Single-tube multi-bend adjustable angiography catheter and manufacturing method thereof

Abstract

The present invention discloses a single-tube multi-bend adjustable angiography catheter and a manufacturing method thereof. The single-tube multi-bend adjustable angiography catheter of the present invention comprises a main catheter and a traction assembly; the main catheter has a support section and an adjustable bend section; a first channel is formed in the support section; a first shaping block is provided in the adjustable bend section; the first shaping block has a first bend shape, so that the adjustable bend section bends in the first bend shape; the first shaping block slides axially in the adjustable bend section; the traction assembly comprises a first traction wire, one end of the first traction wire extends from the proximal opening of the first channel, and the other end is connected to the first shaping block; by pushing and pulling the first traction wire, the first shaping block is driven to axially displace in the adjustable bend section, thereby changing the position of the first bend portion of the adjustable bend section. The present invention can solve the problem of complex surgical procedures and the need for multiple bend selections before surgery, and has the characteristic that the catheter can be moved up high and in place, reducing the difficulty of superselection operation and shortening the operation time.

Description

Technical Field

[0001] The present invention relates to the technical field of medical catheters, and in particular to a single-tube multi-bend adjustable angiography catheter and a manufacturing method thereof. Background Art

[0002] Angiography catheters are key devices used in clinical percutaneous angiography. Appearing as long tubes, they primarily serve as conduits for the smooth introduction of contrast agents into blood vessels, producing an angiographic effect. A wide variety of catheters are commonly used for interventional diagnosis and treatment of vascular diseases, categorized as diagnostic and therapeutic catheters.

[0003] Femoral artery access has long been considered a conventional approach for cerebral angiography. Figure 1 Shown are three current catheter tip bends for femoral artery intervention: the VTK, HI, and H2 bends. These bends are suitable for superselective femoral artery interventions within the aortic arch. Users should select a tip based on the specific approach to meet the specific vascular anatomy requirements.

[0004] As a classic approach for cerebrovascular intervention, the femoral artery approach has certain drawbacks, such as hematoma at the puncture site, arteriovenous leakage, and the need for prolonged bed rest after surgery. Therefore, many researchers have begun to explore alternative approaches, such as the radial artery approach.

[0005] Compared with the transfemoral approach, the transradial approach has more advantages in reducing surgical complications and increasing patient comfort. For example, the radial artery is located superficially, and the risk of nerve damage and arteriovenous leakage caused by puncture is significantly lower than that of the femoral approach; there is no need to interrupt antiplatelet and anticoagulant treatment during the examination; no perineal skin preparation is required before the operation, and no bed rest is required after the operation. However, with the clinical application of transradial cerebrovascular intervention, it has gradually been found that it is more difficult than the transfemoral approach. For example, radial artery puncture is more difficult than femoral artery puncture, the selective cannulation process is cumbersome, catheter manipulation is difficult, the success rate of selective cannulation of secondary vessels above the aortic arch is low, the operator needs a longer learning time, and the operator is exposed to more radiation during the operation than when the femoral approach is used.

[0006] Considering the advantages of radial artery access in reducing complications and increasing patient comfort, the proportion of radial artery access in cerebrovascular interventional treatment has been gradually expanded clinically. For transradial interventional surgery, angiography is indispensable, whether it is a separate angiography examination before the operation or an auxiliary treatment during the operation. Therefore, the use of angiography catheters is bound to increase significantly.

[0007] Figure 2Shown are the SIM-bend catheters currently used in transradial interventional procedures. The conventional SIM bends shown are SIM1, SIM2, and SIM3. SIM1, SIM2, and SIM3 are all designed with a single bend but differing extension lengths. The SIM bend shape is specifically designed for routine, ultra-selective transradial access procedures. This bend is suitable for neurointerventional procedures involving right radial access to the left carotid artery. The most commonly used procedure is descending aortic looping.

[0008] However, whether it is a VTK curved, HI curved, or H2 curved angiography catheter for femoral artery access, or a SIM curved angiography catheter for radial artery access, the shape of the tip is fixed.

[0009] Currently, the main drawbacks of catheter-based interventional procedures are the complex access conditions and the significant variability in vascular conditions due to patient constitutions. Therefore, the surgeon must address the selection of bend and bend length before the procedure. Furthermore, during the procedure, the surgeon is constrained by the limited bend length of a single bend and the significant variability in vascular conditions between individuals. This results in the inability to perfectly match the shape of the catheter tip to the vascular structure. These challenges require extensive experience and considerable time to resolve during the procedure, making it difficult and time-consuming. The surgeon also needs more time to practice superselective maneuvers after the procedure. For low-volume or small- to medium-sized hospitals, this procedure is difficult to perform and master superselective maneuvers within complex blood pathways. During the superselective maneuvers to establish access, catheters often bend, kink, fall, or become misaligned. These problems, along with improper catheter bend selection, not only significantly increase operative time but also the risk of surgery.

[0010] Therefore, there is an urgent need for a single-tube, multi-bend adjustable angiography catheter that can solve the problem of complex surgical procedures and the need for multiple bend selections before surgery, and can enable the catheter to be moved upward to the right position, reduce the difficulty of superselective operations, and save surgical time. Summary of the Invention

[0011] In order to overcome the shortcomings of the existing technology, the present invention provides a single-tube multi-bend adjustable angiography catheter and a manufacturing method thereof, which can solve the problem of complex surgical procedures and the need for multiple bend selections before surgery. The catheter has the characteristic of being able to move upward and into place, reducing the difficulty of superselection operations and shortening the operation time.

[0012] The first aspect of the present invention provides a single-tube multi-bend adjustable angiography catheter, comprising a main catheter and a traction assembly;

[0013] The main catheter is a slender tubular structure having a tube wall and an inner tube cavity; the main catheter is sequentially formed with a support section and an adjustable bend section from the proximal end to the distal end;

[0014] A first channel is formed in the support section for the traction assembly to pass through;

[0015] A first shaping block is provided in the adjustable bending section; the first shaping block is inserted into the adjustable bending section, and a first bending portion is formed at a contact position between the first shaping block and the adjustable bending section; the first shaping block is in a sleeve shape, has a first bending profile, and has shape-retaining capability, thereby causing the first bending portion to bend in the first bending profile; the first shaping block is slidably connected to the adjustable bending section, thereby allowing the first shaping block to be displaced axially relative to the adjustable bending section;

[0016] The traction assembly includes a first traction wire, the first traction wire is inserted into the first channel, and the two ends of the first traction wire respectively form a traction end and a connection end, the traction end of the first traction wire extends from the proximal opening of the first channel, and the connection end of the first traction wire extends from the distal opening of the first channel, and the connection end of the first traction wire is connected to the first shaping block;

[0017] By pushing and pulling the first traction wire, the first shaping block is driven to move axially in the adjustable bending section, thereby changing the position of the first bending portion of the adjustable bending section.

[0018] In the first aspect of the present invention, as a preferred embodiment, the wall of the bending section tube is provided with an inner lining layer, a braided layer and an outer tube layer in sequence from the inside to the outside; an adjustment chamber is formed between the inner lining layer and the braided layer; the adjustment chamber is connected to the first channel; and the first shaping block is slidably connected in the adjustment chamber.

[0019] In the first aspect of the present invention, as a preferred embodiment, it further includes a second shaping block and a third shaping block;

[0020] The second shaping block is disposed within the adjustable bending section, and the first shaping block forms a second bending portion at a contact position with the adjustable bending section; the second shaping block is sleeve-shaped, has a second bending profile, and has shape-retaining capability, thereby causing the second bending portion to bend in the second bending profile; the second shaping block is slidably connected to the adjustable bending section, thereby allowing the second shaping block to be displaced axially relative to the adjustable bending section;

[0021] The third shaping block is disposed within the adjustable bending section, and the contact position between the third shaping block and the adjustable bending section forms a third bending portion; the third shaping block is sleeve-shaped, has a third bending profile, and has shape-retaining capability, thereby enabling the third bending portion to bend in the third bending profile; the third shaping block is slidably connected to the adjustable bending section, thereby enabling the third shaping block to be displaced axially relative to the adjustable bending section;

[0022] The first shaping block, the second shaping block and the third shaping block are sequentially arranged in the adjustment chamber from the proximal end to the distal end.

[0023] In the first aspect of the present invention, as a preferred embodiment, a first connecting wire is provided between the first shaping block and the second shaping block, and both ends of the first connecting wire are respectively fixedly connected to the first shaping block and the second shaping block;

[0024] A second connecting wire is provided between the second shaping block and the third shaping block, and two ends of the second connecting wire are respectively fixedly connected to the second shaping block and the third shaping block;

[0025] By pushing and pulling the first traction wire, the first shaping block, the second shaping block and the third shaping block are simultaneously driven to move axially in the adjustment chamber, thereby changing the positions of the first bending portion, the second bending portion and the third bending portion of the adjustable bending section.

[0026] In the first aspect of the present invention, as a preferred embodiment, the adjustment chamber is provided with A11 position, A12 position and A13 position in sequence from the distal end to the proximal end, and the first shaping block can move between the A11 position, A12 position and A13 position; when the first shaping block is in the A11 position, the adjustable bend section of the main duct is a SIM1 bend.

[0027] In the first aspect of the present invention, as a preferred embodiment, a second channel and a third channel are formed in the support section;

[0028] The traction assembly includes a second traction wire and a third traction wire;

[0029] The second traction wire is passed through the second channel, and the two ends of the second traction wire form a traction end and a connection end respectively. The traction end of the second traction wire extends from the proximal opening of the second channel, and the connection end of the second traction wire extends from the distal opening of the second channel. The connection end of the second traction wire is connected to the second shaping block; by pushing and pulling the second traction wire, the second shaping block is driven to axially displace in the adjustment chamber, thereby changing the position of the second bending portion of the adjustable bending section;

[0030] The third traction wire is passed through the third channel, and the two ends of the third traction wire form a traction end and a connecting end respectively. The traction end of the third traction wire extends from the proximal opening of the third channel, and the connecting end of the third traction wire extends from the distal opening of the third channel. The connecting end of the third traction wire is connected to the third shaping block; by pushing and pulling the third traction wire, the third shaping block is driven to move axially in the adjustment chamber, thereby changing the position of the third bending portion of the adjustable bending section.

[0031] In the first aspect of the present invention, as a preferred embodiment, the adjustment chamber is provided with positions A21, A22, and A23 in sequence from the distal end to the proximal end; positions B1, B2, and B3; and positions C1, C2, and C3.

[0032] The first shaping block can be moved between position A21, position A22, and position A23;

[0033] The second shaping block can move between position B1, position B2, and position B3;

[0034] The third shaping block can move between position C1, position C2, and position C3;

[0035] When the first shaping block is at the A21 position, the second shaping block is at the B1 position, and the third shaping block is at the C1 position, the adjustable bend section of the main conduit is in a SIM1 bend shape;

[0036] When the first shaping block is at the A22 position, the second shaping block is at the B2 position, and the third shaping block is at the C2 position, the adjustable bend section of the main conduit is in a SIM2 bend shape;

[0037] When the first shaping block is at the A23 position, the second shaping block is at the B3 position, and the third shaping block is at the C3 position, the adjustable bend section of the main duct is a SIM3 bend.

[0038] In the first aspect of the present invention, as a preferred embodiment, a catheter seat is further included, the catheter seat is connected to the proximal end of the main catheter through a stress relief tube; the catheter seat is provided with a bend adjustment rotary valve, the bend adjustment rotary valve is connected to the traction assembly, and the bend adjustment rotary valve pushes and pulls the first traction wire, the second traction wire, and the third traction wire by rotating, thereby controlling the first shaping block, the second shaping block, and the third shaping block to move in the adjustment chamber for bending;

[0039] The bending rotary valve has a first gear position, a second gear position and a third gear position;

[0040] When the bend regulating knob is rotated to the first gear, the first shaping block is at the A21 position, the second shaping block is at the B1 position, and the third shaping block is at the C1 position, so that the adjustable bend section of the main conduit is in a SIM1 bend shape;

[0041] When the bend regulating knob is rotated to the second gear, the first shaping block is at the A22 position, the second shaping block is at the B2 position, and the third shaping block is at the C2 position, so that the adjustable bend section of the main conduit is in a SIM2 bend shape;

[0042] When the bending adjustment knob is rotated to the third gear, the first shaping block is at the A23 position, the second shaping block is at the B3 position, and the third shaping block is at the C3 position, the adjustable bending section of the main conduit is a SIM3 bending type.

[0043] In the first aspect of the present invention, as a preferred embodiment, the support section tube wall is provided with an inner lining layer, a braided layer and an outer tube layer in sequence from the inside to the outside;

[0044] The inner lining layer of the adjustable bending section and the inner lining layer of the supporting section are both made of polytetrafluoroethylene;

[0045] The adjustable bending section braided layer and the supporting section braided layer are both woven from multiple strands of stainless steel wire;

[0046] The outer tube layer of the adjustable bending section and the outer tube layer of the supporting section are made of polyetheramide resin and barium sulfate;

[0047] The first traction wire, the second traction wire and the third traction wire are twisted and braided from multiple strands of stainless steel wire;

[0048] The first shaping block, the second shaping block and the third shaping block are formed by laser engraving and bending stainless steel tubes or nickel-titanium tubes.

[0049] A second aspect of the present invention provides a method for manufacturing a single-tube, multi-bend, adjustable angiography catheter, comprising the following steps:

[0050] A liner tube is provided, wherein the liner tube is made of polytetrafluoroethylene; the liner tube has a first segment and a second segment in sequence from the proximal end to the distal end;

[0051] Providing a plurality of braided wires, and braiding the braided wires on the surface of the first segment of the liner tube to form a first braided layer;

[0052] Providing a rheological material, the rheological material comprising polyetheramide resin and barium sulfate, and flowing the rheological material onto the surface of the first braided layer to form a first rheological layer;

[0053] Providing a first cladding tube, a second cladding tube, and a third cladding tube, and fixing the first cladding tube, the second cladding tube, and the third cladding tube in sequence on the surface of the first rheological layer;

[0054] A plurality of braided wires are provided and braided on the surface of the auxiliary tube to form a second braided tube; the second braided tube is sleeved over the first cladding tube, the second cladding tube, the third cladding tube, the surface of the first rheological layer, and the second segmented surface of the liner tube; a rheological material is provided, the rheological material comprising polyetheramide resin and barium sulfate, and the rheological material is segmented and rheologically applied to the surface of the second braided tube to form a second rheological layer; an adjustment chamber is formed between the second braided tube and the liner tube, and the distal end of the adjustment chamber has an open port;

[0055] Providing a plurality of stainless steel wires, twisting the plurality of stainless steel wires into a traction wire, and cutting the traction wire into a first traction wire, a second traction wire, and a third traction wire;

[0056] A plurality of stainless steel tubes or nickel-titanium tubes are provided, and the stainless steel tubes or nickel-titanium tubes are laser engraved. After engraving, a first sleeve, a second sleeve, and a third sleeve are cut out. The first sleeve, the second sleeve, and the third sleeve are bent into a first bend shape, a second bend shape, and a third bend shape, respectively, and heat-treated to have shape-retaining capabilities, thereby forming a first shaping block, a second shaping block, and a third shaping block; the first shaping block, the second shaping block, and the third shaping block are respectively connected to the ends of the first traction wire, the second traction wire, and the third traction wire.

[0057] Insert the free ends of the first traction wire, the second traction wire, and the third traction wire into the first covering tube, the second covering tube, and the third covering tube from the distal end, respectively, until they pass out from the proximal outlets of the first covering tube, the second covering tube, and the third covering tube, continue to pull the first traction wire, the second traction wire, and the third traction wire, and insert the third shaping block, the second shaping block, and the first shaping block into the interior of the regulating chamber from the open port at the distal end of the regulating chamber in sequence;

[0058] Providing a rheological material comprising polyetheramide resin and barium sulfate, allowing the rheological material to flow onto the surface of the second rheological layer, and sealing the adjustment chamber to form an outer tube layer; coating the surface of the outer tube layer with a hydrophilic coating to obtain a main tube;

[0059] A catheter seat and a stress release tube are provided, and the catheter seat and the stress release tube are installed to the proximal end of the main catheter body; a bending adjustment valve is provided on the catheter seat, and the first traction wire, the second traction wire and the third traction wire are respectively connected to the bending adjustment valve, and the bending adjustment valve is rotated to push and pull the first traction wire, the second traction wire and the third traction wire, thereby controlling the first shaping block, the second shaping block and the third shaping block to move in the adjustment chamber, and adjusting the initial state of the distal end of the main catheter to a SIM1 bend.

[0060] Compared with the prior art, the present invention has the following beneficial effects:

[0061] 1. The single-tube multi-bend adjustable angiography catheter of the present invention applies a push-pull force to the first traction wire, thereby driving the first shaping block connected to the distal end of the first traction wire to axially displace in the adjustable bend section, thereby changing the position of the first bending portion of the adjustable bend section, thereby realizing the change of the bend shape of the distal head end of the angiography catheter, that is, multi-bend control of a single catheter, which meets the clinical usage scenarios, does not require multiple judgments on the bend selection before surgery, saves preoperative evaluation and selection time, solves the problem of complicated surgical procedures and the lack of need for multiple bend selections before surgery, and has the advantages that the catheter can be moved up to a high position, reducing the difficulty of super-selection operation and saving surgical time.

[0062] 2. The single-tube, multi-bend adjustable angiography catheter of this invention is naturally SIM-shaped, without pre-shaping. Designed based on the most commonly used transradial bend, it can solve over 95% of transradial ultrasonography and angiography problems. By adjusting the bend according to clinical conditions based on the minimum SIM1 bend, the bend can be quickly adjusted. The bend shaping block is traction-based, and the traction rope is inelastic, ensuring a 1:1 pulling force transmission without loss during the process, real-time feedback, and precise bend adjustment. During the adjustment process, transitional SIM bends beyond the conventional ones can be selected, providing strong operability.

[0063] 3. Conventional SIM catheters are single-bend catheters. Even if they can complete the surgery, they are not completely matched. They are limited by the bend length defined by the single bend, and can only be solved by the doctor through operation and time. The single-tube, multi-bend, adjustable angiography catheter of the present invention can have many intermediate transition bends such as SIM1.5 and SIM2.5 during the transition from SIM1 to SIM3. With finer size and length, it can better adapt to each person's special blood vessels under conditions that are more suitable for different physiques, avoid forced matching by doctors, reduce the learning curve of doctors, perform rapid surgery, better respond to emergencies and other emergencies, shorten treatment time, and effectively benefit the golden time for treatment; broaden the new mode of radial artery interventional treatment; reduce the difficulty of learning curve operation, so that more small and medium-sized hospitals have the ability to carry out interventional surgery and save more people. BRIEF DESCRIPTION OF THE DRAWINGS

[0064] Figure 1 Schematic diagram of three types of bends at the tip of a femoral artery interventional angiography catheter involved in the background artery;

[0065] Figure 2 A schematic diagram of a SIM bend at the tip of a radial artery interventional angiography catheter involved in the background artery is shown;

[0066] Figure 3 Schematic diagram of the structure of the single-tube multi-bend adjustable angiography catheter of the present invention;

[0067] Figure 4 Schematic diagram of the AA cross-section structure of the single-tube multi-bend adjustable angiography catheter of the present invention;

[0068] Figure 5 It is a schematic structural diagram of the adjustable bend section of the single-tube multi-bend adjustable angiography catheter of the present invention;

[0069] Figure 6 This is a schematic diagram of the first shaping block of the single-tube multi-bend adjustable angiography catheter of the present invention in use;

[0070] Figure 7 This is a schematic diagram of the use state of the first shaping block of another embodiment of the single-tube multi-bend adjustable angiography catheter of the present invention;

[0071] Figure 8 The figure is a schematic diagram of the use state of the adjustable bend section of the single-tube multi-bend adjustable angiography catheter of the present invention.

[0072] In the figure: 10. Support section; 20. Adjustable bending section; 21. Inner lining layer; 22. Braided layer; 23. Adjustment chamber; 24. Outer tube layer; 25. First channel; 26. First bending portion; 27. Second bending portion; 28. Third bending portion; 30. First shaping block; A21, A21 position; A22, A22 position; A23, A23 position; 40. Second shaping block; B1, B1 position; B2, B2 position; B3, B3 position; 50. Third shaping block; C1, C1 position; C2, C2 position; C3, C3 position; 60. First traction wire; 70. Catheter seat; 71. Bending adjustment valve; 711, First gear; 712, Second gear; 713, Third gear. DETAILED DESCRIPTION

[0073] Below, the invention is further described in conjunction with the accompanying drawings and specific embodiments. It should be noted that, under the premise of no conflict, the various embodiments described below or the various technical features can be arbitrarily combined to form a new embodiment. Unless otherwise specified, the materials and equipment used in this embodiment can be purchased from the market. Examples of the embodiments are shown in the accompanying drawings, in which the same or similar reference numerals throughout represent the same or similar elements or elements with the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are only used to explain the present application, and cannot be understood as limiting the present application.

[0074] In the description of this application, it should be understood that the terms "upper," "lower," "front," "back," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like, indicating orientations or positional relationships, are based on the orientations or positional relationships shown in the accompanying drawings and are intended only to facilitate the description of this application and simplify the description. They do not indicate or imply that the devices or elements referred to must have a specific orientation, be constructed, or operate in a specific orientation. Therefore, they should not be construed as limiting this application. In the description of this application, "plurality" means two or more, unless otherwise specifically specified.

[0075] In the description of this application, it should be noted that, unless otherwise expressly specified or limited, the terms "connected," "connected," and "connected" should be understood in a broad sense. For example, they may refer to a fixed connection, a connection through an intermediary medium, internal communication between two components, or an interaction between two components. Those skilled in the art will understand the specific meanings of the above terms in this application based on the specific circumstances.

[0076] The terms "first," "second," and the like in the specification and claims of this application and the accompanying drawings are used to distinguish similar objects and are not necessarily used to describe a particular order or sequential sequence. In addition, the terms "including," "comprising," and "having," and any variations thereof, are intended to cover non-exclusive inclusions. For example, a process, method, system, product, or apparatus that includes a series of steps or elements is not necessarily limited to those steps or elements explicitly listed, but may include other steps or elements not explicitly listed or inherent to the process, method, product, or apparatus.

[0077] Example 1:

[0078] like Figure 3-8 As shown, this embodiment provides a single-tube, multi-bend, adjustable angiography catheter, primarily designed to facilitate the smooth introduction of contrast agents into blood vessels, producing angiographic effects. The catheter comprises a main catheter, a traction assembly catheter adapter 70, and a stress relief tube connected between the proximal end of the main catheter and the catheter adapter 70.

[0079] The proximal end referred to in this embodiment is the end closer to the operator when in use, and the distal end is the end farther away from the operator when in use. The central axis is the line connecting the distal center and the proximal center in the natural state; the inner side of this embodiment refers to the side relatively close to the central axis, and the outer side refers to the side relatively far away from the central axis; the proximal end of the main catheter in this embodiment is used to connect with operating equipment such as the stress relief tube and the catheter seat 70, and the distal end is used for entry, which can be understood by those skilled in the art.

[0080] The main catheter is an elongated tubular structure with a wall and an inner lumen. From the proximal end to the distal end, the main catheter is formed with a support section 10 and an adjustable bend section 20. In this embodiment, the effective length of the main catheter is 90-160 cm, and the adjustable bend section is 2-20 cm long from the distal tip. The main catheter is coated with a hydrophilic coating that extends 20-80 cm. The inner diameter of the main catheter lumen is 1-2.5 mm, and the outer diameter is 1.3-3.3 mm. A first channel 25 is formed within the wall of the support section 10, through which the traction assembly passes. The first channel 25 has a proximal opening and a distal opening.

[0081] A first shaping block 30 is provided in the adjustable bending section 20; the first shaping block 30 is passed through the adjustable bending section 20, and the first shaping block 30 forms a first bending portion 26 at the contact position with the adjustable bending section 20; the first shaping block 30 is in the shape of a sleeve, and the first shaping block 30 has a first bending shape, and the first shaping block 30 has shape-retaining ability, so that the first bending portion 26 is bent in the first bending shape; the first shaping block 30 is slidably connected to the adjustable bending section 20, so that the first shaping block 30 can be displaced axially relative to the adjustable bending section 20.

[0082] The traction assembly includes a first traction wire 60, which is passed through the first channel 25. The two ends of the first traction wire 60 form a traction end and a connecting end respectively. The traction end of the first traction wire 60 extends from the proximal opening of the first channel 25, and the connecting end of the first traction wire 60 extends from the distal opening of the first channel 25. The connecting end of the first traction wire 60 is connected to the first shaping block 30.

[0083] During use, a push-pull force is applied to the first traction wire 60 extending from the proximal opening of the first channel 25, thereby driving the first shaping block 30 connected to the distal end of the first traction wire 60 to move axially within the adjustable bend section 20, thereby changing the position of the first bending portion 26 of the adjustable bend section 20, thereby achieving a change in the bend shape of the distal head end of the angiography catheter.

[0084] The first shaping block 30 of this embodiment can be formed by laser engraving and bending a stainless steel tube or a nickel-titanium tube, and is heat-treated to have excellent shape-retaining ability. Figure 6What is shown is an embodiment of the first shaping block 30, which is inserted into the adjustable bend section 20 and supported inside the adjustable bend section 20 by surface tension. It temporarily stays at a preset position by utilizing the abutment and friction force of its own bending shape, and drives the contact part with the adjustable bend section 20 to bend in a preset shape. When in use, the abutment and friction force between the first shaping block 30 and the inner wall of the adjustable bend section 20 are overcome by pushing and pulling the first traction wire 60, so that the first shaping block 30 slides relative to the inner wall of the adjustable bend section 20, the first shaping block 30 is axially displaced a certain distance, and the position of the first bending portion 26 changes accordingly, thereby adjusting the bend shape of the distal tip of the angiography catheter.

[0085] Figure 7 The figure shows another embodiment of the first shaping block 30, wherein the wall of the adjustable bend section is sequentially provided with an inner lining layer 21, a braided layer 22, and an outer tube layer 24, from the inside out. An adjustment chamber 23 is formed between the inner lining layer 21 and the braided layer 22. The adjustment chamber 23 communicates with the first channel 25. The first shaping block 30 is slidably connected within the adjustment chamber 23. The independent adjustment chamber 23 provides a more stable and reliable environment for the sliding of the first shaping block 30 within the adjustable bend section 20, and is less likely to interfere with the passage established by the inner lumen of the main tube.

[0086] The inner lining 21 of the adjustable bend 20 can be made of PTFE (polytetrafluoroethylene), creating a smooth and lubricated lumen to facilitate the passage of other instruments. The braided layer 22 of the adjustable bend 20 is woven from multiple strands of stainless steel braided wire, including but not limited to round wire, flat wire, and a blend of round and flat, providing strong resistance to deformation. The outer tube 24 of the adjustable bend 20 is composed of Pebax (polyetheramide resin) of varying hardness and contains barium sulfate for radiographic imaging. The support section 10 is constructed, from the inside out, with the inner lining 21, braided layer 22, and outer tube 24, using the same materials as the adjustable bend.

[0087] The first traction wire 60 of this embodiment is made of stainless steel, which has excellent material rigidity and toughness. The first traction wire 60 is twisted and braided from multiple strands of stainless steel wire, enabling rapid bending by pulling. The traction wire is inelastic, and the pulling force is transmitted 1:1, with no loss during the process and real-time feedback. The first shaping block 30 can be controlled by a single first traction wire 60, or by two first traction wires 60 spaced 180° apart, or by multiple first traction wires 60 arranged in a circular array, thereby improving the balance and stability of the first shaping block 30 during sliding. Persons skilled in the art can implement this method based on actual needs.

[0088] Specifically, this embodiment further includes a second shaping block 40 and a third shaping block 50;

[0089] The second shaping block 40 is disposed within the adjustable bending section 20, and the first shaping block 30 forms a second bending portion 27 at the contact position with the adjustable bending section 20. The second shaping block 40 is sleeve-shaped and has a second bending profile. The second shaping block 40 has shape-retaining properties, thereby causing the second bending portion 27 to bend in the second bending profile. The second shaping block 40 is slidably connected to the adjustable bending section 20, thereby allowing the second shaping block 40 to be displaced axially relative to the adjustable bending section 20.

[0090] The third shaping block 50 is disposed within the adjustable bending section 20, and the contact position between the third shaping block 50 and the adjustable bending section 20 forms a third bending portion 28. The third shaping block 50 is sleeve-shaped and has a third bending profile. The third shaping block 50 has shape-retaining properties, thereby causing the third bending portion 28 to bend in the third bending profile. The third shaping block 50 is slidably connected to the adjustable bending section 20, thereby allowing the third shaping block 50 to move axially relative to the adjustable bending section 20.

[0091] The first shaping block 30 , the second shaping block 40 , and the third shaping block 50 are sequentially disposed in the regulating chamber 23 from the proximal end to the distal end.

[0092] In one embodiment, the first shaping block 30, the second shaping block 40, and the third shaping block 50 can be connected in series. That is, a first connecting wire is provided between the first shaping block 30 and the second shaping block 40, and the two ends of the first connecting wire are respectively fixed to the first shaping block 30 and the second shaping block; a second connecting wire is provided between the second shaping block 40 and the third shaping block 50, and the two ends of the second connecting wire are respectively fixed to the second shaping block 40 and the third shaping block 50. By connecting the first shaping block 30, the second shaping block 40, and the third shaping block 50 in series at a preset spacing, the first connecting wire is used to simultaneously drive the first shaping block 30, the second shaping block 40, and the third shaping block 50 to move axially within the adjustment chamber 23, thereby changing the positions of the first bending portion 26, the second bending portion 27, and the third bending portion 28 of the adjustable bending section 20, thereby completing the adjustment of the head end bend. The device has the characteristics of simple structure, convenient processing, and convenient control operation. The initial bend is set to the SIM1 bend. When the first shaping block 30, the second shaping block 40, and the third shaping block 50 are pulled in series, they will move axially at the same displacement spacing, and the SIM1 bend can be adjusted to a bend that is approximately SIM2 or SIM3. There are deviations from the SIM2 or SIM3 bends, but they are also within an acceptable range and can meet certain operational requirements.

[0093] In a preferred embodiment, the first shaping block 30 , the second shaping block 40 , and the third shaping block 50 are independently controlled by different traction wires.

[0094] Specifically, a second channel and a third channel are formed in the support section 10; the traction assembly includes a second traction wire and a third traction wire;

[0095] The second traction wire is passed through the second channel, and the two ends of the second traction wire form a traction end and a connection end respectively. The traction end of the second traction wire extends from the proximal opening of the second channel, and the connection end of the second traction wire extends from the distal opening of the second channel. The connection end of the second traction wire is connected to the second shaping block 40. By pushing and pulling the second traction wire, the second shaping block 40 is driven to axially displace in the adjustment chamber 23, thereby changing the position of the second bending portion 27 of the adjustable bending section 20.

[0096] The third traction wire is passed through the third channel, and the two ends of the third traction wire form a traction end and a connecting end respectively. The traction end of the third traction wire extends from the proximal opening of the third channel, and the connecting end of the third traction wire extends from the distal opening of the third channel. The connecting end of the third traction wire is connected to the third shaping block 50; by pushing and pulling the third traction wire, the third shaping block 50 is driven to move axially in the adjustment chamber 23, thereby changing the position of the third bending portion 28 of the adjustable bending section 20.

[0097] During use, the first shaping block 30 is displaced by pulling the first traction wire 60, the second shaping block 40 is displaced by pulling the second traction wire, and the third shaping block 50 is displaced by pulling the third traction wire, thereby changing the positions of the first bending portion 26, the second bending portion 27, and the third bending portion 28 of the adjustable bending section 20. The initial bending profile is set to SIM1, which allows the user to adjust the actual profile closer to SIM2 or SIM3, making the adjustment more user-friendly.

[0098] Furthermore, the regulating chamber 23 is provided with A21 position A21, A22 position A22, A23 position A23 in sequence from the distal end to the proximal end; B1 position B1, B2 position B2, B3 position B3; C1 position C1, C2 position C2, C3 position C3;

[0099] The first shaping block 30 can move between position A21 A21, position A22 A22, and position A23 A23;

[0100] The second shaping block 40 can move between position B1, position B2 and position B3;

[0101] The third shaping block 50 can move between position C1, position C2, and position C3;

[0102] When the first shaping block 30 is at the A21 position A21, the second shaping block 40 is at the B1 position B1, and the third shaping block 50 is at the C1 position C1, the adjustable bend section 20 of the main conduit is in a SIM1 bend shape;

[0103] When the first shaping block 30 is at the A22 position A22, the second shaping block 40 is at the B2 position B2, and the third shaping block 50 is at the C2 position C2, the adjustable bend section 20 of the main conduit is in a SIM2 bend shape;

[0104] When the first shaping block 30 is at the A23 position A23, the second shaping block 40 is at the B3 position B3, and the third shaping block 50 is at the C3 position C3, the adjustable bend section 20 of the main conduit presents a SIM3 bend.

[0105] The catheter adapter 70 in this embodiment is made of PC and comprises a catheter body and a bend adjustment knob 71. One end of the catheter body is a standard Luer connector, while the other end communicates with the inner lumen of the main catheter, allowing for the passage of instruments and the injection of diagnostic reagents such as angiography. The bend adjustment knob 71 is connected to the traction assembly. Rotating the bend adjustment knob 71 pushes and pulls the first, second, and third traction wires 60, thereby controlling the movement of the first, second, and third shaping blocks 30, 40, and 50 within the adjustment chamber 23 to adjust the bend.

[0106] The bend regulating valve 71 has a first gear position 711, a second gear position 712 and a third gear position 713;

[0107] When the bend adjusting rotary valve 71 is rotated to the first gear 711, the first shaping block 30 is at the A21 position A21, the second shaping block 40 is at the B1 position B1, and the third shaping block 50 is at the C1 position C1, so that the adjustable bend section 20 of the main conduit is in the SIM1 bend shape;

[0108] When the bend regulating knob 71 is rotated to the second gear position 712, the first shaping block 30 is at the A22 position A22, the second shaping block 40 is at the B2 position B2, and the third shaping block 50 is at the C2 position C2, so that the adjustable bend section 20 of the main conduit is in the SIM2 bend shape;

[0109] When the bending adjustment rotary valve 71 is rotated to the third gear 713, the first shaping block 30 is at the A23 position A23, the second shaping block 40 is at the B3 position B3, and the third shaping block 50 is at the C3 position C3, the adjustable bending section 20 of the main conduit presents a SIM3 bending type.

[0110] This allows for rapid switching between SIM1, SIM2, and SIM3 without the need for complex pulling operations, resulting in high precision and simple operation, saving the surgeon's intraoperative time and preoperative training time. Of course, in actual implementation, the transition bend profiles between SIM1, SIM2, and SIM3 can also be configured for greater practicality and flexibility. In other implementations, the initial bend profile can also be set to VTK, H1, H2, or other custom bend profiles, providing greater flexibility. Those skilled in the art can implement this according to their specific needs.

[0111] Based on the above structure, the method for using the single-tube multi-bend adjustable angiography catheter of this embodiment in neurointerventional surgery is as follows, including the following steps:

[0112] Step S101: Inspect the exterior of the packaging box for visible damage. Remove the sterile bag from the packaging box and inspect it for damage (i.e., tears, punctures, scratches, etc.). Do not use if the sterile bag has been opened or damaged.

[0113] Step S102: Carefully open the sterile bag, remove the angiographic catheter, check if the product is damaged, and flush the inner and outer lumens of the catheter with heparinized saline. Note: Do not use if the product is damaged.

[0114] Step S103: A guide wire of appropriate size that has been pre-soaked in heparinized saline is inserted into the single-tube, multi-bend, adjustable angiography catheter of this embodiment through the catheter hub 70 until it extends about 5 cm from the tip.

[0115] Step S104: Select relevant equipment to establish vascular access.

[0116] Step S105: After the pathway is established, the single-tube multi-bend adjustable angiography catheter described in this embodiment is inserted into the blood vessel along the guidewire (or coaxially inserted into the blood vessel with other interventional catheters).

[0117] Step S106: Perform the superselection operation under X-ray fluoroscopy. During this process, the bend is controlled by adjusting the bend knob 71 to confirm that the tip of the angiographic catheter has been inserted into the target area. Then, the contrast agent or drug is injected. Note: Before injecting the contrast agent or drug, ensure that the product is not tangled, damaged, twisted, or blocked.

[0118] Step S107: If the angiography catheter is to be sent to the distal end of the blood vessel, insert the guide wire again, place the guide wire first, and carefully insert the product along the guide wire.

[0119] Step S108: When performing the operation using the coaxial method, the guide wire is pulled out, and a sub-catheter (micro-catheter) is carefully inserted into the lumen of the main catheter of the angiography catheter.

[0120] Step S109: When replacing another catheter, move the current angiography catheter away from the target site, reinsert the guide wire so that it slightly protrudes from the tip of the current angiography catheter, and carefully replace the catheter along the guide wire.

[0121] Step S110: After the predetermined operation is completed, the angiography catheter is moved away from the target position, and a guide wire is inserted so that the guide wire slightly extends out of the distal end of the catheter. The catheter and the guide wire are carefully removed together.

[0122] The single-tube multi-bend adjustable angiography catheter of this embodiment applies a push-pull force to the first traction wire 60, driving the first shaping block 30 connected to the distal end of the first traction wire 60 to axially displace in the adjustable bend section 20, thereby changing the position of the first bend portion 26 of the adjustable bend section 20, and realizing the change of the bend shape of the distal head end of the angiography catheter; that is, a single catheter with multi-bend control meets the clinical use scenario, does not require multiple judgments on bend selection before surgery, saves preoperative evaluation and selection time, solves the problem of complicated surgical procedures and the lack of preoperative multi-bend selection, and has the advantages that the catheter can be moved up to a high position, reducing the difficulty of superselection operation and saving surgical time. The natural state is SIM type, without pre-shaping. Based on the design of the most commonly used bend shape of the radial artery, it can solve more than 95% of radial superselection and angiography problems. Initially based on the minimum SIM1 curve, the curve is adjusted according to the clinical situation for traction, enabling rapid curve adjustment. The curve shaping block is applied through traction, with an inelastic traction cord and a 1:1 force transmission ratio. This ensures zero loss, real-time feedback, and precise curve adjustment. During adjustment, transitional SIM curves beyond the conventional can be achieved. Conventional SIM catheters use a single curve, and while this can complete the procedure, it is not a perfect match due to the limited curve length of the single curve. This can only be achieved through the surgeon's skill and time. The single-tube, multi-bend, adjustable angiography catheter of this embodiment can have many intermediate transition bends such as SIM1.5 and SIM2.5 during the transition from SIM1 to SIM3. With finer sizes and lengths, it can better adapt to each person's special blood vessels under vascular conditions that are more suitable for different physical conditions, avoid forced matching by doctors to complete operations, reduce the learning curve of doctors, and perform rapid surgery. It can better respond to emergencies and other sudden situations, shorten treatment time, and effectively benefit the golden time for treatment; it broadens new methods of radial artery interventional treatment; the learning curve operation difficulty is reduced, enabling more small and medium-sized hospitals to have the ability to perform interventional surgery and save more people.

[0123] Example 2:

[0124] This embodiment provides a method for manufacturing a single-tube, multi-bend, adjustable angiography catheter, which is mainly used to manufacture the single-tube, multi-bend, adjustable angiography catheter as described in Example 1, and includes the following steps:

[0125] Step S201: providing an inner lining tube, wherein the inner lining tube is made of polytetrafluoroethylene; the inner lining tube has a first segment and a second segment in sequence from the proximal end to the distal end.

[0126] Step S202 : providing a plurality of braided wires, and braiding the braided wires on the surface of the first segment of the liner tube to form a first braided layer 22 .

[0127] Step S203: providing a rheological material, the rheological material including polyetheramide resin and barium sulfate, and flowing the rheological material onto the surface of the first braided layer 22 to form a first rheological layer.

[0128] Step S204: Providing a first cladding tube, a second cladding tube, and a third cladding tube, each of which is sequentially secured to the surface of the first rheological layer. The distal ends of the first, second, and third cladding tubes extend to the second segmented surface of the liner tube. Each of the first, second, and third cladding tubes has a connecting groove on the side facing the second segmented surface. The first, second, and third cladding tubes each have a first channel 25, a second channel, and a third channel within them for the traction wire to pass through.

[0129] Step S205: provide a plurality of braided wires, and weave the braided wires on the surface of the auxiliary tube to form a second braided tube; sleeve the second braided tube on the first cladding tube, the second cladding tube, the third cladding tube, the surface of the first rheological layer and the second segment surface of the lining tube; provide a rheological material, the rheological material includes polyetheramide resin and barium sulfate, and segmentally rheologically ...

[0130] Step S206 : providing a plurality of stainless steel wires, twisting the plurality of stainless steel wires into a traction wire, and cutting the traction wire into a first traction wire 60 , a second traction wire, and a third traction wire.

[0131] Step S207: Provide a plurality of stainless steel tubes or nickel-titanium tubes, laser engrave the stainless steel tubes or nickel-titanium tubes, and cut out a first sleeve, a second sleeve, and a third sleeve after engraving. Bend the first sleeve, the second sleeve, and the third sleeve into a first bend shape, a second bend shape, and a third bend shape, respectively, and heat-treat them to have shape-retaining capabilities, thereby forming a first shaping block 30, a second shaping block 40, and a third shaping block 50.

[0132] Step S208: Provide a first plug-in, a second plug-in and a third plug-in; fix one end of the first plug-in to the first shaping block 30, and the other end to the end of the first traction wire 60; fix one end of the second plug-in to the second shaping block 40, and the other end to the end of the second traction wire; fix one end of the third plug-in to the third shaping block 50, and the other end to the end of the third traction wire.

[0133] Step S209: Insert the free ends of the first traction wire 60, the second traction wire and the third traction wire from the distal end into the first wrapping tube, the second wrapping tube and the third wrapping tube respectively, until they pass out from the proximal outlets of the first wrapping tube, the second wrapping tube and the third wrapping tube, continue to pull the first traction wire 60, the second traction wire and the third traction wire, so that the first plug-in, the second plug-in and the third plug-in are respectively inserted into the connecting grooves of the first wrapping tube, the second wrapping tube and the third wrapping, and the third shaping block 50, the second shaping block 40 and the first shaping block 30 are sequentially inserted into the interior of the regulating chamber 23 from the open mouth at the distal end of the regulating chamber 23.

[0134] Step S209: providing a rheological material, the rheological material including polyetheramide resin and barium sulfate, flowing the rheological material to the surface of the second rheological layer, and sealing the adjustment chamber 23 to form an outer tube layer 24; coating the surface of the outer tube layer 24 with a hydrophilic coating to obtain a main tube.

[0135] Step S210: Provide a catheter seat 70 and a stress release tube, and install the catheter seat 70 and the stress release tube to the proximal end of the main catheter body; the catheter seat 70 is provided with a bending adjustment rotary valve 71, and the first traction wire 60, the second traction wire and the third traction wire are respectively connected to the bending adjustment rotary valve 71, and the bending adjustment rotary valve 71 is rotated to push and pull the first traction wire 60, the second traction wire and the third traction wire, thereby controlling the first shaping block 30, the second shaping block 40 and the third shaping block 50 to move in the adjustment chamber 23, and adjusting the initial state of the distal end of the main catheter to a SIM1 bend.

[0136] The above embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of protection of the present invention. Any non-substantial changes and replacements made by technicians in this field on the basis of the present invention fall within the scope of protection required by the present invention.

Claims

1. A single-tube, multi-bend, adjustable angiographic catheter, characterized in that: Including main pipe and traction assembly; The main catheter is a slender tubular structure having a tube wall and an inner tube cavity; the main catheter is sequentially formed with a support section and an adjustable bend section from the proximal end to the distal end; A first channel is formed in the support section for the traction assembly to pass through; A first shaping block is provided in the adjustable bending section; the first shaping block is inserted into the adjustable bending section, and a first bending portion is formed at a contact position between the first shaping block and the adjustable bending section; the first shaping block is in a sleeve shape, has a first bending profile, and has shape-retaining capability, thereby causing the first bending portion to bend in the first bending profile; the first shaping block is slidably connected to the adjustable bending section, thereby allowing the first shaping block to be displaced axially relative to the adjustable bending section; The traction assembly includes a first traction wire, the first traction wire is inserted into the first channel, and the two ends of the first traction wire respectively form a traction end and a connection end, the traction end of the first traction wire extends from the proximal opening of the first channel, and the connection end of the first traction wire extends from the distal opening of the first channel, and the connection end of the first traction wire is connected to the first shaping block; By pushing and pulling the first traction wire, the first shaping block is driven to move axially in the adjustable bending section, thereby changing the position of the first bending portion of the adjustable bending section; Also includes a second shaping block and a third shaping block; The second shaping block is disposed within the adjustable bending section, and the first shaping block forms a second bending portion at a contact position with the adjustable bending section; the second shaping block is sleeve-shaped, has a second bending profile, and has shape-retaining capability, thereby causing the second bending portion to bend in the second bending profile; the second shaping block is slidably connected to the adjustable bending section, thereby allowing the second shaping block to be displaced axially relative to the adjustable bending section; The third shaping block is passed through the adjustable bending section, and the contact position between the third shaping block and the adjustable bending section forms a third bending portion; the third shaping block is in the shape of a sleeve, and the third shaping block has a third bending shape. The third shaping block has shape-retaining ability, so that the third bending portion bends in the third bending shape; the third shaping block is slidably connected to the adjustable bending section, so that the third shaping block can be displaced axially relative to the adjustable bending section.

2. The single-tube multi-bend adjustable angiography catheter according to claim 1, characterized in that: The wall of the bending section tube is sequentially provided with an inner lining layer, a braided layer and an outer tube layer from the inside to the outside; an adjustment chamber is formed between the inner lining layer and the braided layer; the adjustment chamber is connected to the first channel; the first shaping block is slidably connected in the adjustment chamber.

3. The single-tube multi-bend adjustable angiography catheter according to claim 2, characterized in that: The first shaping block, the second shaping block and the third shaping block are sequentially arranged in the adjustment chamber from the proximal end to the distal end.

4. The single-tube multi-bend adjustable angiography catheter according to claim 3, characterized in that: A first connecting wire is provided between the first shaping block and the second shaping block, and two ends of the first connecting wire are respectively fixedly connected to the first shaping block and the second shaping block; A second connecting wire is provided between the second shaping block and the third shaping block, and two ends of the second connecting wire are respectively fixedly connected to the second shaping block and the third shaping block; By pushing and pulling the first traction wire, the first shaping block, the second shaping block and the third shaping block are simultaneously driven to move axially in the adjustment chamber, thereby changing the positions of the first bending portion, the second bending portion and the third bending portion of the adjustable bending section.

5. The single-tube multi-bend adjustable angiography catheter according to claim 4, characterized in that: Positions A11, A12 and A13 are sequentially arranged in the adjustment chamber from the distal end to the proximal end, and the first shaping block can move among positions A11, A12 and A13; when the first shaping block is at the A11 position, the adjustable bend section of the main duct is a SIM1 bend.

6. The single-tube multi-bend adjustable angiography catheter according to claim 3, characterized in that: A second channel and a third channel are formed in the support section; The traction assembly includes a second traction wire and a third traction wire; The second traction wire is passed through the second channel, and the two ends of the second traction wire form a traction end and a connection end respectively. The traction end of the second traction wire extends from the proximal opening of the second channel, and the connection end of the second traction wire extends from the distal opening of the second channel. The connection end of the second traction wire is connected to the second shaping block; by pushing and pulling the second traction wire, the second shaping block is driven to axially displace in the adjustment chamber, thereby changing the position of the second bending portion of the adjustable bending section; The third traction wire is passed through the third channel, and the two ends of the third traction wire form a traction end and a connecting end respectively. The traction end of the third traction wire extends from the proximal opening of the third channel, and the connecting end of the third traction wire extends from the distal opening of the third channel. The connecting end of the third traction wire is connected to the third shaping block; by pushing and pulling the third traction wire, the third shaping block is driven to move axially in the adjustment chamber, thereby changing the position of the third bending portion of the adjustable bending section.

7. The single-tube multi-bend adjustable angiography catheter according to claim 6, characterized in that: The adjustment chamber is provided with positions A21, A22, and A23 in sequence from the distal end to the proximal end; positions B1, B2, and B3; and positions C1, C2, and C3. The first shaping block can be moved between position A21, position A22, and position A23; The second shaping block can move between position B1, position B2, and position B3; The third shaping block can move between position C1, position C2, and position C3; When the first shaping block is at the A21 position, the second shaping block is at the B1 position, and the third shaping block is at the C1 position, the adjustable bend section of the main conduit is in a SIM1 bend shape; When the first shaping block is at the A22 position, the second shaping block is at the B2 position, and the third shaping block is at the C2 position, the adjustable bend section of the main conduit is in a SIM2 bend shape; When the first shaping block is at the A23 position, the second shaping block is at the B3 position, and the third shaping block is at the C3 position, the adjustable bend section of the main duct is a SIM3 bend.

8. The single-tube multi-bend adjustable angiography catheter according to claim 7, characterized in that: The catheter seat is further included, and the catheter seat is connected to the proximal end of the main catheter through a stress relief tube; the catheter seat is provided with a bend adjustment rotary valve, and the bend adjustment rotary valve is connected to the traction assembly, and the bend adjustment rotary valve pushes and pulls the first traction wire, the second traction wire, and the third traction wire by rotating, thereby controlling the first shaping block, the second shaping block, and the third shaping block to move in the adjustment chamber for bending; The bending rotary valve has a first gear position, a second gear position and a third gear position; When the bend regulating knob is rotated to the first gear, the first shaping block is at the A21 position, the second shaping block is at the B1 position, and the third shaping block is at the C1 position, so that the adjustable bend section of the main conduit is in a SIM1 bend shape; When the bend regulating knob is rotated to the second gear, the first shaping block is at the A22 position, the second shaping block is at the B2 position, and the third shaping block is at the C2 position, so that the adjustable bend section of the main conduit is in a SIM2 bend shape; When the bending adjustment knob is rotated to the third gear, the first shaping block is at the A23 position, the second shaping block is at the B3 position, and the third shaping block is at the C3 position, the adjustable bending section of the main conduit is a SIM3 bending type.

9. The single-tube multi-bend adjustable angiography catheter according to claim 6, characterized in that: The support section pipe wall is sequentially provided with an inner lining layer, a braided layer and an outer pipe layer from the inside to the outside; The inner lining layer of the adjustable bending section and the inner lining layer of the supporting section are both made of polytetrafluoroethylene; The adjustable bending section braided layer and the supporting section braided layer are both woven from multiple strands of stainless steel wire; The outer tube layer of the adjustable bending section and the outer tube layer of the supporting section are made of polyetheramide resin and barium sulfate; The first traction wire, the second traction wire and the third traction wire are twisted and braided from multiple strands of stainless steel wire; The first shaping block, the second shaping block and the third shaping block are formed by laser engraving and bending stainless steel tubes or nickel-titanium tubes.

10. A method for manufacturing a single-tube, multi-bend, adjustable angiography catheter, characterized in that: The following steps are involved: A liner tube is provided, wherein the liner tube is made of polytetrafluoroethylene; the liner tube has a first segment and a second segment in sequence from the proximal end to the distal end; Providing a plurality of braided wires, and braiding the braided wires on the surface of the first segment of the liner tube to form a first braided layer; Providing a rheological material, the rheological material comprising polyetheramide resin and barium sulfate, and flowing the rheological material onto the surface of the first braided layer to form a first rheological layer; Providing a first cladding tube, a second cladding tube, and a third cladding tube, and fixing the first cladding tube, the second cladding tube, and the third cladding tube in sequence on the surface of the first rheological layer; A plurality of braided wires are provided and braided on the surface of the auxiliary tube to form a second braided tube; the second braided tube is sleeved over the first cladding tube, the second cladding tube, the third cladding tube, the surface of the first rheological layer, and the second segmented surface of the liner tube; a rheological material is provided, the rheological material comprising polyetheramide resin and barium sulfate, and the rheological material is segmented and rheologically applied to the surface of the second braided tube to form a second rheological layer; an adjustment chamber is formed between the second braided tube and the liner tube, and the distal end of the adjustment chamber has an open port; Providing a plurality of stainless steel wires, twisting the plurality of stainless steel wires into a traction wire, and cutting the traction wire into a first traction wire, a second traction wire, and a third traction wire; Providing a plurality of stainless steel tubes or nickel-titanium tubes, laser engraving the stainless steel tubes or nickel-titanium tubes, and cutting out a first sleeve tube, a second sleeve tube, and a third sleeve tube after engraving. The first sleeve tube, the second sleeve tube, and the third sleeve tube are bent into a first bend, a second bend, and a third bend, respectively, and heat treated to have shape retention, thereby forming a first shaping block, a second shaping block, and a third shaping block. The first shaping block, the second shaping block, and the third shaping block are connected to the ends of the first traction wire, the second traction wire, and the third traction wire, respectively. Insert the free ends of the first traction wire, the second traction wire, and the third traction wire into the first covering tube, the second covering tube, and the third covering tube from the distal end, respectively, until they pass out from the proximal outlets of the first covering tube, the second covering tube, and the third covering tube, continue to pull the first traction wire, the second traction wire, and the third traction wire, and insert the third shaping block, the second shaping block, and the first shaping block into the interior of the regulating chamber from the open port at the distal end of the regulating chamber in sequence; Providing a rheological material comprising polyetheramide resin and barium sulfate, allowing the rheological material to flow onto the surface of the second rheological layer, and sealing the adjustment chamber to form an outer tube layer; coating the surface of the outer tube layer with a hydrophilic coating to obtain a main tube; A catheter seat and a stress release tube are provided, and the catheter seat and the stress release tube are installed to the proximal end of the main catheter body; a bending adjustment valve is provided on the catheter seat, and the first traction wire, the second traction wire and the third traction wire are respectively connected to the bending adjustment valve, and the bending adjustment valve is rotated to push and pull the first traction wire, the second traction wire and the third traction wire, thereby controlling the first shaping block, the second shaping block and the third shaping block to move in the adjustment chamber, and adjusting the initial state of the distal end of the main catheter to a SIM1 bend.

Images