Single-interface blood vessel occlusion balloon catheter

Abstract

The invention relates to the technical field of medical instruments, and discloses a single-interface blood vessel occlusion balloon catheter which comprises a balloon body, a catheter body (comprising an outer cavity and an inner cavity) and a catheter connector, and the outer cavity and the inner cavity are fixed through the structure of the catheter connector. And the functions of unifying the filling of the balloon catheter and monitoring the blood pressure by using a single interface are realized. According to the single-connector blood vessel plugging balloon catheter, the technical problems that in the prior art, due to the fact that each cavity of a multi-cavity catheter needs to be provided with a connector, operation is complex, and the infection risk can be possibly generated are solved. According to the balloon catheter, the catheter cavity is integrated, surgical operation can be conducted through one connector, the operation difficulty of connection between the balloon catheter and a host is greatly reduced, and the infection risk is reduced to a great extent.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medical devices, in particular to the technical field of balloon catheters. BACKGROUND

[0002] Cardiovascular diseases account for 30.9% of global mortality, and currently only one in ten people is discharged after cardiac arrest. The large number of disease groups and poor prognosis have put forward the demand for targeted treatment methods with high immediacy and simple operation.

[0003] Resuscitative aortic balloon occlusion (REBOA) is a surgical method that usually involves a balloon catheter device into the blood vessel percutaneously, and then inflates it to control bleeding. In the past decade, REBOA has been increasingly used to improve hemodynamic stability by increasing systolic blood pressure while controlling life-threatening bleeding before and / or during definitive surgical or endovascular intervention.

[0004] The concept of REBOA was first reported in 1954 in wounded soldiers with traumatic torso hemorrhage. In the 1970s, balloon occlusion placed through the axillary was described for the treatment of ruptured aortic aneurysms. This technique is now available percutaneously and is provided in the form of a kit, which includes a femoral access and a REBOA balloon catheter device and fixation material. There are many catheters available for REBOA equipment, including 4-French COBRA-OS, 7-French ER-REBOA, and pREBOA-PRO (or 12-14 French Coda) balloon catheters. Occluding aortic blood flow can only be used with compliant balloons, mainly because non-compliant balloons have a high risk of vascular injury when inflated in the aorta, such as aortic dissection rupture. All REBOA balloon catheter devices contain a compliant balloon assembly, and the balloon can be inflated to a diameter of about 9-40 mm, and the choice of REBOA device depends on the specific clinical scenario (i.e. determine the appropriate balloon assembly size according to the target aortic segment) and the operator's preference. The femoral access can be performed by the method most familiar to the operator, including palpation of the femoral artery puncture or minimally invasive ultrasound-guided percutaneous access.

[0005] Resuscitative aortic balloon occlusion (REBOA) can be applied to the treatment of a variety of clinical diseases, including uncontrolled traumatic hemorrhage, postpartum hemorrhage, placenta spectrum disease (PAS), out-of-hospital cardiac arrest requiring cardiopulmonary resuscitation (CPR), and non-traumatic abdominal hemorrhage, etc., and is usually performed in the non-surgical field.

[0006] Due to the fact that the equipment used in the prior art in the treatment of traumatic hemorrhage, non-traumatic hemorrhage, traumatic cardiac arrest and non-traumatic cardiac arrest needs to be guided by fluoroscopy, and the operation process of large fluoroscopy equipment is too complicated, in the time-critical emergency, the use of fluoroscopy, CT, MR scanning and other methods for intravascular catheterization takes too long, and is not the best choice. Therefore, the demand for portable REBOA operation system is increasing, mainly through portable devices, so that REBOA can be operated in hospital or non-hospital environment, allowing users without much relevant professional training to operate. Thus, not only in-hospital specialists, but also non-medical personnel or people with only medical knowledge can operate.

[0007] The prior art has the problem that, as described above, the balloon catheter used with the REBOA of the prior art has the disadvantage that the balloon catheter generally used is a multi-lumen catheter, each lumen has an interface, and the excess interface is prone to infection risk, which is not conducive to out-of-hospital emergency or treatment of severe vascular wounds in a short period of time.

[0008] The purpose of the application is to realize a single interface that can directly access the REBOA host, so as to design a balloon catheter that can greatly reduce the operation difficulty of the connection between the balloon catheter and the host, and reduce the risk of infection. SUMMARY

[0009] The embodiments of the application provide a single-interface vascular occlusion balloon catheter, which solves the technical problem in the prior art that each lumen of a multi-lumen catheter needs an interface, thereby causing complex operation and potential hygiene risks. The embodiments of the application integrate the catheter lumens and can perform surgical operation through one interface, thereby greatly reducing the operation difficulty of the connection between the balloon catheter and the host, and reducing the risk of infection.

[0010] The embodiments of the application disclose a balloon catheter, which comprises a balloon body (10), a catheter body (20) divided into an outer lumen (201), an inner lumen (202), a developing mark (203), an atraumatic tip (204) and a hole (205) thereon, a catheter connector (30) having an outer lumen fixing member (301), an inner lumen fixing member (302) and a fixing block (303), and a host (40) provided with a pressure measuring device (401).

[0011] The embodiments of the application disclose a balloon catheter, which comprises:

[0012] A balloon body (10) is located at the distal end of the balloon catheter and can enter the corresponding position of the aortic blood vessel, and is a variable-volume balloon capable of being controlled to expand and contract for rapid blocking of trunk hemorrhage;

[0013] A catheter body (20) is divided into an outer cavity (201) and an inner cavity (202): the outer cavity (201) extends from the proximal end of the balloon catheter to the proximal end of the balloon body (10) and extends to the distal end of the balloon catheter at the distal end of the balloon body (10); the inner cavity (202) is in the outer cavity (201), extends from the proximal end of the balloon catheter through the balloon body (10) to the distal end of the balloon catheter, and is in communication with the blood vessel in the body of the subject;

[0014] A catheter connector (30) includes an outer cavity fixing member (301), an inner cavity fixing member (302), and a fixing block (303): the outer cavity fixing member (301) fixes the proximal end of the outer cavity (201); the inner cavity fixing member (302) fixes the proximal end of the inner cavity (202); and the fixing block (303) connects the inner cavity fixing member (302) and the catheter connector (30).

[0015] Further, the balloon body (10) is compliant or semi-compliant, and the material can be selected from PA, TPU, and PEBAX.

[0016] Further, the initial diameter of the balloon body (10) ranges from 5 to 15 mm, preferably 10 mm, and the diameter after filling ranges from 15 to 40 mm, preferably 25 mm.

[0017] Further, the length of the balloon body (10) ranges from 20 to 40 mm, preferably 22 mm.

[0018] Further, the wall thickness of the balloon body (10) ranges from 0.02 to 0.3 mm, preferably 0.04 mm.

[0019] Further, the inflation pressure range at which the balloon body (10) can normally work is 100-400 mmHg, and the burst critical pressure is 2 atm.

[0020] Further, the inner cavity (202) is inside the outer cavity (201), and the relative positions of the two lumens are concentric or eccentric.

[0021] Further, the diameter of the outer cavity (201) ranges from 5Fr to 8Fr, preferably 6Fr; the diameter of the inner cavity (202) ranges from 3Fr to 4.5Fr, preferably 3.3Fr.

[0022] Further, the thickness of the outer cavity (201) ranges from 0.15mm to 0.4mm, preferably 0.3mm; the thickness of the inner cavity (202) ranges from 0.1mm to 0.4mm, preferably 0.3mm.

[0023] Further, there is a gap between the outer cavity (201) and the inner cavity (202), which ranges from 0.1mm to 0.3mm, preferably 0.12mm to 0.2mm.

[0024] Further, the catheter body (20) is provided with at least one radiographic marker (203) located at the inner center of the balloon body (10) or at the proximal and distal ends of the balloon body (10).

[0025] Further, the radiographic marker (203) includes, but is not limited to, tantalum / platinum-iridium radiographic rings, high-molecular radiographic coatings, and other materials with DSA visibility.

[0026] Further, the distal end of the catheter body (20) terminates in atraumatic tip (204).

[0027] Further, the atraumatic tip (204) has at least one opening (205) that communicates the blood vessel with the inner cavity (202); the atraumatic tip (204) can be a tapered tip or a pigtail tube.

[0028] Further, the material of the outer cavity (201) includes, but is not limited to, Pebax and nylon; the material of the inner cavity (202) includes, but is not limited to, stainless steel sus304 and NITI tube.

[0029] Further, the catheter interface (30) has a connectable structure (304) on the outside, which includes, but is not limited to, a threaded interface, a plug-in interface, a bayonet interface, a rubber ring fixing interface, or a pressing interface.

[0030] Further, the inner cavity fixing member (302) has a second taper surface (3021) inside, which can be connected to the target interface to communicate the inner cavity; the second taper surface (3021) can be a tapered design or a threaded design.

[0031] Further, the fixing block (303) has one or more openings to facilitate fluid communication with the outer cavity (201).

[0032] Furthermore, the balloon catheter also includes a main unit (40), which is located at the proximal end of the balloon catheter.

[0033] Furthermore, the host (40) is provided with a pressure measuring device (401), and the host (40) is used to display the pressure value measured by the pressure measuring device (401);

[0034] Furthermore, the pressure measuring device (401) includes a pressure sensor or a wireless pressure sensor, and the pressure measuring device (401) is communicatively connected to the host (40).

[0035] The advantages of this invention are: it provides an inflatable device for vascular intervention, solving the technical problem that in existing multi-lumen catheters, each lumen requires an interface, leading to complex operation and potential hygiene risks. The embodiments of this application, by integrating the catheter lumen and allowing surgical procedures through a single interface, significantly reduce the operational difficulty of connecting the balloon catheter to the main unit and lower the risk of infection. Attached Figure Description

[0036] The accompanying drawings are for illustrative purposes only and are not intended to limit the invention. Furthermore, the same reference numerals are used to identify the same parts throughout the drawings. In the drawings:

[0037] Figure 1 It is a balloon catheter.

[0038] Figure 2 Top view of balloon catheter AA;

[0039] Figure 3 This is a cross-sectional view of the balloon catheter (AA).

[0040] Figure 4 Top view of balloon catheter BB;

[0041] Figure 5 This is a cross-sectional view of the balloon catheter (BB).

[0042] Figure 6 A fixed block 3D view;

[0043] Figure 7 Solution a: One-piece molding of the fixing block;

[0044] Figure 8 Solution b is a one-piece molding method for the fixed block;

[0045] Figure 9 Example diagram for use with the host computer.

[0046] Explanation of reference numerals in the attached figures:

[0047] 10: balloon body; 20: catheter body; 201: outer lumen; 202: inner lumen; 203: radiopaque marker; 204: atraumatic tip; 205: fenestration; 30: catheter adapter; 301: outer lumen fixation; 302: inner lumen fixation; 303: fixation block; 304: connectable structure; 40: main unit; 401: pressure measuring device. DETAILED DESCRIPTION

[0048] Example embodiments of the present disclosure will be described more fully hereinafter with reference to the accompanying drawings. While example embodiments of the present disclosure are shown in the drawings, it is understood that the present disclosure can be embodied in various forms and should not be limited by the embodiments set forth herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the present disclosure to those skilled in the art.

[0049] It is to be understood that the terminology used herein is for the purpose of describing particular example embodiments only and is not intended to be limiting. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. The terms "comprises", "comprising", "includes", "including" and "has" are inclusive and therefore specify the presence of stated features, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, steps, operations, elements, components, and / or groups thereof. The method steps, processes, and operations described herein are not to be construed as necessarily requiring their

[0050] Although the terms first, second, third, etc. can be used herein to describe various elements, components, regions, layers and / or sections, these elements, components, regions, layers and / or sections should not be limited by these terms. These terms can be only used to distinguish one element, component, region, layer or section from another region, layer or section. Unless the context clearly indicates otherwise, terms such as "first", "second" and other numerical terms when used herein do not imply a sequence or order unless clearly indicated by the context. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of example embodiments.

[0051] For the purposes of this description, spatially relative terms such as "inner", "outer", "beneath", "below", "lower", "above", "upper", and the like, can be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. The spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientations depicted in the figures. For example, if the device in the figures is turned over, elements described as "below" or "beneath" other elements or features would then be oriented "above" or "over" the other elements or features. Thus, the exemplary term "below" can encompass both an orientation of above and below. The device can be otherwise oriented (rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0052] In the description of the present application, unless otherwise clearly specified and limited, the terms "mounting", "connection", "connecting", "fixing" should be understood broadly, for example, can be fixed connection, can also be detachable connection, or integral; can be mechanical connection, can also be electrical connection; can be direct connection, can also be indirect connection through intermediate medium, can be internal communication of two elements or interaction relationship between two elements. For those skilled in the art, the specific meaning of the above terms in the present application can be understood according to the specific circumstances.

[0053] In the field of interventional medical devices, the end of a medical device inserted into a human or animal body closer to the operator is generally referred to as the "proximal end", and the end farther away from the operator is referred to as the "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined according to this principle.

[0054] A balloon catheter, see Figure 3 , comprising a balloon body (10), a catheter body (20), a catheter joint (30). Wherein the catheter body (20) is divided into an outer cavity (201) and an inner cavity (202), the outer cavity (201) surrounds the inner cavity (202) and there is a gap between the two; the inner cavity (202) extends from the proximal end of the balloon catheter to the distal end of the balloon catheter, and passes through the inside of the balloon body (10). The catheter joint (30) is located at the proximal end of the balloon catheter, and fixes the outer cavity (201) and the inner cavity (202), through the catheter joint (30), balloon inflation and blood pressure monitoring can be realized from a single interface.

[0055] The catheter joint (30) has an outer cavity fixing part (301), an inner cavity fixing part (302), and a fixing block (303). The outer cavity fixing part (301) is fixedly connected with the outer cavity (201) and integrally formed with the connectable structure (304) at the proximal end of the catheter joint (30), which includes but is not limited to a threaded interface, a plug-in interface, a bayonet interface, a rubber ring fixing interface, or a pressing interface. The proximal end of the outer cavity fixing part (301) is located inside the connectable structure (304), and the outer side of the proximal end of the outer cavity fixing part (301) has a first taper (3011). The inner cavity fixing part (302) is fixedly connected with the inner cavity (202) inside the catheter joint (30) and tightly connected with the fixing block (303) inside the outer cavity fixing part (301). The fixing block (303) is fixedly connected with the inner cavity fixing part (302) or integrally formed on the inner wall of the catheter joint (30). The fixing block (303) has one or more openings to facilitate fluid communication between the outer cavity (201).

[0056] Further, the inner cavity fixing part (302) has a second taper (3021) inside, which can be connected with the target interface to communicate the inner cavity. The second taper (3021) can be a tapered design or a threaded design, which can tightly connect the inner cavity (202) with the corresponding interface of the main machine (40) and will not affect the air tightness.

[0057] When the balloon body (10) needs to close the entire aortic blood vessel, gas or liquid is injected into the outer cavity (201) through the hole channel on the fixing block (303) from the catheter joint (30), and finally fills the balloon body (10). The balloon body (10) expands, and the outer surface of the balloon body (10) tightly adheres to the inner wall of the blood vessel, achieving the occlusion of the blood vessel. At the same time, the blood in the blood vessel flows into the inner cavity (202) from the opening (205) on the non-invasive tip (204), and finally flows to the proximal end of the balloon catheter, and contacts the pressure measuring device (401) at the catheter joint (30), so that the pressure measuring device (401) detects the blood flow pressure value in the blood vessel, indicating whether the balloon catheter reaches the designated target position and completes the occlusion of the blood vessel.

[0058] Further, in order to facilitate the balloon catheter to enter the blood vessel, there are two embodiments.

[0059] The first scheme is: Figures 1-4, the atraumatic tip (204) of the catheter body (20) is designed as a head end with a smooth and tapered head tip. Under this scheme, the inner cavity (202) allows the insertion of a guide wire, and the guide wire can be passed from the inner cavity (202) opening at the catheter joint (30) of the proximal end of the catheter body (20). After the guide wire reaches the target position in the subject's body, the balloon catheter is guided to the target position. After the balloon catheter reaches the specified position, the guide wire is withdrawn, and the catheter joint (30) is connected to the host (40). At this time, the inner cavity (202) is in communication with the blood vessel through the opening (205) on the atraumatic tip (204) at the distal end of the balloon catheter, so the inner cavity (202) is filled with blood, and the inner cavity (202) is in contact with the pressure measuring device (401) through the catheter joint (30), so the blood flow pressure value in the blood vessel can be detected by the pressure measuring device (401) at this time. The outer cavity (201) receives the gas or liquid injected by the host (40) through the hole channel of the fixed block (303) after the catheter joint (30) is connected to the host (40), so as to fill the balloon body (10). As shown in Figures 7-8

[0060] The second scheme is: referring to Figure 5 , the atraumatic tip (204) of the catheter body (20) is designed as a pigtail in the form of "J" type, which will not damage the blood vessel and can directly guide the balloon catheter into the blood vessel without using the guide wire. Under this scheme, the balloon catheter can reach the target position in the subject's body without the guide wire, and the catheter joint (30) can be directly connected to the host (40). At this time, the inner cavity (202) is in communication with the blood vessel through the opening (205) on the atraumatic tip (204) at the distal end of the balloon catheter, so the inner cavity (202) is filled with blood, and the inner cavity (202) is in contact with the pressure measuring device (401) through the catheter joint (30), so the blood flow pressure value in the blood vessel can be detected by the pressure measuring device (401) at this time. The outer cavity (201) receives the gas or liquid injected by the host (40) through the hole channel of the fixed block (303) after the catheter joint (30) is connected to the host (40), so as to fill the balloon body (10).

[0061] Further, the balloon body (10) is a compliant balloon or a semi-compliant balloon, and the maximum diameter of the balloon body (10) after inflation is greater than or equal to the diameter of the aortic blood vessel. Preferably, the maximum diameter of the balloon body (10) after inflation can reach 35mm. Through this design, it can be ensured that the balloon body (10) occludes the aortic blood vessel.

[0062] ​Further, the initial diameter of the balloon body (10) ranges from 5mm to 15mm, preferably 10mm; and the inflated diameter ranges from 15mm to 40mm, preferably 25mm.

[0063] Further, the length of the balloon body (10) ranges from 20mm to 40mm, preferably 22mm.

[0064] Further, the wall thickness of the balloon body (10) ranges from 0.02mm to 0.3mm, preferably 0.04mm.

[0065] Further, the working inflation pressure of the balloon body (10) ranges from 100mmHg to 400mmHg, and the burst pressure is 2atm.

[0066] Further, the catheter body (20) is provided with a visible marker (203) in the region of the balloon body (10), which can be used to indicate the position of the balloon body (10) in the body.

[0067] Further, the visible marker (203) can be a tantalum / platinum-iridium visible ring, which is located on the outer layer of the inner cavity (202) in the inner section of the balloon body (10).

[0068] Further, the visible marker (203) can be a high-molecular coating, which is located on the outer layer of the outer cavity (201) at the two ends of the balloon body (10).

[0069] Further, the inner cavity (202) is located inside the outer cavity (201), and the relative positions of the two lumens are concentric or eccentric.

[0070] Further, the diameter of the outer cavity (201) ranges from 5Fr to 8Fr, preferably 6Fr; and the diameter of the inner cavity (202) ranges from 3Fr to 4.5Fr, preferably 3.3Fr.

[0071] Further, the thickness of the outer cavity (201) ranges from 0.15mm to 0.4mm, preferably 0.3mm; and the thickness of the inner cavity (202) ranges from 0.1mm to 0.4mm, preferably 0.3mm.

[0072] Further, there is a gap between the outer cavity (201) and the inner cavity (202), and the size of the gap ranges from 0.1mm to 0.3mm, preferably 0.2mm.

[0073] Further, the material of the outer cavity (201) includes but is not limited to Pebax and nylon; and the material of the inner cavity (202) includes but is not limited to stainless steel sus304 and NITI tube.

[0074] Further, referring to Figure 3 , the outer side of the catheter interface (30) has a connectable structure (304), which includes but is not limited to: a threaded interface, a plug-in interface, a bayonet interface, a rubber ring fixing interface or a pressing interface.

[0075] Further, the inner cavity fixing member (302) has a second taper surface (3021) inside, which can be connected with the target interface and communicate with the inner cavity, and the second taper surface (3021) can be a tapered design or a threaded design.

[0076] Further, the balloon catheter further comprises a main machine (40) arranged at the proximal end of the balloon catheter.

[0077] Further, referring to Figure 9 , the main machine (40) is provided with a pressure measuring device (401), and the main machine (40) is used to display the pressure value measured by the pressure measuring device (401);

[0078] Further, the pressure measuring device (401) comprises a pressure sensor or a wireless pressure sensor, and the pressure measuring device (401) is in communication connection with the main machine (40). The pressure measuring device (401) is used to monitor the pressure at the distal end of the balloon body (10). In this embodiment, the pressure measuring device (401) is arranged in the main machine (40), and is connected with the blood vessel through the inner cavity (202), so that the potential risk of the electronic elements such as inductors in the body can be avoided, and the pressure change at the distal end of the balloon body (10) can be monitored, and further damage to the blood vessel caused by the balloon body (10) during occlusion can be avoided.

[0079] Further, the main machine (40) can be in communication connection with the pressure measuring device (401). The main machine (40) receives the detection data of the pressure measuring device (401), and displays the detection data, and the data can be displayed in the form of waveform or in the form of numbers or both.

[0080] The above is only the preferred specific embodiment of the present application, but the protection scope of the present application is not limited to this. Any change or replacement within the technical range disclosed by the present application can be easily thought by those skilled in the art, which should be covered in the protection scope of the present application. Therefore, the protection scope of the present application should be subject to the protection scope of the claims.

Claims

1. A balloon catheter, characterized by, The balloon catheter comprises: a balloon body (10) located at the distal end of the balloon catheter; a catheter body (20) divided into an outer cavity (201) and an inner cavity (202): the outer cavity (201) extends from the proximal end of the balloon catheter to the proximal end of the balloon body (10) and extends to the distal end of the balloon catheter at the distal end of the balloon body (10); the inner cavity (202) extends through the balloon body (10) from the proximal end of the balloon catheter to the distal end of the balloon catheter and communicates with the blood vessel in the body of the subject; a catheter connector (30) comprising an outer cavity fixing part (301), an inner cavity fixing part (302), and a fixing block (303): the outer cavity fixing part (301) fixes the proximal end of the outer cavity (201); the inner cavity fixing part (302) fixes the proximal end of the inner cavity (202); and the fixing block (303) connects the inner cavity fixing part (302) and the catheter connector (30); The catheter body (20) is provided with at least one imaging marker (203) located at the center of the balloon body (10) or at the distal end and proximal end of the balloon body (10). The imaging marker (203) includes, but is not limited to, a tantalum / platinum-iridium imaging ring, a high-molecular-weight imaging coating, and other materials with DSA imaging properties.

2. The balloon catheter according to claim 1, wherein The initial diameter of the balloon body (10) ranges from 5 to 15 mm, preferably 10 mm; the diameter after inflation ranges from 15 to 40 mm, preferably 25 mm; the length of the balloon body (10) ranges from 20 to 40 mm, preferably 22 mm; the wall thickness of the balloon body (10) ranges from 0.02 to 0.3 mm, preferably 0.04 mm; and the inflation pressure of the balloon body (10) ranges from 100 to 400 mmHg.

3. The balloon catheter according to claim 2, wherein The distal end of the catheter body (20) terminates in a non-traumatic tip (204) having at least one opening (205) that communicates the blood vessel with the inner cavity (202); the non-traumatic tip (204) can be a tapered tip or a pigtail-like form.

4. The balloon catheter according to claim 1, wherein The material of the outer cavity (201) includes, but is not limited to, Pebax, nylon, etc.; and the material of the inner cavity (202) includes, but is not limited to, stainless steel sus304, NITI tube, etc.

5. The balloon catheter according to claim 1, wherein The diameter of the outer cavity (201) ranges from 5-8 Fr, preferably 6 Fr; the diameter of the inner cavity (202) ranges from 3-4.5 Fr, preferably 3.3 Fr; and the gap between the outer cavity (201) and the inner cavity (202) ranges from 0.1-0.3 mm, preferably 0.2 mm.

6. The balloon catheter of claim 1, wherein, The outer side of the catheter interface (30) has a connectable structure (304), which includes but is not limited to a threaded interface, a plug-in interface, a bayonet interface, a rubber ring fixing interface, or a pressing interface.

7. The balloon catheter according to claim 1, wherein, The inner cavity fixing member (302) has a second tapered surface (3021) inside, which can be connected with the target interface to communicate with the inner cavity, and the second tapered surface (3021) can be a tapered design or a threaded design.

8. The balloon catheter according to claim 1, wherein, The fixing block (303) has one or more openings to facilitate fluid communication with the outer cavity (201).

9. The balloon catheter according to any one of claims 1-8, wherein, The balloon catheter further comprises a main machine (40), which is arranged at the proximal end of the balloon catheter.

10. The balloon catheter according to claim 9, wherein, The main machine (40) is provided with a pressure measuring device (401), and the main machine (40) is used to display the pressure value measured by the pressure measuring device (401); The pressure measuring device (401) includes a pressure sensor or a wireless pressure sensor, and the pressure measuring device (401) is in communication connection with the main machine (40).

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