Suction catheter assembly, suction device, and method for manufacturing the suction catheter assembly

Abstract

The present application discloses a suction catheter assembly, a suction device and a manufacturing method of the suction catheter assembly, wherein the suction catheter assembly comprises: a catheter member, which comprises an inner tube and an outer tube sleeved outside the inner tube, wherein an annular tube cavity for allowing thrombus to pass is formed between the inner tube and the outer tube; the distal end of the inner tube is closed, and a side hole for pumping external liquid toward the annular tube cavity is provided on the tube wall of the inner tube; and a connector connected to the proximal end of the catheter member, wherein the connector comprises a main seat body, wherein a main channel axially penetrating the main seat body is provided in the main seat body, and a suction port and a pumping port connected to the main channel are also provided on the connector, wherein the proximal opening of the annular tube cavity is in communication with the suction port, and the proximal tube port of the inner tube is in communication with the pumping port. The invention can reduce the occurrence of thrombus blocking the suction catheter assembly, and does not excessively increase the difficulty of operation.

Description

Technical Field

[0001] The present application relates to the field of interventional medical devices, and in particular to a suction catheter assembly, a suction device, and a method for manufacturing the suction catheter assembly. Background Art

[0002] Thrombi are small pieces of blood formed in the blood vessels of the cardiovascular system. They are usually composed of insoluble fibrin, deposited platelets, accumulated white blood cells and trapped red blood cells. Smaller thrombi can be dissolved and absorbed, but larger thrombi can usually only be partially dissolved, and under the impact of blood, they will break away from the inner wall of the blood vessel to form emboli, or calcify to form phleboliths. Thrombi can block blood vessels and affect blood flow, causing serious problems such as myocardial infarction and arterial embolism.

[0003] Clinically, the treatment of large and hard blood clots in blood vessels is usually carried out by combining drug thrombolysis with mechanical aspiration. That is, before mechanical aspiration, a certain amount of thrombolytic drugs are intravenously infused into the patient, and then the undissolved thrombi are removed by appropriate thrombus aspiration equipment, thereby completing the removal of thrombi. However, intravenously infused thrombolytic drugs have limited ability to dissolve large blood clots. Therefore, during the process of thrombus aspiration, thrombi often block the aspiration tube.

[0004] Some doctors performing interventional surgeries will prevent blood clots from blocking the aspiration tube by repeatedly pushing and pulling the tube during aspiration. However, this method invisibly increases the difficulty of the operation. Summary of the invention

[0005] The present application provides an aspiration catheter assembly, a suction device, and a method for manufacturing the aspiration catheter assembly, which can reduce the occurrence of blood clots blocking the aspiration catheter assembly while not excessively increasing the difficulty of operation.

[0006] According to a first aspect of the present application, there is provided a suction catheter assembly, the suction catheter assembly comprising:

[0007] A catheter component, comprising an inner tube and an outer tube sleeved outside the inner tube, wherein an annular tube cavity for allowing thrombus to pass is formed between the inner tube and the outer tube; the distal end of the inner tube is closed, and a side hole for pumping external liquid toward the annular tube cavity is opened on the tube wall of the inner tube; and,

[0008] A connector connected to the proximal end of the catheter member, the connector comprising a main seat body, the main seat body being provided with a main channel axially penetrating the main seat body, the connector also being provided with a suction port and a pumping port connected to the main channel, the proximal opening of the annular tube cavity being in communication with the suction port, and the proximal tube opening of the inner tube being in communication with the pumping port.

[0009] According to some embodiments of the present application, the outer tube includes an outer layer tube and an inner layer tube arranged in the outer layer tube, and the inner layer tube includes a first tube segment and a second tube segment that are axially fixed and connected, wherein: the first tube segment is arranged at the distal end of the second tube segment, the flexibility of the first tube segment is greater than the flexibility of the second tube segment, and the distal end of the first tube segment stops before the side hole.

[0010] According to some embodiments of the present application, the first pipe section and the outer layer pipe are both configured as polyether modified polyamide pipes, and the second pipe section is configured as a stainless steel pipe; the stainless steel pipe obtains a preset flexibility through laser spiral cutting, and is bonded and fixed to the outer layer pipe through a thermal rheology molding process.

[0011] According to some embodiments of the present application, the suction duct assembly further includes a developing ring sleeved on the outside of the first pipe segment, and the first pipe segment and the developing ring are bonded and fixed to the outer layer pipe by a hot air welding process.

[0012] According to some embodiments of the present application, the distal end of the inner tube is inserted between the first tube segment and the developing ring and stops at a position flush with the distal end of the outer tube, and the outer wall of the inner tube is respectively glued and fixed to the outer wall of the first tube segment and the inner wall of the developing ring.

[0013] According to some embodiments of the present application, the distance between the center of the side hole and the distal tube opening of the inner tube is set to L1, 0.9mm≤L1≤1.1mm.

[0014] A second aspect of the present application provides a suction device, which includes the above-mentioned suction catheter assembly.

[0015] According to some embodiments of the present application, a pressure sensing port connected to the main channel is also provided on the connector; the suction device also includes: a pressure sensing component, which includes a pressure extension tube and a pressure sensor, and the pressure sensor can sense the pressure in the pressure sensing port through the pressure extension tube; a liquid collecting component, which includes a suction tube and a liquid collecting container, and both ends of the suction tube are respectively connected to the suction port and the inside of the liquid collecting container.

[0016] According to some embodiments of the present application, the suction device also includes a pumping tube assembly, which includes a pumping tube having one end connected to the pumping port, and a pumping mechanism arranged at the other end of the pumping tube, and the pumping mechanism is used to pressurize external liquid and pump it into the pumping tube.

[0017] The third aspect of the present application also provides a method for manufacturing the above-mentioned suction catheter assembly, the method comprising the following steps:

[0018] S1: Sleeve the developing ring on the outside of the first pipe section, pass the distal end of the inner pipe through the gap between the developing ring and the first pipe section, and ensure that the side hole on the inner pipe exceeds the distal end of the first pipe section, and glue the outer wall of the inner pipe, the outer wall of the first pipe section and the inner wall of the developing ring to fix them, so as to form a first pipe group;

[0019] S2: laser spiral cutting is performed on a stainless steel pipe of a preset length to obtain a second pipe segment, and an outer layer tube made of polyether-modified polyamide is fixed to the outside of the second pipe segment by a thermo-rheological process, wherein the distal end of the outer layer tube exceeds the distal end of the second pipe segment, thereby forming a second pipe group;

[0020] S3 inserting the first tube group into the second tube group until the distal end of the second tube segment is butted against the proximal end of the first tube segment and the proximal end of the inner tube extends out of the second tube group, and the first tube segment and the developing ring are fixed to the outer tube by hot air welding to form the conduit member;

[0021] S4: inserting the proximal end of the catheter into the connector, and bonding and fixing the proximal end of the inner tube and the outer tube to the connector.

[0022] The technical solution provided by the embodiments of the present application can have the following beneficial effects:

[0023] The external negative pressure acts on the distal tube opening of the catheter through the suction port, so that the thrombus in the blood vessel can be sucked into the annular tube cavity formed between the inner tube and the outer tube, and the external liquid enters the inner tube through the pumping port and is pumped out into the annular tube cavity through the side hole on the inner tube. In this way, the thrombus entering the annular tube cavity can be impacted and broken by the liquid ejected from the side hole. In addition, before the thrombus is sucked out by negative pressure, the side hole can also be used to pump thrombolytic drugs into a fixed point in the blood vessel, so that the thrombus can be dissolved to a considerable extent before the thrombus is sucked out.

[0024] 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

[0025] Figure 1 is a schematic structural diagram of a suction device according to an embodiment of the present application;

[0026] Figure 2 is a schematic structural diagram of a suction catheter assembly according to an embodiment of the present application;

[0027] Figure 3 yes Figure 2 A cross-sectional view of the structure shown in FIG. 5 after being cut along the AA direction;

[0028] Figure 4 yes Figure 2 A cross-sectional view of the structure shown in FIG. 5 after being cut along the BB direction;

[0029] Figure 5 yes Figure 3 A partial cross-sectional view of the structure shown in FIG. 5 after being cut along the CC direction;

[0030] Figure 6 is a partial half-section view of the inner tube;

[0031] Figure 7 yes Figure 1 Schematic diagram of the structure of the pump tube assembly.

[0032] Reference numerals: 100, suction catheter assembly; 11, catheter member; 111, inner tube; 1111, side hole; 112, outer tube; 1121, outer tube; 1122, first tube section; 1123, second tube section; 113, ring tube cavity; 114, developing ring; 12, connector; 121, main seat body; 122, first support seat body; 123, second support seat body; 124, third support seat body;

[0033] 200. pressure sensing assembly; 21. pressure extension tube; 22. pressure sensor;

[0034] 300, liquid collection component; 31, suction tube; 32, liquid collection container;

[0035] 400. Pump-injection tube assembly; 41. Pump-injection tube; 42. Pump-injection mechanism; 43. Drip bucket. DETAILED DESCRIPTION

[0036] Here, exemplary embodiments will be described in detail, and examples thereof are shown in the accompanying drawings. When the following description refers to the drawings, unless otherwise indicated, the same numbers in different drawings represent the same or similar elements. The methods described in the following exemplary embodiments do not represent all methods consistent with the present application, but are only preferred embodiments of the present application. Those skilled in the art can make some changes or modify them into equivalent embodiments of equivalent changes using the technical contents disclosed above without departing from the scope of the technical solution of the present application. However, any simple modifications, equivalent changes and modifications made to the above embodiments based on the technical essence of the present application without departing from the content of the technical solution of the present application are still within the scope of the technical solution of the present application.

[0037] In addition, in the description of this application, the proximal end and the distal end are defined with reference to the position of the operator when the suction catheter assembly is used, that is, the distal end refers to the end relatively far from the operator, and the proximal end refers to the end relatively close to the operator. Figure 1 , Figure 2 , Figure 5 , Figure 6The left end is the distal end and the right end is the proximal end. The embodiments of the present application will be described in detail below with reference to the accompanying drawings.

[0038] like Figure 1 As shown in , the suction device according to an embodiment of the present application includes a suction catheter assembly 100, a pressure sensing assembly 200, a liquid collection assembly 300 and a pumping tube assembly 400. The suction device can be used in conjunction with a thrombus suction system that can provide negative pressure and monitor suction conditions.

[0039] like Figure 2 As shown in FIG. 1 , a suction catheter assembly 100 according to an embodiment of the present application includes a catheter member 11 and a connector 12, wherein: Figure 5 As shown in the figure, the catheter 11 includes an inner tube 111 and an outer tube 112 sleeved outside the inner tube 111, and an annular lumen 113 for allowing thrombus to pass is formed between the inner tube 111 and the outer tube 112. The distal end of the inner tube 111 is closed, and a side hole 1111 for pumping external liquid toward the annular lumen 113 is opened on the tube wall of the inner tube 111.

[0040] Return to reference Figure 2 As shown in the figure, the connector 12 is connected to the proximal end of the catheter member 11, and includes a main seat body 121 and at least one support body. A main channel is provided in the main seat body 121 that runs through the main seat body 121 in the axial direction, and the proximal end of the catheter member 11 is inserted from the distal end opening of the main channel. In the illustrated embodiment, the connector 12 includes a first support body 122, a second support body 123 and a third support body 124 connected to the main seat body 121, and the channels in the three support bodies are all connected to the main channel.

[0041] The hole in the first support body 122 is formed with a pumping port at one end away from the main support body 121, and the proximal end of the inner tube 111 is connected to the pumping port. The hole in the second support body 123 is formed with a suction port at one end away from the main support body 121, and the proximal end opening of the annular tube cavity 113 is connected to the suction port. The hole in the third support body 124 is formed with a pressure sensing port at one end away from the main support body 121, which is used to install the pressure sensing component 200.

[0042] When the suction catheter assembly 100 is inserted into a blood vessel, the guide wire guiding the insertion direction can be inserted through the proximal opening of the main channel; the proximal opening of the annular lumen 113 is connected to the suction port, and the external negative pressure can act on the annular lumen 113, so that the thrombus in the blood vessel can enter the annular lumen 113 through the distal opening of the annular lumen 113.

[0043] The proximal end of the inner tube 111 is connected to the pump port, and the external liquid can enter the inner tube 111 through the pump port and be discharged through the side hole 1111. Before aspirating the thrombus in the blood vessel, an appropriate amount of thrombolytic drug can be injected into the fixed position in the blood vessel through the pump port and the side hole 1111 to prepare for the next step of thrombus aspiration. Compared with the traditional intravenous infusion method, this method of pumping thrombolytic drugs at fixed points can greatly shorten the action time of thrombolytic drugs and speed up the process of thrombus treatment.

[0044] During the thrombus aspiration process, external liquid (such as saline) is pumped into the annular lumen 113 through the side hole 1111, which can impact the large thrombus entering the annular lumen 113 to break it into small thrombus pieces, thereby preventing the catheter 11 from being blocked by the large thrombus.

[0045] like Figure 5 As shown in the figure, the outer tube 112 includes an outer tube 1121 and an inner tube disposed in the outer tube 1121. The inner tube includes a first tube segment 1122 and a second tube segment 1123 that are axially fixed and connected, and the first tube segment 1122 is disposed at the distal end of the second tube segment 1123. The first tube segment 1122 uses a more flexible tube material, so that the distal end of the outer tube 112 has greater flexibility, thereby reducing damage to the blood vessel. The distal end of the first tube segment 1122 stops before the side hole 1111, thereby avoiding blocking the side hole 1111 and affecting the injection of the liquid.

[0046] In some embodiments, the first tube section 1122 and the outer tube 1121 are both configured as polyether-modified polyamide tubes, and the second tube section 1123 is a stainless steel tube, and the preset flexibility is obtained by laser spiral cutting. After cutting, the stainless steel tube as the second tube section 1123 is fixed to the outer tube 1121 by a thermal flow forming process.

[0047] exist Figure 5 Based on the combination Figure 3 and Figure 4 As shown in , the diameter of the first tube segment 1122 is smaller than the diameter of the second tube segment 1123, the outer tube wall of the second tube segment 1123 is in contact with the inner wall of the outer tube 1121, and only part of the outer tube wall of the first tube segment 1122 is in contact with the outer tube 1121. Figure 4 As shown, the proximal end of the inner tube 111 is disposed inside the second tube section 1123; Figure 3 As shown, the distal end of the inner tube 111 that exceeds the second tube segment 1123 is disposed outside the first tube segment 1122 .

[0048] In order to facilitate the operator to confirm the position of the distal end of the catheter member 11 in the blood vessel, the suction catheter assembly may further include a developing ring 114, which is sleeved on the outside of the first tube section 1122. Figure 3 and Figure 5 As shown in , the outer diameter of the developing ring 114 is substantially consistent with the inner diameter of the outer tube 1121, so that the outer wall of the developing ring 114 is fitted and fixed to the inner wall of the outer tube 1121. The distal end of the inner tube 111 that exceeds the portion of the second tube section 1123 is inserted between the outer side of the first tube section 1122 and the inner side of the developing ring 114, and the outer wall of the inner tube 111, the outer wall of the first tube section 1122 and the inner wall of the developing ring 114 are fixed by gluing. In this way, the inner tube 111 can be relatively reliably fixed by the developing ring 114, preventing the inner tube 111 from jumping when the liquid is pumped outward through the side hole 1111.

[0049] like Figure 5 As shown in , the distal end of the outer tube 1121 exceeds the distal end of the first tube segment 1122, and the distal end of the inner tube 111 is substantially flush with the distal end of the outer tube 1121. The distal end of the first tube segment 1122 extends beyond the developing ring 114, and the outer wall of the first tube segment 1122 is fitted and fixed to the outer tube 1121, and the outer wall of the developing ring 114 is also fitted and fixed to the outer tube 1121. In some embodiments, the fitting and fixing between the first tube segment 1122 and the developing ring 114 and the outer tube 1121 is achieved by a hot air welding process.

[0050] Combination Figure 5 and Figure 6 As shown in , the distal end of the inner tube 111 is flush with the distal end of the outer tube 1121, and the distance between the center of the side hole 1111 and the distal end of the inner tube 111 is set to L1, 0.9mm≤L1≤1.1mm. In this way, the thrombus entering the annular tube cavity 113 can be broken in time. At the same time, since the liquid ejected outward from the side hole 1111 forms a semicircular ejection surface near the distal end of the outer tube 1121, if the side hole 1111 is too close to the distal end of the outer tube 1121, the external liquid is easy to be directly ejected onto the blood vessel wall. Therefore, L1 should not be too short. Setting it to the above range can take into account the effects of both aspects. Along the radial direction, the length of the side hole 1111 is set to L2, 0.13mm≤L2≤0.26mm; along the axial direction or from the proximal end to the distal end, the length of the side hole 1111 is set to L3, 0.03mm≤L3≤0.06mm. In this way, the orifice area of ​​the side hole 1111 is relatively moderate, which can meet the injection rate of 15ml / min-35ml / min to pump saline or thrombolytic drugs outward, thereby ensuring the thrombus-breaking effect and meeting the pumping rate of thrombolytic drugs.

[0051] Return to reference Figure 1As shown in , the pressure sensing assembly 200 in the suction device includes a pressure extension tube 21 and a pressure sensor 22, wherein: one end of the pressure extension tube 21 is conductively connected to the pressure sensing port on the connector 12, and the pressure sensor 22 is installed on the pressure extension tube 21 and is used to sense the pressure in the pressure sensing port. If conditions permit, the pressure sensor 22 can also be directly installed on the connector 12. By installing the pressure extension tube 21, more sufficient installation space can be provided for the pressure sensor 22, avoiding the installation of a large number of structural parts in a relatively small connector 12.

[0052] The liquid collection component 300 includes a suction tube 31 and a liquid collection container 32. The two ends of the suction tube 31 are respectively connected to the suction port of the connector 12 and the inside of the liquid collection container 32. When in use, the liquid collection container 32 can be placed in a cylindrical member, which is a structure in the thrombus suction system. The thrombus suction system sucks the gas between the liquid collection container 32 and the cylindrical member, and transmits negative pressure to the liquid collection container 32. The negative pressure acts on the inside of the catheter member 11 through the suction tube 31 and the suction port, so that the distal opening of the annular lumen 113 can generate negative pressure to suck thrombus.

[0053] Combination Figure 1 and Figure 7 As shown in the figure, the pumping tube assembly 400 includes a pumping tube with one end connected to the pumping port, a pumping mechanism 42 arranged at the other end of the pumping tube 41, and a dripping bucket 43, wherein: the dripping bucket 43 is inserted into a container storing external liquid to introduce the external liquid into the pumping mechanism 42, and the pumping mechanism 42 is used to pressurize this part of the external liquid and pump it into the pumping tube 41, and finally eject it through the inner tube 111 and the side hole 1111.

[0054] Combination Figures 3 to 5 As shown in , in addition to the aforementioned suction device and suction catheter assembly 100, the embodiment of the present application also provides a method for manufacturing the suction catheter assembly 100 in the above embodiment, the method comprising the following steps:

[0055] S1: Sleeve the developing ring 114 on the outside of the first tube section 1122, pass the distal end of the inner tube 111 through the gap between the developing ring 114 and the first tube section 1122, and ensure that the side hole 1111 on the inner tube 111 exceeds the distal end of the first tube section 1122, and glue the outer wall of the inner tube 111, the outer wall of the first tube section 1122 and the inner wall of the developing ring 114 to fix them, so as to form a first tube group;

[0056] S2: A laser spiral cutting process is performed on a stainless steel pipe of a preset length to obtain a second pipe segment 1123, and an outer layer pipe 1121 made of polyether-modified polyamide is fixed to the outside of the second pipe segment 1123 by a thermo-rheological process, with the distal end of the outer layer pipe 1121 extending beyond the distal end of the second pipe segment 1123, thereby forming a second pipe group;

[0057] S3 Insert the first tube group into the second tube group until the distal end of the second tube segment 1123 is butted against the proximal end of the first tube segment 1122, and the proximal end of the inner tube 111 extends out of the second tube group, and the first tube segment 1122 and the developing ring 114 are fixed to the outer tube 1121 by hot air welding to form the catheter member 11;

[0058] S4 Insert the proximal end of the catheter 11 into the connector 12, and bond the proximal end of the inner tube 111 and the outer tube 1121 to the connector 12, ensuring that the proximal end of the inner tube 111 is in communication with the pumping port, and the proximal opening of the annular lumen 113 is in communication with the suction port.

[0059] The above are only preferred embodiments of the present application, and are not intended to limit the present application in any form. Although the present application has been disclosed as above with preferred embodiments, it is not intended to limit the present application. Any technician familiar with the profession can make some changes or modify the technical contents disclosed above into equivalent embodiments with equivalent changes without departing from the scope of the technical solution of the present application. However, any simple modification, equivalent change and modification made to the above embodiments based on the technical essence of the present application without departing from the content of the technical solution of the present application still fall within the scope of the technical solution of the present application.

Claims

1. A suction catheter assembly, characterized in that: The suction catheter assembly comprises: A catheter component (11), comprising an inner tube (111) and an outer tube (112) sleeved outside the inner tube (111), wherein an annular lumen (113) for allowing blood clots to pass through is formed between the inner tube (111) and the outer tube (112); the distal end of the inner tube (111) is closed, and a side hole (1111) for pumping external liquid toward the annular lumen (113) is provided on the tube wall of the inner tube (111); The outer tube (112) comprises an outer tube (1121) and an inner tube arranged in the outer tube (1121); the inner tube comprises a first tube segment (1122) and a second tube segment (1123) which are axially fixed and connected, wherein: the first tube segment (1122) is arranged at the distal end of the second tube segment (1123); the flexibility of the first tube segment (1122) is greater than the flexibility of the second tube segment (1123); the distal end of the first tube segment (1122) stops before the side hole (1111); the first tube segment (1122) and the outer tube (1121) are both polyether-modified polyamide tubes; the second tube segment (1123) is a stainless steel tube; the stainless steel tube obtains a preset flexibility through laser spiral cutting, and is fitted and fixed to the outer tube (1121) through a thermal rheological molding process; The suction catheter assembly further comprises a developing ring (114) sleeved on the outside of the first tube section (1122); the first tube section (1122) and the developing ring (114) are fitted and fixed to the outer tube (1121) by a hot air welding process; the distal end of the inner tube (111) is passed between the first tube section (1122) and the developing ring (114) and is stopped at a position flush with the distal end of the outer tube (112); the outer wall of the inner tube (111) is respectively glued and fixed to the outer wall of the first tube section (1122) and the inner wall of the developing ring (114); and, A connector (12) connected to the proximal end of the catheter member (11), the connector (12) comprising a main seat body (121), the main seat body (121) being provided with a main channel axially penetrating the main seat body (121), the connector (12) also being provided with a suction port and a pumping port connected to the main channel, the proximal opening of the annular tube cavity (113) being in communication with the suction port, and the proximal tube opening of the inner tube (111) being in communication with the pumping port.

2. The suction catheter assembly according to claim 1, characterized in that The distance between the center of the side hole (1111) and the distal end of the inner tube (111) is set to L1, 0.9 mm≤L1≤1.1 mm.

3. A suction device, characterized in that: The suction device comprises the suction catheter assembly as described in any one of claims 1-2.

4. The suction device according to claim 3, characterized in that The connector (12) is also provided with a pressure sensing port connected to the main channel; The suction device also includes: A pressure sensing assembly (200), comprising a pressure extension tube (21) and a pressure sensor (22), wherein the pressure sensor (22) is capable of sensing the pressure in the pressure sensing port through the pressure extension tube (21); The liquid collection component (300) comprises a suction tube (31) and a liquid collection container (32), wherein two ends of the suction tube (31) are respectively connected to the suction port and the interior of the liquid collection container (32).

5. The suction device according to claim 4, characterized in that The pumping device further comprises a pumping tube assembly (400), wherein the pumping tube assembly (400) comprises a pumping tube (41) having one end connected to the pumping port, and a pumping mechanism (42) arranged at the other end of the pumping tube (41), wherein the pumping mechanism (42) is used to pressurize external liquid and pump it into the pumping tube (41).

6. A method for manufacturing the aspiration catheter assembly according to claim 1 or 2, the method comprising the following steps: S1. Sleeve the developing ring (114) on the outside of the first tube section (1122), pass the distal end of the inner tube (111) through the gap between the developing ring (114) and the first tube section (1122), and ensure that the side hole (1111) on the inner tube (111) exceeds the distal end of the first tube section (1122), and glue is applied between the outer wall of the inner tube (111), the outer wall of the first tube section (1122) and the inner wall of the developing ring (114) to fix the three, so as to form a first tube assembly; S2: performing a laser spiral cutting process on a stainless steel tube of a preset length to obtain a second tube segment (1123), and attaching and fixing an outer tube (1121) made of a polyether-modified polyamide material to the outside of the second tube segment (1123) through a thermo-rheological process, wherein the distal end of the outer tube (1121) extends beyond the distal end of the second tube segment (1123), thereby forming a second tube group; S3 inserting the first tube group into the second tube group until the distal end of the second tube segment (1123) is butted against the proximal end of the first tube segment (1122), and the proximal end of the inner tube (111) extends out of the second tube group, and the first tube segment (1122) and the developing ring (114) are fixed to the outer tube (1121) by a hot air welding process to form the conduit member (11); S4: inserting the proximal end of the catheter member (11) into the connector (12), and bonding and fixing the proximal end of the inner tube (111) and the outer tube (1121) to the connector (12).

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