Manual-automatic integrated aorta intervention balloon catheter

Abstract

The utility model relates to the technical field of medical instruments, and discloses a manual-automatic integrated aorta intervention balloon catheter, which comprises a balloon body, a catheter body (comprising an outer cavity and an inner cavity), a catheter joint and a manual interface, 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 aorta intervention balloon catheter, the defects that in the prior art, each cavity of a multi-cavity catheter can only complete one function, and multiple kinds of specific instruments are needed to jointly complete REBOA in the actual operation process are overcome. According to the utility model, 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 utility model relates to the technical field of medical devices, in particular to the technical field of balloon catheters. Background Art

[0002] Cardiovascular disease accounts for 30.9% of global mortality, and currently only one in ten people is discharged from hospital after a cardiac arrest. It causes more mortality than any other disease in industrialized countries and three quarters of non-communicable mortality in developing countries. In the United States, there are 350,000 cardiac arrests in and outside hospitals. The large number of patients and the poor prognosis have created a need for targeted treatments that are highly immediate and easy to use.

[0003] Resuscitative balloon occlusion of the aorta (REBOA) is a surgical procedure that involves the percutaneous introduction of a balloon catheter device into a blood vessel, which is then inflated to control bleeding. Over the past decade, REBOA has been increasingly used to improve hemodynamic stability by increasing systolic blood pressure while controlling life-threatening bleeding prior to and / or during definitive surgical or endovascular intervention.

[0004] The concept of REBOA was first reported in 1954 in injured soldiers with traumatic torso hemorrhage. In the 1970s, transaxillary balloon occlusion was described for the treatment of ruptured aortic aneurysms. This technique is now available percutaneously and is provided in kit form, which includes femoral artery access as well as the REBOA balloon catheter device and fixation materials. There are many catheters available for REBOA devices, including the 4-French COBRA-OS, 7-French ER-REBOA, and pREBOA-PRO (or 12-14 French Coda) balloon catheters. Occlusion of aortic blood flow can only be performed with compliant balloons, primarily because inflation of non-compliant balloons in the aorta carries a high risk of vascular injury, such as aortic dissection. All REBOA balloon catheter devices contain a compliant balloon component that can be inflated to a diameter of approximately 9-40 mm, and the choice of REBOA device depends on the specific clinical scenario (i.e., determining the appropriate balloon component size based on the target aortic segment) and operator preference. Femoral artery access can be achieved using the method that the surgeon is most familiar with, including femoral artery puncture by palpation or minimally invasive percutaneous access under ultrasound guidance.

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

[0006] Since the scenarios for treating traumatic bleeding, non-traumatic bleeding, traumatic cardiac arrest and non-traumatic cardiac arrest are quite varied, the above situations may occur in hospitals or medical places with complete facilities, but they may also occur in non-hospitals or places with incomplete medical equipment, such as battlefields, fields, schools, and residential areas. When emergency treatment of patients is required, a balloon catheter that is compatible with different instruments, such as monitors, REBOA host, or manual inflation without a host is required.

[0007] The problem with the prior art is that, as mentioned above, the disadvantage of the prior art double-lumen balloon catheter is that, although it is a double-lumen catheter and has two interfaces, one interface can only perform one function (the gas port can only be used to inflate the balloon, and the blood pressure measurement port can only be used to measure blood pressure). Therefore, both ports must be connected to the instrument for performing the REBOA operation at the same time, which makes the scope of use of the balloon catheter smaller and may require specific instruments to complete the operation.

[0008] Purpose of the utility model: The utility model provides a double-lumen balloon catheter (and its conversion joint) with a manual interface, which can be applied to various scenarios such as full manual mode, host (including automatic and manual) mode and sharing with a monitor alone. Summary of the invention

[0009] The embodiments of the utility model provide a manual and automatic aortic interventional balloon catheter, which solves the shortcomings of the prior art that each lumen of a multi-lumen catheter can only perform one function and that multiple types of specific instruments are needed to jointly complete the REBOA procedure during actual operation. When combined with a conversion connector or interface cover with a simple structure, it can be used in more scenarios.

[0010] The embodiment of the utility model discloses a balloon catheter, comprising: a balloon body (10); a catheter body (20), which is divided into an outer cavity (201), an inner cavity (202), a developing mark (203), a non-damaging tip (204) and an opening (205) thereon; a catheter connector (30), which has an outer cavity fixing piece (301), an inner cavity fixing piece (302) and a fixing block (303); the outer side of the catheter connector (30) is provided with a connectable structure (304), a manual interface (305), a conversion interface (306) or an interface cover (307); and a host (40), which is provided with a pressure measuring device (401).

[0011] An embodiment of the utility model discloses a balloon catheter, characterized in that the balloon catheter comprises:

[0012] A balloon body (10), the balloon body (10) is located at the distal end of the balloon catheter, and the balloon body (10) can enter the corresponding position of the aorta, and is a volume-variable balloon, which can control its expansion and contraction, and is used to quickly block trunk bleeding;

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

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

[0015] A manual interface (305), the manual interface (305) is located at the proximal end of the balloon catheter, is connected to the outer cavity (201), and can be connected to a Luer connector.

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

[0017] Furthermore, the initial diameter of the balloon body (10) is in the range of 5-15 mm, preferably 10 mm; the diameter after being filled is in the range of 15-40 mm, preferably 25 mm;

[0018] Furthermore, the length of the balloon body (10) is in the range of 20-40 mm, preferably 22 mm;

[0019] Furthermore, the wall thickness of the balloon body (10) is in the range of 0.02-0.3 mm, preferably 0.04 mm;

[0020] Furthermore, the balloon body (10) can operate normally within an inflation pressure range of 100-400 mmHg, and a critical bursting pressure of 2 atm.

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

[0022] Furthermore, 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 Fr to 4.5 Fr, preferably 3.3 Fr;

[0023] Furthermore, 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.

[0024] Furthermore, 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 from 0.12 to 0.2 mm.

[0025] Furthermore, the catheter body (20) is provided with at least one developing mark (203), and the developing mark (203) is located at the center of the balloon body (10) or at the proximal end and the distal end of the balloon body (10);

[0026] Furthermore, the development mark (203) includes but is not limited to a tantalum / platinum-iridium development ring, a polymer development coating, and other materials that have DSA developability.

[0027] Furthermore, the distal end of the catheter body (20) terminates at an atraumatic tip (204);

[0028] Furthermore, the non-damaging tip (204) has at least one opening (205), and the opening (205) connects the blood vessel with the inner cavity (202); the non-damaging tip (204) may be in the form of a tip or a pigtail tube.

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

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

[0031] Furthermore, the inner cavity fixing piece (302) has a second conical surface (3021) inside, which can be docked with the target docking interface to communicate with the inner cavity, and the second conical surface (3021) can be a conical design or a threaded design.

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

[0033] Furthermore, the manual interface (305) of the balloon catheter is located at the proximal end of the balloon catheter and is connected to the outer cavity (201);

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

[0035] Furthermore, the balloon catheter also has a conversion interface (306), and the conversion interface (306) is detachably fixed to the catheter connector (30).

[0036] Furthermore, the conversion interface (306) has a blocking structure, and when the conversion interface (306) is fixed on the catheter connector (30), the outer cavity (201) can be blocked, leaving only the inner cavity (202) connected to the external instrument.

[0037] Furthermore, the balloon catheter may be externally connected to an interface cover (307), and the interface cover (307) may be detachably fixed to the catheter connector (30).

[0038] Furthermore, 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 fully manual mode.

[0039] Furthermore, the balloon catheter also includes a host (40), and the host (40) is arranged at the proximal end of the balloon catheter.

[0040] Furthermore, a pressure measuring device (401) is provided in the host (40), and the host (40) is used to display the pressure value measured by the pressure measuring device (401);

[0041] Furthermore, the pressure measuring device (401) comprises a pressure sensor or a wireless pressure sensor, and the pressure measuring device (401) is communicatively connected to the host (40).

[0042] The advantages of the utility model are: providing a vascular intervention inflatable device with a manual interface, solving the shortcomings of the prior art that each cavity of a multi-lumen catheter can only perform one function and that multiple types of specific instruments are required to perform REBOA in actual operation. The utility model can be applied to more scenarios by integrating the catheter cavity and matching it with a conversion joint or interface cover with a simple structure. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] The accompanying drawings are only used to illustrate preferred embodiments and are not to be considered as limiting the present invention. In addition, the same reference symbols are used to identify the same components throughout the accompanying drawings. In the accompanying drawings:

[0044] Figure 1 For: front view of the balloon catheter;

[0045] Figure 2 For: top view of balloon catheter;

[0046] Figure 3 For: Cross-sectional view of balloon catheter;

[0047] Figure 4 : The front view of the balloon catheter with the docking conversion connector;

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

[0049] Figure 6 : a cross-sectional view of a balloon catheter with a docking conversion connector;

[0050] Figure 7 For: Fixed block 3D view;

[0051] Figure 8 The fixing block is formed in one piece.

[0052] Fig. 9 The fixing block is integrally formed in solution b;

[0053] Fig.10 This is an example diagram for use with a host.

[0054] Description of reference numerals:

[0055] 10: balloon body; 20: catheter body; 201: outer cavity; 202: inner cavity; 203: developing mark; 204: non-damaged tip; 205: opening; 30: catheter connector; 301: outer cavity fixing part; 302: inner cavity fixing part; 303: fixing block; 304: connectable structure; 305: manual interface; 306: conversion interface; 307: interface cover; 40: host; 401: pressure measuring device. DETAILED DESCRIPTION

[0056] The exemplary embodiments of the present disclosure will be described in more detail below with reference to the accompanying drawings. Although the exemplary embodiments of the present disclosure are shown in the accompanying drawings, it should be understood that the present disclosure can be implemented in various forms and should not be limited by the embodiments set forth herein. On the contrary, these embodiments are provided in order to enable a more thorough understanding of the present disclosure and to fully convey the scope of the present disclosure to those skilled in the art.

[0057] It should be understood that the terms used in the text are only for the purpose of describing specific example embodiments, and are not intended to be limiting. Unless the context clearly indicates otherwise, the singular forms "one", "an" and "said" as used in the text may also be meant to include plural forms. The terms "include", "comprise", "contain", and "have" are inclusive, and therefore specify the existence of stated features, steps, operations, elements and / or parts, but do not exclude the existence or addition of one or more other features, steps, operations, elements, parts, and / or combinations thereof. The method steps, processes, and operations described in the text are not interpreted as requiring the specific order in which they are described or illustrated to be performed, unless the execution order is clearly indicated. It should also be understood that additional or alternative steps may be used.

[0058] Although the terms first, second, third, etc. can be used in the text to describe multiple 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 only be used to distinguish an 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 do not imply order or sequence when used in the text. Therefore, the first element, component, region, layer or section discussed below can be referred to as the second element, component, region, layer or section without departing from the teaching of the example embodiments.

[0059] For ease of description, spatial relative terms may be used in the text to describe the relationship of one element or feature relative to another element or feature as shown in the figure, such as "inside", "outside", "inner side", "outer side", "below", "below", "above", "above", etc. Such spatial relative terms are intended to include different orientations of the device in use or operation other than the orientation depicted on the way. For example, if the device on the way turns over, the element described as "below other elements or features" or "below other elements or features" will be subsequently oriented to "above other elements or features" or "above other elements or features". Therefore, the example term "below..." may include both upper and lower orientations. The device may be oriented (rotated 90 degrees or in other directions) and the spatial relative descriptors used in the text are interpreted accordingly.

[0060] In the description of the present invention, unless otherwise clearly specified and limited, the terms "install", "connect", "connect", and "fix" should be understood in a broad sense, for example, it can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium, it can be the internal connection of two elements or the interaction relationship between two elements. For ordinary technicians in this field, the specific meanings of the above terms in the present invention can be understood according to specific circumstances.

[0061] In the field of interventional medical devices, the end of a medical device that intervenes in the human or animal body that is closer to the operator is generally called the "proximal end", and the end that is farther from the operator is called the "distal end". The "proximal end" and "distal end" of any component of a medical device are defined based on this principle.

[0062] A balloon catheter, see Figure 3 , comprising a balloon body (10), a catheter body (20), a catheter connector (30) and a manual interface (306). The catheter body (20) is divided into an outer cavity (201) and an inner cavity (202), wherein 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 interior of the balloon body (10). The catheter connector (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 connector (30), balloon filling and blood pressure monitoring can be achieved through a single interface. The manual interface (305) is located at the proximal end of the balloon catheter and is connected to the outer cavity (201), and can provide a manual withdrawal / injection port without being connected to the REBOA host or other instruments capable of providing balloon filling function.

[0063] A balloon catheter, see Figure 3The catheter connector (30) comprises an outer cavity fixing piece (301), an inner cavity fixing piece (302) and a fixing block (303). The outer cavity fixing piece (301) is fixedly engaged with the outer cavity (201) and is integrally formed with a connectable structure (304) at the proximal end of the catheter connector (30). 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 press interface. The proximal end of the outer cavity fixing member (301) is located inside the connectable structure (304), and the outer side of the proximal end of the outer cavity fixing member (301) has a first conical surface (3011). The inner cavity fixing member (302) is fixedly engaged with the proximal end of the inner cavity (202) inside the outer cavity fixing member (301), and is tightly engaged with a fixing block (303) inside the outer cavity fixing member (301). The fixing block (303) is fixedly engaged with the inner cavity fixing member (302) or is integrally formed on the inner wall of the catheter connector (30), and one or more openings are provided on the fixing block (303) to facilitate fluid communication with the outer cavity (201). Furthermore, the inner cavity fixing member (302) has a second conical surface (302) inside. 1), can be docked with the target docking interface and connected to the inner cavity, the second conical surface (3021) can be of conical design or threaded design, the proximal outer side of the inner cavity fixing piece (302) has a second conical surface (3021), the first conical surface (3011) and the second conical surface (3021) are not parallel, when the balloon catheter is docked with the target docking interface, the first conical surface (3011) can be tightly docked with the first inner conical surface (3061) of the conversion interface (306), and at the same time, the second conical surface (3021) can be tightly docked with the second inner conical surface (3062) of the conversion interface (306), so that the inner cavity (202) and the corresponding docking interface of the host (40) can be tightly connected without causing the risk of affecting the air tightness.

[0064] When the balloon body (10) is required to seal the entire aorta, gas or liquid is injected into the outer cavity (201) from the catheter connector (30) through the hole channel on the fixing block (303), and finally fills the balloon body (10). The balloon body (10) expands, and the outer surface of the balloon body (10) and the inner wall of the blood vessel are closely attached to each other, thereby achieving 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-damaged tip (204), and finally flows to the proximal end of the balloon catheter, and contacts the pressure measuring device (401) at the catheter connector (30), so that the pressure measuring device (401) detects the blood pressure value in the blood vessel, thereby indicating whether the balloon catheter has reached the predetermined target position and completed the vascular occlusion effect.

[0065] Furthermore, in order to facilitate the balloon catheter to enter the blood vessel, there are two implementation schemes.

[0066] The first option is: Figure 2 , Figure 4 As shown, the non-damaged tip (204) of the catheter body (20) is designed to be a smooth tip at the top of the head. In this scheme, the inner cavity (202) allows the insertion of a guide wire, and the guide wire can be passed through the opening of the inner cavity (202) at the catheter connector (30) at 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 connector (30) is connected to the host (40). At this time, the inner cavity (202) is connected to the blood vessel through the opening (205) on the non-damaged tip (204) at the distal end of the balloon catheter, so the inner cavity (202) is filled with blood. Since the inner cavity (202) is in contact with the pressure measuring device (401) through the catheter connector (30), the blood pressure value in the blood vessel can be detected by the pressure measuring device (401). After the catheter connector (30) is connected to the main unit (40), the outer cavity (201) receives gas or liquid injected from the main unit (40) through the hole channel of the fixing block (303), thereby filling the balloon body (10). Figure 7-9 As shown, the fixing block (303) is fixedly joined to the inner cavity fixing piece (302) or is integrally formed on the inner wall of the catheter connector (30).

[0067] The second option is: Figure 1 , Figure 3 , Figure 6 As shown, the non-damaging tip (204) of the catheter body (20) is designed in the form of a pigtail tube, which is in a "J" shape, will not damage the blood vessel, and can directly guide the balloon catheter into the blood vessel without using a guide wire. Under this scheme, the balloon catheter can reach the target position in the subject's body without a guide wire, and the catheter connector (30) can be directly connected to the host (40). At this time, the inner cavity (202) is connected to the blood vessel through the opening (205) on the non-damaging tip (204) at the distal end of the balloon catheter, so the inner cavity (202) is filled with blood. Since the inner cavity (202) is in contact with the pressure measuring device (401) through the catheter connector (30), the blood pressure value in the blood vessel can be detected by the pressure measuring device (401). After the catheter connector (30) is connected to the main unit (40), the outer cavity (201) receives gas or liquid injected from the main unit (40) through the hole channel of the fixing block (303), thereby filling the balloon body (10).

[0068] Furthermore, the balloon body (10) is a compliant balloon or a semi-compliant balloon, and the maximum diameter of the balloon body (10) after expansion is greater than or equal to the diameter of the aortic blood vessel. Preferably, the maximum diameter of the balloon body (10) after expansion can reach 35 mm. With this design, it can be ensured that the balloon body (10) occludes the aortic blood vessel.

[0069] Furthermore, the initial diameter of the balloon body (10) is in the range of 5-15 mm, preferably 10 mm; the diameter after being filled is in the range of 15-40 mm, preferably 25 mm;

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

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

[0072] Furthermore, the balloon body (10) can operate normally within an inflation pressure range of 100-400 mmHg, and a critical bursting pressure of 2 atm.

[0073] Furthermore, a developable mark (203) is provided in the expansion component (10) region of the catheter body (20), and the developable mark (203) can be used to indicate the position of the balloon body (10) in the body.

[0074] Furthermore, the development mark (203) may be a tantalum development ring, which is located on the outer layer of the inner section of the inner cavity (202) of the balloon body (10).

[0075] Furthermore, the development mark (203) may be a polymer coating, which is located on the outer layer of the outer cavity (201) at both ends connected to the balloon body (10).

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

[0077] Furthermore, 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 Fr to 4.5 Fr, preferably 3.3 Fr;

[0078] Furthermore, 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] Furthermore, 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 from 0.12 to 0.2 mm.

[0080] Furthermore, the material of the outer cavity (201) includes but is not limited to: Pebax, nylon; the material of the inner cavity (202) includes but is not limited to: stainless steel sus304, NITI tube.

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

[0082] Furthermore, the inner cavity fixing piece (302) has a second conical surface (3021) inside, which can be docked with the target docking interface to communicate with the inner cavity, and the second conical surface (3021) can be a conical design or a threaded design.

[0083] Furthermore, the balloon catheter also includes a host (40), and the host (40) is arranged at the proximal end of the balloon catheter.

[0084] See also Fig.10 , a pressure measuring device (401) is provided in the host (40), and the host (40) is used to display the pressure value measured by the pressure measuring device (401);

[0085] Furthermore, the pressure measuring device (401) includes a pressure sensor or a wireless pressure sensor, and the pressure measuring device (401) is connected to the host (40) in communication. 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 host (40) and connected to the blood vessel through the inner cavity (202), which can avoid the potential risks of electronic components such as sensors in the body, and can also monitor the pressure changes at the distal end of the balloon body (10), thereby avoiding the balloon body (10) from causing further damage to the blood vessel during the occlusion process.

[0086] Furthermore, the host (40) can be connected to the pressure measuring device (401) for communication. The host (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 waveforms or numbers or both.

[0087] According to the above content, the balloon catheter provided by the utility model can be used 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 docked with the corresponding interface of the host (40).

[0089] Furthermore, when the host (40) adopts 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 all completed by the host (40).

[0090] The second scenario: a semi-manual mode of a monitor or other device capable of implementing blood pressure monitoring. 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] Furthermore, when the host (40) adopts the manual mode, the catheter connector (30) is docked with the corresponding interface of the host (40), and after the manual interface (305) is docked with the Luer connector, the operator can perform extraction / injection operations on the balloon through the manual interface (305); at this time, the pressure measuring device (401) in the host (40) completes the monitoring function of blood pressure.

[0092] Furthermore, when the monitor or other devices (except the host (40)) can be used in a blood pressure monitoring device mode, the catheter connector (30) is fixed to the conversion interface (306), and the other end of the conversion interface (306) can be connected to a catheter of a standard size for connection with a monitor or other device. When connected to the conversion interface (306), only the inner cavity (202) is connected to the monitor or other device, so that data such as blood pressure can be monitored. After the manual interface (305) is connected to the Luer connector, the operator can perform pumping / injecting operations on 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] Furthermore, the catheter connector (30) is docked with the interface cover (307) to seal the outer cavity (201) and the inner cavity (202). After the manual interface (305) is docked with the Luer connector, an operator can perform a pumping / injecting operation on the balloon through the manual interface (305).

[0095] The above is only a preferred specific implementation of the utility model, but the protection scope of the utility model is not limited thereto. Any changes or substitutions that can be easily thought of by a person skilled in the art within the technical scope disclosed by the utility model should be included in the protection scope of the utility model. Therefore, the protection scope of the utility model should be based on the protection scope of the claims.

Claims

1. A manual and automatic aortic interventional balloon catheter, characterized in that: It comprises a balloon body (10), wherein the balloon body (10) is located at the distal end of the balloon catheter; A catheter body (20), the catheter body being divided into an outer cavity (201) and an inner cavity (202): the outer cavity (201) extending from the proximal end of the balloon catheter to the proximal end of the balloon body (10), and extending from the distal end of the balloon body (10) to the distal end of the balloon catheter; the inner cavity (202) is within the outer cavity (201), passes through the balloon body (10), extends from the proximal end of the balloon catheter to the distal end of the balloon catheter, and is in communication with a blood vessel in a subject; A catheter connector (30), the catheter connector (30) comprising an outer cavity fixing piece (301), an inner cavity fixing piece (302) and a fixing block (303): the outer cavity fixing piece (301) fixing the proximal end of the outer cavity (201); the inner cavity fixing piece (302) fixing the proximal end of the inner cavity (202); the fixing block (303) connecting the inner cavity fixing piece (302) and the catheter connector (30); A manual interface (305), the manual interface (305) is located at the proximal end of the balloon catheter, is connected to the outer cavity (201), and can be connected to a Luer connector.

2. The manual-automatic aortic interventional balloon catheter according to claim 1, characterized in that: The distal end of the catheter body (20) terminates at a non-damaging tip (204), and the non-damaging tip (204) has at least one opening (205), and the opening (205) connects the blood vessel with the inner cavity (202); the non-damaging tip (204) can be in the form of a tip or a pigtail tube.

3. The manual-automatic aortic interventional balloon catheter according to claim 1, characterized in that: The initial diameter of the balloon body (10) is in the range of 5-15 mm; the diameter after being filled is in the range of 15-40 mm; the length of the balloon body (10) is in the range of 20-40 mm; the wall thickness of the balloon body (10) is in the range of 0.02-0.3 mm; and the inflation pressure of the balloon body (10) is in the range of 100-400 mmHg.

4. The manual-automatic aortic interventional balloon catheter according to claim 1, characterized in that: The diameter of the outer cavity (201) is in the range of 5-8Fr; the diameter of the inner cavity (202) is in the range of 3Fr-4.5Fr; 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; the material of the outer cavity (201) includes but is not limited to: Pebax, nylon; the material of the inner cavity (202) includes but is not limited to: stainless steel sus304, NITI tube.

5. The manual-automatic aortic interventional balloon catheter according to claim 1, characterized in that: The outer side of the catheter connector (30) has a connectable structure (304), 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 press interface; the inner cavity fixing member (302) has a second conical surface (3021) inside, which can be docked with a target docking interface to connect with the inner cavity, and the second conical surface (3021) can be of conical design or of threaded design.

6. The manual-automatic aortic interventional balloon catheter according to claim 1 or 5, characterized in that: The fixing block (303) has one or more openings to facilitate fluid communication with the outer cavity (201).

7. The manual-automatic aortic interventional balloon catheter according to claim 1, characterized in that: The balloon catheter also has a conversion interface (306), and the conversion interface (306) is detachably fixed to the catheter connector (30). When the conversion interface (306) is fixed to the catheter connector (30), only the inner cavity (202) can be kept connected to the external instrument.

8. The manual-automatic aortic interventional balloon catheter according to any one of claims 1 to 6, characterized in that: The balloon catheter may also be externally connected to an interface cover (307), and the interface cover (307) may be detachably fixed to the catheter connector (30). When the interface cover (307) is fixed to the catheter connector (30), the outer cavity (201) and the inner cavity (202) may be blocked, so that the balloon catheter is converted into a fully manual mode.

9. The manual-automatic aortic interventional balloon catheter according to any one of claims 1 to 6, characterized in that: The balloon catheter further comprises a host (40), wherein the host (40) is arranged at the proximal end of the balloon catheter.

10. The manual-automatic aortic interventional balloon catheter according to claim 9, characterized in that: A pressure measuring device (401) is provided in the host (40), and the host (40) is used to display the pressure value measured by the pressure measuring device (401); The pressure measuring device (401) comprises a pressure sensor or a wireless pressure sensor, and the pressure measuring device (401) is communicatively connected to the host (40).

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