CN117258121B - Double-layer medicine saccule with medicine cavity - Google Patents
Double-layer medicine saccule with medicine cavity Download PDFInfo
- Publication number
- CN117258121B CN117258121B CN202311562444.XA CN202311562444A CN117258121B CN 117258121 B CN117258121 B CN 117258121B CN 202311562444 A CN202311562444 A CN 202311562444A CN 117258121 B CN117258121 B CN 117258121B
- Authority
- CN
- China
- Prior art keywords
- balloon
- layer
- medicine
- drug
- sacculus
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000003814 drug Substances 0.000 title claims abstract description 159
- 210000005077 saccule Anatomy 0.000 title description 4
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 19
- 239000010410 layer Substances 0.000 claims description 128
- 229940079593 drug Drugs 0.000 claims description 72
- 238000004873 anchoring Methods 0.000 claims description 20
- 239000002355 dual-layer Substances 0.000 claims description 13
- 238000000576 coating method Methods 0.000 claims description 8
- 238000003860 storage Methods 0.000 claims description 8
- 239000011248 coating agent Substances 0.000 claims description 7
- 208000037803 restenosis Diseases 0.000 claims description 2
- 238000011049 filling Methods 0.000 abstract description 10
- 238000000151 deposition Methods 0.000 abstract description 3
- 238000010030 laminating Methods 0.000 abstract description 2
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 18
- 230000000052 comparative effect Effects 0.000 description 16
- 239000011259 mixed solution Substances 0.000 description 11
- XZWYZXLIPXDOLR-UHFFFAOYSA-N metformin Chemical compound CN(C)C(=N)NC(N)=N XZWYZXLIPXDOLR-UHFFFAOYSA-N 0.000 description 9
- 229960003105 metformin Drugs 0.000 description 9
- 238000005507 spraying Methods 0.000 description 9
- 230000000694 effects Effects 0.000 description 8
- 238000000034 method Methods 0.000 description 8
- 238000011068 loading method Methods 0.000 description 6
- 239000000243 solution Substances 0.000 description 6
- 229920001800 Shellac Polymers 0.000 description 5
- 239000000412 dendrimer Substances 0.000 description 5
- 229920000736 dendritic polymer Polymers 0.000 description 5
- DGAIEPBNLOQYER-UHFFFAOYSA-N iopromide Chemical compound COCC(=O)NC1=C(I)C(C(=O)NCC(O)CO)=C(I)C(C(=O)N(C)CC(O)CO)=C1I DGAIEPBNLOQYER-UHFFFAOYSA-N 0.000 description 5
- 229960002603 iopromide Drugs 0.000 description 5
- ZAHRKKWIAAJSAO-UHFFFAOYSA-N rapamycin Natural products COCC(O)C(=C/C(C)C(=O)CC(OC(=O)C1CCCCN1C(=O)C(=O)C2(O)OC(CC(OC)C(=CC=CC=CC(C)CC(C)C(=O)C)C)CCC2C)C(C)CC3CCC(O)C(C3)OC)C ZAHRKKWIAAJSAO-UHFFFAOYSA-N 0.000 description 5
- ZLGIYFNHBLSMPS-ATJNOEHPSA-N shellac Chemical compound OCCCCCC(O)C(O)CCCCCCCC(O)=O.C1C23[C@H](C(O)=O)CCC2[C@](C)(CO)[C@@H]1C(C(O)=O)=C[C@@H]3O ZLGIYFNHBLSMPS-ATJNOEHPSA-N 0.000 description 5
- 229940113147 shellac Drugs 0.000 description 5
- 235000013874 shellac Nutrition 0.000 description 5
- 239000004208 shellac Substances 0.000 description 5
- 229960002930 sirolimus Drugs 0.000 description 5
- QFJCIRLUMZQUOT-HPLJOQBZSA-N sirolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1C[C@@H](C)[C@H]1OC(=O)[C@@H]2CCCCN2C(=O)C(=O)[C@](O)(O2)[C@H](C)CC[C@H]2C[C@H](OC)/C(C)=C/C=C/C=C/[C@@H](C)C[C@@H](C)C(=O)[C@H](OC)[C@H](O)/C(C)=C/[C@@H](C)C(=O)C1 QFJCIRLUMZQUOT-HPLJOQBZSA-N 0.000 description 5
- XOOUIPVCVHRTMJ-UHFFFAOYSA-L zinc stearate Chemical compound [Zn+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O XOOUIPVCVHRTMJ-UHFFFAOYSA-L 0.000 description 5
- 238000000338 in vitro Methods 0.000 description 4
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 230000003902 lesion Effects 0.000 description 3
- 238000011056 performance test Methods 0.000 description 3
- 229920000962 poly(amidoamine) Polymers 0.000 description 3
- 210000004351 coronary vessel Anatomy 0.000 description 2
- 238000012377 drug delivery Methods 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
- 229960003444 immunosuppressant agent Drugs 0.000 description 2
- 230000001861 immunosuppressant effect Effects 0.000 description 2
- 239000003018 immunosuppressive agent Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 235000019359 magnesium stearate Nutrition 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000009286 beneficial effect Effects 0.000 description 1
- 238000005253 cladding Methods 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 238000002425 crystallisation Methods 0.000 description 1
- 230000008025 crystallization Effects 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000032798 delamination Effects 0.000 description 1
- 238000003618 dip coating Methods 0.000 description 1
- 238000009826 distribution Methods 0.000 description 1
- 238000010828 elution Methods 0.000 description 1
- 229920002521 macromolecule Polymers 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 239000007921 spray Substances 0.000 description 1
- 231100000216 vascular lesion Toxicity 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M25/1027—Making of balloon catheters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
Abstract
The application discloses take double-deck medicine sacculus of medicine chamber, including the sacculus body, the sacculus body includes sacculus skin and sacculus inlayer, and a plurality of micropores have been seted up to the sacculus skin, the sacculus inlayer is located the sacculus skin inboard, is formed with the medicine chamber with the micropore intercommunication between sacculus skin and the sacculus inlayer, and the sacculus inlayer fills the back, and sacculus skin and sacculus inlayer are at least incomplete laminating, and the medicine chamber keeps certain medicine space of depositing, and this take double-deck medicine sacculus of medicine chamber can keep certain medicine space of depositing in medicine chamber homoenergetic around filling, and sacculus inlayer and sacculus skin can not closely laminate after the sacculus fills, and the medicine chamber is used for releasing the medicine with the micropore intercommunication, consequently is difficult for damaging the blood vessel when filling medicine in convenient treatment simultaneously to the medicine chamber.
Description
Technical Field
The application relates to the technical field of medical instruments, in particular to a double-layer medicine balloon with a medicine cavity.
Background
For calcified lesions, the existing treatment methods include a common balloon Gao Yakuo, a double-guide-wire balloon expansion, a cutting balloon expansion, a coronary rotational atherectomy and the like. In order to improve the treatment effect, a medicine balloon is increasingly adopted, and the balloon and the medicine are combined for treatment.
The patent application document with the publication number of CN211131355U discloses a double-layer medicine balloon, including a catheter and a double-layer balloon axially arranged along the outer wall of the catheter, the balloon cladding is of a closed structure outside the catheter, the balloon can be expanded and expanded after air or liquid is introduced, the narrow part of a blood vessel is expanded, the double-layer balloon comprises an inner balloon and an outer balloon which are mutually clad, after the balloon is sent into a focus position, the balloon is inflated into the balloon through a balloon filling channel to expand, an outer cavity is formed between the inner balloon and the outer balloon after the inner balloon is expanded, an inner cavity is formed in the inner balloon, the two cavities are isolated, the outer cavity is used as a medicine cavity, but after the inner balloon and the outer balloon are expanded, the inner balloon and the outer balloon are subjected to pressure in the balloon and pressure of the blood vessel wall, the outer balloon and the outer wall of the medicine are tightly attached to each other, at the moment, the inner balloon and the outer balloon need to be overcome, the pressure in the balloon and the pressure of the blood vessel wall are not easily controlled, and the blood vessel is not easily damaged, and the risk is not easy to be smoothly treated.
Disclosure of Invention
The utility model aims at providing a take double-deck medicine sacculus of medicine chamber, after the sacculus fills, the medicine chamber keeps certain medicine space of depositing, is convenient for deposit and the blowout of medicine, is difficult for damaging the blood vessel.
In order to achieve the above purpose, the present application provides the following technical solutions: the utility model provides a take double-deck medicine sacculus of medicine chamber, includes the sacculus body, the sacculus body includes sacculus skin and sacculus inlayer, and a plurality of micropores have been seted up to the sacculus skin, the sacculus inlayer is located the sacculus skin inboard, is formed with the medicine chamber with micropore intercommunication between sacculus skin and the sacculus inlayer, and the sacculus inlayer fills the back, and sacculus skin and sacculus inlayer are at least incomplete laminating, and the medicine chamber keeps certain medicine space.
The double-layer medicine balloon with the medicine cavity can keep a certain medicine storage space in the medicine cavity before and after filling, the outer layer of the balloon and the outer layer of the balloon can not be tightly attached after the balloon is filled, and the medicine cavity is communicated with the micropores for releasing medicine, so that blood vessels are not easily damaged when medicine is filled into the medicine cavity at the same time of convenient treatment.
Further, the surface of one side of the balloon outer layer, which is close to the balloon inner layer, is smooth, and the surface of one side of the balloon inner layer, which is close to the balloon outer layer, is uneven, after the balloon is filled, the surface of the balloon inner layer is uneven, a plurality of pits appear, so that a certain medicine storage space is kept in a medicine cavity between the balloon inner layer and the balloon outer layer, and the existence of the medicine cavity ensures that the blood vessel is not easily damaged due to overlarge pressure in the process of treatment.
Further, the surface of one side of the inner layer of the balloon, which is close to the outer layer of the balloon, is a smooth surface with a plurality of grooves, and when the balloon is filled, the grooves form an uneven structure.
Further, the grooves are spiral grooves.
Further, one side of the balloon outer layer, which is far away from the balloon inner layer, is provided with a plurality of anchoring pieces, after the balloon is filled, the anchoring pieces are attached to the inner wall of the blood vessel after the balloon outer layer is attached to the inner wall of the blood vessel, the anchoring pieces are supported between the balloon outer layer and the inner wall of the blood vessel in a stressed manner, the balloon outer layer is extruded towards the balloon inner layer, the balloon outer layer is close to the balloon inner layer at the extruded position, and the balloon outer layer is far away from the balloon inner layer at the position without the anchoring pieces, so that the medicine cavity is divided into a plurality of sub-medicine cavities.
Further, the anchoring piece is of a strip structure with a triangular cross section, the anchoring piece is arranged in parallel with the outer layer of the balloon, one side surface of the anchoring piece is connected with the outer layer of the balloon, and the anchoring piece is made of a high polymer material.
Further, the surface of one side of the outer layer of the balloon, which is close to the inner layer of the balloon, is uneven, the surface of one side of the inner layer of the balloon, which is close to the outer layer of the balloon, is smooth, and after the balloon is filled, the surface of the outer layer of the balloon is uneven, a plurality of pits appear, so that a certain medicine storage space is kept in a medicine cavity between the inner layer of the balloon and the outer layer of the balloon.
Further, be equipped with a plurality of support pieces between sacculus inlayer and the sacculus inlayer, after the sacculus fills, support piece supports between sacculus inlayer and the sacculus inlayer, and a plurality of support pieces make sacculus inlayer and the sacculus skin at least not laminate completely for the medicine cavity keeps certain medicine space.
Further, the cross section of the supporting piece is of a cylindrical strip structure, the supporting piece, the outer layer of the balloon and the inner layer of the balloon are all arranged in parallel, and the supporting piece is made of high polymer materials.
Further, the inner balloon layer is made of a non-compliant or semi-compliant balloon material, and the outer balloon layer is made of a compliant/super-compliant balloon material.
Further, a drug coating for treating restenosis is formed on the surface of one side of the balloon outer layer, which is far away from the balloon inner layer.
Further, the drug coating comprises 1.5-5% of shellac, 9-20% of zinc stearate or magnesium stearate, 15-35% of iopromide, 15-35% of immunosuppressant sirolimus, 15-35% of dendrimer and 9-20% of metformin by mass percent.
Further, the application also provides a preparation method of the drug balloon, wherein the balloon body is filled to 6-14atm, 1.5-5% of shellac, 9-20% of zinc stearate or magnesium stearate, 15-35% of iopromide, 15-35% of immunosuppressant sirolimus, 15-35% of dendritic macromolecule and 9-20% of metformin are fully dissolved in methanol to form a mixed solution, and the mixed solution is coated on the outer surface of the balloon body in a dip-coating, air pressure spraying or ultrasonic spraying mode to form a drug coating.
Compared with the prior art, the beneficial effects of this application are:
the double-layer medicine balloon with the medicine cavity can keep a certain medicine storage space before and after filling, the outer layer of the balloon can not be tightly attached to the outer layer of the balloon after filling, and the medicine cavity is communicated with the micropores for releasing medicine, so that blood vessels are not easily damaged when medicine is filled into the medicine cavity at the same time of convenient treatment;
the arrangement of the anchoring piece and the supporting piece of the double-layer medicine saccule with the medicine cavity not only ensures that a certain medicine storage space is maintained by the medicine cavity, but also plays a role in concentrating stress to provide higher pressure to crush lesions.
Drawings
FIG. 1 is a schematic longitudinal sectional view of a double-layer drug balloon with a drug cavity according to an embodiment of the present application;
FIG. 2 is an enlarged view of portion A of FIG. 1;
FIG. 3 is a schematic cross-sectional view of a dual-layer drug balloon with drug lumen prior to filling in accordance with an embodiment of the present application;
FIG. 4 is a schematic cross-sectional view of a filled double-layered drug balloon with drug lumen according to the first embodiment of the present application;
FIG. 5 is a schematic longitudinal sectional view of a double-layered drug balloon with drug lumen according to a second embodiment of the present application;
FIG. 6 is a schematic cross-sectional view of a dual-layer drug balloon with drug lumen prior to filling in accordance with embodiment II of the present application;
FIG. 7 is a schematic cross-sectional view of a filled dual-layer drug balloon with drug lumen according to embodiment II of the present application;
FIG. 8 is a schematic longitudinal sectional view of a double-layer drug balloon with a drug lumen according to a third embodiment of the present application;
FIG. 9 is a schematic cross-sectional view of a dual-layer drug balloon with drug lumen prior to filling in accordance with embodiment III of the present application;
FIG. 10 is a schematic cross-sectional view of a filled dual-layer drug balloon with drug lumen according to embodiment III of the present application;
fig. 11 is a graph of the effect of spraying the surface of the drug balloon according to the fourth embodiment of the present application;
fig. 12 is a graph showing the effect of spraying the surface of the drug balloon according to the fifth embodiment of the present application;
fig. 13 is a graph showing the effect of spraying the surface of the drug balloon in the sixth embodiment of the present application;
FIG. 14 is a graph showing the effect of spray coating on the surface of a drug balloon according to comparative example one of the present application;
FIG. 15 is a graph showing the effect of spray coating on the surface of a drug balloon according to comparative example II of the present application;
fig. 16 is a graph showing the effect of spraying the surface of a conventional drug balloon.
Reference numerals: 1. a balloon body; 11. an outer balloon layer; 111. micropores; 112. an anchor; 12. an inner balloon layer; 121. a groove; 2. a drug cavity; 21. a sub-drug cavity; 3. a support; 4. a vessel wall; 5. the medicine liquid.
Detailed Description
The following description of the embodiments of the present application will be made clearly and fully with reference to the accompanying drawings, in which it is evident that the embodiments described are only some, but not all, of the embodiments of the present application. All other embodiments, which can be made by one of ordinary skill in the art without undue burden from the present disclosure, are within the scope of the present disclosure.
Example 1
The utility model provides a take double-deck medicine sacculus of medicine chamber, as shown in fig. 1, including sacculus body 1, sacculus body 1 includes sacculus outer layer 11 and sacculus inlayer 12, as shown in fig. 2, a plurality of micropores 111 have been seted up to sacculus outer layer 11, sacculus inlayer 12 is located sacculus outer layer 11 inboard, as shown in fig. 3, be formed with the medicine chamber 2 with micropore 111 intercommunication between sacculus outer layer 11 and the sacculus inlayer 12, sacculus outer layer 11 is close to sacculus inlayer 12 and be close to sacculus inlayer 12 one side surface and all smooth, sacculus inlayer 12 is close to sacculus outer layer 11 one side surface and is the smooth face that has a plurality of recesses 121, a plurality of recesses 121 form the unsmooth structure, a plurality of recesses 121 are around the axis spiral distribution of sacculus inlayer 12 in order to form the helices, as shown in fig. 4, when this takes medicine chamber double-deck medicine sacculus, when the sacculus is not filled, form the department with the blood vessel lesion through seal wire etc., then, it is filled with medium to sacculus inlayer 12 and makes its inflation medium and keeps certain balloon 11 and keep the blood vessel layer 12 to take out and a lot of blood vessel depression and expansion, can be regarded as the surface of balloon 12 after the balloon inner layer 12 is filled with blood vessel 12 and the surface is full of blood vessel, and the surface is full of balloon 12 is contacted with the medicine layer 12 and is the surface that can be taken out, and the surface and is full of the medicine is full of the surface and is the surface can be changed, and the surface is the surface and is the full of the balloon is left and the balloon is the full at the surface is the full.
In this embodiment, the balloon inner layer 12 is disposed near one side surface of the balloon outer layer 11 with the plurality of grooves 121, so that the drug cavity 2 formed between the balloon inner layer 12 and the balloon outer layer 11 of the filled balloon body 1 is not completely closed, but a certain drug storage space is maintained, and thus, the drug solution is easier to be injected into the drug cavity 2 during the treatment process.
Example two
Unlike the implementation, in this embodiment, instead of providing the groove 121, as shown in fig. 5, a plurality of supporting members 3 are provided between the outer balloon layer 11 and the inner balloon layer 12, as shown in fig. 6, the supporting members 3 are in a cylindrical elongated structure in cross section, and the supporting members 3 are parallel to the outer balloon layer 11 and the inner balloon layer 12, as shown in fig. 7, when the inner balloon layer 12 is inflated and kept at a certain pressure, the supporting members 3 are supported between the outer balloon layer 11 and the inner balloon layer 12, the plurality of supporting members 3 enable the medicine cavity between the outer balloon layer 11 and the inner balloon layer 12 to keep a certain medicine storage space, medicine is input into the medicine cavity 2, the medicine is sprayed out along the micropores 111, and finally the inflated medium of the inner balloon layer 12 is pumped away, so that the whole balloon is retracted and withdrawn from the blood vessel.
Example III
Unlike the implementation of the present embodiment, on the basis of setting the groove 121, as shown in fig. 8, a plurality of anchoring elements 112 are further disposed on one side of the balloon outer layer 11 far away from the balloon inner layer 12, as shown in fig. 9, the anchoring elements 112 are in a strip structure with a triangular cross section, the anchoring elements 112 are disposed parallel to the balloon outer layer 11, one side of the anchoring elements 112 is connected with the balloon outer layer 11, when the dual-layer drug balloon with a drug cavity is used, as shown in fig. 10, the stress of the anchoring elements 112 contacts with the vessel wall 4 when the balloon inner layer 12 is filled and maintains a certain pressure, and meanwhile, the anchoring elements 112 are subjected to the force from the interior of the balloon, so that the stress of the anchoring elements 112 is supported between the balloon outer layer 11 and the vessel wall 4, the balloon outer layer 11 is extruded towards the balloon inner layer 12, and the balloon outer layer 11 in the extruded position is close to the balloon inner layer 12, and the balloon outer layer 11 is not disposed at the position of the balloon outer layer 11, so that the cavity 2 is partitioned into a plurality of sub-cavities 21, so that the drug cavity 2 is filled with the balloon outer layer 12 and maintains a certain pressure, and the drug cavity 2 is withdrawn from the whole drug cavity 2, namely, the drug cavity 2 is withdrawn from the whole cavity 5, and the drug cavity is contracted, and the drug solution is pumped into the whole cavity 5, and the drug cavity is pumped into the capillary cavity 5.
The anchor 112 of the present embodiment both allows for more concentration of stress to provide higher pressure to disrupt the vascular lesions and allows for easier filling of the sub-chambers 21 formed.
Example IV
Based on the first to third embodiments, 3% shellac, 9% zinc stearate, 22% iopromide, 22% sirolimus, 35% PAMAM (3 rd generation) and 9% metformin are dissolved in methanol solution and uniformly mixed to prepare mixed solution, the balloon body is filled to 6 atm, the mixed solution is sprayed on the surface of one side of the balloon outer layer 11 far away from the balloon inner layer 12 by using an ultrasonic sprayer to control the sample injection amount, and the mixed solution is uniformly sprayed for at least 1 time and then dried and cured to obtain the double-layer drug coating balloon with the drug cavity.
Example five
Based on the first to third embodiments, 5% of shellac, 15% of zinc stearate, 15% of iopromide, 15% of sirolimus, 35% of PAMAM (3 rd generation) and 15% of metformin are dissolved in methanol solution and uniformly mixed to prepare mixed solution, the balloon body is filled to 6 atm, the mixed solution is sprayed on the surface of one side of the balloon outer layer 11 far away from the balloon inner layer 12 by using an ultrasonic sprayer to control the injection amount, and the mixed solution is uniformly sprayed for at least 1 time and then dried and cured to obtain the balloon with the medicine cavity and the double-layer medicine coating.
Example six
Based on the first to third embodiments, 5% of shellac, 20% of zinc stearate, 20% of iopromide, 20% of sirolimus, 15% of PAMAM (3 rd generation) and 20% of metformin are dissolved in methanol solution and uniformly mixed to prepare mixed solution, the balloon body is filled to 6 atm, the mixed solution is sprayed on the surface of one side of the balloon outer layer 11 far away from the balloon inner layer 12 by using an ultrasonic sprayer to control the injection amount, and the mixed solution is uniformly sprayed for at least 1 time and then dried and cured to obtain the balloon with the medicine cavity and the double-layer medicine coating.
Comparative example one
This comparative example differs from example four only in that the dendrimer is not used, and the equivalent amount of the remaining substance in example four is dissolved in the equivalent amount of methanol, i.e. the remaining substance is amplified comparably.
Comparative example two
This comparative example differs from example four only in that instead of metformin, the equivalent amount of the remaining material in example four is dissolved in an equivalent amount of methanol, i.e. the remaining material is amplified comparably.
The surface spraying effect of the balloons prepared in the fourth, fifth and sixth embodiments and the first and second comparative embodiments was evaluated, as shown in fig. 11, 12 and 13, the surfaces of the drug balloon coatings prepared in the fourth, fifth and sixth embodiments were fine and smooth, and as shown in fig. 16, the surfaces of other drug balloon products in the market were uneven, partially missing and deslagged; as shown in fig. 14 and 15, the drug balloon coating layers prepared in comparative examples one and two showed delamination, bottom stripe crystallization, oil film, and the like.
The balloons prepared in examples four to six and comparative examples one and comparative example two were tested for drug loading, and the following table of drug loading was obtained,
in the case of consistent formulation loading and spray application, it can be seen that the drug loading of the obvious examples four-six is greater than that of the comparative examples one and two, indicating that the formulations using dendrimers in combination with metformin have a greater drug loading, while the examples five and six, with slightly different loading, are also greater than those of the comparative examples one and two without dendrimers or without metformin.
And circulating physiological saline at 37+/-2 ℃ in the coronary artery model, and taking out the balloons prepared in the fourth to sixth examples and the first and second comparative examples after the balloons reach the designated positions through the coronary artery human body model respectively so as to simulate the actual use conveying process. Eluting the residual medicine amount on the saccule with acetonitrile, calculating loss rate of medicine conveying process, and the result is shown in the following table,
in addition, the in vitro performance test of the drug balloon disclosed in publication number CN114177361a shows a drug delivery process loss rate of 40%, and CN114177361a describes that the in vitro performance test delivery process loss rate of CN2009101341746 drug reaches 60%, and the in vitro performance test delivery process loss rate of CN2014104566634 drug reaches 50%. Thus, the comparison is available, and the drug delivery efficiency and the utilization rate of the fourth to sixth embodiments of the application are high.
The balloons prepared in examples four-six and comparative examples one and two were immersed in 30mL of PBS buffer, and the samples were taken at 1 day, 7 days, 14 days, and 28 days, and the three in vitro elution tests described in publication No. CN106421933a were also substantially completed at 13 days, with the comparative example 1 being substantially completed in the first 7 days. In the examples of the present application, the drug is released continuously after 28 days due to the hydrophilicity of metformin and the slow decomposition of dendrimers, and reaches more than 90% after about 50 days according to the release trend. Comparative example two did not release completely for the same 28 days, but had too little initial drug release.
Claims (8)
1. The utility model provides a take double-deck medicine sacculus of medicine chamber, includes sacculus body (1), its characterized in that: the balloon body (1) comprises a balloon outer layer (11) and a balloon inner layer (12), a plurality of micropores (111) are formed in the balloon outer layer (11), the balloon inner layer (12) is located on the inner side of the balloon outer layer (11), a medicine cavity (2) communicated with the micropores (111) is formed between the balloon outer layer (11) and the balloon inner layer (12), after the balloon inner layer (12) is filled, the balloon outer layer (11) and the balloon inner layer (12) are at least incompletely attached, the medicine cavity (2) keeps a certain medicine storage space, one side of the balloon outer layer (11) away from the balloon inner layer (12) is provided with a plurality of anchoring pieces (112), the anchoring pieces (112) are of long-strip structures with triangular cross sections, the anchoring pieces (112) are arranged in parallel with the balloon outer layer (11), one side face of each anchoring piece (112) is connected with the balloon outer layer (11), and the medicine cavity (2) is separated into a plurality of sub-attaching cavities (21) after the balloon outer layer (11) and the blood vessel inner wall are attached.
2. A dual layer drug balloon with a drug lumen as in claim 1, wherein: the surface of one side of the balloon outer layer (11) close to the balloon inner layer (12) is smooth, and the surface of one side of the balloon inner layer (12) close to the balloon outer layer (11) is uneven.
3. A dual layer drug balloon with a drug lumen as in claim 2, wherein: the surface of one side of the inner layer (12) of the balloon, which is close to the outer layer (11) of the balloon, is a smooth surface with a plurality of grooves (121), and the grooves form an uneven structure.
4. A dual layer drug balloon with a drug lumen as in claim 3, wherein: the grooves (121) are spiral grooves.
5. A dual layer drug balloon with a drug lumen as in claim 1, wherein: the surface of one side of the balloon outer layer (11) close to the balloon inner layer (12) is uneven, and the surface of one side of the balloon inner layer (12) close to the balloon outer layer (11) is smooth.
6. A dual layer drug balloon with a drug lumen as in claim 1, wherein: a plurality of supporting pieces (3) are arranged between the outer balloon layer (11) and the inner balloon layer (12), and the supporting pieces (3) enable the outer balloon layer (11) and the inner balloon layer (12) to be at least incompletely attached.
7. The dual-layer drug balloon with a drug lumen of claim 6, wherein: the cross section of the supporting piece (3) is of a cylindrical strip structure, and the supporting piece (3) is parallel to the outer layer (11) and the inner layer (12) of the balloon.
8. A dual layer drug balloon with a drug lumen according to any of claims 1-7, wherein: the surface of one side of the balloon outer layer (11) far away from the balloon inner layer (12) is provided with a drug coating for treating restenosis.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311562444.XA CN117258121B (en) | 2023-11-22 | 2023-11-22 | Double-layer medicine saccule with medicine cavity |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202311562444.XA CN117258121B (en) | 2023-11-22 | 2023-11-22 | Double-layer medicine saccule with medicine cavity |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN117258121A CN117258121A (en) | 2023-12-22 |
| CN117258121B true CN117258121B (en) | 2024-02-02 |
Family
ID=89209106
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN202311562444.XA Active CN117258121B (en) | 2023-11-22 | 2023-11-22 | Double-layer medicine saccule with medicine cavity |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN117258121B (en) |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN212522682U (en) * | 2020-04-07 | 2021-02-12 | 上海微创心通医疗科技有限公司 | Balloon dilatation catheter and balloon dilatation catheter assembly |
| CN215351479U (en) * | 2021-03-30 | 2021-12-31 | 哈尔滨医科大学 | Double-layer balloon catheter delivery system |
| CN113877046A (en) * | 2021-11-18 | 2022-01-04 | 科塞尔医疗科技（苏州）有限公司 | Balloon catheter |
| CN115154854A (en) * | 2022-04-11 | 2022-10-11 | 四川大学华西医院 | Double-layer medicine-carrying balloon catheter |
| CN219022918U (en) * | 2022-09-07 | 2023-05-16 | 健源医疗科技(无锡)有限公司 | Balloon catheter |
| CN116328157A (en) * | 2023-03-20 | 2023-06-27 | 上海康德莱医疗器械股份有限公司 | Balloon |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7354419B2 (en) * | 2004-10-15 | 2008-04-08 | Futuremed Interventional, Inc. | Medical balloon having strengthening rods |
| US8034066B2 (en) * | 2005-09-15 | 2011-10-11 | Boston Scientific Scimed, Inc. | Multi-layer medical balloons |
| US20080228139A1 (en) * | 2007-02-06 | 2008-09-18 | Cook Incorporated | Angioplasty Balloon With Concealed Wires |
| US9370642B2 (en) * | 2007-06-29 | 2016-06-21 | J.W. Medical Systems Ltd. | Adjustable-length drug delivery balloon |
| US8034022B2 (en) * | 2008-04-08 | 2011-10-11 | Cook Medical Technologies Llc | Weeping balloon catheter |
| US8827953B2 (en) * | 2013-01-15 | 2014-09-09 | Krishna Rocha-Singh | Apparatus and method for delivering intraluminal therapy |
| US20170266421A1 (en) * | 2013-01-15 | 2017-09-21 | Krishna Rocha-Singh | Apparatus and method for delivering intraluminal therapy |
-
2023
- 2023-11-22 CN CN202311562444.XA patent/CN117258121B/en active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN212522682U (en) * | 2020-04-07 | 2021-02-12 | 上海微创心通医疗科技有限公司 | Balloon dilatation catheter and balloon dilatation catheter assembly |
| CN215351479U (en) * | 2021-03-30 | 2021-12-31 | 哈尔滨医科大学 | Double-layer balloon catheter delivery system |
| CN113877046A (en) * | 2021-11-18 | 2022-01-04 | 科塞尔医疗科技（苏州）有限公司 | Balloon catheter |
| CN115154854A (en) * | 2022-04-11 | 2022-10-11 | 四川大学华西医院 | Double-layer medicine-carrying balloon catheter |
| CN219022918U (en) * | 2022-09-07 | 2023-05-16 | 健源医疗科技(无锡)有限公司 | Balloon catheter |
| CN116328157A (en) * | 2023-03-20 | 2023-06-27 | 上海康德莱医疗器械股份有限公司 | Balloon |
Also Published As
| Publication number | Publication date |
|---|---|
| CN117258121A (en) | 2023-12-22 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| US9724497B2 (en) | Method of coating a catheter balloon having a fold | |
| CN203724603U (en) | Double-layer medicinal balloon catheter | |
| JP4355494B2 (en) | Medical device for delivering a bioactive substance to a lumen | |
| US20080140002A1 (en) | System for delivery of biologically active substances with actuating three dimensional surface | |
| EP3193954B1 (en) | Medical balloon coated with therapeutic agent, carboxylic acid, and salt thereof | |
| CN203138758U (en) | Combined medical device composed of drug-coated balloon and bracket | |
| JP2011526163A (en) | Metal stent for vascular lesion treatment with package | |
| JP2010516426A (en) | Delivery of therapeutic agents to the heart valve | |
| CN104857615A (en) | Novel dual-layer drug balloon catheter | |
| CN105816921A (en) | Bionic vascular stent and preparation method thereof | |
| Ortega et al. | A shape memory polymer dialysis needle adapter for the reduction of hemodynamic stress within arteriovenous grafts | |
| WO2016101771A1 (en) | Method for manufacturing dilating catheter of drug balloon, and coiled balloon having flaps | |
| WO2014160083A1 (en) | Methods, compositions, and devices for the occlusion of cavities and passageways | |
| JP2007500060A (en) | Therapeutic drug delivery system | |
| CN104857616A (en) | Drug-loading balloon capable of releasing drugs quickly | |
| CN100577221C (en) | Surface modified coat of bracket of blood vessel, and preparation method thereof | |
| CN117258121B (en) | Double-layer medicine saccule with medicine cavity | |
| CN113648114A (en) | Coated stent and preparation method thereof | |
| CN110947082B (en) | Balloon guiding catheter and preparation method thereof | |
| US8372054B2 (en) | Over-the-wire balloon catheter for efficient targeted cell delivery | |
| US9907935B2 (en) | Coating of balloon catheters | |
| CN107995869B (en) | Surface liquefied drug coating sacculus | |
| CN201543095U (en) | Medicine-coated balloon | |
| EP4171704A1 (en) | Articles comprising markings and related methods | |
| JP7190490B2 (en) | Sheet sticking device |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| GR01 | Patent grant | ||
| GR01 | Patent grant |