CN110051921A - A kind of taper drug coated balloon catheter - Google Patents

Abstract

The present invention relates to the field of medical instrument technology, it is especially for the drug coated balloon catheter of interventional therapeutic technique, specifically disclose a kind of taper drug coated balloon catheter, it includes conduit and sacculus, sacculus is in the distensible front for being set to conduit of folded state, the surface of sacculus is equipped with medication coat, and sacculus is along conduit tube axial direction by distally proximally including distal portion, main part and close end；When sacculus is in expansion state, the tapered structure of main part, sacculus is gradually reduced in main part from one side of close end to distal portion side diameter, and sacculus is fixed on conduit by distal portion and close end contraction；When sacculus is in folded state, distal portion is equipped with curved bend tune at conduit.Taper drug coated balloon catheter of the present invention is suitable for long section diseased region, has preferable push ability, and medication coat is bonded perfection with blood vessel, drug is enable more effectively to be discharged into diseased region vascular wall.

Description

A kind of taper drug coated balloon catheter

Technical field

The present invention relates to the field of medical instrument technology, the medicine-coated balloon for being especially for interventional therapeutic technique is led Pipe.

Background technique

So far from the 1970s, vascular interventional treatment experienced balloon dilatation, bare metal stent and drug and wash 3-6 months restenosis rates of the development of de- bracket, target vessel drop to 5%-10% from 30%-50%, achieve it is larger into Exhibition.But after implant FirebirdTM, patient needs to take for a long time duplex Anti-platelet therapy, once occur in bracket again Narrow, the repetition implantation of bracket for eluting medicament can cause the adverse events of high risk.In addition, blood vessel caused by bracket for eluting medicament Endothelium healing delay, bracket advanced thrombus and atherosclerosis etc. all become the problem after influencing clinic more.

The appearance of drug coated balloon catheter (drug coated balloon, DCB) is brought newly to vascular interventional treatment Hope, drug coated balloon catheter is a kind of blood vessel interventional medical device of local administration based on sacculus, distensible ball Capsule surface coats the coating containing therapeutic agent, and when lesion locations are expanded, drug discharges rapidly sacculus in 30-120s, seeps Thoroughly into vascular tissue, inhibit vascellum endometrial hyperplasia, to achieve the purpose that treat vascular lesion.

Different from bracket for eluting medicament, the drug of medicine-coated balloon discharges rapidly in a short time, on the one hand, it is required that medicine For object coating foley's tube in the blood vessels in transmission process, the drug loss of balloon surface is few, and on the other hand, medicine-coated balloon is led When pipe is transported to lesion locations pressurising expansion, the drug of balloon surface can be promptly released into vascular wall, to reach treatment lesion Purpose.

It is good it is adherent be drug coated balloon catheter one of the key factor that can be released effectively rapidly of drug.General feelings Under condition, the medicine-coated balloon of 10%-20% bigger than lesion locations diameter can be selected to lead according to the diameter of lesion vessels when treatment Pipe, to ensure that drug coated balloon catheter can be bonded completely with vascular wall.But the diameter of the blood vessel of human body is simultaneously uneven, with lower limb For blood vessel, blood vessel diameter is smaller more down.For some long section lesions, lesion top and bottom diameter difference is larger.Operation In the process, if the drug coated balloon catheter diameter of selection is excessive, lesion lower end blood vessel excessive tearing may be caused to damage；If The drug coated balloon catheter diameter of selection is too small, and lesion upper end cannot be completely adherent, influences controlling for drug coated balloon catheter Therapeutic effect can only be implanted into two drug coated balloon catheters different even more than diameter respectively, and not only surgical procedure is complicated, and And increase the financial burden of patient.

Application No. is 200720190054.4 Chinese patents to disclose a kind of conical saccule dilating catheter for the prior art, packet Sacculus, conduit, female Luer are included, sacculus is located at conduit front, and conduit, which couples female Luer or couples Rule by pillar, to be connect Head is provided with inner tube in conduit, and the balloon distal and balloon proximal of sacculus are both ends cone section structure, and the interlude of sacculus is transition Pyramidal structure., mainly solving the technical problems that improving the adherent effect of sacculus, improvement balloon expandable causes blood vessel distal end for it Excess damage.However, the conical saccule dilating catheter is not belonging to drug coated balloon catheter, it is primarily adapted for use in coronary artery ball Capsule dilatation or mount, therefore used just for coronary artery pathological changes region.

Application No. is 201310228389.0 Chinese patents to disclose a kind of conical saccule dilating catheter for the prior art, should Sacculus is tapered, and proximal part balloon diameter is greater than distal end balloon diameter, and the balloon surface can be coated with carrying antiproliferative The polymer of drug.

The taper sacculus of the above prior art is all used just for large and medium-sized artery and coronary artery pathological changes region, sacculus cone Shape principal length is shorter, such as conical saccule dilating catheter above-mentioned, and the interlude transition taper length of sacculus is 5-100mm, It is especially greater than the IVC stenosis lesion of 150mm for the length section stenotic lesion of some peripheral blood vessels to length of lesion It is not available.

And longer sacculus can dramatically increase sacculus in interventional procedure with length increase and transport difficulty.And in sacculus When length is longer, due to difficulty of transportation, balloon surface drug premature disconnection can be aggravated, so that the drug of balloon surface was pushed in sacculus It results in greater loss in journey because blood washes away.

Summary of the invention

The technical problem to be solved in the present invention is to provide a kind of taper drug coated balloon catheters, are able to solve medicinal balloon Medication coat be bonded the technologies such as bad, sacculus push ability difference and its caused drug premature disconnection with long section blood vessel and ask Topic.

In order to solve the above technical problems, the technical solution used in the present invention is: a kind of taper drug coated balloon catheter, Including conduit and sacculus, the sacculus is in the distensible front for being set to the conduit of folded state, and the surface of the sacculus is set There is medication coat, the sacculus includes distal portion, main part and close end along conduit tube axial direction；

When sacculus is in expansion state, the tapered structure of main part, the sacculus is in main part by close end side It is gradually reduced to distal portion side diameter, the sacculus is fixed on conduit in distal portion and close end contraction；

When sacculus is in folded state, the sacculus is equipped with curved bend tune, the sacculus in distal portion at conduit It is not more than the collapsed outer diameter of balloon body in the maximum gauge of curved bend tune.

Optionally, distal portion whole installation is curved bend tune or local setting is curved bend tune.

Preferably, the distal portion further includes straight section, and curved bend tune side tends to conduit outer wall, another lateral institute State straight section smooth transition.The curved bend tune is seamlessly transitted to the straight section, further decrease sacculus by resistance, make ball The distal portion of capsule smoothly can stably pass through body lumen.

Further, the distal portion is equipped with supporter, can support the curved bend tune in the balloon distal portion.It folds Under state, setting supporter can make sacculus made of flexible material in the curved bend tune of distal portion composition rock-steady structure.

Preferably, the curved bend tune is set to the junction of the distal portion and conduit outer wall, the distal portion with Conduit outer wall is welded by solder, and the solder is filled between the curved bend tune and conduit outer wall of the distal portion, welded Supporter as curved bend tune afterwards.

Optionally, the solder is identical as the material of sacculus, it is preferred that the material of the solder and sacculus is low compliance Or it is particularly preferred as without compliant material such as one of polyethylene, polyethylene terephthalate, nylon and polyurethane Nylon-12, nylon-11, PEBAX or PEEK；Sacculus and conduit solder through laser welding, curved bend tune side with lead Pipe outer wall is smoothly connected.

Supporter uses solder, and when on the one hand expanding sacculus pressurising, weld stress more evenly, increases welding surface Product is welded stronger；Another aspect solder can support arc bending section, keep balloon body portion smoother by human body pipe Chamber, the passability enhancing of sacculus.

Preferred laser welding includes that arc solder is first welded in inner tube surrounding, then uses identical welding procedure, Sacculus is welded along solder and is extended on conduit, curved bend tune is formed.

Preferably, the radian of the curved bend tune is 10-30 degree.Radian selected by sacculus curved bend tune should not be too small, The entire length that may cause bending section is larger, so that the entire length of balloon tip is influenced, and too long tip length may Cause to cause injury of blood vessel when intravascular transport；If selected radian is excessive, may will increase arc-shaped bend section passes through resistance.

Preferably, the conical apex angle degree of the tapered structure in balloon body portion is 1.1 ± 0.8 degree.Preferred taper Apex angle degree makes balloon body portion match with long sections of straight diameter gradual change blood vessel, can make the medication coat loaded in balloon body portion With long section lesion vessels wall good fit, drug is more accurate in diseased region release, avoids.

Preferably, the length in the balloon body portion is greater than 100 millimeters, further preferably 100-300 millimeters.The present invention Taper drug coated balloon catheter is particularly suitable for long section lesion vessels, can effectively improve the passability and pushability of foley's tube Can, reduce drug premature disconnection.

On the basis of aforementioned balloon structure feature selecting, the preferred distal portion of the present invention, main part and close end are along conduit Axial length ratio is ± 100:8 ± 57 ± 4:200.Distal portion curved bend tune and straight section are preferred along the length ratio of conduit axial direction For 2-3:1.When folded state, sacculus is 1.2mm-1.85mm in 11 maximum gauge of distal end curved bend tune.The taper of the structure Medicine-coated balloon, which can be taken into account, obtains preferable push ability and passability, has excellent operability, effectively avoids being situated between Enter art process to the physical damnification of blood vessel, reduces the conveying difficulty of foley's tube, reduce drug premature disconnection.

To the present invention further improve, the wall thickness in the balloon body portion from one side of close end to distal portion side gradually Reduce.Balloon body portion is reduced from one side of close end to distal portion side balloon wall thickness, so that balloon body portion is close to distal end The collapsed outer diameter of portion side is smaller, to obtain better flexibility, becomes strong by the ability of crooked position, and folded state Balloon body portion with sacculus wall thickness change can also be in approximately conical shape structure, particularly in view of the length of sacculus is grown very much When 100mm or more, the sacculus of the folded state of approximately conical shape structure can be improved push power by the transmission effect of proximate, make The push performance of foley's tube improves the push ability for further increasing foley's tube.

Preferably, the proximal end side in balloon body portion and distal end side sacculus wall thickness are respectively 0.08 ± 0.03mm, 0.07 ± 0.02mm, the ratio between both ends wall thickness are 1-2:1.

Be configured in foley's tube of the present invention sacculus fill substance transfer passage, as needed, conduit be chosen as casing, Double lumen tube or three lumens fill as sacculus using shell clearance or individual lumen and connect in the transfer passage and sacculus of substance It is logical.

Preferably, the conduit is casing, including outer tube and inner tube, and for said inner tube by stretching out in outer tube, the sacculus is remote The closed inner tube for being fixed on extension in end, close end is closed to be fixed on outer tube, and the full of sacculus is formed between outer tube and inner tube Channel.Inner tube stretches out outer tube, is located at conduit front, has smaller caliber, and the passability of foley's tube is more preferable, and full logical Road can be connected to sacculus in a ring, and balloon expandable is rapider, more efficient.

Medication coat of the present invention is optionally the drug containing therapeutic dose and the good load of biocompatibility Body.Coated carrier material preferably includes the poly- cream of l-lactic acid (PLLA), polylactic-co-glycolic acid (PLGA), racemic Acid (PDLLA), polyethylene glycol, polyethylene glycol-polycaprolactone, polysorbate, PVP, xylan alcohol, polyglycerol ester, alginic acid Sodium, chitosan, chitin, glucan, poly- hard acid esters, poly- citrate etc.；Drug preferably includes anti-oxidation medicine, anticoagulant Blood class drug, inhibits in vascular smooth muscle cell curing class drug, anti-inflammatory drug or immune suppressant drug anticancer class drug One or more.

Above-mentioned anti-oxidation medicine includes superoxide dismutase, catalase, Co-Q10, glutathione peroxidase Enzyme；Anticoagulants include aspirin, heparin, clopidogrel etc.；Anticancer class drug includes colchicin, taxol；Suppression Vascular smooth muscle cell curing class drug processed includes angiogenic peptide, cortin, calcium ion antagonist；Anti-inflammatory drug includes more raw Mycin, Depsidomycin, KanglemycinC, Spergualin, Mytiocin, Gllooxin；Immune suppressant drug packet Include rapamycin, Ciclosporin A, cyclosporin C, brefeldin A.

In use, be pushed to lesion locations from puncture orifice about needs 1min to medicinal balloon catheter, and medicinal balloon Drug release effective storage life is 2min or so.Therefore the longer push time, it is early during transportation to will result directly in drug The amount of releasing increases.And since drug is mostly lipophilicity, it is insoluble in water, agglomeration of reuniting is easy, big particle is formed, in transmission process In these big drug microparticles carried by carrier, be easy to be rushed by blood de-.If the particle number to fall off is more, it is easy to cause distal end The complication such as vascular occlusion, thrombus, serious person will lead to amputation.Therefore, for make balloon structure have better blood stream physical strength It learns, the curved bend tune being arranged at catheter tip by balloon distal portion can reduce blood flow to sacculus when sacculus transports Body surfaces medication coat washes away, and helps to reduce medication coat premature disconnection caused by by influence of blood flow in balloon body, so that What drug can be concentrated more discharges in diseased region, improves therapeutic effect.

To sum up, taper drug coated balloon catheter of the present invention has the advantages that compared with the prior art

(1), distal portion setting curved bend tune common flat bevel compared with the prior art, under equal conditions, arc Bending section is tending to conduit side with longer gentle face, and the angle of the gentle face and conduit is smaller, so that balloon distal Enhanced by the ability of Stenosis.And since sacculus is after the maximum gauge of curved bend tune is folded no more than balloon body Outer diameter, therefore, the setting of curved bend tune will not cause to hinder to the push of balloon body, and sacculus integrally has good push away Send power.

(2), balloon structure of the present invention has better hemodynamics, through balloon distal portion at catheter tip The curved bend tune of setting can reduce blood flow when foley's tube transports and wash away to balloon body surface drug coating, help In reducing medication coat premature disconnection caused by by influence of blood flow in balloon body, enable what drug more concentrated to release in diseased region It puts, improves therapeutic effect.

(3), balloon body portion is reduced from one side of close end to distal portion side balloon wall thickness, so that balloon body portion is leaned on The collapsed outer diameter of nearly distal portion side is smaller, to obtain better flexibility, becomes strong by the ability of crooked position, and The balloon body portion of folded state can also be in approximately conical shape structure, cooperate with balloon distal portion and seamlessly transit, passability is more preferable, into one Step improves the push ability of foley's tube.

(4), drug coated balloon catheter of the present invention can be suitable for the length lesion that length is greater than 100mm, especially suitable In peripheral blood vessel lesion, overcome the prior art makes because sacculus is bonded to be segmented due to bad, sacculus passability is poor with blood vessel The problem of with multiple medicinal balloons, the medical treatment cost of patient can be greatly reduced using sacculus coated catheters of the present invention.

Detailed description of the invention

The present invention will be further described in detail below with reference to the accompanying drawings and specific embodiments.

Fig. 1 is a kind of structural schematic diagram of embodiment of taper drug coated balloon catheter of the present invention；

Structural schematic diagram when Fig. 2 is balloon expandable state in Fig. 1；

Structural schematic diagram when Fig. 3 is sacculus folded state in Fig. 1；

Structural schematic diagram when Fig. 4 is a kind of isometrical balloon expandable state of the prior art；

Structural schematic diagram when Fig. 5 is prior art another kind taper balloon expandable state.

Medication coat and sacculus wall thickness are not shown in this specification attached drawing.In each attached drawing, 1, distal portion；11, bending section； 12, straight section；2, main part；3, close end；4；Conduit, 41, outer tube；42, inner tube；5, needle stand；6, guidewire lumen；7, chamber is filled；8, Developing ring；9, solder.

Specific embodiment

Bad cause is bonded with the non-uniform long section lesion vessels wall of diameter for prior art drug coated balloon catheter Drug coated balloon catheter therapeutic effect reduce and the foley's tube of long section push ability and passability poor to cause to apply art tired It is difficult, take a long time, the technical problems such as drug premature disconnection aggravation, the present invention provides a kind of taper drug coated balloon catheters, pass through The pyramidal structure in balloon body portion and the cooperation of balloon distal portion curved bend tune, can make sacculus medication coat and long section lesion Vascular wall good fit, while the premature disconnection effect of drug is reduced, drug can more be discharged in diseased region, to improve treatment Effect, while also effectively raising the push ability and passability of drug coated balloon catheter.

Invention is further described in detail with reference to the accompanying drawings and detailed description.

Total embodiment

Referring to Fig. 1-3, a kind of taper drug coated balloon catheter, including conduit 4 and sacculus, sacculus are expansible in folded state The front for being set to conduit 4, the surface of sacculus is equipped with medication coat, and sacculus along 4 tube axial direction of conduit includes distal portion 1, main Body portion 2 and close end 3；

When sacculus is in expansion state, referring to fig. 2, the tapered structure of main part 2, sacculus is in main part 2 by close end 3 one Lateral 1 side diameter of distal portion is gradually reduced, and sacculus is fixed on conduit 4 in distal portion 1 and the contraction of close end 3；

When sacculus is in folded state, referring to Fig. 3, sacculus is equipped with curved bend tune 11 in distal portion 1 at conduit 4, Sacculus is not more than the collapsed outer diameter of balloon body in the maximum gauge of curved bend tune 11.

Wherein, conduit 4 is casing, including outer tube 41 and inner tube 42, and inner tube 42 in outer tube 41 by stretching out, balloon distal portion 1 The closed inner tube 42 for being fixed on extension, close end 3 is closed to be fixed on outer tube 41, and sacculus is formed between outer tube 41 and inner tube 42 Full channel.Inner tube 42 stretches out outer tube 41, is located at 4 front of conduit, has smaller caliber, and the passability of foley's tube 4 is more preferable, And full channel can be connected to sacculus in a ring, and balloon expandable is rapider, more efficient.

It should be noted that those skilled in the art can voluntarily select other conduit forms, such as two-chamber as needed Pipe or three lumens, are connected in conduit side opening and sacculus using individual lumen, constitute the transfer passage that sacculus fills substance, no There are technical difficulties.

Referring to Fig. 1, as optional component, the rear portion of conduit 4 is provided with the needle stand 5 of full chamber 7 and guidewire lumen 6, fills It is full of chamber 7 and guidewire lumen 6 is connected to full channel, inner tube 42 respectively, for is passed through or withdrawing from full substance and seal wire.Full substance It is chosen as liquid or gas.Inner tube 42 is also being fixed with developing ring 88 close to sacculus both ends position, for indicating in performing the operation Sacculus position in body lumen.

Referring to fig. 2, when balloon expandable state, distal portion 1 and close end 3 is tapered or approximately conical shape structure, curved bend The junction of distal portion 1 Yu 4 outer wall of conduit is arranged in tune 11, and distal portion 1 further includes straight section 12, and 11 side of curved bend tune becomes To 4 outer wall of conduit, another lateral straight section 12 is seamlessly transitted.Curved bend tune 11 is seamlessly transitted to straight section 12, further decreases ball Capsule by resistance, so that the distal portion 1 of sacculus is smoothly stably passed through body lumen.However, whole in distal portion 1 Design length is shorter, in the lesser situation of diameter, and those skilled in the art also can choose is by 1 whole installation of balloon distal portion Technical difficulty is not present in curved bend tune 11.

Referring to Fig. 3, when sacculus folded state, distal portion 1 is equipped with supporter, is capable of the curved bend of supporting balloon distal portion 1 Tune 11.Under folded state, setting supporter can make sacculus made of flexible material in the arc of the composition rock-steady structure of distal portion 1 Shape bending section 11.

Specifically, distal portion 1 is welded with 42 outer wall of inner tube by solder 9, the curved bend tune 11 and conduit 4 of distal portion 1 Solder 9 is filled between outer wall, after weld formation the supporter as curved bend tune 11, sacculus and conduit 4 use solder 9 through Laser Welding It connects, 11 side of curved bend tune is smoothly connected with 4 outer wall of conduit.

Supporter uses solder 9, and when on the one hand expanding sacculus pressurising, weld stress more evenly, increases welding surface Product is welded stronger；Another aspect solder 9 can support arc bending section 11, enable balloon body portion 2 it is smoother pass through people Body lumen, the passability enhancing of sacculus.However, as optional other alternative solutions, those skilled in the art also be can choose Other longitudinal cross-sections are that the annular structural part of arc is fixed on 4 periphery of conduit, constitute arc as support body supports balloon distal portion 1 Shape bending section 11.

As preferred embodiment, solder 9 is identical as the material of sacculus, is low compliance or without compliant material, It is further preferred such as one of polyethylene, polyethylene terephthalate, nylon and polyurethane, solder 9 and sacculus Material be selected as Nylon-12, nylon-11, PEBAX (block polyether acidamide resin) or PEEK (polyether-ether-ketone).

Laser welding process includes that solder 9 is first welded in 42 surrounding of inner tube, then welds sacculus simultaneously along solder 9 It extends on conduit 4, forms curved bend tune 11.

By microscope fitting it has been observed that further selecting the conical apex angle degree of the tapered structure in balloon body portion 2 It is 1.1 ± 0.8 degree, as shown in angle b in attached drawing 2, balloon body portion 2 and long sections of straight is made using the conical apex angle degree of the selection Diameter gradual change blood vessel matches, and can make the medication coat loaded in balloon body portion 2 and long section lesion vessels wall good fit, medicine Object discharges more accurate in diseased region.

Embodiment 1

On the basis of aforementioned total embodiment, in the case that each feature is a certain determining selection in aforementioned selection, into The radian of different curved bend tunes 11 is arranged in one step, as shown in angle a in Fig. 2.

By largely pushing experimental studies have found that radian selected by sacculus curved bend tune 11 should not be too small, bending may cause The entire length of section 11 is larger, to influence the entire length of balloon tip, and too long tip length may cause it is intravascular Injury of blood vessel is caused when transporting；If selected radian is excessive, may will increase arc-shaped bend section 11 passes through resistance.

As preferred embodiment, the radian of curved bend tune 11 is 10-30 degree, reduces pass through resistance as far as possible.

Embodiment 2

On the basis of embodiment 1, further setting sacculus has different following parameters.

Selection balloon distal portion 1, main part 2 and close end 3 are followed successively by 2-20mm, 50- along the axial length of conduit 4 350mm, 2-20mm, 1 curved bend tune 11 of distal portion and straight section 12 are 1-5:1 along the axial length ratio of conduit 4, when folded state Sacculus is 1mm-2mm in the maximum gauge of distal end curved bend tune 11.

By push power and time of delivery statistics discovery, further select distal portion 1, main part 2 and close end 3 along conduit 4 axial length are followed successively by 7 ± 4mm, 200 ± 100mm, 8 ± 5mm, and 1 curved bend tune 11 of distal portion is with straight section 12 along conduit 4 Axial length is than being preferably 2-3:1.When folded state, sacculus is 1.2mm- in 11 maximum gauge of distal end curved bend tune 1.85mm.The taper medicine-coated balloon of the structure, which can be taken into account, obtains preferable push ability and passability, has excellent Operability effectively avoids interventional procedure process to the physical damnification of blood vessel, reduces the conveying difficulty of foley's tube 4, reduces drug Premature disconnection.

Embodiment 3

On the basis of total embodiment, further select the wall thickness in balloon body portion 2 from 3 one side of close end to distal portion 1 Side is gradually reduced.Select balloon body portion 2 proximal end side and distal end side sacculus wall thickness be respectively 0.03-0.15mm, 0.03-0.13mm。

By push power and time of delivery statistics discovery, balloon body portion 2 is from 3 one side of close end to 1 side ball of distal portion Wall thickness reduces, so that collapsed outer diameter of the balloon body portion 2 close to 1 side of distal portion is smaller, to obtain preferably submissive Property, become strong by the ability of crooked position, and the balloon body portion 2 of folded state can also be in approximate cone with sacculus wall thickness change Shape structure, particularly in view of the length of sacculus is grown in 100mm or more very much, the sacculus of the folded state of approximately conical shape structure can Push power is improved by the transmission effect of proximate, the push performance of foley's tube 4 is improved and further increases foley's tube 4 Push ability.

As preferred embodiment, balloon body portion 2 is subtracted from 3 one side of close end to 1 side balloon wall thickness of distal portion Small, the proximal end side in balloon body portion 2 and distal end side sacculus wall thickness are respectively 0.08 ± 0.03mm, 0.07 ± 0.02mm, The ratio between both ends wall thickness is 1-2:1, and the pushability of foley's tube effectively improves, drug premature disconnection rate reduces.

Brought effect is selected in order to which foregoing embodiments are explained further, is illustrated by following comparative example.

It is applied respectively with the taper drug of the isometrical foley's tube of the prior art, taper foley's tube and present invention Layer foley's tube compares experiment, and the barrel forms that each foley's tube is all made of same size are made as conduit, and sacculus is equal For Nylon-12 material, only balloon structure is different, be successively named as DCB1, DCB2 ..., DCB17.

Hereinafter, the sacculus specifications parameter of each foley's tube is all the same in addition to illustrating.

Wherein, DCB1 is isometrical sacculus, and referring to fig. 4, balloon body portion is isometrical cylinder, sacculus in expansion state Distal portion and close end be taper；DCB2 is taper sacculus, and referring to Fig. 5, balloon body portion is taper in expansion state, The distal portion and close end of sacculus are taper.

DCB3-DCB17 of the embodiment of the present invention is the drug coated balloon catheter of previous embodiment different size, sacculus knot Structure is referring to Fig. 1.

All sacculus are all made of same process and prepare medication coat.Medicine coating carrier is poly- hard acid esters, and drug is purple China fir alcohol.

Comparative example 1

Take a simulated blood vessel, the intravascular narrow positions for having one section of 1cm long.Each medication coat is each passed through with guiding wire Foley's tube, and guiding wire and each drug coated balloon catheter are fixed.By leading by drug coated balloon catheter distal end Guide wire penetrates simulated blood vessel, and clamps guiding wire with puller system, opens puller system, records each drug coated balloon catheter Front end passes through the maximum, force F when narrow positions of simulated blood vessel.

Comparative example 2

In addition, the blood vessel of pig is taken to do transporting test in vitro, the loss of drug in transmission process is studied.

Each drug coated balloon catheter is passed through with guiding wire respectively, is placed in 37 DEG C of PBS solution, using simulated blood vessel The push process of system aids drug coating foley's tube in blood, the pipeline diameter of simulated blood vessel system are 5-8cm, blood Flow velocity is 35cm/s.After simulation process, through the loss result S for calculating each sacculus drug.

Each drug coated balloon catheter specification and its test result F, S see the table below.

By the above comparing result as it can be seen that taper drug coated balloon catheter of the embodiment of the present invention is isometrical compared with the prior art Drug coated balloon catheter, taper drug coated balloon catheter, push ability and passability significantly improve, sacculus transport process medicine The premature disconnection amount of object significantly reduces, and is conducive to the application of outer perimeter section lesion vessels, can effectively reduce surgical procedure difficulty, raising is controlled Therapeutic effect.

Taper drug coated balloon catheter provided by the invention is described in detail above, using specific in the present invention A example is expounded embodiments of the present invention, the present invention that the above embodiments are only used to help understand, should It points out, to those of ordinary skill in the art, without departing from the principle of the present invention, the present invention can also be carried out Several improvement, these improvement are also fallen within the protection scope of the claims of the present invention.

Claims (10)

1. a kind of taper drug coated balloon catheter, including conduit and sacculus, the sacculus is set in folded state is distensible The surface of the front of the conduit, the sacculus is equipped with medication coat, it is characterised in that: the sacculus is along conduit tube axial direction packet Include distal portion, main part and close end；

When sacculus is in expansion state, the tapered structure of main part, the sacculus is in main part from one side of close end to remote End side diameter is gradually reduced, and the sacculus is fixed on conduit by distal portion and close end contraction；

When sacculus is in folded state, the sacculus is equipped with curved bend tune in distal portion at conduit, and the sacculus is in arc The maximum gauge of shape bending section is not more than the collapsed outer diameter of balloon body.

2. taper drug coated balloon catheter according to claim 1, it is characterised in that: the distal portion further includes straight Section, the side of the curved bend tune tend to conduit outer wall, another lateral straight section smooth transition.

3. taper drug coated balloon catheter according to claim 2, it is characterised in that: the distal portion is equipped with support Body can support the curved bend tune.

4. taper drug coated balloon catheter according to claim 3, it is characterised in that: the curved bend tune is set to The junction of the distal portion and conduit outer wall；The distal portion and conduit outer wall are welded by solder, the arc of the distal portion The solder is filled between shape bending section and conduit outer wall, after weld formation the supporter as curved bend tune.

5. taper drug coated balloon catheter according to claim 4, it is characterised in that: the material of the solder and sacculus It is identical, it is preferred that the material of the solder and sacculus is for low compliance or without compliant material, such as polyethylene, poly- terephthaldehyde One of sour glycol ester, nylon and polyurethane；It is described to be welded as laser welding.

6. taper drug coated balloon catheter according to claim 1-5, it is characterised in that: the arc-shaped bend The radian of section is 10-30 degree.

7. taper drug coated balloon catheter according to claim 1-5, it is characterised in that: the balloon body The wall thickness in portion is gradually reduced from one side of close end to distal portion side, it is preferred that the proximal end side and distal end one in balloon body portion Side sacculus wall thickness is respectively 0.08 ± 0.03mm, 0.07 ± 0.02mm, and the ratio between both ends wall thickness is 1-2:1.

8. taper drug coated balloon catheter according to claim 1-5, it is characterised in that: the balloon body The conical apex angle degree of the tapered structure in portion is 1.1 ± 0.8 degree.

9. taper drug coated balloon catheter according to claim 1-5, it is characterised in that: the balloon body The length in portion is 100-300 millimeters；Distal portion, main part and close end are 7 ± 4:200 ± 100 along the length ratio of conduit axial direction: 8±5；It is preferably 2-3:1 that distal portion curved bend tune and straight section compare along the length of conduit axial direction；When folded state, sacculus is remote End curved bend tune maximum gauge is 1.2mm-1.85mm.

10. taper drug coated balloon catheter according to claim 1-5, it is characterised in that: the conduit is Casing, including outer tube and inner tube, said inner tube in outer tube by stretching out, the closed inner tube for being fixed on extension in balloon distal portion, Close end is closed to be fixed on outer tube, and the full channel of sacculus is formed between outer tube and inner tube.