Film-covered balloon double-cavity stomach tube and preparation method thereof
By constructing a drug-loaded fiber-coated double-lumen balloon tube on the balloon surface, the problem of inconsistent local drug release in the esophagus was solved, achieving continuous and controllable drug release, thus improving therapeutic efficacy and safety.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-12-23
- Publication Date
- 2026-04-10
AI Technical Summary
In existing technologies, when treating radiation esophagitis via oral administration, the effective duration of the drug at the lesion site is short, making it difficult to achieve continuous and controllable drug release. Furthermore, frequent repeated administration leads to unstable efficacy.
A double-lumen gastric tube with a membrane balloon is used. Drug-loaded fiber membranes are constructed on the surface of the balloon using coaxial electrospinning technology. The drug is encapsulated in a nanofiber sheath made of polylactic acid caprolactone and collagen blend, forming a core-layer drug-loaded strategy. The sheath acts as a diffusion barrier to achieve continuous and controllable drug release.
It significantly prolongs the duration of drug action at the esophageal lesion site, improves treatment efficacy, reduces potential irritation to the esophageal mucosa, enhances user comfort and safety, and provides a flexible drug delivery platform.
Smart Images
Figure CN121819040A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of gastric tube technology, and in particular to a covered balloon double-lumen gastric tube and its preparation method. Background Technology
[0002] Radiation therapy is a common treatment for chest tumors, but while killing tumor cells, it often damages normal esophageal tissue, causing radiation esophagitis. This condition manifests as severe pain and difficulty swallowing and is one of the most significant acute adverse reactions to radiotherapy, seriously affecting the patient's quality of life and the treatment process.
[0003] Currently, clinical treatment for radiation esophagitis primarily focuses on symptom relief. In addition to conventional methods such as fasting, antibiotics, and nutritional support, locally delivered medications via oral routes (such as the corticosteroid dexamethasone and the local anesthetic lidocaine) have been proven effective in reducing inflammation and pain. However, oral administration has significant limitations: due to swallowing difficulties and the rapid emptying of the esophagus by peristalsis, the effective duration of the medication at the lesion site is extremely short. This often necessitates frequent and repeated administration, and the efficacy is inconsistent.
[0004] To address the challenge of drug retention in the esophagus, existing technologies have explored the use of medical balloons as drug carriers for local drug delivery. For example, a drug-loaded coating can be applied to the balloon surface, and the drug is then applied to the esophageal wall through balloon expansion. However, these methods typically face problems such as excessively rapid drug release, insufficient contact between the coating and tissue, or easy peeling off of the coating during balloon deformation, making it difficult to achieve continuous and controllable drug release. Summary of the Invention
[0005] The purpose of this invention is to address the shortcomings of existing technologies by providing a covered balloon double-lumen gastric tube and its preparation method.
[0006] To achieve the above objectives, the technical solution adopted by the present invention is as follows: The first aspect is to provide a covered balloon double-lumen gastric tube for the prevention and treatment of radiation esophagitis, comprising: A double-lumen gastric tube, which includes a main lumen for gastrointestinal drainage and a side lumen for balloon inflation; A compliant balloon, which encloses and is fixed to the esophageal segment of the double-lumen gastric tube and communicates with the side lumen, expands and contracts by inflating and deflating the side lumen; A drug-loaded fiber coating is applied to the outer surface of the compliant balloon; the coating is composed of coaxial drug-loaded nanofibers, wherein the sheath of the coaxial drug-loaded nanofibers comprises a blend of polylactic acid caprolactone and collagen, and the core layer comprises polylactic acid caprolactone and anti-inflammatory and local anesthetic drugs dispersed therein.
[0007] Furthermore, the double-lumen gastric tube is made of polyurethane, polyethylene, or nylon, with a diameter of 7F or 8F and a length of 200cm or 240cm; the compliant balloon is made of natural latex, polyethylene, or nylon, with an inflated diameter of 14-20mm and a length of 50-100mm.
[0008] Furthermore, the anti-inflammatory drug is dexamethasone, and the local anesthetic drug is lidocaine.
[0009] Furthermore, the polylactic acid caprolactone is a copolymer of lactic acid and caprolactone in a 50 / 50 ratio; the collagen is type I collagen.
[0010] The second aspect is to provide a method for preparing the above-mentioned covered balloon double-lumen gastric tube, including the following steps: S1, Preparation of sheath spinning solution: Polylactic acid caprolactone and collagen are dissolved in hexafluoroisopropanol and stirred until completely dissolved to obtain a uniform sheath spinning solution; S2, Core spinning solution preparation: Polylactic acid caprolactone is dissolved in hexafluoroisopropanol and stirred. Then, anti-inflammatory drugs and local anesthetic drugs are added and stirred until homogeneous core spinning solution is obtained. S3, Coaxial electrospinning coating: The compliant balloon of the double-lumen gastric tube is inflated and fixed on the receiving device; coaxial electrospinning is performed using the sheath spinning solution and the core spinning solution as raw materials, so that the generated coaxial drug-loaded nanofibers are deposited on the surface of the inflated balloon to form a drug-loaded fiber coating. S4, Post-processing: After spinning, the balloon is degassed and shrunk, and then ventilated and dried to obtain the final covered balloon double-lumen gastric tube.
[0011] Furthermore, the concentration of polylactic acid caprolactone in the sheath spinning solution is 5~10 w / v, and the concentration of collagen is 2~5 w / v; the concentration of polylactic acid caprolactone in the core spinning solution is 6~10 w / v.
[0012] Furthermore, the concentration of polylactic acid caprolactone in the sheath spinning solution is 7.5 w / v, and the concentration of collagen is 2.5 w / v; the concentration of polylactic acid caprolactone in the core spinning solution is 8 w / v.
[0013] Further, in step S2, the added anti-inflammatory drug is dexamethasone, and the added local anesthetic drug is lidocaine; wherein, in the core spinning solution, the concentration of dexamethasone is 0.5~1.0 mg / mL, and the concentration of lidocaine is 10~15 mg / mL.
[0014] Furthermore, in the core spinning solution, the concentration of dexamethasone is 0.5 mg / mL, and the concentration of lidocaine is 10 mg / mL.
[0015] Furthermore, in the coaxial electrospinning process of step S3, the propulsion speed of the sheath spinning solution is 0.6-1.0 mL / h, and the propulsion speed of the core spinning solution is 0.1-0.2 mL / h.
[0016] Furthermore, in the coaxial electrospinning process of step S3, the propulsion speed of the sheath spinning solution is 0.8 mL / h, and the propulsion speed of the core spinning solution is 0.16 mL / h.
[0017] Furthermore, during the coaxial electrospinning process in step S3, the applied voltage is 14-18kV; the distance between the syringe needle and the balloon on the receiving device is 10-15cm.
[0018] Furthermore, in the coaxial electrospinning process of step S3, the applied voltage is 16kV.
[0019] Furthermore, in step S3, the receiving device rotates at a speed of 100-400 rpm to ensure that the coaxial drug-loaded nanofibers are uniformly coated on the surface of the balloon.
[0020] The present invention adopts the above technical solution and has the following technical effects compared with the prior art: This invention constructs a drug-loaded fiber coating on the surface of a balloon using coaxial electrospinning technology. This coating can encapsulate drugs (such as dexamethasone and lidocaine) in the nanofiber core layer. The sheath polymer material serves as a diffusion barrier, effectively preventing the sudden release of drugs and achieving continuous and controllable release at the esophageal lesion site. This significantly prolongs the duration of drug action and improves efficacy.
[0021] The double-lumen gastric tube with a covered balloon of the present invention uses a blend of polylactic acid caprolactone (PLCL) and collagen as the sheath of the nanofiber. This design cleverly combines the good extensibility of PLCL with the high hydrophilicity and biocompatibility of collagen. This not only ensures the structural integrity of the drug-loaded fiber coating during repeated expansion and contraction of the balloon and avoids coating peeling, but also effectively reduces potential irritation to the esophageal mucosa, improving the comfort and safety of use.
[0022] The drug-loaded fiber coating of the present invention serves as a universal drug delivery platform. The types and proportions of drugs loaded in the core layer of the nanofibers can be flexibly adjusted and changed according to specific clinical needs. It is not limited to radiation esophagitis, but also provides a new solution for local drug treatment of other esophageal diseases. Attached Figure Description
[0023] Figure 1 This is a transmission electron microscope (TEM) image of coaxial electrospun fibers from Embodiment 1 of the present invention. Figure 2Among them, (a) is a scanning electron microscope image of the coaxial electrospun fiber layer of Comparative Example 1; (b) is a scanning electron microscope image of the coaxial electrospun fiber layer of Comparative Example 2; and (c) is a scanning electron microscope image of the coaxial electrospun fiber layer of Example 1. Figure 3 Among them, (a) is a statistical chart of the diameter of nanofibers in Comparative Example 1; (b) is a statistical chart of the diameter of nanofibers in Comparative Example 2; and (c) is a statistical chart of the diameter of nanofibers in Example 1.
[0024] Figure 4 Wherein, (a) is the uninflated form of the covered compliant balloon in Example 1; (b) is the inflated form of the covered compliant balloon in Example 1; Figure 5 The cell proliferation results of Comparative Example 1, Comparative Example 2, and Example 1 are shown.
[0025] Figure 6 The results of flow cytometry analysis of the macrophage differentiation-promoting effects of Comparative Example 1, Comparative Example 2, and Example 1 are shown.
[0026] Figure 7 The results of flow cytometry analysis of the macrophage differentiation-promoting effects of Comparative Example 1, Comparative Example 2, and Example 1 are shown.
[0027] Figure 8 This is a photograph of the covered balloon double-lumen gastric tube (Example 1) used in the animal experiments of this invention.
[0028] Figure 9 The results of histopathological staining of esophageal tissue sections from each group of rats on day 8 after irradiation treatment are shown. Detailed Implementation
[0029] The present invention will be further described below with reference to the accompanying drawings and specific embodiments, but this is not intended to limit the invention. It should be noted that, unless otherwise specified, the embodiments and features described in the embodiments of the present invention can be combined with each other.
[0030] Experimental methods in the following examples, unless otherwise specified, were performed under standard conditions or as recommended by the manufacturer. Unless otherwise stated, all reagents and materials used in the following examples were commercially available.
[0031] Example 1 This embodiment provides a covered balloon double-lumen gastric tube (PLCL-Col / PLCL-DEX-Lido) and its preparation method. The specific steps of the preparation method are as follows: We provide a compliant double-lumen gastric tube and a conforming balloon: the double-lumen gastric tube is made of polyurethane, has a diameter of 8F, and a length of 200cm, while the conforming balloon is made of natural latex, has an inflated diameter of 16mm, and a length of 80mm. The balloon encloses and secures the esophageal segment of the double-lumen gastric tube, and its interior communicates with the side lumen of the double-lumen gastric tube.
[0032] S1, Preparation of sheath spinning solution: Weigh 0.6g of polylactic acid caprolactone (PLCL) (lactic acid to caprolactone feed ratio of 50:50, Shenzhen Maiqi Biomaterials Co., Ltd.) and 0.2g of type I fish skin collagen (Shanghai Maclean Biochemical Technology Co., Ltd., 9064-67-9), dissolve in 8mL of hexafluoroisopropanol (HFIP) (Shanghai Darui Fine Chemicals Co., Ltd., 920-66-1), stir until completely dissolved, and obtain a uniform sheath spinning solution.
[0033] S2, Preparation of core spinning solution: Weigh 0.24 g of polylactic acid caprolactone (lactic acid to caprolactone feed ratio of 50:50), dissolve in 3 mL of hexafluoroisopropanol (HFIP), and stir until completely dissolved; 20 minutes before spinning, add 1.5 mg of dexamethasone (DEX) (Shanghai Yien Chemical Technology Co., Ltd., 50-02-2) and 30 mg of lidocaine (Lido) (Shanghai Aladdin Biochemical Technology Co., Ltd., 137-58-6) to the solution, stir and mix well to obtain a uniform core spinning solution.
[0034] S3, Coaxial Electrospinning Coating: Inflation is performed into the compliant balloon through the side lumen of the double-lumen gastric tube. After the balloon is fully inflated, it is fixed on the receiving device, and the rotation speed of the receiving device is set to 100-400 rpm. Coaxial electrospinning is performed using sheath spinning solution and core spinning solution as raw materials. The applied voltage is 16kV, the propulsion speed of sheath spinning solution is 0.8mL / h, the propulsion speed of core spinning solution is 0.16mL / h, and the distance between the syringe needle and the balloon on the receiving device is 10-15cm. This allows the generated coaxial drug-loaded nanofibers to be deposited on the surface of the inflated balloon, forming a drug-loaded fiber coating.
[0035] S4, Post-processing: After spinning is completed, the covered balloon double-lumen gastric tube is removed from the receiving device, the balloon is degassed and shrunk, and placed in a fume hood to dry for 12 hours to obtain the final covered balloon double-lumen gastric tube.
[0036] Comparative Example 1 This comparative example provides a covered balloon double-lumen gastric tube (PLCL-Col / PLCL) and its preparation method. The difference between this preparation method and Example 1 is that dexamethasone (DEX) and lidocaine (Lido) are not added in the preparation of the core spinning solution; the other steps are the same as in Example 1.
[0037] Comparative Example 2 This comparative example provides a covered balloon double-lumen gastric tube (PLCL-Col-DEX-Lido / PLCL) and its preparation method. The difference between this preparation method and Example 1 is that: S1, Preparation of sheath spinning solution: Weigh 0.6g of polylactic acid caprolactone (lactic acid to caprolactone feed ratio of 50:50) and 0.2g of type I fish skin collagen, dissolve them in 8mL of hexafluoroisopropanol, and stir until completely dissolved; 20 minutes before spinning, add 0.8mg of DEX and 16mg of Lido to the solution to obtain a uniform sheath spinning solution.
[0038] S2, Preparation of core spinning solution: Weigh 0.24g of polylactic acid caprolactone (lactic acid to caprolactone feed ratio is 50:50), dissolve in 3mL of hexafluoroisopropanol (HFIP), stir until completely dissolved, and obtain a uniform core spinning solution. The other steps are the same as in Example 1.
[0039] Experimental Results and Discussion This invention successfully constructed fiber coatings with different drug loading methods on the surface of a balloon using coaxial electrospinning technology. To systematically evaluate the superiority of the core and sheath drug loading strategies, the samples prepared in Example 1 (PLCL-Col / PLCL-DEX-Lido, drug-loaded core), Comparative Example 1 (PLCL-Col / PLCL, no drug), and Comparative Example 2 (PLCL-Col-DEX-Lido / PLCL, drug-loaded sheath) were characterized as follows.
[0040] 1. Morphology and structural characterization of fiber-coated membranes Experimental methods: The morphology of each fiber membrane sample deposited on a silicon wafer was observed using a scanning electron microscope (SEM). At least 100 fibers were randomly selected, and their diameter distribution and average diameter were calculated using ImageJ software.
[0041] Example 1 (Drug loading in the core layer): SEM images ( Figure 2 c) shows that the fiber surface is smooth, the morphology is uniform, there are no beads or defects, and it exhibits a typical coaxial fiber structure. The average fiber diameter is 598.72 nm. Figure 3 c). This result indicates that, under the set process parameters, the spinning process is stable, and structurally complete drug-loaded nanofibers with intact core layers are successfully prepared.
[0042] Comparative Example 1 (without drug): SEM images ( Figure 2 a) shows that the fiber morphology is similar to that of Example 1, with a uniform and continuous structure and an average diameter of 593.78 nm. Figure 3a) The diameter was not significantly different from that of Example 1, demonstrating that the addition of DEX and Lido to the core layer did not have a significant impact on the formability of the fiber.
[0043] Comparative Example 2 (drug loading in the sheath): SEM images ( Figure 2 b) shows that the fibers are still continuous and uniform, but the average diameter is significantly reduced to 430.33 nm. Figure 3 (b) This may be because the addition of the drug to the sheath spinning solution results in a higher viscosity ratio between the sheath spinning solution and the core spinning solution, creating a strong entrainment effect, which leads to a decrease in the flow rate of the core solution and a thinning of the fibers.
[0044] 2. In vitro cell proliferation and biocompatibility evaluation Experimental Methods: Mouse fibroblasts (L929) were used for cytotoxicity experiments. Cells were seeded in Comparative Example 1 (drug-free group), Comparative Example 2 (drug-loaded sheath), and Example 1 (drug-loaded core). Cell viability was assessed using the CCK-8 assay after 1, 4, and 7 days to evaluate the survival of L929 cells growing on the fibrous membrane. The culture medium was changed every 2 days during incubation. At each time point, the culture medium was removed from each well, and fresh medium containing 10% CCK-8 solution was added. After incubation for 2 hours, absorbance was measured.
[0045] Comparative Example 2 (drug-loaded sheath) showed significantly lower cell proliferation activity than Example 1 on days 1 and 4 of culture. Figure 5 This is most likely due to the initial cytotoxicity caused by the rapid release of the drug (especially lidocaine) from the fibrous sheath (burst release effect).
[0046] Example 1 (core-loaded drug) exhibited the best cell proliferation promotion effect throughout the entire culture period. In particular, its cell viability was significantly higher than that of Comparative Example 1 and Comparative Example 2 on day 7. This indicates that the core-loaded drug strategy effectively mitigates the burst release of drugs, reduces initial toxicity, and achieves slow drug release through the diffusion barrier effect of the PLCL shell, thereby providing cells with a more mild and durable favorable microenvironment.
[0047] 3. Evaluation of anti-inflammatory effects Experimental Methods: Rat macrophages (RAW264.7) were used for in vitro anti-inflammatory experiments. The experiment was divided into 5 groups: LPS group: RAW264.7 cells were induced to differentiate by adding lipopolysaccharide (LPS) for 1 day and induction time was 12 hours; Control group: RAW264.7 cells were cultured for 1 day; PLCL-Col / PLCL group: RAW264.7 cells were seeded on Comparative Example 1 (drug-free group) and induced to differentiate by adding LPS for 1 day and induction time was 12 hours; PLCL-Col-DEX-Lido / PLCL group: RAW264.7 cells were seeded on Comparative Example 2 (drug-loaded sheath) and induced to differentiate by adding LPS for 1 day and induction time was 12 hours; PLCL-Col / PLCL-DEX-Lido group: RAW264.7 cells were seeded on Example 1 (drug-loaded core) and induced to differentiate by adding LPS for 1 day and induction time was 12 hours. RAW264.7 cells from each group were pipetted from culture plates or fiber membranes, transferred to centrifuge tubes, centrifuged, and the supernatant was removed. The cells were then washed three times with PBS. CD86 and CD206 antibodies were added to the washed RAW264.7 cells, and the cells were incubated on ice for 30 min. After washing twice with PBS, the cells were filtered through a membrane into flow cytometry tubes, and the M2 / M1 phenotype ratio was detected using flow cytometry.
[0048] The anti-inflammatory effect of Comparative Example 1 (the drug-free group) was comparable to that of the disease control group. Figure 6 ,7), its fibrous membrane only provides a physical barrier function and cannot effectively inhibit the inflammatory response induced by radiation, which confirms the necessity of the drug.
[0049] Comparative Example 2 (drug-loaded sheath) showed a significant anti-inflammatory effect, which was significantly stronger than that of Comparative Example 1 and the disease control group. This demonstrates that DEX exerts an effective therapeutic effect after being released from the fibrous membrane.
[0050] Example 1 (core layer drug loading) demonstrated the most significant anti-inflammatory effect. Figure 6 ,7).
[0051] 4. Animal experiments Forty Wistar rats were randomly divided into five groups. Small animal gastric tubes were inserted into the esophagus of all five groups to simulate intubation treatment, but the gastric tubes used differed: the 6MV-X-ray group and the Control group used ordinary small animal gastric tubes; the PLCL-Col / PLCL group used a gastric tube with approximately 8 mg of fiber from Comparative Example 1 (no drug); the PLCL-Col-DEX-Lido / PLCL group used a gastric tube with approximately 8 mg of fiber from Comparative Example 2 (drug-loaded sheath); and the PLCL-Col / PLCL-DEX-Lido group used a gastric tube with approximately 8 mg of fiber from Example 1 (drug-loaded core). The covered gastric tubes used in the PLCL-Col / PLCL, PLCL-Col-DEX-Lido / PLCL, and PLCL-Col / PLCL-DEX-Lido groups had a covered section approximately 3 cm from the rat's incisors and approximately 2 cm in length. Figure 8 As shown.
[0052] Animals in the 6MV-X-ray group, PLCL-Col / PLCL group, PLCL-Col-DEX-Lido / PLCL group, and PLCL-Col / PLCL-DEX-Lido group were treated with 6MV-X-ray irradiation. The treatment procedure was as follows: Rats were placed in a specially designed acrylic irradiation box and fixed at a distance of 100 cm from the center of the radiation source. The irradiation field was adjusted using an automatic multi-leaf grating, with the central dose point located 1.3 cm below the surface of the rat's abdomen. The irradiation field was 40 mm × 20 mm, the irradiation dose rate was 340 cGy / min, and the total dose was 36 Gy in a single irradiation. The control group did not receive irradiation treatment. After irradiation treatment, the rats in each group were housed for 7 days and fed daily via gastric tube. On the 8th day of feeding, the rats in each group were sacrificed, and the esophageal segments 3 cm from the incisors (membranous segment) and 6 cm from the incisors (non-membranous segment) were removed, respectively. The extracted esophageal specimens were then washed with PBS, fixed with 4% paraformaldehyde, and representative samples were dehydrated with a series of ethanols, embedded in paraffin, and cut into 5μm sections. Hematoxylin and eosin (H&E) were used to stain the cell nuclei and cytoplasm of the sections to observe esophageal pathological changes; Masson's staining was used to stain collagen to observe the recovery of the affected area after radiation esophagitis.
[0053] In Comparative Example 1 (no-drug group), the number of inflammatory cells in the unmembrane and covered segments was partially reduced compared to the 6MV-X-ray group, but compared to the Control group, the esophageal mucosa was not fully repaired, and the mucosal stratification was not fully restored. Figure 9 The drug's therapeutic effect partly comes from the collagen in the material, but it cannot effectively suppress the inflammatory response caused by radiation, thus confirming the necessity of the drug.
[0054] In Comparative Example 2 (drug-loaded sheath), inflammatory cell infiltration was significantly reduced in both the non-membranous and covered segments, and the esophageal mucosal stratification was more pronounced. Figure 9 This indicates that the radiation esophagitis was well treated. This demonstrates that DEX exerted an effective therapeutic effect after being released from the fibrous membrane. However, it is also noteworthy that the esophageal mucosa of the treated covered segment showed significant thickening compared to the Control group, similar to the 6MV-X-ray group, which may be due to the sudden release of the drug at this location.
[0055] Example 1 (core-loaded drug) demonstrated the most significant therapeutic effect on radiation esophagitis, with a substantial reduction in inflammatory cell infiltration in both the unmembrane and covered segments, and clear mucosal stratification with a thinner thickness. Figure 9 ).
[0056] The above description is merely a preferred embodiment of the present invention and does not limit the implementation and protection scope of the present invention. Those skilled in the art should realize that any equivalent substitutions and obvious changes made based on the content and illustrations of the present invention should be included within the protection scope of the present invention.
Claims
1. A double-lumen gastric tube with a covered balloon, characterized in that, include: A double-lumen gastric tube, which includes a main lumen for gastrointestinal drainage and a side lumen for balloon inflation; A compliant balloon, which encloses and is fixed to the esophageal segment of the double-lumen gastric tube and communicates with the side lumen, expands and contracts by inflating and deflating the side lumen; A drug-loaded fiber coating is applied to the outer surface of the compliant balloon; the coating is composed of coaxial drug-loaded nanofibers, wherein the sheath of the coaxial drug-loaded nanofibers comprises a blend of polylactic acid caprolactone and collagen, and the core layer comprises polylactic acid caprolactone and anti-inflammatory and local anesthetic drugs dispersed therein.
2. The covered balloon double-lumen gastric tube according to claim 1, characterized in that, The double-lumen gastric tube is made of polyurethane, polyethylene, or nylon, with a diameter of 7F or 8F and a length of 200cm or 240cm; the compliant balloon is made of natural latex, polyethylene, or nylon, with an inflated diameter of 14-20mm and a length of 50-100mm.
3. The covered balloon double-lumen gastric tube according to claim 1, characterized in that, The anti-inflammatory drug is dexamethasone, and the local anesthetic drug is lidocaine.
4. The covered balloon double-lumen gastric tube according to claim 1, characterized in that, The polylactic acid caprolactone is a copolymer of lactic acid and caprolactone in a 50 / 50 ratio; the collagen is type I collagen.
5. A method for preparing a covered balloon double-lumen gastric tube as described in any one of claims 1-4, characterized in that, Includes the following steps: S1, Preparation of sheath spinning solution: Polylactic acid caprolactone and collagen are dissolved in hexafluoroisopropanol and stirred until completely dissolved to obtain a uniform sheath spinning solution; S2, Core spinning solution preparation: Polylactic acid caprolactone is dissolved in hexafluoroisopropanol and stirred. Then, anti-inflammatory drugs and local anesthetic drugs are added and stirred until homogeneous core spinning solution is obtained. S3, Coaxial electrospinning coating: The compliant balloon of the double-lumen gastric tube is inflated and fixed on the receiving device; coaxial electrospinning is performed using the sheath spinning solution and the core spinning solution as raw materials, so that the generated coaxial drug-loaded nanofibers are deposited on the surface of the inflated balloon to form a drug-loaded fiber coating. S4, Post-processing: After spinning, the balloon is degassed and shrunk, and then ventilated and dried to obtain the final covered balloon double-lumen gastric tube.
6. The preparation method according to claim 5, characterized in that, The concentration of polylactic acid caprolactone in the sheath spinning solution is 5-10 w / v, and the concentration of collagen is 2-5 w / v; the concentration of polylactic acid caprolactone in the core spinning solution is 6-10 w / v.
7. The preparation method according to claim 5, characterized in that, In step S2, the added anti-inflammatory drug is dexamethasone, and the added local anesthetic drug is lidocaine; wherein, in the core spinning solution, the concentration of dexamethasone is 0.5~1.0 mg / mL, and the concentration of lidocaine is 10~15 mg / mL.
8. The preparation method according to claim 5, characterized in that, In the coaxial electrospinning process of step S3, the propulsion speed of the sheath spinning solution is 0.6-1.0 mL / h, and the propulsion speed of the core spinning solution is 0.1-0.2 mL / h.
9. The preparation method according to claim 5, characterized in that, During the coaxial electrospinning process in step S3, the applied voltage is 14-18kV; the distance between the syringe needle and the balloon on the receiving device is 10-15cm.
10. The preparation method according to claim 5, characterized in that, In step S3, the receiving device rotates at 100-400 rpm to ensure that the coaxial drug-loaded nanofibers are uniformly coated on the surface of the balloon.