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CN108283758A - It is a kind of that there is broken, thrombolysis Biochemical analyzer function medicine eluting balloon catheter - Google Patents

It is a kind of that there is broken, thrombolysis Biochemical analyzer function medicine eluting balloon catheter Download PDF

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Publication number
CN108283758A
CN108283758A CN201810067104.2A CN201810067104A CN108283758A CN 108283758 A CN108283758 A CN 108283758A CN 201810067104 A CN201810067104 A CN 201810067104A CN 108283758 A CN108283758 A CN 108283758A
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China
Prior art keywords
cavity
guidewire lumen
suction
metal
biochemical analyzer
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CN201810067104.2A
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CN108283758B (en
Inventor
张海军
王智勇
周超
冯相蓺
李宁
张军伟
宋彩霞
崔晓珊
赵彦伟
尹玉霞
鲁手涛
段翠海
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    • 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
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/225Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for for extracorporeal shock wave lithotripsy [ESWL], e.g. by using ultrasonic waves
    • 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
    • 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0092Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin using ultrasonic, sonic or infrasonic vibrations, e.g. phonophoresis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B2017/22005Effects, e.g. on tissue
    • A61B2017/22007Cavitation or pseudocavitation, i.e. creation of gas bubbles generating a secondary shock wave when collapsing
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B17/22004Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
    • A61B17/22012Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
    • A61B2017/22014Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being outside patient's body; with an ultrasound transmission member; with a wave guide; with a vibrated guide wire
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065Functions of balloons
    • A61B2017/22067Blocking; Occlusion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods
    • A61B17/22Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22082Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
    • A61B2017/22084Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance stone- or thrombus-dissolving
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00General characteristics of surgical instruments
    • A61B2217/002Auxiliary appliance
    • A61B2217/005Auxiliary appliance with suction drainage system
    • 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
    • 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
    • A61M2025/1079Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon
    • 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
    • A61M2025/109Balloon catheters with special features or adapted for special applications having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biomedical Technology (AREA)
  • Surgery (AREA)
  • Anesthesiology (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Medical Informatics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Mechanical Engineering (AREA)
  • Dermatology (AREA)
  • Surgical Instruments (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses the medicine eluting balloon catheters that a kind of Biochemical analyzer and blood vessel dilatation shape function, belong to medical instruments field.Heretofore described guide-tube structure includes:Balloon cavity 1, compensated cavity 2, RX mouths 3, guidewire lumen 4, developing ring 5, suction chamber 6, Y types connector 7.The balloon cavity is in suction catheter outermost layer, and compensated cavity 2 is on 6 inner wall of suction chamber, and guidewire lumen 4 is on 6 distal end inner wall of suction chamber.The present invention can squeeze into Thrombolytic Drugs through suction chamber 6 and carry out drug thrombolysis.Auxiliary cavity is arranged in the present invention on 6 inner wall of suction chamber, external supersonic Thrombolysis (ETUS) function of practicable improvement, being placed in vivo by transport system through compensated cavity 2 has microporous fine metal cylinder, the ultrasonic wave sent out by external supersonic probe, it is reflected ultrasonic wave to multiple directions by micropore cylinder, amplify the cavitation of ultrasonic wave, improves and break bolt efficiency;Also it can be sent into chaff by compensated cavity 2, bolt is broken with mechanical force.

Description

It is a kind of that there is broken, thrombolysis Biochemical analyzer function medicine eluting balloon catheter
Technical field
The present invention relates to medical instruments fields.There is the broken bolt drug thrombolysis of ultrasound, Biochemical analyzer and blood more particularly to one kind Pipe shapes the medicine eluting balloon catheter of function.
Background technology
Statistics indicate that angiocardiopathy number in China's reaches 2.3 hundred million at present, wherein acute myocardial infarction (AMI) patient is It is at least new every year to send out 50 to 800,000 more than 2,000,000 people, and in the trend risen year by year, acute myocardial infarction is died of every year Number be more than 1,000,000.It was predicted that 2015 to the year two thousand thirty, China will newly-increased 21,000,000 acute coronary patients, occur extremely Few 7,000,000 cardiac deaths.In the world, the number display of American Heart Association (AHA) announcement in 2013, U.S. in 2009 Every 100,000 population of state just has 236.1 people to die of angiocardiopathy, accounts for the 32.3% of total death toll, and Canada is 6,05/,100,000, Finland is 8,24/,100,000, and Britain is 8,23/,100,000, and France is 3,14/,100,000, and Italy is 2,70/,100,000, and Australia is 422/ 100000.
The most effective therapies of AMI are to row Urgent percutaneous coronary intervention (PCI) at present, and a large amount of clinics are ground Study carefully the Infant Mortality for confirming that emergency PCI can greatly reduce coronary heart disease.But clinically find, even carrying out in time PCI is treated, Normalized Treatment and the management of improvement and acute AMI although as health care, still cannot be from there are many patient Middle benefit makes ischemic myocardium cannot get effective Reperfu- sion because No-reflow phenoment can occur in emergency PCI art, in addition by into One step is damaged.
Since atherosclerosis is to lead to the pathologic basis of acute cardiocerebrovasculaevents events, lead to acute cardiovascular event Main cause is local intra-arterial atherosclerotic plaque rupture and thrombosis, and thrombosis depends on atherosclerotic plaque Vulnerability, vulnerable plaque is susceptible to plaque rupture and thrombosis, so as to cause the generation of acute coronary syndrome.And it is straight Row PCI treatments are connect, after holder merging, under the squeezing action of sacculus or holder, on the one hand, blood platelet is easily by Vulnerable plaque Exposed lipid is activated, and is formed microthrombus and is sticked aggregation at lesion vessels position, leads to microcirculation blockage;On the other hand, it treats Thrombus is easily broken in the process, falls off, and causes thrombus fragment to flow to coronary artery distal end, causes distal vessels to be blocked, to go out Existing " slow blood flow " phenomenon.With the increase of amount of blockage, distal vessels are blocked again completely, that is, " fluoride-free flux " phenomenon occur, finally Congestive heart failure, malignant arrhythmia and cardiogenic broken dead risk is caused to increase, to increase the difficulty of interventional treatment Degree, the effect of improving the incidence of cardiovascular event, seriously affect PCI, increases the case fatality rate of AMI patient.
Therefore, all the time, after PCI treatments, how to avoid the occurrence of acute in holder and subacute stent thrombosis and formed to come of age Fluoride-free flux caused by weak pulse dyshaemia has become a great problem that emergency PCI faces.Biochemical analyzer is to be applied in recent years A kind of clinical new method, it is easy to operate the purpose is to by mechanism, be quickly drawn out the thrombus of blockage pathology blood vessel, Operating time is short, and therapeutic effect is apparent, but there are still cases ineffective after some Biochemical analyzers.
Patent CN104323823A discloses a kind of thrombus suction catheter, is related to a kind of thrombus suction catheter system, including The central shaft of suction unit, medicine-filling device and four-way pipe, supervisor stirs silk equipped with metal, and the proximal end that silk is stirred in metal is equipped with hand Handle, the distal end that metal stirs silk are equipped with diamond shape circle, can either implement the processing before suction to thrombus and patch and can implement to take out It inhales, while can also inject thrombolysis medicament in time.
CN107468306A discloses a kind of thrombus suction catheter, specifically includes catheter body, in the distal end of catheter body The expandable trace labelling that soft head is set and is embedded in soft head;The soft head and inflatable trace labelling of distal end can effectively increase The radial section of big suction hole and suction chamber product, solve due to the radial section product of suction chamber it is smaller caused by pumping efficiency, The problem of thrombus breaks loose.
CN104586470A discloses a kind of thrombus suction catheter, including catheter body and setting in the catheter body row The guidewire lumen of inlet side, the thrombus suction catheter provided wish to solve radial section product it is smaller caused by aspiration rate it is low, The susceptible to plugging problem of suction chamber.
Patent CN102319097A discloses a kind of thrombus suction catheter comprising suction tube, tube socket, tube socket connection are led It manages, it is mobilizable on the outer wall of suction tube to be arranged with casing, interference wire is can be inserted into suction pipe, the casing of the invention is removable Ground is set to outside suction tube, makes to be limited by sacculus when suction tube activity, the present invention can quickly remove and is dispersed in blood The thrombus of pipe extensive region and the embolism for handling coronary artery tip capilary;It, can profit when encountering big volume and heavy bodied thrombus It is aspirated again after breaing up thrombus with interference wire.
Patent CN104874033A discloses a kind of novel thrombus suction catheter, suction tube include netting suction tube main body and Netting suction tube head end, netting suction tube main body one end connects netting suction tube head end, the other end connects female Luer, and Rule connects The head other end is equipped with check valve body, and check valve body connects suction unit.The invention is quick by thrombus during Biochemical analyzer Suction lead body portion can prevent the generation of thrombus breaks loose event to the full extent using one-way cock technology.
Patent CN104984461A discloses a kind of novel thrombus suction catheter, and conduit includes:Suction chamber, guidewire lumen, capsule Body, utricule pressurizing channel and tube socket, the thrombus suction catheter that the invention provides improve suction effect.
United States Patent (USP) US2017/0348014 discloses a kind of roller traction tube machinery that can be disposed from catheter in situ Thrombectomy device.This device can be transported from conduit, be to be in be compacted state in conduit, by restoring after conduit The structure being unfolded to one, same root conduit are reinserted between tubular type tractor and elongated tractor, belong to a kind of anti- To device for excising.
United States Patent (USP) US2017/0303948 discloses one kind and may be configured to prevent or reduce obstruction(For example, " anti-dry Disturb " thrombectomy device), catch clot and/or make thrombus(Such as clot)The mechanical thrombectomy device of soaking.These machineries Thrombectomy device may include dragger, which includes tubes of material flexible, and the material is flipped to similar at it It is overturn when conduit in the movement of conveyer belt.It is optionally stretched specifically, mechanical thrombectomy device dragger has The protruding portion gone out can help to capture and/or macerate grumeleuse, also describe a kind of ratchet-type for mechanical thrombectomy device Dragger.
The HOII P WO2016/075586 EN of PCT international publications, disclose one kind and being configured to supply cardiac ultrasonic The medical image system of thromboembolism treatment.The equipment, which can be configured as, determines one or more ultrasonic probes, according to whether tool The appropriate view for having heart, by wave beam manipulation to desired position, ultrasonic probe can be used for being imaged and cardiac ultrasonic thrombolysis is controlled Both treat.
By retrieving PubMed and Baidu's Academic Data library, it can be realized that the current situation of ultrasound thrombolysis.1976 Trubestein uses the direct thrombus of intravascular Irradiation of High Frequency Ultrasound successful for the first time.Chinese scholar Shen Xuedong in 1997 The validity of supersonic melting thrombus and safety in percutaneous coronary are demonstrated Deng from live body dog coronary artery thrombus embolism model .Kristen A et al. also demonstrate that conduit guiding ultrasonic wave added thromboembolism treatment is the method for safely and effectively treating embolism.Ultrasound The main mechanism of thrombolysis is related with cavitation effect and mechanical effect, and ultrasound cavitation effect refers to that micro-bubble present in liquid exists Oscillation, expansion are generated under ul-trasonic irradiation, is shunk down to a series of dynamic processes such as implosions, in tissue and intracellular foot To cause " interior explosion " effect for being up to 1~3 atmospheric pressure, be enough to make thrombus within the extremely short time size degradation at tiny Particle.Ultrasound directly thrombolysis form predominantly utilizes the small-sized probe intraluminal ablation thrombus of conduit at present, has been applied to clinic , achieve good thrombolytic effect, but because its is invasive and to operate it is more demanding due to can not popularize, and external supersonic auxiliary is molten Bolt treats (ETUS) and has certain superiority and better adaptability compared to the treatment of internal microdamage evolution.
The present invention devise it is a kind of and meanwhile have ultrasound break bolt, drug thrombolysis, Biochemical analyzer and angioplastic prevent again it is narrow The medicine eluting balloon catheter of narrow function.With the patented technology announced both at home and abroad that retrieves in structure, function and material It is different.
Invention content
The present invention, can be to more micropore metal heads 9 be conveyed by increasing by a compensated cavity 2, and cooperation external supersonic probe 8 assists Ultrasound thrombolysis, when ultrasonic wave is by the larger ferrule 9 of specific surface area, it will to multiple directions multiple reflections, improve ultrasound Wave utilization rate forms a kind of ETUS therapies of improvement.Simultaneously after sacculus fills up, the Thrombolytic Drugs thrown into from suction chamber, Iris action due to sacculus in proximal end can be partially formed the medicament contg of higher concentration in blood vessel, coordinate the cavitation of ultrasound Effect can be such that thrombolysis efficiency improves.Compensated cavity 2 can also convey other auxiliary tools such as metal chaff, special type simultaneously Metal chaff can help to break thrombus.The present invention provides a kind of medicament elution sacculus with Biochemical analyzer function.It is special Sign is, is provided simultaneously with Biochemical analyzer, intracavitary balloon is molded two functions.The drug with Biochemical analyzer function is washed De- balloon structure includes:Balloon cavity 1, compensated cavity 2, RX mouths 3, guidewire lumen 4, developing ring 5 are suction chamber 6, Y types connector 7, external Ultrasonic probe 8, micropore metal head 9 and seal wire 10.The Y types connector proximally connects three lumens(Or the bilayer with gap Pipe), sacculus is set on the distal end outer wall of three lumens, and blood vessel pumping components are set to the end of three lumens.The balloon surface Can carry medication coat, the Biochemical analyzer component include one can traveling seal wire guidewire lumen and a Biochemical analyzer chamber.Three Lumen distal end is opened on the Biochemical analyzer chamber of sacculus and Biochemical analyzer component respectively.
1. the catheter main body structure includes:Balloon cavity 1, compensated cavity 2, RX mouths 3, guidewire lumen 4, developing ring 5, suction chamber 6, Y types connector 7, external supersonic probe 8, micropore metal head 9 and seal wire 10.
2.Y types connector 7 can be plastic material, by technological formings such as injection moldings, by bonding or being molded in suction Catheter proximal end connects.Two openings of wherein Y types connector 7 are connected in proximal end with two chambers of suction catheter respectively respectively.Y types The external tapping of connector may be designed as the female Luer with 6% taper or lock port or the size of other requirements.
3. suction catheter is made of suction catheter chamber 6, compensated cavity 2, guidewire lumen 4, wherein conduit 6 can be compiled by special equipment It is woven to the compound tubing of metal mesh, high molecular material, there is certain support force, is operated convenient for Biochemical analyzer;Outer layer can be by having There is the high molecular material of biocompatibility to be made, hydrophilic coating or lubricant coating can be carried;Compensated cavity 2 is a tiny macromolecule Material conduit, can hold more micropore metal head miniature probes or metal chaff passes through.
4. guidewire lumen proximal end and compensated cavity distal end all open a RX mouthfuls on suction cavity outer wall, RX mouthfuls of length are 1mm ~ 3mm.
5. sacculus is connected to outer tube by way of laser or infrared or hot air welding(Proximal end)And inner tube(Far End);After being completed, folds pressure and hold, convenient for passing through bloody path.
6. Biochemical analyzer component can be the macromolecule materials such as nylon is fixed on inner tube by bonding or welding manner Distally.
7. it is characteristic of the invention that:Guidewire lumen and balloon cavity are not overlapped, and the product for optimizing Biochemical analyzer foley's tube is complicated Degree, improves the reliability of product.Balloon cavity is in seal wire cavity rear end, as shown in Fig. 2.
The thin cylinder that 8. the head of micropore metal more than is diameter 0.2mm, length is 2mm, cylinder are covered with micropore, surpass outside ligand Sonic probe can make ultrasonic wave multiple reflections in micropore, amplify the cavitation of ultrasonic wave, keep brokenly bolt safe and efficient.Metal Head reaches affected area by specific transport system through channel lumens 4.
9. external supersonic head operating power is in 0.4 ~ 15W/cm2, frequency is in 0.02 ~ 3.4MHz.
10. sacculus carries pharmacopoeia class including but not limited to drugs such as taxol, rapamycin, everolimus;
11. thrombolytic drug includes but not limited to streptokinase, urokinase, people's recombination t-PA(Rt-PA, Alteplase), Reteplase (r-PA), lanoplase(n-PA)And Tenecteplase(TNK-tPA)Equal drugs;
12. suction catheter tube chamber 6 has certain intensity, prevent from being crushed when working in negative pressure;
13. the application method of thrombus suction catheter of the present invention, includes the following steps:1. step is placed suction catheter by seal wire At vascular lesion;2. more micropore metal heads are put into the position close to lesion by step by cavity 4, while by external supersonic Probe is put into thrombus and occurs at corresponding body surface;3. step opens the broken bolt of ultrasound, while aspirate thrombi;4. step terminates in suction Afterwards, can conduit system directly be conveyed into a distance further along, reaches balloon position, carries out angioplasty;
14. operation needs three people or more that can complete, and can select not putting more micropore gold according to patient's thrombus degree Belong to head, throwing Thrombolytic Drugs by suction chamber can thrombolysis;
15. micropore metal head and transport system weld to be formed by nanometer interconnection technique, reliability is high, not easily to fall off;
16. micropore metal head specific surface area increases, in vivo with contacting blood, the interface of formation increases, can be more by ultrasonic wave direction A direction multiple reflections;
17. according to thrombus position and lesion degree, the wherein suitable a kind of mode of metal chaff or ultrasound thrombolysis can be selected Remove removing thrombus;
18. the material composition of metal chaff includes but not limited to the shape memories such as Nitinol, nickel-manganese, nickel manganese calcium gold Belong to;
19. development ring material is the good material of the X-rays such as platinumiridio, platinum evanohm development.
Compared with prior art, the beneficial effects of the invention are as follows:
1. simple and reliable for structure, easy to operate, material source is extensive, cost reduction;
2. the external assisting ultrasonic corroded rock mass with improvement;
3. a compensated cavity is arranged in suction chamber, can be used for conveying auxiliary tool;
4. auxiliary tool includes more micropore metal heads and metal special type chaff, head can be ellipse or diamond shape;
5. angioplasty can immediately be carried out after Biochemical analyzer;
6. balloon surface carries drug, there is certain anti-restenosis function.
Description of the drawings:
Fig. 1 is a kind of medicament elution balloon structure schematic diagram with Biochemical analyzer function of efficient thrombolysis;
Fig. 2 is ultrasonic amplification schematic diagram;
Fig. 3 is metal chaff schematic diagram;
Fig. 4 is the ultrasonic wave added thrombolysis schematic diagram of improvement.
Specific implementation mode:
With reference to embodiment, the present invention is described in further detail, but is not intended to limit present disclosure, any at this The change made on the basis of invention, is regarded as protection scope of the present invention.
Embodiment:
With reference to 1 ~ Fig. 3 of figure.As shown in Figure 1, a kind of medicament elution sacculus with thrombolysis, the broken bolt of ultrasound, Biochemical analyzer function, takes out Suction conduit entire length is 1400mm ~ 1800mm, and internal diameter is 1.10mm ~ 2.00mm.Guidewire lumen 4 length in front end is 10mm ~ 20mm, Internal diameter is 0.02mm ~ 0.20mm.Suction chamber front opens a RX mouthfuls, and length is 1.00mm ~ 2.00mm, and guidewire lumen is penetrated from RX mouthfuls And be assembled in suction tube front inner wall, it is welded at RX mouthfuls, guidewire lumen front end carries a mark rings 5, convenient for fixed in surgical procedure Position.A RX mouthfuls is also opened on the offside inner wall of guidewire lumen 4, auxiliary lumen is penetrated from RX mouthfuls, is pierced by and is assembled from suction cavity rear end Onto suction catheter inner wall, auxiliary cavity length is 1000mm ~ 1200mm, a diameter of 0.2mm ~ 0.6mm.It is reloading with outer layer sacculus, Sacculus front end is welded to 3 rear of RX mouths.Y type connectors are finally installed, an interface connects suction chamber, for connecting syringe, Aspirate thrombi or injection drug;Another interface connects balloon cavity, and connection compression pump fills up sacculus use.Front end pump orifice is aspirating Angular cut is formed by mold cutting on cavities conduit pipe.As shown in Fig. 2, 9 cylinder diameter size of porous metals head be 0.01mm ~ 0.2mm, length are 0.01mm ~ 2.00mm, and laser processing or the processing of nano porous metal forging type can be used in processing method, Tail end connects seal wire 10, this auxiliary device can reflect and amplify the cavitation of ultrasonic wave in the blood vessels.Special type metal interferes Silk is transported to site of disease as shown in Figure 3, through compensated cavity 2, and rotation wire can achieve the purpose that cut thrombus, wire head Portion surface it is smooth and have shape memory function, be detached from auxiliary cavity after can self-expanding be shape shown in the drawings.
Ultrasonic wave added thrombolysis (ETUS) principle of work and power schematic diagram of this product improvement is as shown in Figure 4.When external supersonic probe 8 When the ultrasonic wave of generation is through excessive micropore metal head 9, due to the large specific surface area of more micropore metal heads, interface is increased, repeatedly anti- Penetrate ultrasonic wave make the thrombus 12 of blood vessel be melted into due to the cavitation of ultrasonic wave fritter fall to it is intravascular, in time through applying Blood vessel is extracted out with the suction catheter of negative pressure.

Claims (22)

1. a kind of medicine eluting balloon catheter having efficient thrombolysis and Biochemical analyzer function, including balloon cavity 1, compensated cavity 2, RX mouthfuls 3, guidewire lumen 4, developing ring 5, suction chamber 6, Y types connector 7 and external supersonic probe 8 and auxiliary tool 9,11.
2. the medicament elution sacculus with Biochemical analyzer function as described in claim 1, it is characterised in that:The sacculus is fixed In distal end of catheter.
3. sacculus as claimed in claim 2, it is characterised in that:Surface can carry anti-restenosis drugs coating.
4. thrombus suction catheter as described in claim 1, it is characterised in that:The Biochemical analyzer component, have can traveling lead The Biochemical analyzer chamber of the guidewire lumen and smokable thrombus of silk, aspirating on cavity wall has an auxiliary cavity.
5. auxiliary tool as described in claim 1, it is characterised in that:Auxiliary tool includes more micropore metal heads or metal interference Silk, can be through assisting cavity to be transported to diseased region by seal wire.
6. guidewire lumen as claimed in claim 4, it is characterised in that:Inside diameter ranges are 0.01mm ~ 1mm.
7. guidewire lumen as claimed in claim 4, it is characterised in that:It is 1mm, no longer than Biochemical analyzer group that length is most short Part entire length.
8. suction catheter as described in claim 1, it is characterised in that:Three of them chamber can be the different sleeve structure of caliber.
9. suction catheter as described in claim 1, it is characterised in that:Tube chamber material can be metal knitted pipe, PTFE, nylon or Other materials or various material it is compound.
10. suction catheter as described in claim 1, it is characterised in that:Pipe shaft hardness may be designed as inconsistent.
11. suction catheter as described in claim 1, it is characterised in that:Conduit pipe shaft outermost surface can be carried with hydrophilic Coating.
12. suction catheter as described in claim 1, guidewire lumen and balloon cavity be not parallel, and superslide thin layer is coated in guidewire lumen, can So that thrombus suction catheter passes through seal wire.
13. balloon cavity as claimed in claim 12 and guidewire lumen, balloon cavity is in seal wire cavity rear end.
14. compensated cavity as described in claim 1 can be connected by Y type connectors, more micropore metal heads are sent into vascular lesion Place.
15. various cavity materials as described in claim 1 include but not limited to PTFE, pebax or other high molecular materials, can It is connected by welding manners such as hot gas welding, Laser Weldings.
16. micropore metal head as claimed in claim 14, metal material is the metal material of inert non-toxic, including but not limited to The inert metals such as platinum, iridium, gold, stainless steel or other alloy materials.
17. micropore metal head as claimed in claim 16, one of external physical characteristic is cylinder, and cylinder diameter size is 0.01mm ~ 0.2mm, length are 0.01mm ~ 2.00mm,
Its external form is including but not limited to cylinder.
18. micropore metal head transport system is a kind of seal wire, wire distal is connect with metal end surface,
Guidewire material can be metal or high molecular material, and seal wire is the filament with certain toughness.
19. micropore metal head as described in claim 1, the size of micropore is at 10 μm ~ 60 μm.
20. drug as claimed in claim 3, type includes but not limited to taxol, rapamycin, everolimus, Xi Luomo Department etc..
21. sacculus drug as described in claim 1, drug coated technique is including but not limited to techniques such as spraying, immersions.
Can also be machine 22. the processing method of suction chamber as described in claim 1, front end pump orifice can be laser cutting Tool is cut,
Shape is including but not limited to angular cut, concave cutouts, wedge-formed incision.
CN201810067104.2A 2018-01-24 2018-01-24 Drug eluting balloon catheter with thrombus breaking and dissolving and suction functions Active CN108283758B (en)

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CN109125892A (en) * 2018-08-14 2019-01-04 张海军 A kind of distal end blocking type stereo spiral pigtail structure pulmonary thrombosis suction catheter
CN112545607A (en) * 2020-11-27 2021-03-26 杭州云普医疗器械有限公司 Thrombus thrombolysis and suction device
CN113729855A (en) * 2021-08-30 2021-12-03 浙江清华柔性电子技术研究院 Insertion type combined ultrasonic thrombolysis device
WO2022103970A1 (en) * 2020-11-12 2022-05-19 Bard Access Systems, Inc. Medical systems and methods thereof for ultrasonic decomposition of intraluminal clots
CN115089849A (en) * 2022-08-18 2022-09-23 广东博迈医疗科技股份有限公司 Drug balloon catheter for recovering floating drug
CN115430042A (en) * 2022-11-07 2022-12-06 苏州无双医疗设备有限公司 Implanted lead
CN115530923A (en) * 2022-12-02 2022-12-30 北京华通集智医疗器械有限公司 Lumen opening instrument and lumen opening system
CN115607233A (en) * 2022-10-28 2023-01-17 广东博迈医疗科技股份有限公司 Thrombectomy device
CN115804629A (en) * 2022-12-26 2023-03-17 复旦大学 An intravascular thrombolysis device with a distal collection basket

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CN109125892A (en) * 2018-08-14 2019-01-04 张海军 A kind of distal end blocking type stereo spiral pigtail structure pulmonary thrombosis suction catheter
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CN112545607A (en) * 2020-11-27 2021-03-26 杭州云普医疗器械有限公司 Thrombus thrombolysis and suction device
CN113729855A (en) * 2021-08-30 2021-12-03 浙江清华柔性电子技术研究院 Insertion type combined ultrasonic thrombolysis device
CN113729855B (en) * 2021-08-30 2023-11-14 浙江清华柔性电子技术研究院 Interventional combined ultrasonic thrombolysis device
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CN115804629A (en) * 2022-12-26 2023-03-17 复旦大学 An intravascular thrombolysis device with a distal collection basket

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