A method for cutting a hypotube into sections

Abstract

The present application relates to a kind of partition combination cutting methods of hypotube, belong to medical instrument technical field, including the following steps: hypotube is divided in the dense area of cutting groove located in distal end and in the sparse area of cutting groove located in proximal end;The dense area of cutting groove in distal end is carried out laser cutting, forms first group of cutting groove;The sparse area of cutting groove in proximal end is carried out blade cutting, forms second group of cutting groove;The spacing for positioning is reserved between the laser cutting step and the blade cutting step.The present application solves the problems of low efficiency and high cost of existing laser cutting, according to the characteristics of hypotube distal end cutting groove dense, proximal end cutting groove sparse, laser and blade partition processing is adopted, under the premise of guaranteeing cutting groove precision and product performance, production efficiency is significantly improved, and processing cost is reduced.

Description

Technical Field

[0001] This invention belongs to the field of medical device technology, specifically relating to a method for partitioning and combining cutting of a sodium hypochlorite tube. Background Technology

[0002] In neurointerventional and vascular interventional surgeries, the neuroguidewire is a core interventional device for achieving intravascular navigation, lesion localization, and instrument delivery. The hypotube, as a key component of the guidewire, directly determines the guidewire's torsion control transmission, distal flexibility, and passage through tortuous vessels through its fabrication quality. To achieve the high proximal support and high distal flexibility of the hypotube, 5000-6000 grooves need to be machined into the wall of the approximately 35cm long hypotube. The groove distribution exhibits a typical characteristic of being sparse proximal and dense distally, and the dense distal grooves require extremely high consistency in groove depth and spacing to ensure the clinical performance of the guidewire.

[0003] Currently, the mainstream processing method for slotting sodium hypochlorite tubes in this field is through-body laser cutting (refer to...). Figure 4 This process leverages the non-contact, high-precision processing advantages of lasers to meet the precision requirements of dense grooving at the distal end of sodium hypochlorite tubes, ensuring consistent grooving dimensions and stable product performance. However, this traditional processing method has significant drawbacks in industrial applications: 1. Extremely low processing efficiency: Laser cutting of a single sodium hypotube takes 40-50 minutes, and the daily production capacity of a single femtosecond laser cutting machine is only 25-30 tubes, which is difficult to meet the needs of large-scale production. Second, high equipment and production costs: The purchase cost of a single femtosecond laser cutting machine is about 2 million yuan. Enterprises need to invest huge amounts of equipment costs to increase production capacity, which directly increases the processing cost of finished products such as hysterospindle tubes and micro-guide wires, ultimately increasing the medical burden on patients and the pressure on national medical insurance. 3. Poor process adaptability: The high precision of laser cutting is only necessary for dense grooving at the far end. For sparse grooving areas at the near end, using whole-body laser cutting is redundant. The high-precision processing capability is not used properly, which further exacerbates the waste of production costs.

[0004] While existing technologies offer solutions to improve the mechanical properties of hyaluronic acid tubes by optimizing the grooving angle, curvature, and segmented structure, or by using heat treatment to assist laser cutting, they all remain within the framework of whole-body laser cutting. They focus solely on optimizing product structure and performance, failing to address the core issues of low efficiency and high cost associated with laser cutting. Consequently, they cannot achieve a balance between production efficiency and cost while ensuring the processing precision of hyaluronic acid tubes.

[0005] Therefore, how to improve processing efficiency and reduce manufacturing costs while ensuring the key performance of the subwoofer tube is a technical problem that urgently needs to be solved in this field. Summary of the Invention

[0006] The purpose of this invention is to provide a method for partitioned cutting of a subwoofer tube. Based on the structural characteristics of the subwoofer tube, which has dense grooves at the far end and sparse grooves at the near end, laser cutting and blade cutting are combined to improve production efficiency and reduce manufacturing costs while ensuring the key performance of the product.

[0007] On the one hand, the present invention provides a method for partitioning and combining cutting of a sodium hypochlorite tube, which adopts the following technical solution: A method for partitioning and cutting a sodium hypochlorite tube includes the following steps: The submersible tube is divided into a densely grooved area on the distal side and a sparsely grooved area on the proximal side. Laser cutting is performed on the densely grouted area to form the first set of grooves; The sparse area of ​​the groove is cut with a blade to form a second set of grooves.

[0008] Preferably, a spacing for positioning is reserved between the laser cutting step and the blade cutting step; The spacing is 0.1-2mm.

[0009] Preferably, the laser cutting step is performed first, followed by the blade cutting step.

[0010] Preferably, the groove density in the groove-dense region at the far end is greater than the groove density in the groove-sparse region at the near end.

[0011] Preferably, the laser cutting is femtosecond laser cutting.

[0012] On the one hand, the present invention also provides a sodium hypochlorite tube, which adopts the following technical solution: A type of hyaluronic acid tube is manufactured using the above-mentioned partitioned combination cutting method.

[0013] Preferably, it includes a laser cutting segment and a blade cutting segment, with an uncut transition segment between the laser cutting segment and the blade cutting segment.

[0014] Preferably, the length of the transition section is 0.1-2 mm.

[0015] Preferably, the length of the laser-cut segment is 2.9-6.3% of the total length of the hyaluronic acid tube.

[0016] Furthermore, the present invention also provides an interventional catheter, which adopts the following technical solution: An interventional catheter, including the aforementioned hypotube.

[0017] In summary, the present invention has the following beneficial technical effects: 1. To address the structural characteristics of the hypoecho tube, which features dense distal grooves and sparse proximal grooves, a combination of laser and blade cutting is employed for partitioned cutting. This approach not only ensures the processing accuracy of the distal grooves and the performance of the product, but also significantly improves overall processing efficiency, reduces equipment investment and production costs, and lowers the final price of interventional devices, thereby alleviating the economic burden on patients and the pressure on national medical insurance.

[0018] 2. The laser and blade combined cutting process proposed in this invention only requires laser cutting for the high-precision areas at the far end of the sodium hypochlorite tube, ensuring key product performance, with an average cutting time of approximately 15 minutes per tube; the remaining parts are cut using blades, with an average cutting time of approximately 50 minutes per tube. To balance production volume, one laser cutting machine needs to be paired with three blade cutting machines for combined cutting. Conservatively, 80 sodium hypochlorite tubes can be produced per day, while the price of one blade cutting machine is only 500,000 yuan, meaning the total machine cost for producing 80 sodium hypochlorite tubes per day is 3.5 million yuan. Calculations show that when using full-body laser cutting, the daily output of hypotubes is 50-55 tubes at the same machine cost (3.5 million yuan), which is 68% of the daily output of the combined cutting method. Obviously, using a combination of laser and blade cutting can greatly reduce the cutting cost of hypotubes while having less impact on product performance; through the combined cutting process, production costs are reduced, and the economic burden on patients is further reduced. Attached Figure Description

[0019] Figure 1 This is a schematic diagram of the structure of the hyaluronic acid tube obtained by the partitioning and combination cutting method of the present invention; Figure 2 Image a is a cross-sectional view of a sodium hypochlorite tube cut by laser cutting; Figure 2 In the middle b, there is a cross-sectional view of a blade cutting a sodium hypochlorite tube; Figure 3 This is a schematic diagram of the structure of the semi-finished hyaluronic acid tube after laser cutting according to the present invention; Figure 4 The tensile strength test curve of the sodium hypochlorite tube prepared according to the present invention is shown. Figure 5 The T-test diagrams show the differences between the hyaluronic acid tube prepared by this invention and the hyaluronic acid tube prepared by laser cutting. Figure 6 This is a hypotube obtained using existing technology through a full-body laser cutting process.

[0020] Explanation of reference numerals in the attached diagram: 1. Distal end; 2. Proximal end; 3. Laser cutting section; 4. Blade cutting section; 5. Transition section. Detailed Implementation

[0021] The following examples, test cases, and accompanying manual are described in conjunction with the embodiments and test cases. Figure 1-5 The present invention will be described in further detail below.

[0022] Example Reference Figure 1 and Figure 2 A method for partitioned cutting of a hypochlorous acid (HLA) tube is disclosed, which involves partitioning the tube based on its structural characteristics. During interventional surgery, the HLA tube requires a gradual decrease in stiffness from the proximal end (2) to the distal end (1), and its groove distribution exhibits a characteristic of transitioning from sparse at the proximal end (2) to dense at the distal end (1). Based on this characteristic, this embodiment divides the HLA tube into a densely grooved region at the distal end (1) and a sparsely grooved region at the proximal end (2). Laser cutting is used for the densely grooved region at the distal end (1), which requires higher processing precision, while blade cutting is used for the sparsely grooved region at the proximal end (2), which requires relatively lower processing precision.

[0023] Reference Figure 1 and Figure 2 The sodium hypochlorite tube used in this embodiment is made of any one of 304 stainless steel, 316 stainless steel, or nickel-titanium alloy, and its total length is 35cm. The length of the densely grouted area at the distal end 1 is 2.9-6.3% of the total length of the sodium hypochlorite tube. In this embodiment, the length of the densely grouted area is 10-22mm. This area has a small groove spacing and high groove density, requiring stringent cutting precision. The length of the sparsely grouted area at the proximal end 2 is 318-340mm. This area has a larger groove spacing and lower groove density, requiring relatively less stringent cutting precision.

[0024] Reference Figure 3 In the laser cutting step, a laser cutting device is used to laser cut the densely grooved area located at the distal end 1. The laser cutting process parameters are set as follows: laser type: ultrashort pulse laser; wavelength: 1030nm; pulse width: 100-200fs; single pulse energy: 2-8μJ; frequency: 200-600kHz; cutting speed: 1-3mm / s. High-precision laser cutting ensures a high degree of consistency in the groove depth and spacing of the densely grooved area, thereby ensuring the accuracy and flexibility of torque transmission at the distal end 1 of the guide wire. After laser cutting, a semi-finished hypotube is obtained. The distal end 1 region of this semi-finished hypotube has formed the first set of grooves, while the proximal end 2 region has not yet been cut.

[0025] Reference Figure 1 A positioning gap is reserved between the laser cutting step and the blade cutting step. In this embodiment, this gap is set to 0.1-2mm. This gap serves as a transition area between the two cutting methods, facilitating the operator's loading and pre-cutting positioning operations when switching equipment, ensuring precise connection between the two cutting methods.

[0026] Reference Figure 1In the blade cutting step, the semi-finished sodium hypochlorite tube that has undergone laser cutting is transferred to a blade cutting machine, where the sparse groove area of ​​the proximal end 2 is cut with a blade. Through blade cutting, a second set of grooves is formed in the sparse groove area of ​​the proximal end 2. After cutting, the cut surface of this area is smooth and burr-free, which can meet the performance requirements of the proximal end 2 region. After blade cutting is completed, the finished sodium hypochlorite tube is obtained.

[0027] Reference Figure 1 The finished sodium hypochlorite tube produced using the above-described combined cutting method includes a laser-cut section 3 and a blade-cut section 4. The laser-cut section 3 is located near the distal end 1 of the finished sodium hypochlorite tube, and the blade-cut section 4 is located near the proximal end 2 of the finished sodium hypochlorite tube. An uncut transition section 5 exists between the laser-cut section 3 and the blade-cut section 4. In this embodiment, the length of the transition section 5 is 0.1-2 mm. The laser-cut section 3 is located at the distal end 1 of the sodium hypochlorite tube, corresponding to the densely grooved area of ​​the distal end 1, where the grooves are formed by laser cutting. The blade-cut section 4 is located at the proximal end 2 of the sodium hypochlorite tube, corresponding to the sparsely grooved area of ​​the proximal end 2, where the grooves are formed by blade cutting. The transition section 5 is an uncut, complete tube wall structure, and its surface morphology is different from that of the laser-cut section 3 and the blade-cut section 4, and can be clearly distinguished under a microscope.

[0028] Test case Test Example 1 The combined cutting method provided in this embodiment significantly improves processing efficiency while ensuring product performance. The laser cutting step takes approximately 15 minutes, and the blade cutting step takes approximately 50 minutes. In actual production line configuration, to balance output, one laser cutting machine needs to be paired with three blade cutting machines for combined cutting. Conservatively, 80 hypotubes can be produced per day. Since the price of one blade cutting machine is only 500,000 yuan, the total machine cost for producing 80 hypotubes per day is 3.5 million yuan. It can be deduced that when using the whole-body laser cutting method, the number of hypotubes produced per day at the same machine cost (3.5 million yuan) is 50-55, which is 68% of the daily output of the combined cutting method. Clearly, using the laser + blade combined cutting method can greatly reduce the cutting cost of hypotubes while having minimal impact on product performance. Through the combined cutting process, production costs are reduced, further alleviating the economic burden on patients.

[0029] Test Example 2 To verify whether there are statistically significant differences in the key mechanical properties of the hyaluronic acid tube prepared by the combined cutting process of this invention and the traditional whole-body laser-cut hyaluronic acid tube, a comparative test was conducted using tensile strength as an indicator. The test was conducted in accordance with the standard YY0450.1-2020 "Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Devices".

[0030] Fifteen samples each of the hyaluronic acid tube prepared using the combined cutting process of this invention (combined cutting group) and the hyaluronic acid tube prepared using the traditional whole-body laser cutting process (laser cutting group) were selected and tensile strength tests were conducted under the same test conditions (clamp gauge length 100 mm, tensile speed 15 mm / min, ambient temperature 25 °C).

[0031] The tensile strength test results of the two groups of samples are as follows: Laser cutting group (the overall mean is denoted as μ1) sample size N=15, mean tensile strength is 5.801, standard deviation is 0.226, and standard error of mean is 0.058; Combined cutting group (the overall mean is denoted as μ2) sample size N=15, mean tensile strength is 5.751, standard deviation is 0.264, and standard error of mean is 0.068; The difference between the two groups of means μ1-μ2 is 0.0493.

[0032] Statistical analysis was performed on the two groups of data using a two-sample t-test without assuming equal variances. Null hypothesis H0: μ1-μ2=0 (there is no statistically significant difference in the tensile strength between the two groups of sodium hypochlorite tubes); Alternative hypothesis H1: μ1-μ2≠0 (there is a statistically significant difference in the tensile strength between the two groups of sodium hypochlorite tubes); The 95% confidence interval for the difference between the two means is (-0.1348, 0.2335). This interval includes 0, indicating that there is no significant difference between the two means at the 95% confidence level. The test results show that the t-value is 0.55, the degrees of freedom are 27, and the corresponding p-value is 0.587, which is greater than the significance level α=0.05. Therefore, the null hypothesis is not rejected.

[0033] The above test results show that the tensile strength of the hyaluronic acid tube prepared by the combined cutting process of the present invention is not statistically significantly different from that of the hyaluronic acid tube prepared by the traditional whole-body laser cutting process. The key mechanical properties of the products under the two processes are comparable, proving that the present invention achieves the technical effects of improving processing efficiency and reducing cost without sacrificing the core mechanical properties of the hyaluronic acid tube.

[0034] Test Example 3 Reference Figure 4 To verify the tensile properties of the sodium hypotube prepared by the combined cutting process of this invention, a uniaxial tensile test was conducted on typical samples according to the standard YY0450.1-2020 "Disposable Sterile Intravascular Catheter Accessories Part 1: Guiding Devices". The test conditions and parameters are as follows: test speed is 15 mm / min, sample test gauge length is 100 mm, and test ambient temperature is 25℃. The force-deformation curve of the test results is shown in the figure.

[0035] Reference Figure 4In the force-deformation curve, the horizontal axis represents the tensile deformation of the sodium hypochlorite tube sample (unit: mm), and the vertical axis represents the tensile load (unit: N). The curve shows a stable step-like upward trend, indicating that as the tensile deformation increases, the load that the sodium hypochlorite tube can withstand gradually increases without any obvious abnormal fluctuations. When the tensile deformation reaches about 27.5 mm, the load reaches its maximum value of about 5.7 N, after which the sample fractures without premature failure or brittle fracture.

[0036] The above test curves show that the thiopancreatography (H2O) tube prepared by this invention has a stable mechanical response during the tensile process, and its tensile strength meets the clinical safety requirements for interventional catheter H2O tubes, providing reliable basic data for the performance comparison of samples prepared by different processes.

[0037] Test Example 4 Reference Figure 5 To visually represent the distribution characteristics of the tensile strength data of the sodium hypochlorite tubes prepared by the combined cutting process of this invention and the traditional whole-body laser cutting process, box plots of the two sets of data were drawn. In the figures, the horizontal axis represents the process type, corresponding to the laser cutting group and the combined cutting group, respectively; the vertical axis represents the tensile strength test value.

[0038] Reference Figure 5 As can be observed from the box plot: the median of the data in the laser cutting group is about 5.87N, and the mean is about 5.80N; the box range is about 5.56N-6.01N, the minimum value is about 5.39N, and the maximum value is about 6.08N, and the data distribution is relatively concentrated overall. The median of the data in the combined cutting group is approximately 5.78 N, and the mean is approximately 5.75 N; the range of the box is approximately 5.51 N-6.01 N, with a minimum value of approximately 5.32 N and a maximum value of approximately 6.08 N. The data distribution range and dispersion are highly consistent with those of the laser cutting group. The box heights (representing data dispersion) of the two sets of box plots are similar, with minimal deviations between the mean and median. The overall distribution ranges largely overlap, showing no significant systematic differences or outliers. This box plot corroborates the aforementioned two-sample t-test results, further demonstrating that the hypoechoic tube prepared using the combined cutting process of this invention exhibits no significant difference in overall tensile strength or dispersion compared to hypoechoic tubes prepared using the traditional through-body laser cutting process. Its mechanical performance stability and consistency are comparable, meeting the clinical safety requirements for interventional catheter hypoechoic tubes.

[0039] The embodiments shown in this specification are only used to illustrate the technical solutions of the present invention and are intended to help those skilled in the art understand the principles and advantages of the present invention. They do not constitute a limitation on the scope of protection of the present invention. Although the present invention has been specifically described, those skilled in the art can still make any modifications, equivalent substitutions or other reasonable variations to the implementation methods without departing from the spirit and scope of the present invention. All equivalent technical solutions resulting therefrom should be considered within the scope of protection of this patent.

Claims

1. A method for partitioning and assembling cutting of a sodium hypochlorite tube, characterized in that, Includes the following steps: The thallium tube is divided into a densely grooved area on the distal end (1) and a sparsely grooved area on the proximal end (2); Laser cutting is performed on the densely grouted area to form the first set of grooves; The sparse area of ​​the groove is cut with a blade to form a second set of grooves.

2. The method for partitioning and combining cutting of a sodium hypochlorite tube according to claim 1, characterized in that, A spacing for positioning is reserved between the laser cutting step and the blade cutting step; The spacing is 0.1-2mm.

3. The method for partitioning and combining cutting of a sodium hypochlorite tube according to claim 1, characterized in that, The laser cutting step is performed first, followed by the blade cutting step.

4. The method for partitioning and combining cutting of a sodium hypochlorite tube according to claim 1, characterized in that, The groove density in the groove-dense region at the far end (1) is greater than the groove density in the groove-sparse region at the near end (2).

5. The method for partitioning and cutting a sodium hypochlorite tube according to claim 1, characterized in that, The laser cutting is femtosecond laser cutting.

6. A partitioned combined cutting method for sodium hypochlorite tubes, characterized in that, It is prepared by the combined cutting method described in any one of claims 1 to 5.

7. The partitioned combined cutting sub-tube according to claim 6, characterized in that, It includes a laser cutting section (3) and a blade cutting section (4), with an uncut transition section (5) between the laser cutting section (3) and the blade cutting section (4).

8. The partitioned combined cutting sub-tube according to claim 6, characterized in that, The length of the transition section (5) is 0.1-2 mm.

9. The partitioned combined cutting sub-tube according to claim 6, characterized in that, The length of the laser-cut segment (3) is 2.9-6.3% of the total length of the hysteresis tube.

10. An interventional catheter, characterized in that, Includes the partitioned combined cutting of the hyaluronic acid tube as described in any one of claims 5-9.

Images