CN103949006B - A kind of coronary dilatation catheter carrying ligustrazine nanoparticle - Google Patents
A kind of coronary dilatation catheter carrying ligustrazine nanoparticle Download PDFInfo
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- CN103949006B CN103949006B CN201410150992.6A CN201410150992A CN103949006B CN 103949006 B CN103949006 B CN 103949006B CN 201410150992 A CN201410150992 A CN 201410150992A CN 103949006 B CN103949006 B CN 103949006B
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- ligustrazine
- sacculus
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- catheter
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- FINHMKGKINIASC-UHFFFAOYSA-N Tetramethylpyrazine Chemical compound CC1=NC(C)=C(C)N=C1C FINHMKGKINIASC-UHFFFAOYSA-N 0.000 title claims abstract description 82
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- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Abstract
A kind of coronary dilatation catheter carrying ligustrazine nanoparticle, it is characterised in that include tip, silk guide passage, the distal portions of conduit, be loaded with the sacculus of ligustrazine nanoparticle, the proximal part of conduit, side opening, full device at outer surface；Wherein, the described silk guide passage of described most advanced and sophisticated connection also connects described side opening, described sacculus one end is fixed on silk guide passage, the other end connects distal catheter portion, described side opening is positioned at the distal catheter portion outside sacculus, the distal portions of described conduit is connected to the proximal part of conduit, described proximal catheter end portion connects described full device, is not communicated with between described silk guide passage and the distal portions of described conduit, sacculus.Expansion when, the ligustrazine Nano particle medicine of described coronary dilatation catheter can directly contact speckle in coronary artery, reduces resistance；Meanwhile, relative to the dilating catheter of other drug, the drug toxicity of ligustrazine Nano particle medicine is less, low-cost advantage.
Description
Technical field
The present invention relates to a kind of medical apparatus, particularly relate to a kind of coronary artery carrying ligustrazine nanoparticle and expand
Open conduit.
Background technology
Coronary atherosclerotic heart disease is coronary artery generation atherosclerotic lesion and causes
Lumen of vessels stenosis or occlusion, causes myocardial ischemia, anoxia or heart disease that is downright bad and that cause, is commonly referred to as " hat
Cardiopathia ".
At present, percutaneous coronary intervention (pci) (Percutaneous transluminal coronary
Angioplasty, is called for short PTCA) it is a kind of new for treating coronary heart disease method, it is with 20th century 70
Based on the Seldinger technology that initial stage in age occurs, specifically a kind of percutaneous puncture arteries foley's tube
Driving in the wrong direction is inserted at Atherosclerotic Vessels: Changes Observed during Coronary, then with the contrast agent Filled Balloon of dilution, utilizes squeezing of sacculus
Pressure effect, compresses speckle, crushes, and makes narrow coronary artery chamber become big, and blood flow increases, and blood supply improves
Method, has been widely used clinically.
Prior art has had multiple coronary saccule dilating catheter, for the expansion of coronary stricture part
?.Such as, Chinese patent CN202777428U discloses a kind of coronary saccule dilating catheter, including
Distal tube that sacculus is connected with sacculus and be arranged on the front tube of sacculus front end, described front tube is taper,
The front end face of described front tube is cambered surface, is provided with the development pipe being made up of developing material in described sacculus, described far
Being provided with inner tube in end pipe, the front end of said inner tube is connected with development pipe, and said inner tube and development pipe have been inserted into
Seal wire, said inner tube seals with distal tube mutually with the junction of distal tube.
But, once enter the narrowest lesion coronarius, owing to resistance is relatively big, be therefore not easy
Pass through.It addition, often there is also the phenomenon of restenosis at PTCA Post operation, i.e. by treatment arteria coronaria local
" heal " after damage and react and cause the narrowest of local vascular chamber.
Although having some to carry the coronary dilatation catheter of medicine at present, as Chinese patent CN202191582
Disclosed in U.But, the medicine that medicine-coated balloon is loaded is generally the Western medicine such as paclitaxel, medicine
Side effect is relatively big, such as anaphylaxis, late arterial neoplasia etc..
Summary of the invention
For above-mentioned technical problem, the invention provides a kind of coronary artery expansion carrying ligustrazine nanoparticle
Conduit.
The present invention being achieved by the following technical programs:
A kind of coronary dilatation catheter carrying ligustrazine nanoparticle, it is characterised in that include tip, lead
Silk passage, the distal portions of conduit, it is loaded with the close end of the sacculus of ligustrazine nanoparticle, conduit at outer surface
Point, side opening, full device；Wherein, the described silk guide passage of described most advanced and sophisticated connection also connects described side opening, described ball
Capsule one end is fixed on silk guide passage, the other end connects distal catheter portion, and described side opening is positioned at leading outside sacculus
Pipe distal portions, the distal portions of described conduit is connected to the proximal part of conduit, and described proximal catheter end portion is even
Connect described full device, be not communicated with between described silk guide passage and the distal portions of described conduit, sacculus.
Preferably, the particle diameter of described ligustrazine nanoparticle is less than 100nm, is more preferably, less than 80nm,
It is more preferably, less than 60nm.
Described ligustrazine nanoparticle is made up of the method for following steps: extract ligustrazine from chuanxiong, after
Use is milled medium mechanical-chemistry grinding in grinding equipment.
Described ligustrazine nanoparticle is made up of chemical method.
The effective dose that the dosage of described ligustrazine nanoparticle is well known to those skilled in the art, such as
2-1000 μ g, preferably 100-500 μ g.
Preferably, described ligustrazine nanoparticle by spraying, dip-coating, leaching glue, electrostatic coating, collosol and gel
One or more in coating, supercritical fluid coating and other modes commonly used in the art are positioned at described sacculus
On outer surface.
Preferably, the diameter of described sacculus is 0.2-1.8mm/ atmospheric pressure with the rate of change of pressure.
Preferably, a diameter of 1.5-5.5mm of described sacculus, preferably 2-4mm.
Preferably, a length of 7-40mm of described sacculus, preferably 10-35mm.
Preferably, described sacculus uses macromolecule polymeric material to make.
Described macromolecule polymeric material is acrylic acid methyl ester., methylmethacrylate copolymer, polylactic acid, poly-second
Alkyd, poly-racemic lactic acid, lactide coglycolide homopolymer or copolymer, Phosphorylcholine, poly-aethylis carbamas
Or ethylene-vinyl alcohol copolymer, ethylene-vinyl acetate copolymer, polycaprolactone.
Preferably, described side opening is at the about 18-30cm of described tip, it is highly preferred that at about 20-28cm.
Preferably, outside described sacculus, it is coated with balloon protective sleeve, such as, protects sleeve pipe, protection mantle.
Described balloon protective sleeve can be elastomeric material, such as nylon elastomer Pebax material.
Preferably, described coronary dilatation catheter also includes that guiding wire, described guiding wire are positioned at seal wire and lead to
Pass in road and from side opening and tip.
Preferably, described coronary dilatation catheter also includes the point that develops, and described development point is positioned at sacculus
On tube wall, described development point is by being coated in contrast agent on the silk guide passage outer wall in described sacculus.
Described contrast agent is ionic contrast agent and/or non-ionic contrast agent.Described ionic contrast agent is sulfur
Acid barium, cardiografin, meglumine iotalamate, ioxaglic acid etc., described non-ionic contrast agent be iohexol,
Iopromide, iotrolanvist, B-15000 etc..
The distal portions of described conduit is made by having suitable flexible material, and the proximal part of described conduit is by having
Suitable rigid material is had to make.
Preferably, described coronary dilatation catheter also includes that cone joint, described cone joint are described conduit
Near-end and the connecting portion of described full device.
Using ligustrazine nano-particle in the present invention, it is a kind of a kind of life separated from chuanxiong
Alkaloids, has and can substantially increase coronary flow, reduces arterial pressure and coronary resistance.By stabilizing cell membrane, fall
Low cell permeability, anti-cell lipid peroxidation damages, and increases NO level simultaneously, suppresses hemocyte pair
Sticking and damaging of blood vessel endothelium, regulates antiotasis thus improves cell hypoxia ischemic conditions, protects Ink vessel transfusing
The damage of chrotoplast.The smooth muscle cell proliferation of coronary endometrium can also be suppressed, promote its apoptosis, reduce
The generation of restenosis (rate)；And there is anti-inflammatory and reduce the effect that coronary thrombosis is formed.
The invention have the benefit that expansion when, the ligustrazine nanometer of described coronary dilatation catheter
Drug particles can directly contact speckle in coronary artery, reduces resistance；Meanwhile, relative to the expansion of other drug
Opening conduit, the drug toxicity of ligustrazine Nano particle medicine is less, low-cost advantage.
Accompanying drawing explanation
Fig. 1 is the schematic diagram of the coronary dilatation catheter carrying ligustrazine nanoparticle of the present invention.
Detailed description of the invention
In order to make those skilled in the art be more fully understood that the solution of the present invention, below in conjunction with the accompanying drawings and embodiment party
The present invention is described in further detail for formula.
A kind of coronary dilatation catheter carrying ligustrazine nanoparticle, including most advanced and sophisticated 3, silk guide passage 7,
The distal portions 1 of conduit, outer surface be loaded with the sacculus 4 of ligustrazine nanoparticle, the proximal part 2 of conduit,
Side opening 8, full device 5, guiding wire 9, full device 5, cone joint 10, development point 6；
Wherein, most advanced and sophisticated 3 connect silk guide passages 7 also connects side opening 8, sacculus 4 one end be fixed on silk guide passage 7,
The other end connects distal catheter portion 1, and side opening 8 is positioned at the catheter distal end portion 1 point outside sacculus, conduit remote
End portion 1 is connected to the proximal part 2 of conduit, and proximal catheter end portion 2 fills also by cone joint 10 connection
Being full of between the distal portions of device 5, silk guide passage and conduit, sacculus and be not communicated with, development point 6 is positioned at sacculus cincture
Silk guide passage outer wall on, guiding wire 9 is positioned in silk guide passage and passes from side opening and tip.
The proximal part 2 of conduit should have suitable rigidity, the possibility so that the propelling movement acting on its near-end overcomes
How to be sent to its far-end (connecting one end of far-end pipeline section 2).The proximal part 1 of conduit can select by medical
Level metal material is made, such as rustless steel (such as 316L), cobalt-base alloys, titanium-base alloy.
Sacculus 4 uses macromolecule polymeric material to make, and this macromolecule polymeric material can bear the most intrinsic pressure, warp
Hollow blow molding.This macromolecule polymeric material is acrylic acid methyl ester., methylmethacrylate copolymer, poly-breast
Acid (PLLA), polyglycolic acid, poly-racemic lactic acid, polylactide-co-glycolide polymers, Phosphorylcholine, poly-
Aethylis carbamas, and preferably medical grade degradable polymer, such as polylactide-co-glycolide polymers
The particle diameter of the ligustrazine nanoparticle on sacculus 4 is 100nm, it is also possible to for less than 100nm, use
Dosage is 100-500 μ g.This nanoparticle can pass through spraying, dip-coating, leaching is viscous, electrostatic coating, colloidal sol are solidifying
Any one in glue coating, supercritical fluid coating on sacculus, such as, weighs 100 μ g with precision balance
Ligustrazine nanoparticle, be then dissolved in solvent being configured to solution, be sprayed on balloon surface with precision airbrush
On, then dry in 60 degree of baking ovens.
Wherein, ligustrazine nanoparticle is made up of the method for following steps: extract ligustrazine from chuanxiong,
Rear use is milled medium mechanical-chemistry grinding in grinding equipment.
Ligustrazine nanoparticle can also be made up of chemical method.
Being cylindric after the expansion of sacculus 4, diameter is in the range of 1.5-5.5mm, such as 2.5mm；Diameter
It is 0.2-1.0mm/ atmospheric pressure with the rate of change of pressure；Length is in the range of 7-40mm, such as 30mm.
The distal portions 1 of conduit should have suitable flexibility, therefore should select the tubing of flexible relative, logical
Often select the block copolymer PEBAX of polymer, such as polyamide, polyethers and polyamide, polyethylene etc. single
Layer or multi-layer tubes.So can improve the tracing property of ball dilating catheter so that it is can along vascular system certainly
So extend, especially can pass through arteria coronaria region more curved blood vessel and arrive narrow portion position.
Sacculus 4 outside being loaded with ligustrazine nanoparticle can be coated with balloon protective sleeve, was stretching into reduce
The loss of ligustrazine nanoparticle in journey.
Guiding wire 9 appearance has polymer jacket, can reduce rubbing between guiding wire and diseased region
Wipe.
The proximal part 2 of conduit and distal portions 1 in actual use, in order to reduce near-end pipeline section 1 with
Frictional force between described guiding catheter, can cover on the surface of near-end pipeline section 1 or smear one layer smooth
The block copolymer PEBAX etc. of polymer, such as polytetrafluoroethylene PTFE, polyethers and polyamide.
Development point 6 is coated on interior cavity outer wall by prior art, for determining the position of sacculus under X-ray
Putting, wherein, development point contrast agent is ionic contrast agent and/or non-ionic contrast agent, wherein, and ion-type
Contrast agent is barium sulfate, cardiografin, meglumine iotalamate, ioxaglic acid etc., and non-ionic contrast agent is iodine
Benzene six alcohol, Iopromide, iotrolanvist, B-15000 etc..
Most advanced and sophisticated 3 is mellow and full taper, thus more easily arrives and pass at stenotic lesion.
Full device 5 can be made up of the injection pump housing, sensor, and injection pump housing one end is connected to cone joint 10
To inject fluid Filled Balloon.
During use, under the guiding of medical imaging device, first will under common seal wire guides with Percutaneous Techniques
The aorta of guiding catheter (not shown) insertion patient is to coronary ostium, then by guiding wire 9
Pass from tip along silk guide passage, send into coronary artery, and continue to extend beyond guiding catheter, and then enter
Left or the right coronary arteries of patient, then by guiding wire 9 through lead channels, makes ball along guiding wire
9 arrive the narrow positions in blood vessel, inject fluid by full device 5 and realize pressurization or remove pressure, so that sacculus
4 expansions or contraction, when expansion, the Chinese medicine ingredients ligustrazine nanoparticle that sacculus 4 carries can rest on
The narrowest pathological changes cover, has with the inner membrance of coronary artery local and sufficiently contacts, can more give full play to medicine
Antiproliferative in body local, promote the beneficial pharmacological effect such as apoptosis.
It addition, during for postoperative restenosis, can be studied by contrast experiment.Wherein, select
Restenosis case, lesion type is similar, stenosis and the equal no difference of science of statistics of length of lesion, is divided into 2 groups of examinations
Test group and matched group.Test group 1 is the coronary dilatation catheter carrying ligustrazine nanoparticle, by above-mentioned side
Prepared by method；Test group 2 is the coronary dilatation catheter carrying paclitaxel, and it is by the purple of identical treatment dosage
China fir alcohol is sprayed on balloon surface and is prepared from, and preparation method is with the coronary artery expansion carrying ligustrazine nanoparticle
Conduit；Matched group is common coronary dilatation catheter, not carrying medicaments on sacculus.
Be respectively adopted test group 1 carries the coronary dilatation catheter of ligustrazine nanoparticle, test group 2
Carry the coronary dilatation catheter of paclitaxel, matched group common coronary dilatation catheter to restenotic lesions
Position is expanded, the time at about 30s, medicinal balloon group and the late period of common sacculus group when within 6 months, following up a case by regular visits to
Tube chamber loses and is respectively (0.1 ± 0.4) mm, (0.4 ± 0.7) mm and (1.0 soil 1.0) mm (P < 0.01)；
Restenosis rate is respectively 6%, 10% and 52%.
Being described in detail the specific embodiment of the present invention above, but it is intended only as example, the present invention is also
It is not restricted to particular embodiments described above.To those skilled in the art, any the present invention is carried out
Equivalent modifications and substitute the most all among scope of the invention.Therefore, without departing from the spirit of the present invention and model
Enclose lower made impartial conversion and amendment, all should contain within the scope of the invention.
Claims (9)
1. the coronary dilatation catheter carrying ligustrazine nanoparticle, it is characterised in that include tip, lead
Silk passage, the distal portions of conduit, it is loaded with the close end of the sacculus of ligustrazine nanoparticle, conduit at outer surface
Point, side opening, full device；
Wherein, the described silk guide passage of described most advanced and sophisticated connection also connects described side opening, and described sacculus one end is fixed on leads
Silk passage, the other end connect distal catheter portion, and described side opening is positioned at the distal catheter portion outside sacculus, institute
The distal portions stating conduit is connected to the proximal part of conduit, and described proximal catheter end portion connects described full device,
It is not communicated with between described silk guide passage and the distal portions of described conduit, sacculus,
The outside of described sacculus is coated with protection set, a length of 7-10mm of described sacculus；
The particle diameter of described ligustrazine nanoparticle is 60-100nm；
The diameter of described sacculus is 0.2-1.0mm/ atmospheric pressure with the rate of change of pressure.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described ligustrazine nanometer is micro-
Grain by spraying, dip-coating, leaching is viscous, electrostatic coating, collosol and gel apply, one in supercritical fluid coating
Or multiple be positioned on described sacculus outer surface.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described ligustrazine nanometer is micro-
The dosage of grain is 2-1000 μ g.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described ligustrazine nanometer is micro-
Grain is made up of the method for following steps: extract ligustrazine from chuanxiong, rear uses medium of milling to set milling
Standby middle mechanical-chemistry grinding.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described ligustrazine nanometer is micro-
Grain is made by chemical method.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described side opening distance is most advanced and sophisticated
20-30cm。
Coronary dilatation catheter the most according to claim 1, it is characterised in that described coronary artery expansion
Conduit also includes that guiding wire, described guiding wire are positioned in silk guide passage and pass from side opening and tip.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described coronary artery expansion
Conduit also includes that cone joint, described cone joint are described proximal catheter end portion and the connection of described full device
Portion.
Coronary dilatation catheter the most according to claim 1, it is characterised in that described coronary artery expansion
Conduit also includes the point that develops, and described development point is positioned on the silk guide passage outer wall of sacculus cincture.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410150992.6A CN103949006B (en) | 2014-04-15 | 2014-04-15 | A kind of coronary dilatation catheter carrying ligustrazine nanoparticle |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201410150992.6A CN103949006B (en) | 2014-04-15 | 2014-04-15 | A kind of coronary dilatation catheter carrying ligustrazine nanoparticle |
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| CN103949006A CN103949006A (en) | 2014-07-30 |
| CN103949006B true CN103949006B (en) | 2016-08-17 |
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| CN201410150992.6A Expired - Fee Related CN103949006B (en) | 2014-04-15 | 2014-04-15 | A kind of coronary dilatation catheter carrying ligustrazine nanoparticle |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104548317B (en) * | 2015-01-20 | 2018-06-26 | 周玉杰 | A kind of guiding catheter with shaping inner core |
| CN109381783A (en) * | 2017-08-02 | 2019-02-26 | 杭州唯强医疗科技有限公司 | Drug coated balloon catheter |
| WO2023160630A1 (en) * | 2022-02-23 | 2023-08-31 | Sino Medical Sciences Technology Inc. | Method for preparing drug eluting balloons without coating |
| CN115569240A (en) * | 2022-09-15 | 2023-01-06 | 辽宁垠艺生物科技股份有限公司 | Medicine coating plastic capsule and preparation method thereof |
Family Cites Families (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7022104B2 (en) * | 2003-12-08 | 2006-04-04 | Angioscore, Inc. | Facilitated balloon catheter exchange |
| CN101001659A (en) * | 2004-08-11 | 2007-07-18 | 株式会社钟化 | Catheter |
| CN100435798C (en) * | 2005-06-07 | 2008-11-26 | 北京振东光明药物研究院 | Preparation of ligustrazine and ligustrazine salt drop pills utilizing nano technology |
| US8556851B2 (en) * | 2005-07-05 | 2013-10-15 | Angioslide Ltd. | Balloon catheter |
| CN201135683Y (en) * | 2007-11-07 | 2008-10-22 | 乐普（北京）医疗器械股份有限公司 | Conical saccule dilating catheter |
| US9198968B2 (en) * | 2008-09-15 | 2015-12-01 | The Spectranetics Corporation | Local delivery of water-soluble or water-insoluble therapeutic agents to the surface of body lumens |
| CN202191582U (en) * | 2011-07-05 | 2012-04-18 | 科明技术（香港）有限公司 | Medicine balloon dilating catheter |
| CN102793962A (en) * | 2012-07-20 | 2012-11-28 | 易生科技(北京)有限公司 | Balloon dilatation catheter |
| CN202777428U (en) * | 2012-08-23 | 2013-03-13 | 王希成 | Coronary artery balloon dilating catheter |
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2014
- 2014-04-15 CN CN201410150992.6A patent/CN103949006B/en not_active Expired - Fee Related
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