A center spiral setting tool and setting method

Abstract

The application discloses a center spiral shaped wire shaping tool, and relates to the field of medical devices, comprising a main body structure, a connecting structure, a fixing screw, a limiting positioning pin shaft and a shaped wire, wherein the main body structure and the connecting structure are connected through the fixing screw and the limiting positioning pin shaft; the fixing screw is fixedly connected through a bolt and is used in combination with the limiting positioning pin shaft for shaping and fixing of the shaped wire; the main body structure and the connecting structure are both provided with limiting grooves for assisting in fixing of the shaped wire. The application also discloses a shaping method using the tool, which can quickly produce the shaped wire with a controllable variable-pitch spiral shape in the existing conventional horizontal and vertical directions. The application optimizes shaping of the shaped wire, realizes unified, reproducible and standardized bending shaping of the metal wire, obviously reduces the requirement for shaping operation, and is high in shaping product speed and efficiency, controllable in variable pitch, and capable of realizing batch production and processing.

Description

Technical Field

[0001] This invention relates to the field of medical devices, and in particular to a shaping tool and method for a central spiral shaping yarn. Background Technology

[0002] Electrophysiological catheters play a vital role in the field of cardiac electrophysiology, primarily used to treat cardiac diseases such as arrhythmias. Based on their different functions, catheters are divided into two main categories: 1. Mapping catheters used to measure electrophysiological signals; 2. Ablation catheters used to ablate and block the conduction of electrical signals.

[0003] Whether using mapping or ablation catheters, the distal end of the catheter achieves measurement and ablation functions through a metal electrode. The shape of the distal end of the catheter significantly affects the contact between the metal electrode and the target tissue, thus influencing the diagnostic and treatment outcomes. The catheter, along with a handle, works together to adjust the contact between the two.

[0004] The existing distal shaping wires of electrophysiological catheters are mainly of an approximately circular shape. The distal support shape is on the edge of the circle and has a uniform shape. Because the catheter tip needs to be subjected to a certain amount of pressure, and uneven pressure can easily lead to gaps in the catheter fit, the distal shape of the catheter cannot adapt well to different lesion sites. This not only affects the efficiency of the operation, but also causes pain for the patient and increases the risk.

[0005] A central spiral catheter can better address the uneven stress caused by compression. Furthermore, the distal end of the catheter spirals upwards, allowing it to better adapt to different lesion sites and increasing surgical success rates. However, manufacturing a central spiral catheter presents significant challenges. The shaping tooling results in the force-bearing support rod of the shaping wire being located on one side of the coil, hindering rapid mass production.

[0006] Therefore, those skilled in the art are dedicated to developing a shaping tool and method for a central spiral shaping wire. By optimizing a specially designed shaping tool, a central spiral shaping wire catheter can be manufactured and shaped. Since the supporting part of the shaping wire is located at the center of the loop, it can better solve the problem of uneven force caused by compression. At the same time, the distal end of the catheter is in a spiral upward state, which can better adapt to different lesion sites and increase the success rate of surgery. Summary of the Invention

[0007] In view of the above-mentioned defects of the prior art, the technical problem to be solved by the present invention is that the shape of the shaping filament is a straight plane, and the uneven force distribution causes gaps in the fitting of the guide tube and uneven force support of the shaping filament caused by the tooling structure. The present invention aims to optimize the shaping of the shaping filament, conveniently and securely control the shape of the shaping filament, and efficiently and quickly prepare the central spiral shaping filament.

[0008] To achieve the above objectives, the present invention provides a shaping fixture for a central spiral shaping wire, comprising a main structure, a connecting structure, a fixing screw, and a limiting positioning pin. The main structure and the connecting structure are connected by the fixing screw and the limiting positioning pin. The fixing screw is fixedly connected by bolts and, together with the limiting positioning pin, is used for the precise shaping and fixing of the shaping wire. Both the main structure and the connecting structure have limiting grooves to assist in guiding and fixing the shaping wire.

[0009] Furthermore, the main structure includes a cylindrical end, a planar end, and a transition section. The transition section of the main structure is a sloped sectional surface transitioning from the cylindrical end to the planar end. The limiting groove of the main structure is located at the center of the planar end and on the sloped sectional surface of the transition section. Before spiraling upwards around the cylindrical end from the center of the planar end, the shaping wire passes through the transition section of the main structure to form a connecting arc, thereby forming the main structural shape of the shaping wire. The connecting arc is the transition arc of the shaping wire. The shaping wire passes through the limiting groove at the center of the planar end of the main structure. The center of the planar end of the main structure is also the central axis of the cylindrical end of the main structure. The shaping wire spirals upwards around the cylindrical end of the main structure for 3 to 5 turns.

[0010] Furthermore, the connecting structure cooperates with the main structure to press and limit the central straight section of the shaping wire. The limiting groove of the connecting structure is used to fix and limit the transition arc of the shaping wire. The main structure, connecting structure, fixing screw, and limiting positioning pin cooperate with each other to tightly fix the main structure and the connecting structure, thereby completing the overall fixing of the shaping tooling.

[0011] Furthermore, the shaping wire includes a central straight section, a transition arc section, a spiral rising coil section, and a vertical guide wire section. The planar end of the main body structure and the connecting structure are used together to form the central straight section of the shaping wire and fix the shaping wire. The transition section of the main body structure and the connecting structure are used together to form the transition arc section of the shaping wire. The cylindrical end of the main body structure is used to form the spiral rising coil section and the vertical guide wire section of the shaping wire. The connecting structure can be installed and disassembled independently.

[0012] Furthermore, the diameter of the cylindrical end of the main structure is 10-35mm, and the length of the slope tangent of the transition section of the main structure projected onto the central axis of the cylindrical end is 4-6mm.

[0013] Furthermore, all components of the tooling are made of the same material, namely high-temperature resistant stainless steel or mold steel, and the material of the shaping wire is one of nickel-titanium-based shape memory alloy Ni-Ti SMA, copper-based shape memory alloy CuSMA, or iron-based shape memory alloy Fe SMA.

[0014] The present invention also provides a method for shaping a central spiral shaping yarn, using the above-mentioned shaping fixture, the method comprising the following steps:

[0015] Step 1: Starting from the cylindrical end of the main structure, install one fixing screw, the first limiting positioning pin, and the second limiting positioning pin in sequence towards the center.

[0016] Step 2: The shaping wire starts from the planar end of the main structure, passes through the limiting groove of the main structure, is pressed by the connecting structure, then the third limiting positioning pin located at the planar end of the main structure is assembled, and then the fixing screw is fixed to fasten the main structure and the connecting structure together.

[0017] Step 3: The shaping wire rotates 3 to 5 turns around the second limiting positioning pin, ensuring that the shaping wire loops do not squeeze each other, and then rotates around the first limiting positioning pin to reach the fixing screw at the cylindrical end of the main structure. Here, the shaping wire is pulled tight and the fixing screw is tightened to compress the shaping wire.

[0018] Step 4: Heat-treat and cool the fixed shaping wire fixture, then remove the iron wire and fixture components that fix the mold to obtain the finished shaping wire of the desired shape.

[0019] Furthermore, in step 2, there are 5 third limiting and positioning pins, of which 4 are symmetrically distributed on both sides of the limiting groove at the planar end of the main structure, and 1 is located in the center of the limiting groove at the planar end of the main structure. There are 2 fixing screws, which are symmetrically distributed on both sides of the limiting groove at the planar end of the main structure.

[0020] Furthermore, the spacing between the 3 to 5 turns of shaping yarn in step 3 can be finely adjusted. By adjusting the spacing, the helix angle can be changed to achieve a controllable variable pitch effect.

[0021] Furthermore, the heat treatment step in step 4 is specifically as follows: the fixed shaping wire fixture is placed into a muffle furnace with a set temperature of 400-600℃ and a heat treatment time of 10-60 minutes, and then it is taken out and placed in cooling water for cooling.

[0022] In a preferred embodiment of the present invention, the shaping wire produced by the shaping wire fixture of the present invention combines the horizontal and vertical directions of existing traditional methods, and can form a controllable variable pitch spiral shape, realizing various shape transformations of the shaping wire. The main structure of the fixture of the present invention has a simple shape, which is convenient for manufacturers to process and manufacture, and the connecting structure can be installed and disassembled independently.

[0023] Compared with the prior art, the present invention has the following beneficial technical effects:

[0024] 1. Using a specially designed shaping fixture, the shaping wire is shaped from the center of the fixture by clamping two metal parts: the main structure and the connecting structure. The fixture's constraint not only shapes the wire from its center but also limits the perpendicularity of the support rod to the coil, thereby optimizing the fit of the guide tube.

[0025] 2. The central spiral shaping tool of the present invention optimizes the shaping of the shaping wire and facilitates the control of the shaping wire shape for fastening. The outer diameter of the tool matches the size of the shaping wire loop and the overall surface is smooth. The winding direction of the shaping wire is changed by fixing screws, and the spiral upward state of the loops is achieved by adjusting the distance between the loops, resulting in a tighter fit.

[0026] 3. By combining a cylindrical body, a connecting structure, seven limiting and positioning pins and three fixing screws, the metal wire with memory function is heat-treated and shaped into a specified three-dimensional structure. This achieves uniform, reproducible and standardized bending and shaping of the metal wire, significantly reducing the requirements for shaping operations. The shaping process is fast, efficient, and allows for controllable pitch change and mass production.

[0027] The following will further explain the concept, specific structure, and technical effects of the present invention in conjunction with the accompanying drawings, so as to fully understand the purpose, features, and effects of the present invention. Attached Figure Description

[0028] Figure 1 This is a structural diagram of the tooling main body of a preferred embodiment of the present invention;

[0029] Figure 2 This is a tooling connection structure diagram of a preferred embodiment of the present invention;

[0030] Figure 3 This is a schematic diagram of the tooling assembly of a preferred embodiment of the present invention;

[0031] Figure 4 This is a diagram showing the final shaping effect of the tooling according to a preferred embodiment of the present invention;

[0032] Figure 5 This is a side view of the final shaping effect of the tooling according to a preferred embodiment of the present invention;

[0033] Figure 6 This is a front view of the final shaping effect of the tooling according to a preferred embodiment of the present invention;

[0034] Wherein: 1-Main structure; 2-Connecting structure; 3-Fixing screw; 4-Limiting and positioning pin; 5-Shaping thread; 6-Limiting groove. Detailed Implementation

[0035] The following description, with reference to the accompanying drawings, illustrates several preferred embodiments of the present invention to make its technical content clearer and easier to understand. The present invention can be embodied in many different forms, and the scope of protection of the present invention is not limited to the embodiments mentioned herein.

[0036] In the accompanying drawings, components with the same structure are indicated by the same numerical designation, and components with similar structures or functions are indicated by similar numerical designations. The dimensions and thicknesses of each component shown in the drawings are arbitrary, and the present invention does not limit the dimensions and thicknesses of each component. To make the illustrations clearer, the thickness of some components has been appropriately exaggerated in the drawings.

[0037] Example 1

[0038] A central spiral shaping tooling includes a main structure 1, a connecting structure 2, fixing screws 3, limiting and locating pins 4, and a shaping wire 5. The main structure 1 includes a cylindrical end, a transition section, and a flat end. The center of the flat end of the main structure 1 is also the central axis of the cylindrical end. The flat end of the main structure 1 is connected to the connecting structure 2 by two fixing screws 3 and five limiting and locating pins 4. The connection includes pin positioning and bolt fixing, which together are used for shaping the straight section of the shaping wire 5. The connection between the flat end and the cylindrical end of the main structure 1 is a sloped section, which is the transition section of the main structure 1. The main structure 1 has a limiting groove 6 located at the center of the cylindrical end and on the sloped section of the transition section. Before spiraling upwards from the center of the flat end of the main structure 1 around the cylindrical end, the shaping wire 5 passes through the transition section of the main structure 1, forming a connecting arc, thus forming the main structural shape of the shaping wire 5. This connecting arc is the transition arc of the shaping wire 5.

[0039] The connecting structure 2, fixing screw 3, and limiting positioning pin 4 are accessories used to fix the shape of the shaping wire 5, facilitating its fixation and subsequent heat treatment. The connecting structure 2 has a limiting groove 6 for fixing the transition arc of the shaping wire 5. The cylindrical end of the main structure 1 forms the spiral rising section and the vertical guide section of the shaping wire 5. The main structure 1, connecting structure 2, fixing screw 3, and limiting positioning pin 4 work together to form the structural shape of the shaping wire 5.

[0040] The diameter of the cylindrical end of the main structure 1 is selected as 10mm, and the length of the slope tangent of the main structure transition section projected onto the central axis of the cylindrical end is selected as 4mm.

[0041] The main structure 1, connecting structure 2, fixing screws 3, and limiting positioning pins 4 are all made of high-temperature resistant stainless steel. The shaping wire 5 is made of nickel-titanium based shape memory alloy (Ni-Ti SMA).

[0042] like Figure 1 and Figure 2 As shown, this illustrates the structural shapes of the main structure 1 and the connecting structure 2. Figure 3 The image shows the overall shape of this tooling after assembly, as well as the corresponding assembly and fixing positions.

[0043] Example 2

[0044] A central spiral shaping tooling includes a main structure 1, a connecting structure 2, fixing screws 3, limiting and locating pins 4, and a shaping wire 5. The main structure 1 includes a cylindrical end, a transition section, and a flat end. The center of the flat end of the main structure 1 is also the central axis of the cylindrical end. The flat end of the main structure 1 is connected to the connecting structure 2 by two fixing screws 3 and five limiting and locating pins 4. The connection includes pin positioning and bolt fixing, which together are used for shaping the straight section of the shaping wire 5. The connection between the flat end and the cylindrical end of the main structure 1 is a sloped section, which is the transition section of the main structure 1. The main structure 1 has a limiting groove 6 located at the center of the cylindrical end and on the sloped section of the transition section. Before spiraling upwards from the center of the flat end of the main structure 1 around the cylindrical end, the shaping wire 5 passes through the transition section of the main structure 1, forming a connecting arc, thus forming the main structural shape of the shaping wire 5. This connecting arc is the transition arc of the shaping wire 5.

[0045] The connecting structure 2, fixing screw 3, and limiting positioning pin 4 are accessories used to fix the shape of the shaping wire 5, facilitating its fixation and subsequent heat treatment. The connecting structure 2 has a limiting groove 6 for fixing the transition arc of the shaping wire 5. The cylindrical end of the main structure 1 forms the spiral rising section and the vertical guide section of the shaping wire 5. The main structure 1, connecting structure 2, fixing screw 3, and limiting positioning pin 4 work together to form the structural shape of the shaping wire 5.

[0046] The diameter of the cylindrical end of the main structure 1 is selected as 20mm, and the length of the slope tangent of the main structure transition section projected onto the central axis of the cylindrical end is selected as 5mm.

[0047] The main structure 1, connecting structure 2, fixing screws 3, and limiting and positioning pins 4 are all made of high-temperature resistant mold steel. The shaping wire 5 is made of copper-based shape memory alloy (Cu SMA).

[0048] Example 3

[0049] A central spiral shaping tooling includes a main structure 1, a connecting structure 2, fixing screws 3, limiting and locating pins 4, and a shaping wire 5. The main structure 1 includes a cylindrical end, a transition section, and a flat end. The center of the flat end of the main structure 1 is also the central axis of the cylindrical end. The flat end of the main structure 1 is connected to the connecting structure 2 by two fixing screws 3 and five limiting and locating pins 4. The connection includes pin positioning and bolt fixing, which together are used for shaping the straight section of the shaping wire 5. The connection between the flat end and the cylindrical end of the main structure 1 is a sloped section, which is the transition section of the main structure 1. The main structure 1 has a limiting groove 6 located at the center of the cylindrical end and on the sloped section of the transition section. Before spiraling upwards from the center of the flat end of the main structure 1 around the cylindrical end, the shaping wire 5 passes through the transition section of the main structure 1, forming a connecting arc, thus forming the main structural shape of the shaping wire 5. This connecting arc is the transition arc of the shaping wire 5.

[0050] The connecting structure 2, fixing screw 3, and limiting positioning pin 4 are accessories used to fix the shape of the shaping wire 5, facilitating its fixation and subsequent heat treatment. The connecting structure 2 has a limiting groove 6 for fixing the transition arc of the shaping wire 5. The cylindrical end of the main structure 1 forms the spiral rising section and the vertical guide section of the shaping wire 5. The main structure 1, connecting structure 2, fixing screw 3, and limiting positioning pin 4 work together to form the structural shape of the shaping wire 5.

[0051] The diameter of the cylindrical end of the main structure 1 is selected as 35mm, and the length of the slope tangent of the main structure transition section projected onto the central axis of the cylindrical end is selected as 6mm.

[0052] The main structure 1, connecting structure 2, fixing screws 3, and limiting and positioning pins 4 are all made of high-temperature resistant mold steel. The shaping wire 5 is made of iron-based shape memory alloy (Fe SMA).

[0053] The steps for using this tool to produce shaping wire are as follows:

[0054] Starting from the planar end of the main structure 1, the shaping wire 5 passes through the limiting groove 6 of the main structure 1 and is pressed by the connecting structure 2. Next, the limiting positioning pin 4 is assembled, and then the fixing screw 3 is used to fasten the main structure 1 and the connecting structure 2 together. Next, the shaping wire 5 enters the cylindrical end of the main structure 1 through the limiting groove 6 along the transition section of the main structure 1. Then, the shaping wire 5 rotates 3-5 times around one limiting positioning pin 4, ensuring that the shaping wire 5 does not squeeze against each other during these 3-5 rotations. It then rotates again around one limiting positioning pin 4 to reach the fixing screw 3 at the cylindrical end of the main structure 1. At this point, the shaping wire 5 is tightened, and the fixing screw 3 is tightened, pressing the shaping wire 5 into a non-automatic state. This is the tooling tightening procedure.

[0055] Meanwhile, the spacing between 3 to 5 turns of the spiral can be finely adjusted, and different spacings change the helix angle, achieving the function of controllable pitch.

[0056] After fixing the shaping wire fixture, place it in a muffle furnace at a set temperature (400-600℃) for heat treatment for a specified time (10-60 minutes). Then, remove it and place it in cooling water for cooling. Remove the iron wire fixing the mold and all fixture components, and take out the final shaping wire of the desired shape (e.g., finished product 5). Figure 4 ).

[0057] See the specific shape of the 3-turn spiral shaping yarn. Figure 4 As shown, its side view and front view are respectively shown in the figure. Figure 5 and Figure 6 Trim off the excess material to make the final required shaping yarn size.

[0058] Compared to existing technologies, the shaping wire produced using the shaping wire tooling of this invention combines both horizontal and vertical directions, enabling the formation of a controllable variable-pitch spiral shape and achieving various shape transformations. The shaping wire products prepared using this tooling, compared to similar products, integrate horizontal and vertical directions while simultaneously achieving controllable variable-pitch spiral upward three-dimensional shape transformations. This facilitates better tissue adhesion of the catheter during surgery, reduces the need for catheter replacement, shortens surgical time, and reduces surgical difficulty. By applying force initially at the tip of the spiral upward spiral, the contact area between the coil and the affected area gradually increases with increasing force, resulting in a more secure fit.

[0059] The tooling of this invention allows for heat treatment and shaping of metal wires with memory function into a specified three-dimensional structure. This enables uniform, reproducible, and standardized bending and shaping of the metal wires, significantly reducing the requirements for shaping operations. The shaping process is fast, efficient, and allows for controllable pitch changes, enabling mass production.

[0060] The preferred embodiments of the present invention have been described in detail above. It should be understood that those skilled in the art can make numerous modifications and variations based on the concept of the present invention without creative effort. Therefore, all technical solutions that can be obtained by those skilled in the art based on the concept of the present invention through logical analysis, reasoning, or limited experimentation on the basis of existing technology should be within the scope of protection defined by the claims.

Claims

1. A shaping fixture for a central spiral shaping yarn, characterized in that, The device includes a main structure, a connecting structure, fixing screws, and a positioning pin. The main structure and the connecting structure are connected by the fixing screws and the positioning pin. The fixing screws are secured by bolts and, together with the positioning pin, are used for the precise shaping and fixing of the shaping wire. Both the main structure and the connecting structure have limit grooves to assist in guiding and fixing the shaping wire. The main structure includes a cylindrical end, a planar end, and a transition section. The transition section is a sloped sectional surface transitioning from the cylindrical end to the planar end. A limiting groove is located at the center of the planar end and on the sloped sectional surface of the transition section. Before spiraling upwards from the center of the planar end around the cylindrical end, the shaping wire passes through the transition section of the main structure, forming a connecting arc that defines the main structural shape of the shaping wire. This connecting arc is the transition arc of the shaping wire. The shaping wire passes through the limiting groove at the center of the planar end of the main structure, and the center of the planar end is simultaneously the central axis of the cylindrical end of the main structure. The limiting and positioning pins include a first limiting and positioning pin, a second limiting and positioning pin, and a third limiting and positioning pin. The first limiting and positioning pin is located at the far transition section of the cylindrical end, the second limiting and positioning pin is located at the near transition section of the cylindrical end, and the third limiting and positioning pin is located at the planar end. The shaping wire spirals upwards, winding 3 to 5 turns between the first and second limiting and positioning pins. The connecting structure cooperates with the main structure to press and limit the central straight section of the shaping wire. The limiting groove of the connecting structure is used to fix and limit the transition arc of the shaping wire. The main structure, connecting structure, fixing screw, and limiting positioning pin cooperate with each other to tightly fix the main structure and the connecting structure, thereby completing the overall fixing of the shaping tooling.

2. The shaping fixture for the central spiral shaping yarn as described in claim 1, characterized in that, The shaping wire includes a central straight section, a transition arc section, a spiral rising section, and a vertical guide wire section. The planar end of the main structure and the connecting structure are used together to form the central straight section of the shaping wire and fix the shaping wire. The transition section of the main structure and the connecting structure are used together to form the transition arc section of the shaping wire. The cylindrical end of the main structure is used to form the spiral rising section and the vertical guide wire section of the shaping wire. The connecting structure can be installed and disassembled independently.

3. The shaping fixture for the central spiral shaping yarn as described in claim 1, characterized in that, The diameter of the cylindrical end of the main structure is 10~35mm, and the length of the slope tangent of the transition section of the main structure projected onto the central axis of the cylindrical end is 4~6mm.

4. The shaping fixture for the central spiral shaping yarn as described in claim 1, characterized in that, All components of the tooling are made of the same material, namely high-temperature resistant stainless steel or mold steel. The material of the shaping wire is one of nickel-titanium-based shape memory alloy Ni-Ti SMA, copper-based shape memory alloy Cu SMA, or iron-based shape memory alloy Fe SMA.

5. A method for shaping a central spiral shaping yarn, characterized in that, The method, using a shaping fixture with a central spiral shaping wire as described in any one of claims 1 to 4, comprises the following steps: Step 1: Starting from the cylindrical end of the main structure, install one fixing screw, the first limiting positioning pin, and the second limiting positioning pin in sequence towards the center. Step 2: The shaping wire starts from the planar end of the main structure, passes through the limiting groove of the main structure, is pressed by the connecting structure, then the third limiting positioning pin located at the planar end of the main structure is assembled, and then the fixing screw is fixed to fasten the main structure and the connecting structure together. Step 3: The shaping wire rotates 3-5 turns around the second limiting positioning pin, ensuring that the shaping wire loops do not squeeze each other, and then rotates around the first limiting positioning pin to reach the fixing screw at the cylindrical end of the main structure. Here, the shaping wire is pulled tight and the fixing screw is tightened to compress the shaping wire. Step 4: Heat-treat and cool the fixed shaping wire fixture, then remove the iron wire and fixture components that fix the mold to obtain the finished shaping wire of the desired shape.

6. The method for shaping the central spiral shaping yarn as described in claim 5, characterized in that, In step 2, there are 5 third limiting and positioning pins, 4 of which are symmetrically distributed on both sides of the limiting groove at the planar end of the main structure, and 1 is located in the center of the limiting groove at the planar end of the main structure. There are 2 fixing screws, which are symmetrically distributed on both sides of the limiting groove at the planar end of the main structure.

7. The shaping method for the central spiral shaping yarn as described in claim 5, characterized in that, The spacing between the 3-5 turns of shaping yarn in step 3 can be finely adjusted. By adjusting the spacing, the spiral angle can be changed to achieve a controllable variable pitch effect.

8. The method for shaping the central spiral shaping yarn as described in claim 5, characterized in that, The heat treatment step in step 4 is as follows: the fixed shaping wire fixture is placed in a muffle furnace with a set temperature of 400~600℃ and a heat treatment time of 10~60min. Then it is taken out and placed in cooling water for cooling.

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