CN117752920A

CN117752920A - Drug-loaded shock wave balloon catheter

Info

Publication number: CN117752920A
Application number: CN202310370642.XA
Authority: CN
Inventors: 林玉艳; 刘辉; 陈杨; 李晶; 吕琦; 李孟琳; 陈玉芳
Original assignee: Kenover Medical Technology Wuhan Co ltd
Current assignee: Kenover Medical Technology Wuhan Co ltd
Priority date: 2022-09-26
Filing date: 2023-04-07
Publication date: 2024-03-26

Abstract

The invention relates to a medicine carrying vibration wave saccule catheter, which comprises a catheter, a saccule and an electrode assembly, wherein the catheter comprises an inner tube and an outer tube, the inner tube is fixedly connected with the outer tube at the far end, an annular cavity between the inner tube and the outer tube forms a liquid injection channel, and the inner cavity of the inner tube is used for conveying a guide wire; the distal end of the outer tube has an inflatable or collapsible section that forms a balloon; the outer side of the balloon wall of the balloon is provided with a medicine carrying part; the outer side of the balloon wall of the balloon is provided with a sealing part; the outer side of the balloon wall of the balloon is provided with a release element which can puncture the sealing part; the electrode assembly includes an electrode for generating a seismic wave. The medicine is embedded in the medicine carrying part and covered by the sealing part, so that the balloon does not have the loss of the medicine in the process of entering the focus through the blood vessel, and the medicine is released through the release element, thereby reducing the influence of shock waves on the medicine. And the balloon wall in the application has no micropores, but adopts a closed balloon, so that the pressure can be borne more.

Description

Drug-loaded shock wave balloon catheter

Technical Field

The invention relates to the field of medical instruments for interventional procedures, in particular to a medicine-carrying shock wave balloon catheter.

Background

Percutaneous coronary intervention (percutaneous coronary intervention, PCI) refers to a treatment that uses cardiac catheter techniques to open up stenosed and even occluded coronary lumens, thereby improving blood perfusion of the myocardium. The technical classification mainly comprises percutaneous coronary balloon angioplasty, coronary stent implantation, coronary rotational atherectomy, cutting balloon angioplasty, intra-coronary thrombus aspiration and the like.

Conventional catheter interventional techniques typically employ percutaneous balloon dilation angioplasty to open calcified lesions in the blood vessel. When the balloon is inflated to dilate calcified lesions in the vessel wall, the balloon gradually releases pressure, expanding the calcified lesion sites. This way of forcibly expanding the calcified vessel is prone to damage to the vessel wall.

Intravascular Shockwave Lithotripsy (ISL) has been used in clinic abroad as a medical technique that has evolved in recent years. When the shock wave balloon (also called a shock wave balloon) is used, the shock wave balloon is firstly delivered to a calcified lesion part of a blood vessel, then the shock wave balloon is subjected to low-pressure expansion, and finally a high-pressure pulse power supply is started to release high-pressure pulses to the shock wave balloon, so that intermittent shock waves are generated, calcified plaques on the superficial and deep layers of the blood vessel cavity are broken, the blood vessel cavity is fully expanded, and the aim of remarkably improving the compliance of the blood vessel is achieved. The shock wave saccule is used as an effective instrument for treating vascular calcification, can effectively remove calcification focus, and has the advantages of small wound, few complications and the like.

Currently, the use of shock wave balloons for treatment of intravascular calcifications, after the shock wave has destroyed the calcified lesion, the balloon is directly removed, and the trauma of the calcified vessel wall is removed without further treatment, if the treatment is to be performed, the treatment may be performed by a drug carrying balloon or other drug delivery device, which increases the operation cost and operation time. The current shock wave saccule with medicine is to inject medicine into the saccule, the saccule wall is provided with micropores, the medicine enters into blood vessels through the micropores, and the non-closed saccule is adopted, so that the saccule can bear small pressure and the medicine is easy to run off in the transportation process.

Disclosure of Invention

The invention discloses a drug-loaded shock wave balloon catheter, and aims to solve the technical problems in the prior art.

The present invention provides in one embodiment a drug-loaded shock wave balloon catheter comprising:

an axially elongated elongate member;

the electrodes are arranged outside the elongated member and connected with a power supply for generating vibration waves;

a balloon, the balloon being in close connection with the elongate member and covering the regions of the plurality of electrodes;

the balloon wall of the balloon comprises a medicine carrying part, and the medicine carrying part is used for placing medicines;

and the release element is arranged on the balloon wall and is used for releasing the medicine of the medicine carrying part.

-an elongated member;

-a balloon disposed outside the elongated member; the outer side of the balloon wall of the balloon is provided with a medicine carrying part which is used for containing medicine; the outer side of the balloon wall of the balloon is provided with a sealing part which at least covers the medicine carrying part; the release element is arranged at the outer side of the balloon wall of the balloon and at least arranged in a part of the region of the medicine carrying part and/or the sealing part, and can open the sealing part to release the medicine in the medicine carrying part;

-an electrode assembly comprising an electrode disposed within the balloon for generating a seismic wave.

As a preferable technical scheme, the slender component is a catheter, the catheter comprises an inner tube and an outer tube, the inner tube is fixedly connected with the outer tube at the distal end, an annular cavity between the inner tube and the outer tube forms a liquid injection channel, and the lumen of the inner tube is used for conveying a guide wire.

As a preferred technical scheme, the medicine carrying part comprises a plurality of grooves arranged on the balloon wall, and medicines are arranged in the grooves.

As a preferred technical scheme, each groove is provided with a release element, the release elements are arranged at the bottoms of the grooves, the release elements are in sharp structures extending outwards in the radial direction when the balloon is full, and the release elements are adhered in the grooves in a compliant mode when the balloon is collapsed.

As a preferred solution, the height of the release element is greater than the depth of the recess.

As a preferred solution, the closing part comprises a sealing membrane arranged outside the balloon wall, the sealing membrane covering at least the groove.

As the preferable technical scheme, the sealing film also comprises an auxiliary release structure, wherein the auxiliary release structure comprises an indentation line arranged on the sealing film, and the thickness of the indentation line is smaller than that of other areas of the sealing film.

As the preferable technical scheme, the sealing part comprises an outer balloon, the outer balloon covers the outer side of the balloon, the distal end of the outer balloon is fixedly connected with the distal end of the balloon, and the proximal end of the outer balloon is fixedly connected with the proximal end of the balloon.

As a preferable technical scheme, an annular closed region between the outer balloon and the balloon forms a drug carrying part, and the drug is arranged in the annular closed region.

As a preferred solution, the release elements are correspondingly arranged in the annular sealing region, the release elements are in a sharp structure extending radially outwards when the balloon is inflated, and the release elements are compliantly attached to the outer side of the balloon wall when the balloon is collapsed.

As a preferred embodiment, the height of the release element is greater than the height of the annular sealing region when the balloon is inflated.

As the preferable technical scheme, the device further comprises an auxiliary release structure, wherein the auxiliary release structure comprises an indentation line arranged on the outer balloon, and the thickness of the indentation line is smaller than that of other areas of the outer balloon.

As the preferable technical scheme, the auxiliary release structure further comprises a tearing line, the tearing line is of a linear structure, the distal end of the tearing line is connected with the indentation line, and the proximal end of the tearing line extends to the proximal end of the drug-carrying shock wave balloon catheter along the axial direction.

As the preferable technical proposal, the indentation line and the tearing line are arranged along the circumferential direction of the balloon; or, the indentation line and the tearing line are arranged along the axial direction of the balloon.

As a preferred technical scheme, the electrode assembly comprises a plurality of electrodes and leads;

the electrodes are connected in parallel, are axially arranged in the balloon and are fixed on the outer surface of the inner tube;

the guide wire is disposed within an annular lumen defined between the inner tube and the outer tube and extends axially to the proximal end of the catheter.

The technical scheme adopted by the invention can achieve the following beneficial effects:

the drug-carrying vibration wave balloon catheter provided by the embodiment of the invention comprises a catheter, a balloon and an electrode assembly, wherein the balloon covers the region where an electrode in the electrode assembly is positioned, the electrode can emit vibration waves to a focus in a blood vessel, the outer side surface of the balloon wall is provided with a drug-carrying part and a sealing part, the drug-carrying part is used for storing drugs, and the sealing part can cover the drug-carrying part to avoid unexpected loss of the drugs in the conveying process; in particular, a release element is also provided between the drug-carrying portion and the closure portion, the release element being adapted to open (puncture or tear) the closure portion and to allow release of the drug in the drug-carrying portion. Furthermore, the drug-loaded shock wave balloon catheter can be further provided with an auxiliary release structure, and the closing part is opened in an auxiliary way through the operation of the proximal end of a doctor, so that the failure of the function of the release element to cause the drug release failure is prevented.

Through above-mentioned medicine carrying vibration wave sacculus pipe, the medicine is embedded in medicine carrying portion to by the closure portion cover, the sacculus does not have the loss of medicine in the in-process that enters focus through the blood vessel like this, releases the medicine through release element, reduces the influence of vibration wave to the medicine. And the balloon wall in the application has no micropores, but adopts a closed balloon, so that the pressure can be borne more.

The above, as well as additional objectives, advantages, and features of the present application will become apparent to those skilled in the art from the following detailed description of a specific embodiment of the present application when read in conjunction with the accompanying drawings.

Drawings

In order to more clearly illustrate the technical solutions of the embodiments of the present invention, the drawings required for the description of the embodiments are briefly described below to form a part of the present invention, and the exemplary embodiments of the present invention and the description thereof illustrate the present invention and do not constitute undue limitations of the present invention. In the drawings:

FIG. 1 is a schematic illustration of a drug-loaded shock wave balloon catheter in accordance with a preferred embodiment of the present invention disclosed in example 1;

FIG. 2 is a schematic cross-sectional view of a balloon in a folded state according to a preferred embodiment of the present invention disclosed in example 1;

FIG. 3 is a schematic view of a drug-loaded shock balloon catheter according to another preferred embodiment of the present invention disclosed in example 1;

FIG. 4 is a schematic illustration of a drug-loaded shock balloon catheter in accordance with another preferred embodiment of the present invention disclosed in example 1;

FIG. 5 is a schematic illustration of a drug-loaded shock balloon catheter in accordance with another preferred embodiment of the present invention disclosed in example 1;

FIG. 6 is a schematic illustration of a drug-loaded shock balloon catheter in accordance with a preferred embodiment of the present invention disclosed in example 2;

FIG. 7 is a schematic illustration of a drug-loaded shock balloon catheter in accordance with another preferred embodiment of the present invention disclosed in example 2;

fig. 8 is a schematic structural view of a drug-loaded shock balloon catheter according to another preferred embodiment of the invention disclosed in example 2.

Reference numerals illustrate:

catheter 100, annular lumen 110, balloon 200, drug delivery portion 210, closure portion 220, release element 230, groove 240, electrode 300, outer balloon 400, score line 500, tear line 600, and tear port 610.

Detailed Description

In order to make the objects, technical solutions and advantages of the present invention more apparent, the technical solutions of the present invention will be clearly and completely described below with reference to specific embodiments of the present invention and corresponding drawings. In the description of the present invention, it should be noted that the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise.

In the description of the present invention, it should be noted that, unless explicitly specified and limited otherwise, the terms "mounted," "connected," and "connected" are to be construed broadly, and may be either fixedly connected, detachably connected, or integrally connected, for example; the magnetic connection can be mechanical connection or magnetic connection; can be directly connected or indirectly connected through an intermediate medium, and can be communication between two elements. The specific meaning of the above terms in the present invention will be understood in specific cases by those of ordinary skill in the art. In addition, in the description of the present application, the terms "first," "second," and the like are used merely to distinguish between descriptions and are not to be construed as indicating or implying relative importance.

It will be apparent that the described embodiments are only some, but not all, embodiments of the invention. All other embodiments, which can be made by those skilled in the art based on the embodiments of the invention without making any inventive effort, are intended to be within the scope of the invention.

In order to solve the problems existing in the prior art, the present application provides a drug-loaded seismic wave balloon catheter, comprising a catheter 100, a balloon 200 and an electrode assembly; the catheter 100 comprises an inner tube and an outer tube, wherein the inner tube is fixedly connected with the outer tube at the distal end, an annular cavity 110 between the inner tube and the outer tube forms a liquid injection channel, and the inner cavity of the inner tube is used for conveying a guide wire; the distal end of the outer tube has an inflatable or collapsible section that forms a balloon 200; the outside of the balloon wall of the balloon 200 is provided with a medicine carrying part 210, and the medicine carrying part 210 is used for containing medicine; the outside of the balloon wall of the balloon 200 is provided with a sealing part 220, and the sealing part 220 at least covers the medicine carrying part 210; the release element 230 is arranged outside the balloon wall of the balloon 200, the release element 230 is arranged at least in a partial area of the drug carrying part 210, and the release element 230 can pierce the sealing part 220 for releasing the drug in the drug carrying part 210; the electrode assembly includes an electrode 300, and the electrode 300 is disposed in the balloon 200 and fixed to an outer surface of the inner tube for generating a shock wave.

Example 1

Referring to fig. 1-6, in order to solve the technical problems existing in the prior art, in this embodiment, a drug-loaded seismic balloon catheter is provided, preferably, the structure of the catheter includes a catheter 100, a balloon 200 and an electrode assembly, wherein an electrode 300 in the electrode assembly is disposed in the balloon 200 for transmitting a shock wave to a lesion to disintegrate the lesion; the balloon 200 is disposed at the distal end of the catheter 100, and is capable of effectively expanding the vessel wall, thereby achieving a more efficient therapeutic effect on calcified lesions; preferably, a drug loading part 210 is arranged on the outer side of the balloon wall of the balloon 200, the drug loading part 210 is used for containing drugs, a sealing part 220 is arranged on the outer side of the balloon wall of the balloon 200, the sealing part 220 at least covers the drug loading part 210 to prevent the drugs from losing in the conveying process, a release element 230 is arranged on the outer side of the balloon wall of the balloon 200, the release element 230 is at least arranged in a partial area of the drug loading part 210, the release element 230 can radially pierce the sealing part 220 outwards when the balloon 200 is filled, and finally cut open plaque and calcified lesion sites, on one hand, the drug in the drug loading part 210 is released, on the other hand, the drug can better contact with the inside of a focus, and the therapeutic effect is enhanced.

In a preferred embodiment, as shown in FIG. 1, catheter 100 comprises an inner tube and an outer tube fixedly attached at a distal end; the distal end of the outer tube has a section that can be inflated or deflated, which forms a balloon 200, the proximal end of the outer tube is connected to a catheter hub for injecting contrast medium, and the annular cavity 110 between the outer tube and the inner tube forms an infusion channel of the balloon 200; the inner tube of catheter 100 is used to deliver a guidewire to guide the delivery of balloon 200 in the blood vessel and ultimately to the location of the lesion.

Preferably, the distal end of the balloon 200 is also provided with a tip for threading a guidewire into the inner tube and facilitating improved passage of the balloon 200 in the vessel; specifically, the tip is molded by a tip molding machine and is connected to the balloon 200 by welding, crimping, or bonding using a heat shrinkage process molding process.

Preferably, a guide wire outlet is further formed in the side wall of the outer tube, and the guide wire outlet is formed by the inner tube and the outer tube and is used for guiding the guide wire to penetrate from the tip end and finally penetrate out of the tip end, so that the conveying operation of the drug-carrying shock wave balloon catheter is facilitated.

In a preferred embodiment, catheter 100 is 1300mm-1500mm in length, balloon 200 is 5-50mm in length, and 1-5mm in diameter. However, since the patient has different ages, sexes, heights, weights, lesion locations, lesion conditions, etc., in order to ensure that the balloon 200 can be well attached to the blood vessel at the lesion site to perform the function, the sizes of the catheter 100 and the balloon 200 can be adaptively adjusted or selected according to the actual situation, and will not be described herein.

In a preferred embodiment, the structural strength of the inner tube is greater than that of the outer tube, so as to ensure that the inner tube is not easily worn by the guide wire and ensure smooth delivery of the whole drug-loaded shock wave balloon catheter; alternatively, the inner tube is a multi-layer tube structure, for example, made of HDPE, LDPE and nylon, respectively, from inside to outside; alternatively, the material of the outer tube may be nylon or polyether block amide PEBAX material; alternatively, balloon 200 may be fabricated using nylon or polyether block amide PEBAX materials. It will be appreciated by those skilled in the art that although balloon 200 may be fabricated from the same material as the outer tube, in order to ensure that balloon 200 fills successfully after injection of contrast agent, the thickness of the material at balloon 200 should be less than the thickness of the outer tube.

Preferably, developing rings are further provided at the proximal and distal ends of the balloon 200 to facilitate the doctor in determining the actual position of the balloon 200 in the medical imaging system; specifically, the developing rings are made of an X-opaque material and press-held on the inner tube, and preferably two developing rings are provided separately at both ends of the balloon 200.

Preferably, the electrode assembly includes a plurality of electrodes 300, one or more, preferably a plurality of, electrodes 300 disposed on an inner tube within balloon 200 for generating the shock wave, and a wire electrically connected to the plurality of electrodes 300, respectively, and extending along catheter 100 to a proximal end and connected to a power host, which is capable of powering electrodes 300 to generate the high voltage pulse.

Preferably, the electrode 300 has a ring-shaped structure, and the electrode 300 comprises a ring-shaped insulating layer sleeved on the outer surface of the inner tube and a conductive layer arranged on the outer surface of the insulating layer; preferably, the insulating layer is disposed inside the conductive layer for fixing and protecting the conductive layer.

In some alternative embodiments, a hypotube is further sleeved outside the electrode 300, the hypotube is arranged between the outer tube and the inner tube in a penetrating way, and the guide wire is arranged in the hypotube in an axial way and extends to the proximal end of the catheter 100; specifically, the hypotube may be made of a metallic material such as stainless steel, aluminum alloy, or the like.

Preferably, a partial region of the balloon wall is recessed radially inward to form a plurality of grooves 240, the plurality of grooves 240 constituting the drug-carrying portion 210, the drug-carrying portion 210 being for containing a drug.

In a preferred embodiment, the grooves 240 may be disposed in a matrix-like manner on the balloon wall; in a preferred embodiment, grooves 240 may be axially disposed in rows on the balloon wall; in another preferred embodiment, the grooves 240 may be staggered in a lattice pattern on the balloon wall; in some possible embodiments, the location and shape of the lesion may be observed in the imaging system prior to performing the interventional procedure, and then the grooves 240 in the balloon wall may be configured to follow the actual shape and location of the lesion.

Preferably, when grooves 240 are disposed in axial rows, grooves 240 are preferably conformably disposed at folds of balloon 200, as in fig. 2, so that grooves 240 are disposed in three rows when balloon 200 is tri-folded and grooves 240 are disposed in six rows when balloon 200 is hexafolded.

Alternatively, the grooves 240 may be distributed over the entire balloon wall of the balloon 200, may be disposed in a concentrated manner in a certain section of the balloon wall, may be disposed in a dispersed manner in a plurality of sections of the balloon wall, or may be disposed in a dispersed manner in each groove 240, which is not shown here.

Preferably, since the specific size of the balloon 200 can be adjusted according to the actual physiological or pathological state of the patient, the specific size of the groove 240 can be freely adjusted according to the size of the balloon 200 or the lesion, which is not limited herein.

In a preferred embodiment, the drug contained within the recess 240 may be pasty or water-soluble and may be aspirin and clopidogrel (or ticagrelor), paclitaxel and iopromide, copolymers of paclitaxel and polylactic acid-glycolic acid, paclitaxel derivatives, rapamycin.

Alternatively, the process may be carried out in a single-stage, the drug disposed in groove 240 may be paclitaxel, rapamycin derivatives, dimethoxy feverdin-6-one, docetaxel, doxorubicin, daunorubicin, epirubicin, erythromycin, estramustine, etoposide, everolimus, febuxostat, fluburastine, fluvastatin, fludarabine-5' -dihydrogen phosphate, fluorouracil, multi-leaf mold, fosfestrol, gemcitabine, garagazin, ginkgol, ginkgolic acid, idarubicin, ifosfamide, cisamycin, lapachone, lomustine, lovastatin, melphalan, midecamycin, mitoxantrone, nimustine, pitavastatin, pravastatin, procarbazine, mitomycin, methotrexate, mercaptopurine, thioguanine, oxaliplatin, irinotecan topotecan, hydroxyurea, miltefosine, pennistin, exemestane, lei Qu, formestane, mycophenolate mofetil, beta-lapachone, podophyllotoxin, polyethylene glycol interferon alpha-2 b, polyethylene glycol, cytokine antagonists, cytokinin inhibitors, cyclooxygenase-2 inhibitors, angiostatin, monoclonal antibodies that inhibit muscle cell proliferation, bFGF antagonists, probucol, prostaglandin, 1-hydroxy-11-methoxyiron-6-one, scopolamine, nitric oxide donors, pentaerythritol tetranitrate and sildenone imine, tamoxifen, staurosporine, beta-estradiol, alpha-estradiol, estriol, estrone, ethinyl estradiol, medroxyprogesterone, cyclopentanol, estradiol benzoate, tranilast, coriander-tea-propylene and other terpenoids for cancer therapy, verapamil, tyrosine kinase inhibitor, 6-alpha-hydroxy-taxol, taxotere, albumin-bound taxol, mo Feibu zon, clofenazate, lidocaine, ketoprofen, mefenamic acid, piroxicam, meloxicam, penicillamine, hydroxychloroquine, disodium gold thiobutyrate, oxasal, beta-sitosterol, miltecaine, polidocanol, nopelamine, levomenthol, ellipticine, colchicine, cytochalasin A-E, yin Dannuo oct, nocodazole, bacitracin, vitronectin receptor antagonist, azelastine, guanylate cyclase stimulator, tissue inhibitors of metalloprotease-1 and metalloprotease-2, free nucleic acids, nucleic acids incorporated into viral 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, agents from the antibiotic group, cefadroxil, cefazolin, cefaclor, cefotaxime, tobramycin, gentamicin, penicillin, dicloxacillin, oxacillin, sulfanilamide, metronidazole, enoxaparin, heparin, hirudin, D-phenylalanine-proline-arginine-chloromethyl ketone, protamine, urokinase, streptokinase, warfarin, urokinase, vasodilators, dipyridamole, trapidil, nitroprusside, platelet-derived growth factor antagonists, triazolopyrimidine, verapamil, acetylcholinesterase inhibitors, captopril, cilazapril, lisinopril, enalapril, losartan, thiolase inhibitors, protamine, urokinase, streptokinase, dipyridamole, trapezil, nitroprusside, thrombospondin, cilexetil, cilexenatide, cilexetil, prostacyclin, vapreprost, interferon alpha, interferon beta and interferon gamma, histamine antagonists, serotonin blockers, apoptosis inhibitors, apoptosis modulators, halofuginone, nifedipine, tocopherol, tranilast, molsidomine, tea polyphenols, epicatechin gallate, epigallocatechin gallate, leflunomide, etanercept, sulfasalazine, tetracyclines, triamcinolone, mutamycin, procainamide, retinoic acid, quinidine, propidium, fluanide, propafenone, sotalol, natural and synthetically derived steroids, floor rooting toxin A, inofurioside, ma Kuisang glycoside A, garagazin, mansonin, pie renin, hydrocortisone, betamethasone, dexamethasone, non-steroidal substances, fenoprofen, ibuprofen, indomethacin, naproxen, phenylbutazone, antiviral agents, acyclovir, ganciclovir, zidovudine, clotrimazole, flucytosine, griseofulvin, ketoconazole, miconazole, nystatin, terbinafine, antiprotozoal, chloroquine, mefloquine, quinine, natural terpenoids, hippocampus calpain, 14-dehydroeupatoxin, euphorbia toxin, 17-hydroxy eupatoxin Ledebouriella lactone, 4, 7-oxo-cycloledebouriella oxalic acid, alcohol-like elements B1, B2, B3 and B7, tubeimoside, anti-diarrhea brucea javanica glycoside C, brucea javanica glycoside N and P, isodeoxyelephantoin, elephantoin A and B, alcohol-like elements B1, B2, B3 and B7, alcohol-like elements B, alcohol-like elements, alcohol gingerol A, B, C and D, ursolic acid, cilostatic acid A, iso-German tectorial aldehyde, variable-leaf maytansinol, isodesmetin A, isodesmetin and isodesmetin B, long-tube isodesmetin B, isodesmetin C, isodesmin C, and isodesmin, card Mi Baosu, rayleigh Ji Luoer, triptolide, cannabinoid, protoanemonin, colestipol chloride, flemin A and B, dihydronitidine, chloridized nitidine, 12-beta-hydroxy pregnen-3, 20-dione, inuline, sarcandin-N-oxide, maojiao mustard, inonotol, podophyllotoxin, jatrophin A and B, largonine, mallow alkaloid, mallow chromanol, isobutyryl mallow chromanol, maytansine, lycra euphorine, maytansine, podophylline, liriodendrine, oxidized Huang Xinshu, periplanin A, deoxypraline, kappaphorin, ricin A, sanguinarine, manchurian wildginger, methylpearl Mei Gan, rue chromone, stoneley Zuo Pulin, dihydro Wu Saba Ren Xin, hydroxywusanba, malaline base pentaamine, malaline base prin, wusanba Ren Xin, liriodendrine, mevalicariin one or more of sirolimus, lariciresinol, methoxyl-larcenyl alcohol, coumarone, sirolimus, biolimus A9, pimecrolimus, everolimus, zotarolimus, tacrolimus, albumin-bound sirolimus, nap-sirolimus, fasudil, epothilone, somatostatin, roxithromycin, acetotazidimycin, simvastatin, rosuvastatin, vinblastine, vincristine, vindesine, teniposide, vinorelbine, asperosamine, trosoxalan, temozolomide, thiotepa, retinoic acid, spiramycin, umbelliferone, desacetyl vismiiton a, vismiiton a and B, wortmannin.

Preferably, the top of each groove 240 is provided with a sealing part 220, and the sealing parts 220 can be configured as a sealing film; preferably, a release element 230 is disposed in each recess 240, and the release element 230 is disposed at the bottom of each recess 240; preferably, release element 230 is capable of conforming to and adhering to groove 240 as balloon 200 collapses, and release element 230 is capable of protruding radially outward in a sharp configuration as balloon 200 fills.

Optionally, each groove 240 may correspond to one sealing portion 220, for example, a sealing film is attached to each groove 240; alternatively, a sealing film is covered outside the whole drug carrying part 210, that is, a complete and larger sealing film is attached outside the grooves 240.

In a preferred embodiment, the closure 220 is made of a degradable material, such as one or more of chitosan, polypropylene glycol glutarate, diisocyanate, polycarbonate fiber, modified polylactic acid, starch, and the like.

In a preferred embodiment, the release element 230 is a plurality of spikes, which act as the release element 230, capable of puncturing the closure 220 when the balloon 200 is inflated, so that the drug in the recess 240 can be released. Specifically, when balloon 200 is in the folded state, the spikes can be conformably disposed at the folds of balloon 200, similar to the spikes of a hedgehog in a calm state; when the balloon 200 is in the inflated state, the spikes stand radially outward, similar to the spikes of a hedgehog in the stimulated state, at which time the spikes can pierce the closure 220, exposing the drug, rotating the balloon 200, allowing the drug to uniformly spread on the inner wall of a calcified inner tube, and through rotating the balloon 200, the spikes can also cut plaque and calcified lesions, thereby effectively expanding the vessel wall. Meanwhile, the electrode 300 emits shock waves to crush calcified lesions, and the inner wall of the blood vessel can accelerate the absorption of the medicine under the action of the shock waves, so that the medicine utilization rate is improved.

In a preferred embodiment, the grooves 240 are arranged in a row along the axial direction, and the grooves 240 are arranged at folds after the balloon 200 is folded, at this time, the spikes are also arranged at the folds to reduce the diameter of the balloon 200 when folded, increase the trafficability of the balloon 200, and in this way, the damage to the balloon wall caused by the spikes when the balloon 200 is folded can be avoided, when the balloon 200 is inflated and expanded, the spikes rise along with them to pierce the sealing portion 220, and the drug contained in the grooves 240 is released.

Alternatively, the spikes are made of nylon, PE, pebax, PVC, PTFE, FEP or PET material and secured to the bottom of the recess 240 by an adhesive.

Preferably, the bottom area of the spike is smaller than the bottom area of the groove 240 to ensure that there is sufficient space in the groove 240 to hold the drug; preferably, in the inflated condition of balloon 200, the height of the spike is greater than the depth of groove 240 to ensure that the spike is able to puncture closure 220 to release the drug.

Preferably, the drug-loaded shock balloon catheter is further provided with an auxiliary release structure to prevent the release element 230 from being unable to puncture the closure 220 when the balloon 200 is inflated, resulting in the inability of the drug to be released.

In a preferred embodiment, as shown in fig. 3, the auxiliary release structure comprises a score line 500 provided on the sealing film, the score line 500 having a thickness that is smaller than the thickness of other areas of the sealing film.

In a preferred embodiment, when the sealing film covers the entire drug-carrying portion 210, an annular indentation line 500 is provided on the sealing film, the indentation line 500 may be formed by pressing with an indentation machine, so that the sealing film has a series of dotted indentations at positions corresponding to the grooves 240, the indentation line 500 is formed, the structural strength of the indentation line 500 is weak, and when the balloon 200 enters the focus and fills, the sealing film may be ruptured due to the inflation of the balloon 200 due to the small structural strength of the indentation line 500, so as to release the drug in the drug-carrying portion 210.

As shown in fig. 4, preferably, when the sealing film covers the entire drug-carrying portion 210, the auxiliary release structure includes not only the indentation line 500 provided on the sealing film, but also the tear line 600, the tear line 600 is a linear structure, the distal end of the tear line 600 is connected to the indentation line 500, and the proximal end of the tear line 600 extends to the proximal end of the catheter 100 in the axial direction.

In a preferred embodiment, when a plurality of score lines 500 are provided, each score line 500 is provided with a tear line 600, as shown in fig. 5.

In a preferred embodiment, the score lines 500 are disposed circumferentially of the drug delivery part 210, at which point the score lines 500 can open with radial expansion of the balloon 200 to release the drug in the drug delivery part 210, as the balloon 200 can expand radially.

In another preferred embodiment, the indentation line 500 is disposed along the axial direction of the drug-carrying portion 210, at this time, one end of the indentation line 500 is further provided with a tear line 600, so that the sealing portion 220 can be opened at any time without having to wait for the balloon 200 to expand, and when in operation, the drug in the drug-carrying portion 210 can be released only by retracting the tear line 600 proximally, and meanwhile, due to the presence of the tear line 600, the situation that the opening is difficult due to the excessive structural strength of the indentation line 500 can be effectively avoided.

In general, in the drug balloon provided with the electrode, the release of the drug is required to be performed after the calcified lesion is treated, and by the above-mentioned release element 230, the sealing part 220 can be opened after the shock wave is released to the calcified lesion according to the situation, so that the drug reaches the lesion, and the full effect of the drug is ensured.

Preferably, the proximal end of the drug-loaded shock wave balloon catheter in this embodiment is further provided with an operation handle, the operation handle is provided with a catheter seat for injecting contrast agent, and an interface connected with a power host is further provided to ensure that the electrode assembly can work normally; preferably, the tear line 600 extends to the proximal operating handle, allowing the sealing membrane to be more easily torn by withdrawing the tear line 600 and forming a tear port 610, the score line 500 being more easily ruptured by inflation of the balloon 200 to facilitate drug release.

Preferably, the drug-loaded shock wave balloon catheter according to this embodiment may further be provided with an outer sheath, which can circumferentially limit the balloon 200 when it is delivered distally, preventing the balloon 200 from being accidentally deployed, and improving the trafficability of the entire drug-loaded shock wave balloon catheter in the blood vessel.

Example 2

The present embodiment provides a preferred construction of a drug-loaded shock balloon catheter. In this embodiment, the drug-loading seismic wave balloon catheter includes a catheter 100, a balloon 200 and an electrode assembly, and the balloon 200 is provided with a drug-loading portion 210, a sealing portion 220 and a releasing element 230, which are different from the structure disclosed in embodiment 1, in this embodiment, the structures of the drug-loading portion 210, the sealing portion 220 and the releasing element 230 are changed, and other features already described in the above embodiment 1 are naturally inherited in this embodiment and are not described herein.

Referring to fig. 6-8, in a preferred embodiment, an outer balloon 400 is further provided on the outer side of the balloon 200, the outer balloon 400 covers the outer side of the balloon 200 and forms the sealing part 220, and the space between the outer balloon 400 and the balloon 200 forms the drug loading part 210, in this example, the drug loading part 210 can accommodate more drugs than the groove 240 in the above-described example 1.

Preferably, in this embodiment, the medicine contained in the medicine carrying portion 210 may be pasty or water-soluble, and the detailed description thereof will be omitted herein with reference to embodiment 1.

Specifically, the medicine may be distributed over the entire outside of the balloon 200, or may be provided in a dot, ring, or stripe form, or may be provided in one region, or may be provided in another region.

Preferably, the outer balloon 400 has a volume when collapsed that is greater than the volume of the balloon 200, and the outer balloon 400 is capable of expanding with inflation of the balloon 200 to ensure that an annular enclosed area is formed therebetween for containing a sufficient amount of therapeutic agent. Preferably, the distal end of outer balloon 400 is secured with the distal end of balloon 200, and the proximal end of outer balloon 400 is secured with the proximal end of balloon 200. Alternatively, the two ends of the outer balloon 400 may be fixedly connected to the two ends of the balloon 200 by welding, bonding, crimping, or the like.

Preferably, a release element 230 is disposed between the inner balloon 200 and the outer balloon 400, the release element 230 being capable of extending radially outwardly when the balloon 200 is inflated and having a sharp configuration for puncturing the outer balloon 400 to release the drug, the release element 230 being capable of conforming to the outside of the balloon wall when the balloon 200 is collapsed.

In a preferred embodiment, the release element 230 is configured as the same spikes as described above in example 1, more preferably, the spikes are arranged in rows along the folds of the balloon 200 for reducing the diameter of the balloon 200 when folded to increase the passability of the balloon 200; by such folding, the damage of the spikes to the outer balloon 400 wall when the balloon 200 is folded can also be avoided, and when the balloon 200 is inflated and expanded, the spikes rise radially outward at any time to puncture the outer balloon 400, and the drug between the balloon 200 and the outer balloon 400 can be released.

Because the balloon 200 is inflated to dilate the blood vessel at the lesion and simultaneously make the spike cut the plaque and calcified lesion, and the outer balloon 400 is only used for temporarily sealing the drug, avoiding the drug from being released and consumed in advance in the process of delivering the balloon 200, so that the spike can smoothly puncture the outer balloon 400, preferably, the volume of the outer balloon 400 after filling is smaller than the volume of the balloon 200; preferably, the structural strength of outer balloon 400 is less than the structural strength of balloon 200; more preferably, the height of the spikes is greater than the distance between balloon 200 and outer balloon 400 when balloon 200 is inflated.

In a preferred embodiment, outer balloon 400 is made of a material having a lower structural strength than balloon 200; in another preferred embodiment, outer balloon 400 may be made of the same material as balloon 200, but the thickness of outer balloon 400 should be less than the thickness of balloon 200 to ensure that the spikes can puncture outer balloon 400; in another preferred embodiment, the outer balloon 400 is less elastic than the balloon 200, making the outer balloon 400 more prone to being ruptured when the balloon 200 is fully inflated.

Preferably, an auxiliary release structure is further provided on the outer balloon 400 to prevent the spikes from failing to puncture the outer balloon 400 when the balloon 200 is inflated, resulting in a failed drug release.

In a preferred embodiment, as shown in fig. 6, the auxiliary release structure includes an indentation line 500 provided on the outer balloon 400, the thickness at the indentation line 500 being smaller than the thickness at other locations of the outer balloon 400. Specifically, the indentation line 500 may be formed by an indentation machine, and by pressing, the outer balloon 400 has a series of dotted lines of indentations at positions corresponding to the spikes, so as to form the indentation line 500, the structural strength of the indentation line 500 is weaker, and when the balloon 200 enters the focus and fills, the outer balloon 400 may be ruptured due to the inflation of the balloon 200 due to the small structural strength of the indentation line 500, so as to release the drug in the drug-loading portion 210.

In a preferred embodiment, the indentation lines 500 may be disposed circumferentially of the outer balloon 400 in a closed or non-closed ring shape; in another preferred embodiment, the embossing lines 500 may be provided in a strip shape along the axial direction of the outer balloon 400.

As shown in fig. 7, the auxiliary release structure preferably further comprises a tearing wire 600, wherein the tearing wire 600 is in a linear structure, and a distal end of the tearing wire 600 is connected with the indentation wire 500, and a proximal end of the tearing wire 600 extends to a proximal end of the catheter 100 along an axial direction. More preferably, a tear opening is also provided at the junction of tear line 600 and score line 500, the tear opening being configured to be a split provided somewhere in score line 500, such that outer balloon 400 is easily ruptured along score line 500 when tear line 600 is being torn.

Preferably, a plurality of embossing lines 500 may be provided on the outer balloon 400, in which case a tear line 600 is connected to at least one embossing line 500, and more preferably, a tear line 600 is connected to each embossing line 500, as shown in fig. 8.

In a preferred embodiment, the score lines 500 are disposed along the circumference of the outer balloon 400, at which time the score lines 500 can be opened along with the radial expansion of the outer balloon 400 to release the drug in the drug-carrying portion 210, since the outer balloon 400 can follow the radial expansion of the balloon 200.

In another preferred embodiment, the indentation line 500 is disposed along the axial direction of the outer balloon 400, at this time, one end of the indentation line 500 is further provided with a tear line 600, so that the sealing portion 220 can be opened at any time, without having to wait for the outer balloon 400 to expand, and when in operation, the drug in the drug-carrying portion 210 can be released only by retracting the tear line 600 proximally, and meanwhile, due to the presence of the tear line 600, the situation that the opening is difficult due to the excessive structural strength of the indentation line 500 can be effectively avoided.

Preferably, the proximal end of the drug-loaded shock wave balloon catheter according to this embodiment is further provided with an operation handle, the operation handle is provided with a catheter seat for injecting contrast agent, and an interface connected with a power host is further provided to ensure that the electrode assembly can work normally; preferably, the tear line 600 extends to a proximal operating handle, which allows the outer balloon 400 to be more easily torn by withdrawing the tear line 600 to facilitate drug release. It will be appreciated by those skilled in the art that when a plurality of tear lines 600 are provided, the proximal end of each tear line 600 is disposed on the operating handle.

Preferably, the drug-loaded shock wave balloon catheter according to the present embodiment may further be provided with an outer sheath, which can circumferentially limit the balloon 200 when it is delivered distally, so as to prevent the balloon 200 and/or the outer balloon 400 from being accidentally deployed, and improve the trafficability of the entire drug-loaded shock wave balloon catheter in the blood vessel.

The embodiments of the present invention have been described above with reference to the accompanying drawings, but the present invention is not limited to the above-described embodiments, which are merely illustrative and not restrictive, and many forms may be made by those having ordinary skill in the art without departing from the spirit of the present invention and the scope of the claims, which are to be protected by the present invention.

Claims

1. A shock wave drug balloon catheter, comprising:

an axially elongated elongate member;

a plurality of electrodes disposed outside the elongated member and connected to a power source for generating a shock wave;

a balloon sealingly connected to the elongate member and covering a region of the plurality of electrodes;

2. A drug-loaded shock wave balloon catheter, comprising:

-an elongated member;

-a balloon disposed outside the elongated member; the outer side of the balloon wall of the balloon is provided with a medicine carrying part, and the medicine carrying part is used for containing medicines; a sealing part is arranged on the outer side of the balloon wall of the balloon, and the sealing part at least covers the medicine carrying part; a release element is arranged on the outer side of the balloon wall of the balloon and at least arranged in a partial area of the drug carrying part and/or the sealing part, and the release element can open the sealing part to release the drug in the drug carrying part;

3. The drug-loaded shock wave balloon catheter of claim 2, wherein the elongate member is a catheter comprising an inner tube and an outer tube, the inner tube being fixedly connected to the outer tube at a distal end, an annular lumen therebetween forming a fluid injection channel, the lumen of the inner tube being for delivering a guidewire.

4. The drug-loaded shock wave balloon catheter of claim 2, wherein the drug-loaded portion comprises a plurality of grooves disposed on the balloon wall, the drug disposed in the grooves.

5. The drug-loaded seismic balloon catheter of claim 4, wherein the release elements are disposed in each groove, the release elements being disposed at the bottom of the grooves, the release elements being in a radially outwardly extending sharpened configuration when the balloon is inflated, the release elements being conformed to adhere to the grooves when the balloon is collapsed.

6. The drug-loaded seismic balloon catheter of claim 5, wherein a height of the release element is greater than a depth of the groove.

7. The drug-loaded shock wave balloon catheter of claim 4, wherein the closure comprises a sealing membrane disposed outside the balloon wall, the sealing membrane covering at least the groove.

8. The drug-loaded shock wave balloon catheter of claim 7, further comprising an auxiliary release structure comprising an indentation line disposed on the sealing membrane, the thickness at the indentation line being less than the thickness of other areas of the sealing membrane.

9. The drug-loaded seismic balloon catheter of claim 2, wherein the closure comprises an outer balloon, the outer balloon covering the balloon outer side, the distal end of the outer balloon being fixedly connected to the distal end of the balloon, the proximal end of the outer balloon being fixedly connected to the proximal end of the balloon.

10. The drug-loaded seismic balloon catheter of claim 9, wherein an annular enclosed region between the outer balloon and the balloon forms the drug-loaded portion, the drug disposed in the annular enclosed region; the release elements are correspondingly disposed in the annular sealing region, the release elements are in a sharp structure extending radially outwards when the balloon is inflated, and the release elements are compliantly attached to the outer side of the balloon wall when the balloon is collapsed.

11. The drug-loaded seismic balloon catheter of claim 10, wherein a height of the release element is greater than a height of the annular enclosed region when the balloon is inflated.

12. The drug-loaded seismic balloon catheter of claim 9, further comprising an auxiliary release structure comprising an indentation line disposed on the outer balloon, the thickness at the indentation line being less than the thickness of other regions of the outer balloon.

13. The drug-loaded shock wave balloon catheter of claim 12, wherein the auxiliary release structure further comprises a tear line, the tear line being a linear structure, a distal end of the tear line being connected to the indentation line, a proximal end of the tear line extending axially to a proximal end of the drug-loaded shock wave balloon assembly.

14. The drug-loaded seismic balloon catheter of claim 13, wherein the indentation lines and the tear lines are disposed along a circumferential direction of the balloon;

or, the indentation line and the tearing line are arranged along the axial direction of the balloon.