An adjustable curved catheter and its manufacturing method

Abstract

An embodiment of the present application provides an adjustable bending catheter and a manufacturing method thereof, relating to the technical field of medical devices, including: a catheter body; the catheter body is formed with an inner cavity, and the inner cavity is arranged along the extending direction of the catheter body; the cross-sectional shape of the inner cavity is set as a regular polygon, and a wire drawing cavity is arranged along the side of the regular polygon, and the wire drawing cavity is arranged along the extending direction of the catheter body; wherein, the radius of the circumscribed circle of the regular polygon is greater than the minimum distance from the center of the inner cavity to the outer diameter of the wire drawing cavity and less than or equal to the maximum distance from the center of the inner cavity to the outer diameter of the wire drawing cavity.

Description

Technical Field

[0001] This application relates to the technical field of medical devices, and particularly to an adjustable bending catheter and a manufacturing method thereof. Background Art

[0002] An adjustable bending catheter is a medical device widely used in interventional therapy, mainly used to guide other medical devices (such as guide wires, catheters, electronic components, etc.) or fluids into the human body to reach the target site for diagnostic or therapeutic operations. During the operation, the operator adjusts the bending of the adjustable bending catheter according to needs to adapt to complex anatomical structures and surgical paths, thereby improving the safety and effectiveness of the operation.

[0003] In the related art, the adjustable bending catheter is formed with an inner cavity, and the medical device or fluid reaches the target site in the human body through the inner cavity. The cross-section of the inner cavity is usually set to be circular.

[0004] However, since the cross-section of the inner cavity is set to be circular when the outer diameter of the adjustable bending catheter is fixed, it is easy to cause limited inner cavity space, and it is often impossible to provide a larger effective inner cavity space under the same outer diameter condition, thus making it difficult to accommodate more medical devices or transmit more fluids. Summary of the Invention

[0005] The embodiments of this application provide an adjustable bending catheter and a manufacturing method thereof to solve the technical problem that in the related art, the inner cavity space is limited, and it is often impossible to provide a larger effective inner cavity space under the same outer diameter condition, thus making it difficult to accommodate more medical devices or transmit more fluids.

[0006] In a first aspect, the embodiments of this application provide an adjustable bending catheter, including: a catheter body;

[0007] The catheter body is formed with an inner cavity, and the inner cavity is arranged along the extending direction of the catheter body;

[0008] The cross-sectional shape of the inner cavity is set to be a regular polygon, and a wire-drawing cavity is arranged along the side of the regular polygon. The wire-drawing cavity is arranged along the extending direction of the catheter body; wherein, the radius of the circumscribed circle of the regular polygon is greater than the minimum distance from the center of the inner cavity to the outer diameter of the wire-drawing cavity, and less than or equal to the maximum distance from the center of the inner cavity to the outer diameter of the wire-drawing cavity.

[0009] In a feasible implementation manner, the regular polygon is set to be one of a regular quadrilateral, a regular pentagon or a regular hexagon.

[0010] In a feasible implementation manner, the center of the wire-drawing cavity is arranged along the perpendicular bisector of the side of the regular polygon.

[0011] In a feasible implementation manner, the catheter body includes an inner layer, a middle layer and an outer layer from inside to outside in sequence;

[0012] An inner cavity is formed in the middle of the inner layer, and a wire-drawing cavity is arranged around the inner layer;

[0013] The inner layer is made of one of polytetrafluoroethylene material or resin material, the middle layer is made of metal material, and the outer layer is made of resin material.

[0014] Second, the embodiment of the present application also provides a manufacturing method of an adjustable-bend catheter. The manufacturing method is used to manufacture an adjustable-bend catheter in any technical solution of the first aspect; the manufacturing method includes the following steps:

[0015] An inner layer is arranged around the outer wall of the mandrel mold to form an initial structure; wherein, the cross-section of the mandrel mold is set as a regular polygon;

[0016] Metal braided wires are woven on the outer wall of the initial structure to form an intermediate structure;

[0017] A resin tube is sleeved on the outer wall of the intermediate structure to form a processed structure;

[0018] The processed structure is heated and formed and then cooled, and the mandrel mold is taken out to form the catheter body of the adjustable-bend catheter.

[0019] In a feasible implementation manner, arranging an inner layer around the outer wall of the mandrel mold to form an initial structure specifically includes the following steps:

[0020] A tube sleeve made of polytetrafluoroethylene material is sleeved on the mandrel mold to form a first structure, and a support tube is sleeved on the outer wall of the first structure to form an initial structure;

[0021] Or, a polytetrafluoroethylene coating is coated on the outer wall of the mandrel mold to form a second structure, and a support tube is sleeved on the outer wall of the second structure to form an initial structure;

[0022] Wherein, a groove is arranged on the outer wall of the support tube, and the groove is arranged along the extending direction of the mandrel mold.

[0023] In a feasible implementation manner, arranging an inner layer around the outer wall of the mandrel mold to form an initial structure specifically includes the following steps:

[0024] A tube sleeve made of polytetrafluoroethylene material is sleeved on the mandrel mold to form an initial structure.

[0025] In a feasible implementation manner, after the step of arranging an inner layer around the outer wall of the mandrel mold to form an initial structure, the following is further included:

[0026] A wire-drawing tube is placed in the groove of the support tube; wherein, a wire-drawing cavity is formed in the wire-drawing tube, and the wire-drawing cavity is arranged along the extending direction of the mandrel mold.

[0027] In a feasible implementation manner, before the step of weaving metal braided wires on the outer wall of the initial structure to form an intermediate structure, the following is further included:

[0028] The wire drawing tubes are respectively arranged on different faces of a regular polygon; wherein, each wire drawing tube forms a wire drawing cavity, and the wire drawing cavity is arranged along the extending direction of the mandrel die.

[0029] In a feasible implementation manner, after the processing structure is heated and formed and then cooled, the mandrel die is taken out, and forming the adjustable bending catheter specifically includes:

[0030] After the processing structure is heated and formed and then cooled, the mandrel die is taken out, and after a wire is inserted and fixed, the catheter body of the adjustable bending catheter is formed.

[0031] In a first aspect, an embodiment of the present application discloses an adjustable bending catheter. In the embodiment of the present application, by setting the cross-sectional shape of the inner cavity as a regular polygon, and setting the radius of the circumscribed circle of the regular polygon to be greater than the minimum distance from the center of the inner cavity to the outer diameter of the wire drawing cavity and less than or equal to the maximum distance from the center of the inner cavity to the outer diameter of the wire drawing cavity. At the same time, the wire drawing cavity is arranged along the side of the regular polygon. Compared with setting the inner cavity as a circle, on the premise of ensuring the distance limit between the inner cavity and the edge of the wire drawing cavity, setting the inner cavity as a regular polygon, under the condition of the same outer diameter of the adjustable bending catheter, the inner cavity space is approximately increased by the area of the regular polygon minus its inscribed circle, so that the inner cavity space can be greatly improved to accommodate more medical devices or transport more fluids.

[0032] In a second aspect, an embodiment of the present application provides a manufacturing method of an adjustable bending catheter. In the embodiment of the present application, since the inner cavity is set as a regular polygon shape, further, the mandrel die is also set as a regular polygon shape. When setting the wire drawing cavity, because the side of the regular polygon shape is a straight line, unlike a circle, the wire drawing cavity is not prone to deviation and rolling during the fixing process, so the wire can be better fixed, and the situation that the wire inclines along the head and tail of the mandrel die is avoided, and further, large torsion occurs during the bending of the catheter, reducing the bending accuracy. Further, since the manufacturing method of the adjustable bending catheter is a method for manufacturing the adjustable bending catheter disclosed in all the technical solutions of the first aspect of the present application, the manufacturing method of the adjustable bending catheter has the technical effects of all the technical solutions of the first aspect of the present application, and will not be elaborated herein. BRIEF DESCRIPTION OF THE DRAWINGS

[0033] The drawings described herein are used to provide a further understanding of the present invention, and constitute a part of the present invention. The schematic embodiments of the present invention and their descriptions are used to explain the present application and do not constitute an improper limitation to the present invention. In the drawings:

[0034] Figure 1 is a schematic structural diagram of an adjustable bending catheter in the prior art;

[0035] Figure 2 is a schematic structure of an adjustable bending catheter provided by an embodiment of the present applicationFigure 1 ;

[0036] Figure 3 is a schematic diagram of the structure of an adjustable bending catheter provided by an embodiment of the present application Figure 2 ;

[0037] Figure 4 is a schematic diagram of the structure of an adjustable bending catheter provided by an embodiment of the present application Figure 3 ;

[0038] Figure 5 is a schematic diagram of the bending states of an adjustable bending catheter in different directions provided by an embodiment of the present application;

[0039] Figure 6 are the method steps of a manufacturing method of an adjustable bending catheter provided by an embodiment of the present application Figure 1 ;

[0040] Figure 7 is a schematic diagram of the structure of a support tube provided by an embodiment of the present application;

[0041] Figure 8 are the method steps of a manufacturing method of an adjustable bending catheter provided by an embodiment of the present application Figure 2 。

[0042] Explanation of reference numerals:

[0043] 100 - catheter main body; 200 - support tube;

[0044] 110 - inner layer; 111 - inner cavity; 112 - wire drawing cavity; 120 - middle layer; 130 - outer layer;

[0045] 210 - groove. Detailed implementation manners

[0046] In order to enable those skilled in the art to better understand the technical solutions in the present application, the technical solutions in the embodiments of the present application will be clearly and completely described below with reference to the accompanying drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. All other embodiments obtained by those of ordinary skill in the art based on the embodiments in the present application without making creative efforts shall fall within the protection scope of the present application.

[0047] Figure 1 is a schematic diagram of the structure of an adjustable bending catheter in the prior art.

[0048] Refer to Figure 1, The steerable catheter is formed with a lumen 111, and a plurality of wire cavities 112 are evenly arranged around the periphery of the lumen 111. One end of the wire is fixed to the head of the steerable catheter, passes through the wire cavity 112, and the other end extends from the tail of the steerable catheter. Then, by pulling the wire, the one-way or multi-directional bending function is achieved, and the medical device or fluid reaches the target site in the human body through the lumen 111.

[0049] The cross-section of the lumen 111 is usually set as a circle, the outer diameter of the steerable catheter is fixed, and there is a certain distance between the wire cavity 112 and the lumen 111, resulting in limited space in the lumen 111. Often, it is impossible to provide a larger effective lumen 111 space under the same outer diameter condition, making it difficult to accommodate more medical devices or transmit more fluid.

[0050] Therefore, the embodiments of the present application provide a steerable catheter and its manufacturing method to solve the technical problem in the related art that the space in the lumen 111 is limited, and it is often impossible to provide a larger effective lumen 111 space under the same outer diameter condition, thus making it difficult to accommodate more medical devices or transmit more fluid.

[0051] Figure 2 is a structural schematic diagram of a steerable catheter provided by an embodiment of the present application Figure 1 ; Figure 3 is a structural schematic diagram of a steerable catheter provided by an embodiment of the present application Figure 2 ; Figure 4 is a structural schematic diagram of a steerable catheter provided by an embodiment of the present application Figure 3 ; Figure 5 is a schematic diagram of the bending states of a steerable catheter in different directions provided by an embodiment of the present application.

[0052] In the first aspect, referring to Figures 2 to 5 , the embodiments of the present application provide a steerable catheter, including: a catheter body 100;

[0053] The catheter body 100 is formed with a lumen 111, and the lumen 111 is arranged along the extending direction of the catheter body 100;

[0054] The cross-sectional shape of the lumen 111 is set as a regular polygon, and wire cavities 112 are arranged along the sides of the regular polygon. The wire cavities 112 are arranged along the extending direction of the catheter body 100;

[0055] Wherein, the radius of the circumscribed circle of the regular polygon is greater than the minimum distance from the center of the lumen 111 to the outer diameter of the wire cavity 112, and less than or equal to the maximum distance from the center of the lumen 111 to the outer diameter of the wire cavity 112.

[0056] It should be noted that the medical device or fluid reaches the target part of the human body through the inner cavity 111. A wire is threaded through the wire cavity 112. One end of the wire is fixed at the head end of the adjustable bending catheter and passes through the wire cavity 112, and the other end extends from the tail of the adjustable bending catheter. Then, by pulling the wire, the one-way or multi-way bending function can be realized.

[0057] Exemplarily, the regular polygon can be set as one of a regular quadrilateral, a regular pentagon, a regular hexagon, a regular heptagon, etc.

[0058] Refer to Figure 1 , the minimum distance from the center of the inner cavity 111 to the outer diameter of the wire cavity 112 is the distance marked by A, and the maximum distance from the center of the inner cavity 111 to the outer diameter of the wire cavity 112 is the distance marked by B. In specific implementation, when the distance A and the distance B are fixed, that is, when the outer diameter of the adjustable bending catheter is fixed, if the cross-section of the inner cavity 111 is set as a circle, then the inner cavity 111 is set as Figures 2 to 4 the circle marked by M in Figure 2 the inner cavity 111 in Figure 3 is a regular quadrilateral, Figure 4 the inner cavity 111 in Figure 2 is a regular pentagon, Figure 3 the inner cavity 111 in Figure 4 is a regular hexagon, and the circumradius of the regular polygon is set to be greater than the minimum distance A from the center of the inner cavity 111 to the outer diameter of the wire cavity 112 and less than or equal to the maximum distance B from the center of the inner cavity 111 to the outer diameter of the wire cavity 112. In Figure 2 N shows the circumcircle of the regular quadrilateral, and the distance marked by C is the circumradius of the regular quadrilateral; in Figure 3 N shows the circumcircle of the regular pentagon, and the distance marked by C is the circumradius of the regular pentagon; in Figure 4 N shows the circumcircle of the regular hexagon, and the distance marked by C is the circumradius of the regular hexagon; obviously, the space of the inner cavity 111 of the regular polygon is larger than the space of the inner cavity 111 shown by M. That is to say, by setting the inner cavity 111 as a regular polygon and setting the circumradius of the inner cavity 111 between the distance A and the distance B, while the outer diameter of the adjustable bending catheter is fixed and the wire cavity 112 is avoided to ensure the space of the wire cavity 112, the space of the inner cavity 111 is also greatly increased.

[0059] In specific implementation, when the circumradius of the regular polygon is less than the minimum distance from the center of the inner cavity 111 to the wire cavity 112, on the one hand, the space of the inner cavity 111 will be restricted, and on the other hand, since the distance from the wire cavity 112 to the inner cavity 111 is increased, the strength of the inner cavity 111 and the wire cavity will also be affected. When the circumcircle of the regular polygon is larger than the maximum distance from the center of the inner cavity 111 to the outer diameter of the wire cavity 112, the outer diameter of the adjustable bending tube will be increased, and it is impossible to ensure that the outer diameter of the adjustable bending tube is fixed.

[0060] From the above description, it can be seen that the present solution achieves the following technical effects:

[0061] In a first aspect, an embodiment of the present application discloses an adjustable-bend catheter. In the embodiment of the present application, the cross-sectional shape of the inner cavity 111 is set as a regular polygon, and the radius of the circumscribed circle of the regular polygon is set to be greater than the minimum distance from the center of the inner cavity 111 to the outer diameter of the wire-drawing cavity 112 and less than or equal to the maximum distance from the center of the inner cavity 111 to the outer diameter of the wire-drawing cavity 112. At the same time, the wire-drawing cavity 112 is arranged along the sides of the regular polygon. Compared with setting the inner cavity 111 as a circle, on the premise of ensuring the distance limit between the edges of the inner cavity 111 and the wire-drawing cavity 112, when the inner cavity 111 is set as a regular polygon, under the condition of the same outer diameter of the adjustable-bend catheter, the space of the inner cavity 111 is approximately increased by the area of the regular polygon minus the inscribed circle, which not only ensures the space of the wire-drawing cavity 112 but also can greatly improve the space of the inner cavity 111 to accommodate more medical devices or transmit more fluids.

[0062] In some examples, the regular polygon is set as one of a quadrilateral, a pentagon, or a hexagon.

[0063] It should be noted that in the related art, an adjustable-bend catheter includes an inner layer 110, an intermediate layer 120, and an outer layer 130. Among them, an inner cavity 111 is formed in the middle of the inner layer 110, and the wire-drawing cavity 112 is arranged around the inner layer 110.

[0064] When the outer diameter of the adjustable-bend catheter is 3.0 mm, the thickness of the outer layer 130 is 0.1 mm, the thickness of the intermediate layer 120 is 0.05 mm, the diameter of the wire-drawing cavity 112 is 0.3 mm, and the distance between the wire-drawing cavity 112 and the inner cavity 111 is 0.05 mm.

[0065] For example, if the inner cavity 111 is set as a circle, and the radius of the circular inner cavity 111 is set to 1 mm, then the area of the circular inner cavity 111 is:

[0066] ;

[0067] Referring to Figure 2 , if the inner cavity 111 is set as a square, and the side length of the square inner cavity 111 is set to 2 mm, then the area of the square inner cavity 111 is:

[0068] ;

[0069] Then, compared with setting the inner cavity 111 as a circle, the space improvement rate of setting the inner cavity 111 as a square in the embodiment of the present application is:

[0070] ;

[0071] Referring to Figure 3, for another example, if the inner cavity 111 is set as a regular pentagon, the distance from the center of the regular pentagon to the side length is 1 mm, the side length is about 1.45 mm, then the area of the regular pentagon inner cavity 111 is about 3.63 mm 2 .

[0072] Then, compared with setting the inner cavity 111 as a circle, the space improvement rate of setting the inner cavity 111 as a regular pentagon in the embodiment of the present application is:

[0073] ;

[0074] Referring to Figure 4 , for another example, if the inner cavity 111 is set as a regular hexagon, the distance from the center of the regular hexagon to the side length is 1 mm, the side length is about 1.15 mm, then the area of the regular hexagon inner cavity 111 is about 3.46 mm 2 .

[0075] Then, compared with setting the inner cavity 111 as a circle, the space improvement rate of setting the inner cavity 111 as a regular pentagon in the embodiment of the present application is:

[0076] ;

[0077] That is to say, through the setting of the embodiment of the present application, under the condition of the same outer diameter, compared with setting the inner cavity 111 as a circle, setting the inner cavity 111 as one of a regular quadrilateral, a regular pentagon or a regular hexagon in the embodiment of the present application can greatly improve the space of the inner cavity 111.

[0078] In some examples, the center of the wire pulling cavity 112 is arranged along the perpendicular bisector of the side of the regular polygon.

[0079] For example, when the inner cavity 111 is set as a regular quadrilateral, four wire pulling cavities 112 are set, and the four wire pulling cavities 112 correspond to four wires. After experimental verification, when any one of the wires is pulled, the azimuth angle error between the bending direction of the adjustable bending catheter and the wire is less than or equal to 2°.

[0080] For another example, when the inner cavity 111 is set as a regular pentagon, five wire pulling cavities 112 are set, and the five wire pulling cavities 112 correspond to five wires. After experimental verification, when any one of the wires is pulled, the azimuth angle error between the bending direction of the adjustable bending catheter and the wire is less than or equal to 3°.

[0081] For another example, when the inner cavity 111 is set as a regular hexagon, six wire pulling cavities 112 are set, and the six wire pulling cavities 112 correspond to six wires. After experimental verification, when any one of the wires is pulled, the azimuth angle error between the bending direction of the adjustable bending catheter and the wire is less than or equal to 3°.

[0082] In the embodiment of the present application, the center of the wire-drawing cavity 112 is arranged along the perpendicular bisector of the side of the regular polygon, that is, there is a wire corresponding to the perpendicular bisector of each side of the regular polygon, so as to accurately control the bending direction and angle of the distal end of the adjustable bending catheter, so that the adjustable bending catheter can realize the composite bending functions of one-way, two-way and multi-directional, meeting the requirements of complex paths.

[0083] In some other examples, the catheter body 100 sequentially includes an inner layer 110, an intermediate layer 120 and an outer layer 130 from inside to outside;

[0084] An inner cavity 111 is formed in the middle of the inner layer 110, and the wire-drawing cavity 112 is arranged around the inner layer 110;

[0085] The inner layer 110 is set to be one of polytetrafluoroethylene material or resin material, the intermediate layer 120 is set to be a metal material, and the outer layer 130 is set to be a resin material.

[0086] In some examples, the outer diameter of the catheter body 100 can be set to 1.0 mm to 10.0 mm. That is to say, the outer diameter of the outer layer 130 can be set to 1.0 mm to 10.0 mm.

[0087] Exemplarily, the intermediate layer 120 is woven from a metal material, and the metal material can be made of stainless steel or nitinol alloy and other materials.

[0088] Exemplarily, the resin material in the outer layer 130 can be thermoplastic polyurethane elastomer, nylon elastomer or polyamide, etc., and resin materials with different hardnesses can be selected according to the functional requirements of different segments of the adjustable bending catheter.

[0089] In the embodiment of the present application, by setting the inner layer 110 of the adjustable bending catheter to be one of polytetrafluoroethylene material or resin material, the biocompatibility and low friction of the adjustable bending catheter are improved to ensure the stability of long-term use and smooth fluid transmission. Further, the wire-drawing cavity 112 is made of polytetrafluoroethylene material, which has the advantages of low friction and small wire-drawing bending force when threading the wire. In the embodiment of the present application, by setting the intermediate layer 120 of the adjustable bending tube to be a metal braided layer, the tensile strength, compressive performance and bending resistance of the adjustable bending catheter are enhanced. In the embodiment of the present application, by setting the outer side of the adjustable bending catheter to be a resin material, and in specific implementation, resin materials with different hardnesses are selected according to the functional requirements of different segments of the adjustable bending catheter, thereby ensuring that the adjustable bending catheter has the required flexibility and support in different operating parts.

[0090] In a second aspect, the embodiment of the present application further provides a manufacturing method of an adjustable bending catheter, and the manufacturing method is used to manufacture an adjustable bending catheter in any technical solution of the first aspect.

[0091] Figure 6Method steps of a manufacturing method of an adjustable bending catheter provided by an embodiment of the present application Figure 1 。

[0092] Embodiment 1: Refer to Figure 6 , the manufacturing method includes the following steps:

[0093] S1-1: Set the inner layer 110 around the outer wall of the mandrel mold to form an initial structure.

[0094] It should be noted that the cross-section of the mandrel mold is set as a regular polygon.

[0095] Among them, S1-1 specifically includes:

[0096] Sheath a tube sleeve made of polytetrafluoroethylene material on the mandrel mold to form a first structure, and sleeve a support tube 200 on the outer wall of the first structure to form an initial structure.

[0097] Alternatively, coat a polytetrafluoroethylene coating on the outer wall of the mandrel mold to form a second structure, and sleeve a support tube 200 on the outer wall of the second structure to form an initial structure. It should be noted that in this example, the setting of the polytetrafluoroethylene coating facilitates the removal of the mandrel mold after cooling.

[0098] Figure 7 It is a schematic structural diagram of the support tube 200 provided by an embodiment of the present application.

[0099] It should be noted that refer to Figure 6 , a plurality of grooves 210 are uniformly arranged on the outer wall of the support tube 200, and the plurality of grooves 210 are arranged along the extending direction of the support tube 200.

[0100] It should be further noted that the support tube 200 is made of the same resin material as the outer layer 130, and an inner cavity 111 is formed after the support tube 200 is heat-formed, and the support tube 200 is not taken out.

[0101] S1-2: Place a wire-drawing tube in the groove of the support tube 200.

[0102] Among them, a wire-drawing cavity is formed in the wire-drawing tube, and the wire-drawing cavity is arranged along the extending direction of the mandrel mold.

[0103] S1-3: Weave metal braided wires on the outer wall of the initial structure to form an intermediate structure.

[0104] That is, after placing the wire-drawing tube in the groove, weave metal braided wires to form an intermediate structure.

[0105] For example, the metal braided wire can be made of stainless steel or nitinol.

[0106] S1-4: Sleeve a resin tube on the outer wall of the intermediate structure to form a processed structure.

[0107] S1-5: Heat and form the processed structure, and after cooling, remove the mandrel mold. Thread a wire through the wire drawing cavity and fix the wire to form the catheter body 100 of the bendable catheter.

[0108] Figure 8 These are the method steps of a method for manufacturing a bendable catheter provided by an embodiment of the present application. Figure 2 .

[0109] Embodiment 2: Refer to Figure 8 , the manufacturing method includes the following steps:

[0110] S2-1: Arrange an inner layer 110 around the outer wall of the mandrel mold to form an initial structure.

[0111] It should be noted that the cross-section of the mandrel mold is set as a regular polygon.

[0112] Among them, S2-1 specifically includes:

[0113] For example, a tube sleeve made of polytetrafluoroethylene material is sleeved on the mandrel mold to form an initial structure;

[0114] S2-2: Place the wire drawing tubes on different faces of the regular polygon respectively.

[0115] It should be noted that the wire drawing tubes form wire drawing cavities, and the wire drawing cavities are arranged along the extending direction of the mandrel mold.

[0116] S2-3: Weave metal braided wires on the outer wall of the initial structure to form an intermediate structure.

[0117] That is, weave metal braided wires to form an intermediate structure after placing the wire drawing tubes.

[0118] In specific implementation, during the braiding process of the metal braid, under the binding force of the braided wires, the wire can be constrained to the position of the perpendicular bisector of the side of the regular polygon.

[0119] S2-4: Sleeve a resin tube on the outer wall of the intermediate structure to form a processed structure.

[0120] S2-5: Heat and form the processed structure, and after cooling, remove the mandrel mold. Thread a wire through the wire drawing cavity and fix the wire to form the catheter body 100 of the bendable catheter.

[0121] Second aspect, an embodiment of the present application provides a manufacturing method of an adjustable bending catheter. In the embodiment of the present application, since the inner cavity 111 is set to a regular polygon shape, and further, the mandrel die is also set to a regular polygon shape. When setting the wire drawing cavity 112, because the sides of the regular polygon shape are straight lines and are not prone to offset and roll during the fixation process of the wire drawing cavity 112 like a circle, therefore, the wire can be better fixed, avoiding the wire from tilting along the head and tail of the mandrel die, and further preventing large torsion from occurring during the bending of the catheter and reducing the bending accuracy. Further, since the manufacturing method of the adjustable bending catheter is a method for manufacturing the adjustable bending catheter disclosed in all the technical solutions of the first aspect of the present application, therefore, the manufacturing method of the adjustable bending catheter has the technical effects of all the technical solutions of the first aspect of the present application, which will not be elaborated herein.

[0122] It is easily understandable that those skilled in the art can combine, split, and reorganize the embodiments of the present application based on several embodiments provided by the present application to obtain other embodiments, and these embodiments do not exceed the protection scope of the present application.

[0123] The above specific implementation manners further elaborate the purpose, technical solutions, and beneficial effects of the embodiments of the present application. It should be understood that the above are only the specific implementation manners of the embodiments of the present application and are not used to limit the protection scope of the embodiments of the present application. Any modifications, equivalent replacements, improvements, etc. made on the basis of the technical solutions of the embodiments of the present application shall be included in the protection scope of the embodiments of the present application.

Claims

1. An adjustable bending catheter, characterized in that, Comprising: A catheter body; The catheter body sequentially includes an inner layer, an intermediate layer, and an outer layer from inside to outside; The inner layer is formed with an inner cavity, and the inner cavity is arranged along the extending direction of the catheter body; The cross-sectional shape of the inner cavity is set as a regular polygon, and the regular polygon is one of a regular quadrilateral, a regular pentagon, or a regular hexagon. A wire-drawing cavity is arranged along the side of the regular polygon. The center of the wire-drawing cavity is arranged along the perpendicular bisector of the side of the regular polygon, and the wire-drawing cavity surrounds the inner cavity. The wire-drawing cavity is arranged along the extending direction of the catheter body; wherein, the distance between the inner cavity and the wire-drawing cavity is defined, and the radius of the circumscribed circle of the regular polygon is greater than the minimum distance from the center of the inner cavity to the outer diameter of the wire-drawing cavity and less than or equal to the maximum distance from the center of the inner cavity to the outer diameter of the wire-drawing cavity.

2. An adjustable-bend catheter according to claim 1, wherein The inner layer is set as one of polytetrafluoroethylene material or resin material, the intermediate layer is set as a metal material, and the outer layer is set as a resin material.

3. A manufacturing method of an adjustable bending catheter, characterized in that, The manufacturing method is used to manufacture an adjustable-bend catheter according to claim 1 or 2; the manufacturing method includes the following steps: A tube sleeve made of polytetrafluoroethylene material is sleeved on a mandrel mold to form a first structure, and a support tube is sleeved on the outer sidewall of the first structure to form an initial structure; or, a polytetrafluoroethylene coating is coated on the outer sidewall of the mandrel mold to form a second structure, and the support tube is sleeved on the outer sidewall of the second structure to form the initial structure; wherein, the cross-section of the mandrel mold is set as one of a regular quadrilateral, a regular pentagon, or a regular hexagon; a groove is arranged on the outer sidewall of the support tube, and the groove is arranged along the extending direction of the mandrel mold; A wire-drawing tube is placed in the groove of the support tube; wherein, a wire-drawing cavity is formed in the wire-drawing tube, and the wire-drawing cavity is arranged along the extending direction of the mandrel mold; A metal braided wire is woven on the outer sidewall of the initial structure to form an intermediate structure; A resin tube is sleeved on the outer sidewall of the intermediate structure to form a processing structure; The processing structure is heated and formed and then cooled, and the mandrel mold is taken out to form the catheter body of the adjustable-bend catheter.

4. The manufacturing method of an adjustable bending catheter according to claim 3, characterized in that The specific process of heating and forming the processing structure and then cooling and taking out the mandrel mold to form the catheter body of the adjustable-bend catheter includes: The processing structure is heated and formed and then cooled, and the mandrel mold is taken out. After a wire is inserted and fixed along the wire-drawing cavity, the catheter body of the adjustable-bend catheter is formed.

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