Balloon for vascular access intervention

Abstract

The application relates to the technical field of medical devices, in particular to a balloon for vascular access intervention, which comprises an outer catheter, a cleaning pipe and a telescopic hose, one end of the outer catheter is provided with a guide wire connecting port, the cleaning pipe is arranged on the guide wire connecting port, and a guide head is fixedly connected to the end of the outer catheter far from the guide wire connecting port; medicine is smeared into a medicine applying groove, the medicine in the medicine applying groove will be attached to the inner wall of the blood vessel of a patient after the balloon body is inflated, covers the wound, avoids the elution of the medicine when the balloon body moves, and improves the use rate of the medicine.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a balloon for vascular access intervention. Background Technology

[0002] A balloon catheter is a tool used in endovascular angioplasty. It has been widely used in clinical medicine for percutaneous endovascular angioplasty and percutaneous coronary angioplasty. Under the guidance of medical imaging equipment, the balloon catheter is inserted into the narrowed part of the blood vessel using percutaneous puncture technique. Under close monitoring, the balloon is inflated to dilate the narrowed part of the blood vessel, thereby restoring the lumen diameter and accelerating blood flow.

[0003] When vascular access is compromised, balloon catheters are used for interventional treatment. Before use, medication is applied to the balloon, which is then delivered to the affected area via the catheter. However, due to the smooth surface of the balloon, the medication applied to the surface is easily washed away during the movement. When the balloon reaches the affected area, there is not enough medication remaining for treatment, resulting in low medication utilization. Consequently, the balloon needs to be re-intervened, which not only incurs significant costs but also causes extreme discomfort for the patient and poor treatment outcomes. Furthermore, removing the balloon can pull on the wound, easily leading to bacterial infection and various complications, thus affecting the treatment process. Summary of the Invention

[0004] To address the aforementioned problems in the existing technology, a balloon for vascular access intervention is provided.

[0005] The specific technical solution is as follows:

[0006] Design a balloon for vascular access intervention, including an external catheter, a cleaning tube, and a retractable flexible tube. One end of the external catheter is provided with a guidewire connection port, and the cleaning tube is provided on the guidewire connection port. A guide head is fixedly connected to the end of the external catheter away from the guidewire connection port. The guide head is covered with a skin-friendly layer. A balloon body is provided between the guide head and the guidewire connection port. A drug delivery tube is provided on one side of the balloon body. Two drug storage rings are provided at the end of the drug delivery tube near the guide head, and the retractable flexible tube is provided on the drug storage rings.

[0007] Preferably, the guidewire body is penetrated through the center of the guidewire connection port, the cleaning tube is located on the side of the guidewire body away from the drug delivery tube, and one end of the cleaning tube penetrates the guidewire connection port and communicates with the guidewire body.

[0008] Preferably, the drug delivery tube extends through the balloon body and connects the two drug storage rings.

[0009] Preferably, the telescopic hose is fixed around the outside of the drug storage ring, and the telescopic hose is hollow and penetrates through the inside of the drug storage ring.

[0010] Preferably, the balloon body has multiple drug-feeding grooves on its exterior, and the drug-feeding grooves are integrally formed and connected to the balloon body.

[0011] Preferably, a medicine outlet is provided between two adjacent medicine loading tanks, and the medicine outlet is fixedly connected to the end of the telescopic hose away from the medicine storage ring.

[0012] Preferably, the guidewire body penetrates the balloon body, the guide head, and the skin-friendly layer, and has a fluid outlet hole penetrating the guide head and the skin-friendly layer. The connection between the cleaning tube and the guidewire body extends to the end of the guidewire body near the guidewire connection port, which is solid, while the remaining parts are hollow.

[0013] Preferably, the skin-friendly layer comprises: polyvinyl alcohol, chitosan, epichlorohydrin, silane coupling agent, and additives.

[0014] Preferably, the additives include acetic acid and sodium hydroxide.

[0015] The polyvinyl alcohol has an average molecular weight of 120,000-220,000 and a degree of alcoholysis of 80-99%.

[0016] Preferably, the polyvinyl alcohol is at least one of PVA-1788, PVA-1799, PVA-2488, and PVA-2699.

[0017] More preferably, the polyvinyl alcohol is PVA-1788, with an average molecular weight of 170,000 and a degree of alcoholysis of 88%, purchased from Jinan Weixing Chemical Technology Co., Ltd.

[0018] Preferably, the weight-average molecular weight of the chitosan is 100,000 to 300,000.

[0019] More preferably, the chitosan has a weight-average molecular weight of 150,000 and was purchased from Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0020] A polyvinyl alcohol to chitosan weight ratio of 1:(1-3) can improve the lubrication and antibacterial properties of the coating. The amino and hydroxyl groups in the chitosan molecule can react with epichlorohydrin, and the hydroxyl groups in polyvinyl alcohol can also react with epichlorohydrin. In an alkaline reaction solution, the epoxy bonds in epichlorohydrin open and form ether bonds with chitosan, while the carbon-chlorine bonds in epichlorohydrin break, forming carbocations that etherify with the hydroxyl groups in PVA molecules. These two structures react to form a cross-linked three-dimensional network structure, which not only enhances the adhesion of the coating but also improves lubrication, preventing drug elution during balloon movement. This may be due to the higher cross-linking density reducing porosity, thus reducing friction with the vascular wall. Further research found that a polyvinyl alcohol to chitosan weight ratio of 1:2 results in a coating with higher antibacterial properties. This may be because some active groups in the chitosan macromolecule accumulate on the cell surface, affecting its metabolism. The positive charge of the amino groups interacts with the negatively charged biomolecules on the cell surface, altering cell permeability and chelating some essential metal elements for cell growth.

[0021] Preferably, the weight ratio of polyvinyl alcohol to chitosan is 1:(1-3).

[0022] More preferably, the weight ratio of polyvinyl alcohol to chitosan is 1:2.

[0023] The silane coupling agent includes: γ glycidoxypropyltrimethoxysilane, γ glycidoxypropyltriethoxysilane, γ-methacryloyloxypropyltrimethoxysilane, γ One or more of aminopropyltrimethoxysilanes.

[0024] More preferably, the silane coupling agent is γ-aminopropyltriethoxysilane (CAS: 919-30-2) and γ aminopropyltrimethoxysilane (CAS No.: 13822-56-5); γ-aminopropyltriethoxysilane and γ The weight ratio of aminopropyltrimethoxysilane is 1:(0.5-1.5).

[0025] More preferably, the silane coupling agent is γ-aminopropyltriethoxysilane and γ-aminopropyltriethoxysilane. The weight ratio of aminopropyltrimethoxysilane is 1:1.

[0026] The preparation of the skin-friendly layer includes the following steps:

[0027] S1, add polyvinyl alcohol to deionized water and stir to dissolve in a constant temperature water bath for 1-3 hours to prepare a 1-4 wt% polyvinyl alcohol aqueous solution.

[0028] S2, add chitosan to a 1-3 wt% aqueous acetic acid solution and stir at room temperature for 2-6 hours to prepare a 0.3-2 wt% chitosan aqueous solution;

[0029] S3, mix polyvinyl alcohol aqueous solution and chitosan aqueous solution at a certain mass ratio and stir at room temperature for 1-2 hours to obtain a mixed solution;

[0030] S4, add epichlorohydrin to the mixed solution, and add sodium hydroxide aqueous solution dropwise while stirring until the solution pH=9-12, and continue stirring for 0.2-1h to obtain the coating solution;

[0031] S5, Dissolve the silane coupling agent in deionized water to prepare a 1-4 wt% silane coupling agent aqueous solution;

[0032] S6, apply an aqueous solution of silane coupling agent to the guide head, and after drying, obtain a silane coupling agent coating;

[0033] S7. Apply the coating liquid to the silane coupling agent coating, and after drying, obtain the skin-friendly layer.

[0034] The weight ratio of the mixed solution to epichlorohydrin is 100:(0.5-2).

[0035] Preferably, the preparation of the skin-friendly layer includes the following steps:

[0036] S1, add polyvinyl alcohol to deionized water and stir to dissolve in a constant temperature (80℃) water bath for 2 hours to prepare a 2wt% polyvinyl alcohol aqueous solution.

[0037] S2, add chitosan to a 1 wt% aqueous acetic acid solution and stir at room temperature for 4 h to prepare a 4 wt% chitosan aqueous solution;

[0038] S3, mix 2wt% polyvinyl alcohol aqueous solution and 4wt% chitosan aqueous solution at a weight ratio of 1:1 and stir at room temperature for 1 hour to obtain a mixed solution;

[0039] S4, add epichlorohydrin to the mixed solution, and add 1wt% sodium hydroxide aqueous solution dropwise while stirring until the solution pH=10. Continue stirring for 1 hour to obtain the coating solution.

[0040] S5, Dissolve the silane coupling agent in deionized water to prepare a 2wt% silane coupling agent aqueous solution;

[0041] S6, apply an aqueous solution of silane coupling agent to the guide head, and after drying, obtain a silane coupling agent coating;

[0042] S7. Apply the coating liquid to the silane coupling agent coating, and after drying, obtain the skin-friendly layer.

[0043] Preferably, the weight ratio of the mixed solution to epichlorohydrin is 100:0.8.

[0044] The above technical solution has the following advantages or beneficial effects:

[0045] 1. Apply the medication to the medication tray. After the balloon body inflates, the medication in the medication tray will adhere to the inner wall of the patient's blood vessels and cover the wound, preventing the medication from being washed away when the balloon body moves, thus improving the utilization rate of the medication.

[0046] 2. When the drug is delivered through the infusion tube into the storage ring, the drug is then discharged onto the outer wall of the balloon body by the telescopic hose, so that the drug comes into contact with the patient's wound. This allows the drug to be completely applied to the affected area, improving the treatment effect while reducing the patient's discomfort.

[0047] 3. When the balloon body is removed, antibacterial and disinfectant drugs are injected through the cleaning tube. The drugs flow from the outlet to the inner wall of the patient's blood vessels, which can reduce the risk of bacterial infection and wound inflammation during balloon removal.

[0048] 4. A weight ratio of polyvinyl alcohol to chitosan of 1:(1-3) can improve the lubrication effect and antibacterial properties of the coating. Attached Figure Description

[0049] Embodiments of the invention will be described more fully with reference to the accompanying drawings. However, the drawings are for illustration and explanation only and do not constitute a limitation on the scope of the invention.

[0050] Figure 1 This is a schematic diagram of the structure of a balloon for vascular access intervention proposed in this invention;

[0051] Figure 2 This is a schematic diagram of the cross-sectional structure of a balloon for vascular access intervention proposed in this invention;

[0052] Figure 3 This is a schematic diagram of the internal components of a balloon for vascular access intervention proposed in this invention;

[0053] Figure 4 This is a schematic diagram of the internal components of a balloon catheter for vascular access intervention proposed in this invention.

[0054] The above-mentioned reference numerals indicate: external catheter 1, balloon body 2, drug loading tank 3, guidewire connection port 4, guidewire body 5, drug delivery tube 6, cleaning tube 7, drug outlet 8, skin-friendly layer 9, drug storage ring 10, guide head 11, telescopic hose 12, and liquid outlet 13. Detailed Implementation

[0055] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0056] It should be noted that, unless otherwise specified, the embodiments and features described in the present invention can be combined with each other.

[0057] 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 scope of the invention.

[0058] Example 1

[0059] Reference Figure 1-4 A vascular access interventional balloon includes an external catheter 1, a cleaning tube 7, and a retractable flexible tube 12. One end of the external catheter 1 is provided with a guidewire connection port 4, and the cleaning tube 7 is provided on the guidewire connection port 4. The end of the external catheter 1 away from the guidewire connection port 4 is fixedly connected to a guide head 11. The guide head 11 is covered with a skin-friendly layer 9. A balloon body 2 is provided between the guide head 11 and the guidewire connection port 4. A drug delivery tube 6 is provided on one side of the balloon body 2. The end of the drug delivery tube 6 near the guide head 11 is provided with two drug storage rings 10. The drug storage rings 10 are provided with retractable flexible tubes 12. The medication is applied and placed into the drug delivery tank 3. After the balloon body 2 inflates, the medication in the drug delivery tank 3 will adhere to the inner wall of the patient's blood vessel and cover the wound, preventing the medication from being washed away when the balloon body 2 moves, thus improving the medication utilization rate.

[0060] Furthermore, the guidewire body 5 is penetrated through the center of the guidewire connection port 4, and the cleaning tube 7 is located on the side of the guidewire body 5 away from the drug infusion tube 6. One end of the cleaning tube 7 passes through the guidewire connection port 4 and communicates with the guidewire body 5. The connection between the cleaning tube 7 and the guidewire body 5 allows external antibacterial drugs to be injected into the patient's blood vessels, which plays a very good role in antibacterial disinfection.

[0061] Furthermore, the drug delivery tube 6 penetrates the balloon body 2 and connects two drug storage rings 10. The drug storage rings 10 can conduct the drug from the drug delivery tube 6 into the telescopic flexible tube 12.

[0062] Furthermore, the telescopic hose 12 is fixed around the outside of the drug storage ring 10, and the telescopic hose 12 is hollow, penetrating and communicating with the inside of the drug storage ring 10. The telescopic hose 12 is made of the same material as the balloon body 2. It remains in a contracted state when the balloon body 2 is not inflated, and expands simultaneously with the collision of the balloon body 2, transmitting the drug to the drug outlet 8.

[0063] Furthermore, the balloon body 2 is provided with multiple drug delivery slots 3 on its exterior. The drug delivery slots 3 are integrally formed and connected to the balloon body 2. The drug delivery slots 3 can expand when the balloon body 2 is inflated, covering the patient's wound with the drugs carried inside, thus preventing the drugs from being washed away when the balloon body 2 moves.

[0064] Furthermore, a drug outlet 8 is provided between two adjacent drug loading tanks 3. The drug outlet 8 is fixedly connected to the end of the telescopic hose 12 away from the drug storage ring 10. The drug outlet 8 can transfer the drug to the outside of the balloon body 2 and apply the drug to the inner wall of the patient's blood vessels after the balloon body 2 is inflated.

[0065] Furthermore, the guidewire body 5 penetrates the balloon body 2, the guide head 11, and the skin-friendly layer 9, and an outlet hole 13 penetrates the guide head 11 and the skin-friendly layer 9. The connection between the cleaning tube 7 and the guidewire body 5 and the end of the guidewire body 5 near the guidewire connection port 4 is solid, while the rest is hollow. The skin-friendly layer 9 can reduce the stimulation to the patient when the guide head 11 enters the patient's body, thus improving comfort.

[0066] Working principle: When using this device, the medication is applied to the medication reservoir 3. Then, the device is inserted into the patient's opening from one end of the guide head 11. The external catheter 1 is continuously extended so that the uninflated balloon body 2 reaches the affected area. The balloon body 1 is inflated rapidly by the connection between the external pressure pump and the guidewire connection port 4. This causes the telescopic hose 12 to expand simultaneously, covering the wound with the medication in the medication reservoir 3. After the balloon body 2 expands, the medication is injected into the infusion tube 6. The medication flows from the infusion tube 6 to the storage ring 10, and then through the telescopic hose 12 to the outlet 8, adhering to the patient's wound. When removing the device, antibacterial disinfectant is injected into the cleaning tube 7. The medication flows with the cleaning tube 7 to the hollow part inside the guidewire body 5, and then from inside the guidewire body 5 to the outlet 13. As the device retracts, it disinfects the inner wall of the patient's blood vessels, reducing the risk of wound inflammation.

[0067] The skin-friendly layer 9 comprises: polyvinyl alcohol, chitosan, epichlorohydrin, silane coupling agent, and additives.

[0068] The additives include acetic acid and sodium hydroxide.

[0069] The polyvinyl alcohol mentioned is PVA-1788, with an average molecular weight of 170,000 and a degree of alcoholysis of 88%, purchased from Jinan Weixing Chemical Technology Co., Ltd.

[0070] The chitosan had a weight-average molecular weight of 150,000 and was purchased from Xi'an Tianzheng Pharmaceutical Excipients Co., Ltd.

[0071] The alkyl coupling agent is γ-aminopropyltriethoxysilane (CAS: 919-30-2) and γ aminopropyltrimethoxysilane (CAS No.: 13822-56-5); γ-aminopropyltriethoxysilane and γ The weight ratio of aminopropyltrimethoxysilane is 1:1.

[0072] The preparation of the skin-friendly layer includes the following steps:

[0073] S1, add polyvinyl alcohol to deionized water and stir to dissolve in a constant temperature (80℃) water bath for 2 hours to prepare a 2wt% polyvinyl alcohol aqueous solution.

[0074] S2, add chitosan to a 1 wt% aqueous acetic acid solution and stir at 25°C for 4 h to prepare a 4 wt% chitosan aqueous solution;

[0075] S3, mix 2wt% polyvinyl alcohol aqueous solution and 4wt% chitosan aqueous solution in a 1:1 weight ratio and stir at 25°C for 1 h to obtain a mixed solution;

[0076] S4, add epichlorohydrin to the mixed solution, and add 1wt% sodium hydroxide aqueous solution dropwise while stirring until the solution pH=10. Continue stirring for 1 hour to obtain the coating solution.

[0077] S5, Dissolve the silane coupling agent in deionized water to prepare a 2wt% silane coupling agent aqueous solution;

[0078] S6, the aqueous solution of silane coupling agent is coated onto the guide head 11, and dried at 60°C for 1 hour to obtain the silane coupling agent coating.

[0079] S7, the coating liquid is applied to the silane coupling agent coating, and after drying at 60°C for 1 hour, the skin-friendly layer 9 is obtained.

[0080] The weight ratio of the mixed solution to epichlorohydrin is 100:0.8.

[0081] The silane coupling agent coating has a thickness of 5 μm; the coating liquid has a thickness of 10 μm.

[0082] Example 2

[0083] The specific implementation method of this embodiment is the same as that of embodiment 1, except that in step S3, 2wt% polyvinyl alcohol aqueous solution and 4wt% chitosan aqueous solution are mixed at a weight ratio of 5:1 and stirred at 25°C for 1 hour to obtain a mixed solution.

[0084] Example 3

[0085] The specific implementation method of this embodiment is the same as that of Embodiment 1, except that the preparation of the skin-friendly layer includes the following steps:

[0086] S1, add polyvinyl alcohol to deionized water and stir to dissolve in a constant temperature (80℃) water bath for 2 hours to prepare a 2wt% polyvinyl alcohol aqueous solution to obtain the coating liquid;

[0087] S2, Dissolve the silane coupling agent in deionized water to prepare a 2wt% silane coupling agent aqueous solution;

[0088] S3, the aqueous solution of silane coupling agent is coated onto the guide head 11, and dried at 60°C for 1 hour to obtain the silane coupling agent coating.

[0089] S4. The coating liquid is applied to the silane coupling agent coating, and after drying at 60°C for 1 hour, the skin-friendly layer 9 is obtained.

[0090] The silane coupling agent coating has a thickness of 5 μm; the coating liquid has a thickness of 10 μm.

[0091] Performance Evaluation

[0092] 1. Determination of surface friction coefficient

[0093] The skin-friendly layers prepared in Examples 1-3 were placed on a friction panel and immersed in water. A speed was set, and the maximum tensile force within a 100mm stroke was recorded. The test was repeated 10 times and the average value was taken. The coefficient of friction (µ) was calculated according to formula (2): µ=F / W (2) F—the maximum arithmetic mean of the sample tensile force; W—the normal force of the sample. The test results are recorded in Table 1.

[0094] 2. Antibacterial performance test

[0095] Use Staphylococcus aureus ( S.aureus ) and Escherichia coli ( E. coli To evaluate the antibacterial properties of the skin-friendly layer, firstly, on a clean bench, 1 mL of bacterial suspension was taken from each sterilized pipette and poured into an agar plate, then evenly coated with a glass spreader. Next, 5 g of each of the coating solutions prepared in Examples 1-3 was placed on the agar surface. Finally, the agar plates (10 cm in diameter) were placed in a constant temperature incubator at 37°C for 24 hours, and the diameter (cm) of the inhibition zone was measured. The test results are recorded in Table 1.

[0096] Table 1

[0097]

Claims

1. A balloon for vascular access intervention, characterized in that: Includes an external catheter (1), a cleaning tube (7), and a telescopic hose (12). One end of the external catheter (1) is provided with a guidewire connection port (4), and the cleaning tube (7) is provided on the guidewire connection port (4). A guide head (11) is fixedly connected to the end of the external catheter (1) away from the guidewire connection port (4). The guide head (11) is wrapped with a skin-friendly layer (9). A balloon body (2) is provided between the guide head (11) and the guidewire connection port (4). A drug delivery tube (6) is provided on one side of the balloon body (2). The drug delivery tube (6) is close to... Two drug reservoir rings (10) are provided at one end of the guide head (11), and the telescopic hose (12) is provided on the drug reservoir rings (10); the guide wire connection port (4) is through the center of the guide wire body (5), the cleaning tube (7) is located on the side of the guide wire body (5) away from the drug delivery tube (6), and one end of the cleaning tube (7) passes through the guide wire connection port (4) and communicates with the guide wire body (5); the drug delivery tube (6) passes through the balloon body (2) and connects the two drug reservoir rings (10); the telescopic hose (12) surrounds the fixed The balloon body (2) is located outside the drug storage ring (10), and the telescopic hose (12) is hollow and penetrates through the inside of the drug storage ring (10); the balloon body (2) is provided with multiple drug loading grooves (3) on the outside, and the drug loading grooves (3) are integrally formed and connected to the balloon body (2); a drug outlet (8) is provided between two adjacent drug loading grooves (3), and the drug outlet (8) is fixedly connected to the end of the telescopic hose (12) away from the drug storage ring (10); the guide wire body (5) penetrates through the balloon body (2) and the guide head (11). The skin-friendly layer (9) has a liquid outlet hole (13) penetrating through it. The connection between the cleaning tube (7) and the guide wire body (5) is solid from the end of the guide wire body (5) near the guide wire connection port (4), while the rest is hollow. The skin-friendly layer (9) comprises: polyvinyl alcohol, chitosan, epichlorohydrin, silane coupling agent, acetic acid, and sodium hydroxide. The weight ratio of polyvinyl alcohol to chitosan is 1:(1-3). The silane coupling agent is γ-aminopropyltriethoxysilane and γ-aminopropyltriethoxysilane. aminopropyltrimethoxysilane; the γ-aminopropyltriethoxysilane and γ The weight ratio of aminopropyltrimethoxysilane is 1:(0.5-1.5).

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