into the other end; (18) Heat and expand the extrusion tube in step (17). Heat the extrusion tube at 65 - 150 °C and control the internal gas pressure at 15 - 75 psi to soften and expand the extrusion tube; (19) Stretch and shape the extrusion tube in step (18). Stretch both ends of the double-layer extrusion tube at a speed of 0.3 - 45 cm / s, maintain the pressure and temperature for 15 - 60 s. After cooling the extrusion tube, dry and shape it at 40 - 50 °C for 30 - 60 min; (20) Clean the outer layer material of the balloon in step (19) with acetone on the surface for 20 - 60 min; (21) Uniformly spray corrosive acid on the surface of the balloon with the cleaned outer layer of the balloon in step (20) using an atomizing spray device. The number of nozzles can be one or more. The nozzles can move along the mandrel or be fixed on the mandrel. The spraying time is 1 - 10 min; (22) Wash the surface of the balloon treated by spraying in step (21) with water, ethanol, and acetone in sequence to obtain a medical double-core layer pressure-resistant and pressure-sensing balloon with a rough and sunken outer surface; its specific structure is as Figure 4 shown, and the roughness of the rough and sunken upper surface on the outer layer of the balloon can be controlled for drug coating to achieve anti-vagal reflex and prevent the problem of high risk of sudden increase in blood pressure and cardiac arrest caused by compression during the operation; (23) Place a sensor in the sensing layer of the double-core layer three-chamber structure balloon obtained in step (22) through a catheter; (24) The sensor in step (23) usually includes piezoelectric materials or other types of pressure sensing components. These materials can convert pressure changes into electrical signals. When the inner balloon expands, the pressure change causes a voltage change in the piezoelectric material, and this change can be detected by the sensor and converted into an electrical signal; (25) The sensor in step (24) detects the pressure change and converts it into an electrical signal. This signal is transmitted to an external reading device through a wireless connection method, such as radio frequency identification, Bluetooth, Wi-Fi, etc.; After the external device receives the electrical signal transmitted from the sensor in step (25), it processes and analyzes the signal and converts it into a pressure reading that can be understood by the user. This data can be used to monitor and regulate the inflation state of the balloon to ensure its operation within a safe and predetermined pressure range.

[0017] As Figure 1-2 shown, it is the structure after the equipment of the present application, and the balloon includes an outer balloon layer and a plurality of inner layer structures arranged inside the outer balloon layer. The plurality of inner layer structures include a developing layer and a sensing layer; A plurality of concave layers are provided on the surface of the outer balloon layer; A micro pressure sensor is attached to the sensing layer; One end of the outer balloon layer is provided with a plurality of ports. The plurality of ports include a first connection port and a second connection port. The first connection port is communicated with the sensing layer, and the second connection port is communicated with the developing layer; The sensing layer is located between the outer balloon layer and the developing layer. When the inner layer structure expands during filling the inside of the balloon, the developing layer contacts the sensing layer, causing a pressure change on the sensing layer. The piezoelectric material in the micro pressure sensor on the sensing layer generates a voltage change, and the voltage change is detected by the micro pressure sensor and converted into an electrical signal.

[0018] As Figure 3 shown, by providing a plurality of ports at one end of the outer balloon layer, the structure after the balloon expands better forms a pear-shaped structure. Example 1

[0019] A preparation method of a medical double-core layer pressure-resistant and sensorable balloon includes the following steps: (1) Blend 3 wt% of nylon 6 and polyurethane by an injection molding process to produce a thermoplastic polyurethane elastomer rubber (TPU) / nylon 6 blend as the outer layer material; (2) Clean the raw jute fibers and cut them into a length of about 3 mm, and air-dry and bake them (at 105 °C for 5 h); (3) Immerse the jute fibers in step (2) in a 0.06 M sodium periodate solution at a fiber-to-liquid ratio of 1:16; (4) Keep the solution oxidation reaction in step (3) at 70 °C for 5 h, then cool and separate the oxidized jute fibers; (5) Thoroughly wash the oxidized jute fibers in step (4) with tap water and then with distilled water; (6) Air-dry the oxidized fibers in step (5) outdoors and then dry them in an oven at 105 °C for 6 h; (7) Thoroughly mix the oxidized and dried jute fibers (30 wt%) from step (6) with polypropylene (PP) granules as the developing layer material; (8) Prepare a solution with a molar ratio of triol / diol of 1:2.

[0020] (9) Pre-mix the solution obtained in step (8) using a hand-held stirrer at a speed of 1200 RPM for 300 seconds to obtain a mixture called Component A; (10) Add a predetermined amount (180 g) of Component B, diphenylmethane diisocyanate (MDI), to step (9) and stir at 1200 RPM for 16 seconds. Then, immediately transfer the A-B mixture to a closed mold coated with a release agent; (11) Pour the mixture obtained in step (10) into a mold with dimensions of 38.1 × 38.1 × 6.5 cm 3 Set the temperature to 80°C. Foam, mold, and cure in the mold for 10 minutes, and then post-cure in a ventilation oven at 65°C for 2 hours; (12) Demold the polyurethane foam (PUF) obtained in step (11) and condition it at room temperature for 24 hours; (13) Appropriately fill the PUF obtained in step (12) into a mold pre-coated with a release agent and perform hot pressing. Set the temperature of the hot press to 120°C, and gradually increase the compression pressure to a constant pressure of 15 MPa within 10 minutes; (14) After hot pressing the sample obtained in step (13) under a constant pressure for 20 minutes, transfer the mold and the sample to a cold press and re-press at a pressure of 1 MPa at room temperature for 15 minutes; (15) Cut and punch the polyurethane sheet (PUS) obtained in step (14) as the sensing layer material (16) For the outer layer in step (1), the developing layer material in step (7), and the sensing layer material in step (13), ensure that the extrusion temperature is 135 degrees Celsius, set the extrusion speed to 10 Hz, and use a double-layer co-extrusion method to simultaneously extrude the inner layer, developing layer, and sensing layer to form a three-chamber structure; (17) Seal and inflate the extrusion tube in step (16), seal one end, and fill high-pressure gas into the other end; (18) Heat and expand the extrusion tube in step (17), heat the extrusion tube at 120 degrees Celsius, and control the internal gas pressure at 60 psi to soften and expand the extrusion tube; (19) Stretch and shape the extrusion tube in step (18). Stretch both ends of the double-layer extrusion tube at a speed of 30 cm / s, maintain the pressure and temperature for 60 s. After cooling the extrusion tube, dry and shape it at 50 °C for 60 min to obtain a medical double-core layer pressure-resistant and sensorable balloon, where the outer layer has a thickness of 1.2 mm, a diameter of 7.6 mm, and a hardness of 98 D; the imaging layer has a thickness of 0.3 mm, a diameter of 6.5 mm, and a hardness of 40 D; the sensing layer has a thickness of 0.3 mm, a diameter of 4.2 mm, and a hardness of 42 D. (20) Clean the surface of the balloon outer layer material in step (19) with acetone for 20 min. (21) Uniformly spray corrosive acid on the surface of the balloon outer layer cleaned in step (20) using an atomizing spray device. The number of nozzles can be one or more, and the nozzles can move along the mandrel or be fixed on the mandrel. The spraying time is 3 min. (22) Wash the surface of the balloon processed by spraying in step (21) with water, ethanol, and acetone in sequence to obtain a medical double-core layer pressure-resistant and sensorable balloon with a rough and sunken outer layer surface. (23) Place a sensor in the sensing layer of the double-core layer three-chamber structure balloon obtained in step (22) through a catheter. (24) The sensor in step (23) usually includes piezoelectric materials or other types of pressure sensing components, and these materials can convert pressure changes into electrical signals. When the inner balloon expands, the pressure change causes a voltage change in the piezoelectric material, and this change can be detected by the sensor and converted into an electrical signal. (25) The sensor in step (24) detects the pressure change and converts it into an electrical signal, which is transmitted to an external reading device through a radio frequency identification connection method. (26) After the external device receives the electrical signal transmitted from the sensor in step (25), it processes and analyzes the signal, and converts it into a pressure reading that can be understood by the user. These data can be used to monitor and regulate the inflation state of the balloon to ensure its operation within a safe and predetermined pressure range. Example 2

[0021] (1) Blend 2 wt% of nylon 6 and polyurethane through an injection molding process to produce a thermoplastic polyurethane elastomer rubber (TPU) / nylon 6 blend as the outer layer material. (2) Clean the raw jute fibers, cut them into a length of about 3 mm, and air-dry and bake them (at 105 °C for 5 h). (3) Immerse the jute fibers in step (2) in a 0.06 M sodium periodate solution at a fiber-to-liquid ratio of 1:16. (4) Oxidize the solution from step (3) at 70 °C for 5 hours, then cool and separate the oxidized jute fibers; (5) Thoroughly wash the oxidized jute fibers from step (4) with tap water and then with distilled water; (6) Air-dry the oxidized fibers from step (5) and then dry them in an oven at 105 °C for 6 h; (7) Thoroughly mix the oxidized and dried jute fibers (35 wt%) from step (6) with polypropylene (PP) granules as the imaging layer material; (8) Prepare a solution with a molar ratio of triol / diol (HEDS) of 1:4; (9) Premix the solution obtained in step (8) with a handheld stirrer at a speed of 1500 RPM for 200 seconds to obtain a mixture called Component A; (10) Add a predetermined amount (150 g) of Component B, diphenylmethane diisocyanate (MDI), to the mixture from step (9) and stir at 1000 RPM for 18 seconds. Then, immediately transfer the A-B mixture to a closed mold coated with a release agent; (11) Pour the mixture obtained in step (10) into a mold with dimensions of 38.1 × 38.1 × 6.5 cm 3 Set the temperature at 80 °C. Foam, mold, and cure in the mold for 8 minutes, then post-cure in a ventilated oven at 80 °C for 2 hours; (12) Demold the polyurethane foam (PUF) obtained in step (11) and condition it at room temperature for 48 hours; (13) Appropriately fill the PUF obtained in step (12) into a mold pre-coated with a release agent and perform hot pressing. Set the temperature of the hot press at 100 °C and gradually increase the compression pressure to a constant pressure of 15 MPa within 10 minutes; (14) After hot pressing the sample obtained in step (13) under a constant pressure for 20 minutes, transfer the mold and the sample together to a cold press and repress at a pressure of 1 MPa at room temperature for 15 minutes; (15) Cut and punch the polyurethane sheet (PUS) obtained in step (14) as the sensing layer material; (16) For the outer layer from step (1), the imaging layer material from step (7), and the sensing layer material from step (13), ensure an extrusion temperature of 130 °C, set the extrusion speed at 15 Hz, and use a double-layer co-extrusion method to simultaneously extrude the inner layer, imaging layer, and sensing layer to form a three-chamber structure; (17) Seal and inflate the extruded tube from step (16), seal one end, and fill high-pressure gas into the other end; (18) Heat and expand the extruded tube in step (17). The extruded tube is heated at 150 °C, and the internal gas pressure is controlled at 70 psi to soften and expand the extruded tube. (19) Stretch and shape the extruded tube in step (18). Stretch both ends of the double-layer extruded tube at a speed of 5 cm / s, maintain the pressure and temperature for 60 s. After cooling the extruded tube, dry and shape it at 45 °C for 60 min to obtain a medical double-core layer pressure-resistant and sensorable balloon. Among them, the outer layer has a thickness of 1.2 mm, a diameter of 8.0 mm, and a hardness of 118 D; the imaging layer has a thickness of 0.6 mm, a diameter of 6.8 mm, and a hardness of 60 D; the sensing layer has a thickness of 0.6 mm, a diameter of 4.6 mm, and a hardness of 68 D. (20) Perform surface acetone cleaning treatment on the outer layer material of the balloon in step (19) for 30 min. (21) Uniformly spray corrosive acid on the surface of the balloon with the cleaned outer layer of the balloon in step (20) using an atomizing spray device. The number of nozzles can be one or more, and the nozzles can move along the mandrel or be fixed on the mandrel. The spraying time is 5 min. (22) Clean the surface of the balloon treated by spraying in step (21) with water, ethanol, and acetone in sequence to obtain a medical double-core layer pressure-resistant and sensorable balloon with a rough and sunken outer layer surface. (23) Place a sensor in the sensing layer of the balloon with a double-core layer and three-chamber structure obtained in step (22) through a catheter. (24) The sensor in step (23) usually includes piezoelectric materials or other types of pressure sensing components, which can convert pressure changes into electrical signals. When the inner balloon expands, the pressure change causes a voltage change in the piezoelectric material, and this change can be detected by the sensor and converted into an electrical signal. (25) The sensor in step (24) detects the pressure change and converts it into an electrical signal. This signal is transmitted to an external reading device through a Bluetooth wireless connection method. (26) After the external device receives the electrical signal transmitted from the sensor in step (25), it processes and analyzes the signal, and converts it into a pressure reading that can be understood by the user. These data can be used to monitor and regulate the inflation state of the balloon to ensure its operation within a safe and predetermined pressure range. Example 3

[0022] (1) Blend 4 wt% of nylon 6 with polyurethane through an injection molding process to produce a thermoplastic polyurethane elastomer rubber (TPU) / nylon 6 blend as the outer layer material. (2) Clean the raw jute fibers and cut them into lengths of about 3 mm, and air dry and bake them (at 105 °C for 5 h). (3) Immerse the jute fibers from step (2) in a 0.06 M sodium periodate solution at a fiber-to-liquid ratio of 1:16; (4) Carry out the oxidation reaction of the solution from step (3) at 70 °C for 5 h, then cool and separate the oxidized jute fibers; (5) Thoroughly wash the oxidized jute fibers from step (4) with tap water and then with distilled water; (6) Air-dry the oxidized fibers from step (5) and then dry them in an oven at 105 °C for 6 h; (7) Thoroughly mix the oxidized and dried jute fibers (25 wt%) from step (6) with polypropylene (PP) pellets as the developing layer material; (8) Prepare a solution with a molar ratio of triol / diol (HEDS) of 1:6.

[0023] (9) Premix the solution obtained in step (8) using a hand-held stirrer at a speed of 1000 RPM for 400 s to obtain a mixture called Component A.

[0024] (10) Add a predetermined amount (195 g) of Component B, diphenylmethane diisocyanate (MDI), to the mixture from step (9) and stir at 1500 RPM for 12 s. Then, immediately transfer the A-B mixture to a closed mold coated with a release agent.

[0025] (11) Pour the mixture obtained in step (10) into a mold with dimensions of 38.1 × 38.1 × 6.5 cm 3 Set the temperature to 65 °C. Carry out foaming, shaping, and curing in the mold for 10 minutes, then post-cure in a ventilated oven at 65 °C for 2 hours.

[0026] (12) Demold the polyurethane foam (PUF) obtained in step (11) and condition it at room temperature for 32 hours.

[0027] (13) Appropriately fill the PUF obtained in step (12) into a mold pre-coated with a release agent and carry out hot pressing. Set the temperature of the hot press to 120 °C and gradually increase the compression pressure to a constant pressure of 15 MPa within 10 minutes.

[0028] (14) After hot pressing the sample obtained in step (13) under a constant pressure for 28 minutes, transfer the mold and the sample to a cold press and repress at a pressure of 1 MPa at room temperature for 12 minutes.

[0029] (15) Cut and punch the polyurethane sheet (PUS) obtained in step (14) as the sensing layer material (16) Ensure that the extrusion temperature is 140 °C, set the extrusion speed to 12 Hz, and use the double-layer co-extrusion method to simultaneously extrude the inner layer, the imaging layer material from step (7), and the sensing layer material from step (13) to form a three-chamber structure; (17) Seal and inflate the extrusion tube from step (16), seal one end, and fill high-pressure gas into the other end; (18) Heat and expand the extrusion tube from step (17). Heat the extrusion tube at 80 °C and control the internal gas pressure at 60 psi to soften and expand the extrusion tube; (19) Stretch and shape the extrusion tube from step (18). Stretch both ends of the double-layer extrusion tube at a speed of 12 cm / s, maintain the pressure and temperature for 60 s, cool the extrusion tube, and then dry and shape it at 45 °C for 60 min to obtain a medical double-core layer pressure-resistant and pressure-sensing balloon. The outer layer has a thickness of 1.0 mm, a diameter of 7.2 mm, and a hardness of 94 D; the imaging layer has a thickness of 0.4 mm, a diameter of 6.5 mm, and a hardness of 42 D; the sensing layer has a thickness of 0.3 mm, a diameter of 4.2 mm, and a hardness of 38 D.

[0030] (20) Clean the outer layer material of the balloon from step (19) with acetone on the surface for 60 min; (21) Use an atomizing spray device to evenly spray corrosive acid on the surface of the balloon of the cleaned outer layer from step (20). The number of nozzles can be one or more. The nozzles can move along the mandrel or be fixed on the mandrel, and the spraying time is 10 min; (22) Wash the surface of the balloon from step (21) with water, ethanol, and acetone in sequence to obtain a medical double-core layer pressure-resistant and pressure-sensing balloon with a rough and sunken outer layer surface.

[0031] (23) Place a sensor in the sensing layer of the double-core layer three-chamber structure balloon obtained from step (22) through a catheter; (24) The sensor in step (23) usually includes piezoelectric materials or other types of pressure sensing components. These materials can convert pressure changes into electrical signals. When the inner balloon expands, the pressure change causes a voltage change in the piezoelectric material, and this change can be detected by the sensor and converted into an electrical signal; (25) The sensor in step (24) detects the pressure change and converts it into an electrical signal. This signal is transmitted to an external reading device through Wi-Fi wireless connection; After the external device receives the electrical signal transmitted from the sensor in step (25), it processes and analyzes the signal and converts it into a pressure reading that can be understood by the user. These data can be used to monitor and regulate the inflation state of the balloon to ensure its operation within a safe and predetermined pressure range.

[0032] The specific experimental data are shown in Table 1 below: Table 1 Comparison of Compressive Performance Tests Product Name Material Nominal pressure Rated Burst Pressure (RBP) (Commercial) Across HP PA 12 11 bar 22 bar <![CDATA[(Commercial) NC Euphora TM > Nylon 12 atm 20 atm Example 1 Outer layer: 3wt% Nylon 6 and polyurethane Inner layer: Oxidized and dried jute fiber (30wt%) and polypropylene 16 atm 30 atm Example 2 Outer layer: 2wt% Nylon 6 and polyurethane Inner layer: Oxidized and dried jute fiber (35wt%) and polypropylene 14 atm 24 atm Example 3 Outer layer: 4 wt% Nylon 6 and polyurethane Inner layer: Oxidized and dried jute fiber (25wt%) and polypropylene 14 atm 26 atm The modified balloon prepared by the preparation method of the medical double-core layer pressure-resistant and sensorable balloon of the present application has a double-layer structure of an outer layer and an inner layer, and through holes are respectively opened at both ends of the double-layer structure for connecting a guiding tube. The modified balloon with the double-layer structure has patient tolerance, convenient use for doctors, burst pressure resistance, adjustable size and inner diameter, good compliance of the modified balloon, a special imaging mark designed at the head end of the modified balloon, and excellent biocompatibility at the same time. Moreover, even if the outer layer of the modified balloon is ruptured after being loaded with a contrast agent, the inner layer can still be effectively prevented from rupturing, making it not easy to leak into the cerebrospinal fluid.

[0033] Furthermore, the modified balloon is made of a double-layer composite material, which effectively increases the burst pressure of the balloon and also enables the balloon itself to have a certain flexibility, and can effectively cope with the corrosion of the contrast agent when used as a trigeminal ganglion balloon.

[0034] The number of devices and the processing scale described here are used to simplify the description of the present invention, and the applications, modifications, and changes to the present invention will be obvious to those skilled in the art.

[0035] Although the embodiments of the present invention have been disclosed as above, they are not limited to the applications listed in the specification and embodiments. It can be fully applied to various fields suitable for the present invention. For those familiar with the field, additional modifications can be easily achieved. Therefore, without departing from the general concept defined by the claims and the equivalent scope, the present invention is not limited to the specific details and the illustrated examples described here.

Claims

1. A medical double-core pressure-resistant sensing balloon, characterized in that: include: The balloon comprises a balloon outer layer and a plurality of inner layer structures arranged in the balloon outer layer, wherein the plurality of inner layer structures comprises a developing layer and a sensing layer; The surface of the outer layer of the balloon is provided with a plurality of concave layers; A micro pressure sensor is attached to the sensing layer; One end of the outer layer of the balloon is provided with a plurality of ports, the plurality of ports including a first connection port and a second connection port, wherein the first connection port is connected to the sensing layer, and the second connection port is connected to the developing layer; The sensing layer is located between the outer layer of the balloon and the developing layer, and when the balloon is filled and the inner layer structure expands, the developing layer contacts the sensing layer, so that the developing layer generates a pressure change on the sensing layer, and the piezoelectric material in the micro pressure sensor on the sensing layer generates a voltage change, which is detected by the micro pressure sensor and converted into an electrical signal; The outer layer of the balloon is 1.0 mm thick, 7.2 mm in diameter, and 94 D in hardness; the developing layer is 0.4 mm thick, 6.5 mm in diameter, and 42 D in hardness; the sensing layer is 0.3 mm thick, 4.2 mm in diameter, and 38 D in hardness; the distance between the surface spherical concave layers of the outer layer of the balloon is 10~500nm; The preparation method of a medical double-core pressure-resistant sensing balloon comprises the following steps: S1. preparing a balloon outer layer by using the blend material, wherein the balloon outer layer is a pressure-resistant layer on which drugs can be coated; S2, preparing a developing layer and a sensing layer; S3, forming a double-core layer and three-cavity structure by a material forming process for the outer layer, the developing layer and the sensing layer of the balloon; S4, heating and expanding the double-core layer three-cavity structure, and then stretching and shaping the double-core layer three-cavity structure; S5, performing corrosion spray treatment on the outer surface of the balloon to achieve a concave layer on the surface; S6, a micro pressure sensor is placed on the sensing layer through a catheter; In step S1, the material of the outer layer of the balloon and the inner layers of the plurality of balloons are any one material or a combination of several materials of nylon, thermoplastic polyurethane, polyether block amide, polyester elastomer, latex Pebax, polyethylene terephthalate, polyethylene, polypropylene or polyamide, polyvinyl chloride or silicone material; The surface of the outer layer of the balloon is roughened so that the surface of the outer layer of the balloon has a plurality of nanoscale concave layers; In step S6, the micro pressure sensor in the sensing layer is used to monitor the pressure of the developing layer when it expands and squeezes due to the injection of developer.

2. A medical double-core pressure-resistant sensing balloon as claimed in claim 1, characterized in that: Step S5 specifically includes the following steps: S51, cleaning the surface of the material of the outer layer of the balloon with acetone; S52, after cleaning, spraying the mixture evenly on the outer surface of the balloon using an oxidation system atomization spray device; S53. Commonly used oxidation systems include: any one or a combination of several solvents among chloric acid, sulfuric acid, permanganic acid, anhydrous chromic acid, tetrachloroethane, chromic acid, acetic acid, dichromic acid, and nitric acid; S54. After the spraying treatment, the surface of the outer layer of the balloon is cleaned with water, ethanol and acetone.

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