WO2022052524A1

WO2022052524A1 - Balloon catheter

Info

Publication number: WO2022052524A1
Application number: PCT/CN2021/097502
Authority: WO
Inventors: 段志邦; 史增佐; 周宇; 朱清
Original assignee: 上海鸿脉医疗科技有限公司
Priority date: 2020-09-09
Filing date: 2021-05-31
Publication date: 2022-03-17
Also published as: CN114159676A

Abstract

A balloon catheter (100), comprising a catheter body (12) and a balloon (11) provided at a distal end of the catheter body (12), wherein a drug delivery hole (111) is provided on the surface of the balloon (11); the balloon catheter (100) has a first state and a second state; when the balloon catheter (100) is in the first state, the drug delivery hole (111) does not penetrate through a balloon wall; when the balloon catheter (100) is in the second state, the drug delivery hole (111) penetrates through the balloon wall for releasing a liquid medicine. During use, when the drug delivery hole does not penetrate through the balloon wall, the pressure of balloon expansion can be ensured to fully expand the balloon, the effect of dilating a blood vessel by the balloon is ensured, and the drug transfer rate is improved; when the drug delivery hole penetrates through the balloon wall, the liquid medicine can be released through the drug delivery hole to achieve the purpose of targeted treatment.

Description

Balloon catheter

technical field

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

Background technique

Treatment of various cardiovascular diseases with interventional medical devices has become increasingly common since the 1970s. Interventional medical devices have experienced three milestones of rapid development: simple balloon dilatation (PTCA), bare metal stent (BMS), and drug-eluting stent (DES). In particular, the emergence of drug-eluting stents has achieved great success in the treatment of vascular stenosis, showing the potential of DES in the treatment of 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 influence on vascular pulsation. In-stent restenosis (ISR), small vessel disease and bifurcation disease all limit the application of DES. Under this circumstance, drug-coated balloon (DCB) came into being and showed good therapeutic effect.

In the current drug balloons, anti-proliferative drugs are coated on the surface of the balloon, and when in use, the balloon is pushed to the target lesion to expand the balloon to release the drug. There are still some problems in the use of the drug balloon of this design. For example, in the process of pushing, the drug is easy to fall off and lose, resulting in insufficient dose of the drug or even the drug that falls off will cause toxic side effects; the drug coated on the surface of the drug balloon is likely to form large drug particles during expansion, which can easily lead to distal vascular embolism. , has a high safety risk; and the drug dose is not controllable, and one balloon can only be used for one site. In response to these problems, perfusion drug balloons are designed, 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, so that the drug solution is absorbed by the tissue. The advantages of this designed drug balloon are that there is no drug loss during the pushing process, no large particles are generated, and the drug dosage is controllable.

However, the existing perfusion drug balloon (such as Chinese patent CN 104436421 A) has the problem that it cannot be fully expanded, resulting in the inability of the balloon and the blood vessel wall to fully fit, resulting in a large amount of drug loss (drug loss to the distal end), reducing The transfer rate of the drug is improved, and the side effect of the drug on the human body is improved. Not only that, but this kind of drug balloon also has the problem that the air cannot be completely expelled during the folding process, so that air remains inside the balloon. This not only increases the outside diameter of the passage of the balloon, but also prevents the balloon from being emptied to contain gas before entering the body. These gases can easily form air emboli in the human body, endangering the lives of patients.

SUMMARY OF THE INVENTION

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 be fully expanded 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 , to improve security.

In order 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 administration hole is provided 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 administration hole does not penetrate the balloon wall; when the balloon catheter is in the second state In the state, the drug delivery hole penetrates through the balloon wall and is used for releasing the drug solution.

Optionally, when the balloon catheter is in the first state, the administration hole is provided on the outer surface of the balloon and does not penetrate through the inner surface of the balloon, or the administration hole It is disposed on the inner surface of the balloon and does not penetrate the 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, when the balloon catheter is in the first state, the depth of the administration hole is 80% of the wall thickness of the balloon.

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

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

Optionally, the expanded shape of the balloon is a straight shape or a dumbbell shape.

Optionally, the balloon is made of imaging material.

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

Optionally, the balloon includes a first balloon and a second balloon, and the second balloon is nested in the first balloon;

The dosing hole includes a first dosing hole and a second dosing hole, and the first dosing hole is provided on the surface of the first balloon, and the second dosing hole is provided on the surface of the second balloon. the second administration hole;

When the balloon catheter is in the first state, the first administration hole does not penetrate the balloon wall of the first balloon; when the balloon catheter is in the second state, the first administration hole does not penetrate the balloon wall of the first balloon; The first dosing hole penetrates the balloon wall of the first balloon for releasing the medicinal liquid; the second dosing hole always penetrates 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 does not penetrate the balloon wall of the second balloon; The second dosing hole penetrates the balloon wall of the second balloon for releasing the medical liquid; the first dosing hole always penetrates the balloon wall of the first balloon.

Optionally, the first dosing hole and the second dosing hole are dislocated.

Optionally, the drug delivery hole is used to penetrate through the balloon wall under the pressure of the medicinal liquid when the medicinal liquid fills the balloon.

In the balloon catheter of the present invention, a dosing hole is provided on the surface of the balloon, and the dosing hole does not pass through with the balloon before releasing the medicinal liquid, so that the balloon can be fully expanded during the filling process, so as to be fully connected with the blood vessel wall. fit. When the pressure inside the balloon reaches a certain value, due to the weak structure of the drug delivery hole, the drug delivery hole ruptures under the pressure of the drug solution and leaks the drug solution, thereby releasing the drug solution, so that the injected drug solution can continue to Metastases to the lesion site to achieve the purpose of targeted therapy. The structure design of this drug delivery hole ensures the effect of balloon dilation of blood vessels, so that the medicinal liquid can be transferred to the diseased part in time, which reduces the loss of medicinal liquid, prevents excessive drugs from entering the human body circulation, and reduces the effect of drugs on the human body. side effect. Moreover, before the dosing hole is ruptured and the liquid medicine leaks, it is also convenient to completely empty the air inside the balloon during the folding process, so that no air remains inside the balloon, thereby reducing the passing outer diameter of the balloon and improving the efficiency of the balloon. The ability of the balloon to pass through the lesion. In addition, the balloon is evacuated before entering the body, and there is no air inside, which also reduces the probability of air embolism in the blood vessel, improves the safety of the operation, and reduces the risk of the operation.

Description of drawings

1 is a schematic structural diagram of a balloon catheter provided by a preferred embodiment of the present invention;

Fig. 2 is a schematic diagram of setting round dosing holes on the surface of the balloon provided by a preferred embodiment of the present invention, wherein the dosing holes are regularly distributed on the balloon;

Fig. 3 is a schematic diagram of setting rectangular dosing holes on the surface of the balloon provided by a preferred embodiment of the present invention, wherein the dosing holes are regularly distributed on the balloon;

Fig. 4 is a schematic diagram of setting round dosing holes on the surface of the balloon provided by a preferred embodiment of the present invention, wherein the dosing holes are regularly distributed on the balloon, and the diameter of the dosing holes is larger and the distribution is more sparse;

5 is a schematic diagram of setting regular and irregular shaped dosing holes on the surface of the balloon provided by a preferred embodiment of the present invention;

FIG. 6 is a schematic diagram of setting a drug delivery hole on the inner surface of the balloon according to a preferred embodiment of the present invention;

Figure 7 is a schematic diagram of setting a drug delivery hole on the outer surface of the balloon provided by a preferred embodiment of the present invention;

FIG. 8 is a schematic diagram of the distal end position of a balloon catheter with a double-layered balloon provided by a preferred embodiment of the present invention.

detailed description

The embodiments of the present invention are described below through specific 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 in other different specific embodiments. Various details in this specification can also be modified or changed in various ways without departing from the spirit of the present invention based on different viewpoints and applications. It should be noted that the drawings provided in this embodiment are only used to illustrate the basic concept of the present invention in a schematic way, so the drawings only show the components related to the present invention rather than the number, shape and the number of components in actual implementation. Dimensions are drawn. In actual implementation, the type, quantity and proportion of each component can be changed at will, and the layout of each component may also be more complicated.

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

In order to make the objects, advantages and features of the present invention clearer, the present invention will be further described in detail below with reference to the accompanying drawings. It should be noted that, the accompanying drawings are all in a very simplified form and in inaccurate scales, and are only used to facilitate and clearly assist the purpose of explaining 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 "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 will also be understood that the present invention repeats reference numerals and/or letters in various embodiments. This repetition is for simplicity and clarity, and does not in itself indicate 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. Here, the proximal end is the end close to the operator, and the distal end is the end that first enters the human body.

The core idea of the present invention is to provide a balloon catheter, wherein the drug delivery hole is provided on the surface of the balloon for releasing the medicinal liquid, but before the medicinal liquid is released, it does not penetrate through the balloon wall, and there is no medicinal liquid from The problem of balloon leakage. In this way, the integrity of the balloon is ensured, so that the pressure of the balloon can be maintained during the filling process, so that the balloon can be fully expanded and fully fitted with the blood vessel wall, reducing the loss of the drug solution, improving the transfer rate of the drug, and preventing overdose. Enter the circulation of the human body and reduce the side effects of the drug on the human body. In addition, when the pressure inside the balloon reaches a certain value, due to the relatively weak structure at the dosing hole (that is, the wall of the balloon at the dosing hole is thin, the ultimate compression strength is low, and it is easy to rupture), the balloon will not The drug hole is easily ruptured by the pressure of the drug solution. After the dosing hole is ruptured, the medicinal liquid inside the balloon can be released, so that the medicinal liquid can be transferred to the lesion site to achieve the purpose of targeted therapy. In particular, because the dosing hole does not penetrate the balloon initially, it is easy to completely empty the air inside the balloon during the folding process, so that no air remains inside the balloon, thereby reducing the outer diameter of the balloon. , so that the outer diameter of the balloon can be easily designed to be the theoretical minimum value. It should be understood that, the smaller the passing outer diameter of the balloon, the easier it is to pass through the diseased part, and the stronger the ability to pass through the diseased part. 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 evacuated before entering the body, there is no air inside, which reduces the probability of air embolism in the blood vessel, improves the safety of the operation, and reduces the risk of the operation.

The balloon catheter proposed by the present invention will be further described below with reference to the accompanying drawings and preferred embodiments.

FIG. 1 is a schematic structural diagram of a balloon catheter provided by a preferred embodiment of the present invention. As shown in FIG. 1 , an embodiment of the present invention provides a balloon catheter 100 , and the balloon catheter 100 may be a coaxial overall exchange type (Over The Wire, OTW) or a rapid exchange type (Rapid Exchange System). The specific exchange form is not limited.

The balloon catheter 100 of the present embodiment is a drug perfusion balloon, which provides drugs to the lesion through a hole on the surface of the balloon. Specifically, the balloon catheter 100 includes a balloon 11 and a catheter body 12 , and the balloon 11 is disposed at the distal end of the catheter body 12 . The balloon 11 may be a single-layer balloon or a multi-layer balloon, which is not limited. The so-called single-layer balloon means that the number of balloons 11 is one, but the balloon 11 has only one wall made of the same material. The so-called multi-layer balloon means that the number of the balloon 11 is one, but the balloon 11 is composed of multi-layer walls made of different materials, such as two layers of walls of different materials.

Next, as shown in FIG. 2 and FIG. 3 , a plurality of drug administration holes 111 are opened on the surface of the balloon 11 . The number of the administration holes 111 is not required, and the shape of the administration holes 111 is not limited. It may be a regular shape as shown in FIG. 2 to FIG. The regular-shaped dosing hole 111 may be a circle, a rectangle, a triangle, a quadrangle or other polygons, an ellipse, or the like. Further, the shapes of the administration holes 111 on the balloon 11 may be the same or different. Further, the balloon 11 can be provided with both regular-shaped drug delivery holes 111 and irregularly-shaped drug delivery holes 111 at the same time. Irregularly shaped dosing holes 111 . For example, as shown in FIG. 2 and FIG. 4 , circular drug administration holes 111 are uniformly provided on the balloon 11 ; or as shown in FIG. 3 , rectangular drug administration holes 111 are uniformly provided on the balloon 11 ; or as shown in FIG. 5 . As shown, the balloon 11 is provided with both an elliptical dosing hole 111 and an irregularly shaped dosing hole 111 . Therefore, the administration holes 111 can be arranged in various manners, which are not limited in the present invention.

It should be known that no matter what kind of administration hole 111 is, when the balloon catheter 100 is in the first state (ie, the initial state), the administration hole 111 does not penetrate through the balloon wall, that is, the administration hole 111 is only connected to the balloon. The outer surface penetrates or communicates with the inner surface of the balloon without penetrating both the inner and outer surfaces of the balloon 11 at the same time. However, when the balloon catheter 100 is in the second state (ie, the drug delivery hole 111 is ruptured and the drug solution is leaked, which is the use state), the drug delivery hole 111 penetrates the wall of the balloon, that is, the drug delivery hole 111 and the outer surface of the balloon It penetrates through the inner surface to release the liquid medicine. In some embodiments, as shown in FIG. 6 , the inner surface 112 of the balloon is perforated to form the administration hole 111 , and the depth of the administration hole 111 may be the same or different. For example, the depths of the administration holes 111 are different to accommodate balloons with uneven wall thickness, and none of these administration holes 111 penetrates through the outer surface 113 of the balloon. In other embodiments, as shown in FIG. 7 , holes are formed on the outer surface 113 of the balloon to form dosing holes 111 , and the depths of the dosing holes 111 may be the same or different. For example, the depths of the administration holes 111 are different to accommodate balloons with uneven wall thickness, and none of these administration holes 111 penetrates through the inner surface 112 of the balloon. The present invention does not limit the formation method of the drug delivery hole 111 , for example, a circular drug delivery hole 111 can be formed by punching a hole on the surface of the balloon 11 through a sample injection needle, or a laser etching process can be used on the surface of the balloon 11 The upper holes are punched to form regular or irregular shaped dosing holes 111 . It should be understood that the wall thickness of the balloon is usually very small, eg, only 0.03 mm to 0.04 mm. There are certain difficulties in the process of 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 preferable to use a laser etching process to open a drug delivery hole 111 on the surface of the balloon 11 that does not penetrate the balloon wall, and in order to ensure the accuracy of the punching, the laser control parameters are optimized. 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. In addition, the laser light source is preferably carbon dioxide, ultraviolet light or blue light source, the energy of the laser is 0.001MW～1000MW, and the wavelength of the laser is preferably 1nm～2000nm, so as to facilitate accurate processing on the ball-like balloon without breaking the balloon. The medicine hole 111 ensures the machining accuracy of the medicine hole 111 .

Further, the administration holes 111 may be distributed on the balloon 11 regularly or irregularly, for example, as shown in FIG. 2 to FIG. 4 , the administration holes 111 are regularly distributed on the balloon 11 , as shown in FIG. 5, the administration holes 111 are irregularly distributed on the balloon 11. Preferably, the dosing holes 111 are irregularly distributed on the balloon 11, which not only helps to reduce the diameter of the dosing holes 111, but also facilitates adaptation to irregular lesions, so as to achieve the targeting of irregular lesions. dosing. In addition, in the first state, the depth of the administration hole 111 is preferably 1% to 99% of the wall thickness of the balloon. For example, 10% to 90%, 30% to 90%, 50% to 90%, and 70% to 90%. More preferably, the depth of the administration hole 111 is 80% of the wall thickness of the balloon, so as to ensure that the administration hole 111 can rupture and leak under the action of a lower pressure of the medical fluid. 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 the distal end of the inner tube 122 protrudes from 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 . Wherein, the inner tube 122 is used for a guide wire, a perfusion channel is formed between the outer tube 121 and the inner tube 122, and the distal end of the perfusion channel is communicated with the inner cavity of the balloon 11, so as to pass the perfusion channel to the balloon The inside of the balloon 11 is transported with a medical liquid. In the process of delivering the drug solution, first, when the drug delivery hole 111 is not opened, the balloon 11 can be filled with the drug solution, and after the drug solution hole 111 is opened, the drug solution can be released through the drug solution hole 111 .

Further, a section of the inner tube 122 located in the balloon 11 is provided with a developing structure made of a developing material for positioning the balloon 11 during the operation. The developing structures may include proximal developing structures 123 and distal developing structures 124, and these developing structures may be developing spots, developing rings or developing segments. For example, the developing structure can be nested on the inner tube 122 , or made integrally with the inner tube 122 . For example, during manufacture, some lengths of the inner tube 122 inside the balloon 11 are designed to be developed, so that the developing structure and the inner tube 122 are integrally formed. The proximal visualization structure 123 is disposed corresponding to the proximal end of the balloon 11, which is convenient for imaging and positioning the position of the proximal end of the balloon under X-rays. The position of the distal end of the balloon is located by X-ray imaging.

Preferably, the balloon 11 is made of a developing material, so that the balloon 11 itself can also be visualized, 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 balloon 11 after expansion is a cylinder with a uniform diameter, which is convenient for matching blood vessels with a uniform diameter. In other embodiments, the shape of the balloon 11 may be a dumbbell shape, that is, the two ends are large and the middle is small. Considering that for long lesions, the blood vessel itself has 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 damage the normal blood vessel, the shape of the balloon 11 is preferably a dumbbell shape. The advantage of the dumbbell-shaped balloon 11 is that it can form a blockage at both ends to prevent the loss of the medicinal liquid to the distal end and ensure the transfer rate of the medicinal liquid. Wherein, when the balloon 11 is in the shape of a dumbbell, the drug delivery hole 111 is mainly arranged on the middle straight section.

Further, the balloon catheter further includes a handle 13 . The handle 13 may have a “Y” shape, is disposed at the proximal end of the catheter body 12 , and can 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 . The guide wire can be passed through the catheter through the luer connector, and the external fluid supply device can be connected with the luer connector, so as to deliver the medical fluid into the catheter. Further, the balloon catheter further includes a stress diffusion tube 14 , and the outer tube 121 is connected to the handle 13 through the stress diffusion tube 14 . The function of the stress diffuser tube 14 is to reduce the loss of pushing force during the advancement of the catheter. Further, the stress diffusion tube 14 and the handle 13 are physically connected together, 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 combined by elastic deformation. together.

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

First, after the balloon 11 enters the body, after positioning the balloon 11 through the imaging structure on the inner tube 122 , the medicinal liquid is sent into the balloon 11 through the perfusion channel to inflate the balloon 11 . When the balloon 11 reaches the nominal diameter, the pressure is kept constant, so that the balloon 11 is kept in a fully expanded state and fully in contact with the vessel wall. Thereafter, the pressure can be continued or maintained until the administration hole 11 is ruptured to release the medicinal liquid. This enables the medicinal liquid to be released through the drug delivery hole 111 and absorbed by the diseased site, so as to achieve a corresponding therapeutic effect. With this arrangement, while achieving targeted drug delivery, it can also prevent excessive drugs from entering the circulation of the human body and reduce the side effects of the drugs on the human body. Moreover, the administration holes 111 on the surface of the balloon 11 can be distributed 360° in the circumferential direction, so as to realize 360° omnidirectional administration, and the administration efficiency is high.

Further, the present invention does not limit the types of drugs to be administered, such as antitumor drugs, antibiotics, thrombolytic drugs, antithrombotic drugs, vasodilators or 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 this embodiment may include a single balloon, or include two nested balloons. As shown in FIG. 8, 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), the second balloon 11b Nested in the first balloon 11a; wherein, the surface of the first balloon 11a is provided with a first administration hole (not shown). When the balloon catheter 100 is in the first state, the first administration hole does not penetrate the balloon wall of the first balloon 11a; when the balloon catheter 100 is in the second state, the The first dosing hole penetrates through the balloon wall of the first balloon 11a; in addition, the surface of the second balloon 11b is provided with a second dosing hole (not shown), and in the first state and the second state The second dosing hole is always penetrated with the balloon wall of the second balloon 11b. In the same way, during the filling process, the double-layer balloon can be fully expanded to make full contact with the vessel wall and the air inside the double-layer balloon can be evacuated during the folding process, so as to avoid the formation of air embolism after the air enters the body and the balloon. The outer diameter is small, and the ability to pass through the lesion is strong. In more detail, after the medicinal liquid 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 inflated. After sufficient expansion, the second balloon 11b is continuously filled with the medicinal solution. Under the action of the pressure of the medicinal liquid, the medicinal liquid flows into the first balloon 11a through the second dosing hole on the second balloon 11b, and when the first dosing hole on the first balloon 11a is ruptured, the medicinal liquid flows from the second dosing hole on the second balloon 11b. A balloon 11a overflows into the blood vessel from the first administration hole. The design of this double-layer balloon is beneficial to the buffering effect of the outer layer of the balloon, avoiding the direct injection of the medicinal liquid into the blood vessel at a relatively large speed, reducing the stimulation effect on the blood vessel and reducing the occurrence of vasospasm. Alternatively, the second dosing hole of the second balloon 11b may not penetrate the balloon wall in the initial state, but rupture after subsequent compression, and the first dosing hole of the first balloon 11a Always penetrate the balloon wall of the first balloon 11a. More specifically, when the balloon catheter 100 is in the first state, the second administration hole does not penetrate through the balloon wall; when the balloon catheter 100 is in the second state, the first drug delivery hole does not penetrate the wall of the balloon; The second drug delivery hole runs through the balloon wall and is used to release the drug solution. Furthermore, it should be understood that the first dosing hole on the first balloon and the second dosing hole on the second balloon may be dislocated.

Finally, it should be understood that the balloon catheter 100 of this embodiment can be applied to unbranched blood vessels or branched blood vessels, and can be used for the treatment of blood vessels or cancer. The balloon catheter 100 of the present embodiment can not only administer more accurately, but also has higher safety of administration, and at the same time, the transfer rate of the drug is also high, and the ability to pass through the lesion site is stronger, and the passability is better. In addition, the balloon catheter 100 of this embodiment can reduce the side effects of the drug on the human body on the one hand, and realize the slow release and long-term treatment of the drug on the other hand, increase the action period of the drug, and improve the therapeutic effect.

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 and modifications made by those of ordinary skill in the field of the present invention based on the above disclosure all belong to the protection scope of the present invention.

Claims

A balloon catheter, characterized in that it comprises a catheter body and a balloon disposed at the distal end of the catheter body; wherein, a drug administration hole is provided 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 administration hole does not penetrate the balloon wall; when the balloon catheter is in the first state In the second state, the dosing hole penetrates the wall of the balloon and is used for releasing the medicinal liquid.
The balloon catheter according to claim 1, wherein when the balloon catheter is in the first state, the drug administration hole is provided on the outer surface of the balloon and does not penetrate the balloon Alternatively, the administration hole is provided on the inner surface of the balloon and does not penetrate through the outer surface of the balloon.
The balloon catheter according to claim 2, wherein 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 .
The balloon catheter according to claim 3, wherein when the balloon catheter is in the first state, the depth of the administration hole is 80% of the wall thickness of the balloon.
The balloon catheter according to any one of claims 1-4, wherein the number of the administration holes is multiple, and when the balloon catheter is in the first state, there are multiple The depth of the administration holes may or may not be the same.
The balloon catheter according to any one of claims 1-4, wherein the shape of the administration hole is a regular shape or an irregular shape.
The balloon catheter according to any one of claims 1-4, wherein the number of the administration holes is multiple, and the shapes of the multiple administration holes are the same or different.
The balloon catheter according to any one of claims 1-4, wherein the number of the administration holes is multiple, and the plurality of administration holes are regularly or irregularly distributed in the ball on the sac.
The balloon catheter according to any one of claims 1-4, characterized in that, the expanded shape of the balloon is a straight shape or a dumbbell shape.
The balloon catheter according to any one of claims 1-4, wherein the balloon is made of imaging material.
The balloon catheter according to any one of claims 1-4, characterized in that, the drug administration hole that does not penetrate the balloon wall is formed on the surface of the balloon by using a laser etching process.
The balloon catheter according to claim 1, wherein the balloon comprises a first balloon and a second balloon, and the second balloon is nested in the first balloon;

The dosing hole includes a first dosing hole and a second dosing hole, and the first dosing hole is provided on the surface of the first balloon, and the second dosing hole is provided on the surface of the second balloon. the second administration hole;

When the balloon catheter is in the first state, the first administration hole does not penetrate the balloon wall of the first balloon; when the balloon catheter is in the second state, the first administration hole does not penetrate the balloon wall of the first balloon; The first dosing hole penetrates the balloon wall of the first balloon for releasing the medicinal liquid; the second dosing hole always penetrates the balloon wall of the second balloon.
The balloon catheter according to claim 1, wherein the balloon comprises a first balloon and a second balloon, and the second balloon is nested in the first balloon;

The dosing hole includes a first dosing hole and a second dosing hole, and the first dosing hole is provided on the surface of the first balloon, and the second dosing hole is provided on the surface of the second balloon. the second administration hole;

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 does not penetrate the balloon wall of the second balloon; The second dosing hole penetrates the balloon wall of the second balloon for releasing the medical liquid; the first dosing hole always penetrates the balloon wall of the first balloon.
The balloon catheter according to claim 12 or 13, wherein the first drug delivery hole and the second drug delivery hole are arranged in a staggered position.
The balloon catheter according to claim 1, wherein the drug delivery hole is used to penetrate the balloon wall under the action of the pressure of the medicinal liquid when the medicinal liquid fills the balloon.