Manual-automatic integrated blood vessel plugging balloon catheter

Abstract

The invention relates to the technical field of medical instruments, and discloses a manual-automatic integrated blood vessel occlusion balloon catheter which comprises a balloon body, a catheter body (comprising an outer cavity and an inner cavity), a catheter connector and a manual connector. The adapter can block the outer cavity, the interface cover can block the outer cavity and the inner cavity at the same time, and the multi-mode medical instrument is suitable for various scenes such as a completely manual mode, a host (including an automatic mode and a manual mode), a monitor mode and the like. According to the manual-automatic integrated blood vessel occlusion balloon catheter, the defects that in the prior art, each cavity of a multi-cavity catheter can only complete one function, and in the actual operation process, multiple kinds of specific instruments are needed to complete REBOA jointly are overcome. According to the invention, the catheter cavity is integrated and matched with the adapter or the interface cover with an uncomplicated structure, so that the catheter can be applied to more scenes.

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 disease accounts for 30.9% of global mortality, and currently only one in ten people is discharged after cardiac arrest. It causes higher mortality than any other disease in industrialized countries, and accounts for three-quarters of non-communicable mortality in developing countries. In the United States, there are 350,000 cases of cardiac arrest occurring inside and outside the hospital. The large number of disease groups and poor prognosis have raised the demand for targeted treatment methods with high immediacy and simple operation.

[0003] Resuscitative aortic balloon occlusion (REBOA) is a surgical method that usually intervenes 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 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 bleeding. 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 use a compliant balloon, 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 performing femoral artery puncture by palpation or performing percutaneous puncture under ultrasound guidance by minimally invasive technique.

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

[0006] Due to the scene of treating traumatic hemorrhage, non-traumatic hemorrhage, traumatic cardiac arrest and non-traumatic cardiac arrest is variable, the above-mentioned conditions may occur in a hospital or medical place with complete facilities, but also may occur in a battlefield, an open field, a school, a residential area and other places without hospital or medical equipment, when a patient needs to be treated urgently, the balloon catheter can be compatible with different instruments, such as a monitor, a REBOA host or manual inflation under the condition of no host.

[0007] The prior art has the problem that, as described above, the double-lumen balloon catheter of the prior art has the disadvantage that, although it is a double-lumen catheter and has two interfaces, only one interface can perform one function (the gas port can only be used to inflate the balloon, and the blood pressure measuring port can only be used to measure blood pressure), so it is necessary to connect both ports to the instrument for performing REBOA surgery at the same time, which makes the range of use of the balloon catheter smaller, and specific instruments may also be needed to complete the operation.

[0008] The purpose of the application is to provide a double-lumen balloon catheter with a manual interface (and a conversion connector), which can be used in various scenes such as complete manual mode, host (including automatic and manual) mode and shared with a monitor alone. SUMMARY

[0009] The embodiment of the application provides a hand-operated and automatic blood vessel occlusion balloon catheter, which solves the problem in the prior art that each lumen of a multi-lumen catheter can only perform one function and needs multiple specific instruments to complete REBOA surgery in actual operation, and can be used in more scenes by matching a simple conversion connector or an interface cover.

[0010] The embodiment of the application discloses 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), a non-injury tip (204) and a hole (205) on the non-injury tip (204), a catheter connector (30) with an outer lumen fixing part (301), an inner lumen fixing part (302) and a fixing block (303), a manual interface (305), a conversion interface (306) or an interface cover (307) on the outside of the catheter connector (30), and a host (40) with a pressure measuring device (401) arranged therein.

[0011] The embodiment of the application discloses 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, which 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] A manual interface (305) is located at the proximal end of the balloon catheter and is in communication with the outer cavity (201) and can be connected to a luer connector.

[0016] Further, the material of the balloon body (10) is compliant or semi-compliant.

[0017] 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.

[0018] Further, the length of the balloon body (10) ranges from 20 to 40 mm, preferably 22 mm.

[0019] Further, the wall thickness of the balloon body (10) ranges from 0.02 to 0.3 mm, preferably 0.04 mm.

[0020] Further, the inflation pressure range for normal operation of the balloon body (10) is 100-400 mmHg, and the burst critical pressure is 2 atm.

[0021] Further, the inner cavity (202) is inside the outer cavity (201), and the relative positions of the two lumens are coaxial or eccentric.

[0022] Further, 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 Fr-4.5 Fr, preferably 3.3 Fr.

[0023] Further, the thickness of the outer cavity (201) ranges from 0.15-0.4 mm, preferably 0.3 mm; the thickness of the inner cavity (202) ranges from 0.1-0.4 mm, preferably 0.3 mm.

[0024] Further, there is a gap between the outer cavity (201) and the inner cavity (202), which ranges from 0.1-0.3 mm, preferably 0.12-0.2 mm.

[0025] 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).

[0026] 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.

[0027] Further, the distal end of the catheter body (20) terminates in atraumatic tip (204).

[0028] 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 in the form of a tip head or a pigtail tube.

[0029] Further, the material of the outer cavity (201) includes, but is not limited to, Pebax, nylon, etc.; the material of the inner cavity (202) includes, but is not limited to, stainless steel sus304, NITI tube, etc.

[0030] Further, the outer side of the catheter interface (30) has a connectable structure (304) that 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.

[0031] Further, the inner cavity fixing member (302) has a second conical surface (3021) inside that can be connected to the target interface to communicate the inner cavity; the second conical surface (3021) can be conical or threaded.

[0032] Further, the fixing block (303) has one or more openings to facilitate fluid communication with the outer cavity (201).

[0033] Further, the manual interface (305) of the balloon catheter is located at the proximal end of the balloon catheter, and is in communication with the outer cavity (201);

[0034] Further, the manual interface (305) can be connected to a luer connector.

[0035] Further, the balloon catheter further has a conversion interface (306), which is detachably fixed to the catheter connector (30).

[0036] Further, the conversion interface (306) has a blocking structure, and when the conversion interface (306) is fixed to the catheter connector (30), the outer cavity (201) can be blocked, and only the inner cavity (202) is in communication with external instruments.

[0037] Further, the balloon catheter can further be externally connected to an interface cover (307), which is detachably fixed to the catheter connector (30);

[0038] Further, when the interface cover (307) is fixed to the catheter connector (30), the outer cavity (201) and the inner cavity (202) can be blocked, so that the balloon catheter is converted into a completely manual mode.

[0039] Further, the balloon catheter further includes a host (40), which is arranged at the proximal end of the balloon catheter.

[0040] Further, the host (40) is internally 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);

[0041] Further, 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 host (40).

[0042] The advantage of the present application is to provide a balloon catheter with a manual interface, which solves the problem that each cavity of the multi-cavity catheter can only complete one function, and a plurality of specific instruments are required to complete the REBOA operation in the actual operation process. The catheter cavity is integrated and matched with a conversion connector or an interface cover with a simple structure, which can be applied to more scenes. BRIEF DESCRIPTION OF DRAWINGS

[0043] The accompanying drawings are included to provide a further understanding of the preferred embodiments and are incorporated in and constitute a part of this specification. Like reference numerals refer to like elements throughout the drawings. In the drawings:

[0044] Figure 1 Figure 1 is a front view of a balloon catheter;

[0045] Figure 2 Figure 2 is a top view of a balloon catheter;

[0046] Figure 3 Figure 3 is a cross-sectional view of a balloon catheter;

[0047] Figure 4 Figure 4 is a front view of a balloon catheter with a docking adapter;

[0048] Figure 5 Figure 5 is a top view of a balloon catheter with a docking adapter;

[0049] Figure 6 Figure 6 is a cross-sectional view of a balloon catheter with a docking adapter;

[0050] Figure 7 Figure 7 is a three-dimensional view of a fixing block;

[0051] Figure 8 Figure 8 is a one-piece fixing block scheme a;

[0052] Figure 9 Figure 9 is a one-piece fixing block scheme b;

[0053] Figure 10 Figure 10 is an example diagram of use with a main machine.

[0054] BRIEF DESCRIPTION OF DRAWINGS

[0055] 10: balloon body; 20: catheter body; 201: outer cavity; 202: inner cavity; 203: radiopaque marker; 204: atraumatic tip; 205: aperture; 30: catheter adapter; 301: outer cavity fixing member; 302: inner cavity fixing member; 303: fixing block; 304: connectable structure; 305: manual interface; 306: adapter interface; 307: interface cover; 40: main machine; 401: pressure measuring device. DETAILED DESCRIPTION

[0056] Exemplary embodiments of the present disclosure will be described in detail below with reference to the accompanying drawings. While exemplary embodiments of the present disclosure are shown in the drawings, it is to be understood that the present disclosure can be embodied in various forms without being 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.

[0057] 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

[0058] 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. 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 the example embodiments.

[0059] Spatially relative terms, such as "inner", "outer", "inward", "outward", "lower", "bottom", "top", "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. Such spatially relative terms can encompass different orientations of the device in use or operation in addition to the orientation 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.

[0060] In the description of the present application, unless otherwise explicitly specified and limited, the terms "mounting", "connecting", "connecting", "fixing" should be understood broadly, for example, it can be fixedly connected, or it can be detachably connected, or it can be integrated; it can be mechanically connected, or it can be electrically connected; it can be directly connected, or it can be indirectly connected through an intermediate medium, it can be the internal communication of two elements or the interaction relationship of 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.

[0061] In the field of interventional medical devices, the end of the medical device inserted into the human or animal body closer to the operator is generally called "proximal end", and the end farther away from the operator is called "distal end", and the "proximal end" and "distal end" of any component of the medical device are defined according to this principle.

[0062] A balloon catheter, see Figure 3 , comprising a balloon body (10), a catheter body (20), a catheter joint (30) and a manual interface (306). 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 has a gap between them; 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. The manual interface (305) is located at the proximal end of the balloon catheter, and is connected with the outer cavity (201), which can provide a manual suction / injection port in the case of not being connected with REBOA host or other instruments capable of providing balloon inflation function.

[0063] A balloon catheter, see Figure 3, 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), and the connectable structure (304) 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 surface (3011). The inner cavity fixing part (302) is fixedly connected with the proximal end of the inner cavity (202) inside the outer cavity fixing part (301) 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 for facilitating fluid communication between the outer cavity (201). Further, the inner cavity fixing part (302) has a second taper surface (3021) inside, which can be connected with a target interface to communicate the inner cavity. The second taper surface (3021) can be a tapered design or a threaded design. The proximal end of the inner cavity fixing part (302) has a second taper surface (3021) on the outer side. The first taper surface (3011) and the second taper surface (3021) are not parallel. When the balloon catheter is connected with the target interface, the first taper surface (3011) can tightly connect with the first inner taper surface (3061) of the conversion interface (306), and at the same time, the second taper surface (3021) can tightly connect with the second inner taper surface (3062) of the conversion interface (306), so that the inner cavity (202) and the corresponding interface of the host (40) can be tightly connected, and there is no risk of affecting the air tightness.

[0064] 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 of the fixing block (303) at the catheter joint (30), and finally fills the balloon body (10). The balloon body (10) expands, the outer surface of the balloon body (10) tightly adheres to the inner wall of the blood vessel, and the blood vessel is closed. 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 blood vessel occlusion.

[0065] Further, in order to facilitate the balloon catheter to enter the blood vessel, there are two embodiments.

[0066] The first solution is as shown in Figure 2 , Figure 4 , the atraumatic tip (204) of the catheter body (20) is designed in the form of a head tip. In this solution, the inner cavity (202) allows the insertion of a guide wire, and the guide wire can be inserted from the inner cavity (202) opening at the proximal end of the catheter joint (30) of the catheter body (20). After the guide wire reaches the target position in the body of the subject, 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 filled with blood due to the communication between the inner cavity (202) and the blood vessel through the opening (205) on the atraumatic tip (204) at the distal end of the balloon catheter, 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 7-9 , the fixed block (303) is fixedly connected with the inner cavity fixing member (302) or integrally formed on the inner wall of the catheter joint (30).

[0067] The second solution is as shown in Figure 1 , Figure 3 , Figure 6 , the atraumatic tip (204) of the catheter body (20) is designed in the form of a pigtail, which is "J" shaped, will not damage the blood vessel, and can directly guide the balloon catheter into the blood vessel without using a guide wire. In this solution, the balloon catheter can reach the target position in the body of the subject without a guide wire, and the catheter joint (30) can be directly connected to the host (40). At this time, the inner cavity (202) is filled with blood due to the communication between the inner cavity (202) and the blood vessel through the opening (205) on the atraumatic tip (204) at the distal end of the balloon catheter, 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).

[0068] 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 is up to 35 mm. By this design, the balloon body (10) can ensure occlusion of the aortic blood vessel.

[0069] Further, the initial diameter of the balloon body (10) is in the range of 5-15 mm, preferably 10 mm, and the diameter after inflation is in the range of 15-40 mm, preferably 25 mm.

[0070] Further, the length of the balloon body (10) is in the range of 20-40 mm, preferably 22 mm.

[0071] Further, the wall thickness of the balloon body (10) is in the range of 0.02-0.3 mm, preferably 0.04 mm.

[0072] Further, the inflation pressure at which the balloon body (10) can normally work is in the range of 100-400 mmHg, and the burst critical pressure is 2 atm.

[0073] Further, the inflation assembly (10) of the catheter body (20) is provided with a visible marker (203) to indicate the position of the balloon body (10) in the body.

[0074] Further, the visible marker (203) can be a tantalum-made visible ring, which is located on the outer layer of the inner cavity (202) in the inner section of the balloon body (10).

[0075] 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).

[0076] Further, the inner cavity (202) is inside the outer cavity (201), and the relative positions of the two lumens are coaxial or eccentric.

[0077] Further, the diameter of the outer cavity (201) is in the range of 5-8 Fr, preferably 6 Fr, and the diameter of the inner cavity (202) is in the range of 3 Fr-4.5 Fr, preferably 3.3 Fr.

[0078] Further, the thickness of the outer cavity (201) is in the range of 0.15-0.4 mm, preferably 0.3 mm, and the thickness of the inner cavity (202) is in the range of 0.1-0.4 mm, preferably 0.3 mm.

[0079] Further, the outer cavity (201) and the inner cavity (202) have a gap therebetween, the gap ranges from 0.1 mm to 0.3 mm, preferably from 0.12 mm to 0.2 mm.

[0080] Further, 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.

[0081] Referring to FIG. 3, the catheter interface (30) has a connectable structure (304) on the outer side, 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.

[0082] Further, the inner cavity fixing member (302) has a second tapered surface (3021) inside, which can be connected with a target interface to communicate with the inner cavity, and the second tapered surface (3021) can be a tapered design or a threaded design.

[0083] Further, the balloon catheter further includes a main machine (40) arranged at the proximal end of the balloon catheter.

[0084] Referring to Figure 10 , 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);

[0085] Further, 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). The pressure measuring device (401) is used to monitor the pressure at the distal end of the balloon body (10). In the 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 potential risks of electronic elements such as sensors 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.

[0086] 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), displays the detection data, and the data can be displayed in the form of a waveform or a number or both.

[0087] According to the above, the balloon catheter provided by the application can be applied in three main scenarios:

[0088] The first scenario: automatic mode. After the balloon catheter is successfully introduced into the target position in the human body, the catheter connector (30) is connected to the corresponding interface of the main machine (40).

[0089] Further, when the main machine (40) is in the automatic mode, the manual interface (305) is closed with a cover, and the extraction / injection of the balloon catheter and the monitoring of the blood pressure are completed by the main machine (40).

[0090] The second scenario: semi-automatic mode of a monitor or other blood pressure monitoring device. After the balloon catheter is successfully introduced into the target position in the human body, the manual interface (305) can be connected to a luer connector.

[0091] Further, when the main machine (40) is in the manual mode, the catheter connector (30) is connected to the corresponding interface of the main machine (40), and after the manual interface (305) is connected to the luer connector, the operator can extract / inject the balloon from the manual interface (305); at this time, the pressure measuring device (401) in the main machine (40) completes the monitoring of the blood pressure.

[0092] Further, in the mode of the monitor or other blood pressure monitoring device (except the main machine (40)), the catheter connector (30) is fixed to the conversion interface (306), and at this time, the other end of the conversion interface (306) can be connected to a catheter of a standard size for connection to a monitor or other instrument. In the case of connection to the conversion interface (306), only the inner cavity (202) is in communication with the monitor or other instrument, so that the blood pressure and other data can be monitored. After the manual interface (305) is connected to the luer connector, the operator can extract / inject the balloon from the manual interface (305).

[0093] The third scenario: fully manual mode. After the balloon catheter is successfully introduced into the target position in the human body, the manual interface (305) can be connected to a luer connector.

[0094] Further, the catheter connector (30) is connected to the interface cover (307) to close the outer cavity (201) and the inner cavity (202). After the manual interface (305) is connected to the luer connector, the operator can extract / inject the balloon from the manual interface (305).

[0095] The above is only a preferred embodiment of the present application, but the protection scope of the present application is not limited thereto, and any person skilled in the art can easily think of changes or replacements within the technical scope disclosed by the present application, which should be covered within 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 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); a manual interface (305) located at the proximal end of the balloon catheter and communicating with the outer cavity (201) and connectable to a luer connector; 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).

2. The balloon catheter according to claim 1, wherein the distal end of the catheter body (20) terminates in an atraumatic tip (204) having at least one opening (205) communicating the blood vessel with the inner cavity (202); and the atraumatic tip (204) can be in the form of a tip head or a pigtail.

3. 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.

4. The balloon catheter according to claim 1, wherein the diameter of the outer cavity (201) ranges from 5 to 8 Fr, preferably 6 Fr; the diameter of the inner cavity (202) ranges from 3 to 4.5 Fr, preferably 3.3 Fr; and there is a gap between the outer cavity (201) and the inner cavity (202), and the gap ranges from 0.1 to 0.3 mm, preferably 0.2 mm. The material of the outer cavity (201) includes, but is not limited to, Pebax, nylon, etc.; 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 any one of claims 1-4, wherein, The outer side of the catheter connector (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. The inner cavity fixing part (302) has a second taper surface (3021) inside, which can be connected with a target interface to communicate with the inner cavity. The second taper surface (3021) can be a conical design or a threaded design.

6. The balloon catheter according to any one of claims 1-5, wherein, The fixing block (303) has one or more openings to facilitate fluid communication between the outer cavity (201).

7. The balloon catheter according to claim 1, wherein, The balloon catheter further has a conversion interface (306) which is detachably fixed with the catheter connector (30). When the conversion interface (306) is fixed on the catheter connector (30), only the inner cavity (202) can communicate with external instruments.

8. The balloon catheter according to any one of claims 1-6, wherein, The balloon catheter can further be externally connected with an interface cover (307) which is detachably fixed with the catheter connector (30). When the interface cover (307) is fixed on the catheter connector (30), the outer cavity (201) and the inner cavity (202) can be sealed, so that the balloon catheter is converted into a completely manual mode.

9. The balloon catheter according to any one of claims 1-6, wherein, The balloon catheter further includes a host (40) which is arranged at the proximal end of the balloon catheter.

10. The balloon catheter according to claim 9, wherein, The host (40) is provided with a pressure measuring device (401) inside. The host (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. The pressure measuring device (401) is in communication connection with the host (40).

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