CN212416628U

CN212416628U - Balloon catheter

Info

Publication number: CN212416628U
Application number: CN202020627799.8U
Authority: CN
Inventors: 王钰富; 李猛; 李俊菲
Original assignee: Shanghai Microport Medical Group Co Ltd
Current assignee: Minimally invasive Investment Holdings Ltd.
Priority date: 2020-04-23
Filing date: 2020-04-23
Publication date: 2021-01-29
Anticipated expiration: 2030-04-23

Abstract

The utility model relates to a sacculus pipe, the outside liquid medicine of sacculus pipe is taken back to the accessible liquid return passage to this guarantees to be kept higher drug concentration by the target area of shutoff all the time, thereby reduces the loss of medicine in carrying and filling the in-process, improves the efficiency that the medicine shifted to the target tissue, and reduces the risk that the thrombus produced.

Description

Balloon catheter

Technical Field

The utility model relates to the technical field of medical equipment, in particular to sacculus pipe.

Background

The coronary heart disease seriously affects the health of human beings, and in 6 months in 2017, data published in 'Chinese cardiovascular disease report 2016' show that the prevalence rate and death rate of cardiovascular diseases in China are still in an ascending stage at present, the coronary heart disease is calculated to be more than 1100 thousands, and a drug eluting stent is a preferred mode for treating the coronary heart disease and is widely applied. But there is increasing evidence that comprehensive evaluation of drug balloons may show advantages in some cases. The drug balloon is a new interventional therapy technology. The medicine balloon attaches the medicine for inhibiting cell proliferation on the surface of the balloon, and the medicine is delivered into the local vascular wall of pathological changes by expanding the balloon so as to achieve the effect of inhibiting smooth muscle proliferation.

In clinical application, the balloon is expanded at a narrow part and kept for a certain time, and the medicine coated on the surface of the balloon is contacted with the blood vessel wall so as to transfer the medicine to the blood vessel wall to play the therapeutic effect of the medicine. The use of a drug balloon typically expands for 30 to 60 seconds and the entire delivery is completed within 25 minutes. Drug balloons present therapeutic challenges due to the very short contact time between the drug on the balloon surface and the vessel wall, and limited transfer and utilization of the drug. The delivery and expansion of the balloon are accompanied by a great loss of the medicine: the drug loss during the vascular delivery of the balloon is about 10% to 25%, the actual transfer to the target tissue is about 1% to 10%, the distal circulation after balloon inflation is 60% to 70%, and the drug remaining on the balloon after inflation is 10% to 20%.

Therefore, how to reduce the mass loss of the drug during the delivery process and improve the efficiency of transferring the drug to the tissue is a further problem to be solved by the drug balloon.

SUMMERY OF THE UTILITY MODEL

An object of the utility model is to provide a sacculus pipe to there is the medicine to lose in a large number in transportation process in solving current medicine coating sacculus, and medicine transfer efficiency hangs down the scheduling problem.

In order to achieve the above object, according to an aspect of the present invention, there is provided a balloon catheter, including a catheter body and balloons, wherein the balloons include a first balloon, a second balloon and a third balloon, and the first balloon, the second balloon and the third balloon are sequentially sleeved on the catheter body at intervals along an axial direction of the catheter body from a proximal end and a distal end;

the expanded diameters of the first balloon and the third balloon are both larger than the expanded diameter of the second balloon; the conduit body at least comprises a liquid inlet channel and a liquid return channel which are separated from each other; the liquid inlet channel is used for conveying liquid to the second balloon, and the surface of the second balloon is provided with a plurality of micropores for releasing the liquid; the distal end of the liquid return channel is provided with at least one suction port, and liquid on the periphery of the second balloon is withdrawn through the at least one suction port.

Optionally, at least one of the suction ports is located between the first balloon and the second balloon.

Optionally, the catheter body further comprises an filling channel, which is isolated from the liquid inlet channel and the liquid return channel respectively;

the inflation channel has at least one inflation port in communication with the first balloon for delivering an inflation medium through the inflation channel to the first balloon to inflate the first balloon;

the liquid inlet channel is provided with at least two liquid inlets which are respectively communicated with the second balloon and the third balloon so as to convey liquid to the second balloon and the third balloon through the liquid inlet channel to enable the second balloon and the third balloon to be inflated.

Optionally, the catheter body comprises an outer tube and an inner tube; the outer tube comprises first, second and third axially extending lumens, the first lumen being configured as the flashback passage, the third lumen being configured as the filling passage, and the inner tube being configured as the insufflation passage;

the inner tube is inserted into the second lumen and extends beyond a distal end of the second lumen; the second balloon and the third balloon are sleeved at the distal end of the inner tube; the first balloon is sleeved on the outer tube.

Optionally, the catheter body comprises an outer tube, an inner tube, and a suction catheter; the outer tube comprises first, second and third axially extending lumens, the third lumen being configured as the filling channel, the inner tube being configured as the feed channel, the suction catheter being configured as the return channel;

the suction catheter is inserted into the first lumen and extends out of the distal end of the first lumen; the inner tube is inserted into the second lumen and extends out of the distal end of the second lumen; the second balloon and the third balloon are sleeved at the distal end of the inner tube; the first balloon is sleeved on the outer tube.

Optionally, the liquid inlet channel has at least three liquid inlets, and the liquid inlets are respectively communicated with the first balloon, the second balloon and the third balloon, so as to deliver liquid medicine to the first balloon, the second balloon and the third balloon through the liquid inlet channel, so as to inflate the first balloon, the second balloon and the third balloon.

Optionally, the catheter body comprises an outer tube and an inner tube, the outer tube comprising first and second axially extending lumens, the first lumen configured as the flashback passage, the inner tube configured as the insufflation passage;

the inner tube is inserted into the second lumen and extends out of the distal end of the second lumen; the second balloon and the third balloon are sleeved at the distal end of the inner tube; the first balloon is sleeved on the outer tube.

Optionally, the catheter body comprises an outer tube, an inner tube, and a suction catheter; the outer tube comprises first and second axially extending lumens, the suction catheter is configured as the flashback passage, and the inner tube is configured as the intake passage;

Optionally, the second balloon is a single layer balloon or a double layer balloon; when the second sacculus is double-deck sacculus, the micropore has been seted up on the outer sacculus of double-deck sacculus on the surface, perhaps, a plurality of micropores have all been seted up on the surface of the outer sacculus of double-deck sacculus and inlayer sacculus.

Optionally, the first balloon has an expanded axial length less than a radial height, and/or the third balloon has an expanded axial length less than a radial height.

Optionally, the first and/or third balloon is a non-compliant balloon.

In order to achieve the above object, according to another aspect of the present invention, there is provided a balloon catheter, including a catheter body and a balloon, wherein the balloon includes a proximal balloon and a distal balloon, and the proximal balloon and the distal balloon are sequentially sleeved on the catheter body at intervals along an axial direction of the catheter body from a proximal end and a distal end;

the conduit body at least comprises a liquid inlet channel and a liquid return channel which are separated from each other; the liquid inlet channel is used for conveying liquid; the surface of the far-end balloon or the liquid inlet channel is provided with a plurality of micropores for releasing the liquid; the distal end of the liquid return channel is provided with at least one suction port, and liquid outside the balloon catheter is withdrawn through the at least one suction port, and the at least one suction port is positioned between the proximal balloon and the distal balloon.

Optionally, when the distal balloon has a plurality of micropores formed on a surface thereof, the distal balloon includes a proximal portion and a distal portion, the expanded diameter of the distal portion is larger than the expanded diameter of the proximal portion, and the micropores are located on the surface of the proximal portion.

Optionally, the proximal balloon has an expanded axial length less than a radial height.

Optionally, when the surface of the liquid inlet channel is provided with a plurality of micropores, the axial length of the inflated distal balloon is smaller than the radial height.

Optionally, the proximal balloon and/or the distal balloon are non-compliant balloons.

The utility model provides a sacculus pipe has following advantage:

the utility model discloses a sacculus pipe mainly used carries the medicine, when the in-service use, accessible near-end sacculus and distal end sacculus are abundant at internal target area, the short time blocks the blood flow and passes through, make things convenient for the liquid medicine to pass through the micropore that distal end sacculus or inlet channel set up on the surface and get into target area (like the blood vessel), realize lasting the pouring of liquid medicine, and at the in-process that fills the liquid medicine, the liquid medicine in the shutoff area is taken back to the liquid medicine of withdrawing continuously on the accessible pipe body, new liquid medicine then carries to inlet channel continuously simultaneously, make the liquid medicine continuously spill over to the target area by the shutoff from the micropore of distal end sacculus or inlet channel in, do so, can make the liquid medicine in the shutoff area can continuously maintain at higher concentration, improve the efficiency that the liquid medicine diffuses to the target tissue, reduce the loss of medicine in transport and filling process. Meanwhile, due to the suction effect of the liquid return channel in the plugging area, the liquid circularly flows, the probability of forming thrombus in the plugging area is reduced, and the safety of the instrument is improved. Moreover, the target area is blocked by the near-end balloon and the far-end balloon, so that the loss of the liquid medicine flowing to the two ends of the balloons is reduced, and the transfer efficiency of the medicine is further improved;

near-end sacculus (including first sacculus) and/or axial length after distal end sacculus (including the third sacculus) inflation is preferred to be less than radial height, sets up like this, and solution vascular calcification pathological change problem that can be better because the shape at vascular calcification pathological change position is anomalous usually, and the unable better vascular wall of laminating calcification pathological change of conventional sacculus shape can not effectively shutoff pathological change blood vessel, and the utility model discloses a near-end sacculus and distal end sacculus inflation back can be the disc, have ensured the adherence of sacculus and vascular wall, and the shutoff is effectual.

Drawings

Those skilled in the art will appreciate that the drawings are provided for a better understanding of the invention and do not constitute any limitation on the scope of the invention. In the drawings:

fig. 1 is a schematic structural view of an exemplary balloon catheter of the present invention, wherein the outer tube is a cross-sectional view;

FIG. 2 is an enlarged partial view of the balloon catheter of FIG. 1;

FIG. 3 is a schematic view of an exemplary balloon catheter of the present invention in use;

fig. 4 is an end view of an exemplary outer tube of the present invention;

fig. 5 is an enlarged partial view of an exemplary balloon catheter of the present invention;

fig. 6 is an enlarged partial view of an exemplary balloon catheter of the present invention, wherein the first balloon has a disk shape;

FIG. 7 is a micrograph of a microwell provided in an assay of the present invention;

fig. 8 is a comparison graph of the drug concentration of the immediate tissue of the balloon catheter and the balloon coated balloon of the present invention.

In the figure: a balloon catheter 100; a catheter body 110; an outer tube 110 a; an inner tube 110 b; a suction duct 110 c; a balloon 120; a first balloon 121; a second balloon 122; a third balloon 123; a micro-pore 124; a liquid inlet passage 111; a liquid return passage 112; an inflation channel 113; a suction port 114; a first lumen 115; a second lumen 116; a third lumen 117; the blood vessel S.

The same or similar reference numbers in the drawings identify the same or similar elements.

Detailed Description

The following description of the embodiments of the present invention is provided for illustrative purposes, and other advantages and effects of the present invention will be readily apparent to those skilled in the art from the disclosure herein. The present invention can also be implemented or applied through other different specific embodiments, and various details in the present specification can be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the drawings provided in the present embodiment are only for illustrating the basic idea of the invention in a schematic manner, and only the components related to the invention are shown in the drawings rather than being drawn according to the number, shape and size of the components in actual implementation, and the form, quantity and proportion of the components in actual implementation may be changed at will, and the layout of the components may be more complicated.

Furthermore, each embodiment described below has one or more technical features, which does not mean that all technical features of any embodiment need to be implemented simultaneously by a person using the present invention, or that all technical features of different embodiments can be implemented separately. In other words, in the implementation of the present invention, based on the disclosure of the present invention, and depending on design specifications or implementation requirements, a person skilled in the art can selectively implement some or all of the technical features of any embodiment, or selectively implement a combination of some or all of the technical features of a plurality of embodiments, thereby increasing the flexibility in implementing the present invention.

To make the objects, advantages and features of the present invention clearer, the present invention will be described in further detail with reference to the accompanying drawings. It should be noted that the drawings are in simplified form and are not to precise scale, and are provided for convenience and clarity in order to facilitate the description of the embodiments of the present invention. As used in this specification, the singular forms "a," "an," and "the" include plural referents unless the content clearly dictates otherwise. As used in this specification, the meaning of "a plurality" generally includes two or more unless the content clearly dictates otherwise. As used in this specification, the term "or" is generally employed in its sense including "and/or" unless the content clearly dictates otherwise. The term "axial" generally refers to a direction parallel to the longitudinal axis of the balloon catheter; "proximal" generally refers to the direction of approach to the balloon catheter operator; "distal" refers to a direction away from the operator of the balloon catheter. It should also be understood that the present invention repeats reference numerals and/or letters in the various embodiments. This repetition is for the purpose of simplicity and clarity and does not in itself dictate a relationship between the various embodiments and/or configurations discussed. It will also be understood that when an element is referred to as being "connected" to another element, it can be directly connected to the other element or one or more intervening elements may be present.

The utility model discloses a core thought lies in providing a sacculus pipe, including pipe body and sacculus, the sacculus includes first sacculus, second sacculus and third sacculus, first sacculus, second sacculus and third sacculus are established by near and distant interval ground cover in proper order along the axial of pipe body on the pipe body, just first sacculus with diameter after the inflation of third sacculus all is greater than diameter after the inflation of second sacculus. In addition, the catheter body at least comprises a liquid inlet channel and a liquid return channel which are separated from each other, and the distal end of the liquid return channel is provided with at least one suction port. During practical use, after each sacculus expands in a target area in vivo, because the diameters of the first sacculus and the third sacculus are larger than that of the second sacculus, the target areas can be blocked at two ends of the second sacculus by the first sacculus and the third sacculus, blood flow can be blocked for a short time to pass through, then liquid medicine (containing liquid medicine) can be conveyed to the second sacculus through the liquid inlet channel on the catheter body, and because a plurality of micropores are formed in the surface of the second sacculus, the liquid medicine in the second sacculus can overflow from the micropores to the blocked target area under the pressure action of the liquid medicine, and because of the concentration difference of the medicine, the liquid medicine is transferred to a target tissue through diffusion action and is absorbed by the target tissue. However, as the drug is transferred, the drug concentration in the target tissue increases and the drug concentration difference is also reduced, and at this time, if no measure is taken, the efficiency of diffusion of the drug to the target tissue decreases. Therefore, in the process of injecting the liquid medicine, the liquid medicine on the periphery of the second balloon (namely, the liquid medicine in the target plugging region) needs to be pumped back through the liquid return channel on the catheter body through at least one suction port at the far end of the liquid return channel, so that new liquid medicine can be continuously injected into the target plugging region from the micropores of the second balloon, the liquid medicine in the target plugging region can be always kept at a high concentration, the medicine concentration difference is improved, the liquid medicine is continuously diffused into target tissues, and the medicine transfer efficiency is improved. In particular, due to the suction effect of the liquid return channel, the liquid in the plugging area is driven to circularly flow, so that the risk of forming thrombus by residual blood can be reduced or avoided even if the target area is plugged, and the use safety of the device is improved. It should be understood that the target region herein includes, but is not limited to, a blood vessel. Moreover, the balloon catheter of the utility model is not limited to the delivery of liquid medicine, and can also deliver other liquid substances under other conditions, such as a nano robot. It is also understood that the expanded diameters of the first and third balloons being greater than the expanded diameter of the second balloon include the expanded maximum diameters of the first and third balloons being greater than the expanded maximum diameter of the second balloon.

The utility model discloses in, the distal end of returning the liquid passageway has at least one suction mouth, at least one the suction mouth is preferred to be located first sacculus with between the second sacculus, the liquid medicine of the second sacculus periphery of being convenient for can in time be sucked to returning the liquid passageway through the suction mouth of near-end, and suction efficiency is high, and suction effect is good, can simplify the structure of pipe moreover, and the cost of manufacture is low. It is also understood that the second balloon may be a single layer balloon or a double layer balloon. When the second balloon is a double-layer balloon, there are two cases: the first one is that only the surface of the outer saccule is provided with a plurality of micropores, the inner saccule is not provided with any micropores, the inner saccule is nested in the outer saccule, a perfusion cavity is formed between the inner saccule and the outer saccule, at the moment, the whole saccule is expanded through the inner saccule, the liquid medicine is conveyed to the perfusion cavity between the inner saccule and the outer saccule through a liquid inlet channel, and then overflows to a target area through the micropores on the outer saccule; the second is that set up a plurality of micropores on the surface of outer sacculus and inlayer sacculus simultaneously, inlayer sacculus nestification is in outer sacculus, and also forms between inlayer sacculus and the outer sacculus and fill the chamber, at this moment, through the whole sacculus of inlayer sacculus inflation, and the liquid medicine fills the inlayer sacculus earlier, and the micropore on the rethread inlayer sacculus overflows outer sacculus, and further the micropore on the outer sacculus of rethread overflows the target area. Here, it should be understood that the "micro-hole" in the present invention refers to a hole having a size in the micron order, but the shape of the hole is not limited, and the micro-hole is preferably a circular hole in view of convenience of processing.

The utility model discloses in, first sacculus, second sacculus and third sacculus are makeed by non-compliance or semi-compliance material, expand to appointed size along with the pressure increase and do not expand along with the pressure increase again. And adopt non-compliance or semi-compliance material, prevented that the second sacculus from hindering the medicine absorption after laminating with the vascular wall, can improve the absorptivity of liquid medicine. For example, the material from which the balloon is made may be selected from PEBAX (polyether block polyamide), polyethylene or polyamide, and the like. The second balloon may be an angioplasty balloon or any other balloon used in interventional cardiovascular procedures and is inflated primarily by means of a perfusion solution, while the first and third balloons may be inflated in a percutaneous interventional procedure using conventional means.

In addition, the utility model discloses do not limit to the difference of the diameter after the inflation of second sacculus and the diameter after inflation of first sacculus and third sacculus. Moreover, the utility model discloses do not do the restriction to the shape after first sacculus, second sacculus and the inflation of third sacculus, can be spherical, oval, cylindrical etc. preferably oval. Preferably, the axial length of the first balloon after being inflated is larger than the radial height, and/or the axial length of the third balloon after being inflated is smaller than the radial height, for example, the first balloon and/or the third balloon are disc-shaped, so as to better solve the problem of the calcified vascular lesion.

The utility model discloses also there is not special requirement to micropore quantity and distribution mode on the second sacculus, can evenly distributed, perhaps unevenly distributed all can. In a preferred embodiment, the micropores on the second balloon are uniformly arranged about the longitudinal axis of the second balloon and are disposed in layers along the longitudinal axis. And when the second balloon is a single-layer balloon, the pore diameter of the micropores is preferably in a range of 5.0 to 500 μm, more preferably in a range of 10 to 250 μm, and still more preferably in a range of 10 to 50 μm. Further, when the second balloon is a single-layer balloon, the number of micropores is preferably 5.0 to 100, more preferably 5.0 to 50, and still more preferably 5.0 to 25. It is understood that the pore size and number of pores defined by a single layer balloon are equally applicable to the outer layer balloon in a double layer balloon.

Each sacculus accessible blow molding process preparation in the utility model, just the pipe body can be integrated into one piece or components of a whole that can function independently shaping. The catheter body may be a double, triple or higher lumen tube. Furthermore, the utility model discloses a sacculus pipe is not limited to and intervenes the blood vessel, and all be human lumen, like esophagus, bile duct, uterus and annex, prostate etc. when needing to carry medicine or other materials etc. to treat, all can adopt the utility model discloses a sacculus pipe.

The balloon catheter of the present invention will be further described with reference to the accompanying drawings and preferred embodiments to further highlight the features and characteristics of the above embodiments. And in the following description, the features and characteristics that can be achieved by the present invention will be described assuming that the balloon catheter is used for delivering a liquid medicine and for treating cardiovascular diseases, but should not be taken as limiting the present invention.

Fig. 1 is a schematic structural view of a balloon catheter according to a preferred embodiment of the present invention, and fig. 2 is a partially enlarged view of the balloon catheter shown in fig. 1. As shown in fig. 1 to 2, the present embodiment provides a balloon catheter 100, and the balloon catheter 100 specifically includes a catheter body 110 and a balloon 120. The balloon 120 includes a first balloon 121, a second balloon 122, and a third balloon 123. The first balloon 121, the second balloon 122 and the third balloon 123 are sequentially sleeved on the catheter body 110 at intervals from the proximal end to the distal end along the axial direction of the catheter body 110. Wherein, the expanded diameters of the first balloon 121 and the third balloon 123 are larger than the expanded diameter of the second balloon 122. In this embodiment, the second balloon 122 is a single-layer balloon and is provided with a plurality of micropores 124, and the micropores 124 are used for releasing the liquid medicine. The pore diameter of the micropores 124 is 5.0 to 500. mu.m, preferably 10 to 250. mu.m, and more preferably 10 to 50 μm. The number of the micropores 124 is 5.0 to 100, preferably 5.0 to 50, and more preferably 5.0 to 25. Further, the micropores 124 are uniformly arranged about the longitudinal axis of the second balloon 122 and are disposed in several layers along the longitudinal axis.

In this embodiment, the catheter body 110 includes a liquid inlet passage 111, a liquid return passage 112 and a filling passage 113 which are isolated from each other. The liquid inlet channel 111 is used for delivering liquid medicine to the second balloon 122 and the third balloon 123 to inflate the second balloon 122 and the third balloon 123, and after inflation, the liquid medicine is also delivered to the second balloon 122 through the liquid inlet channel 111, and the liquid medicine is forced to overflow from the micropores 124 of the second balloon 122 into the blood vessel by the pressure of the liquid medicine. Specifically, the inlet channel 111 has at least two inlet ports (not shown) respectively communicating with the second balloon 122 and the third balloon 123, so that the inlet channel 111 delivers the liquid medicine to the second balloon 122 and the third balloon 123 through the inlet ports. The inflation channel 113 is used to deliver an inflation medium to the first balloon 121 to inflate the first balloon 121. Specifically, the inflation channel 113 has at least one inflation port (not shown) in communication with the first balloon 121 for delivering the inflation medium to the first balloon 121. The utility model discloses do not do the restriction to filling medium, filling medium is mainly liquid, and liquid includes but not limited to normal saline, can also be contrast medium etc.. The distal ends of the liquid inlet passage 111 and the filling passage 113 are closed, and the distal end of the liquid return passage 112 has at least one suction port 114, and at least one suction port 114 is preferably located between the first balloon 121 and the second balloon 122.

In another preferred embodiment, the third balloon 123 may not be provided, but rather may be provided by providing a protrusion on the distal end of the second balloon 122. In this manner, the balloon 120 includes a first balloon 121 (i.e., a proximal balloon) and a second balloon 122 (i.e., a distal balloon), the second balloon 122 including a proximal portion and a distal portion, the distal portion having an expanded diameter (including a maximum diameter) that is greater than the diameter (including a maximum diameter) of the proximal portion, the micropores being located on a surface of the proximal portion.

In another preferred embodiment, the second balloon 122 may not be provided, instead being perforated directly on the surface of the catheter body 110 for the release of the medical fluid. In this way, the balloon 120 includes a first balloon 121 (i.e., a proximal balloon) and a third balloon 123 (i.e., a distal balloon), and the section of the tube between the first balloon 121 and the third balloon 123 on the liquid inlet channel 111 is provided with micropores.

In another preferred embodiment, the shape of the first balloon 121 and/or the third balloon 123 is specially designed to address the problem of calcified lesions in the blood vessel. As shown in fig. 6, the first balloon 121 has a disk shape after being inflated. In the inflated state of the first balloon 121, the length of the first balloon 121 in the axial direction of the catheter is smaller than the height of the radial projection of the first balloon, preferably twice or more the length of the radial projection of the first balloon. In a more preferred embodiment, the first balloon 121 is a non-compliant balloon and has a maximum expanded diameter equal to or slightly larger than the diameter of the blood vessel, so that free deformation can be realized in the blocked blood vessel, and good blocking effect in the case of calcified lesion of the blood vessel can be realized, and the damage to the blood vessel can be reduced. Similarly, the third balloon 123 may be in the shape of a disk after inflation, not shown. In the inflated state of the third balloon 123, the length of the third balloon 123 in the axial direction of the catheter is smaller than the height of the radial projection of the third balloon 123, preferably twice or more the length. In a more preferred embodiment, the third balloon 123 is also a non-compliant balloon, which not only achieves good occlusion in case of calcified lesions of the blood vessel, but also reduces damage to the blood vessel. It will be appreciated that when the inlet passage is provided with micro-holes or the distal balloon is provided with micro-holes, it is preferred that the axial length of the proximal balloon after inflation is less than its radial height. It should also be understood that when the surface of the inlet channel is provided with micropores, the axial length of the inflated distal balloon is preferably smaller than the radial height thereof.

In the following description, three balloons are mainly used as an example, but the present invention should not be limited thereto, and those skilled in the art should be able to apply the following description to the case of two balloons.

Fig. 3 is a schematic view of a balloon catheter according to a preferred embodiment of the present invention in use. As shown in fig. 3, taking an interventional blood vessel as an example, after the balloon catheter 100 is introduced into the blood vessel S, the three balloons are inflated, wherein the first balloon 121 and the third balloon 123 swell at the proximal end and the distal end of the second balloon 122 to block the blood vessel S for a short time, and block the blood flow, and thereafter, the liquid medicine is delivered into the second balloon 122 through the liquid inlet channel 111, under the action of the liquid medicine pressure, the liquid medicine overflows into the blood vessel S through the micropores 124 on the second balloon 122, and due to the concentration difference of the liquid medicine, the overflowing liquid medicine is diffused and transferred into the blood vessel tissue and absorbed by the blood vessel tissue. In fig. 3, the arrows indicate the flow direction of the chemical solution. And when the liquid medicine is filled, the liquid medicine on the periphery of the second balloon 122 is pumped back through the liquid return channel 112 through the at least one suction port 114 at the far end of the liquid return channel, so that a part of the overflowed liquid medicine is sucked into the liquid return channel 112 (the pumped back liquid medicine is not used any more), and meanwhile, new liquid medicine is continuously conveyed to the second balloon 122 through the liquid inlet channel 111 and overflows from the micropores 124. And because the flow brought by the suction of the suction port 114 also reduces the probability of thrombosis, the safety of the instrument is improved.

The utility model discloses do not limit to the kind of the medicine of carrying, for example can be the medicine that restraines cell proliferation, anti-inflammatory medicine, antibiotic medicine, antineoplastic medicine, antimitotic medicine, anti osteoporosis medicine, anti-angiogenesis's medicine etc.. And may be a combination of multiple drugs. Illustratively, the drug is, for example, one or more of an mTOR inhibitor, paclitaxel and its derivatives, antiplatelet drugs, cilostazol, ticlopidine, triptolide, dexamethasone, methotrexate, fluorouracil, mercaptopurine, hydroxyurea, cytarabine, carboplatin, cisplatin, oxaliplatin, dicycloplatin, daunorubicin, doxorubicin, and arsenic trioxide. The mTOR inhibitor may be one or more combinations of rapamycin (sirolimus), everolimus, ridaforolimus, temsirolimus, and zotarolimus.

In this embodiment, the catheter body 110 can be manufactured separately. In some embodiments, the catheter body 110 may be assembled from an outer tube 110a and an inner tube 110 b. Referring to fig. 1 and 2, the catheter body 110 includes an outer tube 110a and an inner tube 110 b. As shown in fig. 4, the outer tube 110a is a triple lumen tube, and specifically includes a first lumen 115, a second lumen 116, and a third lumen 117 extending axially. The distal end of the first lumen 115 opens to be directly configured as the return fluid passage 112. The distal end of the third lumen 117 is closed and configured to fill the passage 113. In addition, the second inner cavity 116 is used for being installed in the inner tube 110b, and the distal end of the inner tube 110b extends out of the second inner cavity 116, so that the liquid inlet channel 111 is constructed by the inner tube 110 b. In addition, the first balloon 121 is fitted over the outer tube 110a, and the second balloon 122 and the third balloon 123 are fitted over the distal end portion of the inner tube 110b extending out of the outer tube 110 a. In an alternative embodiment, the catheter body 110 may also be integrally formed, such as by machining, to form the outer tube 110a and the inner tube 110 b.

Further, as shown in fig. 5, the catheter body 110 further includes a suction catheter 110c for providing the fluid return passage 112. The suction catheter 110c is inserted into the first lumen 115, and preferably, the distal end of the suction catheter 110c extends out of the first lumen 115 into the blood vessel, so that the medical fluid can be pumped back through the suction catheter 110c through at least one suction port 114 at the distal end thereof, and thus, the suction efficiency is high, and the suction effect is good. In this embodiment, a syringe or a pump may be provided at the proximal end of the suction catheter 110c, and the medical fluid may be withdrawn manually or mechanically through the syringe. It should also be understood that it is not necessary for the distal end of the aspiration catheter 110c to extend out of the first lumen 115 into the blood vessel, and in other instances, the distal end of the aspiration catheter 110c may be concealed within the first lumen 115.

The outer tube 110a may also be a double lumen tube, including a first inner lumen 115 and a second inner lumen 116 extending axially, the first inner lumen 115 being open at a distal end thereof to be directly configured as the fluid return passage 112, and the second inner lumen 116 being configured to receive the inner tube 110b, and a distal end of the inner tube 110b extending out of the second inner lumen 116, so that the fluid inlet passage 111 is directly provided by the inner tube 110b, in which case, the first balloon 121 is disposed on the outer tube 110a, the second balloon 122 and the third balloon 123 are disposed on a distal end portion of the inner tube 110b extending out of the outer tube 110a, and the fluid inlet passage 111 has at least three fluid inlets respectively communicating with the first balloon 121, the second balloon 122 and the third balloon 123, so that the three balloons are inflated by delivering the fluid from the inner tube 110b to the three balloons. Similarly, when the outer tube 110a is a double lumen tube, the fluid return channel 112 may also be provided by the aspiration catheter 110 c.

Further, the catheter body 110 further has a guide wire cavity for passing a guide wire. For example, inner tube 110b provides a guidewire lumen. The proximal end and the distal end of the second balloon 122 are further provided with developing marks so as to judge the position where the liquid medicine needs to be infused according to the developing marks. The development mark is made of a metal development material. In some embodiments, visualization markers are provided adjacent the proximal and distal ends, respectively, of the second balloon 122; in some embodiments, visualization markers are disposed adjacent the distal end of first balloon 121 and visualization markers are disposed adjacent the proximal end of third balloon 123. The development mark may be a development spot or a development ring.

In this embodiment, the number of the suction ports 114 is one, and in other embodiments, the number of the suction ports 114 may be multiple, including 2 or more than 2.

Next, the present embodiment also provides a test result of the drug transfer effect of the existing drug-coated balloon and the balloon catheter of the present invention; wherein, a micro-injection needle is used to perforate in the direction perpendicular to the longitudinal axis of the second balloon 122 to form micropores 124, and the pore diameter of the micropores 124 is 245 μm. As shown in FIG. 7, after the perforation, the pore size of the micropores 124 can be confirmed by a microscope, and FIG. 7 is a micrograph of the micropores 124 having a size of 245 μm. In addition, in the experiment, the experiment was performed using an in vitro animal blood vessel, and the number of specimen duplicate in the experiment was 3.

Specifically, a conventional drug coating balloon is prepared, wherein the drug is a mixture of paclitaxel and iopromide, the mixing mass ratio is 1:1, the mixture is coated on the surface of the balloon by ultrasonic spraying, the diameter of the expanded balloon is 3.0mm, the length of the expanded balloon is 18mm, and the total content of the drug on the sprayed balloon is 508 micrograms. In the balloon catheter of the utility model, equivalent paclitaxel and surfactant tween80 are added into water and are vibrated for 180 minutes by probe type ultrasonic wave, so that the paclitaxel and the surfactant are uniformly dispersed as perfusion liquid medicine. During the experiment, the drug coating sacculus expands 60 seconds after getting into the blood vessel, and the utility model discloses a fill 1 ml liquid medicine in 60 seconds after the sacculus pipe gets into the blood vessel, the liquid medicine content that fills is 508 micrograms. After inflation or perfusion, the experimental vessel sections were cut and tested for drug tissue concentration, with the results shown in fig. 8. The test result shows, uses the utility model discloses a behind the sacculus pipe, instant tissue drug concentration is 2.5 times of drug coating sacculus, and is visible, the utility model discloses a sacculus pipe has apparent medicine transfer effect.

To sum up, according to the utility model provides a technical scheme utilizes the mode that the sacculus perfused the liquid medicine to organize and carry the medicine, has solved the problem that traditional medicine coating sacculus loses the medicine in a large number in transportation process, and the medicine is carried effectually, and medicine transfer efficiency is high. Moreover, the blood vessel is blocked by the near-end balloon and the far-end balloon, so that the loss of the liquid medicine flowing to the two ends in the perfusion process is further reduced, and the transfer efficiency of the medicine is further improved. In addition, the liquid medicine is pumped back through the suction catheter, so that the efficiency of transferring the medicine to the tissue is further improved, the risk of thrombus generation in the blocked blood vessel is reduced, and the safety is good. In addition, the near-end saccule and/or the far-end saccule are disc-shaped, so that the problem of vascular calcification lesion is solved well, and the treatment effect is good.

It should be understood that the above-described embodiments specifically disclose features of preferred embodiments of the present invention so that those skilled in the art may better understand the present invention. It will be appreciated by those skilled in the art that, in light of the disclosure provided herein, the present invention can be readily modified to carry out the same purposes and/or to carry out the same advantages as the disclosed embodiments of the invention. Those skilled in the art should also realize that such similar constructions do not depart from the scope of the present disclosure, and that they may make various changes, substitutions and alterations herein without departing from the scope of the present disclosure.

Claims

1. A balloon catheter is characterized by comprising a catheter body and balloons, wherein the balloons comprise a first balloon, a second balloon and a third balloon, and the first balloon, the second balloon and the third balloon are sequentially sleeved on the catheter body at intervals from a near end and a far end along the axial direction of the catheter body;

2. A balloon catheter according to claim 1, wherein at least one said suction port is located between said first balloon and said second balloon.

3. A balloon catheter according to claim 1 or 2, wherein the catheter body further comprises an inflation channel isolated from the inlet channel and the return channel, respectively;

4. A balloon catheter according to claim 3, wherein the catheter body comprises an outer tube and an inner tube; the outer tube comprises first, second and third axially extending lumens, the first lumen being configured as the flashback passage, the third lumen being configured as the filling passage, and the inner tube being configured as the insufflation passage;

5. A balloon catheter according to claim 3, wherein the catheter body comprises an outer tube, an inner tube and a suction catheter; the outer tube comprises first, second and third axially extending lumens, the third lumen being configured as the filling channel, the inner tube being configured as the feed channel, the suction catheter being configured as the return channel;

6. A balloon catheter according to claim 1 or 2, wherein the inlet channel has at least three inlets communicating with the first, second and third balloons, respectively, for delivering liquid to the first, second and third balloons through the inlet channel to inflate the first, second and third balloons.

7. The balloon catheter of claim 6, wherein the catheter body comprises an outer tube and an inner tube, the outer tube comprising first and second axially extending lumens, the first lumen configured as the flashback passage, the inner tube configured as the intake passage;

8. The balloon catheter of claim 6, wherein the catheter body comprises an outer tube, an inner tube, and a suction catheter; the outer tube comprises first and second axially extending lumens, the suction catheter is configured as the flashback passage, and the inner tube is configured as the intake passage;

9. A balloon catheter according to claim 1 or 2, wherein the second balloon is a single layer balloon or a double layer balloon; when the second sacculus is double-deck sacculus, a plurality of micropores have been seted up on the surface of the outer sacculus of double-deck sacculus, perhaps, a plurality of micropores have all been seted up on the surface of the outer sacculus of double-deck sacculus and inlayer sacculus.

10. A balloon catheter according to claim 1, wherein the first balloon has an expanded axial length less than a radial height and/or the third balloon has an expanded axial length less than a radial height.

11. A balloon catheter according to claim 10, wherein the first and/or third balloon is a non-compliant balloon.

12. The balloon catheter is characterized by comprising a catheter body and balloons, wherein the balloons comprise a near-end balloon and a far-end balloon, and the near-end balloon and the far-end balloon are sequentially sleeved on the catheter body at intervals from the near end to the far end along the axial direction of the catheter body;

13. A balloon catheter according to claim 12, wherein when the distal balloon has a plurality of micropores formed on a surface thereof, the distal balloon includes a proximal portion and a distal portion, the distal portion having an expanded diameter larger than an expanded diameter of the proximal portion, and the micropores are formed on a surface of the proximal portion.

14. The balloon catheter of claim 12, wherein an axial length of the proximal balloon after inflation is less than a radial height.

15. The balloon catheter according to claim 12, wherein when the surface of the liquid inlet channel is provided with a plurality of micropores, the axial length of the inflated distal balloon is smaller than the radial height.

16. A balloon catheter according to claim 12, wherein the proximal balloon and/or the distal balloon is a non-compliant balloon.