Balloon catheter device and manufacturing method

Abstract

The present invention relates to the field of medical device technology, and in particular to a balloon catheter device and a manufacturing method, wherein the balloon catheter device comprises a balloon dilatation catheter; a retractor, wherein the retractor comprises a retractor tube, wherein the retractor tube has a receiving cavity, wherein the retractor tube is arranged at the distal end of the balloon dilatation catheter and is communicated with the balloon dilatation catheter, wherein a guide wire connected to a filter umbrella passes through the retractor tube and the balloon dilatation catheter and extends relative to the balloon dilatation catheter, and the guide wire is pulled to pull the filter umbrella into the receiving cavity. The present invention can effectively retract the filter umbrella, reduce surgical risks, and avoid unnecessary medical damage to patients.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a balloon catheter device and a manufacturing method thereof. Background Art

[0002] For atherosclerotic stenosis of the carotid artery, atherosclerotic plaques may fall off during interventional recanalization treatment. The detached plaques may cause occlusion of distal cerebral blood vessels, endangering the patient's nerve tissue and function. The embolic protection device is released at the distal end of the stenosis to intercept the detached emboli without affecting the normal passage of the fluid in the cavity. When the cavity is opened, the embolic protection device and the intercepted emboli are collected into the catheter and removed from the body.

[0003] Currently, filter-type embolic protection devices are commonly used on the market to provide patients with protection against distal vascular embolism. An umbrella-shaped filter is placed in a sheath tube and pushed to the downstream blood vessels of the surgical site. The filter umbrella is then opened in the blood vessels to filter the blood flow, blocking and recovering larger debris and thrombi that exceed the filter aperture. When recovering the filter, the recovery sheath tube is inserted again and pushed to the filter position for recovery.

[0004] In carotid artery stent surgery, when the stent is poorly adhered to the wall or the stent is not fully expanded, a balloon dilatation catheter is required for post-dilatation of the stent. In this clinical scenario, traditional surgery requires the insertion of a balloon dilatation catheter along the guide wire to expand the stent. After the expansion is completed, the balloon dilatation catheter must be withdrawn first, and then a special embolic protection device retractor is inserted through the guide wire, pushed up to the filter umbrella, and the filter umbrella is collected in the recovery tube of the retractor, and finally withdrawn from the human body. This traditional procedure requires repeated instrument exchanges in human blood vessels, and the travel required to exchange surgical instruments is relatively long, which may cause vascular spasm or increase surgical risks. This leads to a decrease in the success rate of carotid artery stent surgery and unnecessary medical damage to patients.

[0005] Therefore, a balloon catheter device and a manufacturing method are needed to solve the above problems. Summary of the invention

[0006] The purpose of the present invention is to provide a balloon catheter device and a manufacturing method, which can effectively recover the filter umbrella, reduce the surgical risk, and avoid unnecessary medical damage to the patient.

[0007] To achieve this object, the present invention adopts the following technical solutions:

[0008] A balloon catheter device comprising:

[0009] Balloon dilatation catheter;

[0010] The retriever includes a retrieval tube having a accommodating cavity. The retrieval tube is arranged at the distal end of the balloon dilatation catheter and is connected to the balloon dilatation catheter. A guide wire connected to the filter umbrella passes through the retrieval tube and the balloon dilatation catheter and extends relative to the balloon dilatation catheter. Pulling the guide wire can pull the filter umbrella into the accommodating cavity.

[0011] Furthermore, the recovery pipe comprises a recovery section and a transition section which are connected in sequence, the recovery section has the accommodating cavity, and the diameter of the recovery section is greater than the diameter of the transition section.

[0012] Furthermore, the recycler also includes a recovery hose, and the recovery hose is wrapped on the recovery pipe.

[0013] Furthermore, the recovery hose is made of pebax or silicone, and the recovery hose is covered on the recovery pipe by welding or gluing.

[0014] Furthermore, the retriever also includes a development marker ring, which is arranged at an end of the retrieval tube away from the balloon dilatation catheter.

[0015] Furthermore, the retriever also includes a guide assembly, and the guide assembly is arranged at an end of the retrieval tube away from the balloon dilatation catheter.

[0016] Furthermore, the guide assembly includes at least three elastic metal wires, one end of which is connected to the recoverer, and the elastic metal wires are arranged at intervals along the circumference of the recovery tube, the end of the guide assembly forms a channel, the main body of the guide assembly forms a accommodating space, and the filter umbrella can be placed in the accommodating space.

[0017] Furthermore, a metal end is provided at the end of the elastic metal wire away from the recycler, and the surface of the metal end is arc-shaped.

[0018] Furthermore, a wrapping layer is attached to the guide assembly, and the wrapping layer can be opened or closed along with the elastic metal wire.

[0019] Furthermore, the wrapping layer is in the form of a film or a net.

[0020] A manufacturing method for manufacturing the balloon catheter device as described above comprises the following steps:

[0021] S1, welding the proximal end pin of the balloon to one end of the outer tube to form an assembly, setting an opening at a set position of the outer tube, and pre-pressing and gripping the developing ring on the inner tube;

[0022] S2, inserting the inner tube from the distal end of the balloon and passing it out from the opening of the outer tube;

[0023] S3, welding the opening to make it sealed and firmly connected, and cutting off the excess inner tube to form a quick-exchange guide wire port;

[0024] S4, welding the distal end of the balloon to the inner tube;

[0025] S5, inserting the recovery pipe, reducing the diameter after welding, splicing or overlapping the reduced-diameter recovery pipe with the inner pipe, and putting it into the protective sleeve for heat shrinkage and integration;

[0026] S6, pre-welding the developing marking ring and the guide assembly on the recovery pipe;

[0027] S7, the head end of the recovery tube is pressed and gripped with the pre-treated developing marking ring, and a recovery hose is put on, and the entire recovery tube is heat-shrinkably wrapped;

[0028] S8. Welding the outer tube and the hypotube into one, and coating a hydrophilic coating at a set position to form the balloon catheter device.

[0029] Beneficial effects of the present invention:

[0030] 1. A balloon catheter device provided by the present invention has a retrieval tube at the distal end of the balloon dilatation catheter, the retrieval tube has a receiving cavity, the retrieval tube is connected to the balloon dilatation catheter, and a guide wire connected to the filter umbrella passes through the retrieval tube and the balloon dilatation catheter and extends relative to the balloon dilatation catheter. By adopting the above structure, after the balloon dilatation catheter is expanded after the stent is completed, the guide wire can be pulled to pull the filter umbrella into the receiving cavity of the retrieval tube, so that the retrieval tube directly retrieves the filter umbrella of the embolic protection device, and then it can be taken out together, reducing the number of repeated exchanges of instruments in the blood vessel during surgery, reducing surgical risks, alleviating the pain of patients, and avoiding unnecessary medical damage to patients.

[0031] 2. The present invention adopts a guide component. During the filter umbrella recovery process, the guide component forms a receiving space to wrap the filter umbrella, and adjusts the central axis of the filter umbrella to coincide with the central axis of the blood vessel, so that the filter umbrella enters the recovery tube more smoothly. During this process, the guide component will not squeeze the filter umbrella 8 to prevent the captured thrombus from overflowing. At the same time, when the guide component is provided with a wrapping layer, the broken thrombus that escapes during the recovery process can be captured to prevent distal embolism.

[0032] 3. The present invention provides a manufacturing method for manufacturing the balloon catheter device as described above. The manufactured balloon catheter device can effectively recover the filter umbrella, reduce the surgical risk, and avoid unnecessary medical damage to the patient. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in the description of the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without paying any creative work.

[0034] Figure 1 is a schematic diagram of a balloon catheter device of the present invention;

[0035] Figure 2 is a schematic diagram of a retriever in a balloon catheter device of the present invention;

[0036] Figure 3 It is a schematic diagram of a balloon catheter device of the present invention, in which a filter umbrella is in an expanded state;

[0037] Figure 4 It is a schematic diagram showing a filter umbrella in a balloon catheter device of the present invention in a retracted state.

[0038] In the figure:

[0039] 1. Balloon; 2. Inner tube; 3. Outer tube; 4. Development ring; 5. Hypotube; 6. Hydrophilic coating; 7. Recoverer; 71. Recovery tube; 711. Accommodation cavity; 72. Development marking ring; 73. Recovery hose; 74. Elastic metal wire; 741. Metal end; 742. Accommodation space; 75. Transition section; 8. Filter umbrella; 81. Guide wire; 82. Positioning block. DETAILED DESCRIPTION

[0040] Before any embodiments of the application are explained in detail, it is to be understood that the application is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the above drawings.

[0041] In this application, the terms "comprises", "includes", "has" or any other variations thereof are intended to cover non-exclusive inclusion, so that a process, method, article or device that includes a series of elements includes not only those elements, but also includes other elements not explicitly listed, or also includes elements inherent to such process, method, article or device. In the absence of more restrictions, an element defined by the sentence "comprises a ..." does not exclude the presence of other identical elements in the process, method, article or device that includes the element.

[0042] In the present application, the terms “connected”, “combined”, “coupled” and “installed” may refer to a direct connection, combination, coupling or installation or an indirect connection, combination, coupling or installation.

[0043] In the present application, directional words such as "up", "down", "left", "right", "front", and "back" are used to describe the directions and positional relationships shown in the accompanying drawings and should not be understood as limitations on the embodiments of the present application.

[0044] In carotid artery stent surgery, in order to effectively recover the filter umbrella, reduce surgical risks, and avoid unnecessary medical damage to patients, such as Figure 1-Figure 4 As shown, the present invention provides a balloon catheter device. The balloon catheter device includes a balloon dilatation catheter and a retriever 7.

[0045] Among them, the recoverer 7 includes a recovery tube 71, which has a accommodating cavity 711. The recovery tube 71 is fixedly arranged at the distal end of the balloon dilatation catheter (the end away from the surgical operation), and the recovery tube 71 is connected to the balloon dilatation catheter. The guide wire 81 connected to the filter umbrella 8 passes through the recovery tube 71 and the balloon dilatation catheter, and extends relative to the balloon dilatation catheter. By pulling the guide wire 81, the filter umbrella 8 can be pulled into the accommodating cavity 711.

[0046] By adopting the above structure, after the balloon dilatation catheter has expanded the stent, the guide wire 81 can be pulled to pull the filter umbrella 8 into the accommodating cavity 711 of the recovery tube 71, so that the recovery tube 71 can directly recover the filter umbrella 8 of the embolic protection device, and then take it out together, thereby reducing the number of repeated exchanges of instruments in the blood vessel during the operation, reducing the surgical risk, alleviating the patient's pain, and avoiding unnecessary medical damage to the patient.

[0047] Further, the balloon dilatation catheter is composed of a balloon 1, an inner tube 2, an outer tube 3, a developing ring 4, a hypotube 5 and a hydrophilic coating 6. The inner tube 2 is inserted into the outer tube 3, the balloon 1 is connected to the outer tube 3, the hypotube 5 is connected to the end of the outer tube 3 away from the balloon 1, and the developing ring 4 is arranged at intervals in the inner tube 2, and is located at the balloon 1. Through development, when the balloon 1 moves into place, it starts to inflate the balloon 1, and the balloon 1 expands after being inflated, thereby propping up the stent and achieving the expansion of the stent. The hydrophilic coating 6 is coated on the outer surface of the balloon 1, which can ensure the smoothness of the balloon 1 and facilitate movement in the blood vessel. The inner tube 2 of the balloon dilatation catheter is a three-layer composite material or a braided structure, preferably a composite material. The outer layer of the inner tube 2 is nylon, the middle layer is low-density polyethylene, and the inner layer is high-density polyethylene; the balloon 1 and the outer tube 3 of the balloon dilatation catheter are made of nylon; the hydrophilic coating 6 of the balloon dilatation catheter is preferably polyethylene pyroxanone, and the developing ring 4 is made of platinum-iridium alloy.

[0048] Further, the recovery tube 71 includes a recovery section and a transition section 75 connected in sequence, the recovery section has a accommodating cavity 711, and the diameter of the recovery section is greater than the diameter of the transition section 75. Specifically, the material of the recovery tube 71 is PA (nylon) or Pebax (polyetheramide block copolymer), PA and Pebax have high mechanical strength, high softening point, heat resistance, low friction coefficient, wear resistance, and can well meet the requirements of use. Preferably, the recovery tube 71 is designed to be a recovery section and a transition section 75 connected in sequence, so that after the recovery tube 71 is reduced in diameter, the end of the transition section 75 away from the recovery section is welded to the inner tube 2 and connected, and the inner diameter of the recovery section is 1.00mm-1.40mm, and the effective length is 10mm-30mm. In other embodiments, the size of the recovery section can be designed according to actual needs, and no excessive restrictions are made here.

[0049] Furthermore, the reclaimer 7 also includes a reclaim hose 73, which is coated on the reclaim tube 71. Specifically, the outer layer of the reclaim tube 71 can be heat-shrinkably coated with the reclaim hose 73. The reclaim hose 73 is made of pebax or silicone material, and can also be welded or glued to the reclaim tube 71, and the covering area includes part of the distal pin of the balloon 1, which can ensure that the reclaim tube 71 is stably combined with the balloon dilatation catheter.

[0050] Furthermore, the recovering device 7 further includes a developing marker ring 72, which is arranged at one end of the recovering tube 71 away from the balloon dilatation catheter. Specifically, the developing marker ring 72 is made of a platinum-iridium alloy, and is located between the recovering tube 71 and the recovering hose 73, and is located within 5 mm of one end of the recovering tube 71 away from the balloon dilatation catheter. By providing the developing marker ring 72, it is convenient to perform developing positioning on the position of the recovering tube 71.

[0051] Furthermore, the retrieving device 7 further comprises a guide assembly, which is arranged at one end of the retrieving tube 71 away from the balloon dilatation catheter. By arranging the guide assembly, it is possible to guide the filter umbrella 8 during the retrieving process, thereby ensuring that the filter umbrella 8 smoothly enters the retrieving tube 71.

[0052] In some embodiments, if there is no guide assembly, the filter umbrella 8 is retracted by pulling the guide wire 81, and if the blood vessel condition is good, it can be recovered normally. However, in actual situations, the blood vessels are tortuous and have narrow sections. After collecting the thrombus, the filter umbrella 8 is in an expanded state, and the placement state is not ideal when passing through the tortuous blood vessels: that is, the central axis of the filter umbrella 8 does not coincide with the central axis of the blood vessel, and there will be a certain inclination, which may cause the filter umbrella 8 to be stuck at the distal opening of the recovery tube 71, and the operator needs to adjust the position of the filter umbrella 8 before recovery. The guide assembly of the present invention forms a accommodating space 742, which wraps the filter umbrella 8, and adjusts the central axis of the filter umbrella 8 to coincide with the central axis of the blood vessel, so that the filter umbrella 8 can enter the recovery tube 71 more smoothly. In this process, the guide assembly will not squeeze the filter umbrella 8 to prevent the captured thrombus from overflowing.

[0053] Further, the guide assembly includes at least three elastic wires 74, one end of the elastic wire 74 is connected to the developing mark ring 72 in the recoverer 7, and the elastic wires 74 are arranged at intervals along the circumference of the recovery tube 71, the end of the guide assembly forms a channel, and the main body of the guide assembly forms a receiving space 742, and the filter umbrella 8 can be placed in the receiving space 742. Specifically, the filter umbrella 8 has a positioning block 82 at one end facing the recovery tube 71. When the filter umbrella 8 needs to be recovered, the guide wire 81 is pulled so that the positioning block 82 moves toward the elastic wire 74, and the positioning block 82 pushes the end of the elastic wire 74 to open radially. As the positioning block 82 enters the channel and the receiving space 742, the elastic wire 74 enters the radial opening with the filter umbrella 8, and the elastic wire 74 is in an expanded state. The guide wire 81 is continuously pulled until the filter umbrella 8 completely enters the recovery tube 71, and the elastic wire 74 returns to a retracted state. At this point, the filter umbrella 8 is dragged and recovered into the recovery tube 71 with the guide wire 81. The elastic metal wire 74 may be made of a memory alloy, preferably a nickel-titanium alloy, to facilitate resetting after elastic deformation. In this embodiment, four elastic metal wires 74 are provided. In other embodiments, the elastic metal wires 74 may be arranged as needed, and no further restrictions are made here.

[0054] Furthermore, a metal end 741 is fixedly provided at the end of the elastic metal wire 74 away from the recycler 7, and the surface of the metal end 741 is arc-shaped, and the metal end 741 can be integrally formed with the elastic metal wire 74. The end of the elastic metal wire 74 is arranged to have an arc-shaped smooth surface, which is conducive to the positioning block 82 to smoothly enter the channel; the elastic metal wire 74 is fixedly connected to the developing mark ring 72, and is symmetrically arranged relative to the developing mark ring 72, so as to ensure that the position of the elastic metal wire 74 is relatively stable when it expands.

[0055] Furthermore, a wrapping layer is attached to the guide assembly, and the wrapping layer can be opened or closed along with the elastic metal wire 74. By providing the wrapping layer, a part of the broken plugs escaping from the filter umbrella 8 can be captured during the recovery process of the filter umbrella 8, which plays a certain protective role, thereby further improving the removal effect of the plug body.

[0056] Furthermore, the wrapping layer is in the form of a film or a mesh, and the material of the wrapping layer is a polymer material. By using a polymer material, the broken plug can be effectively intercepted, and it is easy to expand or retract with the movement of the elastic metal wire 74. In other embodiments, the elastic metal wire 74 can be used as a skeleton to weave a dense mesh with metal wires, such as nickel-titanium alloy, stainless steel, etc., which can also intercept the broken plug.

[0057] The balloon catheter device provided by the present invention can directly use the recovery tube 71 to recover the filter umbrella 8 after the stent is expanded, thereby avoiding repeated exchange of instruments in the blood vessel, reducing surgical risks, and shortening surgical time.

[0058] In some embodiments of the present invention, as an example but not a limitation, in a carotid artery stent implantation surgery, the push guide wire 81 pushes the filter umbrella 8 to the distal end of the target implantation position of the balloon dilatation catheter, and the positioning block 82 of the filter umbrella 8 is used for visualization and positioning, and then the balloon dilatation catheter is pushed to the target site along the filter umbrella guide wire 81, and the balloon and the stent are positioned under X-ray using the developing ring 4 on the balloon. The balloon is inflated to completely adhere to the blood vessel wall, and the filter umbrella 8 at the distal end captures the thrombus escaping with the blood flow to avoid distal embolism; when withdrawing, the medium in the balloon dilatation catheter is emptied, for example, a negative pressure device is used, and at this time, the guide wire 81 is withdrawn, so that the positioning block 82 enters the channel formed by the end of the elastic metal wire 74, and the guide wire 81 is continued to be withdrawn, and the filter umbrella 8 is completely recovered into the distal recovery tube 71 of the balloon dilatation catheter. Finally, the recovered filter umbrella 8 is withdrawn into the guide catheter together with the balloon dilatation catheter, and finally withdrawn from the human body according to the conventional surgical process, and the operation is completed.

[0059] This embodiment also provides a manufacturing method for manufacturing the balloon catheter device as described above, comprising the following steps:

[0060] S1. Weld the proximal pin of the balloon 1 to one end of the outer tube 3 to form an assembly, and set an opening at a set position on the outer tube 3. Use a welding mandrel to support and pre-press the developing ring 4 onto the inner tube 2. Specifically, a blade can be used to make an opening on the outer tube 3.

[0061] S2, insert the inner tube 2 from the distal end of the balloon 1 and pass it out from the opening of the outer tube 3;

[0062] S3, insert the guide wire port welding mandrel support from the unwelded section of the outer tube 3, weld the opening to make it sealed and firmly connected, cut off the excess inner tube 2, and form a quick-exchange guide wire port;

[0063] S4, welding the distal end of the balloon 1 to the inner tube 2, with the inner tube 2 pre-lengthened by 3mm-5mm outside the welding position;

[0064] S5, insert the recovery tube 71, reduce its diameter after laser welding or hot air welding, splice or overlap the reduced diameter recovery tube 71 with the inner tube 2, and put it into the protective sleeve for heat shrinkage and integration;

[0065] S6. Pre-weld the developer mark ring 72 and the guide assembly on the recovery pipe 71; specifically, pre-weld the developer mark ring 72 and the four elastic metal wires 74 by laser welding (using a muffle furnace to pre-shape the elastic metal wires 74 at high temperature). The elastic metal wires 74 are evenly distributed, and a polymer coating is coated on the surface of the elastic metal wires 74.

[0066] S7, the head end of the recovery tube 71 is pressed and gripped with the pre-treated developing mark ring 72, and the recovery hose 73 is put on, and the entire recovery tube 71 is heat-shrink wrapped;

[0067] S8. Weld the outer tube 3 and the hypotube 5 into one body, and apply a hydrophilic coating 6 at a set position to form a balloon catheter device.

[0068] Obviously, the above embodiments of the present invention are merely examples for clearly illustrating the present invention, and are not intended to limit the embodiments of the present invention. For those skilled in the art, other different forms of changes or modifications can be made based on the above description. It is not necessary and impossible to list all the embodiments here. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included in the protection scope of the claims of the present invention.

Claims

1. A balloon catheter device, characterized in that: include: Balloon dilatation catheter; A recoverer (7), the recoverer (7) comprising a recovering tube (71), the recovering tube (71) having a containing chamber (711), the recovering tube (71) being arranged at the distal end of the balloon dilatation catheter and being in communication with the balloon dilatation catheter, a guide wire (81) connected to the filter umbrella (8) passing through the recovering tube (71) and the balloon dilatation catheter and extending relative to the balloon dilatation catheter, and pulling the guide wire (81) to pull the filter umbrella (8) into the containing chamber (711); The retriever (7) further comprises a guide assembly, wherein the guide assembly is arranged at an end of the retrieval tube (71) away from the balloon dilatation catheter; The end of the guide assembly forms a channel, the main body of the guide assembly forms a receiving space (742), and the filter umbrella (8) can be placed in the receiving space (742); The guide assembly comprises at least three elastic metal wires (74), one end of each of the elastic metal wires (74) is connected to the recoverer (7), and the elastic metal wires (74) are arranged at intervals along the circumference of the recovery pipe (71).

2. The balloon catheter device according to claim 1, characterized in that: The recovery pipe (71) comprises a recovery section and a transition section (75) connected in sequence, the recovery section having the accommodating cavity (711), and the diameter of the recovery section being greater than the diameter of the transition section (75).

3. The balloon catheter device according to claim 1, characterized in that: The recoverer (7) further comprises a recovery hose (73), wherein the recovery hose (73) is wrapped around the recovery pipe (71).

4. The balloon catheter device according to claim 3, characterized in that: The material of the recovery hose (73) is pebax or silicone, and the recovery hose (73) is covered on the recovery pipe (71) by welding or gluing.

5. The balloon catheter device according to claim 1, characterized in that: The retriever (7) further comprises a developing marker ring (72), and the developing marker ring (72) is arranged at one end of the retrieval tube (71) away from the balloon dilatation catheter.

6. The balloon catheter device according to claim 1, characterized in that: The end of the elastic metal wire (74) away from the recycler (7) is provided with a metal end head (741), and the surface of the metal end head (741) is arc-shaped.

7. The balloon catheter device according to claim 1, characterized in that: A wrapping layer is attached to the guide component, and the wrapping layer can be opened or closed along with the elastic metal wire (74).

8. The balloon catheter device according to claim 7, characterized in that: The wrapping layer is in the form of a film or a net.

9. A production method, characterized in that: The method for manufacturing the balloon catheter device according to any one of claims 1 to 8 comprises the following steps: S1, welding the proximal tube pin of the balloon (1) to one end of the outer tube (3) to form an assembly, and providing an opening at a set position of the outer tube (3), and pre-pressing and gripping the developing ring (4) on the inner tube (2); S2, inserting the inner tube (2) from the distal end of the balloon (1) and passing it out from the opening of the outer tube (3); S3, welding the opening to make it sealed and firmly connected, and cutting off the excess inner tube (2) to form a quick-exchange guide wire port; S4, welding the distal end of the balloon (1) to the inner tube (2); S5, inserting the recovery tube (71), reducing its diameter after welding, splicing or overlapping the reduced-diameter recovery tube (71) and the inner tube (2), and inserting them into a protective sleeve to shrink them into one; S6, pre-welding the developing mark ring (72) and the guide assembly on the recovery pipe (71); S7, the head end of the recovery tube (71) is pressed and gripped with the pre-treated developing mark ring (72), and the recovery hose (73) is put on, and the entire recovery tube (71) is heat-shrinkably wrapped; S8. Welding the outer tube (3) and the hypotube (5) into one body, and coating a hydrophilic coating (6) at a set position to form the balloon catheter device.

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