CN107088259A - A kind of medicinal balloon and preparation method thereof - Google Patents

A kind of medicinal balloon and preparation method thereof Download PDF

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Publication number
CN107088259A
CN107088259A CN201710434178.0A CN201710434178A CN107088259A CN 107088259 A CN107088259 A CN 107088259A CN 201710434178 A CN201710434178 A CN 201710434178A CN 107088259 A CN107088259 A CN 107088259A
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CN
China
Prior art keywords
balloon
medicine
balloon body
medicinal
folded
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.)
Pending
Application number
CN201710434178.0A
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Chinese (zh)
Inventor
盛卫文
朱平
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Shanghai Heart To Medical Technology Co Ltd
Original Assignee
Shanghai Heart To Medical Technology Co Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Shanghai Heart To Medical Technology Co Ltd filed Critical Shanghai Heart To Medical Technology Co Ltd
Priority to CN201710434178.0A priority Critical patent/CN107088259A/en
Publication of CN107088259A publication Critical patent/CN107088259A/en
Priority to PCT/CN2018/083316 priority patent/WO2018223775A1/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0009Making of catheters or other medical or surgical tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0021Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M2025/0025Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter having a collapsible lumen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0057Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • A61M2025/1004Balloons with folds, e.g. folded or multifolded
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1027Making of balloon catheters
    • A61M25/1029Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
    • A61M2025/1031Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Hematology (AREA)
  • Biomedical Technology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Manufacturing & Machinery (AREA)
  • Materials For Medical Uses (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The invention discloses a kind of medicinal balloon, including balloon body, whole body is all covered with 360 ° of the surface of medicine, i.e. balloon body covered with medicine on the balloon body;Balloon body has folded state and expanded state;In a folded configuration, a part of medicine be folded in do not contacted with vascular wall;Under expanded state, be folded in medicine emerge and contacted with vascular wall.The invention also discloses the preparation method of said medicine sacculus, it is related to and is covered medicine on balloon body by Iopromide by the way of extraction and/or ultrasound spraying.Medicinal balloon involved in the present invention, 360 ° of covering medicines cause blood vessel is all-round can receive medicine, and therapeutic effect more preferably, and produces more convenient.

Description

A kind of medicinal balloon and preparation method thereof
Technical field
The invention belongs to medical instruments field, more particularly, to a kind of medicinal balloon and preparation method thereof.
Background technology
Narrow angiocarpy is the one of the main reasons for causing coronary heart disease.PCI (Percutaneous Coronary Intervention, PCI) it is the cardiovascular narrow important means for the treatment of.And with the increase of support usage quantity, in support again Narrow (in-stent restenosis, ISR) problem is increasingly serious.Patient 5~60% by treatment can send out in short, mid-term Angiogenic ISR, seriously limits PCI development.
In recent years, new technology --- the medicinal balloon of reangiostenosis after prevention interventional therapy operation is occurred in that.It is by The medicine of anti-angiogenic endometrial hyperplasia applies and is placed in balloon surface, when sacculus reaches lesion vesselses wall and is softened, fills, with vascular wall Inner membrance is contacted, and the technology in quick release of pressurizeing, diversion medicaments to local vessel wall.Medicine is locally playing anti-angiogenic inner membrance The effect of hyperplasia, so as to prevent ISR after vascular procedure.Research in terms of its clinical practice shows that medicinal balloon handles ISR Good curative effect is shown during lesion, and available for treatment Small vessel, bifurcated lesions, part tubular arteries protopathy Become, and be not resistant to or be not suitable for Long-term Oral duplex antiplatelet drug patient (《In medicine-coated balloon clinical practice State's Consensus of experts》Expert group, medicine-coated balloon clinical practice China Consensus of experts, Chinese Interventional cardiology magazine, Volume 2016,24, the 2nd phase, 61-67 pages).
Because when medicinal balloon is in the state for being softened, filling, medicinal balloon understands blocking blood flow, therefore it persistently fills Otherwise the time being full of at most can only may cause myocardial ischemia at 40 seconds or so.This requires medicine rapid in a short time Release reaches the dosage for meeting needs.
The content of the invention
The problem of in order to solve to discharge enough drug doses in a short time, the present invention provides a kind of medicinal balloon, bag Balloon body is included, whole body is all covered with 360 ° of the surface of medicine, i.e. balloon body covered with medicine on the balloon body;Sacculus sheet Body has folded state and expanded state;In a folded configuration, a part of medicine be folded in do not contacted with vascular wall;Filling Be full of under state, be folded in medicine emerge and contacted with vascular wall.
Further, balloon body has at least one flap, and flap has inside and outside two surfaces;In a folded configuration, In medicine on the inner surface of flap is folded in.
Preferably, flap is 3 to 5.
In a kind of embodiment, under expanded state, the circular in cross-section of balloon body.
In another embodiment, under expanded state, the cross section of balloon body shows as setting between flap It is equipped with depression.
Further, axis of the folding line of flap parallel to balloon body.The axis of balloon body is generally through sacculus The conduit of body.
Further, it is provided with developing element on balloon body.
Further, developing element is ring-type.
Further, balloon body is proximally and distally provided with developing element.Distally refer in the present invention away from behaviour That one end of author (such as doctor);Near-end refers to close to that one end of operator (such as doctor).
In another embodiment, under expanded state, the surface of the cross section of balloon body is provided with depression.
Further, the material of balloon body is Pebax or nylon.Pebax scientific name is block polyether acidamide resin, It is the nylon elastomer of French ARKEMA companies production.
Further, medicine is selected from taxol and rapamycin, or its combination.
Further, medicine is covered on balloon body by adhesive by the way of extraction and/or ultrasound spraying, Adhesive is Iopromide.
The present invention also provides a kind of preparation method of medicinal balloon as described above, is sprayed using extraction and/or ultrasound Mode covers medicine on balloon body by adhesive, and adhesive is Iopromide.
Further, it is specially by the operation of ultrasonic spraying method:
Step 1: configuration mixed solution:In mass ratio 1:2 to 2:1 takes taxol and Iopromide, is configured to mix with solvent Solution is closed, wherein the solvent is selected from ethanol, methanol, acetone, tetrahydrofuran, isopropanol, acetonitrile, ethyl acetate and formic acid first Ester, or its combination;
Step 2: the mixed solution to be coated to the surface of balloon body by the way of ultrasound spraying;
Step 3: dry naturally, or less than 60 DEG C heating, dryings.
Further, natural flash-off time is 5-30 minutes.Heating, drying in less than 60 DEG C of baking oven, the time is 3-20 points Clock.
Beneficial effect:
1st, 360 ° of covering medicines are carried out to balloon body so that blood vessel is all-round can to receive medicine, therapeutic effect more preferably, And produce more convenient.
2nd, flap is conducive to protecting the medicine in being folded in be not washed away by the blood flow, so as to avoid drug loss.
3rd, the circular in cross-section of balloon body is conducive to fitting with blood vessel.
4th, under expanded state, the cross section of balloon body shows as being provided with depression between flap, is conducive to blood flow to pass through, So as to suitably extend the persistently full time, drug effectiveness is lifted.
5th, material is Pebax, and semi-compliant, adherent performance is good.Suitable for being blocked for cardiac stent, sacculus can be stretched Enter, block part is supportted big, the medicine of balloon surface can coat the medicine for putting endothelial cell growth.
6th, material is nylon, and harder, non-compliance is more suitable for being expanded before stenter to implant.
Brief description of the drawings
Fig. 1 is a kind of structural representation of medicinal balloon involved in the present invention in a folded configuration.
Fig. 2 is the partially unfolded structural representation of medicinal balloon in Fig. 1.
Fig. 3 is structural representation of the medicinal balloon under expanded state in embodiment 1.
Fig. 4 is structural representation of the medicinal balloon under expanded state in embodiment 2.
Embodiment
The present invention will be further described with specific embodiment below in conjunction with the accompanying drawings, and of the invention protects content not limit to In following examples.Under the spirit and scope without departing substantially from inventive concept, those skilled in the art it is conceivable that change and excellent Point is all included in the present invention, and using appended claims as protection domain.
Embodiment 1
Fig. 1-3 shows a specific embodiment of medicinal balloon involved in the present invention.In the present embodiment, medicine ball Capsule includes balloon body 1.360 ° of the surface of balloon body 1 is covered with medicine 2.Balloon body 1 has three flaps 3.At this The quantity of flap 3 is not limited to three in invention.In a folded configuration, in the medicine 2 in the inner surface of flap 3 is folded in, because This is not contacted with vascular wall, ensures that this some drugs 2 will not be depleted during balloon body 1 passes through blood vessel Fall.Under expanded state, as shown in Fig. 3, the medicine 2 of the inner surface of flap 3 is emerged together with (including the flap of remaining medicine 2 The medicine 2 of 3 outer surfaces) contacted together with vascular wall, play drug effect.In the present embodiment, the cross section of balloon body 1 is in circle Shape, to be fitted with blood vessel so that more medicines are acted on angiogenesis.
Axis of the folding line of flap 3 parallel to balloon body 1.The axis of balloon body 1 is leading through balloon body 1 Pipe.The developing element for being proximally and distally provided with ring-type of balloon body 1.
The material of balloon body 1 is Pebax or nylon;Medicine 2 is selected from taxol and rapamycin, or its combination.
Embodiment 2
Fig. 4 shows under another medicinal balloon of the present invention, its expanded state that the cross section of balloon body 1 is shown as Depression 4 is provided between adjacent flaps.Depression 4 effect be so that medicinal balloon will not also hinder completely under expanded state Clinopodium polycephalum, so as to extend the persistently full time, provides more times, so as to reach more preferable effect for insoluble drug release Really.Remaining design is same with embodiment 1, is 360 ° of covering medicines 2, and possess flap 3.The quantity of depression 4 and flap 3 Quantity is identical.
Embodiment 3
Under expanded state, the surface of the cross section of balloon body is provided with depression, is conducive to blood flow to pass through.With embodiment Unlike 2, the depression is not limited to the depression between flap.Remaining be the same as Example 2.
The medicine covering method of embodiment 4
Medicine is covered on balloon body by adhesive by the way of extraction and/or ultrasound spraying, adhesive is Iopromide.
It is specially by the operation of ultrasonic spraying method:
Step 1: configuration mixed solution:In mass ratio 1:1 takes taxol and Iopromide, mixing is configured to solvent molten Liquid, wherein the solvent is ethanol;
Step 2: the mixed solution to be coated to the surface of balloon body by the way of ultrasound spraying;
Step 3: dry naturally, or less than 60 DEG C heating, dryings.
Wherein, the mass ratio of taxol and Iopromide is not limited to the present embodiment, can be 1:2 to 2:1.And solvent is not yet It is limited to ethanol, can is methanol, acetone, tetrahydrofuran, isopropanol, acetonitrile, ethyl acetate and methyl formate, or its combination.
Preferred embodiment of the invention described in detail above, technical concept and spy only for the explanation present invention Point, its object is to allow those skilled in the art to understand present disclosure and implement according to this, can not limit this with this The protection domain of invention.It should be appreciated that one of ordinary skill in the art just can be according to the present invention's without creative work Many modifications and variations are made in design.Therefore, all technical staff in the art are under this invention's idea in prior art On the basis of by the available technical scheme of logical analysis, reasoning, or a limited experiment, all should be by claims institute In the protection domain of determination.

Claims (10)

1. a kind of medicinal balloon, including balloon body, it is characterised in that whole body is all covered with medicine on the balloon body, i.e., 360 ° of the surface of the balloon body is covered with medicine;The balloon body has folded state and expanded state;In the folding Under overlapping state, a part of medicine be folded in do not contacted with vascular wall;Under the expanded state, it is described be folded in Medicine is emerged to be contacted with vascular wall.
2. medicinal balloon as claimed in claim 1, it is characterised in that the balloon body has at least one flap, described Flap has inside and outside two surfaces;Under the folded state, the medicine on the inner surface of the flap is folded in interior.
3. medicinal balloon as claimed in claim 2, it is characterised in that the flap is 3 to 5.
4. medicinal balloon as claimed in claim 2, it is characterised in that under the expanded state, the horizontal stroke of the balloon body Section is rounded.
5. medicinal balloon as claimed in claim 2, it is characterised in that under the expanded state, the horizontal stroke of the balloon body Section shows as being provided with depression between the flap.
6. medicinal balloon as claimed in claim 1, it is characterised in that the material of the balloon body is Pebax or nylon.
7. medicinal balloon as claimed in claim 1, it is characterised in that the medicine is selected from taxol and rapamycin, or It is combined.
8. medicinal balloon as claimed in claim 1, it is characterised in that will be described by the way of extraction and/or ultrasound spraying Medicine is covered on the balloon body by adhesive, and the adhesive is Iopromide.
9. a kind of preparation method of medicinal balloon as claimed in claim 1, it is characterised in that using extraction and/or ultrasound spray The mode of painting covers the medicine on the balloon body by adhesive, and the adhesive is Iopromide.
10. preparation method as claimed in claim 9, it is characterised in that be specially by the operation of ultrasonic spraying method:
Step 1: in mass ratio 1:2 to 2:1 takes taxol and Iopromide, and mixed solution is configured to solvent, wherein described molten Agent is selected from ethanol, methanol, acetone, tetrahydrofuran, isopropanol, acetonitrile, ethyl acetate and methyl formate, or its combination;
Step 2: the mixed solution to be coated to the surface of balloon body by the way of ultrasound spraying;
Step 3: dry naturally, or less than 60 DEG C heating, dryings.
CN201710434178.0A 2017-06-09 2017-06-09 A kind of medicinal balloon and preparation method thereof Pending CN107088259A (en)

Priority Applications (2)

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CN201710434178.0A CN107088259A (en) 2017-06-09 2017-06-09 A kind of medicinal balloon and preparation method thereof
PCT/CN2018/083316 WO2018223775A1 (en) 2017-06-09 2018-04-17 Drug-coated balloon and preparation method therefor

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
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WO (1) WO2018223775A1 (en)

Cited By (6)

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CN107519571A (en) * 2017-07-27 2017-12-29 上海心至医疗科技有限公司 Medicinal balloon and preparation method thereof
WO2018223775A1 (en) * 2017-06-09 2018-12-13 上海心至医疗科技有限公司 Drug-coated balloon and preparation method therefor
CN109481827A (en) * 2018-11-05 2019-03-19 南京友德邦医疗科技有限公司 A kind of medicine eluting balloon catheter and preparation method thereof
CN111298272A (en) * 2020-03-11 2020-06-19 科塞尔医疗科技(苏州)有限公司 Drug-coated balloon, preparation method thereof and drug-coated balloon dilatation catheter
CN111603664A (en) * 2020-05-28 2020-09-01 上海市东方医院(同济大学附属东方医院) Balloon catheter
CN112827055A (en) * 2019-11-25 2021-05-25 丁海雁 Medicine-feeding balloon assembly and medical instrument comprising same

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JPH08112351A (en) * 1994-10-14 1996-05-07 Terumo Corp Balloon catheter
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US20090204082A1 (en) * 2008-02-13 2009-08-13 Biotronik Vi Patent Ag Catheter, system for inserting an intraluminal endoprosthesis and method for manufacturing same
CN103949003A (en) * 2014-05-12 2014-07-30 辽宁生物医学材料研发中心有限公司 Expanding continuous-flow balloon catheter and preparation method thereof
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CN106075703A (en) * 2016-07-27 2016-11-09 杭州唯强医疗科技有限公司 Medicine carrying sacculus and the manufacture method of medicine carrying sacculus thereof
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CN106237485A (en) * 2016-08-29 2016-12-21 恒壹(北京)医疗科技有限公司 A kind of medicine-coated balloon dilating catheter and preparation method thereof
CN106620887A (en) * 2016-11-03 2017-05-10 上海申淇医疗科技有限公司 Production method for drug balloon
CN208003247U (en) * 2017-06-09 2018-10-26 上海心至医疗科技有限公司 A kind of medicinal balloon

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018223775A1 (en) * 2017-06-09 2018-12-13 上海心至医疗科技有限公司 Drug-coated balloon and preparation method therefor
CN107519571A (en) * 2017-07-27 2017-12-29 上海心至医疗科技有限公司 Medicinal balloon and preparation method thereof
CN109481827A (en) * 2018-11-05 2019-03-19 南京友德邦医疗科技有限公司 A kind of medicine eluting balloon catheter and preparation method thereof
CN112827055A (en) * 2019-11-25 2021-05-25 丁海雁 Medicine-feeding balloon assembly and medical instrument comprising same
CN112827055B (en) * 2019-11-25 2022-02-18 丁海雁 Medicine-feeding balloon assembly and medical instrument comprising same
CN111298272A (en) * 2020-03-11 2020-06-19 科塞尔医疗科技(苏州)有限公司 Drug-coated balloon, preparation method thereof and drug-coated balloon dilatation catheter
CN111603664A (en) * 2020-05-28 2020-09-01 上海市东方医院(同济大学附属东方医院) Balloon catheter

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