CN109731206B - Balloon for bifurcation lesion of biological body pipeline and application thereof - Google Patents

Abstract

The invention relates to the technical field of medical treatment, in particular to a balloon for bifurcation lesion of a biological body pipeline and application thereof, and particularly relates to a balloon for bifurcation lesion of a human blood vessel and application thereof. The sacculus includes first sacculus and second sacculus that the components of a whole that can function independently set up. The drug-loaded balloon has the following advantages: the medicine carrying saccule can play a greater role in a diseased part, two medicine carrying saccules are respectively arranged in two branch blood vessels to be expanded simultaneously when complex bifurcation lesion is treated, and corresponding accessories are matched for modification, so that the realization of an operation treatment process is greatly simplified, and the prognosis of disease treatment is improved.

Description

Balloon for bifurcation lesion of biological body pipeline and application thereof

Technical Field

The invention relates to the technical field of medical treatment, in particular to a balloon for treating bifurcation lesion of a biological body internal pipeline, and particularly relates to a balloon for treating bifurcation lesion of a human body blood vessel and application thereof.

Background

In living bodies, especially blood vessels, respiratory tracts, digestive tracts, auditory canals, nasal cavities and other lumens in human bodies all have a large number of branch pipelines, but due to the special air flow and liquid flow characteristics of the branches, the branches are high-incidence areas of various obstructions and infections. Interventional therapy using stents or balloons is one of the currently rapidly developing treatment modalities.

Coronary bifurcation lesions account for about 20-30% of the interventional coronary treatment field, and are a common clinical problem and one of the most challenging lesions in the coronary interventional treatment field. The treatment operation difficulty of the coronary bifurcation lesion is high, the success rate of the operation is low, the complication incidence rate is high, and the long-term effect is poor.

The medicine coating saccule is one kind of interventional therapeutic apparatus, and has saccule as cell proliferation resisting medicine carrier to release cell proliferation resisting medicine to the wall of coronary artery blood vessel during expansion so as to inhibit vascular endothelial proliferation.

Coronary stenting is currently the mainstay of treatment for bifurcation lesions in coronary arteries. Methods of Coronary stenting to achieve consensus are disclosed in, for example, the Percutaneous Coronary intervention for Coronary Bifurcation disease: 11th presentation from the European Bifurcation Club (EuroIntervision; 2016, Vol12: 38-46) and the contextual Approach to Coronary Bifurcation therapy (JACC: Cardiovascular Interventions; 2016, Vol9: 1861-78).

In fact, in the operation diagnosis and treatment of stent implantation of bifurcation lesion of coronary artery, there are the situations of long time consumption and complicated steps at present, and for the stent implanted in advance, the stent needs to be reshaped in the blood vessel and attached to the blood vessel, so that the time is urgent, the space is narrow, and the near-term treatment and the long-term treatment are uncertain.

In the treatment of coronary bifurcation lesions, Proximal Optimization Technique (POT) is a treatment method of balloon dilatation at the Proximal end of the bifurcation after stent implantation. The POT operation has the advantage that the proximal end of the stent is shaped, and the meshes of the main stent protrude into and cover the branch openings to the maximum extent, so that the wall adhesion of the stent is ensured. The POT technical points are as follows: selecting a non-compliant balloon; the size of the saccule exceeds the size of the stent; and thirdly, positioning. The far end of the balloon is flush with the lower edge of the branch opening and is horizontal, and the near end does not exceed the bracket; and fourthly, expanding the saccule under medium pressure. The operation process of the proximal optimization technology requires frequent switching between balloon and stent operation by an operator, and has the disadvantages of complicated steps and many uncontrollable factors.

Another treatment method adopted in the prior art is an active transfer of a collateral Plaque single stent (ATP) technology, which comprises the following specific steps: 1. the main branch and branch enter the guide wire 2, respectively, the main branch presets the stent, the branch is placed into the balloon, and the plaque is transferred to the main branch by expansion (balloon waist disappears +1 atm). 3. Releasing the main stent by named pressure under the expansion state of the branch balloon 4, and performing negative pressure on the branch balloon and the main stent balloon; 5. withdrawing the branch saccule, and reserving or withdrawing the branch guide wire; 6. the main stent saccule is expanded again to ensure the adherence of the stent. The ATP operation type has the advantages of simple operation of a single-stent operation type and simultaneously has the advantage of unobstructed side support of a double-stent operation type. Similarly, the ATP-based surgical procedure requires frequent switching between the balloon and stent operations by the surgeon, which is complicated in procedure and has more uncontrollable factors.

Particularly, the most commonly used stent implantation for the treatment of the bifurcation lesion of the blood vessel has the biggest problems of long implantation time, complicated steps and extremely high requirement on the operation capability of an operator, and the simplest single stent implantation of the bifurcation lesion blood vessel needs more than eight operation steps.

Meanwhile, the main technical difficulties of the naked balloon (non-drug-loaded balloon) technology in coronary bifurcation lesion include:

1. when single balloon dilatation treatment is carried out on the plaque-burdened bifurcation lesion, myocardial ischemia in the interventional therapy process can be caused by the fact that the bifurcation lesion is affected by branch blood vessels caused by plaque displacement, and restenosis can exist at a high probability if no stent support or local anti-proliferative drugs are released after the blood vessels are expanded by the balloon.

2. When the two balloons are required to simultaneously expand a main branch vessel and a branch vessel of a bifurcation lesion, the tail ends of the two balloons are aligned as soon as possible, and the unsynchronized expansion or contraction of the balloons caused by human factors is avoided as much as possible in the process of balloon expansion.

3. The recurrence rate of vascular restenosis and thrombosis is high.

If the problems can be well solved, the treatment effect on improving the coronary bifurcation lesion can be positively achieved.

The references mentioned in the literature of the present invention are figures from the perspective of the present invention for the perspective biofunctionalization of 11th presentation from the perspective Bifuration Club (EuroIntervision; 2016, Vol12: 38-46) and the context of the perspective Bifuration evaluation (JACC: cardio interrelations; 2016, Vol9: 1861-78), which are used to illustrate the background art of the present invention.

Disclosure of Invention

The invention provides the following technical scheme for solving the defects in the prior art.

The invention aims to provide a balloon for bifurcation lesion of a biological body pipeline, which comprises a first balloon and a second balloon which are arranged in a split way and are sequentially sent into a blood vessel; a tubular first inner cavity is arranged in the first balloon, and a tubular second inner cavity is arranged in the second balloon; a first guide wire is used to guide the first balloon and a second guide wire is used to guide the second balloon.

Further, at least one of the first balloon and the second balloon is a drug-loaded balloon.

Further, the drug-loaded balloon is coated with a drug by one or more methods of a hydrophobic coating, a hydrophilic coating, a water-insoluble drug coating or a semi-hydrophobic coating.

Further, the surface of the first balloon and/or the second balloon is provided with a drug-loading structure, and the drug-loading structure is at least one of a zigzag gully structure, a rectangular groove structure and a circular groove structure which are arranged around the surface of the first balloon and/or the second balloon.

Further, the drug-loaded balloon-loaded drug is selected from paclitaxel, rapamycin derivatives, dimethoxy-fexofam-6-one, docetaxel, doxorubicin, daunorubicin, epirubicin, erythromycin, estramustine, etoposide, everolimus, filgrastim, flubenstine, fluvastatin, fludarabine-5' -dihydrogen phosphate, fluorouracil, tobramycin, fosfestival, gemecibine, galaxolide, ginkgol, ginkgolic acid, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, medecamycin, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, irinotecan, topotecan, epirubicin, and another, Hydroxyurea, miltefosine, pentostatin, pemetrexed, exemestane, letrozole, formestane, mycophenolate mofetil, beta-lapachone, podophyllotoxin, peg interferon alpha-2 b, polyethylene glycol, cytokine antagonists, cytokinin inhibitors, cyclooxygenase-2 inhibitors, angiostatin, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1-hydroxy-11-methoxy-fagomine-6-one, scopoletin, nitric oxide donors, pentaerythritol tetranitrate and sydnonimine, tamoxifen, staurosporine, beta-estradiol, alpha-estradiol, estriol, estrone, ethinylestradiol, medroxyprogesterone, estradiol cypionate, estradiol benzoate, tranilast, rabdoside and other terpenoids for cancer therapy, Verapamil, tyrosine kinase inhibitors, 6-alpha-hydroxy-paclitaxel, taxotere, albumin-bound paclitaxel, mofebuzone, clonazelate, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, disodium aurothioate, oxacero, beta-sitosterol, etidocaine, polidocanol, nonivamide, levomenthol, ellipticine, colchicine, cytochalasin A-E, indomethacin, nocodazole, bacitracin, vitronectin receptor antagonists, azelastine, guanylate cyclase stimulators, tissue inhibitors of metalloproteinase-1 and metalloproteinase-2, free nucleic acids, nucleic acids incorporated into virus transmitters, deoxyribonucleic acids and ribonucleic acid fragments, plasminogen activator inhibitor-1, plasminogen activator inhibitor, beta-sitosterol, glutethine, medroxyprogesterone, norgalantamine, tissue inhibitors of metalloproteinase-1 and metalloproteinase-2, free nucleic acids, nucleic acids incorporated into virus transmitters, deoxyribonucleic acids, and ribonucleic acid fragments, plasminogen activator inhibitor-1, Plasminogen activator inhibitor-2, antisense oligonucleotides, vascular endothelial growth factor inhibitors, insulin-like growth factors, active agents from the antibiotic group, cefmenoxene, cefazolin, cefaclor, cefotaxime, tobramycin, gentamicin, penicillin, dicloxacillin, oxacillin, sulfonamide, metronidazole, enoxaparin, heparin, hirudin, D-phenylalanine-proline-arginine-methanone, protamine, prourokinase, streptokinase, warfarin, urokinase, vasodilators, dipyridamole, trapidil, nitroprusside, platelet-derived growth factor antagonists, triazolopyrimidine, tryptamine, acetylcholinesterase inhibitors, captopril, cilazapril, lisinopril, enalapril, losartan, thioprotease inhibitors, prostacyclin, prochloraz, and the like, Vapreotide, interferon alpha, interferon beta and interferon gamma, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis modulators, halofuginone, nifedipine, tocopherol, tranilast, moldomine, catechin, epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, tetracycline, triamcinolone, mutamycin, procainamide, retinoic acid, quinidine, propiram, flecainide, propafenone, sotalol, natural and synthetically derived steroids, ragged toxin A, fuscoporianol, marquisin A, glarginine, mansonine, strepavidin, hydrocortisone, betamethasone, dexamethasone, non-steroidal substances, fenoprofen, ibuprofen, indomethacin, naproxen, phenylbutazone, antiviral agents, phenylbutazone, fenoprofen, ibuprofen, indomethacin, and the like, Acyclovir, ganciclovir, zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprotozoal, chloroquine, mefloquine, quinine, natural terpenoids, hippocampal calpain, 14-dehydroeuphorbia toxin, euphorbiadin, euphorbia toxin, 17-hydroxypoitrin toxin, ledebouriella lactone, 4, 7-oxocyclo-ledebouriella oxalic acid, cantalouperin B1, B2, B3 and B7, tubeimoside, anticholinergicide C, brucin N and P, isodeoxyelephantopin, swertin A and B, zingiberin A, B, C and D, ursolic acid, cetacoric acid A, iso-German iridic aldehyde, maytansinol, bergenin A, vanillyladenin and vanillylB, vanillyl B, crocin, milfoil, mibevacrol, mibevachin A, crocin B, crocin, mefenacin, mehodin B, mefenacin, Triptolide, cymoxanthin, protoanemonin, carpesin chloride, mogrosides A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxyprogesterone-3, 20-dione, alantolidine, caucasine-N-oxide, lasiocalcine, inonotus alcohol, podophyllotoxin, acantholipin A and B, larcetin, malvidin, isobutoyl malvidin, maytansine, lecrycin, maytenin, diphylline, lappaucine, lirionine, theophylline oxide, periplocin A, deoxyspergualin, nonagroside, ricin A, sanguinarine, mannstituric acid, methylmargarine, euphorbiaceae chromone, sarsopulin, dihydropiper, hydroxypiper nigra, maclealine pentamine, malachitine, macleaine, One or more of urabamine, tulipine, daparine, daphnoretin, lariciresinol, methoxylariciresinol, syringaresinol, sirolimus, biolimus A9, pimecrolimus, everolimus, oxazololimus, tacrolimus, albumin-bound sirolimus, nap-sirolimus, fasudil, epothilone, somatostatin, roxithromycin, oleandomycin, simvastatin, rosuvastatin, vinblastine, vincristine, vindesine, teniposide, vinorelbine, trofosfamide, troosufen, temozolomide, thiotepa, tretinoin, spiramycin, umbelliferone, deacetylvisomiton A, visomiton A and B, and zeptopene.

Furthermore, the first balloon and the second balloon are respectively connected with a control valve or a three-way valve, one end of the control valve, which is far away from the first balloon and the second balloon, is connected with a perfusion liquid delivery pump, and the control valves can respectively and independently control perfusion of the first balloon and the second balloon.

Further, the control valve includes a three-position four-way reversing valve and a three-way valve, the three-position four-way reversing valve has a first port, a second port, a third port and a fourth port, the first port is connected with the first balloon port, the second port is connected with the second balloon port, the first port of the three-way valve is connected with the third port, and the second port of the three-way valve is connected with the first balloon port and the second balloon port through a first access port and a second access port respectively.

Further, the perfusion liquid delivery pump comprises a first injector and a second injector, the first injector is connected with the three-position four-way reversing valve, the first port of the three-way valve is connected with the third port, the first port is connected with the first balloon port, the second injector is directly connected with the fourth port, the second port is connected with the second balloon port, and the second port of the three-way valve is connected with the first balloon port and the second balloon port through the first access port and the second access port respectively.

Further, a timer is arranged on a control valve of the balloon and used for calculating the balloon expansion or contraction time.

Furthermore, a timer is arranged on a control valve of the balloon, and the control valve can control the pipeline to be opened or closed so as to preset the expansion or contraction of the balloon.

Further, a timer is arranged on a control valve of the balloon, and the expansion or contraction time of the balloon can be recorded.

Further, a timer is arranged on a control valve of the balloon, and data can be transmitted to a recording terminal. The data transmitted to the terminal can directly generate case records and be reviewed by a doctor.

Furthermore, a control valve of the balloon is provided with a timer, a chip is arranged, and the control valve can be associated with other computing terminals such as a mobile phone and the like by adopting App or other programs.

Furthermore, the balloon is provided with a blood flow channel penetrating through the balloon, which means that the expansion time of the drug-loaded balloon is longer, the drug is more completely released on the blood vessel wall, the pre-expansion of the blood vessel and the drug release are combined into one operation, and a faster and better clinical path is provided for the treatment of bifurcation lesion.

In the balloon, the first balloon and the second balloon are respectively provided with a plurality of positioning parts inside, and the positioning parts are used for providing positioning guide for an operator during angiography and also can be used for providing guide for filling of the chambered balloon.

In the balloon, the positioning component is made of any one or more of a magnetic material, a simple substance metal material and an alloy material.

It is a further object of the present invention to provide a use of the balloon described above for treating a vascular bifurcation lesion.

It is a further object of the present invention to provide a use of a medicated balloon for directional or localized release within a biological lumen for treating bifurcation lesions in a blood vessel.

Further, the vascular bifurcation lesion is a coronary artery bifurcation lesion or an above knee artery bifurcation lesion or an below knee artery bifurcation lesion.

Further, the inner diameter of the coronary artery is less than 7 mm, preferably, the inner diameter of the coronary artery is less than 5mm, more preferably, the inner diameter of the coronary artery is less than 4mm, and more preferably, the inner diameter of the coronary artery is less than 3 mm.

Further, the drug-loaded balloon is coated with drugs by one or more methods of a hydrophobic coating, a hydrophilic coating, a water-insoluble coating or a semi-hydrophobic coating.

Further, the drug-loaded balloon-loaded drug is selected from paclitaxel, rapamycin derivatives, dimethoxy-fexofam-6-one, docetaxel, doxorubicin, daunorubicin, epirubicin, erythromycin, estramustine, etoposide, everolimus, filgrastim, flubenstine, fluvastatin, fludarabine-5' -dihydrogen phosphate, fluorouracil, tobramycin, fosfestival, gemecibine, galaxolide, ginkgol, ginkgolic acid, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, medecamycin, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, irinotecan, topotecan, epirubicin, and another, Hydroxyurea, miltefosine, pentostatin, pemetrexed, exemestane, letrozole, formestane, mycophenolate mofetil, beta-lapachone, podophyllotoxin, peg interferon alpha-2 b, polyethylene glycol, cytokine antagonists, cytokinin inhibitors, cyclooxygenase-2 inhibitors, angiostatin, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1-hydroxy-11-methoxy-fagomine-6-one, scopoletin, nitric oxide donors, pentaerythritol tetranitrate and sydnonimine, tamoxifen, staurosporine, beta-estradiol, alpha-estradiol, estriol, estrone, ethinylestradiol, medroxyprogesterone, estradiol cypionate, estradiol benzoate, tranilast, rabdoside and other terpenoids for cancer therapy, Verapamil, tyrosine kinase inhibitors, 6-alpha-hydroxy-paclitaxel, taxotere, albumin-bound paclitaxel, mofebuzone, clonazelate, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, disodium aurothioate, oxacero, beta-sitosterol, etidocaine, polidocanol, nonivamide, levomenthol, ellipticine, colchicine, cytochalasin A-E, indomethacin, nocodazole, bacitracin, vitronectin receptor antagonists, azelastine, guanylate cyclase stimulators, tissue inhibitors of metalloproteinase-1 and metalloproteinase-2, free nucleic acids, nucleic acids incorporated into virus transmitters, deoxyribonucleic acids and ribonucleic acid fragments, plasminogen activator inhibitor-1, plasminogen activator inhibitor, beta-sitosterol, glutethine, medroxyprogesterone, norgalantamine, tissue inhibitors of metalloproteinase-1 and metalloproteinase-2, free nucleic acids, nucleic acids incorporated into virus transmitters, deoxyribonucleic acids, and ribonucleic acid fragments, plasminogen activator inhibitor-1, Plasminogen activator inhibitor-2, antisense oligonucleotides, vascular endothelial growth factor inhibitors, insulin-like growth factors, active agents from the antibiotic group, cefmenoxene, cefazolin, cefaclor, cefotaxime, tobramycin, gentamicin, penicillin, dicloxacillin, oxacillin, sulfonamide, metronidazole, enoxaparin, heparin, hirudin, D-phenylalanine-proline-arginine-methanone, protamine, prourokinase, streptokinase, warfarin, urokinase, vasodilators, dipyridamole, trapidil, nitroprusside, platelet-derived growth factor antagonists, triazolopyrimidine, tryptamine, acetylcholinesterase inhibitors, captopril, cilazapril, lisinopril, enalapril, losartan, thioprotease inhibitors, prostacyclin, prochloraz, and the like, Vapreotide, interferon alpha, interferon beta and interferon gamma, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis modulators, halofuginone, nifedipine, tocopherol, tranilast, moldomine, catechin, epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, tetracycline, triamcinolone, mutamycin, procainamide, retinoic acid, quinidine, propiram, flecainide, propafenone, sotalol, natural and synthetically derived steroids, ragged toxin A, fuscoporianol, marquisin A, glarginine, mansonine, strepavidin, hydrocortisone, betamethasone, dexamethasone, non-steroidal substances, fenoprofen, ibuprofen, indomethacin, naproxen, phenylbutazone, antiviral agents, phenylbutazone, fenoprofen, ibuprofen, indomethacin, and the like, Acyclovir, ganciclovir, zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprotozoal, chloroquine, mefloquine, quinine, natural terpenoids, hippocampal calpain, 14-dehydroeuphorbia toxin, euphorbiadin, euphorbia toxin, 17-hydroxypoitrin toxin, ledebouriella lactone, 4, 7-oxocyclo-ledebouriella oxalic acid, cantalouperin B1, B2, B3 and B7, tubeimoside, anticholinergicide C, brucin N and P, isodeoxyelephantopin, swertin A and B, zingiberin A, B, C and D, ursolic acid, cetacoric acid A, iso-German iridic aldehyde, maytansinol, bergenin A, vanillyladenin and vanillylB, vanillyl B, crocin, milfoil, mibevacrol, mibevachin A, crocin B, crocin, mefenacin, mehodin B, mefenacin, Triptolide, cymoxanthin, protoanemonin, carpesin chloride, mogrosides A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxyprogesterone-3, 20-dione, alantolidine, caucasine-N-oxide, lasiocalcine, inonotus alcohol, podophyllotoxin, acantholipin A and B, larcetin, malvidin, isobutoyl malvidin, maytansine, lecrycin, maytenin, diphylline, lappaucine, lirionine, theophylline oxide, periplocin A, deoxyspergualin, nonagroside, ricin A, sanguinarine, mannstituric acid, methylmargarine, euphorbiaceae chromone, sarsopulin, dihydropiper, hydroxypiper nigra, maclealine pentamine, malachitine, macleaine, One or more of urabamine, tulipine, daparine, daphnoretin, lariciresinol, methoxylariciresinol, syringaresinol, sirolimus, biolimus A9, pimecrolimus, everolimus, oxazololimus, tacrolimus, albumin-bound sirolimus, nap-sirolimus, fasudil, epothilone, somatostatin, roxithromycin, oleandomycin, simvastatin, rosuvastatin, vinblastine, vincristine, vindesine, teniposide, vinorelbine, trofosfamide, troosufen, temozolomide, thiotepa, tretinoin, spiramycin, umbelliferone, deacetylvisomiton A, visomiton A and B, and zeptopene.

In the invention, the preferred shellac or shellac ammonium salt is taken as a coating medium, and the paclitaxel or the rapamycin and the rapamycin derivative are taken as the drug-carrying saccule of the drug.

The most preferable method in the invention is that shellac ammonium salt is used as a coating medium, and paclitaxel is used as a drug-loaded balloon of the drug.

Still another object of the present invention is to provide a method for operating a vascular bifurcation lesion, which comprises preparing a vessel for the vascular bifurcation lesion; and then, saccules are adopted to treat the bifurcation lesion of the blood vessel, wherein at least one saccule is a medicine-carrying saccule, and preferably, both the saccules are the medicine-carrying saccules.

Further, the blood vessel preparation in the above-mentioned operation method includes, but is not limited to, pre-expanding lesion blood vessel treatment using a bare balloon, a cutting balloon, a spinous process balloon or a nicking balloon; or a rotational atherectomy catheter or a laser ablation catheter or the like may be used to prepare for the pretreatment of the coronary lesions.

Further, no stent is used during the above-described surgical method.

Further, the above-described surgical method does not use a stent that penetrates or covers the lesion site of the main artery during the procedure.

Further, the final stage of the procedure of the above-described surgical method may use a stent for fixing a vascular splint.

Further, the above-mentioned surgical method employs the balloon of the first aspect.

Further, the vessel bifurcation lesion of the above-mentioned surgical method is a coronary artery having an inner diameter of less than 7 mm, preferably less than 5mm, more preferably less than 4mm, and still more preferably less than 3 mm.

Another objective of the present invention is to provide a method for performing an operation on a vascular bifurcation lesion, which comprises performing an image diagnosis on the vascular bifurcation lesion; and then, saccules are adopted to treat the bifurcation lesion of the blood vessel, wherein at least one saccule is a medicine-carrying saccule, and preferably, both the saccules are the medicine-carrying saccules.

Further, the imaging diagnosis during the above-described surgical method includes, but is not limited to, one or more of angiography, nuclear magnetic resonance, and photoacoustic imaging.

Furthermore, in the process of the above-mentioned operation method, no stent is used in the operation process, especially no stent penetrating or covering the main vessel lesion is used.

Further, the final stage of the procedure of the above-described surgical method may use a stent for fixing a vascular splint.

Further, the balloon of the first aspect is used in the procedure of the above-described surgical method.

Further, the vessel bifurcation lesion of the above-mentioned surgical method is a coronary artery having an inner diameter of less than 7 mm, preferably less than 5mm, more preferably less than 4mm, and still more preferably less than 3 mm.

The invention can supplement the stent according to the condition of the blood vessel interlayer after the drug balloon is used for the anastomosis treatment, but can avoid a longer stent which penetrates or covers the main blood vessel.

The drug-loaded balloon and the naked balloon in the invention can also be adjusted and improved by adopting the existing technical schemes of a restraint balloon, a cutting balloon, a spinous process balloon or a nicking balloon and the like.

The preferred method in the invention refers to a drug-loaded balloon with shellac or shellac ammonium salt as a coating medium and paclitaxel or rapamycin and rapamycin derivatives as drugs.

The most preferred medicine carrying balloon coating method in the invention is a medicine carrying balloon (RESTORE DEB) taking shellac ammonium salt as a coating medium and taxol as a medicine.

The invention has the following specific beneficial effects: when the complex bifurcation lesion is treated, the two drug-carrying balloons are respectively arranged in the two branch blood vessels to expand or contract simultaneously.

In addition, the medicine-carrying balloon can play a more important role in the clinical treatment difficulty of coronary artery bifurcation lesion by solving part of key links.

Meanwhile, when the drug-loaded balloon disclosed by the invention is attached to a target lesion, the paclitaxel drug micromolecules can enter endothelial cells and subcutaneous tissue gaps more quickly through passive diffusion, so that the tissue proliferation and migration at the target lesion can be inhibited more quickly and long-term, and a more effective treatment effect is achieved.

In addition, compared with the traditional stent implantation of bifurcation lesion, the strategy of applying the drug-loaded balloon to carry out interventional therapy not only simplifies the operation process of the operation, but also has no foreign body implantation, reduces the risk of thrombus generation, lightens inflammatory reaction brought by the foreign body, can greatly shorten the duplex antiplatelet treatment time of the patient, and lightens the bleeding complication and the economic burden of the patient.

Description of the drawings:

in order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings of the embodiments of the present invention will be briefly described below.

Wherein the drawings are only for purposes of illustrating some embodiments of the invention and are not to be construed as limiting the invention to all embodiments thereof.

FIG. 1: the balloon provided by the embodiment of the invention is in a structural schematic view.

FIG. 2: the drug-loaded balloon is schematically depicted as kissing.

FIG. 3: schematic coating of drug-loaded balloon.

FIG. 4: schematic diagram of partial chambers in a dual-chamber drug-loaded balloon.

FIG. 5: partial cavity schematic diagram in three chamber medicine carrying sacculus.

FIG. 6: the interior passage of the drug-loaded balloon is schematically shown.

FIG. 7: a first schematic of a control valve of an embodiment of the invention.

FIG. 8: a schematic cross-sectional view of a control valve of an embodiment of the invention.

FIG. 9: case 1 coronary artery lesion representation.

FIG. 10: case 2 coronary lesions.

FIG. 11: case 3 coronary lesions.

Reference numerals:

a first balloon-1; a second balloon-2; a first lumen-3; a second lumen-4; a first guide wire-5; a second guide wire-6; a control valve-7; a perfusion liquid delivery pump-8; penetrates through the inner pipe-9; a multi-chamber balloon-100; a sub-chamber-101; a perfusion branch-102; a first sub-chamber-101 a; a second sub-chamber-101 b; a third sub-chamber-101 c; a first perfusion branch-102 a; a second perfusion branch-102 b; a third perfusion branch-102 c; a main perfusion path-103; a drug-loading structure-104; first balloon port-1010, second balloon port-2010, first port-a, second port-B, third port-P1, fourth port-P2, three-position four-way reversing valve-701, three-way valve-702, first access port-703, second access port-704, three-way valve first port-V1, three-way valve second port-V2, first injector-D1, second injector-D2, H1-vessel endothelium, H2-bifurcation lesion plaque.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings of specific embodiments of the present invention.

Like reference symbols in the various drawings indicate like elements. It should be noted that the described embodiments are only some embodiments of the invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the described embodiments of the invention without any inventive step, are within the scope of protection of the invention.

Unless defined otherwise, technical or scientific terms used herein shall have the ordinary meaning as understood by one of ordinary skill in the art to which this invention belongs.

The use of "first," "second," and similar terms in the description and claims of the present application do not denote any order, quantity, or importance, but rather the terms are used to distinguish one element from another.

Also, the use of the terms "a" or "an" and the like do not necessarily denote a limitation of quantity. The word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items.

The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical connections, whether direct or indirect. "upper", "lower", "left", "right", and the like are used merely to indicate relative positional relationships, and when the absolute position of the object being described is changed, the relative positional relationships may also be changed accordingly.

It should be noted that, in the drug-loaded balloon of the present invention, the drug is coated by one or more methods of a hydrophobic coating, a hydrophilic coating, a water-insoluble drug coating or a semi-hydrophobic coating.

The preferred method in the invention refers to a drug-loaded balloon with shellac or shellac ammonium salt as a coating medium and paclitaxel or rapamycin and rapamycin derivatives as drugs.

The most preferable method in the invention is that shellac ammonium salt is used as a coating medium, and paclitaxel is used as a drug-loaded balloon of the drug.

Referring to fig. 1-2, the embodiment of the invention provides a balloon for bifurcation lesion in a biological body pipeline, which comprises a first balloon 1 and a second balloon 2 which are arranged separately and are sequentially sent into a blood vessel; a tubular first inner cavity 3 is arranged inside the first balloon 1, and a tubular second inner cavity 4 is arranged inside the second balloon 2; a first guide wire 5 is used to guide the first balloon 1 and a second guide wire 6 is used to guide the second balloon 2.

In the treatment of bifurcation lesion plaque H2 at the vascular endothelium H1, in order to prevent plaque movement and/or SB clamping caused by stent struts, the entering sequence of the first balloon 1 and the second balloon 2 of the bifurcation lesion basically follows the principle of entering preferentially in which branch is difficult to enter, and the operation action of the second balloon is reduced as much as possible, thereby reducing the probability of winding the two guide wires. Among them, the location of the bifurcated lesion H2 may be distributed on the surface of the vascular endothelium H1 or distributed below the surface of the vascular endothelium H1.

The proximal ends of the first balloon 1 and the second balloon 2 are respectively provided with one positioning component, and the positioning components are used for providing positioning guidance for an operator during angiography and also can be used for providing guidance for filling of the chambered balloon. The positioning component is made of any one or more of a magnetic material, a simple substance metal material and an alloy material. Before anastomosis, the tail ends of the first balloon 1 and the second balloon 2 can be positioned through the positioning component.

In some embodiments of the invention, at least one of the first balloon 1 and the second balloon 2 is a drug-loaded balloon. The drug-loaded balloon adopts one or more methods of a hydrophobic coating, a hydrophilic coating or a semi-hydrophobic coating to coat drugs. The balloon is coated with the semi-hydrophobic coating or the water-insoluble drug coating, and particularly relates to the drug coating balloon prepared from a special coating material, so that therapeutic drugs can be kept from being lost into body fluid or blood before the balloon reaches bifurcation lesion.

Referring to fig. 3, in some embodiments of the present invention, the surface of the first balloon 1 and/or the second balloon 2 has a drug-loading structure 104, and the drug-loading structure 104 is at least one of a zigzag ravine structure, a rectangular groove structure, and a circular groove structure disposed around the surface of the first balloon 1 and/or the second balloon 2.

In some embodiments of the present invention, preferably, a drug-loaded balloon with shellac or shellac ammonium salt as a matrix is used.

In some embodiments of the present invention, the first balloon 1 and the second balloon 2 are respectively connected to a control valve 7, one end of the control valve 7 away from the first balloon 1 and the second balloon 2 is connected to a perfusion liquid delivery pump 8, and the control valve 7 can respectively or simultaneously control perfusion of the first balloon 1 and the second balloon 2.

Referring to fig. 7, the embodiment of the present invention provides a typical control valve 7, and the control valve 7 of the embodiment of the present invention can not only control the perfusion of the first balloon 1 and the second balloon 2 respectively or simultaneously, but also can simultaneously pressurize, expand and depressurize and contract the first balloon 1 and the second balloon 2 according to actual needs.

Referring specifically to fig. 7-8, the control valve 7 includes a three-position, four-way reversing valve 701 having four ports, namely a first port a, a second port B, a third port P1, and a fourth port P2, and having three operating positions, namely a first position, a second position, and a third position. Wherein:

when the valve core is positioned at the first position, the third port P1 is connected with the first port A, and the fourth port P2 is connected with the second port B; when the valve core is positioned at the second position, the first port A, the second port B, the third port P1 and the fourth port P2 are all in a cut-off state; when the valve spool is in the third position, the third port P1 is connected to the second port B and the fourth port P2 is connected to the first port A.

The perfusion liquid delivery pump 8, in this embodiment specifically a first syringe D1 and a second syringe D2, are well known to those skilled in the art and may be used to pressurize the balloon and also to depressurize the balloon, which in the pressurized state is inflated with a contrast-containing fluid to inflate the first balloon 1 and/or the second balloon 2.

The first injector D1 is connected with the three-way valve 702, the three-way valve first port V1 of the three-way valve 702 is connected with the third port P1, the first port A is connected with the first balloon port 1010, the second injector D2 is directly connected with the fourth port P2, the second port B is connected with the second balloon port 2010, the three-way valve second port V2 of the three-way valve 702 is connected with the first balloon port 1010 through the first access port 703, and the three-way valve second port V2 of the three-way valve 702 is connected with the second balloon port through the second access port 704.

The specific use mode is as follows:

at a bifurcation lesion, the first balloon and the second balloon are sequentially in place, if the first balloon needs to be expanded and the second balloon needs to be kept in an unexpanded state, the three-way valve 702 opens the first port V1 of the three-way valve, the valve core of the three-position four-way reversing valve 701 is located at a first position, the first port A is communicated with the third port P1, the first syringe D1 can only supply fluid to the first balloon at the moment, and the second syringe D2 is not operated although connected with the second balloon; if the first balloon is required to keep the current pressure unchanged, the valve spool of the three-position four-way reversing valve 701 is only required to be located at the second position, and the first port A, the second port B, the third port P1 and the fourth port P2 are all disconnected; if it is desired to inflate the second balloon, the spool of the three-position, four-way reversing valve 701 is placed in the third position, in which the first syringe D1 can only supply fluid to the second balloon, and the first balloon is connected to the second syringe D2, optionally in which the second syringe D2 can depressurize the first balloon.

If it is desired to expand the first balloon and the second balloon simultaneously after the first balloon 1 and the second balloon 2 are successively positioned, and the pressures for the expansion are the same, the three-way valve second port V2 of the three-way valve 702 is opened, and the first syringe D1 supplies pressure directly to the first balloon port 1010 and the second balloon port 2010, it is understood that both balloons may be depressurized simultaneously.

The control valve 7 has the advantages that the doctor who performs the operation controls the first injector D1 and instructs the three-position four-way reversing valve 701 and the three-way valve 702 to make and break the flow path, the doctor who performs the operation has rich experience and can better cope with the outstanding events in the operation, the operation assistant personnel controls the second injector D2 and is only used for simple operations of reducing the pressure of the second injector D2, and therefore the control valve 7 can effectively cope with various outstanding events and emergencies in the double-balloon operation.

It should be noted that the control valve 7 of the present invention may also adopt other flow path switching valves, or a combination of valves connected in parallel or in series, so as to control the expansion or contraction of the first balloon and the second balloon 2 and their respective multi-chambers separately or simultaneously.

In some embodiments of the invention, the first balloon 1 and/or the second balloon 2 are multi-chamber balloons 100. The multi-chamber balloon 100 comprises more than two sub-chambers 101 which are independent and separated from each other, the sub-chambers 101 are communicated with a perfusion branch 102, the perfusion branch 102 is converged at one end of a main perfusion path 103, and the other end of the main perfusion path 103 is connected with a perfusion liquid delivery pump 8.

The embodiment of the invention also provides a using method for treating the bifurcation lesion of the blood vessel by adopting the balloon, and a using method for treating the bifurcation lesion of the blood vessel by adopting the medicine-carrying balloon to directionally or positionally release in the biological cavity tube.

In addition, the proximal ends of the first balloon 1 and the second balloon 2 are respectively provided with one or more positioning components, and the positioning components are used for providing positioning guidance for an operator during angiography and also can be used for providing guidance for filling of the chambered balloon.

The positioning component is made of any one or more of a magnetic material, a simple substance metal material and an alloy material. Before anastomosis, the tail ends of the first balloon 1 and the second balloon 2 can be positioned through the positioning component.

In some embodiments of the invention, the cardiovascular system is a coronary artery. The inner diameter of the coronary artery is less than 7 mm, preferably the inner diameter of the coronary artery is less than 5mm, more preferably the inner diameter of the coronary artery is less than 4mm, and more preferably the inner diameter of the coronary artery is less than 3 mm.

Example 1

Referring to fig. 4, in this embodiment, the first balloon 1 and/or the second balloon 2 are multi-chamber balloons 100. The multi-chamber balloon 100 includes a first sub-chamber 101a and a second sub-chamber 101b separately provided from each other. The first sub-chamber 101a and the second sub-chamber 101b are respectively communicated with the first perfusion branch 102a and the second perfusion branch 102 b; the first perfusion branch 102a and the second perfusion branch 102b are joined together at one end of a main perfusion path 103, and the other end of the main perfusion path 103 is connected to the perfusion liquid delivery pump 8.

Example 2

Referring to fig. 5, in this embodiment, the first balloon 1 and/or the second balloon 2 are multi-chamber balloons 100. The multi-chamber balloon 100 includes a first sub-chamber 101a, a second sub-chamber 101b, and a third sub-chamber 101c, which are separated from each other. The first sub-chamber 101a, the second sub-chamber 101b and the third sub-chamber 101c are respectively communicated with a first perfusion branch 102a, a second perfusion branch 102b and a third perfusion branch 102 c; the first perfusion branch 102a, the second perfusion branch 102b and the third perfusion branch 102c are joined together at one end of a main perfusion circuit 103, and the other end of the main perfusion circuit 103 is connected to the perfusion liquid delivery pump 8. The tail ends of the first sub-chamber 101a, the second sub-chamber 101b and the third sub-chamber 101c are coincident; the head ends of the second 101b and third 101c subchambers are flush with the middle of the first 101a subchamber; the second sub-chamber 101b and the third sub-chamber 101c are respectively positioned at two sides of the first sub-chamber 101 a; the first sub-chamber 101a has a spindle-shaped structure, and the second sub-chamber 101b and the third sub-chamber 101c have a petal-shaped structure that semi-surrounds the first sub-chamber 101 a.

Example 3

Referring to fig. 6, in this embodiment, the inside of the first balloon 1 and/or the second balloon 2 further includes a through inner tube 9, the through inner tube 9 is hollow, and two ends of the through inner tube are respectively connected with the outside of the first balloon 1 and/or the second balloon 2.

Example 4

Referring to fig. 7-8, embodiments of the present invention provide a control valve 7 that can be used to control the perfusion of the first and second balloons 1, 2 independently of each other, using the perfusion liquid delivery pump 8 and control valve 7 of embodiments of the present invention. When the first balloon 1 and/or the second balloon 2 are the multi-chamber balloon 100, for example, the multi-chamber balloon 100 includes a first sub-chamber 101a, a second sub-chamber 101b, and a third sub-chamber 101c that are separately provided, the control valve 7 provided in the embodiment of the present invention can perform precise control on the first sub-chamber 101a, the second sub-chamber 101b, and the third sub-chamber 101c independently. Therefore, in the process of performing surgical treatment by using the balloon provided by the embodiment of the invention, a surgical assistant can be used for accurately controlling the 2 balloons which are sequentially sent into the blood vessel and the plurality of sub-chambers in the balloons, so that simultaneous filling and releasing of the two balloons are ensured, and accurate control on the shape of the balloons is facilitated.

Case 1

Patients' wang x, 56 year old male, admission diagnosis "coronary heart disease, unstable angina", coronary angiography suggested "bifurcation lesion, 85% stenosis of proximal descending branch, 80% stenosis of the 1 st diagonal branch", diameter of proximal descending branch 3.0mm and diameter of proximal diagonal branch 2.75mm, as shown in fig. 9.

Prepare before improving interventional therapy according to coronary artery interventional therapy conventionality, arrange medicine coating sacculus 1 (RESTORE DEB) with the specification of 3.0mm and the length of 20mm in descending branch before, arrange medicine coating sacculus 2 (RESTORE DEB) with the specification of 2.75mm and the length of 20mm in diagonal branch, align the medicine coating sacculus 1 and the medicine coating sacculus 2 positioning part in descending branch near section before through manual rapid adjustment, rapidly connect the tail ends of the two medicine coating sacculus with a control valve 7 and a liquid delivery pump 8, firstly adjust the control valve 7 to a double-pass position, inject liquid in the liquid delivery pump 8 to the medicine coating sacculus 1 and the medicine coating sacculus 2 simultaneously to enable the liquid to expand by 12atm simultaneously and last for 45 seconds, then use the liquid delivery pump 8 to suck back liquid in the medicine coating sacculus 1 and the medicine coating sacculus 2 simultaneously, enable the two to retract to a deflation state simultaneously, and (4) carrying out repeated examination and radiography, wherein anterior descending branch and diagonal branch have no obvious residual stenosis, blood flow TIMI3 grade, no clear vascular dissection is seen, and the operation treatment is ended.

The whole operation process lasts for about 30 minutes, patients are followed up for 9 months after operation without angina, and coronary angiography is reviewed to prompt anterior descending branch and diagonal branch without obvious diameter restenosis of blood vessels.

Case 2

Patients' Cai;, 70 year old women, hospitalized diagnosis "coronary heart disease, unstable angina pectoris", coronary heart diseaseArteriography suggests that the bifurcation is diseased, 50% of the proximal section of the anterior descending branch is narrow, the opening of the 1 st diagonal branch is narrow, the diameter of the proximal section of the anterior descending branch is 3.5mm under visual estimation, the diameter of the proximal section of the diagonal branch is 2.5mm, and as shown in figure 10, the minimum lumen area of the proximal section of the anterior descending branch is further discovered by ultrasonic in the coronary artery²。

Preparing before improving interventional therapy according to the conventional coronary artery interventional therapy, arranging a drug coated balloon 1 (RESTORE DEB) with the specification of 3.5mm and the length of 22mm in a front descending branch, arranging a drug coated balloon 2 with the specification of 2.5mm and the length of 22mm in a diagonal branch, aligning the drug coated balloon 1 (RESTORE DEB) and a positioning part of the drug coated balloon 2 in the front descending branch near section through manual rapid adjustment, rapidly connecting the tail ends of the two drug coated balloons with a control valve 7 and a liquid delivery pump 8, adjusting the control valve 7 to a two-way position, simultaneously injecting liquid in the liquid delivery pump 8 into the drug coated balloon 1 and the drug coated balloon 2 to expand by 12atm for 45 seconds, then simultaneously pumping the liquid in the drug coated balloon 1 and the drug coated balloon 2 by using the liquid delivery pump 8, and simultaneously retracting the two balloons to a pumping-flat state, the examination of the coronary artery has no clear residual stenosis in the anterior descending branch and the diagonal branch, the blood flow is TIMI3 grade, the coronary artery intravascular ultrasound has no clear vascular dissection or intramural hematoma, and the minimum lumen area of the anterior descending branch is 6.2mm²And the minimum lumen area of the diagonal branch is 4.4mm²And ending the operation treatment.

The whole operation process lasts for about 45 minutes, patients are followed up for 9 months after operation without angina, and coronary angiography is reviewed to prompt anterior descending branch and diagonal branch without obvious diameter restenosis of blood vessels.

Case 3

Patient Liu × 64 years old female, hospitalized for diagnosis of "coronary heart disease, unstable angina", coronary angiography suggested "bifurcation lesion, 50% stenosis of distal right coronary artery, spread of lesion to proximal posterior descending branch, 90% stenosis of posterior collateral opening", visual assessment of distal right coronary artery diameter of 2.5mm, proximal posterior descending branch diameter of 2.5mm, proximal posterior collateral branch diameter of 2.25mm, as shown in FIG. 11.

Prepare before intervene the treatment according to the conventional perfection of coronary artery interventional therapy, carry out abundant pre-expansion to the back collateral branch through cutting the sacculus expansion, after the evaluation accords with the success standard of pre-expansion, place the specification in diameter 2.5mm, length 22 mm's medicine coating sacculus 1 (RESTORE DEB) into right coronary artery-fall after, place the specification in diameter 2.25mm, length 22 mm's medicine coating sacculus 2 (RESTORE DEB) into the back collateral branch, through manual rapid adjustment make medicine coating sacculus 1 and medicine coating sacculus 2 locating component fall the section in the front and align closely, be connected two medicine coating sacculus terminal with control valve 7 and liquid delivery pump 8 rapidly, adjust control valve 7 to the bi-pass position earlier, inject liquid in the liquid delivery pump 8 simultaneously to medicine coating sacculus 1 and medicine coating sacculus 2 and make it expand with 12atm simultaneously, last 45 seconds, later use liquid delivery pump 8 to pull back the liquid in medicine coating sacculus 1 and medicine coating sacculus 2 simultaneously, the two are retracted to a deflated state at the same time, the radiography is carried out again, the right coronary artery, the posterior descending branch and the posterior collateral have no obvious residual stenosis, the blood flow is TIMI3 grade, no clear vascular dissection is seen, and the operation treatment is ended.

The whole operation process lasts for about 35 minutes, patients are followed up for 9 months after the operation without angina, and the review of coronary angiography indicates that the right coronary artery, the posterior descending branch and the posterior collateral branch have no obvious vascular diameter restenosis.

Although exemplary embodiments of the present invention have been described in detail with reference to preferred embodiments and cases, it will be understood by those skilled in the art that various changes and modifications may be made to the specific embodiments described above, and various combinations of the various features and structures proposed by the present invention may be made without departing from the spirit and scope of the present invention.

Claims (18)

1. A saccule for bifurcation lesion of a biological body pipeline comprises a first saccule (1) and a second saccule (2) which are arranged in a split mode and are sequentially sent to the bifurcation lesion; a tubular first inner cavity (3) is arranged in the first balloon (1), and a tubular second inner cavity (4) is arranged in the second balloon (2); the first guide wire (5) is used for guiding the first balloon (1), the second guide wire (6) is used for guiding the second balloon (2), the first balloon (1) and the second balloon (2) are respectively connected with a control valve (7), one end, far away from the first balloon (1) and the second balloon (2), of the control valve (7) is connected with a perfusion liquid delivery pump (8), and the control valve (7) can respectively or simultaneously control perfusion of the first balloon (1) and the second balloon (2); the control valve (7) comprises a three-position four-way reversing valve 701 which is provided with four ports, namely a first port A, a second port B, a third port P1 and a fourth port P2, wherein the valve core has three working positions, namely a first position, a second position and a third position, wherein:

when the valve core is positioned at the first position, the third port P1 is connected with the first port A, and the fourth port P2 is connected with the second port B; when the valve core is positioned at the second position, the first port A, the second port B, the third port P1 and the fourth port P2 are all in a cut-off state; when the valve core is positioned at the third position, the third port P1 is connected with the second port B, and the fourth port P2 is connected with the first port A;

the perfusion liquid delivery pump (8) comprises a first syringe D1 and a second syringe D2, the first syringe D1 is connected with a three-way valve (702), a first port V1 of the three-way valve (702) is connected with a third port P1, a first port A is connected with a first balloon port (1010), a second syringe D2 is directly connected with a fourth port P2, a second port B is connected with a second balloon port (2010), a second port V2 of the three-way valve (702) is connected with the first balloon port (1010) through a first access port (703), and a second port V2 of the three-way valve (702) is connected with the second balloon port (2010) through a second access port (704).

2. The balloon of claim 1, wherein: at least one of the first balloon (1) and the second balloon (2) is a drug-loaded balloon, the drug-loaded balloon is coated with drugs by one or more methods of a hydrophobic coating, a hydrophilic coating, a water-insoluble drug coating or a semi-hydrophobic coating, the surface of the first balloon (1) and/or the second balloon (2) is provided with a drug-loaded structure (104), and the drug-loaded structure (104) is at least one of a zigzag gully structure, a rectangular groove structure and a circular groove structure which are arranged around the surface of the first balloon (1) and/or the second balloon (2).

3. The balloon of claim 2, wherein: the control valve (7) is connected with a timer.

4. The balloon of any one of claims 2-3, wherein: the drug loaded balloon is selected from paclitaxel, rapamycin derivatives, dimethoxy-fexofenamid-6-one, docetaxel, doxorubicin, daunomycin, epirubicin, erythromycin, estramustine, etoposide, everolimus, filgrastim, fluberastine, fluvastatin, fludarabine-5' -dihydrogen phosphate, fluorouracil, myriocin, fosfestrol, gemcitabine, galaxalin, ginkgol, ginkgolic acid, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, midecamycin, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, irinotecan, topotecan, hydroxyurea, and a pharmaceutically acceptable carrier, Miltefosine, pentostatin, pemetrexed, exemestane, letrozole, formestane, mycophenolate mofetil, beta-lapachone, podophyllotoxin, peg interferon alpha-2 b, polyethylene glycol, cytokine antagonists, cytokinin inhibitors, cyclooxygenase-2 inhibitors, angiostatin, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1-hydroxy-11-methoxy-fexofam-6-one, scopoletin, nitric oxide donors, pentaerythritol tetranitrate and sydnonimine, tamoxifen, staurosporine, beta-estradiol, alpha-estradiol, estriol, estrone, ethinylestradiol, medroxyprogesterone, estradiol cypionate, estradiol benzoate, tranilast, bergamottin and other terpenoids for cancer therapy, Verapamil, tyrosine kinase inhibitors, 6-alpha-hydroxy-paclitaxel, taxotere, albumin-bound paclitaxel, mofebuzone, clonazelate, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, disodium aurothioate, oxacero, beta-sitosterol, etidocaine, polidocanol, nonivamide, levomenthol, ellipticine, colchicine, cytochalasin A-E, indomethacin, nocodazole, bacitracin, vitronectin receptor antagonists, azelastine, guanylate cyclase stimulators, tissue inhibitors of metalloproteinase-1 and metalloproteinase-2, free nucleic acids, nucleic acids incorporated into virus transmitters, deoxyribonucleic acids and ribonucleic acid fragments, plasminogen activator inhibitor-1, and the like, Plasminogen activator inhibitor-2, antisense oligonucleotides, vascular endothelial growth factor inhibitors, insulin-like growth factors, active agents from the antibiotic group, cefmenoxene, cefazolin, cefaclor, cefotaxime, tobramycin, gentamicin, penicillin, dicloxacillin, oxacillin, sulfonamide, metronidazole, enoxaparin, heparin, hirudin, D-phenylalanine-proline-arginine-methanone, protamine, prourokinase, streptokinase, warfarin, urokinase, vasodilators, dipyridamole, trapidil, nitroprusside, platelet-derived growth factor antagonists, triazolopyrimidine, tryptamine, acetylcholinesterase inhibitors, captopril, cilazapril, lisinopril, enalapril, losartan, thioprotease inhibitors, prostacyclin, prochloraz, and the like, Vapreotide, interferon alpha, interferon beta and interferon gamma, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis modulators, halofuginone, nifedipine, tocopherol, molsidomine, tea polyphenol, epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, tetracycline, triamcinolone, mutamycin, procainamide, retinoic acid, quinidine, propiram, flecainide, propafenone, sotalol, natural and synthetically derived steroids, deltoid toxin A, fuscoporial, marquioside A, galagaloside, pinine, rennin, hydrocortisone, betamethasone, dexamethasone, non-steroidal substances, fenoprofen, ibuprofen, indomethacin, naproxen, phenylbutazone, antiviral agents, acyclovir, indomethacin, pindolol, doxepinastine, and the like, Ganciclovir, zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprotozoal agent, chloroquine, mefloquine, quinine, natural terpenoids, hippocampal calpain, 14-dehydroeuphorbia toxin, euphorbia pekinensis, 17-hydroxypoitrin, ledebouriella lactone, 4, 7-oxocyclo-ledebouriella oxalic acid, chrysanthemic B1, B2, B3 and B7, tubeimoside, anticholinergicide C, brucin N and P, isodeoxyelephantopin, dilantin A and B, zingiberin A, B, C and D, ursolic acid, cetocolic acid A, iso-German iridal, maytansinol, Isomenademetin A, vanillyladecin and vanillyl B, long-tube vanillin B, citronellol, crocin, triptolide, Magadiside, protoanemonin, carpesin chloride, mogrosides A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxyprogenadiene-3, 20-dione, alantoline, caucasine-N-oxide, lasiostatin, fuscophyllotoxin, podophyllotoxin, jalapatin A and B, larcetin, malvidine, malvidin, isobutyrylmalvidin, maytansine, lecithin, maytenin, margeminin, copropodium, amacridine, liriopine, oxerucin, periplocin, nonajiegulin, ricin A, sanguinarine, mannstitude, methylmarmosin, rutaceae chromone, staphyloprene, dihydrosaratin, hydroxyabalin, mayonnine, mabusianin, marusianin A, dihydrostaphylokinin, dihydrostaphyloprine, dihydrosaxifragarine, marusianin A, One or more of isabazocine, daphnoretin, laricirol, methoxylaricirol, syringaresinol, sirolimus, biolimus A9, pimecrolimus, everolimus, oxazololimus, tacrolimus, albumin bound sirolimus, nap-sirolimus, fasudil, epothilone, somatostatin, roxithromycin, acearundomycin, simvastatin, rosuvastatin, vinblastine, vincristine, vindesine, teniposide, vinorelbine, trofosfamide, treosulfan, temozolomide, thiotepa, retinoic acid, spiramycin, umbelliferone, deacetylvisomacin A, visomacin A and B, and zeotyledin.

5. Use of a balloon according to any one of claims 2-3 for the preparation of a medical device for bifurcation lesions.

6. Use according to claim 5, wherein the medical device is for a vascular bifurcation lesion.

7. Use according to claim 6, characterized in that: the vascular bifurcation lesion is a coronary artery bifurcation lesion, an above knee artery bifurcation lesion or an below knee artery bifurcation lesion.

8. Use according to claim 7, characterized in that: the inner diameter of the coronary artery is less than 7 mm.

9. Use according to claim 7, wherein the inner diameter of the coronary artery is less than 4 mm.

10. Use according to claim 7, wherein the inner diameter of the coronary artery is less than 3 mm.

11. Use according to any one of claims 6 to 10, characterized in that: the drug-loaded balloon adopts one or more methods of a hydrophobic coating, a hydrophilic coating, a water-insoluble coating or a semi-hydrophobic coating to coat drugs.

12. Use according to claim 11, characterized in that: the drug loaded balloon is selected from paclitaxel, rapamycin derivatives, dimethoxy-fexofenamid-6-one, docetaxel, doxorubicin, daunomycin, epirubicin, erythromycin, estramustine, etoposide, everolimus, filgrastim, fluberastine, fluvastatin, fludarabine-5' -dihydrogen phosphate, fluorouracil, myriocin, fosfestrol, gemcitabine, galaxalin, ginkgol, ginkgolic acid, idarubicin, ifosfamide, josamycin, lapachol, lomustine, lovastatin, melphalan, midecamycin, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, irinotecan, topotecan, hydroxyurea, and a pharmaceutically acceptable carrier, Miltefosine, pentostatin, pemetrexed, exemestane, letrozole, formestane, mycophenolate mofetil, beta-lapachone, podophyllotoxin, peg interferon alpha-2 b, polyethylene glycol, cytokine antagonists, cytokinin inhibitors, cyclooxygenase-2 inhibitors, angiostatin, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandins, 1-hydroxy-11-methoxy-fexofam-6-one, scopoletin, nitric oxide donors, pentaerythritol tetranitrate and sydnonimine, tamoxifen, staurosporine, beta-estradiol, alpha-estradiol, estriol, estrone, ethinylestradiol, medroxyprogesterone, estradiol cypionate, estradiol benzoate, tranilast, bergamottin and other terpenoids for cancer therapy, Verapamil, tyrosine kinase inhibitors, 6-alpha-hydroxy-paclitaxel, taxotere, albumin-bound paclitaxel, mofebuzone, clonazelate, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, disodium aurothioate, oxacero, beta-sitosterol, etidocaine, polidocanol, nonivamide, levomenthol, ellipticine, colchicine, cytochalasin A-E, indomethacin, nocodazole, bacitracin, vitronectin receptor antagonists, azelastine, guanylate cyclase stimulators, tissue inhibitors of metalloproteinase-1 and metalloproteinase-2, free nucleic acids, nucleic acids incorporated into virus transmitters, deoxyribonucleic acids and ribonucleic acid fragments, plasminogen activator inhibitor-1, and the like, Plasminogen activator inhibitor-2, antisense oligonucleotides, vascular endothelial growth factor inhibitors, insulin-like growth factors, active agents from the antibiotic group, cefmenoxene, cefazolin, cefaclor, cefotaxime, tobramycin, gentamicin, penicillin, dicloxacillin, oxacillin, sulfonamide, metronidazole, enoxaparin, heparin, hirudin, D-phenylalanine-proline-arginine-methanone, protamine, prourokinase, streptokinase, warfarin, urokinase, vasodilators, dipyridamole, trapidil, nitroprusside, platelet-derived growth factor antagonists, triazolopyrimidine, tryptamine, acetylcholinesterase inhibitors, captopril, cilazapril, lisinopril, enalapril, losartan, thioprotease inhibitors, prostacyclin, prochloraz, and the like, Vapreotide, interferon alpha, interferon beta and interferon gamma, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis modulators, halofuginone, nifedipine, tocopherol, molsidomine, tea polyphenol, epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, tetracycline, triamcinolone, mutamycin, procainamide, retinoic acid, quinidine, propiram, flecainide, propafenone, sotalol, natural and synthetically derived steroids, deltoid toxin A, fuscoporial, marquioside A, galagaloside, pinine, rennin, hydrocortisone, betamethasone, dexamethasone, non-steroidal substances, fenoprofen, ibuprofen, indomethacin, naproxen, phenylbutazone, antiviral agents, acyclovir, indomethacin, pindolol, doxepinastine, and the like, Ganciclovir, zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprotozoal agent, chloroquine, mefloquine, quinine, natural terpenoids, hippocampal calpain, 14-dehydroeuphorbia toxin, euphorbia pekinensis, 17-hydroxypoitrin, ledebouriella lactone, 4, 7-oxocyclo-ledebouriella oxalic acid, chrysanthemic B1, B2, B3 and B7, tubeimoside, anticholinergicide C, brucin N and P, isodeoxyelephantopin, dilantin A and B, zingiberin A, B, C and D, ursolic acid, cetocolic acid A, iso-German iridal, maytansinol, Isomenademetin A, vanillyladecin and vanillyl B, long-tube vanillin B, citronellol, crocin, triptolide, Magadiside, protoanemonin, carpesin chloride, mogrosides A and B, dihydronitidine, nitidine chloride, 12-beta-hydroxyprogenadiene-3, 20-dione, alantoline, caucasine-N-oxide, lasiostatin, fuscophyllotoxin, podophyllotoxin, jalapatin A and B, larcetin, malvidine, malvidin, isobutyrylmalvidin, maytansine, lecithin, maytenin, margeminin, copropodium, amacridine, liriopine, oxerucin, periplocin, nonajiegulin, ricin A, sanguinarine, mannstitude, methylmarmosin, rutaceae chromone, staphyloprene, dihydrosaratin, hydroxyabalin, mayonnine, mabusianin, marusianin A, dihydrostaphylokinin, dihydrostaphyloprine, dihydrosaxifragarine, marusianin A, One or more of isabazocine, daphnoretin, laricirol, methoxylaricirol, syringaresinol, sirolimus, biolimus A9, pimecrolimus, everolimus, oxazololimus, tacrolimus, albumin bound sirolimus, nap-sirolimus, fasudil, epothilone, somatostatin, roxithromycin, acearundomycin, simvastatin, rosuvastatin, vinblastine, vincristine, vindesine, teniposide, vinorelbine, trofosfamide, treosulfan, temozolomide, thiotepa, retinoic acid, spiramycin, umbelliferone, deacetylvisomacin A, visomacin A and B, and zeotyledin.

13. Use of the balloon of claim 1 in the preparation of a medical device for bifurcation lesions.

14. The use as claimed in claim 13, wherein the medical device is for a vascular bifurcation lesion.

15. Use according to claim 14, characterized in that: the vascular bifurcation lesion is a coronary artery bifurcation lesion, an above knee artery bifurcation lesion or an below knee artery bifurcation lesion.

16. Use according to claim 15, characterized in that: the inner diameter of the coronary artery is less than 7 mm.

17. Use according to claim 15, wherein the inner diameter of the coronary artery is less than 4 mm.

18. Use according to claim 15, wherein the inner diameter of the coronary artery is less than 3 mm.

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