CN116020042A - Medicine carrying saccule with mark - Google Patents

Abstract

The invention discloses a medicine carrying balloon with a mark, which comprises a multi-pass tailstock, a stress diffusion tube, a multi-cavity catheter, a radio-opaque mark, a medicine carrying balloon and an inner tube, wherein the multi-cavity catheter is arranged in the multi-pass tailstock and is connected with the inner tube; a guide wire cavity and a balloon filling cavity are arranged in the multi-cavity catheter; a medicine carrying saccule is arranged between the multi-cavity catheter and the inner tube, and the medicine carrying saccule is respectively connected with the multi-cavity catheter and the inner tube; the multi-cavity catheter is provided with a mark; the medicine carrying balloon comprises a balloon first component and a balloon second component, and a plurality of concave parts are arranged on the balloon second component; the concave part and the medicine carrying saccule are integrally formed. The concave part can realize a certain sealing effect on the medicine in the groove; the marker on the balloon catheter can easily judge whether the catheter reaches the expected narrow lesion, so that multiple angiography of the catheter in the conveying process is avoided, and the damage and side effects of the contrast agent on the body of a patient are reduced.

Description

Medicine carrying saccule with mark

Technical Field

The invention relates to a medicine carrying balloon, in particular to a medicine carrying balloon with marks.

Background

Since the last 70 s, percutaneous transluminal balloon angioplasty has begun to be used in treating a patient's vascular narrowing due to atherosclerosis. In the early stages of percutaneous balloon dilation catheter angioplasty, there are often immediate therapeutic effects, but because of the high incidence of postoperative complications, especially restenosis, long-term therapeutic effects are unsatisfactory. The subsequent intravascular stent forming operation is to implant a metal bare stent or a drug-loaded stent while the balloon expands at the narrow part of the blood vessel, so that the problem of restenosis caused by elastic retraction of the blood vessel can be effectively prevented, but the implantation of the stent also causes a plurality of new problems, such as endothelialization disorder, poor late iron wall of the stent, thrombus formation in the stent and the like, and in addition, if the intravascular stent is subjected to restenosis after being formed, the treatment difficulty is greatly improved.

The medicine saccule is one kind of treating mode in recent years, and has the medicine coating adhered to the saccule outer surface to contact with pathological change while expanding narrow blood vessel to inhibit the proliferation of inner film, so as to avoid re-narrowing and avoid the problems of endothelialization obstacle, thrombus, etc.

In recent years, the medicine saccule has good application in diseases such as arteriovenous fistula, coronary artery constriction, peripheral blood vessel constriction under knee, and the like. Clinical data indicate that the time required for re-intervention after dilating an arteriovenous fistula using a drug balloon is much higher than using Percutaneous Transluminal Angioplasty (PTA). In addition, the medicine saccule has good application in the fields of treating coronary artery, peripheral artery, below knee artery and the like. However, how to ensure that the loss of the drug is reduced as much as possible before the drug reaches the lesion site, the combination of the drug and the balloon is improved, and the content of the drug is enough and effective when the balloon reaches the lesion site. Meanwhile, when the saccule reaches the lesion position, the medicine has the effect of quick release. This is the key point in current drug balloon research.

The existing medicine saccule and the preparation technology mainly comprise the following steps:

patent US8439868 to braun, german company b; US8257305B2 relates to a pharmaceutical coating of a company pharmaceutical balloon product sequence plus, which adopts paclitaxel as a therapeutic drug for inhibiting intimal hyperplasia, and iopromide as a pharmaceutical carrier of the paclitaxel. Iopromide is a drug-carrying matrix with good water solubility, and can help paclitaxel to achieve the effect of rapid release. As a typical representative of the first generation of drug balloons, there is a small ratio in the market, but in the use process, it is found that the drug coating of such balloons has poor bonding property with the balloon, a large amount of drug is easily lost before reaching the lesion site due to the steps of balloon folding, vascular pushing, balloon expanding, etc., and the amount of drug actually reaching the lesion site has a small therapeutic effect.

Related patents US8425459B2, US8414526B2 and US8241249B2 to Bard corporation, the balloon products of the aforementioned patents and their chinese patent applications, are primarily concerned with improvements in the selection and formulation of coatings, additives and therapeutic agents that promote drug absorption or tissue absorption of the drug, but still present a risk of drug loss during delivery.

Patent CN209108383U of Beijing first Ruida medical science and technology Co-Ltd discloses a novel drug coating balloon, wherein the thickness of the drug coating can be controlled by arranging a coating control device on the outer surface of the balloon, but the thickness of the drug coating is adjustable and the problem that the drug coating is easy to fall off cannot be solved; patent CN209108382U filed by beijing first rayleigh medical science and technology limited discloses a drug balloon dilation catheter which can completely withdraw contrast medium in a balloon and enable blood to flow smoothly, but the problem that multiple radiography is required is still not solved.

Patent CN104353132B applied by zhejiang gui medical instruments limited relates to a coating process of a drug coating on an implanted or interventional medical instrument. The coating process is to form a layer of drug coating on the surface of the saccule by a method of reducing the drug solubility and spraying fine drug crystal particles in a supersound mode. The surface energy of the drug coating can be increased due to smaller drug particles. However, there is no special bonding mode between the balloon and the drug coating, and the drug particles are easily detached from the surface of the balloon.

Patent WO2013152713A1 filed by Shanghai minimally invasive medical instruments limited relates to a drug balloon based on hydrogen bonding and a coating method thereof. The coating method is to modify the surfaces of the drug coating and the balloon so that the drug coating and the balloon are combined in a hydrogen bond mode, and the bonding force between the balloon and the drug coating is enhanced. But the combination of the medicine and the saccule is too firm.

Patent CN104056341B applied by Shenzhen Jin Kairui biological technology Co-efficient relates to a preparation method of a medicine balloon. The preparation method comprises the steps of etching the balloon by plasma sputtering, forming a nanoscale micropore structure on the surface of the balloon, so that the balloon has larger specific surface area, the drug loading capacity on the surface of the balloon is improved, the binding force between the surface of the balloon and a drug coating layer is improved, and the drug loss in the balloon conveying process is reduced. However, the surface of the formed balloon is damaged by the post etching treatment, so that the physical properties of the balloon are greatly influenced, the requirement of high burst pressure cannot be met, and even the balloon is broken.

In addition, the traditional medicine carrying saccule has no obvious prompting device, and a doctor cannot accurately judge the position of the catheter during operation, so that multiple angiography is required, and the damage and side effects of the contrast agent on the body of a patient are increased.

Disclosure of Invention

The invention aims to overcome the defects of the prior art and provide a medicine carrying balloon with a mark.

In order to solve the technical problems, the invention provides the following technical scheme:

the invention relates to a medicine carrying saccule with a mark, which comprises a multi-way tailstock, a stress diffusion tube, a multi-cavity catheter, a radio-opaque mark, a medicine carrying saccule and an inner tube, wherein,

a multi-cavity catheter is arranged in the multi-way tailstock, wherein,

the multi-cavity catheter is connected with the inner tube;

a guide wire cavity and a balloon filling cavity are arranged in the multi-cavity catheter;

a medicine carrying saccule is arranged between the multi-cavity catheter and the inner tube, wherein,

the medicine carrying saccule is respectively connected with the multi-cavity catheter and the inner tube;

the multi-lumen catheter is provided with a marker thereon, wherein,

the marks include a first mark and a second mark;

the medicine carrying balloon comprises a balloon first component and a balloon second component, wherein,

a plurality of concave parts are arranged on the second component part of the saccule;

the concave part and the medicine carrying balloon are integrally formed so as to realize that the medicine carrying balloon carries higher blasting pressure.

As a preferred embodiment of the present invention, the first mark and the second mark of the mark are each provided with a plurality of marks, wherein,

the first mark is a scale mark,

the second mark is a digital mark;

the marking material comprises one of metal, polymer or inorganic nonmetal, wherein,

the marking material comprises one of metal or macromolecule, wherein,

the metallic material from which the tag is made comprises one of a platinum iridium alloy, a tantalum alloy or a gold alloy,

the high polymer material for making the mark comprises nylon, resin or ink, wherein the ink contains particles of one of platinum iridium alloy, tantalum alloy or gold alloy;

the shape of the mark comprises a convex mark, a concave mark or a special mark;

the processing mode of the mark comprises annular printing, pad printing, laser engraving, ultraviolet engraving, physical cutting or physical polishing.

As a preferable mode of the present invention, the inner tube is provided with at least two radiopaque markers, wherein a first one of the radiopaque markers and a last one of the radiopaque markers are provided at positions on the inner tube opposite to both end portions of the balloon second component;

the radiopaque marker includes, but is not limited to, one of a developer ring, an ink marker, or a laser marking.

As a preferred technical scheme of the invention, the second component of the balloon is a straight section of the balloon and is covered with a drug coating, wherein the drug coating comprises one of combination of a drug and a drug carrier or pure drug, the drug is a lipophilic active drug, the active drug comprises one or more of an intimal hyperplasia inhibiting drug, an anticancer drug or an anti-vascular narrow drug,

an anti-intimal hyperplasia agent, an anti-cancer agent, or an anti-vascular narrow agent including, but not limited to, paclitaxel, rapamycin, or derivatives thereof;

the drug carrier of the drug coating formed by combining the drug and the drug carrier is a hydrophilic additive, and the hydrophilic additive comprises one of an alcohol group-containing contrast agent, a biosoluble plasticizer, a polyol or a biodegradable additive;

the contrast agent containing alcohol group comprises at least one of iohexol, iodiplon alcohol, iopromide or their derivatives;

the biosoluble plasticizer comprises at least one of triethyl citrate or butyryl trihexyl citrate;

the polyalcohol comprises at least one of xylitol, sorbitol, polyethylene glycol or amino alcohol;

the biodegradable additive comprises at least one of polylactic acid, polyethylene oxide, or phospholipid;

the coating mode of the drug coating comprises one of solution spraying, ultrasonic spraying and liquid dip coating;

the concentration of the drug coating on the two end parts of the surface of the second component part of the balloon and the outer surface is 1.01 to 1.3 times that of the drug coating on the middle part of the surface of the second component part of the balloon and the inner layer,

the concentration of the hydrophilic carrier of the drug coating at the two ends of the surface of the second component of the balloon and the outer surface is 0.8 to 1 time that of the hydrophilic carrier of the drug coating at the middle part of the surface of the second component of the balloon and the inner layer.

As a preferred embodiment of the present invention, the drug-carrying balloon includes at least three flaps.

As a preferable technical scheme of the invention, the end part of the multi-way tailstock is connected with a stress diffusion pipe;

the point of attachment of the drug-loaded balloon to the multi-lumen catheter includes a first weld,

the connection point of the medicine carrying saccule and the inner tube comprises a second welding point.

As a preferable technical scheme of the invention, the connection mode of the drug-carrying balloon, the multi-cavity catheter and the inner tube is welding, and the welding mode comprises one of hot melt welding, laser welding and ultrasonic welding.

As a preferred embodiment of the present invention, at least one guide wire lumen and at least one balloon filling lumen are provided.

As a preferred embodiment of the present invention, the concave portion includes, but is not limited to, at least one of a circular dot groove, a diamond dot groove, a rectangular straight groove, a parallelogram groove, a wavy groove, and a curved groove.

As a preferable technical scheme of the invention, the top opening of the concave part is smaller than the groove opening inside the concave part.

The beneficial effects achieved by the invention are as follows: the concave part of the invention can realize a certain sealing effect on the medicine in the groove, can realize the effect of improving the combination property of the saccule and the medicine coating, realizes that larger dosage reaches the lesion position, and realizes better treatment effect; the medicine coating and the medicine are convenient to fall off, the medicine is more convenient, and the treatment effect is improved; the concave part and the medicine carrying saccule are integrally formed, so that higher burst pressure can be borne, more sufficient expansion can be realized, the narrow part of the blood vessel can be better combined with the medicine, the integral forming has more uniform wall thickness and smaller stress concentration, higher pressure resistance can be effectively provided without rupture, the saccule with high burst pressure can better expand the narrow blood vessel of lesions, the medicine coating fully contacts the inner membrane of the blood vessel, and the medicine coating has help to the treatment effect of the medicine; the multi-cavity catheter is provided with the first mark and the second mark, when in use, a doctor can evaluate the position of the multi-cavity catheter in the blood vessel of a patient through primary angiography when conveying the medicine balloon catheter, can judge the position of the multi-cavity catheter in the blood vessel of the patient according to the first mark and the second mark, can easily judge whether the catheter reaches an expected narrow lesion position by comparing the estimated position of the blood vessel narrow in the primary angiography with the position of the multi-cavity catheter, avoids multiple angiography of the catheter in the conveying process, lightens the damage and side effect of the contrast agent on the body of the patient, and simultaneously provides assistance for the doctor to judge whether the catheter reaches the lesion narrow position.

Drawings

The accompanying drawings are included to provide a further understanding of the invention and are incorporated in and constitute a part of this specification, illustrate the invention and together with the embodiments of the invention, serve to explain the invention. In the drawings:

FIG. 1 is one of the structural schematic diagrams of the present invention;

FIG. 2 is a second schematic diagram of the structure of the present invention;

FIG. 3 is a third schematic diagram of the structure of the present invention;

FIG. 4 is a fourth schematic diagram of the structure of the present invention;

FIG. 5 is a fifth schematic diagram of the structure of the present invention;

FIG. 6 is a sixth schematic diagram of the structure of the present invention;

FIG. 7 is a seventh schematic diagram of the structure of the present invention;

FIG. 8 is a schematic diagram of an eighth embodiment of the present invention;

FIG. 9 is a ninth schematic view of the structure of the present invention;

FIG. 10 is a schematic view of a construction of the present invention;

FIG. 11 is an eleventh view of the structural schematic of the present invention;

FIG. 12 is a schematic view of a twelfth embodiment of the present invention;

FIG. 13 is a thirteenth schematic view of the structure of the present invention;

FIG. 14 is a schematic diagram of fourteen aspects of the present invention;

in the figure: 1. a multi-way tailstock; 2. a stress diffusion tube; 3. a multi-lumen catheter; 301. a guidewire lumen; 302. the balloon fills the cavity; 4. A radiopaque marker; 5. marking; 501. a first mark; 502. a second mark; 6. a drug-carrying balloon; 601. a balloon first component; 602. a balloon second component; 603. a recessed portion; 604. a flap; 7. an inner tube; 801. a first weld; 802. And a second welding point.

Detailed Description

The preferred embodiments of the present invention will be described below with reference to the accompanying drawings, it being understood that the preferred embodiments described herein are for illustration and explanation of the present invention only, and are not intended to limit the present invention.

Example 1

As shown in fig. 1-14, the invention provides a drug-carrying balloon with a mark, which comprises a multi-way tailstock 1, a stress diffusion tube 2, a multi-cavity catheter 3, a radio-opaque mark 4, a mark 5, a drug-carrying balloon 6 and an inner tube 7, wherein the multi-cavity catheter 3 is arranged inside the multi-way tailstock 1, the inner tube 7 is connected with the multi-cavity catheter 3, at least one guide wire cavity 301 and at least one balloon filling cavity 302 are arranged, the guide wire cavity 301 penetrates through the whole multi-cavity catheter 3, and the balloon filling cavity 302 is connected with the drug-carrying balloon 6 so as to control the expansion and the shrinkage of the drug-carrying balloon 6;

the multi-cavity catheter 3 is internally provided with the guide wire cavity 301 and the balloon filling cavity 302, the multi-cavity catheter 3 can be provided with a plurality of cavities with different shapes, the cavity shapes comprise but are not limited to a round shape, a crescent shape, a quadrilateral shape and the like, compared with the traditional round double-cavity catheter, the multi-cavity catheter in the embodiment has a more sufficient pipeline volume utilization rate, can be provided with a larger guide wire cavity and the balloon filling cavity, can be matched with a guide wire specification with a larger diameter and more suitable for operation, provides a larger balloon filling passage, improves the filling speed of the balloon, and meanwhile, the balance design of the multi-cavity catheter 3 also ensures the bending resistance of the multi-cavity catheter 3, and the multi-cavity catheter 3 can be made of metal materials or high polymer materials. Materials selected include, but are not limited to: ti alloys, ni—ti alloys, 304 stainless steel, 316L stainless steel, pebax, PTFE, nylon, PU, PE, PA, PI, etc. or blended products thereof;

a medicine carrying balloon 6 is arranged between the multi-cavity catheter 3 and the inner tube 7, wherein the medicine carrying balloon 6 is respectively connected with the multi-cavity catheter 3 and the inner tube 7;

the multi-cavity catheter 3 is provided with a mark 5, wherein the mark 5 comprises a first mark 501 and a second mark 502, the first mark 501 and the second mark 502 of the mark 5 are provided with a plurality of marks, the first mark 501 is a scale, the second mark 502 is a digital mark representing the distance between the far end development point of the multi-cavity catheter 3 and the second mark 502, the distance between the adjacent digital marks (the second mark 502) is 5 cm-50 cm, in the embodiment, each 10cm distance is selected to have the digital mark (the second mark 502), equidistant first marks 501 are distributed between the adjacent digital marks (the second mark 502), the first marks 501 are generated in a pad printing mode, 2-20 first marks with distinguishable sizes can be distributed between the adjacent digital marks (the second mark 502), 10 small marks and 1 large mark are used as the first marks 501 in the embodiment, the large mark is positioned in the middle of the adjacent digital marks (the second mark 502), the small marks are distributed between the small marks with equidistant sizes and the large marks (the large marks 502) can be distinguished in the mode of equidistant between the small marks and the large marks (the small marks 502;

the manufacturing material of the mark 5 comprises one of metal or polymer, wherein the metal material for manufacturing the mark 5 comprises one of platinum iridium alloy, tantalum alloy or gold alloy, the polymer material for manufacturing the mark 5 comprises nylon, resin or ink, the ink contains particles of one of the platinum iridium alloy, the tantalum alloy or the gold alloy, the mark 5 can be detected by rays or ultrasonic waves simultaneously or respectively, and particularly, when the platinum iridium alloy, the tantalum alloy, the gold alloy or the ink with the metal particles are selected by the mark 5, the characteristic of being detected by rays is realized because the materials are impermeable to rays; when the metal or the polymer is selected, the mark 5 has the obvious echo difference under ultrasonic detection due to the different materials from the multi-cavity catheter 3, so that the characteristic of being detected by ultrasonic waves is realized, and when the metal is selected, the mark also has the characteristic of being radio-opaque, so that the characteristic of being detected by the rays and the characteristic of being detected by the ultrasonic waves at the same time is realized; the shape of the mark 5 comprises a convex mark, a concave mark or a special-shaped mark (such as wave shape), and the mark 5 has obvious echo under ultrasonic detection due to irregular shape, so that the characteristic of ultrasonic detection is realized, and the processing modes of the mark 5 comprise annular printing, laser engraving, ultraviolet engraving, physical excision, physical polishing and the like.

The drug-carrying balloon 6 comprises a balloon first component 601 and a balloon second component 602, wherein the balloon first component 601 is a conical section of the drug-carrying balloon 6, a plurality of concave parts 603 are arranged on the balloon second component 602, compared with a smooth balloon without grooves, the balloon with grooves (namely the concave parts 603) can be coated with more drugs, as shown in fig. 14, when the drug-carrying balloon 6 is not inflated, the drugs are protected in the grooves due to the shrinkage effect of the balloon body, when the balloon body is inflated, the grooves are opened, the drugs can be diffused to lesion tissues without obstruction, part of the drugs can not be released and remain on the balloon in the retracting process of the balloon, and at the moment, the shrinkage effect of the balloon also wraps a part of the drugs, so that the drugs are prevented from flowing into the distal end of a blood vessel to form blockage, as shown in fig. 2; the concave part 603 and the medicine carrying balloon 6 are integrally formed to realize that the medicine carrying balloon 6 bears higher burst pressure, and through the design of a balloon mold, the initial balloon forming is provided with a groove in the balloon forming stage, and compared with the later reprocessing of the balloon surface, the groove formed by the method has less influence on the burst pressure of the balloon, the balloon has higher burst pressure, compared with the low-pressure balloon, the high-pressure balloon can better dilate a narrow vascular area, and the medicine is better combined with vascular tissues.

The guide wire cavity 301 of the multi-cavity catheter 3 is fixedly connected with the inner tube 7, the proximal end section of the drug carrying balloon 6 is connected with the multi-cavity catheter 3, the distal end section is connected with the inner tube 7, at least two radiopaque markers 4 are arranged on the inner tube 7, wherein the first radiopaque marker 4 and the last radiopaque marker 4 are arranged on the inner tube 7 at positions corresponding to two ends of the balloon second component 602, the radiopaque markers 4 comprise but are not limited to one of a developing ring, an ink marker or a laser marking, can be developed under X-ray irradiation, can be effectively developed in a patient, and can display the effective length of the balloon straight section (the effective length of the balloon second component 602 is larger than that of the two radiopaque markers 4, other functions can be realized, such as the function of realizing the midpoint or the special position of the balloon straight section can be realized, and the doctor can conveniently operate.

The second balloon component 602 is a straight section of the balloon and is covered with a drug coating, wherein the drug coating comprises one of combination of a drug and a drug carrier or pure drug, and the drug is selected from one or more of a lipophilic active drug, an active drug which can be an intimal hyperplasia inhibiting drug, an anticancer drug, an anti-vascular narrow drug and the like, including but not limited to paclitaxel, rapamycin or derivatives thereof and the like; the crystal forms and the particle sizes of the medicines in the pure medicine formula are controllable, and the medicines are not easy to accumulate into blocks, so that the blocking of the medicines in the accumulation of the blood vessels at the far end can be effectively avoided;

the drug carrier of the drug coating formed by combining the drug and the drug carrier is a hydrophilic additive, and the hydrophilic additive comprises one of an alcohol group-containing contrast agent, a biosoluble plasticizer, a polyalcohol or a biodegradable additive;

the contrast agent containing alcohol group comprises at least one of iohexol, iodiplon alcohol, iopromide or derivatives thereof, which enhances the absorption of the medicine by tissues and improves the contrast performance of the medicine carrying saccule 6;

the biosoluble plasticizer comprises at least one of triethyl citrate or butyryl trihexyl citrate;

the polyalcohol comprises at least one of xylitol, sorbitol, polyethylene glycol or amino alcohol;

the biodegradable additive comprises at least one of polylactic acid, polyethylene oxide, or phospholipid;

the coating mode of the drug coating comprises one of solution spraying, ultrasonic spraying and liquid dip coating, wherein the coating is sprayed on the outer surface of the straight section (the balloon second component 602) of the inflatable balloon, the inflatable balloon is dried and folded to obtain the drug balloon, the groove (the concave part 603) is gradually unfolded in the balloon inflation process, and most of the drug can be retained in the groove on the outer surface of the balloon. The drug coating is coated on the outer surface of the balloon in the state of filling the balloon. In the balloon filling state, the grooves on the surface are spread, and most of the medicines enter the groove parts. When the balloon is folded, the groove part is retracted due to the elasticity of the self material, the drug coating is wrapped in the groove part for protection, and excessive loss of the coating before reaching the lesion position is reduced. In operation, when the saccule reaches the lesion position, the saccule is filled, at the moment, the groove on the outer surface is opened again, and the medicine is separated from the saccule without obstruction under the help of the hydrophilic medicine carrier, so that the medicine is fully released and diffused to the lesion tissue.

The drug-carrying balloon 6 comprises at least three flaps 604, in this embodiment, the number of selected folded wings is 3 wings, and can be selected to be 3-8 wings, because the grooves and the balloon are folded to protect the drug, the loss of the drug is reduced in the process of delivering the multi-cavity catheter 3, the grooves can be gradually unfolded in the process of expanding the balloon, the drug protected in the grooves can be released from the balloon without obstruction, and the drug release and diffusion can be fully carried out to the lesion tissues.

The end part of the multi-way tailstock 1 is connected with a stress diffusion tube 2, and a guide wire input cavity, a balloon filling input cavity and a luer connector which correspond to the multi-cavity catheter 3 are arranged in the multi-way tailstock 1;

the point of attachment of the medicated balloon 6 to the multi-lumen catheter 3 comprises a first weld 801 and the point of attachment of the medicated balloon 6 to the inner tube 7 comprises a second weld 802.

The drug-carrying balloon 6 is welded with the multi-cavity catheter 3 and the inner tube 7 in a welding mode, and the welding mode comprises one of hot melt welding, laser welding and ultrasonic welding.

The recess 603 includes, but is not limited to, at least one of a circular dot groove, a diamond dot groove, a rectangular straight groove, a parallelogram groove, a wavy groove and a curved groove, and in this embodiment, the circular dot groove is adopted, the drug solution is paclitaxel and iopromide dissolved in ethanol and water solution, then the surface of the balloon is dried and folded, the balloon which is originally expanded is vacuumized in the folding process, and the groove on the outer surface of the balloon wraps the drug coating in the groove due to elastic shrinkage, so as to play a role of protecting the drug coating.

The top opening of the concave part 603 is smaller than the groove opening inside the concave part 603, so that the medicine carrying balloon 6 has larger medicine contact area when inflated and expanded, and better coating of medicine or medicine coating can be realized when the medicine carrying balloon 6 contracts, and medicine falling is avoided.

In another preferred embodiment of the present invention, the drug coating may be sprayed at the same concentration and at different concentrations, wherein the concentration of the drug coating at both ends of the surface and the outer surface of the second component 602 of the balloon is 1.01 to 1.3 times that of the drug coating at the middle of the surface and the inner layer of the second component 602 of the balloon,

the concentration of the hydrophilic carrier of the drug coating at the two ends of the surface of the second component 602 and the outer surface of the second component 602 is 0.8 to 1 times that of the hydrophilic carrier of the drug coating at the middle part of the surface of the second component 602 and the inner layer of the second component;

the same concentration, namely the uniform spraying of the medicines with the same concentration within the effective length range of the saccule, the medicine concentration can be 0.1-4 mug/mm < 2 >.

Specifically, the drug coating with different concentrations (i.e. the mode of different concentrations) can be sprayed with different drug concentrations, different hydrophilic carrier concentrations or a combination thereof.

The medicine concentration is different, and can be that the medicine concentration at the end side of the medicine coating is higher than that at the middle section of the medicine coating, the medicine concentration at the outer layer of the medicine coating is higher than that at the inner layer of the medicine coating, and the like. The drug concentration of the middle section and the drug concentration of the inner layer of the drug coating are the concentration values (0.1-9 mug/mm < 2 >) under the same concentration, and the drug concentration of the end side of the drug coating and the drug concentration of the outer layer of the drug coating can be 101-130% of the drug concentration of the middle section and the drug concentration of the inner layer of the drug coating. Because the drug balloon is in the use process, the drug loss amount is gradually reduced from the balloon end side to the balloon middle section and the outer layer of the drug coating to the inner layer, and more drugs are sprayed at the position with large drug loss amount, when the drug balloon reaches the lesion position, the drug coating has enough drug amount at each position, and the treatment effect is ensured.

The hydrophilic carrier concentration is different, and the concentration of the hydrophilic carrier at the end side of the drug coating is lower than that of the hydrophilic carrier at the middle section of the drug coating, the concentration of the hydrophilic carrier at the outer layer of the drug coating is lower than that of the hydrophilic carrier at the inner layer of the drug coating, and the like. The concentration of the hydrophilic carrier at the middle section of the drug coating and the hydrophilic carrier at the outer layer of the drug coating can be 10 mug/mm 2-300 mug/mm 2, and the concentration of the hydrophilic carrier at the end side of the drug coating and the outer layer of the drug coating can be 80% -100% of the concentration of the hydrophilic carrier at the middle section of the drug coating and the outer layer of the drug coating. The drug loss is mainly caused by the fact that the drug coating is contacted with human blood in the process of delivering the drug balloon, and the lipophilic drug enters the blood along with the hydrophilic carrier. The hydrophilic coating with low concentration is added at the position with serious drug loss, so that the loss of the drug coating in the conveying process can be effectively reduced, and the treatment effect of the drug balloon is ensured.

Specifically, during the operation, the doctor can determine the position of the drug-carrying balloon 6 in the blood vessel and the distance from the distal end of the balloon to the narrow part of the blood vessel through angiographic images. As shown in fig. 13, if the distal end of the drug-loaded balloon 6 is located 10cm from the narrow position of the vascular lesion according to the contrast determination, the physician can determine the distance the multi-lumen catheter 3 is advanced by the digital marker (second marker 502) and the scale (first marker 501) outside the multi-lumen catheter 3 outside the patient, such as pushing from the digital marker 70 position to the digital marker 80 position. The digital mark (the second mark 502) and the scale (the first mark 501) outside the multi-cavity catheter 3 can effectively assist a doctor to accurately push the catheter of the medicine carrying balloon 6 in the operation process, help the doctor to accurately push the medicine carrying balloon 6 to the narrow position of vascular lesions, reduce the angiography times in the operation and lighten the damage of contrast agent to the body of a patient; the concave part 603 and the medicine carrying balloon 6 are integrally formed, and through the design of a balloon mold, the initial balloon forming is provided with a groove in the balloon forming stage, compared with the later-stage balloon surface reprocessing, the groove formed by the method has less influence on the burst pressure of the balloon, the balloon has higher burst pressure, compared with the low-pressure balloon, the high-pressure balloon can better dilate a narrow vascular area, and the medicine can be better combined with vascular tissues.

Example 2

Unlike example 1, the spacing between the digital markers (second markers 502) on the outside of the multi-lumen catheter 3 was 20cm, with 16 small markers and 3 large markers equally spaced between the markers as the first markers 501. The concave part 603 of the medicine carrying saccule 6 is a curved groove, the surface area of the groove is improved, and the medicine carrying capacity of the saccule is also improved. The medicine is prepared by dissolving rapamycin and iodobenzene hexaol in acetone and water solution. And placing the balloon in the drug solution in a dip-coating mode, standing for 5 minutes, taking out and drying for 2 minutes, folding the balloon, wherein the number of folding wings is 5, and finally obtaining the drug balloon with the mark.

The concave part of the invention can realize a certain sealing effect on the medicine in the groove, can realize the effect of improving the combination property of the saccule and the medicine coating, realizes that larger dosage reaches the lesion position, and realizes better treatment effect; the medicine coating and the medicine are convenient to fall off, the medicine is more convenient, and the treatment effect is improved; the concave part and the medicine carrying saccule are integrally formed, so that higher blasting pressure can be carried, more sufficient expansion can be realized, and the narrow part of the blood vessel can be better combined with the medicine; the multi-cavity catheter is provided with the first mark and the second mark, when in use, a doctor can evaluate the position of the multi-cavity catheter in the blood vessel of a patient through primary angiography when conveying the medicine balloon catheter, can judge the position of the multi-cavity catheter in the blood vessel of the patient according to the first mark and the second mark, can easily judge whether the catheter reaches an expected narrow lesion position by comparing the estimated position of the blood vessel narrow in the primary angiography with the position of the multi-cavity catheter, avoids multiple angiography of the catheter in the conveying process, lightens the damage and side effect of the contrast agent on the body of the patient, and simultaneously provides assistance for the doctor to judge whether the catheter reaches the lesion narrow position.

Finally, it should be noted that: the foregoing description is only a preferred embodiment of the present invention, and the present invention is not limited thereto, but it is to be understood that modifications and equivalents of some of the technical features described in the foregoing embodiments may be made by those skilled in the art, although the present invention has been described in detail with reference to the foregoing embodiments. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention should be included in the protection scope of the present invention.

Claims (10)

1. The medicine carrying saccule with the mark is characterized by comprising a multi-way tailstock (1), a stress diffusion tube (2), a multi-cavity catheter (3), a radio-opaque mark (4), a mark (5), a medicine carrying saccule (6) and an inner tube (7), wherein,

a multi-cavity catheter (3) is arranged in the multi-way tailstock (1), wherein,

the multi-cavity catheter (3) is connected with the inner tube (7);

a guide wire cavity (301) and a balloon filling cavity (302) are arranged in the multi-cavity catheter (3);

a medicine carrying saccule (6) is arranged between the multi-cavity catheter (3) and the inner tube (7), wherein,

the medicine carrying saccule (6) is respectively connected with the multi-cavity catheter (3) and the inner tube (7);

the multi-cavity catheter (3) is provided with a marker (5), wherein,

the marks (5) comprise a first mark (501) and a second mark (502);

the drug-carrying balloon (6) comprises a balloon first component (601) and a balloon second component (602), wherein,

a plurality of concave parts (603) are arranged on the balloon second component part (602);

the concave part (603) and the medicine carrying balloon (6) are integrally formed so as to realize that the medicine carrying balloon (6) bears higher blasting pressure.

2. A medicated balloon with markings according to claim 1, characterized in that the first marking (501) and the second marking (502) of the marking (5) are each provided with several, wherein,

the first mark (501) is a scale,

the second mark (502) is a digital mark;

the mark (5) is made of one of metal or polymer, wherein,

the metallic material of which the tag (5) is made comprises one of a platinum iridium alloy, a tantalum alloy or a gold alloy,

the high polymer material for making the mark (5) comprises nylon, resin or ink, wherein the ink contains particles of one of platinum iridium alloy, tantalum alloy or gold alloy;

the shape of the mark (5) comprises a convex mark, a concave mark or a special mark;

the processing mode of the mark (5) comprises annular printing, pad printing, laser engraving, ultraviolet engraving, physical cutting or physical polishing.

3. A medicated balloon with markings according to claim 1, characterized in that the inner tube (7) is provided with at least two radiopaque markings (4), wherein,

the first (4) and last (4) of said radiopaque markers are arranged on said inner tube (7) in a position opposite to the two ends of said balloon second component (602);

the radiopaque marker (4) includes, but is not limited to, one of a developer ring, an ink marker, or a laser marking.

4. The drug-loaded balloon with a marker of claim 1, wherein the balloon second component (602) is a straight balloon segment and is covered with a drug coating, wherein the drug coating comprises one of a combination of a drug and a drug carrier or a pure drug, the drug is a lipophilic active drug, the active drug comprises one or more of an intimal hyperplasia-inhibiting drug, an anticancer drug or an anti-vascular narrow drug,

an anti-intimal hyperplasia agent, an anti-cancer agent, or an anti-vascular narrow agent including, but not limited to, paclitaxel, rapamycin, or derivatives thereof;

the drug carrier of the drug coating formed by combining the drug and the drug carrier is a hydrophilic additive, and the hydrophilic additive comprises one of an alcohol group-containing contrast agent, a biosoluble plasticizer, a polyol or a biodegradable additive;

the contrast agent containing alcohol group comprises at least one of iohexol, iodiplon alcohol, iopromide or their derivatives;

the biosoluble plasticizer comprises at least one of triethyl citrate or butyryl trihexyl citrate;

the polyol includes at least one of xylitol, sorbitol, polyethylene glycol or amino alcohol.

The coating mode of the drug coating comprises one of solution spraying, ultrasonic spraying and liquid dip coating;

the biodegradable additive comprises at least one of polylactic acid, polyethylene oxide, or phospholipid;

the concentration of the drug coating at the two ends of the surface of the balloon second component (602) and the outer surface is 1.01 to 1.3 times that of the drug coating at the middle part of the surface of the balloon second component (602) and the inner layer,

the concentration of the hydrophilic carrier of the drug coating at the two ends of the surface of the second component (602) of the balloon and the outer surface is 0.8 to 1 times that of the hydrophilic carrier of the drug coating at the middle part of the surface of the second component (602) of the balloon and the inner layer.

5. A medicated balloon with markings according to claim 2, characterized in that the medicated balloon (6) comprises at least three flaps (604).

6. A drug-loaded balloon with a mark according to claim 1, wherein the end part of the multi-way tailstock (1) is connected with a stress diffusion tube (2);

the connection point of the medicine carrying balloon (6) and the multi-cavity catheter (3) comprises a first welding point (801),

the connection point of the medicine carrying balloon (6) and the inner tube (7) comprises a second welding point (802).

7. The medicated balloon with markings according to claim 5, wherein the medicated balloon (6) is welded to the multi-lumen catheter (3) and the inner tube (7) by one of a heat weld, a laser weld and an ultrasonic weld.

8. A drug-loaded balloon with a marking according to claim 1, characterized in that the guidewire lumen (301) and the balloon filling lumen (302) are each provided with at least one.

9. The drug-loaded balloon with indicia of claim 1, wherein the depressions (603) include, but are not limited to, at least one of circular dot grooves, diamond-shaped dot grooves, rectangular straight grooves, parallelogram-shaped grooves, wavy grooves, and curvilinear grooves.

10. A drug-loaded balloon with a marking according to claim 1 or 9, characterized in that the top opening of the recess (603) is smaller than the groove opening inside the recess (603).

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