CN104971422A - Medicinal balloon catheter and preparation method thereof - Google Patents
Medicinal balloon catheter and preparation method thereof Download PDFInfo
- Publication number
- CN104971422A CN104971422A CN201510419680.5A CN201510419680A CN104971422A CN 104971422 A CN104971422 A CN 104971422A CN 201510419680 A CN201510419680 A CN 201510419680A CN 104971422 A CN104971422 A CN 104971422A
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- Prior art keywords
- heat
- medicinal balloon
- shrinkable tube
- balloon
- medicinal
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- 238000002360 preparation method Methods 0.000 title claims description 11
- 239000003814 drug Substances 0.000 claims abstract description 51
- 230000008602 contraction Effects 0.000 claims abstract description 7
- 239000011248 coating agent Substances 0.000 claims description 11
- 238000000576 coating method Methods 0.000 claims description 11
- 229930012538 Paclitaxel Natural products 0.000 claims description 9
- 229960001592 paclitaxel Drugs 0.000 claims description 9
- RCINICONZNJXQF-MZXODVADSA-N taxol Chemical compound O([C@@H]1[C@@]2(C[C@@H](C(C)=C(C2(C)C)[C@H](C([C@]2(C)[C@@H](O)C[C@H]3OC[C@]3([C@H]21)OC(C)=O)=O)OC(=O)C)OC(=O)[C@H](O)[C@@H](NC(=O)C=1C=CC=CC=1)C=1C=CC=CC=1)O)C(=O)C1=CC=CC=C1 RCINICONZNJXQF-MZXODVADSA-N 0.000 claims description 9
- HKVAMNSJSFKALM-GKUWKFKPSA-N Everolimus Chemical compound C1C[C@@H](OCCO)[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 HKVAMNSJSFKALM-GKUWKFKPSA-N 0.000 claims description 5
- 229960005167 everolimus Drugs 0.000 claims description 5
- 229920002313 fluoropolymer Polymers 0.000 claims description 4
- 229920000098 polyolefin Polymers 0.000 claims description 4
- 241000218691 Cupressaceae Species 0.000 claims description 3
- 238000000034 method Methods 0.000 abstract description 25
- 230000001681 protective effect Effects 0.000 abstract description 10
- 230000008569 process Effects 0.000 abstract description 9
- 230000006378 damage Effects 0.000 abstract description 6
- 239000011247 coating layer Substances 0.000 abstract 1
- 230000003247 decreasing effect Effects 0.000 abstract 1
- 230000002349 favourable effect Effects 0.000 abstract 1
- 238000001356 surgical procedure Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 description 29
- 230000004224 protection Effects 0.000 description 21
- 239000000463 material Substances 0.000 description 8
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 238000010586 diagram Methods 0.000 description 6
- 239000007921 spray Substances 0.000 description 6
- 238000007796 conventional method Methods 0.000 description 5
- 238000004806 packaging method and process Methods 0.000 description 5
- 230000001954 sterilising effect Effects 0.000 description 5
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 4
- 239000004812 Fluorinated ethylene propylene Substances 0.000 description 4
- 238000004090 dissolution Methods 0.000 description 4
- 238000001035 drying Methods 0.000 description 4
- 229920009441 perflouroethylene propylene Polymers 0.000 description 4
- 208000037803 restenosis Diseases 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 239000004698 Polyethylene Substances 0.000 description 3
- 239000002202 Polyethylene glycol Substances 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 3
- 230000014759 maintenance of location Effects 0.000 description 3
- 230000007246 mechanism Effects 0.000 description 3
- 229920001223 polyethylene glycol Polymers 0.000 description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 3
- 238000005507 spraying Methods 0.000 description 3
- 239000004372 Polyvinyl alcohol Substances 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 239000012159 carrier gas Substances 0.000 description 2
- 238000005516 engineering process Methods 0.000 description 2
- 230000006698 induction Effects 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 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 2
- 229960002930 sirolimus Drugs 0.000 description 2
- 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 2
- 210000004509 vascular smooth muscle cell Anatomy 0.000 description 2
- 206010061218 Inflammation Diseases 0.000 description 1
- 235000021355 Stearic acid Nutrition 0.000 description 1
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 1
- 208000027418 Wounds and injury Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000012752 auxiliary agent Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000006735 deficit Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 238000012377 drug delivery Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 230000003463 hyperproliferative effect Effects 0.000 description 1
- 238000002513 implantation Methods 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 230000004054 inflammatory process Effects 0.000 description 1
- 230000005764 inhibitory process Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000013508 migration Methods 0.000 description 1
- 230000005012 migration Effects 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 description 1
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 description 1
- 238000012858 packaging process Methods 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920000642 polymer Polymers 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 239000004945 silicone rubber Substances 0.000 description 1
- 239000008117 stearic acid Substances 0.000 description 1
- 238000012956 testing procedure Methods 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 238000002137 ultrasound extraction Methods 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 230000024883 vasodilation Effects 0.000 description 1
- 238000005303 weighing Methods 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
- A61M25/1029—Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L29/00—Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
- A61L29/14—Materials characterised by their function or physical properties, e.g. lubricating compositions
- A61L29/16—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
-
- 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
- A61M25/1002—Balloon catheters characterised by balloon shape
- A61M2025/1004—Balloons with folds, e.g. folded or multifolded
-
- 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
-
- 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
- A61M2025/1081—Balloon catheters with special features or adapted for special applications having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
-
- 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
- A61M25/104—Balloon catheters used for angioplasty
Abstract
The invention discloses a medicinal balloon catheter. The medicinal balloon catheter comprises a medicinal balloon and a heat-shrinkable tube. The medicinal balloon is of a folding structure. The heat-shrinkable tube closely wraps the folded medicinal balloon. Due to great internal diameter of the heat-shrinkable tube prior to contraction, loss of medicine is avoided when the balloon is inserted. According to different contraction ratios, the diameter can be greatly decreased so that the medicinal balloon is closely wrapped and the wrapped balloon part has smaller external diameter.During an operation process of a doctor, the heat-shrinkable tube can be torn off. Therefore, damage to a coating layer during a removing process of a conventional protective sleeve pipe is avoided. At the same time, the closely-wrapped balloon part has smaller external diameter, which is favorable for operation of the doctor during a surgery.
Description
Technical field
The present invention relates to medical instruments field, be specifically related to a kind of medicinal balloon catheter and preparation method thereof.
Background technology
Along with the extensive use of intravascular intervention or implantation, thing followed Vascular Restenosis after Balloom problem is more and more subject to people's attention.Research shows, the factor of Restenosis is caused to be not quite similar, as blood vessel internal membrane damage, thrombosis, inflammation, healing, gene etc., but the Forming Mechanism of generally acknowledging at present except elastical retraction and thrombosis, also serves pivotal role to inner membrance migration because damaging vascular smooth muscle cell (VSMC) hyper-proliferative of inducing except blood vessel wall after vasodilation.In recent years, the various mechanisms for Restenosis have developed the multiple intervention or the implanted medical device that contain medication coat.Medicine-coated balloon and bracket for eluting medicament, inherently come from this concept of local drug delivery devices based on conduit, and by carrying Drug inhibition neointimal hyperplasia, mode and the topical remedy of just carrying medicine are different for action time.This kind of equipment surfaces is coated with certain polymer, and on this basis in conjunction with medicative medicine, after in the apparatus intravasation of medication coat, medicine can discharge in blood vessel local slow, and by different mechanisms play effects, thus reach the object for the treatment of and prevention Restenosis.
Foley's tube all needs protective casing to protect sacculus in packaging process, prevents from destroying in transportation.At present, the main protective casing that adopts is protected sacculus, the method be sacculus folded roll around rear, the balloon portion after folding is inserted in the protective casing of certain specification internal diameter, after thermal finalization, packs molding.But there is shortcoming in the method: medication coat can because the reason of friction in the process of installing protective casing, and cause the loss of medicine, this loss is normally uncontrollable, can impact the stability of technique; This friction simultaneously is also a kind of damage for sacculus, causes sacculus to be destroyed, and finally affects the result of use of product.In addition the medicine run off can cause potential injury to environment, producers and operating theatre staff.
Summary of the invention
In order to overcome the defect of prior art, the present invention by the following technical solutions:
A kind of medicinal balloon catheter, comprise medicinal balloon and heat-shrinkable tube, medicinal balloon is foldable structure, the tight coated folding medicinal balloon of heat-shrinkable tube.Described medicinal balloon is the sacculus that surface coverage has medication coat, and balloon surface covers the prior art that medication coat is well known to those skilled in the art, and medication coat is made up of medicine, as paclitaxel, thunder cypress mycin or everolimus etc.; Also auxiliary agent may be comprised, as PVP (polyvinylpyrrolidone), PEG (Polyethylene Glycol), PVA (polyvinyl alcohol) or stearic acid etc.The preparation of medication coat adopts conventional method, as: prepare drug solution, by modes such as spraying, submergences, solution is coated on the balloon surface of foley's tube, after drying, namely obtains the medicinal balloon that surface coverage has medication coat.
Further, above-mentioned heat-shrinkable tube is preferably made up of polyolefin (as polythene PE, ethylene propylene copolymer EPM etc.) or fluoroplastics (as fluorinated ethylene propylene copolymer FEP etc.), and the shrinkage ratio of heat-shrinkable tube is preferably 1.1 ~ 5:1.Because the present invention is the surface using heat-shrinkable tube to be coated on medicinal balloon, the contraction of heat-shrinkable tube and coatedly have certain influence to medication coat, its impact shows difference according to the material of heat-shrinkable tube, through screening, when selecting polyolefin or fluoroplastics heat-shrinkable tube, minimum on the impact of medication coat, in coating, the loss of medicine is minimum.
Further, above-mentioned foldable structure is preferably three wings foldable structure, four wingfold structures, five wingfold structures or six wingfold structures.
The overall structure of medicinal balloon catheter of the present invention is the structure of conventional balloon catheter, generally comprises sacculus, advances the parts such as induction system.Medicinal balloon catheter of the present invention is generally primarily of catheter block, outer tube (generally comprising near-end, middle part, far-end), interior pipe, medicinal balloon, Marking ring, most advanced and sophisticated composition.The far-end of outer tube, middle part, near-end are connected successively, and near-end is connected with catheter block.One end of medicinal balloon is connected with distal outer tube, and the other end is connected with tip.Interior pipe is located in outer tube (comprising far-end, middle part, near-end), and stretches into medicinal balloon and be connected to tip, and interior pipe is provided with Marking ring, and Marking ring is positioned at medicinal balloon.In the present invention, medicinal balloon is foldable structure, the tight coated folding medicinal balloon of heat-shrinkable tube.
Medicinal balloon catheter of the present invention, prepare by following steps: first, medicinal balloon is folded, the medicinal balloon folded is put into the heat-shrinkable tube of certain internal diameter, shrinkage ratio, under the shrinkage temperature of heat-shrinkable tube, heat-shrinkable tube is shunk, medicinal balloon is closely coated, described medicinal balloon catheter can be obtained.Before contraction, the internal diameter of heat-shrinkable tube should be larger than the medicinal balloon external diameter folded, and can not produce friction when making medicinal balloon insert heat-shrinkable tube because of contact; The shrinkage ratio of heat-shrinkable tube is according to the size Selection of the perisystolic internal diameter of heat-shrinkable tube and foldable structure medicinal balloon, internal diameter after shrinking to make heat-shrinkable tube, the external diameter of medicinal balloon before ratio is coated by heat-shrinkable tube, foldable structure is little, preferred difference 0.1 ~ 0.3mm, closely can encase medicinal balloon and don't can destroy the structure of stake body.
Further, the perisystolic internal diameter of described heat-shrinkable tube is preferably 2.0 ~ 3.0mm, and hot contraction ratio is preferably 1.1 ~ 5.0:1.
Compared with prior art, medicinal balloon catheter of the present invention has the following advantages:
(1) adopt heat-shrinkable tube protection with the sacculus of medication coat; because heat-shrinkable tube internal diameter before deflation can be larger; in the process that sacculus inserts; avoid the dose of medication coat in traditional protection technique because of fricative loss; the medicament contg of medication coat is stablized; in addition this method avoids the dose loss in operation and use procedure, protect the healthy of user and operator.
(2) after heat-shrinkable tube carries out thermal contraction, according to different shrinkage ratios, diameter can reduce greatly, is tightly wrapped by medicinal balloon, makes the balloon portion after wrapping up have less external diameter.
(3) this heat-shrinkable tube can tear off by doctor in operative process; this avoid conventional protective casing and remove the destruction to coating in process; simultaneously because the balloon portion after tight parcel has less external diameter, be more conducive to the operation of doctor in operation process.In addition, tear the simple to operation of heat-shrinkable tube off, can't using and operating and bring extra inconvenience medicinal balloon catheter.
(4) preparation technology is simply controlled.
Accompanying drawing explanation
Fig. 1 is medicinal balloon catheter schematic diagram of the present invention.
Fig. 2 is medicinal balloon catheter balloon regions of the present invention schematic diagram.
Fig. 3 is the schematic diagram after medicinal balloon catheter balloon regions of the present invention tears heat-shrinkable tube, balloon expandable off.
Fig. 4 is the schematic cross-section of the embodiment of the present invention 2 medicinal balloon catheter balloon regions.
Fig. 5 is the photo of the balloon surface of the embodiment of the present invention 2 and GPF (General Protection False sleeve pipe.
Fig. 6 is the embodiment of the present invention 2 and the photo of pipe in the sacculus of GPF (General Protection False sleeve pipe.
Wherein, 1: heat-shrinkable tube; 2: most advanced and sophisticated; 3: interior pipe; 4: Marking ring; 5: medicinal balloon; 6: distal outer tube; 7: in the middle part of outer tube; 8: proximal outer tube; 9: catheter block.
Detailed description of the invention
Below in conjunction with drawings and Examples, the present invention will be described.
The overall structure of medicinal balloon catheter of the present invention is the structure of conventional balloon catheter, generally comprises sacculus, advances the parts such as induction system.Fig. 1 is medicinal balloon catheter schematic diagram of the present invention, Fig. 2 is medicinal balloon catheter balloon regions of the present invention schematic diagram (enlarged drawing of Fig. 1 respective regions), and Fig. 3 is the schematic diagram after medicinal balloon catheter balloon regions of the present invention tears heat-shrinkable tube, balloon expandable off.Medicinal balloon catheter of the present invention is generally primarily of catheter block 9, outer tube (generally comprising near-end 6, middle part 7, far-end 8), interior pipe 3, medicinal balloon 5, Marking ring 4, most advanced and sophisticated 2 compositions.Distal outer tube 6, middle part 7, near-end 8 are connected successively, and near-end 8 is connected with catheter block 9.One end of medicinal balloon 5 is connected with distal outer tube 6, and the other end is connected with most advanced and sophisticated 2.Interior pipe 3 is located in outer tube (comprising far-end 6, middle part 7, near-end 8), and stretches into medicinal balloon 5 and be connected to most advanced and sophisticated 2, and interior pipe 3 is provided with Marking ring 4, and Marking ring 4 is positioned at medicinal balloon 5.In the present invention, medicinal balloon 5 is foldable structure, the tight coated folding medicinal balloon 5 of heat-shrinkable tube 1.In Fig. 1,2, medicinal balloon is foldable structure (such as, six wingfold shown in Fig. 4), the tight coated folding medicinal balloon 5 of heat-shrinkable tube 1.Medication coat is covered in balloon surface, but does not represent in the accompanying drawings.
Embodiment 1:
(1) preparation of drug solution: weigh 0.1g paclitaxel, add 20ml vial; The ethanol of 10ml is added, ultrasonic dissolution in vial.
(2) sacculus coating: by sacculus (the diameter 2.0mm of foley's tube, length 20mm) be placed in ultrasonic spray head under, arrange that supersonic frequency is 30khz, the flow velocity of spray solution is 0.1ml/min, flow rate of carrier gas is 30L/h, spray above-mentioned solution toward sacculus.After spraying terminates, take out sacculus, after drying, obtain the medicinal balloon that surface coverage has taxol drug coating.
(3) medicinal balloon is carried out three wingfold.
(4) sacculus folded is put into internal diameter is 2mm, shrinkage temperature is 100 DEG C, shrinkage ratio is the heat-shrinkable tube of 2:1,100 DEG C of thermal finalization 1min.
(5) sacculus shunk is put into coil pipe, packaging, sterilizing.
Embodiment 2:
(1) preparation of drug solution: weigh 0.1g paclitaxel, add 20ml vial; The ethanol of 10ml is added, the PVP of 2g, ultrasonic dissolution in vial.
(2) sacculus coating: be immersed in by the sacculus (diameter 4.0mm, length 60mm) of foley's tube in above-mentioned solution and take out after 1 minute, dry 10 minutes, obtains the medicinal balloon that surface coverage has taxol drug coating.
(3) medicinal balloon is carried out six wingfold.
(4) medicinal balloon folded is put into internal diameter is 2.5mm, shrinkage temperature is 130 DEG C, shrinkage ratio is the heat-shrinkable tube of 1.1:1,130 DEG C of thermal finalization 30 seconds.
(5) sacculus shunk is put into coil pipe, packaging, sterilizing.
Fig. 4 is the schematic cross-section of the present embodiment medicinal balloon catheter balloon regions.Medicinal balloon 5 is six wingfold, the tight coated folding medicinal balloon 5 of heat-shrinkable tube 1.
Embodiment 3:
(1) preparation of drug solution: weigh 0.1g everolimus, add 20ml vial; The methanol of 10ml is added, ultrasonic dissolution in vial.
(2) sacculus coating: the medicinal liquid quantitatively drawing 30 μ l, is carefully coated on sacculus (diameter 6.0mm, the length 40mm) surface of foley's tube, obtains the medicinal balloon that surface coverage has everolimus medication coat after drying.
(3) medicinal balloon is carried out five wingfold.
(4) medicinal balloon folded is put into internal diameter is 3mm, shrinkage temperature is 90 DEG C, shrinkage ratio is the heat-shrinkable tube of 3:1,90 DEG C of thermal finalization 1min.
(5) sacculus shunk is put into coil pipe, packaging, sterilizing.
Embodiment 4:
(1) preparation of drug solution: the PEG weighing 0.3g rapamycin and 0.2g, adds 20ml vial; The oxolane of 10ml is added, ultrasonic dissolution in vial.
(2) sacculus coating: under the sacculus (diameter 4.0mm, length 60mm) of foley's tube is placed in ultrasonic spray head, arrange that supersonic frequency is 15khz, the flow velocity of spray solution is 0.15ml/min, flow rate of carrier gas is 30L/h, sprays above-mentioned solution toward sacculus.After spraying terminates, take out sacculus, after drying, obtain the medicinal balloon that surface coverage has rapamycin drug coating.
(3) medicinal balloon is carried out four wingfold.
(4) sacculus folded is put into internal diameter is 2.5mm, shrinkage temperature is 120 DEG C, shrinkage ratio is the heat-shrinkable tube of 5:1,100 DEG C of thermal finalization 1min.
(5) sacculus shunk is put into coil pipe, packaging, sterilizing.
Different protected mode balloon diameter measures
By the medicinal balloon catheter that embodiment 1 obtains; contrast with the medicinal balloon catheter adopting common process to be inserted in protective casing; after packaging sterilizing, the sacculus of two foley's tubes is taken out respectively from heat-shrink tube and GPF (General Protection False sleeve pipe, tests the balloon diameter of two kinds of methods with image instrument.Comparing result is in table one.
Table one balloon diameter contrasts
As can be seen from the table; adopt the balloon diameter of heat-shrinkable tube protection less relative to the balloon diameter of GPF (General Protection False sleeve pipe; can find out simultaneously; adopt heat-shrinkable tube protection balloon diameter standard deviation relative to GPF (General Protection False casing methods obtain less; technique is more stable, advantageously the operation of Yu doctor.
Different protected mode dose test
By the medicinal balloon catheter that embodiment 1 obtains, contrast with the medicinal balloon catheter adopting common process to be inserted in protective casing, adopt the medicament contg of both following methods tests:
(1) balloon portion is shredded, be immersed in the methanol solution of 10ml, ultrasonic extraction 15min.
(2) extract above-mentioned lixiviating solution, detect with reference to Chinese Pharmacopoeia 2010 content of taxol detection method.
Comparing result is in table two.
Table two dose contrasts
| Content of taxol (mg) | Standard deviation |
| Heat-shrinkable tube | 0.38 | 0.36 | 0.35 | 0.39 | 0.018 |
| GPF (General Protection False sleeve pipe | 0.3 | 0.26 | 0.33 | 0.24 | 0.04 |
As can be seen from the table; adopt the medicament contg of the medicinal balloon of heat-shrinkable tube protection higher relative to the medicament contg of GPF (General Protection False sleeve pipe; can find out simultaneously; adopt heat-shrinkable tube protection dose standard deviation relative to GPF (General Protection False casing methods obtain less, illustrates heat-shrinkable tube protection be more conducive to dose stablizing.
Balloon surface degree of impairment
In Fig. 5; a is the photo on the medicinal balloon surface adopting embodiment 2 method to obtain; b is that the medicinal balloon in embodiment 2 does not use heat-shrinkable tube but adopts conventional method to insert the photo of the balloon surface after protective sleeve; we can find out that the balloon surface adopting heat-shrink tube to protect is very level and smooth, and the balloon surface adopting conventional method to protect has folding line.
In Fig. 6; a be adopt example 2 method to obtain sacculus in the photo of pipe; b is that the medicinal balloon in example 2 does not use heat-shrinkable tube but adopts conventional method to insert the photo of pipe in the sacculus after protective sleeve; we can find out that the interior pipe of the sacculus adopting heat-shrink tube to protect is level and smooth, and in the sacculus adopting conventional method to protect, pipe damages.
Unlike material heat-shrink tube is on the impact of coating
Select the heat-shrinkable tube of unlike material to prepare medicine difference, medicinal balloon catheter that specification is identical, test heat-shrinkable tube material is on the impact of medication coat, and testing procedure is as follows:
Get the identical medicinal balloon catheter of specification 10, wherein 5 use heat-shrinkable tube protection, 5 not protections.Previously mentioned method is used to measure medicament contg on the sacculus of each foley's tube; the meansigma methods of the medicament contg of the sacculus of protection is had to be A1; the meansigma methods not having the medicament contg of the sacculus protected is A2 (medicament contg of the medication coat namely not having heat-shrinkable tube to affect), then medicine retention rate=A1/A2.The results are shown in Table three.
The medicine retention rate of the different heat-shrinkable tube material of table three
| PE | EPM | FEP | EVA | PET | ABS | Silicone rubber | GPF (General Protection False sleeve pipe | |
| Paclitaxel | 94.2％ | 93.1％ | 96.4％ | 83.4％ | 74.2％ | 78.2％ | 72.8％ | 80.2％ |
| Thunder cypress mycin | 96.7％ | 92.2％ | 90.5％ | 86.2％ | 76.8％ | 76.4％ | 71.5％ | 81.6％ |
| Everolimus | 94.8％ | 91.5％ | 93.2％ | 90.2％ | 71.9％ | 79.5％ | 78.6％ | 82.4％ |
Contrast above-mentioned data, can find out, use heat-shrinkable tube protection medicinal balloon, if use as materials such as PET, ABS, suitable with GPF (General Protection False sleeve pipe on the impact of medication coat.And the impact of heat-shrinkable tube on medication coat of polyolefin based materials (as PE, EPM) and fluoroplastics (as FEP) is less, retention rate is the highest, the preferred this kind of material when preparing medicinal balloon catheter of the present invention.
Claims (6)
1. a medicinal balloon catheter, is characterized in that, comprises medicinal balloon and heat-shrinkable tube, and medicinal balloon is foldable structure, the tight coated folding medicinal balloon of heat-shrinkable tube.
2. medicinal balloon catheter as claimed in claim 1, it is characterized in that, described heat-shrinkable tube is made up of polyolefin or fluoroplastics.
3. medicinal balloon catheter as claimed in claim 1, it is characterized in that, described foldable structure is three wings foldable structure, four wingfold structures, five wingfold structures or six wingfold structures.
4. medicinal balloon catheter as claimed in claim 1, it is characterized in that, the medicine of described medicinal balloon is selected from paclitaxel, thunder cypress mycin or everolimus.
5. the preparation method of the medicinal balloon catheter as described in as arbitrary in Claims 1 to 4, it is characterized in that, comprise the following steps: medicinal balloon is folded, the sacculus folded is inserted in heat-shrinkable tube, then being heated to shrinkage temperature makes heat-shrinkable tube shrink, and makes the tight coating medicine sacculus of heat-shrinkable tube.
6. preparation method as claimed in claim 5, it is characterized in that, the perisystolic internal diameter of described heat-shrinkable tube is 2.0 ~ 3.0mm, and hot contraction ratio is 1.1 ~ 5.0:1.
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| CN105999523A (en) * | 2016-06-27 | 2016-10-12 | 南京双威生物医学科技有限公司 | Dilation catheter with folded bladders |
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| CN105999523A (en) * | 2016-06-27 | 2016-10-12 | 南京双威生物医学科技有限公司 | Dilation catheter with folded bladders |
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| CN106362275A (en) * | 2016-11-21 | 2017-02-01 | 山东吉威医疗制品有限公司 | Protective sleeve for drug eluting stent system and method |
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| CN113646030B (en) * | 2019-03-28 | 2023-08-29 | 株式会社钟化 | balloon catheter |
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| WO2021193140A1 (en) * | 2020-03-24 | 2021-09-30 | テルモ株式会社 | Balloon protector and balloon catheter support device |
| CN111685809A (en) * | 2020-07-03 | 2020-09-22 | 重庆橙壹科技有限公司 | Improved extractor for gastrointestinal surgery |
| CN111685812A (en) * | 2020-07-03 | 2020-09-22 | 重庆橙壹科技有限公司 | Medical extractor |
| CN111685821B (en) * | 2020-07-09 | 2021-07-02 | 中南大学湘雅医院 | Fluffy medical fetching device |
| CN111685819A (en) * | 2020-07-09 | 2020-09-22 | 重庆橙壹科技有限公司 | Medical object taking device easy to unfold and manufacturing method thereof |
| CN111685819B (en) * | 2020-07-09 | 2021-07-02 | 天津市第四中心医院 | Medical object taking device easy to unfold and manufacturing method thereof |
| CN111685820A (en) * | 2020-07-09 | 2020-09-22 | 重庆橙壹科技有限公司 | Medical object taking device with telescopic hollow tube |
| CN111685821A (en) * | 2020-07-09 | 2020-09-22 | 重庆橙壹科技有限公司 | Fluffy medical fetching device |
| CN111685817B (en) * | 2020-07-09 | 2022-03-25 | 杭州洁伊医疗器械有限公司 | Hollow tube for medical extractor |
| CN111700655B (en) * | 2020-07-09 | 2022-11-25 | 合肥亚卡普机械科技有限公司 | Medical object taking device containing loose state |
| CN111700655A (en) * | 2020-07-09 | 2020-09-25 | 重庆橙壹科技有限公司 | Medical object taking device containing loose state |
| CN111685817A (en) * | 2020-07-09 | 2020-09-22 | 重庆橙壹科技有限公司 | Hollow tube for medical extractor |
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