Surgical needle structure and production process thereof

Abstract

The invention discloses a surgical needle structure and a production process thereof, and aims to solve the technical problems that in the prior art, a surgical needle production process generally needs manual operation, the machining precision and efficiency are influenced by the experience and skill level of workers, and meanwhile, the batch is unstable, the production period is long, and the quality is difficult to guarantee. Comprising a surgical needle body, one end of the surgical needle body is provided with a hemispherical part, an L-shaped face is longitudinally cut at the end, away from the hemispherical part, of the surgical needle body, the top end of the L-shaped face is connected with an inclined connecting face, and a first groove is formed in the outer circumferential wall of the surgical needle body and located above the L-shaped face and the connecting face; the surgical needle can be automatically and accurately processed by controlling various process steps and flows, and meanwhile, the preparation process of the surgical needle is subjected to weight detection, so that the production quality of the surgical needle is guaranteed while the production efficiency is improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of surgical needle production, and particularly relates to a surgical needle structure and its production process. Background Art

[0002] A surgical needle is a medical device used to penetrate human tissues, suture wounds or insert objects during surgery; surgical needles are usually made of metal and have various different shapes and sizes to meet different surgical needs. Surgical needles have a certain hardness to facilitate puncture and suture, and at the same time, they are required to have excellent surface smoothness and easy cleanability to avoid bacterial infection and cross-infection. Therefore, the preparation process of surgical needles requires strict quality control and testing.

[0003] However, the existing surgical needle production process usually requires manual operation, and the processing accuracy and efficiency are affected by the experience and skill level of workers. At the same time, there are also problems such as unstable batches, long production cycles, and difficult quality assurance. Therefore, it is necessary to design a surgical needle structure and its production process to overcome the above technical defects. Summary of the Invention

[0004] (1) Technical Problems to be Solved

[0005] Aiming at the deficiencies of the prior art, the purpose of the present invention is to provide a surgical needle structure, aiming to solve the technical problems that the existing surgical needle production process usually requires manual operation, the processing accuracy and efficiency are affected by the experience and skill level of workers, and there are also problems such as unstable batches, long production cycles, and difficult quality assurance.

[0006] (2) Technical Solutions

[0007] To solve the above technical problems, the present invention provides such a surgical needle structure, including a surgical needle body. One end of the surgical needle body is provided with a hemispherical portion. The end of the surgical needle body away from the hemispherical portion is longitudinally cut with an L-shaped surface. The top end of the L-shaped surface is connected with an inclined connecting surface. A first groove is opened on the outer circumferential wall of the surgical needle body and above the L-shaped surface and the connecting surface. A second groove is opened on the outer circumferential wall of the surgical needle body and near one end of the first groove. A through hole is opened inside the surgical needle body.

[0008] When manufacturing the surgical needle body of this technical solution, first, prepare a raw metal rod for the surgical needle with a diameter of 1.03 mm and a length of 18.1 mm. Then, inspect the metal rod to check the quality of the raw metal rod for the surgical needle and determine whether the raw metal rod for the surgical needle meets the requirements, including the size, shape, material, hardness, surface quality, etc. of the metal rod. Then, perform CNC BND turning and milling compounding on the quality-inspected metal rod. By performing operations such as turning the blank, centerless grinding, drilling, milling the angle, and chamfering the back on the quality-inspected metal rod, the surgical needle body is prepared, and the standard size and weight of the surgical needle body are determined. Then, perform Ele-polish electrolytic polishing on the processed surgical needle body. By using a polishing machine to perform electrolytic polishing on the processed surgical needle, and during the polishing process, add 2 cups of 2000 mld of polishing material, 1 cup of 300 mld of grinding fluid, and 2600 ml of water, and control the polishing time to 40 minutes. Through the polishing treatment, the oxide layer and burrs on the surface of the surgical needle body are removed, ensuring the surface quality and smoothness of the product. After the polishing is completed, the finished surgical needle is obtained. Then, perform a full quality inspection on the processed surgical needle to ensure whether the size and surface smoothness of the surgical needle meet the factory requirements. Then, package the surgical needle to prevent the surgical needle from being damaged or contaminated during transportation. In addition, perform a packaging inspection on the surgical needle before shipping to ensure the quality of the products leaving the factory. Finally, ship the surgical needle after the packaging inspection.

[0009] Preferably, the outer edge of the connection surface is designed with an "arc" profile.

[0010] Furthermore, the total length of the surgical needle body and the hemispherical part is 18.1 mm, and the outer diameter of the surgical needle body is 1.03 mm.

[0011] Even further, chamfering is performed at both ends of the through hole inside the surgical needle body. The inner diameter of the through hole is 0.38 mm - 0.42 mm, and the deviation cannot exceed ±0.02 mm. The inner diameter of the chamfered part of the through hole is 0.6 mm, and the chamfering angle is 90°.

[0012] Even further, the distance from the end of the first groove away from the second groove to the center of the through hole is 5.2 mm - 5.4 mm. The inner length of the first groove is 0.45 mm, and the inner length of the second groove is 2 mm.

[0013] Even further, the hemispherical part is an arc with an equal radius, and the radius of the hemispherical part is 0.3 mm. The distance from the center of the through hole to the end of the hemispherical part is 12.35 mm - 12.5 mm.

[0014] A surgical needle production process includes the following specific steps:

[0015] Incoming inspection: Inspect the quality of the raw material metal rods for surgical needles to determine whether the raw material metal rods for surgical needles meet the requirements, including the size, shape, material, hardness, surface quality, etc. of the metal rods. The diameter of the metal rod is 1.03 mm and the length is 18.1 mm;

[0016] S1. CNC BND turning and milling compound: Through turning the blank, centerless grinding, drilling, milling the angle and chamfering the back of the metal rod after quality inspection, determine the standard size and weight of the surgical needle;

[0017] S2. FQC: Inspect the appearance, size, etc. of the surgical needle after turning and milling compound to confirm whether the processed surgical needle is qualified;

[0018] S3. Ele-polish electrolytic polishing: Use a polishing machine to perform electrolytic polishing on the processed surgical needle. During polishing, 2 cups of polishing material, 1 cup of grinding fluid and an appropriate amount of water need to be added, and the polishing time is controlled within 40 minutes. Through the polishing process, remove the oxide layer and burrs on the surface of the surgical needle to ensure the surface quality and smoothness of the product. After the polishing is completed, the finished surgical needle is obtained;

[0019] S4. IQC: Then conduct a full quality inspection on the processed surgical needle to ensure whether the size and surface smoothness of the surgical needle meet the factory requirements;

[0020] S5. Packing: Pack the surgical needles to prevent the surgical needles from being damaged or contaminated during transportation;

[0021] S6. OQC: Conduct a packing inspection on the surgical needles before shipment;

[0022] Finally, ship the surgical needles after the packing inspection.

[0023] Preferably, in S1, the equipment used for the turning blank process is SR-20 and the processing time is 30 minutes; the equipment used for the centerless grinding process is CGM and the processing time is 5 minutes; the equipment used for the drilling, milling angle and back chamfering processes is FANUC, the processing time is 40 minutes, and the clamping time is 20 minutes.

[0024] Further, in S3, the amount of two cups of polishing material is 4000 ml, the amount of one cup of grinding fluid is 300 ml, and the water consumption is 2600 m.

[0025] Still further, in S4, the full quality inspection process mainly includes the following specific steps:

[0026] a. Determine the detection procedure: According to the requirements and characteristics of the surgical needle, set the corresponding detection procedure. For appearance detection, image processing software can be written to extract the features on the surface of the surgical needle, and detection algorithms are used to analyze and determine the defects of the surgical needle. For dimensional detection, corresponding algorithms can be written according to the characteristics of the surgical needle, and corresponding software is used to automatically detect the dimensions of the surgical needle.

[0027] b. Install the detection system: Select appropriate detection devices such as cameras, light sources, sensors, etc., and configure and install them through software.

[0028] c. Place the conveyor belt: Place the processed surgical needles on the conveyor belt, and determine the speed and direction of the conveyor belt.

[0029] d. Transform the image: For optical images, the images can be captured by an imaging card or a camera, and then transformed and corrected to make them in a state suitable for analysis.

[0030] e. Collect data: Transmit the image data to a computer for collection, and use computer algorithms to detect and analyze the dimensions, surface roughness, glossiness, etc. of the surgical needle.

[0031] f. Judge the detection results: Evaluate and judge the detection results according to the set standards.

[0032] (3) Beneficial effects

[0033] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0034] The production process of preparing surgical needles in the present invention greatly improves the production efficiency, reduces the labor cost, and at the same time ensures the surface finish and precision of the surgical needles, guaranteeing the product quality. Secondly, through the automated processing technology and strict quality detection process, the problems of unstable production batches and unguaranteed quality can be effectively avoided, improving the product shipment rate and ensuring the product quality. In addition, through the electrolytic polishing process, the appearance quality and finish of the surgical needles can be effectively improved. Furthermore, through the control of various process steps, the surgical needles can be automatically and precisely processed, and the preparation process of the surgical needles is detected layer by layer, improving the production efficiency while ensuring the production quality of the surgical needles. Description of the drawings

[0035] Figure 1 is the process flow chart of the present invention;

[0036] Figure 2 is the schematic diagram of the main structure of the surgical needle of the present invention Figure 1 ;

[0037] Figure 3 is the schematic diagram of the main structure of the surgical needle of the present invention Figure 2 ;

[0038] Figure 4 Schematic diagram of the main structure of the surgical needle of the present invention Figure 3 ;

[0039] Figure 5 Schematic diagram of the main structure of the surgical needle of the present invention Figure 4 ;

[0040] Figure 6 For the present invention Figure 2 Enlarged view A

[0041] The reference signs in the drawings are: 1, main body of the surgical needle; 101, hemispherical part; 102, L-shaped surface; 103, connecting surface; 2, first groove; 3, second groove; 4, through hole Specific embodiments

[0042] Please refer to Figures 2 - 6 , the present invention provides the following technical solutions:

[0043] A surgical needle structure, including a main body 1 of the surgical needle, one end of the main body 1 of the surgical needle is provided with a hemispherical part 101, the end of the main body 1 of the surgical needle away from the hemispherical part 101 is longitudinally cut with an L-shaped surface 102, the top end of the L-shaped surface 102 is connected with an inclined connecting surface 103, a first groove 2 is opened on the outer circumferential wall of the main body 1 of the surgical needle and above the L-shaped surface 102 and the connecting surface 103, a second groove 3 is opened on the outer circumferential wall of the main body 1 of the surgical needle and near one end of the first groove 2, and a through hole 4 is opened inside the main body 1 of the surgical needle

[0044] Among them, the outer edge of the connecting surface 103 is designed with an "arc" contour. The total length of the main body 1 of the surgical needle and the hemispherical part 101 is 18.1 mm, the outer diameter of the main body 1 of the surgical needle is 1.03 mm, both ends of the inside of the main body 1 of the surgical needle and located at both ends of the through hole 4 are chamfered, the inner diameter of the through hole 4 is 0.38 mm - 0.42 mm, and the deviation cannot exceed ±0.02 mm. The inner diameter of the chamfered part of the through hole 4 is 0.6 mm, and the chamfering angle is 90°. The distance from the end of the first groove 2 away from the second groove 3 to the center of the circle of the through hole 4 is 5.2 mm - 5.4 mm, the inner length of the first groove 2 is 0.45 mm, the inner length of the second groove 3 is 2 mm, the hemispherical part 101 is an arc with an equal radius, and the radius of the hemispherical part 101 is 0.3 mm. The distance from the center of the circle of the through hole 4 to the end of the hemispherical part 101 is 12.35 mm - 12.5 mm

[0045] Please refer to Figure 1 , a surgical needle production process, including the following specific steps:

[0046] First, before processing the metal rod, conduct an incoming inspection on it

[0047] Further, by inspecting the quality of the raw metal rod of the surgical needle, it is determined whether the raw metal rod of the surgical needle meets the requirements, including the size, shape, material, hardness, surface quality, etc. of the metal rod;

[0048] Among them, the diameter of the metal rod is 1.03 mm and the length is 18.1 mm;

[0049] Step 1, S1, CNC BND turning and milling compound: By processing the quality-inspected metal rod through turning the blank, centerless grinding, drilling, milling the angle, and back chamfering, the standard size and weight of the surgical needle are determined;

[0050] In Step 1, the equipment used for the turning blank process is SR-20, and the processing time is 30 min;

[0051] Turning blank processing flow: Install the metal rod on the SR-20 equipment, fix it to ensure no shaking and displacement; then start the SR-20 equipment, run the numerical control program, and set the parameters of the turning tool (such as feed rate, cutting speed, etc.); then adjust the position of the turning tool to make it contact with the metal rod; start turning, control the feed rate and cutting speed, turn the metal rod, and ensure the smoothness and stability of the turning tool during the movement; when the metal rod is turned into the required shape, stop turning; inspect the turned blank to ensure that the size and surface quality meet the requirements.

[0052] Further, the equipment used for the centerless grinding process is CGM, and the processing time is 5 min;

[0053] Centerless grinding processing flow: First, import the designed CAD file into the CGM software, then set the best process parameters as needed, such as cutting speed, feed rate, and tool radius, etc., then use the CGM software for simulation, and check each step of the processing process to ensure its correctness and accuracy; then generate the G code that can be used for processing according to the simulation results; upload the G code to the CGM processing equipment and perform actual processing operations; during the processing, the metal rod is automatically processed by the equipment according to the pre-set parameters.

[0054] Still further, the equipment used for drilling, milling the angle, and back chamfering is FANUC. Among them, the processing time is 40 min and the clamping time is 20 minutes;

[0055] Drilling, milling angle and back chamfering processing flow: Fix and load the semi-finished surgical needle after centerless grinding into the FANUC equipment, then adjust the drill bit and processing parameters of the FANUC equipment, perform drilling on it, and unload the fixture after processing; then put the drilled part into the fixture and re-clamp it on the FANUC equipment; adjust the milling cutter and processing parameters of the FANUC equipment, start milling angle processing, and unload the fixture after processing; put the part after milling angle processing into the fixture and re-clamp it on the FANUC equipment; then adjust the tool and processing parameters of the FANUC equipment and start back chamfering processing.

[0056] Step 2, FQC: Inspect the appearance, size, etc. of the surgical needle after turning and milling compounding to confirm whether the processed surgical needle is qualified.

[0057] Step 3, Ele-polish electrolytic polishing: Use a polishing machine to perform electrolytic polishing on the processed surgical needle. During polishing, 2 cups of polishing material, 1 cup of grinding fluid and an appropriate amount of water need to be added, and the polishing time is controlled within 40 minutes. Through polishing treatment, the oxide layer and burrs on the surface of the surgical needle are removed to ensure the surface quality and smoothness of the product. After polishing is completed, the finished surgical needle is obtained.

[0058] In Step 3, the amount of two cups of polishing material is 4000 ml, the amount of one cup of grinding fluid is 300 ml, and the water consumption is 2600 m.

[0059] Step 4, IQC: Then conduct a comprehensive quality inspection on the processed surgical needle to ensure whether the size and surface smoothness of the surgical needle meet the factory requirements.

[0060] In Step 4, the comprehensive quality inspection process mainly includes the following specific steps:

[0061] a. Determine the detection program: According to the requirements and characteristics of the surgical needle, set the corresponding detection program. For appearance detection, image processing software can be written to extract the features on the surface of the surgical needle, and detection algorithms are used to analyze and judge the defects of the surgical needle; for size detection, corresponding algorithms can be written according to the characteristics of the surgical needle, and corresponding software is used to automatically detect the size of the surgical needle.

[0062] b. Install the detection system: Select appropriate detection equipment such as cameras, light sources, sensors, etc., and configure and install them through software.

[0063] c. Place the conveyor belt: Place the processed surgical needle on the conveyor belt and determine the speed and direction of the conveyor belt.

[0064] d. Convert the image: For optical images, the image can be captured through an imaging card or a camera, and then transformed and corrected to make it reach a state suitable for analysis.

[0065] e. Data collection: Transmit the image data to a computer for collection, and use computer algorithms to detect and analyze the size, surface roughness, glossiness, etc. of the surgical needle.

[0066] f. Determine the test results: Evaluate and determine the test results according to the set standards.

[0067] Step Five. Packing: Pack the surgical needles to prevent damage or contamination during transportation;

[0068] Step Six. OQC: Conduct packing inspection on the surgical needles before shipment;

[0069] In Step Six, identify whether the surgical needle packing meets the relevant standards and whether the packing is intact through inspection operations.

[0070] Finally, ship the surgical needles after packing inspection.

[0071] The implementation principle of the present invention is as follows: First, prepare a raw material metal rod for the surgical needle with a diameter of 1.03 mm and a length of 18.1 mm. Then, inspect the metal rod to check the quality of the raw material metal rod for the surgical needle and determine whether the raw material metal rod for the surgical needle meets the requirements, including the size, shape, material, hardness, surface quality, etc. of the metal rod. Then, perform CNCBND turning and milling compounding on the quality-inspected metal rod. Through turning the rough blank, centerless grinding, drilling, milling the angle, and back chamfering the quality-inspected metal rod, the main body of the surgical needle is prepared, and the standard size and weight of the main body of the surgical needle are determined. Then, perform Ele-polish electrolytic polishing on the processed main body of the surgical needle. By using a polishing machine to perform electrolytic light polishing on the processed surgical needle, and during polishing, add 2 cups of 2000 mld of polishing material, 1 cup of 300 mld of grinding fluid, and 2600 ml of water, and control the polishing time within 40 minutes. Through the polishing treatment, remove the oxide layer and burrs on the surface of the main body of the surgical needle to ensure the surface quality and smoothness of the product. After the polishing is completed, the finished surgical needle is obtained. Then, conduct a full quality inspection on the processed surgical needle to ensure whether the size and surface smoothness of the surgical needle meet the factory requirements. Then, pack the surgical needles to prevent damage or contamination during transportation. In addition, conduct packing inspection on the surgical needles before shipment to ensure the quality of the products leaving the factory. Finally, ship the surgical needles after packing inspection. The entire production process is simple and convenient. Through the control of various technological process steps, the present invention can perform automated and precise processing on the surgical needles, and at the same time conduct multiple inspections on the preparation process of the surgical needles, improving the production efficiency while ensuring the production quality of the surgical needles.

[0072] All technical features in this embodiment can be freely combined according to actual needs.

[0073] The above embodiments are preferred implementation solutions of the present invention. In addition, the present invention can also be implemented in other ways. Any obvious substitution without departing from the concept of the technical solution is within the protection scope of the present invention.

Claims

1. A surgical needle structure, comprising a surgical needle body (1), characterized in that, One end of the surgical needle body (1) is provided with a hemispherical portion (101). One end of the surgical needle body (1) away from the hemispherical portion (101) is longitudinally cut with an L-shaped surface (102). The top end of the L-shaped surface (102) is connected with an inclined connecting surface (103). A first groove (2) is formed on the outer circumferential wall of the surgical needle body (1) and above the L-shaped surface (102) and the connecting surface (103). A second groove (3) is formed on the outer circumferential wall of the surgical needle body (1) and at one end close to the first groove (2). A through hole (4) is formed inside the surgical needle body (1).

2. The surgical needle structure and its production process according to claim 1, characterized in that, The outer edge of the connecting surface (103) is designed with an "arc" profile.

3. A surgical needle structure and its production process according to claim 1, characterized in that, The total length of the surgical needle body (1) and the hemispherical portion (101) is 18.1 mm, and the outer diameter of the surgical needle body (1) is 1.03 mm.

4. A surgical needle structure and its production process according to claim 1, characterized in that, Both ends of the through hole (4) inside the surgical needle body (1) are chamfered. The inner diameter of the through hole (4) is 0.38 mm - 0.42 mm, and the deviation cannot exceed ±0.02 mm. The inner diameter of the chamfered part of the through hole (4) is 0.6 mm, and the chamfering angle is 90°.

5. A surgical needle structure and its production process according to claim 1, characterized in that, The distance from one end of the first groove (2) away from the second groove (3) to the center of the through hole (4) is 5.2 mm - 5.4 mm. The inner length of the first groove (2) is 0.45 mm, and the inner length of the second groove (3) is 2 mm.

6. The surgical needle structure and its production process according to claim 1, characterized in that, The hemispherical portion (101) is an arc with an equal radius, and the radius of the hemispherical portion (101) is 0.3 mm. The distance from the center of the through hole (4) to the tail end of the hemispherical portion (101) is 12.35 mm - 12.5 mm.

7. A production process for surgical needles, characterized in that, It includes the following specific steps: Incoming inspection: Check the quality of the raw material metal rod of the surgical needle to determine whether the raw material metal rod of the surgical needle meets the requirements, including the size, shape, material, hardness, surface quality, etc. of the metal rod. The diameter of the metal rod is 1.03 mm, and the length is 18.1 mm; S1. CNC BND turning and milling compounding: Through processing the quality-inspected metal rod by turning the blank, centerless grinding, drilling, milling the angle, and back chamfering, determine the standard size and weight of the surgical needle; S2. FQC: Check the appearance, size, etc. of the surgical needle after turning and milling compounding to confirm whether the processed surgical needle is qualified; S3. Ele-polish electrolytic polishing: Use a polishing machine to perform electrolytic polishing on the processed surgical needle. During polishing, 2 cups of polishing material, 1 cup of grinding fluid, and an appropriate amount of water need to be added, and the polishing time is controlled within 40 minutes. Through the polishing treatment, remove the oxide layer and burrs on the surface of the surgical needle to ensure the surface quality and smoothness of the product. After the polishing is completed, the finished surgical needle is obtained; S4. IQC: Then conduct a full quality inspection on the processed surgical needle to ensure whether the size and surface smoothness of the surgical needle meet the factory requirements; S5. Packing packaging: Package the surgical needle to prevent the surgical needle from being damaged or contaminated during transportation; S6. OQC: Conduct a packaging inspection on the surgical needle before shipment; Finally, the surgical needles after package inspection are shipped out.

8. A surgical needle production process according to claim 7, characterized in that, In S1, the equipment used for the blank turning process is SR-20, and the processing time is 30 minutes; the equipment used for the centerless grinding process is CGM, and the processing time is 5 minutes; the equipment used for the drilling, milling angle and back chamfering processes is FANUC, the processing time is 40 minutes, and the clamping time is 20 minutes.

9. A surgical needle production process according to claim 7, characterized in that, In S3, the two-cup amount of the polishing material is 4000 ml, the one-cup amount of the grinding fluid is 300 ml, and the water consumption is 2600 m.

10. A surgical needle production process according to claim 7, characterized in that, In S4, the full quality inspection process mainly includes the following specific steps: a. Determine the detection program: According to the requirements and characteristics of the surgical needles, set the corresponding detection program. For appearance detection, an image processing software can be written to extract the features on the surface of the surgical needles, and detection algorithms are used to analyze and determine the defects of the surgical needles; for dimension detection, corresponding algorithms can be written according to the characteristics of the surgical needles, and corresponding software is used to automatically detect the dimensions of the surgical needles. b. Install the detection system: Select appropriate detection equipment such as cameras, light sources, sensors, etc., and configure and install them through software. c. Place the conveyor belt: Place the processed surgical needles on the conveyor belt, and determine the speed and direction of the conveyor belt. d. Transform the image: For optical images, the images can be captured by an imaging card or a camera, and then transformed and corrected to make them in a state suitable for analysis. e. Collect data: Transmit the image data to a computer for collection, and use computer algorithms to detect and analyze the dimensions, surface roughness, glossiness, etc. of the surgical needles. f. Judge the detection results: Evaluate and judge the detection results according to the set standards.

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