A balloon catheter for fallopian tube with strong biocompatibility

Abstract

The application relates to the technical field of balloon catheters, in particular to a strong biocompatibility balloon catheter for oviducts, which comprises a shell, a catheter and a solid pipeline, the inside of the shell is provided with the catheter, one side of the catheter is provided with a liquid pipeline, the side, away from the liquid pipeline, of the catheter is provided with the solid pipeline, one end of the solid pipeline is connected with a solid medicine inlet in a penetrating mode, one end of the liquid pipeline is connected with a liquid medicine inlet in a penetrating mode, then air is injected into the inside of the air bag through the catheter, the air bag is expanded to support the oviduct, when it is needed to deliver medicine, when it is needed to inject liquid medicine, the liquid medicine needed to be used is injected into the inside of the liquid pipeline through the liquid medicine inlet, when it is needed to inject solid medicine, the solid medicine is injected through the solid medicine inlet, different pipelines are used to inject medicine, different medicines are prevented from mixing together to cause medicine pollution, and the use effect on patients is reduced.

Description

TECHNICAL FIELD

[0001] The application relates to the technical field of A61L29 / 14, and in particular to a fallopian tube balloon catheter with high biocompatibility. BACKGROUND

[0002] The balloon dilatation catheter is a medical interventional device, and the main function is to dilate the upper gastrointestinal tract stenosis for treatment.

[0003] When a patient's fallopian tube needs to be treated, a fallopian tube balloon catheter needs to be used, the balloon catheter is inserted into the patient's body, and then the balloon is inflated by an external device to expand and then treat the patient's diseased part, but the existing fallopian tube balloon catheter is prone to blockage of the pipeline when delivering drugs into the patient's body for a long time, and is prone to mixing of two different drugs to cause pollution, thereby reducing the treatment effect of the drugs on the patient, and different drugs cannot be delivered through different catheters.

[0004] The anti-adhesion uterine balloon disclosed by Chinese patent CN201580069408 comprises a material selected from the group consisting of silicone rubber, natural rubber or synthetic rubber and fabric, and the patent is unique and satisfactory for preventing uterine adhesion. However, the bending performance is not good enough.

[0005] The stent disclosed by Chinese patent CN200480016464 selects an SMP material segment, surface modification, in particular micro-structuring, or appropriate coating, or uses a disinfectant substance that can be released from the stent after implantation. However, it does not have the function of delivering drugs.

[0006] Chinese patent CN202011108599 discloses a fallopian tube balloon catheter containing a hydrophilic coating, and the drug delivery block is always in contact with the inner wall of the catheter. Each drug delivery process is a cleaning process for the inside of the catheter, which avoids drug retention and blockage on the one hand, and avoids mixed secondary pollution caused by drug residues on the other hand. However, the flexibility of the material is not good enough. SUMMARY

[0007] In view of the above problems existing in the prior art, the present application provides a fallopian tube balloon catheter with high biocompatibility.

[0008] The specific technical solutions are as follows:

[0009] The application discloses a fallopian tube balloon catheter with high biocompatibility, which comprises a shell, a catheter and a solid pipeline, the inside of the shell is provided with the catheter, one side of the catheter is provided with a liquid pipeline, the side, away from the liquid pipeline, of the catheter is provided with the solid pipeline, one end of the solid pipeline is connected with a solid medicine inlet in a penetrating mode, one end of the liquid pipeline is connected with a liquid medicine inlet in a penetrating mode, one end of the shell is fixedly connected with a conveying pipe, the outside of the conveying pipe is provided with a second compatible layer, the end, away from the shell, of the conveying pipe is provided with an air bag, the outer wall of the air bag is provided with a first compatible layer, the inside of the solid medicine inlet is provided with a placing block, and one end of the placing block is fixedly connected with one end of a flexible pipe.

[0010] Preferably, one end of the shell is fixedly connected with one end of the conveying pipe, and the outer wall of the conveying pipe is connected with the second compatible layer in a sticking mode.

[0011] Preferably, the end, away from the shell, of the conveying pipe is fixedly connected with one end of the air bag, and the outer wall of the air bag is connected with the first compatible layer in a sticking mode.

[0012] Preferably, the solid medicine inlet penetrates one side of the shell and is connected with one end of the solid pipeline in an embedding mode, and the end, away from the solid medicine inlet, of the solid pipeline is connected with the air bag in a penetrating mode.

[0013] Preferably, the liquid medicine inlet penetrates the side, away from the solid medicine inlet, of the shell and is connected with the liquid pipeline in an embedding mode, and the end, away from the liquid medicine inlet, of the liquid pipeline is connected with the air bag in a penetrating mode.

[0014] Preferably, one end of the catheter penetrates the end, away from the conveying pipe, of the shell, the end, away from the shell, of the catheter is connected with the air bag in a penetrating mode, and a through hole is formed in the catheter at the air bag.

[0015] Preferably, the placing block is movably connected with the solid medicine inlet, and one end of the placing block is fixedly connected with the flexible pipe.

[0016] The application further discloses a preparation raw material of the fallopian tube balloon catheter shell (1) with high biocompatibility, which comprises, by weight, 100-110 parts of thermoplastic resin, 3-7 parts of inorganic filler, 10-20 parts of paraffin substance, 2-6 parts of antioxidant, 1-3 parts of antibacterial agent and 30-40 parts of curing agent.

[0017] Preferably, the raw material comprises, by weight, 101 parts of thermoplastic resin, 3.6 parts of inorganic filler, 13 parts of paraffin substance, 2.1 parts of antioxidant, 1.2 parts of antibacterial agent and 32 parts of curing agent.

[0018] Preferably, the thermoplastic resin is selected from one or more of polylactide, polycarbonate, polyurethane.

[0019] Further preferably, the thermoplastic resin is selected from both polylactide and polyurethane, with a weight ratio of 3: (7-15).

[0020] Preferably, the polylactide and polyurethane have a weight ratio of 3:10.

[0021] Preferably, the polylactide is of brand PLLA, purchased from Hong Kong Plastic Chemical Co. Ltd.

[0022] Preferably, the polyurethane is of brand 8302, purchased from Guangzhou Shilunxin New Material Co. Ltd.

[0023] Preferably, the inorganic filler is selected from ceramic, titanium dioxide, mica powder.

[0024] Further preferably, the inorganic filler is mica powder and titanium dioxide, with a weight ratio of 1: (1-5).

[0025] Preferably, the mica powder and titanium dioxide have a weight ratio of 1:3.

[0026] Preferably, the mica powder is modified mica powder, and the titanium dioxide is coupling agent modified titanium dioxide.

[0027] Preferably, the coupling agent is selected from amino silane coupling agent and vinyl silane coupling agent in silane coupling agent, with a weight ratio of 1:1.

[0028] Preferably, the amino silane coupling agent is N-(β-aminoethyl)-γ-aminopropyl trimethoxysilane.

[0029] Preferably, the vinyl silane coupling agent is vinyl trimethoxysilane.

[0030] The preparation method of the modified mica powder and modified silicon dioxide is as follows: mix the mica powder and silicon dioxide uniformly according to the weight ratio, add 2% of the coupling agent and 16% of ethanol according to the total weight, mix and ultrasonically oscillate for 30 min, and then dry to obtain the modified mica powder and modified silicon dioxide.

[0031] Preferably, the mica powder is purchased from Baofeng Mica Processing Co. Ltd.

[0032] Preferably, the silicon dioxide is of brand QS-L200, purchased from Ximeng Chemical Co. Ltd.

[0033] In order to enhance the practicability of the catheter, the shell material needs to have certain support so that the medicine in the catheter can reach the affected area smoothly without being extruded by the human body structure, but the support force cannot be too good to prevent the shell material from causing damage to the fallopian tube in the presence of external force. When the modified mica powder is added, the support strength of the shell is increased, especially the mica powder modified by the coupling agent, and especially the amino silane coupling agent and the vinyl silane coupling agent in the silane coupling agent, and when the weight ratio is 1:1, the molecular chains interact with each other, and are intertwined and connected together, and the paraffin-like substance cooperates to improve the support strength of the shell material, and at the same time, the tensile strength of the material is improved, and the material has good bending performance.

[0034] Preferably, the paraffin-like substance is low-molecular paraffin polyethylene glycol 200, model CY-040, purchased from Guangzhou Chen Yi New Material Co., Ltd.

[0035] Preferably, the antioxidant is antioxidant 168, purchased from Zhenming Chemical Co., Ltd.

[0036] Preferably, the antibacterial agent is selected from quaternary ammonium salt antibacterial agents.

[0037] Further preferably, the antibacterial agent is polysiloxane quaternary ammonium salt, grade P0121611, purchased from Beijing Lingbao Technology Co., Ltd.

[0038] Preferably, the curing agent is a mercapto curing agent, trimethylolpropane tris(3-mercaptopropionate).

[0039] In one embodiment, the preparation method of the balloon tube shell (1) comprises:

[0040] S1: The above raw materials are added to a rubber mixing machine, the rubber mixing temperature is 30-50℃, the rubber mixing time is 30-60min, and the discharge temperature is 100-120℃.

[0041] S2: The mixed raw materials in step S1 are poured into a mold, heated to 80-90℃, and cured for 4-6h, and then demolded.

[0042] Preferably, the preparation method is specifically:

[0043] S1: The above raw materials are added to a rubber mixing machine, the rubber mixing temperature is 45℃, the rubber mixing time is 42min, and the discharge temperature is 110℃.

[0044] S2: The mixed raw materials in step S1 are poured into a mold, heated to 87℃, and cured for 5h, and then demolded.

[0045] The above technical solution has the following advantages or beneficial effects:

[0046] 1. By setting the liquid pipeline and solid pipeline, when the patient's fallopian tube needs to be treated, the end of the air bag is sent into the patient's body through the delivery pipe until the air bag is sent to the place where the treatment is needed, then air is injected into the inside of the air bag through the catheter, the air bag expands to support the fallopian tube, when the drug needs to be delivered, different pipelines are used according to the drug to be injected, when the liquid medicine needs to be injected, the liquid medicine inlet is used to inject the liquid medicine needed inside the liquid pipeline, when the solid medicine needs to be injected, the solid medicine inlet is used to inject the solid medicine, by using different pipelines for drug injection, different drugs are prevented from mixing together to cause drug pollution, and the use effect on the patient is reduced.

[0047] 2. By setting the placing groove and flexible pipe, when the solid medicine needs to be delivered to the patient's treatment site, the medicine is placed inside the placing block, then the placing block is placed into the solid medicine inlet through the solid medicine inlet, the flexible pipe at one end of the placing block is pushed, the flexible pipe pushes the placing block to move in the solid pipeline until it moves to the outside of the solid pipeline, the flexible pipe is rotated, the placing block is rotated to pour out the medicine inside to complete the work, effectively preventing the solid medicine from blocking the pipeline to cause inconvenience and reduce work efficiency.

[0048] 3. By optimizing the catheter shell material, the catheter can have the same softness as the fallopian tube, and can play a supporting role in the fallopian tube to prevent the drug from being blocked due to human pressure, and the shell material has good biocompatibility, which can avoid the discomfort caused by the catheter entering the human body. BRIEF DESCRIPTION OF DRAWINGS

[0049] Reference is made to the accompanying drawings to more fully describe embodiments of the present application. However, the accompanying drawings should be read with the understanding that they are illustrative and explanatory only and do not limit the scope of the present application.

[0050] Figure 1 A front view of a fallopian tube balloon catheter with strong biocompatibility is provided for the present application;

[0051] Figure 2 A cross-sectional view of a fallopian tube balloon catheter with strong biocompatibility is provided for the present application;

[0052] Figure 3 A liquid pipeline and solid pipeline structure diagram of a fallopian tube balloon catheter with strong biocompatibility is provided for the present application;

[0053] Figure 4 A placing block and flexible pipe structure diagram of a fallopian tube balloon catheter with strong biocompatibility is provided for the present application.

[0054] The above reference signs represent: housing 1, catheter 2, first compatible layer 3, second compatible layer 4, placement block 5, solid medicine inlet 6, liquid medicine inlet 7, flexible tube 8, air bag 9, delivery tube 10, liquid conduit 11, solid conduit 12. DETAILED DESCRIPTION

[0055] The technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0056] It should be noted that the embodiments in the present application and the features in the embodiments can be combined with each other without conflict.

[0057] The present application will be further described below with reference to the drawings and specific embodiments, but not as a limitation of the present application.

[0058] EMBODIMENT

[0059] EMBODIMENT 1

[0060] This embodiment 1 discloses a balloon catheter for fallopian tube with strong biocompatibility,

[0061] REFERENCE Figures 1-4The utility model provides a kind of strong biocompatibility oviduct balloon catheter, including shell 1, catheter 2 and solid pipeline 12, the inside of shell 1 is equipped with catheter 2, one side of catheter 2 is equipped with liquid pipeline 11, the side of catheter 2 away from liquid pipeline 11 is equipped with solid pipeline 12, one end of solid pipeline 12 is connected solid drug inlet 6 by penetrating form, one end of liquid pipeline 11 is connected liquid drug inlet 7 by penetrating form, one end of shell 1 is fixedly connected with delivery pipe 10, the outside of delivery pipe 10 is equipped with second compatible layer 4, the end of delivery pipe 10 away from shell 1 is equipped with air bag 9, the outer wall of air bag 9 is equipped with first compatible layer 3, solid drug inlet 6 is equipped with placing block 5, one end of placing block 5 is fixedly connected with flexible pipe 8 one end, by being provided with liquid pipeline 11 and solid pipeline 12, when needing to treat patient's oviduct, air bag 9 one end is sent into the body of patient by delivery pipe 10, until air bag 9 is sent to the place needing to be treated, then air is injected into the inside of air bag 9 by catheter 2, air bag 9 expands and supports oviduct, when needing to deliver medicine, different pipelines are used according to the medicine needing to be injected, when needing to inject liquid medicine, the liquid needed to be used is injected into the inside of liquid pipeline 11 by liquid drug inlet 7, when needing to inject solid medicine, solid medicine is injected by solid drug inlet 6, by using different pipelines to inject medicine, prevent different medicines from mixing together to cause medicine pollution, reduce the use effect to patient, by being provided with placing groove and flexible pipe 8, when needing to deliver solid medicine to the place needing to be treated of patient, medicine is placed in the inside of placing block 5, then placing block 5 is placed into solid drug inlet 6 by solid drug inlet 6, flexible pipe 8 of one end of placing block 5 is pushed, and flexible pipe 8 pushes placing block 5 to move in solid pipeline 12, until it is moved to the outside of solid pipeline 12, and flexible pipe 8 is rotated, and flexible pipe 8 drives placing block 5 to rotate, and the medicine in the inside thereof is poured out to complete work, effectively prevent solid medicine from blocking pipeline, cause inconvenience and reduce work efficiency.

[0062] Further, one end of the shell 1 is fixedly connected to one end of the delivery pipe 10, the outer wall of the delivery pipe 10 is connected to the second compatible layer 4 by adhesion, the pipeline and the air bag 9 are made of medical material, the delivery pipe 10 can be extended as needed, the catheter 2 is in a sealed environment at the air bag 9, so that the air bag 9 can be effectively inflated.

[0063] Further, one end of the delivery pipe 10 is fixedly connected to one end of the air bag 9, the outer wall of the air bag 9 is connected to the first compatible layer 3 by adhesion, the existing oviduct balloon catheter 2 does not have hydrophilicity, when the balloon catheter 2 enters the inside of the human body, the human body will be uncomfortable, and the compatible layer prevents the balloon catheter 2 from being repelled by the human body.

[0064] Further, the solid medicine inlet 6 is connected to one end of the solid pipeline 12 by embedding on one side of the shell 1, and the other end of the solid pipeline 12 is connected to the air bag 9 by penetrating, the solid medicine inlet 6 and the solid pipeline 12 are used for conveying solid medicine, and the solid medicine and the liquid medicine are conveyed separately to prevent mixing and pollution.

[0065] Further, the liquid medicine inlet 7 is connected to the liquid pipeline 11 by embedding on the side of the shell 1 far from the solid medicine inlet 6, and the other end of the liquid pipeline 11 is connected to the air bag 9 by penetrating, the liquid medicine inlet 7 and the liquid pipeline 11 are used for conveying liquid medicine into the human body, and the solid medicine and the liquid medicine are conveyed separately by the liquid pipeline 11 and the liquid medicine inlet 7 to prevent mixing and pollution.

[0066] Further, one end of the catheter 2 penetrates the shell 1 far from the conveying pipe 10, and the other end of the catheter 2 is connected to the air bag 9 by penetrating, the catheter 2 is provided with a through hole at the air bag 9, and when the air bag 9 needs to be inflated, the catheter 2 is injected with gas by an external device, and the gas is injected into the air bag 9 through the through hole, and the air bag 9 is inflated.

[0067] Further, the placement block 5 is movably connected to the solid medicine inlet 6, one end of the placement block 5 is fixedly connected to the flexible pipe 8, the flexible pipe 8 can be extended as needed, and is used for pushing the placement block 5 to move in the solid pipeline 12 to convey solid medicine and prevent the solid medicine from blocking the pipeline.

[0068] Working principle: when using the device, first, the air bag 9 is sent into the human body through the conveying pipe 10 until the air bag 9 reaches the place where the patient needs to be treated, then air is injected into the catheter 2 by an external device, the air enters the air bag 9 through the through hole of the catheter 2, and the air bag 9 is inflated, when conveying medicine for treatment, different pipelines are used according to different medicines, when conveying solid medicine, the medicine to be conveyed is placed in the placement block 5, and then the placement block 5 is placed at the solid medicine inlet 6, the placement block 5 is pushed to move in the solid pipeline 12 by the flexible pipe, and then the placement block 5 is rotated to pour out the medicine in the placement block 5, and the flexible pipe 8 is pulled out to complete the conveying of the solid medicine, when conveying liquid medicine, the liquid medicine is injected into the liquid pipeline 11 through the liquid medicine inlet 7, and the liquid medicine enters the human body through the liquid pipeline 11, so that different medicines are conveyed separately to prevent mixing and pollution, and the medicine is prevented from blocking the pipeline.

[0069] The preparation raw material of the oviduct balloon catheter shell (1) with strong biocompatibility comprises 100 parts of thermoplastic resin, 3 parts of inorganic filler, 10 parts of paraffin substance, 2 parts of antioxidant, 1 part of antibacterial agent and 30 parts of curing agent.

[0070] The thermoplastic resin is selected from polylactide and polyurethane, and the weight ratio is 3:7.

[0071] The inorganic filler is mica powder and titanium dioxide, and the weight ratio is 1:1.

[0072] The mica powder is a coupling agent modified mica powder, and the titanium dioxide is a coupling agent modified titanium dioxide.

[0073] The preparation method of the modified mica powder and modified silicon dioxide is that the mica powder and silicon dioxide are mixed uniformly according to the weight ratio, 2% of the coupling agent and 16% of ethanol are added according to the total weight, and then the mixture is ultrasonically oscillated for 30 min and dried.

[0074] The coupling agent is selected from amino silane coupling agent and vinyl silane coupling agent in silane coupling agent, and the weight ratio is 1:1.

[0075] The amino silane coupling agent is N-(β-aminoethyl)-γ-aminopropyl trimethoxysilane.

[0076] The vinyl silane coupling agent is vinyl trimethoxysilane.

[0077] The paraffin substance is low molecular paraffin polyethylene glycol 200, model CY-040, purchased from Guangzhou Chen Yi New Material Co., Ltd.

[0078] The antioxidant is antioxidant 168, purchased from Zhenming Chemical Co., Ltd.

[0079] The antibacterial agent is polysiloxane quaternary ammonium salt, grade P0121611, purchased from Beijing Lingbao Technology Co., Ltd.

[0080] The polylactide is grade PLLA, purchased from Australia Hong Kong Plastic Chemical Co., Ltd.

[0081] The polyurethane is grade 8302, purchased from Guangzhou Shilun New Material Co., Ltd.

[0082] The mica powder is purchased from Baofeng Mica Processing Co., Ltd.

[0083] The silicon dioxide is grade QS-L200, purchased from Ximeng Chemical Co., Ltd.

[0084] The curing agent is trimethylolpropane tris(3-mercaptopropionic acid) ester.

[0085] The preparation method of the balloon tube shell (1) comprises the following steps:

[0086] S1: The above raw materials are added into a rubber mixing machine, the rubber mixing temperature is 30℃, the rubber mixing time is 30 min, and the discharge temperature is 100℃.

[0087] S2: The mixed raw materials in step S1 are poured into a mold, heated to 80℃, and cured for 4 h, and then demolded to obtain the product.

[0088] Example 2

[0089] The embodiment 2 discloses a fallopian tube balloon catheter with strong biocompatibility, and the difference between the specific embodiment and the embodiment 1 lies in that the preparation raw materials of the shell (1) comprise, by weight fraction: 101 parts of thermoplastic resin, 3.6 parts of inorganic filler, 13 parts of paraffin substance, 2.1 parts of antioxidant, 1.2 parts of antibacterial agent, and 32 parts of curing agent.

[0090] The thermoplastic resin is selected from polylactide and polyurethane, and the weight ratio is 3:10.

[0091] The inorganic filler is mica powder and titanium dioxide, and the weight ratio is 1:3.

[0092] The mica powder is a coupling agent modified mica powder, and the titanium dioxide is a coupling agent modified titanium dioxide.

[0093] The paraffin substance is polyethylene glycol 200, model CY-040, and is purchased from Guangzhou Chen Yi New Material Co., Ltd.

[0094] The antioxidant is antioxidant 168, and is purchased from Zhenming Chemical Co., Ltd.

[0095] The antibacterial agent is polysiloxane quaternary ammonium salt, model P0121611, and is purchased from Beijing Lingbao Technology Co., Ltd.

[0096] The polylactide is model PLLA, and is purchased from Australia Hong Kong Plastic Chemical Co., Ltd.

[0097] The polyurethane is model 8302, and is purchased from Guangzhou Shilun New Material Co., Ltd.

[0098] The mica powder is purchased from Baofeng Mica Processing Co., Ltd.

[0099] The silicon dioxide is model QS-L200, and is purchased from Ximeng Chemical Co., Ltd.

[0100] The preparation method of the modified mica powder and the modified silicon dioxide is that the mica powder and the silicon dioxide are mixed uniformly according to the weight ratio, 2% of a coupling agent and 16% of ethanol are added according to the total weight, ultrasonic oscillation is performed for 30 min, and then drying is performed to obtain the product.

[0101] The coupling agent is selected from amino silane coupling agent and vinyl silane coupling agent in silane coupling agent, and the weight ratio is 1:1.

[0102] The amino silane coupling agent is N-(β-aminoethyl)-γ-aminopropyl trimethoxysilane.

[0103] The vinyl silane coupling agent is vinyl trimethoxysilane.

[0104] The curing agent is trimethylolpropane tris(3-mercaptopropionic acid) ester.

[0105] The preparation method of the balloon tube shell (1) comprises:

[0106] S1: The above raw materials are added to a rubber mixing machine, the rubber mixing temperature is 45℃, the rubber mixing time is 42min, and the discharge temperature is 110℃.

[0107] S2: The mixed raw materials in step S1 are poured into a mold, heated to 87℃, and cured for 5h, and then demolded.

[0108] Example 3

[0109] The embodiment 3 discloses a fallopian tube balloon catheter with strong biocompatibility, and the difference between the specific embodiment and the embodiment 1 is that the preparation raw materials of the shell (1) comprise, by weight fraction: thermoplastic resin 100 parts, inorganic filler 3 parts, paraffin substance 10 parts, antioxidant 2 parts, antibacterial agent 1 part 2, and curing agent 40 parts.

[0110] The thermoplastic resin is selected from polylactide and polyurethane, and the weight ratio is 3:15.

[0111] The inorganic filler is mica powder and titanium dioxide, and the weight ratio is 1:5.

[0112] The mica powder is a coupling agent modified mica powder, and the titanium dioxide is a coupling agent modified titanium dioxide.

[0113] The preparation method of the modified mica powder and the modified silicon dioxide is that the mica powder and the silicon dioxide are mixed uniformly according to the weight ratio, 2% of the coupling agent and 16% of the ethanol are added according to the total weight, mixed and ultrasonically oscillated for 30min, and then dried to obtain the modified mica powder and the modified silicon dioxide.

[0114] The coupling agent is selected from amino silane coupling agent and vinyl silane coupling agent in silane coupling agent, and the weight ratio is 1:1.

[0115] The amino silane coupling agent is N-(β-aminoethyl)-γ-aminopropyl trimethoxysilane.

[0116] The vinyl silane coupling agent is vinyl trimethoxysilane.

[0117] The paraffin substance is low molecular paraffin polyethylene glycol 200, model CY-040, purchased from Guangzhou Chen Yi New Material Co., Ltd.

[0118] The antioxidant is antioxidant 168, purchased from Zhenming Chemical Co., Ltd.

[0119] The antibacterial agent is polysiloxane quaternary ammonium salt, brand P0121611, purchased from Beijing Lingbao Technology Co., Ltd.

[0120] The polylactide is brand PLLA, purchased from Australia Hong Kong Plastic Chemical Co., Ltd.

[0121] The polyurethane is brand 8302, purchased from Guangzhou Shilun New Material Co., Ltd.

[0122] The mica powder is purchased from Baofeng Mica Processing Co., Ltd.

[0123] The silicon dioxide is brand QS-L200, purchased from Ximeng Chemical Co., Ltd.

[0124] The curing agent is trimethylolpropane tris(3-mercaptopropionate).

[0125] The preparation method of the balloon tube shell (1) comprises:

[0126] S1: The above raw materials are added into a rubber mixing machine, the rubber mixing temperature is 50°C, the rubber mixing time is 60 min, and the discharge temperature is 120°C.

[0127] S2: The mixed raw materials in step S1 are poured into a mold, heated to 90°C, cured for 6 h, and demolded to obtain.

[0128] Comparative Example 1

[0129] The comparative example 1 discloses a fallopian tube balloon catheter with strong biocompatibility, and the difference between the specific embodiment and the embodiment 2 is that the mica powder is not modified.

[0130] Comparative Example 2

[0131] The comparative example 2 discloses a fallopian tube balloon catheter with strong biocompatibility, and the difference between the specific embodiment and the embodiment 2 is that the mica powder is C14-C18 modified mica powder.

[0132] The above only describes the preferred embodiments of the present application, and does not limit the implementation and protection scope of the present application. For those skilled in the art, it should be realized that any equivalent replacement and obvious changes made according to the content of the present application description and drawings should be included in the protection scope of the present application.

[0133] Performance test

[0134] 1. Skin Sensitization Test: According to ISO 10993-10 test method, the shell material prepared in Examples 1-3 and Comparative Examples 1-2 of the oviduct balloon catheter with strong biocompatibility in the application was subjected to skin sensitization test, and the test standard was whether skin erythema appeared.

[0135] 2. Intracutaneous Test Reaction: According to ISO 10993-10; 2022 test method, the shell material prepared in Examples 1-3 and Comparative Examples 1-2 of the oviduct balloon catheter with strong biocompatibility in the application was subjected to intracutaneous test, and the test standard was that the difference in the comprehensive average score of intracutaneous stimulation reaction was less than 1.0.

[0136] 3. Cytotoxicity Test: According to ISO 10993-5; 2009 test method, the shell material prepared in Examples 1-3 and Comparative Examples 1-2 of the oviduct balloon catheter with strong biocompatibility in the application was subjected to cytotoxicity test, and the test standard was that the number of normal cells was not less than 80% of the blank control group.

[0137] 4. Compression Deformation Test: According to GB / T7759.1-2015 test method, the shell material prepared in Examples 1-3 and Comparative Examples 1-2 of the oviduct balloon catheter with strong biocompatibility in the application was subjected to compression deformation test, and the results were recorded in Table 1.

[0138] Table 1

[0139]

Claims

1. A fallopian tube balloon catheter with strong biocompatibility, characterized by: The invention comprises a shell (1), a conduit (2) and a solid pipe (12), wherein the shell (1) is provided with a conduit (2), one side of the conduit (2) is provided with a liquid pipe (11), the side of the conduit (2) away from the liquid pipe (11) is provided with the solid pipe (12), one end of the solid pipe (12) is connected to the solid drug inlet (6) in a through-hole manner, and one end of the liquid pipe (11) is connected to the liquid drug inlet (7) in a through-hole manner, one end of the shell (1) is fixedly connected to the delivery pipe (10), the outside of the delivery pipe (10) is provided with a second compatible layer (4), the end of the delivery pipe (10) away from the shell (1) is provided with an air bag (9), the outer wall of the air bag (9) is provided with a first compatible layer (3), a placement block (5) is provided inside the solid drug inlet (6), and one end of the placement block (5) is fixedly connected to one end of the flexible tube (8); The raw materials for preparing the shell (1) include, by weight: 100-110 parts of thermoplastic resin, 3-7 parts of inorganic filler, 10-20 parts of paraffin wax, 2-6 parts of antioxidant, and 1-3 parts of antibacterial agent; The inorganic filler is mica powder and titanium dioxide, and the weight ratio thereof is 1:1-5; the mica powder is modified mica powder, and the titanium dioxide is coupling agent modified titanium dioxide; the coupling agent is selected from N-(β-aminoethyl)-γ-aminopropyltrimethoxysilane and vinyltrimethoxysilane among silane coupling agents, and the weight ratio thereof is 1:1; The thermoplastic resin is selected from polylactide and polyurethane, and the weight ratio thereof is 3:7-15.

2. The fallopian tube balloon catheter with strong biocompatibility according to claim 1, characterized in that: One end of the shell (1) is fixedly connected to one end of the delivery pipe (10), and the outer wall of the delivery pipe (10) is connected to the second compatible layer (4) by adhesion.

3. The fallopian tube balloon catheter with strong biocompatibility according to claim 1, characterized in that: One end of the delivery tube (10) away from the shell (1) is fixedly connected to one end of the airbag (9), and the outer wall of the airbag (9) is connected to the first compatible layer (3) by adhesion.

4. The biocompatible fallopian tube balloon catheter according to claim 1, characterized in that: The solid medicine inlet (6) penetrates one side of the shell (1) and is connected to one end of the solid pipe (12) in an embedded manner, and the end of the solid pipe (12) away from the solid medicine inlet (6) is connected to the air bag (9) in a penetrating manner.

5. The fallopian tube balloon catheter with strong biocompatibility according to claim 1, characterized in that: The liquid medicine inlet (7) penetrates the side of the shell (1) away from the solid medicine inlet (6) and is connected to the liquid pipeline (11) in an embedded manner, and the end of the liquid pipeline (11) away from the liquid medicine inlet (7) is connected to the air bag (9) in a penetrating manner.

6. The fallopian tube balloon catheter with strong biocompatibility according to claim 1, characterized in that: One end of the catheter (2) passes through the end of the shell (1) away from the delivery tube (10), and the end of the catheter (2) away from the shell (1) is connected to the airbag (9) in a penetrating manner, and a through hole is opened in the airbag (9).

7. The biocompatible balloon catheter for fallopian tube according to claim 1, characterized in that: The placement block (5) is movably connected to the solid medicine inlet (6), and one end of the placement block (5) is fixedly connected to the flexible tube (8).

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