Microcatheter

Abstract

The present application relates to a microcatheter. The microcatheter comprises a tube body assembly, the tube body assembly comprising a first tube body and a second tube body, the first tube body being used for a guide wire to passing through, the distal end of the first tube body being provided with a Tip outlet and a guide wire outlet used for the guide wire to extend out, a balloon surrounding the first tube body and the second tube body, and the tube body assembly being provided with an air channel communicated with the balloon. An operating portion is provided with a first catheter seat and a second catheter seat which are independent of each other, the first catheter seat being connected to the first tube body, the second catheter seat being connected to the second tube body, the first catheter seat being provided with an air channel connection port, and the second catheter seat being provided with a suction connection port. A suction port communicated with the second tube body is formed at the distal end of the second tube body. The balloon is located on the proximal end side of the suction port, the guide wire outlet is provided at the distal end side of the balloon, and the suction port is located between the guide wire outlet and the Tip outlet. The solution provided by the present application can avoid the defect of large subintimal hematomas affecting accurate operation and control of guide wires in related technologies, thereby helping to improve the efficiency and the success rate of surgeries.

Description

microcatheter

[0001] This application claims priority to the Chinese patent application filed with the State Intellectual Property Office on March 1, 2024, with application number 2024102352600 and application name “Microcatheter”, the entire contents of which are incorporated by reference into this application. Technical Field

[0002] The present application relates to the technical field of medical devices, and in particular to a microcatheter. Background Art

[0003] During interventional treatment of chronic total occlusion (CTO) lesions, the guidewire often unexpectedly enters the subintimal layer of the vascular anatomy. Antegrade dissection and re-entry (ADR) is a forward guidewire re-entry technique based on the Stingray Balloon. As an important means of CTO patency, it can return the guidewire to the distal subintimal layer of the occluded area, further improving the success rate of CTO patency. However, when using the Stingray Balloon in the presence of a large subintimal hematoma, the guidewire often floats in the hematoma dissection, making it difficult to accurately control. Technical issues

[0004] To address or partially address the problems in the related art, this application provides a microcatheter with a second tube capable of aspirating subintimal hematomas at the guidewire exit. This avoids the drawback of the related art where large subintimal hematomas can affect precise guidewire manipulation, thereby improving surgical efficiency and success rates. Furthermore, during aspiration, the balloon can block the proximal end of the guidewire exit, reducing the likelihood of thrombosis in the blood vessel. Technical Solutions

[0005] The present application provides a microcatheter, comprising:

[0006] A tube assembly comprising a first tube body and a second tube body arranged in parallel, wherein a lumen of the first tube body is provided for passage of a guide wire, a tip outlet is provided at the distal end of the first tube body, and a guide wire outlet is provided near the distal end of the first tube body for extension of the guide wire, a balloon is provided around the outer periphery of the first tube body and the second tube body, and the tube assembly is provided with an airway connected to the balloon;

[0007] An operating portion, wherein the operating portion is provided with a first catheter seat and a second catheter seat that are independent of each other, the first catheter seat being connected to the first tube body, the second catheter seat being connected to the second tube body, the first catheter seat being provided with an airway interface, and the second catheter seat being provided with a suction interface;

[0008] The distal end of the second tube body is provided with a suction port connected to the lumen of the second tube body; the balloon is located on the proximal side of the suction port, the guidewire outlet is provided on the distal side of the balloon, and the suction port is located between the guidewire outlet and the Tip outlet.

[0009] In one embodiment, the plane formed by the center lines of the first tube body and the second tube body is perpendicular to the direction of the guidewire outlet;

[0010] There are two guidewire outlets, which are distributed along the length direction of the tube body component, and the angle between the directions of the two guidewire outlets is 180 degrees.

[0011] In one embodiment, the distance between the balloon and the suction port is 30-50 mm;

[0012] The distance between the guide wire outlet and the tip outlet is 7-10 mm;

[0013] The distance between the suction port and the Tip outlet is 3-4 mm.

[0014] In one embodiment, the balloon is a compliant balloon or a semi-compliant balloon; and / or,

[0015] The outer surface of the balloon is coated with a hydrophobic coating; and / or,

[0016] The surface of the balloon is provided with spinous processes.

[0017] In one embodiment, the developing length of the developing assembly in the longitudinal direction of the second tube is 1-5 mm.

[0018] In one embodiment, the airway includes a first sub-airway and a second sub-airway, the first sub-airway and the second sub-airway are connected, the first sub-airway is arranged at the proximal end of the tube body assembly, and the second sub-airway is arranged at the distal end of the tube body assembly, the first sub-airway is arranged on the radial side of the tube body assembly, and is parallel to the first tube body and the second tube body; the cross-section of the second sub-airway is annular, and the second sub-airway is arranged around the periphery of the first tube body and the second tube body; the second sub-airway is connected to the balloon.

[0019] In one embodiment, the cross-section of the tube body assembly is elliptical, the first tube body and the second tube body are arranged along the long axis direction of the ellipse, and the guide wire outlet is opened along the short axis direction of the ellipse; a developing assembly is provided between the two guide wire outlets, and the developing length of the developing assembly in the length direction of the tube body assembly is equal to the spacing between the two guide wire outlets; the developing assembly includes a plurality of developing rings, and the plurality of developing rings are sleeved on the periphery of the tube body assembly, and the plurality of developing rings are spaced apart in the length direction of the tube body assembly.

[0020] In one embodiment, the maximum outer diameter of the balloon when inflated is 2-5 mm, the inflation pressure is 5-8 atm, and the maximum bursting pressure is 10-12 atm.

[0021] In one embodiment, the microcatheter includes a first tube segment, a second tube segment, and a third tube segment connected sequentially from the proximal end to the distal end; the first tube body and the second tube body of the first tube segment are separated and connected to the first catheter seat and the second catheter seat, respectively, and the first tube body and the second tube body of the second tube segment and the third tube segment are connected as a whole; wherein the balloon is provided in the second tube segment, and the guidewire outlet and the suction port are provided in the third tube segment;

[0022] In one embodiment, the first catheter seat is connected to the first tube body via a first transition tube segment, and the second catheter seat is connected to the second tube body via a second transition tube segment;

[0023] The first transition pipe section is arranged along the axial direction of the pipe body assembly, the second transition pipe section has an angle with the first transition pipe section, the first sub-air duct is arranged in the first transition pipe section and at least part of the second pipe section, and the second sub-air duct is arranged in the second pipe section. Beneficial effects

[0024] The technical solution provided by this application may have the following beneficial effects:

[0025] The microcatheter provided in the present application includes a tube body assembly, which includes a first tube body and a second tube body arranged in parallel, the first tube body is for a guide wire to pass through, the distal end of the first tube body is provided with a Tip outlet, and the first tube body is provided with a guide wire outlet for the guide wire to extend out near the distal end, a balloon is provided around the outer periphery of the first tube body and the second tube body, and the tube body assembly is provided with an airway connected to the balloon; an operating part, the operating part is provided with an independent first catheter seat and a second catheter seat, the first catheter seat is connected to the first tube body, the second catheter seat is connected to the second tube body, the first catheter seat is provided with an airway interface, and the second catheter seat is provided with a suction interface; the distal end of the second tube body is provided with a suction port connected to the second tube body; the balloon is located on the proximal side of the suction port, and the suction port is located between the guide wire outlet and the Tip outlet. The microcatheter provided in this application comprises a first tube body and a second tube body. When a guidewire is inserted through the guidewire outlet of the first tube body, the second tube body can aspirate the subintimal hematoma at the guidewire outlet. This avoids the drawback of related techniques where large subintimal hematomas can affect the precise manipulation of the guidewire, thereby improving surgical efficiency and success rates. Furthermore, during aspiration, the balloon can block the proximal side of the guidewire outlet, reducing the probability of thrombosis in the blood vessel.

[0026] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0027] The above and other objects, features and advantages of the present application will become more apparent by describing in more detail exemplary embodiments of the present application in conjunction with the accompanying drawings, wherein the same reference numerals generally represent the same components in the exemplary embodiments of the present application.

[0028] FIG1 is a schematic structural diagram of a microcatheter according to an embodiment of the present application;

[0029] FIG2 is a schematic structural diagram of a first catheter seat of a microcatheter according to an embodiment of the present application;

[0030] FIG3 is a schematic diagram of the coordinated structure of the airway and tube body assembly of a microcatheter according to an embodiment of the present application;

[0031] FIG4 is a schematic diagram of the coordination structure of the airway and tube body assembly of a microcatheter according to another embodiment of the present application;

[0032] FIG5 is a schematic structural diagram of the distal end of a microcatheter according to an embodiment of the present application;

[0033] FIG6 is a schematic cross-sectional view of the microcatheter at AA shown in the embodiment of FIG1 .

[0034] Figure markings: 100, tube body assembly; 110, first tube body; 120, second tube body; 111, guidewire outlet; 112, balloon; 113, airway; 114, first catheter seat; 1141, airway interface; 1142, guidewire interface; 115, first transition pipe section; 116, Tip outlet; 1161, developing part; 117, developing assembly; 121, suction port; 122, second catheter seat; 1121, suction interface; 123, second transition pipe section; 131, inner tube layer; 132, intermediate reinforcement layer; 133, outer tube layer. Modes for Carrying Out the Invention

[0035] The following describes embodiments of the present application in more detail with reference to the accompanying drawings. Although the accompanying drawings illustrate embodiments of the present application, it should be understood that the present application can be implemented in various forms and should not be limited by the embodiments described herein. Rather, these embodiments are provided to make the present application more thorough and complete, and to fully convey the scope of the present application to those skilled in the art.

[0036] The terms used in this application are for the purpose of describing specific embodiments only and are not intended to limit this application. As used in this application and the appended claims, the singular forms "a," "an," "the," and "the" are intended to include the plural forms, unless the context clearly indicates otherwise. It should also be understood that the term "and / or" as used herein refers to and encompasses any and all possible combinations of one or more of the associated listed items.

[0037] It should be understood that although the terms "first", "second", "third", etc. may be used in this application to describe various information, this information should not be limited to these terms. These terms are only used to distinguish information of the same type from each other. For example, without departing from the scope of this application, the first information may also be referred to as the second information, and similarly, the second information may also be referred to as the first information. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of the features. In the description of this application, the meaning of "plurality" is two or more, unless otherwise clearly and specifically defined.

[0038] In the case of a large subintimal hematoma, the guidewire of the manta ray balloon in the related art often floats in the hematoma layer, making it difficult to accurately control. To address the above problems, the embodiment of the present application provides a microcatheter, in which the second tube body can aspirate the subintimal hematoma at the guidewire outlet, thereby avoiding the defect of the related art that a large subintimal hematoma affects the precise control of the guidewire, and is conducive to improving the efficiency and success rate of the operation. At the same time, when aspirating the hematoma, the balloon can block the proximal side of the guidewire outlet, reducing the probability of thrombosis in the blood vessel.

[0039] The technical solutions of the embodiments of the present application are described in detail below with reference to the accompanying drawings.

[0040] FIG1 is a schematic structural diagram of a microcatheter according to an embodiment of the present application; FIG6 is a schematic cross-sectional diagram of the microcatheter at AA according to the embodiment of FIG1 .

[0041] Referring to Figures 1 and 2, the present application provides a microcatheter, comprising a tube assembly 100 and an operating portion, wherein the tube assembly 100 comprises a first tube 110 and a second tube 120 arranged in parallel, wherein the lumen of the first tube 110 is for a guide wire to pass through, a tip outlet 116 is provided at the distal end of the first tube 110, and a guide wire outlet 111 is provided near the distal end of the first tube 110 for the guide wire to extend out, a balloon 112 is provided around the outer periphery of the first tube 110 and the second tube 120, and the tube assembly is provided with an airway 113 in communication with the balloon 112; and the operating portion is provided with an independent first tube 110. A catheter seat 114 and a second catheter seat 112, the first catheter seat 114 is connected to the first tube body 110, and the second catheter seat 112 is connected to the second tube body 120, the first catheter seat 114 is provided with an airway interface, and the second catheter seat 112 is provided with a suction interface 1121; the distal end of the second tube body 120 is provided with a suction port 121 connected to the lumen of the second tube body 120; the balloon 112 is located on the proximal side of the suction port 121, and the guidewire outlet 111 is provided on the distal side of the balloon 112, and the suction port 121 is located between the guidewire outlet and the Tip outlet 116.

[0042] The microcatheter provided herein comprises a first tubular body 110 and a second tubular body 120. When a guidewire is inserted through a guidewire outlet 111 at the distal end of the first tubular body 110, the suction port of the second tubular body 120 can aspirate hematoma in the intimal space at the guidewire outlet 111. This avoids the drawback of related art whereby a large subintimal hematoma affects the precise manipulation of the guidewire, thereby improving surgical efficiency and success rate. Furthermore, during aspiration of the hematoma, the balloon 112 can block the proximal side of the guidewire outlet 111, reducing the probability of thrombosis in the blood vessel.

[0043] In the related art, in the intima and media layer of the blood vessel, the microcatheter will float up and down with the flow of blood. Therefore, when the guidewire pierces the intima, it will be disturbed by the floating of the microcatheter and it will be difficult to operate and bear force accurately. The solution provided in this embodiment is that when the balloon 112 is inflated, the blood stops flowing temporarily and the distal end of the catheter is stationary, which is more conducive to the guidewire passing through the guidewire outlet 111 to pierce the intima and return to the true lumen.

[0044] The intravascular tunica space mentioned in this embodiment refers to the space after the endothelium and the media of the blood vessel are separated. The microcatheter of this embodiment is provided with a developing tip end, which is arranged at the distal end of the first tube body 110. When the tube body assembly 100 moves in the endothelium space, the developing tip end can bluntly separate the endothelium and the media, and the puncture guidewire can puncture the vascular endothelium through the guidewire outlet 111 and return to the true lumen. The balloon 112 is arranged close to the guidewire outlet 111 and is located on the proximal side of the guidewire outlet 111, that is, the guidewire outlet 111 and the suction port 121 are located on the distal side of the balloon 112. After the balloon 112 is inflated, on the one hand, the tube body assembly 100 can be limited to a specific position in the endometrial space, thereby facilitating precise puncture of the guidewire. On the other hand, it can block the endometrial space on the proximal side of the guidewire outlet 111, which can reduce the probability of thrombosis in the blood vessel. Moreover, after the balloon 112 is blocked, negative pressure is formed at the position of the hematoma in the endometrial space, so that the endometrium is tightly attached to the guidewire outlet 111 under the action of negative pressure, avoiding the defect in related technologies that the guidewire floats in the hematoma interlayer and is difficult to puncture accurately, which can save operation time and improve the success rate of the operation.

[0045] Since the ADR scenario is a blood vessel branch, the maximum outer diameter of the balloon 112 when inflated is 2-5 mm, and the inflation pressure of the balloon 112 is smaller than that of the balloon in the related art. For example, the inflation pressure of the balloon 112 in this embodiment is 5-8 atm, and the maximum bursting pressure is 10-12 atm.

[0046] In some embodiments, the balloon 112 is a compliant balloon or a semi-compliant balloon. The balloon 112 has good retraction properties and can be better compatible with the anchoring balloon. Since there is basically no calcification lesion in the blocked blood vessel, in order to reduce vascular damage, the material of the balloon 112 in this embodiment can be POC, PU, ​​PE, nylon and other materials. In some embodiments, the balloon 112 can also use non-compliant materials such as PET. After the balloon 112 is expanded, it has a better blocking effect.

[0047] In some embodiments, the outer surface of the balloon 112 is coated with a non-hydrophilic or hydrophobic coating, the surface of the balloon 112 is provided with granular spines, or the balloon 112 is a double-guidewire balloon, to ensure that when the balloon 112 occludes the blood vessel, it can more stably adhere to the blood vessel wall, further improving the occlusion effect.

[0048] Since hematoma may affect guidewire puncture, in order to ensure that the hematoma can be aspirated in time when the guidewire returns to the true lumen, the suction port 121 of this embodiment extends beyond the distal guidewire outlet 111. In addition, the balloon 112 is arranged close to the guidewire outlet 111, which can provide stronger support for guidewire puncture and is applicable to shorter calcified lesions.

[0049] In this embodiment, the suction port 121 is located between the guidewire outlet 111 and the tip outlet 116 . The suction port 121 is disposed at the distal end of the second tube 120 , and the opening of the suction port 121 faces the opening direction of the tip outlet 116 .

[0050] In this embodiment, a set distance is established between the balloon 112 and the guidewire outlet 111, and between the suction port 121 and the tip outlet 116. Because the length of a chronic total occlusion segment using ADR is generally greater than 20 mm, the balloon 112 must remain within the vessel. Therefore, in this embodiment, the distance between the balloon 112 and the suction port is 30-50 mm, and the distance between the suction port 121 and the tip outlet 116 is 3-4 mm.

[0051] In some embodiments, there is a set distance between the guidewire outlet 111 and the tip outlet 116, and the distance is 7-10 mm, so as to facilitate the puncture operation of the distal end of the catheter within a limited distance.

[0052] In some embodiments, the plane formed by the center lines of the first tube body 110 and the second tube body 120 is perpendicular to the direction of the guidewire outlet 111, that is, the parallel direction of the first tube body 110 and the second tube body 120 is perpendicular to the opening direction of the guidewire outlet 111. When the microcatheter enters the space within the vascular membrane, the guidewire outlet 111 can be oriented towards the blood vessel and facilitate directional puncture of the puncture guidewire.

[0053] In addition, the first tube body 110 and the second tube body 120 are arranged side by side, so that the tube body assembly 100 is flat, which improves the pushability and twistability of the microcatheter, so that when the microcatheter enters the space inside the vascular membrane, the catheter can bend more easily when passing through a curved blood vessel, which can make it more convenient for the operator to operate and help improve the success rate of the operation.

[0054] At the same time, since the tube body assembly 100 is flat, after the tube body assembly 100 reaches between the intima and the media of the blood vessel, it will be deflected due to the force, and the deflected guidewire outlet 111 will face the blood vessel intima, and then the guiding guidewire will be withdrawn from the guidewire cavity, and then the puncture guidewire will enter the first tube body 110, and the puncture guidewire will puncture the intima through the guidewire outlet 111. After the puncture is completed, the catheter will be withdrawn from the human body along the puncture guidewire, and the puncture guidewire will remain in the human body to assist in completing subsequent operations.

[0055] In this embodiment, the balloon 112 is arranged around the periphery of the first tube body 110 and the second tube body 120. After the balloon 112 is inflated, the radial outer surface of the balloon 112 can be tightly attached between the tunica media and the tunica intima of the blood vessel, thereby achieving a blocking effect on the proximal side of the guidewire outlet 111. After blocking, the hematoma in the endothelial space forms a negative pressure during suction, causing the endothelial membrane to be tightly attached to the guidewire outlet 111.

[0056] FIG3 is a schematic diagram of the cooperation structure of the airway 113 of the microcatheter and the tube body assembly 100 according to one embodiment of the present application; FIG4 is a schematic diagram of the cooperation structure of the airway 113 of the microcatheter and the tube body assembly 100 according to another embodiment of the present application.

[0057] 3 and 4 , in some embodiments, the airway 113 includes a first sub-airway and a second sub-airway, the first sub-airway and the second sub-airway are connected, the first sub-airway is arranged at the proximal end of the tube body assembly, and the second sub-airway is arranged at the distal end of the tube body assembly, the first sub-airway is arranged on the radial side of the tube body assembly, and is parallel to the first tube body 110 and the second tube body 120; the cross-section of the second sub-airway is annular, and the second sub-airway is arranged around the periphery of the first tube body 110 and the second tube body 120, and the second sub-airway is connected to the balloon 112, that is, the first sub-airway is connected to the balloon through the second sub-airway transition, and the second sub-airway is connected to the balloon 112 at the same time around the tube body assembly 100, which can increase the inflation or decompression speed of the balloon, and can also ensure that the contrast agent can synchronously pass from the airway to various parts of the balloon.

[0058] In some embodiments, the length of the second sub-airway is 2-5 mm.

[0059] In some embodiments, two guidewire outlets 111 are provided, and the two guidewire outlets 111 are distributed along the length direction of the catheter. The two guidewire outlets 111 have a set spacing in the axial direction of the tube body assembly 100, and the angle between the directions of the two guidewire outlets 111 is 180 degrees. The directions of the two guidewire outlets 111 are perpendicular to the center line of the first tube body 110.

[0060] In some embodiments, the cross-section of the tube body assembly 100 near the distal end can be circular or elliptical. When the cross-section of the tube body assembly is elliptical, the first tube body 110 and the second tube body 120 are distributed in the long axis direction of the ellipse, and the two guide wire outlets 111 are distributed in the short axis direction of the ellipse.

[0061] In some embodiments, the cross-section of the tube body assembly 100 near the distal end of the technical solution of the present application can be an ellipse, the first tube body 110 and the second tube body 120 are arranged along the long axis direction of the ellipse, and the guidewire outlet 111 is opened along the short axis direction of the ellipse; the pushability and twistability of the catheter are improved, so that when the catheter enters the space inside the vascular membrane, the guidewire outlet 111 distributed in the short axis direction can be close to the blood vessel and facilitate directional puncture of the puncture guidewire.

[0062] Since the catheter needs to be compatible with an anchoring balloon with a maximum diameter of 2.5mm in a conventional 6F (tube diameter) guiding catheter and with an ordinary balloon with a maximum diameter of 2.5mm in a 7F guiding catheter, the cross-section of the tube body assembly of this embodiment is flat, and the maximum radial dimension of the entire catheter does not exceed 3.1F×3.5F. Compared with related technologies, the radial dimension of the microcatheter is effectively reduced.

[0063] FIG5 is a schematic structural diagram of the distal end of a microcatheter according to an embodiment of the present application.

[0064] Referring to Figure 5 , in some embodiments, the microcatheter further includes a developing member 1161 disposed at the distal end of the tube assembly 100. A developing assembly 117 is disposed between the two guidewire outlets 111. The developing length of the developing assembly 117 along the length of the tube assembly is equal to the distance between the two guidewire outlets 111. The developing member 1161 is disposed at the tip of the first tube 110. The developing member 1161 and the developing assembly 117 can be visualized under X-rays, providing a location indication for the tip outlet and directional guidance for guidewire insertion.

[0065] In some embodiments, the developing assembly 117 may not be limited to being located between the two guide wire outlets 111 in the axial direction of the tube assembly 100 , but may also be located outside the two guide wire outlets 111 .

[0066] In some embodiments, the developing member 1161 and the developing assembly 117 may be made of a resin material containing a radiation-opaque metal such as tungsten, bismuth, or barium.

[0067] In some embodiments, the developing assembly 117 includes multiple developing rings, which are sleeved on the periphery of the tube body assembly, and the multiple developing rings are spaced apart in the length direction of the tube body assembly. The developing assembly of this embodiment adopts a design of multiple developing rings in series development, which can not only improve the development brightness but also appropriately reduce the hardness of the distal end of the microcatheter. It can avoid the development obstruction that may exist due to the guide wire in the lumen of the first tube body 110 in the related technology, and avoid the defects of the related technology that the pure flexible resin development is not bright enough and the single long developing ring is too hard.

[0068] In this embodiment, the two guide wire outlets 111 straddle the two ends of the developing assembly 117, that is, the proximal end of the developing assembly 117 is connected to the proximal guide wire outlet, and the distal end of the developing assembly 117 is connected to the distal guide wire outlet. This makes it convenient for doctors to perform more accurate puncture operations based on the development at both ends.

[0069] In this embodiment, the distance between the two guidewire outlets 111 is 1-5 mm. The developing length of the developing assembly 117 along the length of the second tube is the same as the distance between the two guidewire outlets 111, also 1-5 mm. Since the maximum diameter of a blood vessel branch in an ADR scenario is 4 mm, the dimensional design of this embodiment ensures a clearer relationship between the developing image and the axial direction of the vessel, facilitating accurate surgical procedures.

[0070] Referring to FIG6 , in some embodiments, the first tube body 110 and the second tube body 120 are both composite structural layers, comprising an outer tube layer 133, an intermediate reinforcement layer 132, and an inner tube layer 131, which are sequentially connected in radial direction. The inner tube layer 131 has a smooth inner wall, which can provide a less frictional entry and exit passage for the guidewire. The intermediate reinforcement layer 132 is a reinforcement layer that provides better pushability and twistability for the first and second tube bodies 110, 120. The outer tube layer 133 provides a smooth and gradual transition between the tube body at different outer diameters of the tube assembly 100. The intermediate reinforcement layer 132 can be a spiral elastic member, which gives the microcatheter of this embodiment better pushability and twistability, providing better support for guidewire pushing, manipulation, and puncture, and facilitating twisting operations after entering the subintimal region, thereby making it easier to adjust the position and angle of the distal end of the catheter.

[0071] In this embodiment, the first tube body 110 and the outer tube layer 133 of the second tube body 120 are formed as a whole, and the intermediate reinforcement layer 132 of the first tube body 110 and the second tube body 120 is embedded in the outer tube layer 133, that is, the outer tube layer 133 is wrapped around the outer periphery of the outer tube layer 133 of the first tube body 110 and the second tube body 120, and the airway 113 of the balloon 112 is arranged on the outside of the outer tube layer 133.

[0072] In some embodiments, the inner tube layer 131 is made of PTFE (Polytetrafluoroethylene) or other smooth resin materials, the middle reinforcement layer is a metal braid and / or metal spring structure, and the outer layer can be made of polymer resin.

[0073] The microcatheter of the related technology is prone to bending / twisting / breaking, and the guidewire is easy to pierce the guidewire cavity and the tube cavity, and the tube cavity is easy to collapse when the catheter is bent. In this embodiment, the first tube body 110 and the second tube body 120 are designed as a composite structure, and the reinforcement layer improves the strength, which can prevent the guidewire from piercing the microcatheter. The double-cavity design of the first tube body 110 and the second tube body 120 allows suction and puncture to be performed simultaneously. When the microcatheter is bent, the suction cavity reinforcement layer can provide support for the inner cavity and reduce the risk of collapse.

[0074] FIG2 is a schematic structural diagram of a first catheter seat 114 of a microcatheter according to an embodiment of the present application.

[0075] Referring to Figures 1 and 2, in some embodiments, the first catheter seat 114 is provided with a guidewire interface 1142 and an airway interface 1141, that is, the guidewire interface 1142 and the airway interface 1141 are provided on the same catheter seat, and the second catheter seat 122 is provided with a suction interface 1221, which is convenient for the operator to operate the guidewire puncture through the guidewire interface 1142 of the first catheter seat 114. The inflation state of the balloon can be controlled through the airway interface, and the hematoma can be timely aspirated through the suction interface 1221 of the second catheter seat 122.

[0076] In some embodiments, the first catheter hub 114 and the second catheter hub 122 are made of a resin material such as polycarbonate.

[0077] In some embodiments, the first catheter seat 114 is connected to the first tube body 110 via a first transition tube section 115, and the second catheter seat 122 is connected to the second tube body 120 via a second transition tube section 123. The second transition tube section 123 includes a stress relief tube to prevent bending caused by stress concentration. In some embodiments, the stress relief tube is made of polyester elastomer material.

[0078] Continuing to refer to Figure 1, in this embodiment, the microcatheter includes a first tube segment A, a second tube segment B, and a third tube segment C connected in sequence from the proximal end to the distal end; the first tube body 110 and the second tube body 120 of the first tube segment A are separated and are respectively connected to the first catheter seat 114 and the second catheter seat 122, and the first tube body 110 and the second tube body 120 of the second tube segment B and the third tube segment C are connected as a whole; wherein, the balloon 112 is arranged on the second tube segment B, and the guidewire outlet 111 and the suction port 121 are arranged on the third tube segment C.

[0079] In some embodiments, the first transition pipe section 115 is arranged along the axial direction of the pipe body assembly 100, the second transition pipe section 123 has an angle with the first transition pipe section 115, the first sub-airway is arranged in the first transition pipe section 115 and at least part of the second pipe section B, and the second sub-airway is arranged in the second pipe section B.

[0080] In combination with the above embodiments, it can be seen that the solution provided by the present application, the first tube body 110, the second tube body 120, the guidewire outlet 111, and the balloon 112 are designed in coordination, which can effectively control the hematoma proximal to the lesion while assisting the guidewire to return to the true cavity, thereby improving the efficiency and success rate of the operation. The dual-cavity structure of the tube body assembly 100, combined with the spatial position design of the developing component and the guidewire outlet 111, can provide the doctor with clear puncture guidance, increase the puncture efficiency, and at the same time have good pushing properties, which can expand the applicable scenarios of the operation and improve the success rate of the operation.

[0081] The embodiments of the present application have been described above. The above description is exemplary, not exhaustive, and is not limited to the disclosed embodiments. Many modifications and variations will be apparent to those skilled in the art without departing from the scope and spirit of the described embodiments. The terminology used herein is selected to best explain the principles of the embodiments, their practical applications, or improvements to the technology in the market, or to enable other persons skilled in the art to understand the embodiments disclosed herein.

Claims

1. A microcatheter, characterized in that: include: A tube assembly comprising a first tube body and a second tube body arranged in parallel, wherein a lumen of the first tube body is provided for passage of a guide wire, a tip outlet is provided at the distal end of the first tube body, and a guide wire outlet is provided near the distal end of the first tube body for extension of the guide wire, a balloon is provided around the outer periphery of the first tube body and the second tube body, and the tube assembly is provided with an airway connected to the balloon; An operating portion, wherein the operating portion is provided with a first catheter seat and a second catheter seat that are independent of each other, the first catheter seat being connected to the first tube body, the second catheter seat being connected to the second tube body, the first catheter seat being provided with an airway interface, and the second catheter seat being provided with a suction interface; The distal end of the second tube body is provided with a suction port connected to the lumen of the second tube body, the balloon is located on the proximal side of the suction port, the guidewire outlet is provided on the distal side of the balloon, and the suction port is located between the guidewire outlet and the Tip outlet.

2. The microcatheter according to claim 1, wherein: The plane formed by the center lines of the first tube body and the second tube body is perpendicular to the direction of the guidewire outlet; there are two guidewire outlets, and the two guidewire outlets are distributed along the length direction of the tube body assembly, and the angle between the directions of the two guidewire outlets is 180 degrees.

3. The microcatheter according to claim 2, wherein: Therefore, the distance between the balloon and the suction port is 30-50 mm.

4. The microcatheter according to claim 2, wherein: The distance between the guide wire outlet and the tip outlet is 7-10 mm; The distance between the suction port and the Tip outlet is 3-4 mm.

5. The microcatheter according to claim 1, wherein: The balloon is a compliant balloon or a semi-compliant balloon.

6. The microcatheter according to claim 1, characterized in that: The outer surface of the balloon is coated with a hydrophobic coating; and / or the surface of the balloon is provided with spinous processes.

7. The microcatheter according to claim 1, wherein: The airway includes a first sub-airway and a second sub-airway, the first sub-airway and the second sub-airway are connected, the first sub-airway is arranged at the proximal end of the tube body assembly, and the second sub-airway is arranged at the distal end of the tube body assembly, the first sub-airway is arranged on the radial side of the tube body assembly, and is parallel to the first tube body and the second tube body; the cross-section of the second sub-airway is annular, and the second sub-airway is arranged around the periphery of the first tube body and the second tube body; the second sub-airway is connected to the balloon.

8. The microcatheter according to claim 1, wherein: The cross section of the tube assembly is elliptical, the first tube and the second tube are arranged along the long axis direction of the ellipse, and the guide wire outlet is opened along the short axis direction of the ellipse; A developing assembly is provided between the two guide wire outlets, and a developing length of the developing assembly in the longitudinal direction of the tube assembly is equal to the distance between the two guide wire outlets; The developing assembly includes a plurality of developing rings, which are sleeved on the periphery of the tube assembly and spaced apart in the length direction of the tube assembly.

9. The microcatheter according to claim 8, characterized in that: The developing length of the developing assembly in the longitudinal direction of the second tube body is 1-5 mm.

10. The microcatheter according to claim 8, characterized in that: The distance between the two guide wire outlets is 1-5 mm, and the developing length of the developing assembly in the length direction of the second tube body is the same as the distance between the two guide wire outlets.

11. The microcatheter according to claim 1, characterized in that: The maximum outer diameter of the balloon when inflated is 2-5 mm, the inflation pressure is 5-8 atm, and the maximum bursting pressure is 10-12 atm.

12. The microcatheter according to claim 8, characterized in that: The microcatheter includes a first tube segment, a second tube segment and a third tube segment connected in sequence from the proximal end to the distal end; the first tube body and the second tube body of the first tube segment are separated and connected to the first catheter seat and the second catheter seat respectively, and the first tube body and the second tube body of the second tube segment and the third tube segment are connected as a whole; wherein the balloon is arranged in the second tube segment, and the guidewire outlet and the suction port are arranged in the third tube segment.

13. The microcatheter according to claim 12, characterized in that: The first catheter seat is connected to the first tube body via a first transition tube section, and the second catheter seat is connected to the second tube body via a second transition tube section; The first transition pipe section is arranged along the axial direction of the pipe body assembly, the second transition pipe section has an angle with the first transition pipe section, the first sub-air duct is arranged in the first transition pipe section and at least part of the second pipe section, and the second sub-air duct is arranged in the second pipe section.

14. The microcatheter according to claim 2, characterized in that: The cross section of the tube assembly near the distal end is elliptical, the first tube body and the second tube body are distributed in the long axis direction of the ellipse, and the two guidewire outlets are distributed in the short axis direction of the ellipse.

15. The microcatheter according to claim 8, characterized in that: The two guide wire outlets are straddling the two ends of the developing assembly, and the proximal end of the developing assembly is connected to one of the guide wire outlets at the proximal end.

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