CN104971422B - Medicinal balloon catheter and preparation method thereof - Google Patents
Medicinal balloon catheter and preparation method thereof Download PDFInfo
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- CN104971422B CN104971422B CN201510419680.5A CN201510419680A CN104971422B CN 104971422 B CN104971422 B CN 104971422B CN 201510419680 A CN201510419680 A CN 201510419680A CN 104971422 B CN104971422 B CN 104971422B
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- 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 54
- 229940079593 drug Drugs 0.000 claims abstract description 44
- 239000011248 coating agent Substances 0.000 claims abstract description 13
- 238000000576 coating method Methods 0.000 claims abstract description 13
- 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
- 230000008602 contraction Effects 0.000 claims description 7
- 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 4
- 229960005167 everolimus Drugs 0.000 claims description 4
- 241000218691 Cupressaceae Species 0.000 claims description 3
- PEVRKKOYEFPFMN-UHFFFAOYSA-N 1,1,2,3,3,3-hexafluoroprop-1-ene;1,1,2,2-tetrafluoroethene Chemical compound FC(F)=C(F)F.FC(F)=C(F)C(F)(F)F PEVRKKOYEFPFMN-UHFFFAOYSA-N 0.000 claims 1
- -1 polyethylene, ethylene propylene copolymer Polymers 0.000 claims 1
- 230000006378 damage Effects 0.000 abstract description 7
- 238000003780 insertion Methods 0.000 abstract description 5
- 230000037431 insertion Effects 0.000 abstract description 5
- 238000001356 surgical procedure Methods 0.000 abstract description 2
- 238000000034 method Methods 0.000 description 19
- 239000000463 material Substances 0.000 description 9
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- 238000005253 cladding Methods 0.000 description 5
- 238000007796 conventional method Methods 0.000 description 5
- 238000010586 diagram Methods 0.000 description 5
- 230000008569 process Effects 0.000 description 5
- 239000007921 spray Substances 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
- 229920009441 perflouroethylene propylene Polymers 0.000 description 4
- 208000037803 restenosis Diseases 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 238000005303 weighing 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
- 239000002775 capsule Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 229920002313 fluoropolymer Polymers 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
- 229920000098 polyolefin 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
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 2
- 208000007536 Thrombosis Diseases 0.000 description 2
- 239000012159 carrier gas Substances 0.000 description 2
- 235000019441 ethanol Nutrition 0.000 description 2
- 229920002451 polyvinyl alcohol Polymers 0.000 description 2
- 230000001681 protective effect Effects 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
- 230000002792 vascular Effects 0.000 description 2
- 210000004509 vascular smooth muscle cell Anatomy 0.000 description 2
- RSWGJHLUYNHPMX-UHFFFAOYSA-N 1,4a-dimethyl-7-propan-2-yl-2,3,4,4b,5,6,10,10a-octahydrophenanthrene-1-carboxylic acid Chemical compound C12CCC(C(C)C)=CC2=CCC2C1(C)CCCC2(C)C(O)=O RSWGJHLUYNHPMX-UHFFFAOYSA-N 0.000 description 1
- 206010061218 Inflammation Diseases 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
- 230000008901 benefit Effects 0.000 description 1
- 229920001577 copolymer Polymers 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
- 201000006828 endometrial hyperplasia Diseases 0.000 description 1
- HQQADJVZYDDRJT-UHFFFAOYSA-N ethene;prop-1-ene Chemical group C=C.CC=C HQQADJVZYDDRJT-UHFFFAOYSA-N 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000035876 healing Effects 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000003463 hyperproliferative effect Effects 0.000 description 1
- 238000002513 implantation Methods 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
- 238000002386 leaching Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000005259 measurement Methods 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
- 239000000203 mixture Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 238000004806 packaging method and process Methods 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
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000012216 screening Methods 0.000 description 1
- 229920002379 silicone rubber Polymers 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000011105 stabilization Methods 0.000 description 1
- 238000012956 testing procedure Methods 0.000 description 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
- 230000000699 topical effect Effects 0.000 description 1
- 238000002137 ultrasound extraction 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 kind of medicinal balloon catheter, including medicinal balloon and heat-shrinkable tube, medicinal balloon is foldable structure, and heat-shrinkable tube closely coats the medicinal balloon of folding.Since the internal diameter of heat-shrinkable tube before deflation can be larger, during sacculus insertion, the loss of drug is avoided.According to different shrinkage ratios, diameter can be can be greatly reduced, and medicinal balloon is tightly wrapped, so that the balloon portion after package has smaller outer diameter.During surgical operation; the heat-shrinkable tube can be torn off; this avoid conventional protection sleeve pipe to the destruction of coating during removal, simultaneously because the balloon portion after tight has smaller outer diameter, it is more advantageous to the operation of doctor in the course of surgery.
Description
Technical field
The present invention relates to medical instruments fields, and in particular to a kind of medicinal balloon catheter and preparation method thereof.
Background technique
With the extensive use of intravascular intervention or implantation, the following Vascular Restenosis after Balloom problem increasingly by
To the attention of people.Studies have shown that the factor of Restenosis is caused to be not quite similar, as blood vessel internal membrane damage, thrombosis,
Inflammation, healing, gene etc., but Forming Mechanism generally acknowledged at present removes vascular wall elastical retraction and thrombosis after blood vessel dilatation
Outside, because damaging induced vascular smooth muscle cells (VSMC) hyper-proliferative and playing key effect to inner membrance migration.In recent years
Come, has been developed that a variety of interventions containing medication coat or implantable medical for the various mechanisms of Restenosis
Instrument.Medicine-coated balloon and bracket for eluting medicament, inherently derived from based on conduit local drug delivery devices this
One concept, by carrying Drug inhibition endometrial hyperplasia, only carry drug mode and topical remedy's action time it is different and
?.This kind of equipment surfaces are coated with certain polymer, and combine medicative drug on this basis, have medication coat
Instrument enter it is intravascular after, drug can discharge in blood vessel local slow, and by different mechanisms play effects, to reach
Treat and prevent the purpose of Restenosis.
Foley's tube is required to protection sleeve pipe during the packaging process and protects to sacculus, prevents from occurring in transportational process broken
It is bad.Currently, mainly protected to sacculus using protection sleeve pipe, this method is sacculus folded roll around rear, by folded sacculus
In the protection sleeve pipe of partial insertion certain specification internal diameter, molding is packed after thermal finalization.But this method has the disadvantage that medication coat
The loss of drug can be caused because of the reason of rubbing during protection sleeve pipe is installed, this loss is usually uncontrollable
, the stability of technique can be impacted；This friction is also a kind of damage for sacculus simultaneously, and sacculus is caused to be destroyed,
The final using effect for influencing product.Furthermore the drug being lost can cause to dive to environment, producers and operating theatre staff
Injury.
Summary of the invention
In order to overcome the drawbacks of the prior art, the invention adopts the following technical scheme:
A kind of medicinal balloon catheter, including medicinal balloon and heat-shrinkable tube, medicinal balloon are foldable structure, and heat-shrinkable tube is tight
The medicinal balloon that close cladding folds.The medicinal balloon is the sacculus that surface is covered with medication coat, and balloon surface covers drug
The prior art that coating is well known to those skilled in the art, medication coat are made of drug, as taxol, thunder cypress mycin or according to
Wei Mosi etc.；It may also contain auxiliary agent, such as PVP (polyvinylpyrrolidone), PEG (polyethylene glycol), PVA (polyvinyl alcohol) or hard
Resin acid etc..The preparation of medication coat uses conventional method, such as: preparing drug solution, solution is applied by the modes such as spraying, submerging
It is overlying on the balloon surface of foley's tube, obtains to surface the medicinal balloon for being covered with medication coat after dry.
Further, above-mentioned heat-shrinkable tube preferably by polyolefin (such as polythene PE, ethylene propylene copolymer EPM) or
Fluoroplastics (such as fluorinated ethylene propylene copolymer FEP) are made, and the shrinkage ratio of heat-shrinkable tube is preferably 1.1~5:1.Due to this hair
Bright is the surface that medicinal balloon is coated on using heat-shrinkable tube, and the contraction of heat-shrinkable tube and cladding have centainly medication coat
It influences, influence shows to distinguish according to the material of heat-shrinkable tube, by screening, when selection polyolefin or fluoroplastics are heat-shrinked
Guan Shi, the influence to medication coat is minimum, and the loss of drug is minimum on coating.
Further, above-mentioned foldable structure is preferably three wings foldable structure, four wingfold structures, five wingfold structures or six
Wingfold structure.
The overall structure of medicinal balloon catheter of the present invention be conventional balloon catheter structure, generally comprise sacculus, promote it is defeated
Send the components such as system.Medicinal balloon catheter of the present invention generally mainly by catheter block, outer tube (generally comprising proximal end, middle part, distal end),
Inner tube, medicinal balloon, Marking ring, tip composition.Distal end, middle part, the proximal end of outer tube are sequentially connected, and proximal 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.Inner tube be set to outer tube (including distal end, middle part, closely
End) in, and protrude into medicinal balloon and be connected to tip, inner tube is equipped with Marking ring, and Marking ring is located in medicinal balloon.In the present invention
In, medicinal balloon is foldable structure, and heat-shrinkable tube closely coats the medicinal balloon of folding.
Medicinal balloon catheter of the present invention can be prepared by following steps: firstly, medicinal balloon is folded, by what is folded
Medicinal balloon be put into certain internal diameter, shrinkage ratio heat-shrinkable tube in, under the shrinkage temperature of heat-shrinkable tube, make heat-shrinkable tube
It shrinks, medicinal balloon is closely coated, the medicinal balloon catheter can be obtained.Before contraction, the internal diameter of heat-shrinkable tube should be than folding
The medicinal balloon outer diameter folded is big, so that medicinal balloon will not generate friction when being inserted into heat-shrinkable tube because of contact；It is heat-shrinked
The shrinkage ratio of pipe is according to the size selection of heat-shrinkable tube perisystolic internal diameter and foldable structure medicinal balloon, so that heat-shrinkable tube
Internal diameter after contraction, it is smaller than outer diameter before being coated by heat-shrinkable tube, the medicinal balloon of foldable structure, preferably differ 0.1~
0.3mm can closely encase medicinal balloon without the structure of destruction support body.
Further, the perisystolic internal diameter of the 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 advantage that
(1) sacculus that medication coat is had using heat-shrinkable tube protection, since the internal diameter of heat-shrinkable tube before deflation can be with
It is larger, during sacculus insertion, the loss that dose of the medication coat in traditional protection technique is generated by friction is avoided,
The medicament contg of medication coat is stablized, and furthermore this method avoids the dose loss in operation and use process, protects use
The health of person and operator.
(2) after heat-shrinkable tube is heat-shrinked, according to different shrinkage ratios, diameter can be can be greatly reduced, by drug ball
Capsule tightly wraps, so that the balloon portion after package has smaller outer diameter.
(3) doctor can tear the heat-shrinkable tube off in operative process, and this avoid conventional protection sleeve pipes
To the destruction of coating during removal, simultaneously because the balloon portion after tight has smaller outer diameter, it is more advantageous to
The operation of doctor in the course of surgery.In addition, tear the simple to operate of heat-shrinkable tube off, it can't be to medicinal balloon catheter
It uses and operates and bring additional inconvenience.
(4) preparation process is simply controllable.
Detailed description of the invention
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 that medicinal balloon catheter balloon regions of the present invention tear the schematic diagram after heat-shrinkable tube, balloon expandable off.
Fig. 4 is the schematic cross-section of 2 medicinal balloon catheter balloon regions of the embodiment of the present invention.
Fig. 5 is the photo of the balloon surface of the embodiment of the present invention 2 and GPF (General Protection False casing.
Fig. 6 is the photo of the sacculus inner tube of the embodiment of the present invention 2 and GPF (General Protection False casing.
Wherein, 1: heat-shrinkable tube；2: tip；3: inner tube；4: Marking ring；5: medicinal balloon；6: distal outer tube；7: in outer tube
Portion；8: proximal outer tube；9: catheter block.
Specific embodiment
Below in conjunction with drawings and examples, the present invention will be described.
The overall structure of medicinal balloon catheter of the present invention be conventional balloon catheter structure, generally comprise sacculus, promote it is defeated
Send the components such as system.Fig. 1 is medicinal balloon catheter schematic diagram of the present invention, and Fig. 2 is that medicinal balloon catheter balloon regions of the present invention show
It is intended to (enlarged drawing of Fig. 1 corresponding region), Fig. 3 is that medicinal balloon catheter balloon regions of the present invention tear heat-shrinkable tube off, sacculus expands
Schematic diagram after.Medicinal balloon catheter of the present invention generally mainly (generally comprises proximal end 6, middle part 7, remote by catheter block 9, outer tube
End 8), inner tube 3, medicinal balloon 5, Marking ring 4, tip 2 form.Distal outer tube 6, middle part 7, proximal end 8 are sequentially connected, proximal end 8 with
Catheter block 9 is connected.One end of medicinal balloon 5 is connected with distal outer tube 6, and the other end is connected with tip 2.Inner tube 3 is set to outer tube (packet
Include distal end 6, middle part 7, proximal end 8) in, and protrude into medicinal balloon 5 and be connected to tip 2, inner tube 3 is equipped with Marking ring 4, Marking ring 4
In medicinal balloon 5.In the present invention, medicinal balloon 5 is foldable structure, the drug ball that closely cladding folds of heat-shrinkable tube 1
Capsule 5.Fig. 1, in 2, medicinal balloon is foldable structure (for example, six wingfold shown in Fig. 4), the close cladding folding of heat-shrinkable tube 1
Folded medicinal balloon 5.Medication coat is covered in balloon surface, but does not indicate in the accompanying drawings.
Embodiment 1:
(1) preparation of drug solution: weighing 0.1g taxol, and 20ml vial is added；It is added 10ml's in vial
Ethyl alcohol, ultrasonic dissolution.
(2) sacculus coating: the sacculus (diameter 2.0mm, length 20mm) of foley's tube is placed under ultrasonic spray head, setting
Supersonic frequency is 30khz, the flow velocity of spray solution is 0.1ml/min, flow rate of carrier gas 30L/h, sprays above-mentioned solution toward sacculus.
After spraying, sacculus is taken out, obtains the medicinal balloon for being covered with taxol drug coating to surface after dry.
(3) medicinal balloon is subjected to three wingfold.
(4) sacculus folded is put into the heat-shrinkable tube that internal diameter is 2mm, shrinkage temperature is 100 DEG C, shrinkage ratio is 2:1
In, 100 DEG C of thermal finalization 1min.
(5) sacculus shunk is put into coil pipe, is packed, sterilizing.
Embodiment 2:
(1) preparation of drug solution: weighing 0.1g taxol, and 20ml vial is added；It is added 10ml's in vial
Ethyl alcohol, the PVP of 2g, ultrasonic dissolution.
(2) sacculus coating: by sacculus (diameter 4.0mm, length 60mm) submergence 1 minute in the above solution of foley's tube
After take out, dry 10 minutes, obtain to surface and be covered with the medicinal balloon of taxol drug coating.
(3) medicinal balloon is subjected to six wingfold.
(4) medicinal balloon folded is put into internal diameter is 2.5mm, shrinkage temperature is 130 DEG C, shrinkage ratio is 1.1:1's
In heat-shrinkable tube, 130 DEG C thermal finalization 30 seconds.
(5) sacculus shunk is put into coil pipe, is packed, sterilizing.
Fig. 4 is the schematic cross-section of the present embodiment medicinal balloon catheter balloon regions.Medicinal balloon 5 is in six wingfold, heat
The medicinal balloon 5 that closely cladding folds of collapsible tube 1.
Embodiment 3:
(1) preparation of drug solution: weighing 0.1g everolimus, and 20ml vial is added；10ml is added in vial
Methanol, ultrasonic dissolution.
(2) sacculus coating: quantitatively drawing the medical fluid of 30 μ l, is carefully coated on sacculus (the diameter 6.0mm, length of foley's tube
Spend 40mm) surface, the medicinal balloon that everolimus medication coat is covered with to surface is obtained after dry.
(3) medicinal balloon is subjected to five wingfold.
(4) medicinal balloon folded is put into the thermal contraction that internal diameter is 3mm, shrinkage temperature is 90 DEG C, shrinkage ratio is 3:1
Guan Zhong, 90 DEG C of thermal finalization 1min.
(5) sacculus shunk is put into coil pipe, is packed, sterilizing.
Embodiment 4:
(1) preparation of drug solution: weighing the PEG of 0.3g rapamycin and 0.2g, and 20ml vial is added；In vial
The middle tetrahydrofuran that 10ml is added, ultrasonic dissolution.
(2) sacculus coating: the sacculus (diameter 4.0mm, length 60mm) of foley's tube is placed under ultrasonic spray head, setting
Supersonic frequency is 15khz, the flow velocity of spray solution is 0.15ml/min, flow rate of carrier gas 30L/h, is sprayed toward sacculus above-mentioned molten
Liquid.After spraying, sacculus is taken out, obtains the medicinal balloon for being covered with rapamycin drug coating to surface after dry.
(3) medicinal balloon is subjected to four wingfold.
(4) sacculus folded is put into the thermal contraction that internal diameter is 2.5mm, shrinkage temperature is 120 DEG C, shrinkage ratio is 5:1
Guan Zhong, 100 DEG C of thermal finalization 1min.
(5) sacculus shunk is put into coil pipe, is packed, sterilizing.
Different protected mode balloon diameter measurements
The medicinal balloon catheter that embodiment 1 is obtained, with the medicinal balloon catheter for being inserted in protection sleeve pipe using common process
It compares, after packaging sterilizing, the sacculus of two foley's tubes is taken out from heat-shrink tube and GPF (General Protection False casing respectively, uses shadow
As two methods of the balloon diameter of instrument test.Comparing result is shown in Table one.
The comparison of one balloon diameter of table
As can be seen from the table, more using the balloon diameter of the relatively conventional protection sleeve pipe of balloon diameter of heat-shrinkable tube protection
It is small, while can be seen that and be obtained using the balloon diameter standard deviation of heat-shrinkable tube protection relative to GPF (General Protection False casing methods
It is smaller, technique is more stable, is more conducive to the operation of doctor.
Different protected mode dose tests
The medicinal balloon catheter that embodiment 1 is obtained, with the medicinal balloon catheter for being inserted in protection sleeve pipe using common process
It compares, using the medicament contg of both following methods tests:
(1) balloon portion is shredded, is immersed in the methanol solution of 10ml, ultrasonic extraction 15min.
(2) above-mentioned leaching liquor is extracted, is detected referring to 2010 content of taxol detection method of Chinese Pharmacopoeia.
Comparing result is shown in Table two.
The comparison of two dose of table
| Content of taxol (mg) | Standard deviation |
| Heat-shrinkable tube | 0.38 | 0.36 | 0.35 | 0.39 | 0.018 |
| GPF (General Protection False casing | 0.3 | 0.26 | 0.33 | 0.24 | 0.04 |
As can be seen from the table, using the relatively conventional protection sleeve pipe of medicament contg of the medicinal balloon of heat-shrinkable tube protection
Medicament contg is higher, while can be seen that the standard deviation using the dose of heat-shrinkable tube protection relative to GPF (General Protection False casing
Method obtains smaller, illustrates that heat-shrinkable tube protection is more advantageous to the stabilization of dose.
Balloon surface degree of impairment
In Fig. 5, a is the photo on the medicinal balloon surface obtained using 2 method of embodiment, and b is the drug ball in embodiment 2
Capsule does not use heat-shrinkable tube but uses the photo of the balloon surface after conventional method insertion protective case, we can see that adopting
Balloon surface with pyrocondensation protection of pipe is very smooth, and the balloon surface of conventional method protection is used to have folding line.
In Fig. 6, a is the photo of the sacculus inner tube obtained using 2 method of example, and b is that the medicinal balloon in example 2 does not make
Photo with heat-shrinkable tube but using the sacculus inner tube after conventional method insertion protective case, we can see that using heat-shrink tube
The sacculus inner tube of protection is smooth, and the sacculus inner tube of conventional method protection is used to damage.
Influence of the unlike material heat-shrink tube to coating
The heat-shrinkable tube of unlike material is selected to prepare drug difference, the identical medicinal balloon catheter of specification, test is heat-shrinked
Influence of the tube material to medication coat, testing procedure are as follows:
The identical medicinal balloon catheter of specification 10 is taken, wherein 5 are protected using heat-shrinkable tube, 5 are not protected.It uses
Previously mentioned method measures the medicament contg on the sacculus of each foley's tube, there is the flat of the medicament contg of the sacculus of protection
Mean value is A1, and the average value of the medicament contg for the sacculus that do not protect is the A2 (medication coat that i.e. no heat-shrinkable tube influences
Medicament contg), then drug retention rate=A1/A2.It the results are shown in Table three.
The drug retention rate of the different heat-shrinkable tube materials of table three
| PE | EPM | FEP | EVA | PET | ABS | Silicon rubber | GPF (General Protection False casing | |
| Taxol | 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% |
Compare above-mentioned data, it can be seen that medicinal balloon is protected using heat-shrinkable tube, if using such as PET, ABS material,
Influence to medication coat is suitable with GPF (General Protection False casing.And polyolefin based materials (such as PE, EPM) and fluoroplastics (such as FEP)
Influence of the heat-shrinkable tube to medication coat is smaller, retention rate highest, the preferably this kind of material when preparing medicinal balloon catheter of the present invention
Material.
Claims (4)
1. a kind of medicinal balloon catheter, which is characterized in that including medicinal balloon and heat-shrinkable tube, medicinal balloon is foldable structure,
Heat-shrinkable tube closely coats the medicinal balloon of folding；The heat-shrinkable tube is by polyethylene, ethylene propylene copolymer or perfluoroethylene
Propylene copolymer is made, and the drug of the medicinal balloon is selected from taxol, thunder cypress mycin or everolimus.
2. medicinal balloon catheter as described in claim 1, which is characterized in that the foldable structure is three wings foldable structure, four
Wingfold structure, five wingfold structures or six wingfold structures.
3. the preparation method of medicinal balloon catheter as described in claim 1 or 2 is any, which comprises the following steps:
Medicinal balloon is folded, the sacculus folded is inserted into heat-shrinkable tube, being then heated to shrinkage temperature shrinks heat-shrinkable tube,
Make the close coating medicine sacculus of heat-shrinkable tube.
4. preparation method as claimed in claim 3, which is characterized in that the perisystolic internal diameter of heat-shrinkable tube be 2.0 ~
3.0mm, hot contraction ratio are 1.1 ~ 5.0:1.
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| CN201510419680.5A CN104971422B (en) | 2015-07-16 | 2015-07-16 | Medicinal balloon catheter and preparation method thereof |
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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 |
| WO2018093329A1 (en) * | 2016-11-17 | 2018-05-24 | Vascuros Medical Pte Ltd | Drug eluting balloon |
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| CN109173016A (en) * | 2018-08-01 | 2019-01-11 | 中国医学科学院北京协和医院 | A kind of medicinal balloon catheter and balloon-system |
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| CN113303841A (en) * | 2020-07-09 | 2021-08-27 | 重庆橙壹科技有限公司 | Surgical medical extractor with reducing hollow tube |
| 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 |
| CN113303842A (en) * | 2020-07-09 | 2021-08-27 | 重庆橙壹科技有限公司 | Product bag containing object taking device for minimally invasive surgery |
| 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 |
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