Balloon Catheter

Abstract

The present invention relates to a balloon catheter, comprising a catheter body and a balloon arranged at the distal end of the catheter body; wherein, a drug delivery hole is arranged on the surface of the balloon; the balloon catheter has a first state and a second state; when the balloon catheter is in the first state, the drug delivery hole does not penetrate the balloon wall; when the balloon catheter is in the second state, the drug delivery hole penetrates the balloon wall for releasing liquid medicine; when in use, when the drug delivery hole and the balloon wall do not penetrate, the pressure of balloon expansion can be ensured, the balloon can be fully expanded, the effect of balloon expansion of blood vessels can be ensured, and the transfer rate of the drug can be improved; and when the drug delivery hole and the balloon wall penetrate, the liquid medicine can be released through the drug delivery hole to achieve the purpose of targeted treatment.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon catheter. Background Art

[0002] Since the 1970s, it has become increasingly common to treat various cardiovascular diseases through interventional medical devices. It has experienced three milestones of rapid development: percutaneous balloon angioplasty (PTCA), bare metal stents (BMS), and drug-eluting stents (DES). In particular, the emergence of drug-coated stents has achieved great success in treating vascular stenosis, showing the potential of DES in treating stenosis. At present, DES is the first choice for the treatment of obstructive coronary heart disease, but it has problems such as late stent thrombosis, long vascular healing time, and easy impact on vascular pulsation. In addition, the application of DES is limited in in-stent restenosis (ISR), small vessel lesions, and bifurcation lesions. In this case, drug-coated balloons (DCBs) came into being and showed good therapeutic effects.

[0003] At present, drug-eluting balloons are coated with anti-proliferative drugs on the surface of the balloons. When in use, the balloons are pushed to the target lesions to expand the balloons to release the drugs. There are still some problems in the use of drug-eluting balloons with this design. For example, the drugs are easily lost during the pushing process, resulting in insufficient drug dosage or even toxic side effects caused by the fallen drugs. The drugs coated on the surface of the drug balloons are easy to form large drug particles during expansion, which can easily cause distal vascular embolism, posing a high safety risk. In addition, the drug dosage is uncontrollable, and one balloon can only be used in one part. In response to these problems, people have designed perfusion drug balloons, that is, the drug solution is injected from the inner cavity of the balloon and flows out through the micropores on the surface of the balloon or other parts of the micropores, and the drug solution is absorbed by the tissue. The advantages of this design of drug balloons are that there is no loss of drugs during the pushing process, no large particles are generated, and the drug dosage is controllable.

[0004] However, the existing drug-infused balloons (such as Chinese patent CN 104436421 A) have the problem of not being able to fully expand, resulting in the balloon not being able to fully fit the blood vessel wall, causing a large amount of drug loss (drug loss to the distal end), reducing the drug transfer rate, and reducing the side effects of the drug on the human body. In addition, this type of drug balloon also has the problem of not being able to completely discharge the air during the folding process, leaving air inside the balloon, which not only increases the outer diameter of the balloon, but also if the balloon cannot be emptied before entering the body, the balloon itself has gas, and these gases are easy to form gas emboli in the human body, endangering the patient's life safety. Summary of the invention

[0005] In order to solve the above technical problems, the purpose of the present invention is to provide a balloon catheter, which can ensure that the balloon can fully expand during the filling process, reduce the loss of drugs, improve the transfer rate of drugs, and will not form air emboli in the human body, thereby improving safety.

[0006] To achieve the above object, the present invention provides a balloon catheter, comprising a catheter body and a balloon disposed at the distal end of the catheter body; wherein a drug delivery hole is disposed on the surface of the balloon;

[0007] The balloon catheter has a first state and a second state; when the balloon catheter is in the first state, the drug delivery hole does not penetrate the balloon wall; when the balloon catheter is in the second state, the drug delivery hole penetrates the balloon wall for releasing the drug solution.

[0008] Optionally, when the balloon catheter is in the first state, the drug delivery hole is arranged on the outer surface of the balloon and does not penetrate the inner surface of the balloon, or, the drug delivery hole is arranged on the inner surface of the balloon and does not penetrate the outer surface of the balloon.

[0009] Optionally, when the balloon catheter is in the first state, the depth of the drug delivery hole is 1% to 99% of the wall thickness of the balloon.

[0010] Optionally, when the balloon catheter is in the first state, the depth of the drug delivery hole is 80% of the wall thickness of the balloon.

[0011] Optionally, there are multiple drug delivery holes, and when the balloon catheter is in the first state, the depths of the multiple drug delivery holes are the same or different.

[0012] Optionally, the shape of the drug delivery hole is regular or irregular.

[0013] Optionally, there are multiple dosing holes, and the shapes of the multiple dosing holes are the same or different.

[0014] Optionally, there are multiple drug delivery holes, and the multiple drug delivery holes are regularly or irregularly distributed on the balloon.

[0015] Optionally, the shape of the balloon after expansion is straight or dumbbell-shaped.

[0016] Optionally, the balloon is made of a developing material.

[0017] Optionally, the drug delivery hole that does not penetrate the balloon wall is formed on the surface of the balloon by laser etching process.

[0018] Optionally, the balloon comprises a first balloon and a second balloon, and the second balloon is nested in the first balloon;

[0019] The drug delivery holes include a first drug delivery hole and a second drug delivery hole, and the first drug delivery hole is arranged on the surface of the first balloon, and the second drug delivery hole is arranged on the surface of the second balloon;

[0020] When the balloon catheter is in the first state, the first drug delivery hole does not penetrate the balloon wall of the first balloon; when the balloon catheter is in the second state, the first drug delivery hole penetrates the balloon wall of the first balloon to release the drug solution; the second drug delivery hole always penetrates the balloon wall of the second balloon.

[0021] Optionally, the balloon comprises a first balloon and a second balloon, and the second balloon is nested in the first balloon;

[0022] The drug delivery holes include a first drug delivery hole and a second drug delivery hole, and the first drug delivery hole is arranged on the surface of the first balloon, and the second drug delivery hole is arranged on the surface of the second balloon;

[0023] When the balloon catheter is in the first state, the second drug delivery hole does not penetrate the balloon wall of the second balloon; when the balloon catheter is in the second state, the second drug delivery hole penetrates the balloon wall of the second balloon to release the drug solution; the first drug delivery hole always penetrates the balloon wall of the first balloon.

[0024] Optionally, the first medication hole and the second medication hole are staggered.

[0025] Optionally, the drug delivery hole is used to penetrate the balloon wall under the pressure of the drug solution when the drug solution fills the balloon.

[0026] The balloon catheter of the present invention is provided with a dosing hole on the balloon surface, and the dosing hole is not connected with the balloon before releasing the liquid medicine, so that the balloon can be fully expanded during the filling process, so as to fully fit with the blood vessel wall, and then when the pressure inside the balloon reaches a certain value, due to the relatively weak structure at the dosing hole, the dosing hole is broken and leaked under the pressure of the liquid medicine, so as to release the liquid medicine, so that the infused liquid medicine can be continuously transferred to the lesion site, and the purpose of targeted treatment is achieved. The structure of this dosing hole ensures the effect of the balloon dilating blood vessels, so that the liquid medicine can be transferred to the lesion site in time, reduces the loss of the liquid medicine, and prevents excessive drugs from entering the human body circulation, reducing the side effects of drugs on the human body. Moreover, before the dosing hole is broken and leaked, it is also convenient to completely empty the air inside the balloon during the folding process, so that no air will remain inside the balloon, thereby reducing the outer diameter of the balloon and improving the ability of the balloon to pass through the lesion site. In addition, the balloon is emptied before entering the body, and there is no air inside, which also reduces the probability of gas embolism in the blood vessels, improves the safety of the operation, and reduces the risk of the operation. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] Figure 1 It is a schematic structural diagram of a balloon catheter provided by a preferred embodiment of the present invention;

[0028] Figure 2 It is a schematic diagram of providing circular drug delivery holes on the surface of a balloon provided by a preferred embodiment of the present invention, wherein the drug delivery holes are regularly distributed on the balloon;

[0029] Figure 3 It is a schematic diagram of providing rectangular drug delivery holes on the surface of a balloon provided by a preferred embodiment of the present invention, wherein the drug delivery holes are regularly distributed on the balloon;

[0030] Figure 4 It is a schematic diagram of a preferred embodiment of the present invention providing circular drug delivery holes on the surface of a balloon, wherein the drug delivery holes are regularly distributed on the balloon, and the diameter of the drug delivery holes is larger and the distribution is more sparse;

[0031] Figure 5 It is a schematic diagram of providing regular and irregular shaped drug delivery holes on the surface of a balloon provided by a preferred embodiment of the present invention;

[0032] Figure 6 It is a schematic diagram of providing a drug delivery hole on the inner surface of a balloon provided by a preferred embodiment of the present invention;

[0033] Figure 7 It is a schematic diagram of providing a drug delivery hole on the outer surface of a balloon provided by a preferred embodiment of the present invention;

[0034] Figure 8 It is a schematic diagram of the distal end position of a balloon catheter with double balloons provided in a preferred embodiment of the present invention. DETAILED DESCRIPTION

[0035] The following is an explanation of the embodiments of the present invention by specific examples, and those skilled in the art can easily understand other advantages and effects of the present invention from the contents disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and the details in this specification can also be modified or changed in various ways based on different viewpoints and applications without departing from the spirit of the present invention. It should be noted that the illustrations provided in the present embodiment only illustrate the basic concept of the present invention in a schematic manner, and only the components related to the present invention are shown in the figure instead of being drawn according to the number, shape and size of the components in the actual implementation. The type, quantity and proportion of each component in the actual implementation can be a random change, and the component layout type may also be more complicated.

[0036] In addition, each embodiment of the following description has one or more technical features, but this does not mean that the user of the present invention must implement all the technical features in any embodiment at the same time, or can only implement part or all of the technical features in different embodiments separately. In other words, under the premise that implementation is possible, those skilled in the art can selectively implement part or all of the technical features in any embodiment according to the disclosure of the present invention and according to the design specifications or implementation requirements, or selectively implement a combination of part or all of the technical features in multiple embodiments, thereby increasing the flexibility of the implementation of the present invention.

[0037] To make the purpose, advantages and features of the present invention clearer, the present invention is further described in detail below in conjunction with the accompanying drawings. It should be noted that the accompanying drawings are all in very simplified form and all use non-precise proportions, which are only used to facilitate and clearly assist in explaining the purpose of the embodiments of the present invention. As used in this specification, the singular forms "one", "a" and "the" include plural objects, unless the content clearly indicates otherwise. As used in this specification, the meaning of "multiple" usually includes at least two, unless the content clearly indicates otherwise. As used in this specification, the term "or" is usually used to include the meaning of "and / or", unless the content clearly indicates otherwise. It should also be understood that the present invention repeats reference numbers and / or letters in various embodiments. This repetition is for the purpose of simplicity and clarity, and it does not itself indicate the relationship between the various embodiments and / or configurations discussed. It will also be understood that when an element is referred to as "connecting" another element, it can be directly connected to another element, or one or more intermediate elements can be present. In this article, the proximal end is an end close to the operator, and the distal end is an end that first enters the human body.

[0038] The core idea of ​​the present invention is to provide a balloon catheter, on the surface of the balloon, a drug delivery hole is provided for releasing the drug solution, but before releasing the drug solution, the drug delivery hole does not penetrate the balloon wall, and there is no problem of drug solution leakage from the balloon. In this way, the integrity of the balloon is ensured, and the pressure of the balloon during the filling process can be maintained, so that it can fully expand and fully fit with the blood vessel wall, reduce the loss of drug solution, improve the transfer rate of the drug, prevent excessive drugs from entering the human circulation, and reduce the side effects of the drug on the human body. When the pressure inside the balloon reaches a certain value, due to the relatively weak structure at the drug delivery hole (that is, the wall of the balloon at the drug delivery hole is thin, the compressive limit strength is low, and it is easy to rupture), the balloon is easily ruptured by the pressure of the drug solution at the drug delivery hole. After rupture, the drug solution inside the balloon can be released, and the drug solution is transferred to the lesion site to achieve the purpose of targeted treatment. In particular, because the drug delivery hole does not penetrate the balloon at the beginning, it is easy to completely empty the air inside the balloon during the folding process, so that no air will remain inside the balloon, thereby reducing the passing outer diameter of the balloon, and making it easy to design the passing outer diameter of the balloon as the theoretical minimum. It should be understood that the smaller the passing outer diameter of the balloon, the easier it is to pass through the lesion, and the stronger the ability to pass through the lesion. It should be understood that the passing outer diameter is the minimum outer diameter of the balloon catheter passing through the lesion. Moreover, since the balloon is emptied before entering the body, there is no air inside, thereby reducing the probability of gas embolism in the blood vessels, improving the safety of the operation, and reducing the risk of the operation.

[0039] The balloon catheter proposed by the present invention is further described below in conjunction with the accompanying drawings and preferred embodiments.

[0040] Figure 1 The schematic diagram of the structure of the balloon catheter provided by the preferred embodiment of the present invention. Figure 1 As shown, an embodiment of the present invention provides a balloon catheter 100, which can be a coaxial overall exchange type (Over The Wire, OTW) or a rapid exchange type (Rapid Exchange System), and the specific exchange form is not limited.

[0041] The balloon catheter 100 of this embodiment is a drug-infused balloon to provide drugs to the lesion site through the holes on the balloon surface. Specifically, the balloon catheter 100 includes a balloon 11 and a catheter body 12, and the balloon 11 is arranged at the distal end of the catheter body 12. The balloon 11 can be a single-layer balloon or a multi-layer balloon, without limitation. The so-called single-layer balloon means that the number of balloons 11 is one, but the balloon 11 has only one layer of wall made of the same material. The so-called multi-layer balloon means that the number of balloons 11 is one, but the balloon 11 is composed of multiple layers of walls made of different materials, such as two layers of walls of different materials.

[0042] Then as Figure 2 and Figure 3As shown, the surface of the balloon 11 is provided with a plurality of drug delivery holes 111. There is no requirement for the number of drug delivery holes 111, and the shape of the drug delivery holes 111 is not limited. Figures 2 to 4 The regular shape shown can also be Figure 5 The irregular shape shown. The regular-shaped drug delivery hole 111 can be circular, rectangular, triangular, quadrilateral or other polygonal, or elliptical. Furthermore, the shapes of the drug delivery holes 111 on the balloon 11 can be the same or different. Furthermore, both regular-shaped drug delivery holes 111 and irregular-shaped drug delivery holes 111 can be set on the balloon 11, or both regular-shaped drug delivery holes 111 and irregular-shaped drug delivery holes 111 can be set on the balloon 11. For example Figure 2 and Figure 4 As shown, a circular drug delivery hole 111 is uniformly provided on the balloon 11; or as Figure 3 As shown, a rectangular drug delivery hole 111 is uniformly provided on the balloon 11; or as Figure 5 As shown, both elliptical medication holes 111 and irregular medication holes 111 are provided on the balloon 11. Therefore, there are many ways to arrange the medication holes 111, and the present invention is not limited thereto.

[0043] It should be known that no matter what kind of drug delivery hole 111, when the balloon catheter 100 is in the first state (i.e., the initial state), the drug delivery hole 111 does not penetrate the balloon wall, i.e., it only penetrates the outer surface of the balloon or penetrates the inner surface of the balloon, but does not penetrate the inner and outer surfaces of the balloon 11 at the same time. However, when the balloon catheter 100 is in the second state (i.e., after the drug delivery hole 111 ruptures and leaks, this is the use state), the drug delivery hole 111 penetrates the balloon wall, i.e., it penetrates the outer and inner surfaces of the balloon to release the drug solution. In some embodiments, as Figure 6 As shown, the inner surface 112 of the balloon is perforated to form a dosing hole 111, and the depths of the dosing holes 111 can be the same or different. For example, the depths of the dosing holes 111 are different to adapt to balloons with uneven wall thicknesses, and these dosing holes 111 do not penetrate the outer surface 113 of the balloon. In other embodiments, such as Figure 7As shown, a dosing hole 111 is formed by punching holes on the outer surface 113 of the balloon, and the depths of the dosing holes 111 may be the same or different, for example, the depths of the dosing holes 111 are different to adapt to balloons with uneven wall thicknesses, and none of these dosing holes 111 penetrate the inner surface 112 of the balloon. The present invention does not limit the formation method of the dosing hole 111, for example, a circular dosing hole 111 may be formed by punching holes on the surface of the balloon 11 with an injection needle, or a dosing hole 111 of a regular or irregular shape may be formed by punching holes on the surface of the balloon 11 using 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. There are certain technical difficulties in processing a drug delivery hole that does not penetrate the balloon on such a thin balloon wall. In order to overcome this difficulty, it is preferred to use a laser etching process to open a drug delivery hole 111 that does not penetrate the balloon wall on the surface of the balloon 11, and in order to ensure the accuracy of the drilling, the laser control parameters are optimized. Preferably, the focus of the laser is at a predetermined depth in the thickness direction of the balloon, and the focus of the laser is much smaller than the wall thickness of the balloon. In addition, the laser light source is preferably a carbon dioxide, ultraviolet light or blue light source, the laser energy 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 the balloon on a sphere-like balloon, thereby ensuring the processing accuracy of the drug delivery hole 111.

[0044] Furthermore, the drug delivery holes 111 may be regularly or irregularly distributed on the balloon 11, for example Figures 2 to 4 As shown, the drug delivery holes 111 are regularly distributed on the balloon 11. Figure 5 As shown, the dosing holes 111 are irregularly distributed on the balloon 11. Preferably, the dosing holes 111 are irregularly distributed on the balloon 11, which is not only conducive to reducing the aperture of the dosing holes 111, but also convenient for adapting to irregular lesion locations, and realizing targeted drug delivery at irregular lesion locations. In addition, in the first state, the depth of the dosing holes 111 is preferably 1% to 99% of the balloon wall thickness, and more preferably 80% of the balloon wall thickness, to ensure that the dosing holes 111 can rupture and leak under the action of a lower liquid medicine pressure. In addition, the dosing holes 111 are preferably distributed along the entire circumference of the balloon 11 to achieve 360° drug delivery.

[0045] Further, the catheter body 12 includes an outer tube 121 and an inner tube 122, wherein the inner tube 122 is inserted into the outer tube 121, and the distal end of the inner tube 122 extends out of the distal end of the outer tube 121. The proximal end of the balloon 11 is connected to the outer tube 121, and the distal end of the balloon 11 is connected to the inner tube 122. The inner tube 122 is used for passing a guide wire, and a perfusion channel is formed between the outer tube 121 and the inner tube 122. The distal end of the perfusion channel is connected to the inner cavity of the balloon 11 to deliver liquid medicine to the inside of the balloon 11 through the perfusion channel. In the process of delivering liquid medicine, first, when the drug delivery hole 111 is not opened, the balloon 11 can be filled with liquid medicine, and after the drug delivery hole 111 is opened, the drug delivery hole 111 is released.

[0046] Furthermore, a developing structure made of developing material is provided on the section of the inner tube 122 located inside the balloon 11, which is used to locate the balloon 11 during surgery. The developing structure may include a proximal developing structure 123 and a distal developing structure 124, which may be developing points, developing rings or developing segments. For example, the developing structure may be nested on the inner tube 122, or may be integrally manufactured with the inner tube 122. For example, during manufacturing, some length of the inner tube 122 located inside the balloon 11 is designed to be developable, so that the developing structure is integrally formed with the inner tube 122. The proximal developing structure 123 corresponds to the proximal end of the balloon 11, which facilitates the development and positioning of the proximal end of the balloon under X-rays, and the distal developing structure 124 corresponds to the distal end of the balloon 11, which facilitates the development and positioning of the distal end of the balloon under X-rays.

[0047] Preferably, the balloon 11 is made of a developing material so that the balloon 11 itself can also be developed, which is convenient for observing the expansion state of the balloon 11 during the operation, so that the doctor can perform the operation more accurately. The developing material for preparing the balloon 11 is not limited, including but not limited to barium sulfate. The shape of the balloon 11 can be straight, that is, the expanded balloon 11 is a cylinder with a uniform diameter, which is convenient for matching blood vessels with uniform diameters. In other embodiments, the shape of the balloon 11 can be dumbbell-shaped, that is, large at both ends and small in the middle. Considering that for long lesions, the blood vessels originally have a certain taper, in order to make the drug fully contact with the blood vessel wall, and the balloon at the distal end does not hurt the normal blood vessels, the shape of the balloon 11 is preferably dumbbell-shaped. The advantage of the dumbbell-shaped balloon 11 is that it can be blocked at both ends to prevent the drug solution from being lost to the distal end, and ensure the transfer rate of the drug solution. Among them, when the balloon 11 is dumbbell-shaped, the drug delivery hole 111 is mainly arranged on the straight section in the middle.

[0048] Further, the balloon catheter also includes a handle 13, which may be in a "Y" shape, 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 connectors, such as two Luer connectors, may be provided on the handle 13, through which the guide wire may be inserted into the catheter, and an external liquid supply device may be connected to the Luer connector, so as to deliver liquid medicine into the catheter. Further, the balloon catheter also includes a stress diffusion tube 14, through which the outer tube 121 is connected to the handle 13. The function of the stress diffusion tube 14 is to reduce the loss of pushing force during the advancement of the catheter. Further, the stress diffusion tube 14 is connected to the handle 13 by means of physical combination, 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 is inserted into the handle 13 and is combined together by means of elastic deformation.

[0049] Next, the working mode of the balloon catheter of this embodiment will be further described.

[0050] First, after the balloon 11 enters the body, the balloon 11 is positioned by the developing structure on the inner tube 122, and the liquid medicine is sent into the balloon 11 through the perfusion channel to fill the balloon 11. When the balloon 11 reaches the nominal diameter, the pressure is kept constant so that the balloon 11 remains in a fully expanded state and in full contact with the blood vessel wall. Thereafter, the pressure can be continued to be increased or maintained until the drug delivery hole 11 ruptures and leaks, releasing the liquid medicine, so that the liquid medicine is released through the drug delivery hole 111 and absorbed by the lesion site, achieving the corresponding therapeutic effect. Such a setting can not only achieve targeted drug delivery, but also prevent excessive drugs from entering the human circulation and reduce the side effects of drugs on the human body. Moreover, the drug delivery holes 111 on the surface of the balloon 11 can be distributed 360° in the circumferential direction, achieving 360° all-round drug delivery, and high drug delivery efficiency.

[0051] Furthermore, the present invention does not limit the type of drug administered, such as anti-tumor drugs, antibiotics, thrombolytic drugs, antithrombotic drugs, vasodilators or developers, etc. In addition, the surface of the balloon 11 can be provided with a hydrophilic coating to improve the lubricity of the balloon surface.

[0052] Further, the balloon catheter 100 of this embodiment may include a single balloon, or may include two nested balloons. Figure 8As shown, when the balloon catheter 100 includes two nested balloons, it may include a first balloon 11a (outer balloon) and a second balloon 11b (inner balloon), and the second balloon 11b is nested in the first balloon 11a; wherein, a first drug delivery hole (not shown) is provided on the surface of the first balloon 11a; when the balloon catheter 100 is in the first state, the first drug delivery hole does not penetrate the balloon wall of the first balloon 11a; when the balloon catheter 100 is in the second state, the first drug delivery hole penetrates the balloon wall of the first balloon 11a; in addition, a second drug delivery hole (not shown) is provided on the surface of the second balloon 11b, and in the first state and the second state, the second drug delivery hole always penetrates the balloon wall of the second balloon 11b. Similarly, during the filling process, the double balloons can be fully expanded and fully contact the blood vessel wall, and the air inside the double balloons can be emptied during the folding process to avoid the formation of gas embolism after entering the body, and the small outer diameter and the ability to pass through the lesion site are strong. In more detail, after the liquid medicine enters the second balloon 11b through the perfusion channel in the conductive body 12, the second balloon 11b and the first balloon 11a are fully expanded. After the full expansion, the liquid medicine is continuously perfused into the second balloon 11b. Under the pressure of the liquid medicine, the liquid medicine flows into the first balloon 11a through the second drug delivery hole on the second balloon 11b. When the first drug delivery hole on the first balloon 11a ruptures, the liquid medicine overflows from the first drug delivery hole on the first balloon 11a into the blood vessel. This double-balloon design is beneficial to prevent the liquid medicine from being directly sprayed into the blood vessel at a high speed through the buffering effect of the outer balloon, thereby reducing the stimulation to the blood vessel and reducing the occurrence of vascular spasm. Alternatively, the second drug delivery hole of the second balloon 11b may not penetrate the balloon wall in the initial state, but may rupture after subsequent pressure, and the first drug delivery hole of the first balloon 11a may always penetrate the balloon wall of the first balloon 11a. More specifically, when the balloon catheter 100 is in the first state, the second drug delivery hole does not penetrate the balloon wall; when the balloon catheter 100 is in the second state, the second drug delivery hole penetrates the balloon wall for releasing the drug solution. In addition, it should be known that the first drug delivery hole on the first balloon and the second drug delivery hole on the second balloon are staggered.

[0053] Finally, it should be understood that the balloon catheter 100 of this embodiment can be applicable to unbranched blood vessels or branched blood vessels, and can be used for the treatment of blood vessels or cancer. It can not only deliver drugs more accurately, but also deliver drugs with higher safety. At the same time, the drug transfer rate is also high, and the ability to pass through the lesion site is stronger and the permeability is better, which reduces the side effects of the drug on the human body. On the other hand, it can also achieve slow release and long-term treatment of drugs, increase the drug action cycle, and improve the treatment effect.

[0054] The above description is only a description of the preferred embodiments of the present invention, and is not intended to limit the scope of the present invention. Any changes or modifications made by a person skilled in the art in the field of the present invention based on the above disclosure shall fall within the protection scope of the present invention.

Claims

1. A balloon catheter is a drug-infused balloon, which provides drugs to the lesion through the holes on the balloon surface, characterized in that: The invention comprises a catheter body and a balloon arranged at the distal end of the catheter body; wherein a drug delivery hole is arranged on the surface of the balloon; and the drug delivery hole which does not penetrate the balloon wall is formed on the surface of the balloon by laser etching process; The balloon catheter has a first state and a second state; when the balloon catheter is in the first state, the drug delivery hole does not penetrate the balloon wall; when the balloon catheter is in the second state, the drug delivery hole penetrates the balloon wall for releasing the drug solution; the drug delivery hole is used to penetrate the balloon wall under the pressure of the drug solution when the balloon is filled with the drug solution.

2. The balloon catheter according to claim 1, characterized in that: When the balloon catheter is in the first state, the drug delivery hole is arranged on the outer surface of the balloon and does not penetrate the inner surface of the balloon, or the drug delivery hole is arranged on the inner surface of the balloon and does not penetrate the outer surface of the balloon.

3. The balloon catheter according to claim 2, characterized in that: When the balloon catheter is in the first state, the depth of the drug delivery hole is 1% to 99% of the wall thickness of the balloon.

4. The balloon catheter according to claim 3, characterized in that: When the balloon catheter is in the first state, the depth of the drug delivery hole is 80% of the wall thickness of the balloon.

5. The balloon catheter according to any one of claims 1 to 4, characterized in that: There are multiple drug delivery holes, and when the balloon catheter is in the first state, the depths of the multiple drug delivery holes are the same or different.

6. The balloon catheter according to any one of claims 1 to 4, characterized in that: The shape of the drug delivery hole is regular or irregular.

7. The balloon catheter according to any one of claims 1 to 4, characterized in that: The number of the drug delivery holes is multiple, and the shapes of the multiple drug delivery holes are the same or different.

8. The balloon catheter according to any one of claims 1 to 4, characterized in that: The number of the drug delivery holes is multiple, and the multiple drug delivery holes are regularly or irregularly distributed on the balloon.

9. The balloon catheter according to any one of claims 1 to 4, characterized in that: The balloon has a straight or dumbbell shape after expansion.

10. The balloon catheter according to any one of claims 1 to 4, characterized in that: The balloon is made of a developing material.

11. The balloon catheter according to claim 1, characterized in that: The balloon comprises a first balloon and a second balloon, wherein the second balloon is nested in the first balloon; The drug delivery holes include a first drug delivery hole and a second drug delivery hole, and the first drug delivery hole is arranged on the surface of the first balloon, and the second drug delivery hole is arranged on the surface of the second balloon; When the balloon catheter is in the first state, the first drug delivery hole does not penetrate the balloon wall of the first balloon; when the balloon catheter is in the second state, the first drug delivery hole penetrates the balloon wall of the first balloon to release the drug solution; the second drug delivery hole always penetrates the balloon wall of the second balloon.

12. The balloon catheter according to claim 1, characterized in that: The balloon comprises a first balloon and a second balloon, wherein the second balloon is nested in the first balloon; The drug delivery holes include a first drug delivery hole and a second drug delivery hole, and the first drug delivery hole is arranged on the surface of the first balloon, and the second drug delivery hole is arranged on the surface of the second balloon; When the balloon catheter is in the first state, the second drug delivery hole does not penetrate the balloon wall of the second balloon; when the balloon catheter is in the second state, the second drug delivery hole penetrates the balloon wall of the second balloon to release the drug solution; the first drug delivery hole always penetrates the balloon wall of the first balloon.

13. The balloon catheter according to claim 11 or 12, characterized in that: The first medication hole and the second medication hole are staggered.

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