Drug balloon catheter
By setting up multiple layers of drug sacs and membrane layers in the drug balloon catheter, the orderly release of drugs is achieved using coating bodies of different thicknesses and materials, and the problems of uneven drug release and limited drug dosage in the prior art are solved. , improves the drug delivery efficiency and therapeutic effect.
Patent Information
- Application Number
- CN202323546349.9
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- Filing Date
- 2023-12-25
- Publication Date
- 2024-12-27
- Estimated Expiration
- 2033-12-25
AI Technical Summary
During the drug release process, existing drug balloon catheters have problems such as limited dosage, difficulty in dissolution, and uneven release, resulting in insufficient adhesion of drugs on the inner wall of blood vessels, making it difficult to achieve effective drug delivery and control.
A drug balloon catheter was designed. By installing multiple layers of medicine sacs and membrane layers outside the balloon, the medicine sacs were wrapped with coating bodies of different thicknesses or materials, and the orderly release of drugs was achieved by using through holes on the membrane layer. Reduce drug loss and control drug release time through different materials and thicknesses of the coating body.
It realizes efficient and even distribution of drugs, reduces the loss of drugs during delivery, improves the controllability of drug release and the efficiency of drug delivery, can adjust the amount and time of drug release as needed, and adapts to the treatment of different lesion areas. need.
Smart Images
Figure CN222238532U_ABST
Abstract
Description
Technical Field
[0001] The utility model relates to the technical field of medical catheters, in particular to a drug balloon catheter. Background Art
[0002] At present, the most commonly used treatment for cardiovascular diseases is percutaneous transluminal angioplasty, which mainly includes drug-eluting stents and drug-eluting balloon catheters. Among them, drug-eluting balloon catheters use a minimally invasive intervention method to deliver anti-proliferative drugs to the area of vascular lesions using the balloon of the catheter. Through the expansion of the balloon, the drugs on the balloon are transferred to the inner wall of the blood vessel. Under the dual effects of balloon expansion and anti-proliferative drugs, it can achieve the purpose of treating vascular stenosis. It can effectively inhibit the excessive proliferation of smooth muscle cells and reduce the incidence of restenosis. There is no need to insert a stent and the risk of bleeding is low.
[0003] However, the drug balloon catheters of the prior art generally dope the drug with excipients and the like and then directly coat the drug on the outer surface of the balloon catheter to form a drug coating. When the drug reaches the drug release position, the drug layer formed on the surface dissolves first, and after dissolving, it is adhered to the inner wall of the blood vessel due to the squeezing force of the balloon. The drug dosage of this method is limited by the dissolution degree of the drug sprayed on the balloon surface. The amount of drug applied is limited. If a large dose is required, the balloon needs to stay for a longer time to dissolve more drugs in the relatively deep layer of the balloon surface. The drug as a coating is difficult to dissolve itself, which takes a long time and is not convenient for drug release. Utility Model Content
[0004] The purpose of the utility model is to provide a drug balloon catheter to solve the deficiencies in the prior art, thereby enabling convenient drug administration, and setting different coatings to different thicknesses or using different materials so that different coatings can release drugs at different times, thereby achieving control of drug release time, and through the setting of the membrane layer, the loss of drugs can be reduced during the process of being transported to the lesion site.
[0005] The drug balloon catheter provided by the utility model comprises:
[0006] catheter;
[0007] a balloon, disposed in the catheter;
[0008] The membrane layer is arranged outside the balloon and forms a containing space with the balloon; the membrane layer is provided with a plurality of through holes connecting the containing space with the outside of the membrane layer;
[0009] The medicine capsules are located in the accommodating space and are arranged in plurality, including a coating body and a medicine wrapped in the coating body. The accommodating space contains at least two medicine capsules with coating bodies of different thicknesses and / or the accommodating space contains at least two medicine capsules with coating bodies of different materials.
[0010] Furthermore, the aperture size of the through hole is between 100nm and 2000nm.
[0011] Furthermore, the medicine capsule is arranged on the outer surface of the balloon.
[0012] Furthermore, a plurality of the medicine capsules form multiple layers stacked on top of each other, and the medicine capsules are closely arranged.
[0013] Furthermore, the coating has a thickness of 0.1 μm to 5 μm.
[0014] Furthermore, the drug capsules having the same coating thickness are evenly distributed in the accommodating space.
[0015] Furthermore, the number of drug capsules with different coating thicknesses is different; as the thickness of the coating increases, the overall proportion of the number of drug capsules with the coating of this thickness tends to decrease.
[0016] Furthermore, the through holes are evenly arranged on the film layer.
[0017] Furthermore, the coating is one or more of paraffin, beeswax, stearic acid triglyceride, hydrogenated oil, lecithin, monoglyceride, diglyceride, maltodextrin, pullulan, cellulose, colloidal material and corresponding derivatives.
[0018] Furthermore, the coating may contain one or more drugs; the medicine capsule may have multiple layers of the coating, and the coating located relatively outside may simultaneously wrap multiple coatings located relatively inside.
[0019] Compared with the prior art, the drug is wrapped in a coating, and after the coating is ruptured, the drug can diffuse outward by diffusion, thereby achieving convenient drug administration, and different coatings are set to different thicknesses or use different materials so that different coatings can release drugs at different times, thereby achieving control of drug release time. In addition, the setting of the membrane layer can reduce the loss of drugs in the process of transporting them to the lesion site, and the setting of the membrane layer can make the drugs more orderly released outward through the through holes on the membrane layer after dissolution, and the drug release is better controllable. BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Figure 1 It is a schematic diagram of the structure of the drug balloon catheter disclosed in the embodiment of the utility model;
[0021] Figure 2 yes Figure 1 A partial enlarged view of the middle A;
[0022] Figure 3 yes Figure 1A partial enlarged view of point B in the middle;
[0023] Figure 4 It is a structural schematic diagram of the first drug balloon in the drug balloon catheter disclosed in the embodiment of the utility model;
[0024] Figure 5 It is a schematic structural diagram of a second drug balloon in the drug balloon catheter disclosed in the embodiment of the utility model;
[0025] Figure 6 It is a schematic structural diagram of a third drug balloon in the drug balloon catheter disclosed in the embodiment of the utility model;
[0026] Explanation of the reference numerals: 1 - catheter, 11 - inner tube, 12 - outer tube, 13 - fluid channel, 2 - balloon, 20 - balloon cavity, 3 - base, 31 - first inlet hole, 32 - second inlet hole, 4 - drug capsule, 40 - drug cavity, 41 - coating body, 5 - membrane layer, 50 - accommodating space. DETAILED DESCRIPTION
[0027] The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present invention, and should not be construed as limiting the present invention.
[0028] The utility model discloses a drug balloon catheter, such as Figure 1 As shown, it includes a catheter 1, a balloon 2 and a base 3, and the balloon 2 is arranged on the catheter 1. In this embodiment, the balloon 2 is arranged at the distal end of the catheter 1, and the catheter 1 includes an inner tube 11 and an outer tube 12 sleeved outside the inner tube 11, and a guide wire hole is arranged in the inner tube 11. The two ends of the balloon 2 are respectively fixed to the distal ends of the inner tube 11 and the outer tube 12, and a capsule cavity 20 is formed between the balloon 2 and the inner tube 11, and a fluid channel 13 connected with the capsule cavity 20 is formed between the inner tube 11 and the outer tube 12.
[0029] The base 3 is fixed to the proximal end of the catheter 1, and the catheter 3 has a first inlet hole 31 connected to the fluid channel 13 and a second inlet hole 32 connected to the guide wire hole. It should be emphasized here that the "proximal end" mentioned in the embodiment of the utility model refers to the end close to the operator during operation; the "distal end" refers to the end far away from the operator during operation.
[0030] The drug balloon catheter further comprises a plurality of drug capsules 4 and a membrane layer 5. The drug capsules 4 are located outside the balloon 2 and comprise a coating body 41 and a drug wrapped in the coating body 41. The coating body 41 has a drug cavity 40 and the drug is wrapped in the drug cavity 40.
[0031] The film layer 5 is arranged outside the medicine capsule 4 and between the medicine capsule 4 to form a accommodating space 50, and the film layer 5 is provided with a plurality of through holes connecting the accommodating space 50 with the outside of the film layer; the medicine capsule 4 is located in the accommodating space 50, and the accommodating space 50 contains at least two medicine capsules 4 with coating bodies 41 of different thicknesses and / or the accommodating space 50 contains at least two medicine capsules 4 with coating bodies 41 of different materials.
[0032] The coating 41 is a soluble material, which can be water-soluble or can be dissolved by human enzymes. The drug capsule 4 can enter the human body along with the balloon 2, and the coating 41 of the drug capsule 4 can be dissolved under the action of enzymes in the body fluids of the human body, and the drug in the drug cavity 40 can be released after the coating 41 is dissolved.
[0033] like Figure 4 As shown in FIG. 6 , the drug cavity 40 in the coating 41 is used to store the drug to be released. In this embodiment, the drug to be released includes anti-proliferation drugs such as paclitaxel and rapamycin. Since the coating 41 is a soluble material, the drug stored in the coating 41 can be released by diffusion after the coating 41 is dissolved. Compared with the drug coating formed on the surface of the balloon 2 by using excipients in the prior art, the drug release efficiency is better and the drug administration is more convenient.
[0034] In the present invention, the coating body 41 is set to different thicknesses so that the coating bodies 41 of different thicknesses have different dissolution and release times, thereby achieving control of the drug release time. In addition, by setting two coating bodies 41 of different materials, since the solubility of the different materials is also different, the dissolution time of the coating body 41 can also be controlled, thereby achieving control of the drug release time.
[0035] It should be noted that there are at least two factors that affect the dissolution efficiency: thickness and material. Therefore, when the materials are different, the thicknesses of different coatings can be the same or different. When the thicknesses and materials are different, different coatings 41 may dissolve at the same time, which should be avoided.
[0036] Therefore, in other embodiments, the drug capsule 4 disposed in the accommodating space 50 not only has a coating body 41 of various thicknesses, but also the materials of the coating bodies 41 of different drug capsules 4 can be different, as long as there are more than two coating bodies 41 with different dissolution times in the multiple drug capsules 4.
[0037] It should be noted that the particle size of the drug capsule 4 has no effect on the speed of dissolution and rupture of the coating 41, so there is no excessive restriction on the particle size of the drug capsule 4, and the drug capsules of corresponding sizes can be set according to the actual needs of the user to provide different amounts of medication, thereby achieving the effect of personalized treatment for patients. The same drug can be stored in different coatings 41, and when storing different drugs, if the coatings of the drug capsules 4 storing two different drugs dissolve at different times, the corresponding drugs can be supplied at different locations as needed, thereby achieving a better treatment effect.
[0038] In this embodiment, the material of the coating body 41 is one of paraffin, beeswax, triglyceride of stearic acid, hydrogenated oil, lecithin, monoglyceride, diglyceride, maltodextrin, pullulan, cellulose, colloid and other materials and corresponding derivatives. Of course, it can be understood that the material of the coating body 41 can also be a mixture of multiple materials mentioned above. Since different materials are accompanied by different decomposition rates, the release time and release amount of the drug in the drug capsule 4 can be controlled.
[0039] Since human body fluids contain a variety of enzymes, including amylase, lipase, protease and other biological enzymes, in order to better utilize these enzymes in the body fluids to dissolve the coating 41, the materials of the coating 41 listed above are mainly starch-based, fat-based, and protein-based. The coating 41 is dissolved by using a variety of biological enzymes in the human body.
[0040] As a preferred solution, the material of the coating 41 is made of starch-based, fat-based, and protein-based materials in different proportions, and the coating 41 may contain two or three of the starch-based, fat-based, and protein-based materials. Such a setting enables multiple enzymes in the body fluid to simultaneously act on the dissolution of the coating 41, thereby improving the dissolution efficiency of the coating 41.
[0041] In this embodiment, the material of the coating body 41 is made of starch-based, fat-based, and protein-based materials in a ratio of 1:1:1.
[0042] In order to facilitate the movement of the drug capsule 4 with the balloon 1, the drug capsule 4 is directly arranged on the outer surface of the balloon. A microcapsule process can be used, and the drug is wrapped in a coating 41 to prepare a microcapsule-type drug capsule 4. The drug capsule 4 uses a coating 41 of various materials or a coating 41 of various thicknesses to form various types of drug capsules 4, and the various types of drug capsules 4 are sprayed onto the surface of the balloon 2 by ultrasonic spraying.
[0043] The specific preparation method of the microcapsule-type drug capsule 4 can be one of the following: spray drying method, air suspension method, inclusion complexation method, interfacial polymerization method, in-situ polymerization method, coacervation method, oil phase separation method, etc.
[0044] Furthermore, in order to better realize the supply of drugs, after the spraying of the microcapsule-type drug capsule 4 is completed, the drug can be directly sprayed on the outside of the balloon 2. Specifically, paclitaxel or rapamycin is selected as the anti-proliferation drug, doped with excipients, and sprayed on the surface of the balloon 2 and the drug capsule 4 by ultrasonic spraying, and a drug coating is formed in the gap between the drug capsules 4 and the outer surface of the drug capsule 4. Of course, in other embodiments, the drug can also be directly sprayed on the outside of the balloon 2 to form a drug coating, and then the drug capsule 4 is sprayed on the surface of the drug coating.
[0045] The above embodiment actually uses two types of drugs to achieve drug administration, which can make the drug release more efficient. During the dissolution of the coating 41, the drug coating directly sprayed on the outer surface of the balloon 2 or the drug capsule 4 can be dissolved and released first to achieve drug administration, and then the coating 41 is released to achieve further drug administration.
[0046] In this embodiment, after the drug is arranged on the balloon 2, the film layer 5 is fixed on the balloon 2, and the film layer 5 is covered on the outside of the drug capsule 4 to form a cover for the drug capsule 4. The setting of the film layer 5 can protect the drug capsule 4 sprayed on the outer surface of the balloon 2, thereby preventing the balloon 2 from being dissolved by the solution during the intermediate process of being transported to the administration position, delaying the dissolution and release of the drug capsule 4, and ensuring that the loss of the drug is reduced during the transportation of the balloon 2, thereby reducing the loss of the drug.
[0047] In addition, the presence of the membrane layer 5 can filter the body fluid through the through holes set thereon, for example, by setting the size of the pores, the macromolecular substances in the body fluid can be filtered out, and only relatively small molecular substances can be passed through, so as to better achieve the dissolution of the coating 41 of the drug capsule 4. In a specific embodiment, the pore size of the through hole ranges from 100nm to 2000nm. The main purpose of setting the pore size of the through hole to be greater than 100nm is to enable various biological enzymes in the blood to pass through the through hole, and the main purpose of setting the pore size to be less than 2000nm is to filter out some macromolecular proteins in the blood, so as to prevent the protein from entering the accommodating space through the through hole and thus affecting the release of the drug from the through hole.
[0048] After the balloon 2 reaches the drug administration position, the fluid entering from the fluid channel 13 fills the balloon 2, and the biological enzymes such as lipase, protease, and amylase in the blood enter the accommodating space 50 through the through holes of the membrane layer 5 to dissolve the drug capsule 4 in the accommodating space 50. The coating 41 of the drug capsule 4 is dissolved and ruptured, and the drug stored in the coating 41 will be released into the accommodating space 50. When the osmotic pressure of the drug in the accommodating space 50 is higher than that outside the membrane layer 5, the drug will flow out along the through holes of the membrane layer 5 to the vascular endothelium to exert its effect, thereby achieving the effect of inhibiting hyperplasia.
[0049] The utility model utilizes the osmotic pressure difference to make the drug flow out of the through hole of the membrane layer 5 to the vascular endothelium to exert its effect. Due to the arrangement of the membrane layer, the drug can be released outward through the through hole on the membrane layer in a more orderly manner after being dissolved, and the drug release is more controllable.
[0050] By changing the ratio of drugs in different medicine capsules 4 and the material of the coating 41 of the medicine capsule 4, the enzyme will decompose the coating 41 of different materials over time, and the drugs inside the coating 41 will be gradually released, so as to achieve controllable drug release. Users can control the amount of decomposed medicine capsules 4 by changing the expansion and pressure holding time according to the degree of stenosis of the patient, and finally control the release amount of the drug to achieve the best treatment effect.
[0051] It should be noted that when setting the membrane layer 5, due to the presence of the membrane layer 5, the medicine capsule 4 set in the accommodating space 50 can be chosen not to be arranged on the outer surface of the balloon 2. The medicine capsule 4 can be placed directly in the accommodating space 50, and the medicine capsule 4 can move in the accommodating space 50 without fixing the position of the medicine capsule 4.
[0052] In order to better control the drug release, it is generally chosen to arrange the drug capsules 4 on the outer surface of the balloon 2, and the drug capsules 4 are also stacked and tightly arranged together, the drug capsules 4 are bonded to each other, all the drug capsules 4 are tightly arranged into multiple layers, and the drug capsules 4 are connected and fixed to each other.
[0053] In the prior art, the amount of drug administered is limited, because the drug is mainly dissolved by the balloon 2 after expansion, so that part of the drug is adhered to the blood vessel wall, and only the outermost layer of the drug on the balloon 2 can be used by the blood vessel wall, so the amount of drug administered is limited. In this embodiment, as the amount of drug released after the coating 41 is dissolved increases, the concentration is increased, and the drug is released under the action of the concentration difference. This has the advantage of being able to release more drugs, and the drugs in the relatively lower layer of the tightly arranged multi-layer drug capsules 4 can also be released.
[0054] The coating 41 can contain the same drug, and the same drug can be controlled in amount according to the length of time by setting coatings of different thicknesses or coatings of different materials. Of course, different drugs can also be contained in the coating 41, and coatings of different thicknesses can be set as needed, so as to release different drugs at different stages, thereby achieving better therapeutic effects.
[0055] In a specific embodiment, the coating bodies 41 of different thicknesses are evenly distributed in the accommodating space 50. When the coating bodies 41 are directly arranged on the outer surface of the balloon 2, the coating bodies 41 are evenly distributed on the outer surface of the balloon 2. When the drug capsules 4 are closely arranged in multiple layers, the coating bodies 41 of different thicknesses are also evenly distributed in the three-dimensional space of the accommodating space 50.
[0056] It can be understood that the through holes are also evenly distributed on the film layer 5 , and the even distribution of the coating bodies 41 of different thicknesses, combined with the even distribution of the through holes on the film layer 5 , can make the drug release more even.
[0057] In this embodiment, the thickness of the coating 41 is between 0.1 μm and 5 μm. And the number of coatings 41 of different thicknesses is different. Specifically, as the thickness of the coating 41 increases, the overall proportion of the number of coatings of this thickness decreases accordingly. The overall proportion here refers to the proportion of the coating of this thickness to all coatings of all thicknesses. Such a structural setting can make the release amount of the drug before the start large enough, so as to better achieve the therapeutic effect.
[0058] The drug volume of this drug balloon is 10 times larger than that of ordinary drug balloons, so most diseases can be treated after the coating with a very small thickness is dissolved. If the doctor thinks that treatment is still necessary, he can wait for a certain period of time. As time goes by, the overall release amount of the drug gradually increases, and the two are positively correlated.
[0059] In a specific embodiment, the coating body 41 with a thickness of 0.1 μm accounts for 30%, the coating body 41 with a thickness of 0.5 μm accounts for 20%, the coating body 41 with a thickness of 1 μm accounts for 15%, the coating body 41 with a thickness of 2 μm accounts for 15%, the coating body 41 with a thickness of 4 μm accounts for 10%, and the coating body 41 with a thickness of 5 μm accounts for 10%.
[0060] The medicine capsule 4 has various forms, such as Figure 4 As shown, only one drug can be encapsulated in a coating 41, and the drug is completely filled in the coating 41 to form a single-core drug capsule 4. Figure 5 As shown, the drug can also be formed into spheres of different sizes, which are encapsulated in a coating to form a multi-core drug capsule. The drugs formed into spheres of multiple different sizes can be one drug or different kinds of drugs.
[0061] Of course, in other embodiments, such as Figure 6 As shown, the drug capsule 4 has a multi-layer coating 41, and the coating 41 located relatively outside can simultaneously wrap multiple relatively inside coatings 41. The multi-layer coating 41 can also control the release time of the drug in the drug capsule 4 to a certain extent.
[0062] In a specific embodiment, a plurality of coating bodies 41 may share a large outer coating body 41 , and the coating bodies 41 located relatively inside may contain different drugs or the same drug.
[0063] The above describes in detail the structure, features and effects of the utility model based on the embodiments shown in the drawings. The above is only a preferred embodiment of the utility model, but the utility model is not limited to the scope of implementation shown in the drawings. Any changes made in accordance with the concept of the utility model, or modifications to equivalent embodiments with equivalent changes, which still do not exceed the spirit covered by the description and the drawings, should be within the protection scope of the utility model.
Claims
1. A drug balloon catheter, characterized in that: include: catheter; a balloon, disposed in the catheter; A membrane layer, disposed outside the balloon and forming a containing space between the balloon; The film layer is provided with a plurality of through holes connecting the accommodating space with the outside of the film layer; The medicine capsules are located in the accommodating space and are arranged in plurality, including a coating body and a medicine wrapped in the coating body. The accommodating space contains at least two medicine capsules with coating bodies of different thicknesses and / or the accommodating space contains at least two medicine capsules with coating bodies of different materials.
2. The drug balloon catheter according to claim 1, characterized in that: The aperture of the through hole ranges from 100 to 2000 nm.
3. The drug balloon catheter according to claim 1, characterized in that: The medicine bag is arranged on the outer surface of the balloon.
4. The drug balloon catheter according to claim 3, characterized in that: A plurality of the medicine capsules form multiple layers stacked on each other, and the medicine capsules are closely arranged.
5. The drug balloon catheter according to claim 1, characterized in that: The coating has a thickness of 0.1 μm to 5 μm.
6. The drug balloon catheter according to claim 1, characterized in that: The drug capsules with the same coating thickness are evenly distributed in the accommodating space.
7. The drug balloon catheter according to claim 1, characterized in that: The number of drug capsules with different coating thicknesses is different; as the thickness of the coating increases, the overall proportion of the number of drug capsules with the coating of this thickness tends to decrease.
8. The drug balloon catheter according to claim 1, characterized in that: The through holes are evenly arranged on the film layer.
9. The drug balloon catheter according to claim 1, characterized in that: One or more drugs may be wrapped in the coating; the medicine capsule may have multiple layers of the coating, and the coating located relatively on the outside may simultaneously wrap multiple coatings located relatively on the inside.