CN114159676A

CN114159676A - Balloon catheter

Info

Publication number: CN114159676A
Application number: CN202010940389.3A
Authority: CN
Inventors: 段志邦; 史增佐; 周宇; 朱清
Original assignee: Shanghai Hongmai Medical Technology Co ltd
Current assignee: Shanghai Hongmai Medical Technology Co ltd
Priority date: 2020-09-09
Filing date: 2020-09-09
Publication date: 2022-03-11
Also published as: WO2022052524A1

Abstract

The invention relates to a balloon catheter, which comprises a catheter main body and a balloon arranged at the far end of the catheter main body; wherein the surface of the balloon is provided with an administration hole; the balloon catheter has a first state and a second state; when the balloon catheter is in the first state, the administration hole does not penetrate through the balloon wall; when the balloon catheter is in the second state, the medicine feeding hole penetrates through the balloon wall and is used for releasing medicine liquid; when the drug delivery hole is not penetrated through the balloon wall, the balloon expansion pressure can be ensured, the balloon is fully expanded, the balloon blood vessel expansion effect is ensured, the transfer rate of the drug is improved, and when the drug delivery hole is penetrated through the balloon wall, the drug liquid can be released through the drug delivery hole, so that the purpose of targeted therapy is achieved.

Description

Balloon catheter

Technical Field

The invention relates to the technical field of medical instruments, in particular to a balloon catheter.

Background

Since the last 70 s of the century, the treatment of various cardiovascular diseases by interventional type medical devices has become increasingly common. And the rapid development of three milestones, namely, simple balloon dilatation (PTCA), a Bare Metal Stent (BMS) and a Drug Eluting Stent (DES) is performed in sequence. In particular, the advent of drug-coated stents has enjoyed great success in treating vascular stenosis, demonstrating the potential of DES in treating stenosis. At present, DES is the first choice for the treatment of obstructive coronary heart disease, but has the problems of late stent thrombosis, long vessel healing time, easy influence on vessel pulsation and the like. And DES applications are limited in-stent restenosis (ISR), small vessel lesions, and bifurcation lesions, in which case drug-coated balloons (DCB) are produced and show superior therapeutic efficacy.

The conventional medicine balloon is coated with antiproliferative medicines on the surface of the balloon, the balloon is pushed to a target lesion to expand the balloon to release the medicines when in use, and the medicine balloon with the design has certain problems in use, for example, medicines are easy to fall off and lose in the pushing process, so that the medicine with insufficient medicine dosage or even falls off can cause toxic and side effects, the medicines coated on the surface of the medicine balloon easily form large medicine particles when being expanded, so that far-end vascular embolism is easy to cause, high safety risk is realized, the medicine dosage is uncontrollable, and one balloon can only be used for one part. Aiming at the problems, people design a drug-filled balloon, namely, drug solution is injected from the inner cavity of the balloon and flows out through micropores on the surface of the balloon or other parts of the balloon, and the drug solution is absorbed by tissues.

However, the existing drug-infused balloon (such as chinese patent CN 104436421 a) has a problem of insufficient expansion, resulting in insufficient attachment of the balloon to the vessel wall, resulting in a great loss of the drug (drug loss to the far end), a decrease in the transfer rate of the drug, and a decrease in the side effects of the drug on the human body. Not only does this type of medicine sacculus still have the problem that can't discharge air completely in the folding process, makes the inside residual air of sacculus, not only increases the through external diameter of sacculus, and if the sacculus can't empty before getting into the body, the sacculus itself has gas, and these gas easily form the air cock in the human body, endanger patient's life safety.

Disclosure of Invention

In order to solve the above technical problems, an object of the present invention is to provide a balloon catheter, which can ensure sufficient expansion of a balloon during filling, reduce the loss of a drug, improve the transfer rate of the drug, prevent the formation of an air embolism in a human body, and improve safety.

In order to achieve the above object, the present invention provides a balloon catheter, comprising a catheter main body and a balloon disposed at a distal end of the catheter main body; wherein the surface of the balloon is provided with an administration hole;

the balloon catheter has a first state and a second state; when the balloon catheter is in the first state, the administration hole does not penetrate through the balloon wall; when the balloon catheter is in the second state, the administration hole penetrates through the balloon wall and is used for releasing the liquid medicine.

Optionally, the drug delivery hole is disposed on an outer surface of the balloon and does not penetrate through an inner surface of the balloon when the balloon catheter is in the first state, or the drug delivery hole is disposed on an inner surface of the balloon and does not penetrate through an outer surface of the balloon.

Optionally, when the balloon catheter is in the first state, the depth of the administration hole is 1% to 99% of the wall thickness of the balloon.

Optionally, the depth of the administration hole is 80% of the wall thickness of the balloon when the balloon catheter is in the first state.

Optionally, the number of the drug delivery holes is multiple, and when the balloon catheter is in the first state, the depths of the drug delivery holes are the same or different.

Optionally, the shape of the administration hole is a regular shape or an irregular shape.

Optionally, the number of the administration holes is multiple, and the shapes of the administration holes are the same or different.

Optionally, the number of the administration holes is multiple, and the multiple administration holes are regularly or irregularly distributed on the balloon.

Optionally, the balloon is shaped as a straight or dumbbell after expansion.

Optionally, the balloon is made of a visualization material.

Optionally, the drug delivery hole which does not penetrate through the balloon wall is formed on the surface of the balloon by using a laser etching process.

Optionally, the balloon comprises a first balloon and a second balloon nested within the first balloon;

the drug delivery holes comprise a first drug delivery hole and a second drug delivery hole, the first drug delivery hole is formed in the surface of the first balloon, and the second drug delivery hole is formed in the surface of the second balloon;

when the balloon catheter is in the first state, the first administration hole does not penetrate through the balloon wall of the first balloon; when the balloon catheter is in the second state, the first administration hole penetrates through the balloon wall of the first balloon and is used for releasing the liquid medicine; the second administration hole always penetrates through the balloon wall of the second balloon.

when the balloon catheter is in the first state, the second administration hole does not penetrate through the balloon wall of the second balloon; when the balloon catheter is in the second state, the second administration hole penetrates through the balloon wall of the second balloon and is used for releasing the liquid medicine; the first drug delivery hole penetrates through the balloon wall of the first balloon all the time.

Optionally, the first dosing hole and the second dosing hole are arranged in a staggered manner.

Optionally, the drug delivery hole is used for penetrating through the balloon wall under the pressure of the drug solution when the drug solution fills the balloon.

According to the balloon catheter, the dosing holes are formed in the surface of the balloon, and the dosing holes are not communicated with the balloon before the liquid medicine is released, so that the balloon can be fully expanded in the filling process and is fully attached to the wall of a blood vessel, and after the pressure in the balloon reaches a certain value, the structure of the dosing holes is weak, so that the dosing holes are broken and leaked under the pressure action of the liquid medicine, the liquid medicine is released, the poured liquid medicine can be continuously transferred to a lesion part, and the purpose of targeted therapy is achieved. The structure of the medicine feeding hole ensures the effect of expanding blood vessels by the balloon, so that the medicine liquid can be transferred to the pathological change part in time, the loss of the medicine liquid is reduced, the excessive medicine is prevented from entering the human body circulation, and the side effect of the medicine on the human body is reduced. Moreover, before the drug delivery hole is broken and leaked, air in the balloon can be completely emptied conveniently in the folding process, so that air cannot be left in the balloon, the passing outer diameter of the balloon is reduced, and the capacity of the balloon passing through a lesion part is improved. And the saccule is emptied before entering the body, no air exists in the saccule, the probability of forming air embolism in the blood vessel is reduced, the safety of the operation is improved, and the operation risk is reduced.

Drawings

FIG. 1 is a schematic structural view of a balloon catheter provided in accordance with a preferred embodiment of the present invention;

FIG. 2 is a schematic view of a balloon surface provided with circular administration holes, wherein the administration holes are regularly distributed on the balloon;

FIG. 3 is a schematic view of a balloon surface provided with rectangular administration holes, wherein the administration holes are regularly distributed on the balloon;

FIG. 4 is a schematic view of the balloon surface provided with circular administration holes according to the preferred embodiment of the present invention, wherein the administration holes are regularly distributed on the balloon, and the diameter of the administration holes is larger and the distribution is more sparse;

FIG. 5 is a schematic view of a balloon surface provided with regular and irregular shaped drug delivery holes according to a preferred embodiment of the present invention;

FIG. 6 is a schematic view of the placement of an administration port on the inner surface of a balloon provided by a preferred embodiment of the present invention;

FIG. 7 is a schematic view of the placement of an administration port on the outer surface of a balloon provided by a preferred embodiment of the present invention;

fig. 8 is a schematic view of the distal end position of a balloon catheter with a dual balloon provided by a preferred embodiment of the present invention.

Detailed Description

The embodiments of the present invention are described below with reference to specific embodiments, and other advantages and effects of the present invention will be easily understood by those skilled in the art from the disclosure of the present specification. The invention is capable of other and different embodiments and of being practiced or of being carried out in various ways, and its several details are capable of modification in various respects, all without departing from the spirit and scope 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 present invention, and the components related to the present invention are only shown in the drawings rather than drawn according to the number, shape and size of the components in actual implementation, and the type, quantity and proportion of the components in actual implementation may be changed freely, and the layout of the components may be more complicated.

Furthermore, each of the embodiments described below has one or more technical features, and thus, the use of the technical features of any one embodiment does not necessarily mean that all of the technical features of any one embodiment are implemented at the same time or that only some or all of the technical features of different embodiments are implemented separately. In other words, those skilled in the art can selectively implement some or all of the features of any embodiment or combinations of some or all of the features of multiple embodiments according to the disclosure of the present invention and according to design specifications or implementation requirements, thereby increasing the flexibility in implementing the invention.

To further clarify the objects, advantages and features of the present invention, a more particular description of the invention will be rendered by reference to the appended drawings. It is to be noted that the drawings are in a very simplified form and are not to precise scale, which is merely for the purpose of facilitating and distinctly claiming 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 at least two 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. It is also to 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. Herein, the proximal end is the end near the operator, and the distal end is the end that enters the body first.

The core idea of the invention is to provide a balloon catheter, wherein the surface of the balloon is provided with an administration hole for releasing liquid medicine, but before the liquid medicine is released, the administration hole does not penetrate through the wall of the balloon, so that the problem of liquid medicine leakage from the balloon does not exist, and thus, the integrity of the balloon is ensured, the pressure of the balloon in the filling process can be maintained, the balloon can be fully expanded and fully attached to the wall of a blood vessel, the loss of the liquid medicine is reduced, the transfer rate of the medicine is improved, the excessive medicine is prevented from entering the circulation of a human body, and the side effect of the medicine on the human body is reduced. When the pressure in the balloon reaches a certain value, the structure at the administration hole is weak (namely, the wall of the balloon at the administration hole is thin, the pressure limit strength is low, and the balloon is easy to break), so that the balloon is easy to break under the pressure action of the liquid medicine at the administration hole, and after the balloon is broken, the liquid medicine in the balloon can be released, and the liquid medicine is transferred to a lesion part, thereby achieving the purpose of targeted therapy. In particular, since the administration hole does not initially penetrate the balloon, it is easy to completely evacuate air inside the balloon during folding so that no air remains inside the balloon, thereby reducing the passing outer diameter of the balloon so that the passing outer diameter of the balloon can be easily designed to a theoretical minimum value. It will be appreciated that the smaller the outer diameter of the balloon, the easier it is to pass through the lesion and the greater its ability to pass through the lesion. It will be understood that the through outer diameter is the smallest outer diameter of the balloon catheter through the lesion. In addition, because the saccule is emptied before entering the body, the inside of the saccule does not have air, thereby reducing the probability of forming air embolism in the blood vessel, improving the safety of the operation and reducing the operation risk.

The balloon catheter provided by the invention is further described with reference to the accompanying drawings and preferred embodiments.

Fig. 1 is a schematic structural view of a balloon catheter according to a preferred embodiment of the present invention. As shown in fig. 1, The embodiment of The present invention provides a balloon catheter 100, and The balloon catheter 100 may be of a coaxial whole Exchange type (OTW) or a Rapid Exchange type (Rapid Exchange System), and The specific Exchange form is not limited.

The balloon catheter 100 of the present embodiment is a drug-infused balloon to provide drugs to the lesion site through the holes on the surface of the balloon. Specifically, the balloon catheter 100 includes a balloon 11 and a catheter main body 12, and the balloon 11 is disposed at a distal end of the catheter main body 12. The balloon 11 may be a single layer balloon or a multi-layer balloon, without limitation. By single layer balloon is meant that the number of balloons 11 is one, but that the balloons 11 have only one wall made of the same material. By a multilayer balloon is meant that the number of balloons 11 is one, but that the balloon 11 consists of a multilayer wall made of different materials, for example of two layers of walls of different materials.

Next, as shown in fig. 2 and 3, a plurality of administration holes 111 are opened on the surface of the balloon 11, the number of administration holes 111 is not required, and the shape of the administration holes 111 is not limited, and may be a regular shape as shown in fig. 2 to 4, or an irregular shape as shown in fig. 5. The regular-shaped administration hole 111 may be circular, rectangular, triangular, quadrangular, polygonal, elliptical, or the like. Further, the shape of the administration holes 111 on the balloon 11 may be the same or different. Further, the balloon 11 may be provided with the regular-shaped administration holes 111, the irregular-shaped administration holes 111 may be provided at the same time, or the regular-shaped administration holes 111 or the irregular-shaped administration holes 111 may be provided in the balloon 11 in a uniform manner. For example, as shown in fig. 2 and 4, a circular administration hole 111 is uniformly provided in the balloon 11; alternatively, as shown in fig. 3, a rectangular administration hole 111 is provided in the balloon 11; alternatively, as shown in fig. 5, the balloon 11 may be provided with both an oval administration hole 111 and an irregularly shaped administration hole 111. Accordingly, the administration hole 111 may be provided in various ways, and the present invention is not limited thereto.

It will be appreciated that, regardless of the drug delivery holes 111, when the balloon catheter 100 is in the first state (i.e., the initial state), the drug delivery holes 111 do not extend through the balloon wall, i.e., only extend through the outer surface of the balloon or only extend through the inner surface of the balloon, but do not extend through both the inner and outer surfaces of the balloon 11. However, when the balloon catheter 100 is in the second state (i.e. after the drug delivery hole 111 is ruptured and leaked, which is the use state), the drug delivery hole 111 penetrates the balloon wall, that is, penetrates the outer surface and the inner surface of the balloon, to release the drug solution. In some embodiments, as shown in fig. 6, the inner surface 112 of the balloon is perforated to form the drug delivery holes 111, and the depths of the drug delivery holes 111 may be the same or different, for example, the depths of the drug delivery holes 111 may be different to accommodate a balloon with a non-uniform wall thickness, and none of the drug delivery holes 111 penetrates through the outer surface 113 of the balloon. In other embodiments, as shown in fig. 7, the outer surface 113 of the balloon is perforated to form the drug delivery holes 111, and the depths of the drug delivery holes 111 may be the same or different, for example, the depths of the drug delivery holes 111 may be different to accommodate balloons with non-uniform wall thickness, and none of the drug delivery holes 111 penetrate the inner surface 112 of the balloon. The present invention is not limited to the formation of the administration hole 111, and for example, a circular administration hole 111 may be formed by punching a hole on the surface of the balloon 11 through a needle, or a regular or irregular administration hole 111 may be formed by punching a hole on the surface of the balloon 11 through a laser etching process. It should be understood that the wall thickness of the balloon is usually very small, for example, only 0.03mm to 0.04mm, and the drug delivery hole that does not penetrate through the balloon is processed on the balloon wall that is so thin, and there is a certain difficulty in the process, in order to overcome this difficulty, it is preferable to form the drug delivery hole 111 that does not penetrate through the balloon wall on the surface of the balloon 11 by using a laser etching process, and in order to ensure the drilling precision, optimization is made on laser control parameters, preferably, the focal point of the laser is at a predetermined depth in the thickness direction of the balloon, and the focal point of the laser is much smaller than the wall thickness of the balloon, and further, the laser light source is preferably a carbon dioxide, ultraviolet or blue light source, the energy of the laser is 0.001MW to 1000MW, and the laser wavelength is preferably 1nm to 2000nm, so as to facilitate the precise processing of the drug delivery hole 111 that does not penetrate through the balloon on a balloon similar to the balloon, and ensure the processing precision of the drug delivery hole 111.

Further, the drug delivery holes 111 may be regularly or irregularly distributed on the balloon 11, for example, as shown in fig. 2 to 4, the drug delivery holes 111 may be regularly distributed on the balloon 11, and for example, as shown in fig. 5, the drug delivery holes 111 may be irregularly distributed on the balloon 11. Preferably, the administration holes 111 are irregularly distributed on the balloon 11, which is not only beneficial to reducing the aperture of the administration holes 111, but also convenient to adapt to irregular lesion positions, and realizes targeted administration of the irregular lesion positions. In addition, in the first state, the depth of the administration hole 111 is preferably 1% to 99% of the balloon wall thickness, and more preferably 80% of the balloon wall thickness, so that the administration hole 111 can be ruptured and leaked under the action of low medical liquid pressure. In addition, the administration holes 111 are preferably distributed along the entire circumference of the balloon 11 to achieve 360 ° administration.

Further, the catheter body 12 includes an outer tube 121 and an inner tube 122, the inner tube 122 is inserted into the outer tube 121, and a distal end of the inner tube 122 extends out of a distal end of the outer tube 121. The proximal end of the balloon 11 is connected to an outer tube 121 and the distal end of the balloon 11 is connected to an inner tube 122. Wherein, the inner tube 122 is used for guiding a wire, a perfusion channel is formed between the outer tube 121 and the inner tube 122, a distal end of the perfusion channel is communicated with the inner cavity of the balloon 11 to deliver a liquid medicine to the inside of the balloon 11 through the perfusion channel, during the process of delivering the liquid medicine, firstly when the administration hole 111 is not opened, the balloon 11 can be filled with the liquid medicine, and after the administration hole 111 is opened, the liquid medicine is released through the administration hole 111.

Further, a visualization structure made of a visualization material is provided on the section of the inner tube 122 inside the balloon 11 for positioning the balloon 11 during the procedure. The visualization structures may include proximal visualization structure 123 and distal visualization structure 124, which may be visualization points, visualization rings, or visualization segments. For example, the image-developing structure may be embedded in the inner tube 122 or may be integrally formed with the inner tube 122. For example, during manufacture, some of the length of the inner tube 122 inside the balloon 11 is designed to be visualized, such that the visualization structure is integrally formed with the inner tube 122. The near-end developing structure 123 is arranged corresponding to the near end of the balloon 11, so that the position of the near end of the balloon can be conveniently developed and positioned under X-rays, and the far-end developing structure 124 is arranged corresponding to the far end of the balloon 11, so that the position of the far end of the balloon can be conveniently developed and positioned under X-rays.

Preferably, the balloon 11 is made of a developing material, so that the balloon 11 itself can be developed, and the expanded state of the balloon 11 can be observed conveniently during the operation, so that the doctor can perform the operation more accurately. The imaging material from which the balloon 11 is made is not limited, and includes, but is not limited to, barium sulfate. The shape of the balloon 11 may be straight, that is, the balloon 11 after being expanded is a cylinder with a uniform diameter, so as to be convenient for matching with a blood vessel with a uniform diameter. In other embodiments, the balloon 11 may be dumbbell-shaped, i.e., large at both ends and small in the middle. Considering that the blood vessel has a certain taper for long lesions, the shape of the balloon 11 is preferably dumbbell-shaped in order to make the drug contact with the blood vessel wall sufficiently and to prevent the balloon at the distal end from damaging the normal blood vessel. The dumbbell-shaped balloon 11 also has the advantages that the balloon can be plugged at two ends, so that the liquid medicine is prevented from running off to the far end, and the transfer rate of the liquid medicine is ensured. Wherein, when the balloon 11 is dumbbell-shaped, the administration hole 111 is mainly provided on the middle flat section.

Further, the balloon catheter further includes a handle 13, and the handle 13 may be "Y" shaped, disposed at the proximal end of the catheter body 12, and may be connected to the proximal ends of the inner tube 122 and the outer tube 121. Further, a plurality of luer fittings, such as two luer fittings, may be provided on the handle 13, through which a guide wire may be threaded into the catheter, and an external liquid supply device may be connected to the luer fittings to deliver a liquid medicine into the catheter. Further, the balloon catheter further comprises a stress diffusion tube 14, and the outer tube 121 is connected with the handle 13 through the stress diffusion tube 14. The effect of the stress diffusion tube 14 is to reduce the loss of push force during catheter advancement. Further, the stress diffusion tube 14 is connected to the handle 13 by means of physical bonding, for example, the inner diameter of the handle 13 is larger than the outer diameter of the stress diffusion tube 14, so that the stress diffusion tube 14 can be inserted into the handle 13 and bonded together by means of elastic deformation.

Next, the operation of the balloon catheter of the present embodiment will be described further.

Firstly, after the balloon 11 enters the body, after the balloon 11 is positioned by the developing structure on the inner tube 122, the liquid medicine is sent into the balloon 11 through the perfusion channel, so that the balloon 11 is inflated, and after the balloon 11 reaches the nominal diameter, the pressure is kept unchanged, so that the balloon 11 is kept in a fully expanded state and fully contacts with the blood vessel wall, and then the pressurization or the pressure maintenance can be continued until the administration hole 11 is broken and leaked, the liquid medicine is released, and the liquid medicine is released through the administration hole 111 and absorbed by the lesion part, so that the corresponding treatment effect is achieved. By the arrangement, when the targeted drug delivery is realized, excessive drugs can be prevented from entering human body circulation, and the side effect of the drugs on the human body is reduced. Moreover, the administration holes 111 on the surface of the balloon 11 can be distributed in 360 degrees in the circumferential direction, 360-degree all-directional administration is realized, and the administration efficiency is high.

Furthermore, the present invention is not limited to the type of drug to be administered, and examples thereof include antitumor drugs, antibiotics, thrombolytic drugs, antithrombotic drugs, vasodilators, and imaging agents. In addition, the surface of the balloon 11 can be provided with a hydrophilic coating to improve the lubricity of the surface of the balloon.

Further, the balloon catheter 100 of the present embodiment may include a single balloon, or two nested balloons. As shown in fig. 8, when the balloon catheter 100 includes two nested balloons, a first balloon 11a (outer balloon) and a second balloon 11b (inner balloon) may be included, the second balloon 11b being nested within the first balloon 11 a; wherein, a first administration hole (not shown) is provided on the surface of the first balloon 11 a; when the balloon catheter 100 is in the first state, the first administration hole does not penetrate through the balloon wall of the first balloon 11 a; when the balloon catheter 100 is in the second state, the first administration hole penetrates through the balloon wall of the first balloon 11 a; a second administration hole (not shown) is provided in the surface of the second balloon 11b, and the second administration hole is always inserted through the balloon wall of the second balloon 11b in the first state and the second state. In a similar way, in the filling process, the double balloons can be fully expanded and fully contacted with the vascular wall, the air inside the double balloons can be emptied in the folding process, the air embolism formed in the body can be avoided, and the double balloons are small in outer diameter and strong in ability of passing through the pathological change part. More specifically, after the medical fluid enters the second balloon 11b through the perfusion channel in the conduction body 12, the second balloon 11b and the first balloon 11a are fully expanded, after the second balloon 11b and the first balloon are fully expanded, the medical fluid is continuously perfused into the second balloon 11b, and under the pressure of the medical fluid, the medical fluid flows into the first balloon 11a through the second administration hole in the second balloon 11b, and after the first administration hole in the first balloon 11a is broken, the medical fluid overflows into the blood vessel from the first administration hole in the first balloon 11 a. The design of the double saccules is beneficial to preventing the liquid medicine from being directly sprayed into the blood vessel at a higher speed through the buffer action of the outer saccule, reducing the stimulation effect on the blood vessel and reducing the occurrence of vasospasm. Alternatively, the second administration hole of the second balloon 11b may not penetrate through the balloon wall in the initial state and be ruptured after subsequent pressurization, and the first administration hole of the first balloon 11a may always penetrate through the balloon wall of the first balloon 11a, more specifically, when the balloon catheter 100 is in the first state; when the balloon catheter 100 is in the second state, the second administration hole penetrates through the balloon wall and is used for releasing the liquid medicine. Furthermore, it will be appreciated that the first drug delivery aperture in the first balloon and the second drug delivery aperture in the second balloon are offset.

Finally, it should be understood that the balloon catheter 100 of the present embodiment may be applicable to an unbranched blood vessel or a branched blood vessel, and may be used for treatment of a blood vessel or cancer, and not only may be more accurately administered, but also the administration safety is higher, and at the same time, the transfer rate of the drug is also high, and the ability of passing through a diseased region is stronger, and the passability is better, and in addition, the side effect of the drug on the human body is reduced, and on the other hand, slow release and long-term treatment of the drug may also be achieved, and the action period of the drug is increased, and the treatment effect is improved.

The above description is only for the purpose of describing the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention, and any variations and modifications made by those skilled in the art based on the above disclosure are within the scope of the present invention.

Claims

1. A balloon catheter is characterized by comprising a catheter main body and a balloon arranged at the far end of the catheter main body; wherein the surface of the balloon is provided with an administration hole;

the balloon catheter has a first state and a second state; when the balloon feeding catheter is in the first state, the drug delivery hole does not penetrate through the balloon wall; when the balloon catheter is in the second state, the administration hole penetrates through the balloon wall and is used for releasing the liquid medicine.

2. A balloon catheter according to claim 1, wherein the drug delivery hole is provided in an outer surface of the balloon and does not extend through an inner surface of the balloon when the balloon catheter is in the first state, or wherein the drug delivery hole is provided in an inner surface of the balloon and does not extend through an outer surface of the balloon.

3. A balloon catheter according to claim 2, wherein the depth of the administration hole is 1-99% of the wall thickness of the balloon when the balloon catheter is in the first state.

4. A balloon catheter according to claim 3, wherein the depth of the administration hole is 80% of the wall thickness of the balloon when the balloon catheter is in the first state.

5. A balloon catheter according to any one of claims 1-4, wherein the number of the administration holes is plural, and the depths of the plural administration holes are the same or different when the balloon catheter is in the first state.

6. A balloon catheter according to any of claims 1-4, wherein the shape of the administration holes is regular or irregular.

7. A balloon catheter according to any one of claims 1 to 4, wherein the number of the administration holes is plural, and the plural administration holes are the same or different in shape.

8. A balloon catheter according to any one of claims 1-4, wherein the number of said administration holes is plural, and plural of said administration holes are regularly or irregularly distributed on said balloon.

9. A balloon catheter according to any of claims 1-4 wherein the balloon is flat or dumbbell shaped after expansion.

10. A balloon catheter according to any of claims 1-4, wherein the balloon is made of a contrast material.

11. A balloon catheter according to any one of claims 1-4, wherein the administration hole which does not penetrate through the balloon wall is formed on the surface of the balloon by a laser etching process.

12. A balloon catheter according to claim 1, wherein said balloon comprises a first balloon and a second balloon nested within said first balloon;

13. A balloon catheter according to claim 1, wherein said balloon comprises a first balloon and a second balloon nested within said first balloon;

14. A balloon catheter according to claim 12 or 13, wherein said first and second administration holes are offset.

15. The balloon catheter according to claim 1, wherein the administration hole is adapted to penetrate the balloon wall under pressure of the medical fluid when the medical fluid fills the balloon.