A bifurcated balloon catheter assembly and its preparation method

Abstract

The present invention relates to a bifurcated balloon catheter assembly and a preparation method thereof, comprising an inner tube, a balloon and an adjustment assembly. The inner tube includes a first inner tube section, a second inner tube section and a third inner tube section, and the balloon includes a first balloon body, a second balloon body and a third balloon body; the adjustment assembly includes a connecting piece and a traction piece. When the traction piece is pulled, the second inner tube section and the third inner tube section approach or move away from each other so that the second balloon body and the third balloon body approach or move away from each other. When using this bifurcated balloon catheter assembly to pre-dilate a diseased bifurcated blood vessel, the angle of the balloon is adjusted by controlling the adjustment assembly to adapt to bifurcated blood vessels of different shapes, which has a good dredging effect on the diseased part, has a better treatment effect, and has a simple implantation process, a short operation time and a low operation risk.

Description

Technical Field

[0001] The present invention belongs to the technical field of medical devices, and particularly relates to a bifurcated balloon catheter assembly and a preparation method thereof. Background Art

[0002] The most important cause of vascular arterial diseases is atherosclerosis, which causes stenosis and occlusion of blood vessels, leading to myocardial infarction, stroke, and many peripheral vascular diseases. Interventional treatment using stents or balloons is one of the rapidly developing treatment methods at present.

[0003] In clinical practice, it often occurs that bifurcated coronary arteries are diseased at the bifurcation at the same time. However, for the blockage of lesions at the vascular bifurcation, in the currently known lesion dilation procedures, mostly two balloons are respectively delivered to the corresponding bifurcated blood vessel parts and dilated and dredged. However, since parts of the two balloons will overlap each other, the treatment effect on the bifurcated part is limited, and this method also has defects such as complicated operation during the dilation process.

[0004] In addition, the shapes of human blood vessels are diverse and the structures are relatively complex, especially there are many bifurcated blood vessels with complex structures. For the lesions of bifurcated blood vessels, higher technical requirements are put forward for new balloon dilation catheters. Summary of the Invention

[0005] The technical problem to be solved by the present invention is to provide a bifurcated balloon catheter assembly suitable for bifurcated blood vessels of different shapes and with simple operation.

[0006] To achieve the above object, the technical solution adopted by the present invention is:

[0007] A first object of the present invention provides a bifurcated balloon catheter assembly, and the bifurcated balloon catheter assembly includes an inner tube, a balloon, and an adjustment assembly;

[0008] The inner tube includes a first inner tube section at the proximal end, a second inner tube section and a third inner tube section respectively fixedly connected to the distal end of the first inner tube section, and the interior of the first inner tube section is respectively communicated with the interior of the second inner tube section and the interior of the third inner tube section;

[0009] The balloon includes a first balloon body fixedly sleeved on the first inner tube section, and a second balloon body and a third balloon body respectively fixedly sleeved on the second inner tube section and the third inner tube section;

[0010] The adjusting assembly includes a connecting member and a pulling member. One end of the connecting member is fixedly connected to the second inner pipe section, and the other end is fixedly connected to the third inner pipe section. The distal end of the pulling member is slidably connected to the connecting member and can slide along the length direction of the connecting member, and the proximal end penetrates into the first inner pipe section. When the pulling member is pulled, the second inner pipe section and the third inner pipe section approach or separate from each other so that the second bladder and the third bladder approach or separate from each other.

[0011] Preferably, the distance between the center of the connection point where the connecting member is connected to the second inner pipe section and the proximal end of the second inner pipe section is equal to the distance between the center of the connection point where the connecting member is connected to the third inner pipe section and the proximal end of the third inner pipe section.

[0012] Preferably, the distance between the center of the connection point where the connecting member is connected to the second inner pipe section and the proximal end of the second inner pipe section, and the distance between the center of the connection point where the connecting member is connected to the third inner pipe section and the proximal end of the third inner pipe section are independently 0.3 to 0.6 times the length of the shorter inner pipe section among the second inner pipe section and the third inner pipe section.

[0013] Preferably, a pull ring is provided at the distal end of the pulling member, the pull ring is sleeved on the connecting member, a pulling opening is formed on the first inner pipe section, and the proximal end of the pulling member penetrates into the first inner pipe section through the pulling opening.

[0014] Further preferably, the distance between the center of the pulling opening and the distal end of the first inner pipe section is 0.1 to 0.2 times the sum of the lengths of the second inner pipe section and the third inner pipe section.

[0015] Even more preferably, the distance between the center of the pulling opening and the distal end of the first inner pipe section is 0.1 to 0.15 times the sum of the lengths of the second inner pipe section and the third inner pipe section.

[0016] Preferably, a first channel, a second channel, and a third channel that extend along the length direction of the first inner pipe section and are independent of each other are respectively provided in the first inner pipe section;

[0017] A fourth channel that extends along the length direction of the second inner pipe section is provided in the second inner pipe section;

[0018] A fifth channel that extends along the length direction of the third inner pipe section is provided in the third inner pipe section;

[0019] The first channel communicates with the fourth channel to form a first guide wire channel; the second channel communicates with the fifth channel to form a second guide wire channel;

[0020] The proximal end of the traction member penetrates into the third channel through the traction opening on the first inner tube section.

[0021] The circumferential part at the distal end of the second bladder is hermetically connected to the distal end of the second inner tube section, the circumferential part at the distal end of the third bladder is hermetically connected to the distal end of the third inner tube section, the distal end of the first bladder is hermetically connected to or integrally formed with the proximal ends of the second bladder and the third bladder respectively, and the inner cavities of the first bladder, the second bladder, and the third bladder communicate with each other to form a Y-shaped structure.

[0022] Preferably, one end of the connecting member is connected to the part of the second inner tube section located inside the second bladder, and the other end is connected to the part of the third inner tube section located inside the third bladder. A traction opening is provided on the part of the first inner tube section located inside the first bladder, and the proximal end of the traction member penetrates into the first inner tube section through the traction opening.

[0023] Preferably, in the inflated state, the outer diameter of the first bladder is greater than the outer diameters of the second bladder and the third bladder.

[0024] In another specific and preferred embodiment, the bifurcated balloon catheter assembly further includes an outer tube. Part of the first inner tube section is located in the outer tube, the distal end of the first inner tube section extends out from the distal end of the outer tube, the circumferential part at the proximal end of the first bladder is hermetically connected to the outer tube, and there is a filling channel between the outer tube and the first inner tube section through which gas or liquid can pass to control the inflation or deflation of the balloon.

[0025] Preferably, the bifurcated balloon catheter assembly further includes a braided mesh covering the balloon.

[0026] More preferably, the braided mesh is woven from nylon filaments.

[0027] More preferably, the end of the balloon is independently fixedly connected to the corresponding end of the braided mesh.

[0028] Preferably, the material of the connecting member is a polymer material, and the material of the traction member is a metal.

[0029] Preferably, the inner tube communicates with the inside of the balloon.

[0030] Preferably, in the inflated state, the maximum angle formed by the axis lines of the second bladder and the third bladder is 30° to 40°.

[0031] Preferably, the first inner tube section, the second inner tube section, and the third inner tube section are fixedly connected by integral molding or welding by extrusion or blow molding.

[0032] Preferably, the balloon is made by a blow molding process.

[0033] Preferably, the bifurcated balloon catheter assembly is a non-compliant balloon.

[0034] The second object of the present invention is to provide a method for manufacturing a bifurcated balloon catheter assembly as described in any one of the above, which includes:

[0035] Manufacturing the inner tube of the bifurcated balloon catheter assembly;

[0036] Installing the adjustment assembly on the inner tube;

[0037] Putting the balloon tubing film into a balloon forming mold and blow molding it into a pre-formed embryo;

[0038] Putting the two pre-formed embryos into a balloon catheter assembly forming mold, and placing the inner tube equipped with the adjustment assembly between the two pre-formed embryos, and fusing the two pre-formed embryos into a whole by heating to form a balloon;

[0039] Connecting the outer tube to the balloon (2), welding and fixing the proximal end of the first balloon body (21) to the distal end of the outer tube, and welding and fixing the distal ends of the second balloon body and the third balloon body to the distal ends of the second inner tube section and the third inner tube section respectively.

[0040] Preferably, the manufacturing method further includes weaving a braided mesh by mechanical weaving, covering the outer surface of the balloon with the braided mesh and fixedly connecting it thereto.

[0041] Due to the application of the above technical solutions, the present invention has the following advantages compared with the prior art:

[0042] There are many bifurcated blood vessels with complex structures in the human body, and the bifurcation angles of the bifurcated blood vessels and the inner diameters of the blood vessels are not the same. When using the bifurcated balloon catheter assembly provided by the present invention to pre-dilate the diseased bifurcated blood vessels, by controlling the adjustment assembly to adjust the angle of the balloon to adapt to different-shaped bifurcated blood vessels, it can have a good dredging effect on the blocked blood vessels and the treatment effect is better; the balloon has good performance while being thin and light; the bifurcated balloon catheter assembly provided by the present invention simplifies the implantation process, shortens the operation time, and reduces the operation risk; when manufacturing the bifurcated balloon catheter assembly, no special materials are required, which is convenient for production. BRIEF DESCRIPTION OF THE DRAWINGS

[0043] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for description in the embodiments will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present application. For those of ordinary skill in the art, without creative efforts, other drawings can also be obtained based on these drawings.

[0044] Figure 1 Schematic diagram of the Y-shaped balloon structure of the bifurcated balloon catheter assembly in one embodiment of the present invention (expanded state);

[0045] Figure 2 Schematic diagram of the Y-shaped balloon structure of the bifurcated balloon catheter assembly in one embodiment of the present invention (contracted state);

[0046] Figure 3 Partial cross-sectional view of the bifurcated balloon catheter assembly in one embodiment of the present invention (expanded state);

[0047] Figure 4 Schematic diagram of the inner tube structure of the bifurcated balloon catheter assembly of the present invention;

[0048] Figure 5 Schematic diagram of the internal channel structure of the inner tube of the bifurcated balloon catheter assembly in another embodiment of the present invention;

[0049] Figure 6 Schematic diagram of the guide wire and adjustment assembly of the bifurcated balloon catheter assembly of the present invention;

[0050] Figure 7 is Figure 6 Partial enlarged view;

[0051] Figure 8 Schematic diagram of the inner tube structure of the present invention provided with a guide wire and an adjustment assembly;

[0052] Figure 9 Schematic diagram of the Y-shaped balloon structure of the bifurcated balloon catheter assembly coated with a braided layer in one embodiment of the present invention;

[0053] Figure 10 Schematic diagram of the Y-shaped balloon for fabricating the bifurcated balloon catheter assembly of the present invention;

[0054] Figure 11 Schematic diagram of the mold of the bifurcated balloon catheter assembly of the present invention;

[0055] Figure 12 Schematic diagram for fabricating the bifurcated balloon catheter assembly of the present invention;

[0056] Among them,

[0057] 1. Inner tube; 11. First inner tube section; 110. First channel; 111. Second channel; 112. Third channel;

[0058] 12. Second inner tube section; 120. Fourth channel; 121. Sixth channel;

[0059] 13. Third inner tube section; 130. Fifth channel; 131. Seventh channel;

[0060] 2. Balloon; 21. First bladder; 22. Second bladder; 23. Third bladder;

[0061] 3. Connector; 31. First connection port; 32. Second connection port;

[0062] 4. Traction member; 41. Pull ring; 42. Traction port;

[0063] 5. First guide wire;

[0064] 6. Second guide wire;

[0065] 7. Braided mesh;

[0066] 8. Blastocyst; 81. Balloon tube film;

[0067] 9. Intake pipe;

[0068] 10. Balloon forming die;

[0069] 101. Balloon catheter assembly forming die. Detailed implementation manners

[0070] In the following, only some exemplary embodiments are simply described. As those skilled in the art can recognize, the described embodiments can be modified in various different ways without departing from the spirit or scope of the embodiments of the present invention. Therefore, the drawings and the description are considered to be exemplary in nature rather than restrictive.

[0071] In the description of the present application, it should be understood that the distal end refers to the end of the instrument or component that is far from the operator, and the proximal end refers to the end of the instrument or component that is close to the operator; the axial direction refers to the direction parallel to the center line connecting the distal end and the proximal end of the instrument or component, the radial direction refers to the direction perpendicular to the axial direction, and the circumferential or circular direction refers to the direction surrounding the axial direction; the inner and outer are positions defined by the distance relative to the center of the instrument or component, where the inner is the position close to the center of the instrument or component, and the outer is the position far from the center of the instrument or component. The description of the above orientation terms is only for the convenience of describing the embodiments of the present invention and simplifying the description, rather than indicating or implying that the device or element referred to must have a specific orientation, be constructed and operated in a specific orientation, and thus cannot be understood as a limitation to the embodiments of the present invention.

[0072] In addition, the terms "first" and "second" are only used for descriptive purposes and cannot be understood as indicating or implying relative importance or implicitly indicating the quantity of the indicated technical features. Thus, the features defined with "first" and "second" may explicitly or implicitly include one or more of such features. In the description of the embodiments of the present invention, "a plurality" means two or more unless otherwise specifically defined.

[0073] In this application, unless otherwise clearly defined and limited, terms such as "install", "connect", "couple", "fix", etc. shall be understood in a broad sense. For example, it may be a fixed connection, a detachable connection, or integrated; it may be directly connected, or indirectly connected through an intermediate medium, and it may be the communication inside two components or the interaction relationship between two components. For those of ordinary skill in the art, the specific meanings of the above terms in the embodiments of the present invention can be understood according to specific circumstances.

[0074] The following disclosure provides many different embodiments or examples for implementing different structures of the embodiments of the present invention. To simplify the disclosure of the embodiments of the present invention, the components and settings of specific examples are described below. Of course, they are only examples and are not intended to limit the embodiments of the present invention. In addition, the embodiments of the present invention may repeat reference numerals and / or reference letters in different examples. This repetition is for the purpose of simplification and clarity, and does not itself indicate the relationship between the various embodiments and / or settings discussed.

[0075] The embodiments of the present invention will be described in detail below with reference to the accompanying drawings.

[0076] As Figures 1 to 3 shown, the bifurcated balloon catheter assembly provided by the present invention includes a hub (not shown in the figure), an inner tube 1, a balloon 2, and an adjustment assembly. By controlling the adjustment assembly, the bifurcated balloon catheter assembly can be deployed or retracted, and the deployment angle can be adjusted by the control assembly.

[0077] The hub is disposed at the proximal end of the bifurcated balloon catheter assembly for enabling liquid or gas to enter or withdraw from the balloon 2. The hub may adopt a structure commonly used in the prior art. The length and inner diameter of the inner tube 1 are selected according to actual needs. The materials of the inner tube 1 and the balloon 2 are both conventional selections in the art. Imaging markers may be provided inside the balloon 2, which will not be elaborated in the present invention.

[0078] As Figure 3As shown in Fig. 3 or Fig. 4, the inner tube 1 includes a first inner tube section 11 at the proximal end, a second inner tube section 12 and a third inner tube section 13 located at the distal end of the first inner tube section 11 and fixedly connected thereto respectively. The interior of the first inner tube section 11 is in communication with the interiors of the second inner tube section 12 and the third inner tube section 13 respectively. In the natural state, the axes of the second inner tube section 12 and the third inner tube section 13 form a certain angle, and the angle between the second inner tube section 12 and the third inner tube section 13 can be adjusted to different angles according to the angle between the main branch vessel and the side branch vessel of the bifurcated lesion. Preferably, in the natural state, the angle range between the axes of the second inner tube section 12 and the third inner tube section 13 is 30° - 40°. The first inner tube section 11, the second inner tube section 12, and the third inner tube section 13 are fixedly connected by integral molding by extrusion or blow molding or by welding. In this embodiment, the distal end portions of the first inner tube section 11 are connected to the proximal end portions of the second inner tube section 12 and the third inner tube section 13 respectively by hot melt welding technology. The natural state described in this application refers to the state without applying external force to the adjustment assembly.

[0079] In a specific embodiment, a first channel 110, a second channel 111, and a third channel 112 that extend along the length direction of the first inner tube section 11 and are independent of each other are respectively provided in the first inner tube section 11. A fourth channel 120 that extends along the length direction of the second inner tube section 12 is provided in the second inner tube section 12. A fifth channel 130 that extends along the length direction of the third inner tube section 13 is provided in the third inner tube section 13. Among them, the first channel 110 is in communication with the fourth channel 120 to form a first guide wire channel, and the first guide wire 5 penetrates into the first guide wire channel to deliver the balloon 2 to the proximal end of the bifurcated blood vessel. The second channel 111 is in communication with the fifth channel 130 to form a second guide wire channel, and the second guide wire 6 penetrates into the second guide wire channel to enable the balloon 2 to reach the blood vessel lesion, as Figure 6 shown.

[0080] The balloon 2 includes a first balloon body 21 fixedly sleeved on the first inner tube section 11, a second balloon body 22, and a third balloon body 23 fixedly sleeved on the second inner tube section 12 and the third inner tube section 13 respectively.

[0081] In one embodiment, as Figure 1 or Figure 3As shown, a first inner tube section 11 is fixedly sleeved with a first balloon 21, and a circumferential portion of the proximal end of the first balloon 21 is sealingly connected to the distal end of the first inner tube section 11. A circumferential portion of the distal end of the second balloon 22 is sealingly connected to the distal end of the second inner tube section 12, and a circumferential portion of the distal end of the third balloon 23 is sealingly connected to the distal end of the third inner tube section 13. The distal end of the first balloon 21 is respectively sealingly connected to the proximal ends of the second balloon 22 and the third balloon 23 or integrally formed therewith. The inner cavities of the first balloon 21, the second balloon 22, and the third balloon 23 communicate with each other to form a Y-shaped structure.

[0082] The balloon 2 is made by a blow molding process. The balloon 2 has a filling state and a release state. In the filling state, the maximum outer diameters of the first balloon 21, the second balloon 22, and the third balloon 23 can be independently set to adapt to the inner diameters of different blood vessels. In this embodiment, in the filling state, the maximum outer diameter of the first balloon 21 is greater than the maximum outer diameters of the second balloon 22 and the third balloon 23. The inner tube 1 communicates with the inside of the balloon 2 to allow gas or liquid to pass through, so as to realize the filling or release of the balloon 2. When the balloon 2 is in the release state, the balloon 2 fits on the outer surface of the inner tube 1, so that the outer diameter is reduced, facilitating the entry or exit of the balloon 2 into or out of the blood vessel. When the balloon 2 is in the filling state, the balloon 2 expands, squeezing the bifurcated blood vessel lesion, and further expanding the lumen of the bifurcated blood vessel.

[0083] As Figure 3 or Figure 8 shown, the adjusting assembly includes a connecting member 3 and a traction member 4. One end of the connecting member 3 is fixedly connected to the second inner tube section 12, and the other end is fixedly connected to the third inner tube section 13. Specifically, as Figure 3 shown, one end of the connecting member 3 is connected to the portion of the second inner tube 12 section located inside the second balloon 22, and the other end is connected to the portion of the third inner tube section 13 located inside the third balloon 23, and the connecting member 3 is located inside the balloon 2. The material of the connecting member 3 is a polymer material, preferably nylon.

[0084] The length of the second inner tube section 12 and the length of the third inner tube section 13 can be the same or different. In this embodiment, the length of the second inner tube section 12 is less than the length of the third inner tube section 13. The distance from the center of the connection point where the connecting member 3 is connected to the second inner tube section 12 to the proximal end of the second inner tube section 12 is 0.3 to 0.6 times the length of the second inner tube section 12. The distance from the center of the connection point where the connecting member 3 is connected to the third inner tube section 13 to the proximal end of the third inner tube section 13 is 0.3 to 0.6 times the length of the second inner tube section 12.

[0085] Specifically, the distance between the center of the connection point where the connecting member 3 is connected to the second inner pipe section 12 and the proximal end of the second inner pipe section 12 is equal to the distance between the center of the connection point where the connecting member 3 is connected to the third inner pipe section 13 and the proximal end of the third inner pipe section 13, and both distances are 0.3 to 0.6 times the length of the second inner pipe section 12.

[0086] As Figures 6 to 8 shown, the distal end of the traction member 4 is slidably connected to the connecting member 3 and can slide along the length direction of the connecting member 3, and the proximal end penetrates into the first inner pipe section 11. When the distance between the center of the connection point where the connecting member 3 is connected to the second inner pipe section 12 and the proximal end of the second inner pipe section 12 is not equal to the distance between the center of the connection point where the connecting member 3 is connected to the third inner pipe section 13 and the proximal end of the third inner pipe section 13, the sliding connection between the traction member 4 and the connecting member 3 can bring the second inner pipe section 12 and the third inner pipe section 13 closer so that they are in an I shape with the first inner pipe section 11. The material of the traction member 4 is preferably a ductile metal.

[0087] Specifically, as Figure 7 shown, a pull ring 41 is provided at the distal end of the traction member 4, and the pull ring 41 is sleeved on the connecting member 3. As Figure 4 shown, a traction opening 42 is opened on the first inner pipe section 11, and the distance between the center of the traction opening 42 and the distal end of the first inner pipe section 11 is 0.1 to 0.2 times the sum of the lengths of the second inner pipe section 12 and the third inner pipe section 13, preferably 0.1 to 0.15 times, and the proximal end of the traction member 4 penetrates into the first inner pipe section 11 through the traction opening 42. In this embodiment, as Figure 3 or Figure 8 shown, the traction opening 42 is opened on the part of the first inner pipe section 11 located inside the first balloon 21, and the proximal end of the traction member 4 penetrates into the third channel 112 provided in the first inner pipe section 11 through the traction opening 42. The distal end of the traction member 4 is located inside the balloon 2.

[0088] When the traction member 4 is pulled, the connecting member 3 connected thereto is deformed by the force, and then drives the second inner pipe section 12 and the third inner pipe section 13 fixedly connected to the connecting member 3 to approach or separate from each other, so that the second balloon 22 and the third balloon 23 approach or separate from each other, thereby changing the deployment angle of the bifurcated balloon catheter assembly to adapt to bifurcated blood vessels with different bifurcation angles. Under the action of the traction member 4, the included angle formed by the axis lines of the second balloon 22 and the third balloon 23 can be adjusted according to the angle between the main branch vessel and the side branch vessel of the bifurcated lesion. In the inflated state, the maximum included angle formed by the axis lines of the second balloon 22 and the third balloon 23 is 30 to 40°.

[0089] As Figure 9As shown in the figure, the bifurcated balloon catheter assembly further includes a braided mesh 7 wrapped around the balloon 2. The braided mesh 7 is fixedly connected to the balloon 2. Specifically, the proximal end of the first balloon body 21 is fixedly connected to the proximal end of the braided mesh 7, and the distal ends of the second balloon body 22 and the third balloon body 23 are independently fixedly connected to the corresponding two distal ends of the braided mesh 7. The braided mesh 7 wrapped around the balloon 2 can protect the blood vessel from being scratched by the burrs of the balloon 2, and at the same time enables the compliance of the balloon 2 to meet the requirements. In the present invention, the balloon 2 is a non-compliant balloon, and its compliance is less than 15%. Preferably, the compliance of the balloon 2 is controlled within 5%.

[0090] In this embodiment, the braided mesh 7 is woven by nylon filaments. When the balloon 2 is in the inflated state, the braided mesh 7 is expanded by the balloon 2 to the inflated state; when the balloon 2 is in the released state, the braided mesh 7 is wrapped around the balloon 2 and is in the contracted state.

[0091] In another embodiment, as Figure 5 shown, a sixth channel 121 extending along the length direction of the second inner tube section 12 is further provided in the second inner tube section 12. The fourth channel 120 and the sixth channel 121 are independently provided. A seventh channel 131 extending along the length direction of the third inner tube section 13 is further provided in the third inner tube section 13. The fifth channel 130 and the seventh channel 131 are independently provided. Preferably, the interiors of the sixth channel 121 and the seventh channel 131 are respectively communicated with the interior of the third channel 112.

[0092] In this embodiment, as Figure 4 shown, the second inner tube section 12 and the third inner tube section 13 are respectively provided with a first connection port 31 and a second connection port 32. The first connection port 31 is communicated with the sixth channel 121. One end of the connecting member 3 penetrates into the first connection port 31 to be fixedly connected to the second inner tube section 12. The second connection port 32 is communicated with the seventh channel 131. The other end of the connecting member 3 penetrates into the second connection port 32 to be fixedly connected to the third inner tube section 13.

[0093] In still another embodiment, the bifurcated balloon catheter assembly further includes an outer tube. A part of the first inner tube section 11 is located in the outer tube, and the distal end of the first inner tube section 11 extends out of the distal end of the outer tube. The peripheral part of the proximal end of the first balloon body 21 is hermetically connected to the outer tube. There is a filling channel between the outer tube and the first inner tube section 11 that can allow gas or liquid to pass through to control the inflation or release of the balloon 2.

[0094] Pull the traction member 4 to drive the deformation of the connecting member 3. The deformation of the connecting member 3 causes the second inner tube section 12 and the third inner tube section 13 to approach each other. When the second inner tube section 12 and the third inner tube section 13 are close enough and can no longer approach, the bifurcated balloon catheter assembly is in a retracted state. Through an interventional approach, the distal end of the bifurcated balloon catheter assembly in the retracted state enters the blood vessel along the first guide wire 5. When it is delivered to the designated position (the proximal end of the bifurcated blood vessel), adjust the traction member 4 according to the angle of the bifurcated blood vessel to drive the connecting member 3 to adjust the angle between the second inner tube 12 and the third inner tube section 13 to adapt to the angle of the bifurcated blood vessel. After adjusting to the appropriate angle, the second guide wire 6 is inserted into the second guide wire channel, so that the second balloon body 22 and the third balloon body 23 respectively enter the bifurcated blood vessel to reach the lesion site. Connect the filling seat of the proximal tube seat with the stamping device, inject liquid or gas into the balloon 2. As the liquid or gas is injected, the balloon 2 expands accordingly, and the lesion site of the bifurcated blood vessel is fully squeezed, and the lumen of the bifurcated blood vessel expands accordingly. After the lumen of the bifurcated blood vessel is expanded, use the stamping device to withdraw the liquid or gas, withdraw the second guide wire 6, pull the traction member 4 to drive the second inner tube section 12 and the third inner tube section 13 to approach each other to make the bifurcated balloon catheter assembly in a retracted state, and withdraw the first guide wire 5, and the bifurcated balloon catheter assembly is withdrawn from the human body accordingly.

[0095] A manufacturing method of a bifurcated balloon catheter assembly of the present invention mainly includes the following steps:

[0096] Manufacture the inner tube 1 of the bifurcated balloon catheter assembly: The distal ends of the first inner tube section 11 are respectively welded to the proximal ends of the second inner tube section 12 and the third inner tube section 13 by a hot melt welding technique.

[0097] Install the adjustment assembly on the inner tube 1: The distal end of the traction member 4 is slidably connected to the connecting member 3 and can slide along the length direction of the connecting member 3. By a hot melt welding technique, one end of the connecting member 3 is connected to the second inner tube section 12, and the other end of the connecting member 3 is connected to the third inner tube section 13. The proximal end of the traction member 4 passes through the traction port 42 on the first inner tube section 11 and penetrates into the first inner tube section 11.

[0098] As Figure 10 shown, place the balloon tube film 81 into the balloon forming mold 10, and blow nitrogen into it through the air inlet pipe 9 to blow the balloon tube film 81 into a balloon embryo 8.

[0099] As Figure 12 shown, place two balloon embryos 8 into the balloon catheter assembly forming mold 101 as Figure 11 shown, and place the inner tube equipped with the adjustment assembly between the two balloon embryos 8. Blow nitrogen into it through the air inlet pipe 9 and fuse the two balloon embryos 8 into a whole by heating to form the balloon 2.

[0100] After the balloon 2 is formed, the intake pipe 9 is withdrawn, and the outer tube is inserted into the balloon 2 along the gap between the inner tube 1 and the balloon 2. The proximal end of the first bladder 21 is welded to the distal end of the outer tube, and the distal ends of the second bladder 22 and the third bladder 23 are respectively welded and fixed to the distal ends of the second inner tube section 12 and the third inner tube section 13.

[0101] The braided mesh 7 is wrapped around the outer surface of the balloon 2 by mechanical braiding. The proximal end of the first bladder 21 is welded and fixed to the proximal end of the braided mesh 7, and the distal ends of the second bladder 22 and the third bladder 23 are independently welded and fixed to the corresponding two distal ends of the braided mesh 7.

[0102] The above embodiments are only for illustrating the technical concept and features of the present invention, and the purpose is to enable those skilled in the art to understand the content of the present invention and implement it accordingly, and cannot be used to limit the protection scope of the present invention. Any equivalent changes made according to the spirit and essence of the present invention.

Claims

1. A bifurcated balloon catheter assembly, characterized in that, The bifurcated balloon catheter assembly includes an inner tube (1), a balloon (2), and an adjustment assembly; The inner tube (1) includes a first inner tube section (11) at the proximal end, a second inner tube section (12) and a third inner tube section (13) at the distal end of the first inner tube section (11) and fixedly connected thereto respectively. The interior of the first inner tube section (11) is in communication with the interior of the second inner tube section (12) and the interior of the third inner tube section (13) respectively; The balloon (2) includes a first balloon body (21) fixedly sleeved on the first inner tube section (11), a second balloon body (22) and a third balloon body (23) fixedly sleeved on the second inner tube section (12) and the third inner tube section (13) respectively; The adjustment assembly includes a connecting member (3) and a traction member (4). One end of the connecting member (3) is fixedly connected to the part of the second inner tube section (12) inside the second balloon body (22), and the other end is fixedly connected to the part of the third inner tube section (13) inside the third balloon body (23). A traction opening (42) is formed in the part of the first inner tube section (11) inside the first balloon body (21). The distal end of the traction member (4) is slidably connected to the connecting member (3) and can slide along the length direction of the connecting member (3), and the proximal end passes through the traction opening (42) into the first inner tube section (11). When the traction member (4) is pulled, the second inner tube section (12) and the third inner tube section (13) approach or separate from each other so that the second balloon body (22) and the third balloon body (23) approach or separate from each other.

2. The bifurcated balloon catheter assembly according to claim 1, wherein, The distance between the center of the connection point where the connecting member (3) is connected to the second inner tube section (12) and the proximal end of the second inner tube section (12) is equal to the distance between the center of the connection point where the connecting member (3) is connected to the third inner tube section (13) and the proximal end of the third inner tube section (13).

3. The bifurcated balloon catheter assembly according to claim 1, wherein The distance between the center of the connection point where the connecting member (3) is connected to the second inner tube section (12) and the proximal end of the second inner tube section (12), and the distance between the center of the connection point where the connecting member (3) is connected to the third inner tube section (13) and the proximal end of the third inner tube section (13) are independently 0.3 - 0.6 times the length of the shorter inner tube section among the second inner tube section (12) and the third inner tube section (13).

4. The bifurcated balloon catheter assembly according to claim 1, wherein, A pull ring (41) is provided at the distal end of the traction member (4). The pull ring (41) is sleeved on the connecting member (3). A traction opening (42) is formed in the first inner tube section (11). The proximal end of the traction member (4) passes through the traction opening (42) into the first inner tube section (11).

5. The bifurcated balloon catheter assembly according to claim 4, wherein The distance between the center of the traction opening (42) and the distal end of the first inner tube section (11) is 0.1 - 0.2 times the sum of the length of the second inner tube section (12) and the length of the third inner tube section (13).

6. The bifurcated balloon catheter assembly according to any one of claims 1 to 5, characterized in that, The first inner tube section (11) is respectively provided with a first channel (110), a second channel (111), and a third channel (112) that extend along the length direction of the first inner tube section (11) and are independent of each other; The second inner tube section (12) is provided with a fourth channel (120) that extends along the length direction of the second inner tube section (12); The third inner tube section (13) is provided with a fifth channel (130) that extends along the length direction of the third inner tube section (13); The first channel (110) communicates with the fourth channel (120) to form a first guide wire channel; the second channel (111) communicates with the fifth channel (130) to form a second guide wire channel; The proximal end of the traction member (4) passes through the traction port (42) on the first inner tube section (11) and penetrates into the third channel (112).

7. The bifurcated balloon catheter assembly according to claim 1, wherein, The circumferential part at the distal end of the second bladder (22) is hermetically connected to the distal end of the second inner tube section (12), the circumferential part at the distal end of the third bladder (23) is hermetically connected to the distal end of the third inner tube section (13), the distal end of the first bladder (21) is hermetically connected to the proximal end of the second bladder (22) and the proximal end of the third bladder (23) respectively or integrally formed, and the inner cavities of the first bladder (21), the second bladder (22), and the third bladder (23) communicate with each other to form a Y-shaped structure.

8. The bifurcated balloon catheter assembly according to claim 1, wherein, The bifurcated balloon catheter assembly further includes an outer tube. A part of the first inner tube section (11) is located in the outer tube, the distal end of the first inner tube section (11) extends out of the distal end of the outer tube, the circumferential part at the proximal end of the first bladder (21) is hermetically connected to the outer tube, and there is a filling channel between the outer tube and the first inner tube section (11) through which gas or liquid can pass to control the inflation or release of the balloon (2).

9. The bifurcated balloon catheter assembly according to claim 1, wherein The bifurcated balloon catheter assembly further includes a braided mesh (7) covering the outside of the balloon (2).

10. The bifurcated balloon catheter assembly according to claim 9, wherein, The braided mesh (7) is woven by nylon filaments.

11. The bifurcated balloon catheter assembly according to claim 1, wherein, The material of the connecting member (3) is a polymer material, and the material of the traction member (4) is a metal; and / or, the inner tube (1) communicates with the inside of the balloon (2); and / or, in the inflated state, the maximum included angle formed by the axis lines of the second bladder (22) and the third bladder (23) is 30° - 40°; and / or, the first inner tube section (11), the second inner tube section (12), and the third inner tube section (13) are fixedly connected by integral molding or welding by extrusion or blow molding; and / or, the balloon (2) is made by a blow molding process.

12. A method for manufacturing a bifurcated balloon catheter assembly as claimed in any one of claims 1 to 11, characterized in that, Including: Manufacturing the inner tube (1) of the bifurcated balloon catheter assembly; Installing the adjustment assembly on the inner tube (1); Placing the balloon tube film (81) into the balloon molding die (10) and blow molding it into a preform (8); Place the two blastocysts (8) into the balloon catheter assembly forming mold (101), and place the inner tube (1) equipped with the adjustment assembly between the two blastocysts (8). Fuse the two blastocysts (8) into a whole by heating to form a balloon (2). Connect the outer tube to the balloon (2). The proximal end of the first bladder (21) is welded and fixed to the distal end of the outer tube. The distal ends of the second bladder (22) and the third bladder (23) are respectively welded and fixed to the distal end of the second inner tube section (12) and the distal end of the third inner tube section (13).

13. The method according to claim 12, wherein The method further includes mechanically weaving a woven mesh (7), covering the outer surface of the balloon (2) with the woven mesh (7) and fixedly connecting them.

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