TWI682795B - The use picosecond lasers of color marking processing method at surface of the needle head - Google Patents

Abstract

The invention relates to a processing method for color marking on the surface of a needle, which includes the following steps: step 1: picosecond laser color marking; step 2: cutting by a cutter; step 3: ultrasonic pickling to remove oxide film; step four: Electrolytic passivation treatment of needles; Step 5: Washing and drying; Step 6: Glue assembly of needle and needle base; Step 7: Vacuum packaging and optical inspection; Step 8: Sterilization; Mainly use picosecond laser to color the surface of the needle Mark on the surface color of the needle, respectively, and give three different color marks, and the middle of the three different colors give two segments of the primary color of the needle; thereby providing low temperature processing, low internal stress, smooth surface, high cleanliness 1. The color processing method of the laser surface of the needle skin without iron rust, strong corrosion resistance and low repulsion.

Description

Color processing method of needle skin second laser surface

The invention belongs to one of the invasive medical instruments, in particular to a processing method for marking the color of the picosecond laser on the surface of the needle.

In recent years, with the advancement of micro-machining methods and micro-precision technology, the quality of general medical devices has been greatly improved, and the processing technology has also tended to be simplified. The general needles are mostly smooth surfaces without any scale, so During the operation, it is difficult for the operator to accurately predict the position of the needle and the depth of entry into the body tissue, especially when invading a special tissue site, it is easier to destroy the surrounding tissue site, such as the orbital site commonly used in medical and aesthetic treatment The related medical behaviors are most likely to cause operator errors, lead to clinical medical disputes, or cause inconvenience in the patient's life in the future, but also make the clinical operator's heart become difficult and uncomfortable in the operation process. To achieve effective medical behavior and treatment effect.

Therefore, we use the technology and products of the present invention to solve the inconvenience of medical personnel and avoid the clinically-prone defects, and then by inventing the technology and products, we can provide the surface color that meets the needs of medical personnel Early warning needle.

In order to solve the shortcomings of the insecure depth and position of the injection device in invading body tissue, we used the surface color processing technology of the picosecond laser to give different colors on the surface of the needle Safety warning processing technology; the surface of the needle is marked with different colors, and the different colors can directly identify the depth of intrusion through the human eye, so the processed needle will be given to medical staff or operators for advance reminders or warnings The function is convenient for the operator and the medical staff to accurately and measure the depth and position of the body tissue part entered.

The needle of the present invention can be applied to the input of various liquid medicines and the extraction of body fluids for detection. For example, when the liquid medicine is input to the face or the inside of the mouth, the depth of the needle tube entering the body tissue can be determined according to the color of the surface of the needle The depth and position of the tissue allows the operator to easily operate to the desired position, and gives the injection of liquid medicine, so as to achieve accurate medical results and avoid damage to other body tissues.

Based on the above-mentioned problems to be solved, the purpose of this invention is to provide a miniature and precise picosecond laser surface color processing method, to improve the processing method of the surface of the injection device without marking and recognizable depth; the products produced by this technology, It will be expected to give medical staff to overcome the psychological barriers to errors; then to achieve this goal, the processing steps of the present invention include: Step 1: picosecond laser color marking; Step 2: cut off by the cutter; Step 3: super Sonic acid pickling to remove the oxide film; Step four: surface treatment of the needle; Step five: cleaning and drying; Step six: glue assembly of the needle and the needle base; Step seven: vacuum packaging and optical inspection; Step eight: sterilization treatment; this invention The key is to use the picosecond laser to mark the color on the surface of the needle, and the position of 3mm from the tip of the needle is the first mark position of the starting point. A total of 3 small segments are given, the length of each small segment is 2.5mm, and then the front segment The distance between the color and the rear color is 2.5mm, which belongs to the non-processing position, and the color is the primary color of the needle; according to the invention, the surface color of the needle is given different 3 color marks, and the middle of the 3 different colors is given 2 primary colors of the needle ; For example, the first paragraph is green, representing the safety zone; the second paragraph is yellow, representing the warning zone; the third paragraph is red, representing the danger zone, as shown in Figure 2 for this invention Schematic diagram of the color of the surface of the needle of the injection device; the injection device includes a syringe, piston, push pin, needle seat, needle and sheath, as shown in Figure 3 is a schematic diagram of the injection device; the finished product of the syringe is used for various liquid drugs Body fluid extraction used for input and human detection.

The present invention is an invasive medical device and processing behavior. The function of the injection device is to draw out body fluids during the input or detection of liquid drugs. The needle can be accurately observed and recognized through the vision of the human eye. It can avoid damage to the body tissue that is easy to be injured, so that medical staff or operators can avoid mistakes, and provide clinically safe and reliable equipment; in addition, the color needles with warning signs on the surface will be easy to identify and judge The depth and position of the body tissue where the needle is located.

The surface color processing technology of the picosecond laser of the present invention is based on the picosecond laser surface coloring technology. The processing technology belongs to the characteristics of low temperature processing. The technology can obtain excellent quality, small internal stress, smooth surface and high cleanliness. The method of processing the surface color of the needle with high degree of corrosion resistance, high corrosion resistance and low repulsion; our invention process uses easily available stainless steel raw materials (such as SUS304 series or SUS316 series), and then the picosecond laser is a low temperature processing technology , It can produce needle surface color processing technology with excellent quality, low price, low internal stress, smooth surface, obvious passivation edges, many chromium-rich layers, high cleanliness, strong corrosion resistance, and low repulsion. It meets the needs of innovation, novelty, progress and applicability of invention patents, which shows its processing gains.

S101‧‧‧Use picosecond laser to mark the color on the surface of a needle

S102‧‧‧Cut the needle with a cutter

S103‧‧‧Using ultrasound to pickle the surface of the needle to remove the oxide film on the surface of the needle

S104‧‧‧ Perform a surface treatment on the needle

S105‧‧‧Clean and dry the needle

S106‧‧‧The needle and a needle base are glued together to form an injection device

S107‧‧‧ Vacuum package the injection device and perform an optical inspection on the needle

S108‧‧‧ Perform a sterilization treatment on the needle

The first picture: a block diagram of the invention's processing method; the second picture: the color position of the invention; the third picture: a schematic structural diagram of the injection device of the invention; The fourth picture is a sample diagram of the surface color of the needle completed by the picosecond laser of the technology of the present invention.

In order to facilitate your examiner to understand the features, content, advantages and achievable effects of this invention, please refer to Figures 1 to 4 of the drawings of this invention for detailed descriptions of related embodiments and expressions. , And please refer to the diagrams used in the text for assistance; my main text and illustrations are for the purpose of illustration and auxiliary instructions only, and may not be the true scale and precise configuration after the implementation of the present invention, so they should not be attached The relationship between the process and the configuration limits the patent scope of the present invention in actual implementation, and is in accordance with the descriptions previously described.

Please refer to the first figure, which is a block diagram of the processing flow of the present invention; the processing method of the surface color of the needle of this invention is the most optimized embodiment, which includes the steps: Step 1: use a picosecond laser on a needle Mark the color on the surface (S101); Step 2: Cut the needle with a cutter (S102); Step 3: Pickle the surface of the needle with ultrasound to remove the oxide film on the surface of the needle (S103) ; Step 4: Perform a surface treatment on the needle (S104); Step 5: Wash and dry the needle (S105); Step 6: Glue the needle and a needle base to assemble an injection device (S106); Step 7 : Vacuum packaging the injection device and performing an optical inspection on the needle (S107); Step 8: Performing a sterilization process on the needle (S108).

The aforementioned needle 1, the invasive needle can be divided into two kinds of staying needles and non-staying needles; the common needle material is annealed 304 series stainless steel, but it does not limit the present invention, it can also be The 316 series stainless steel and any other materials that can be used as needles belong to the protection scope of the present invention; the materials used in the present invention are the annealed 304 series stainless steel, the inner surface of which has been surface-polished, and the outer surface It needs to be subjected to centerless grinding and polishing, which conforms to the international ASTM material standard, but does not limit the invention in this way. Various materials with characteristics belong to the protection scope of the present invention.

Among them, the first step is the picosecond laser surface color processing method, this step is to use three-dimensional computer graphics (3D CAD) software to draw the surface of the needle surface 3 color positions and dimensions; enter the picosecond laser processing machine computer Write the processing path program, and then confirm the color position of the path program, modify the file header and file end of the path program, and finally set the processing conditions of the relevant color labeling and perform the color labeling processing steps. The setting range and items of the processing parameters of the picosecond laser surface color are as follows: (1). Color depth h (μm), 10 μm ± 10 μm, (2). Speed s (mm/sec), 25mm/s-125mm /s, (3). Spot size Φ (μm), 0.025mm-0.03mm, (4). Optical focal length f (mm), 20mm-30mm, (5). Processing power W (W), 7W-19W automatic Adjustment, (6). Pulse frequency Hz (kHz), 400kHz-715kHz, (7). Pulse energy w (μ) 10μ-40μ, (8). Pulse width B (ns), 3ns-80ns, (9). The wavelengths λ/(nm) of the picosecond lasers of the three colors are: green 755nm, yellow 532nm-755nm and red 532nm, (10). Material surface temperature T (℃), 200℃-350℃, the needle Constant temperature liquid is introduced into the tube to maintain the processing temperature of the material.

The second step is to add a cutter to the position (right position) in front of the picosecond laser processing chuck and the laser head. After the picosecond laser processing the surface color of the needle, use this cutter to cut The needle.

The ultrasonic deoxidizing film in step 3 also explains the reason why this technology is adopted. The main reason is that after the skin laser is processed, the surface of the needle surface is prone to be contaminated with fine debris. Therefore, we use ultrasonic pressure that can generate high vibration frequencies. Clean the surface of the needle; in the process of ultrasonic cleaning, the needle will vibrate at the same frequency as the sound wave, and the liquid will also continuously produce negative pressure, at this time the liquid will produce cavitation and shock wave effects of cracking; clean the tank After receiving ultrasonic vibration energy, the cleaning fluid will generate shock waves similar to positive and negative alternating, which can be cavitation Liquid bubble group, the bubble group will invade the surface of the needle, and this bubble will repeatedly shrink and expand, and clean the fine chips or dirt hidden in the slits or deep holes. In this way, the invention is combined with pickling liquid to remove fine chips or dirt generated by picosecond laser processing. Among them, the chemical formula of the ultrasonic deoxidizing film in step 3 is a mixture of 5% dilute sulfuric acid and 95% deionized water. Its operating control temperature is between 25℃-30℃, and the time control is 10-15 minutes; finally It is rinsed several times with deionized water and dried; the present invention does not require the process of degreasing, because the problem of oil pollution does not occur on the surface after laser processing in picoseconds, so we only process the deoxidized film part.

The surface treatment of the needle in step 4 is also performed with the Hastelloy tank for simultaneous polishing and passivation treatment. The needle is connected to the anode, and the reduced metal is connected to the cathode. The foregoing two are placed in the electrolyte and passed through a DC power source. The stirrer at the bottom is started, which is conducive to the control of the electrolyte uniformity and temperature during the process; the role of electrolytic polishing is to use the principle of reverse electroplating and the concentrated effect of the electric field to produce a dissolving effect and achieve flatness and gloss on the surface of the needle (Mirror-level gloss, surface can reach Ra=0.15-0.55μm), processing technology to improve corrosion resistance and body tissue compatibility; the most important part of the technology of the present invention is to move the iron atoms in the surface layer of the needle In addition, the chromium atoms in the surface layer are retained, so that the surface of the needle is filled with chromium atoms (because chromium atoms are easily accepted by human tissues, it is not easy to produce repulsion). Among them, in the surface treatment of the needle in step 4, the total content of the electrolytic polishing solution added with deionized water is 150ml, and its chemical formula is: (1), the concentration of phosphoric acid solution is 10%; (2), the concentration of sulfuric acid solution is 40%; (3), the concentration of chromium trioxide solution is 5%; (4), the concentration of deionized water and other additives (such as ethylene glycol) is 45%; and the temperature of the electrolyte is controlled to 80-100℃ , Voltage control 12V±5V, time control is 1-2 hours. The chemical formula disclosed above can be adjusted according to the actual situation. When the formula of the electrolytic polishing solution is different, the concentration will change, and the viscosity will also change at this time; for example, to improve the needle Surface quality, additives will It is an important control factor. The additive in this embodiment is ethylene glycol, but it does not limit the invention in this way, and it can also be any additive that can achieve this purpose, which falls within the protection scope of the invention. The passivation process of the surface treatment of the needle of the present invention is to passivate the right-angled edge after the picosecond laser processing into a rounded edge to prevent the damage of the inner wall layer of the blood vessel when the needle enters the body tissue; The total liquid content of ionized water is 100ml; the chemical formula and dosage of the passivation liquid include: (1), the concentration of potassium dichromate solution is 20%; (2), the concentration of sodium hydroxide solution is 4%; (3) , 76% deionized aqueous solution; and control its (acid value) PH value to 6-7, and the operating time is controlled at 30-55 minutes.

The cleaning and drying in step 5 is also rinsed with deionized water several times and dried with a hair dryer; the purpose of the implementation of the present invention is to remove the surface chemical substances remaining in steps 3 and 4 and facilitate subsequent sterilization In this step, let the sterilization agent be completely sterilized and avoid re-contact with the microbial cells, so as to obtain the effect of sterilization or sterilization.

The needle of step 6 is glued and assembled with the needle base. The injection needle is placed in the needle base. After the fixation is completed, the adhesive is penetrated at the joint and then dried. The finished product is shown in Figure 2.

Step 7: Optical inspection and vacuum packaging; also put the injection device into the plastic protective shell, and affix a protective sticker on the plastic protective shell; the plastic protective shell is made of PE material, and the protective sticker is made of waterproof and low-permeability paper. Both are suitable for materials with ethylene oxide EO sterilization treatment; the purpose of optical inspection is to measure whether the color position and length of the needle surface conform to the designed method after the needle is processed by picosecond laser.

Needle sterilization in step 8; sterilization is to eliminate all microorganisms, including bacterial propagules, spores, viruses and molds, and achieve complete sterility. The invention is used Ethylene oxide EO sterilization is widely used in the sterilization and disinfection of medical equipment or semi-finished products. Its use temperature is 60℃, aeration time is 8 hours, and the storage period of EO sterilization can be stored within six months. The invasive medical equipment used must be thoroughly cleaned before sterilization, and preliminary classification, soaked in "maintenance solution", waiting for sterilization treatment. The aforementioned needle is processed through the aforementioned steps to complete the color marking of the needle surface, as shown in Figure 4. Compared with the conventional technology, the processing procedure of the present invention is an injection device completed by a series of conventional processing procedures and methods with readily available materials, processing techniques and equipment; the needle processing procedure of the present invention belongs to a low-temperature processing method, There is no problem of residual internal stress, and the color of the needle surface is marked with a picosecond laser, then the surface residue is treated with ultrasonic pickling solution, and finally the surface treatment of the needle is added, such as polishing, passivation and triggering of the cutting edge The surface is chromium-rich; this needle is suitable for the transient intrusion of the human body and also stays on the surface of the body tissue (generally 3 days to 4 days).

At the same time, in order to seek its stable quality, reasonable price, smooth surface, high cleanliness, good corrosion resistance, low rejection, and can improve the service life, the patent is particularly novel, progressive and innovative. The unique point; at the same time, it can also break through the current processing method of the color marking on the surface of the needle, which shows its gain.

In view of the above knowledge, the present invention has broken through the difficulties of the previous manufacturing technology and has indeed achieved the desired improvement. Then this is the processing process that is unfamiliar to the known technology and easy to think of; therefore, the present invention It has not been published or published before the application, and its novelty, progress, and innovation have clearly met the requirements of domestic and foreign invention patent applications. You have filed an application for invention according to law and urge your office to approve this application for an invention patent. To inspire invention, to feel virtuous.

The foregoing embodiments are only for explaining the technical ideas and features of the present invention, and its purpose is to enable those skilled in the art to understand the contents of the present invention and implement it accordingly. In this way, the patent scope of the present invention is defined, that is, any equal changes or modifications made according to the spirit disclosed by the present invention should still be covered by the patent scope of the present invention.

S101‧‧‧Use picosecond laser to mark the color on the surface of a needle

S102‧‧‧Cut the needle with a cutter

S103‧‧‧Using ultrasound to pickle the surface of the needle to remove the oxide film on the surface of the needle

S104‧‧‧ Perform a surface treatment on the needle

S105‧‧‧Clean and dry the needle

S106‧‧‧The needle and a needle base are glued together to form an injection device

S107‧‧‧ Vacuum package the injection device and perform an optical inspection on the needle

S108‧‧‧ Perform a sterilization treatment on the needle

Claims (15)

A method for processing the color of a needle picosecond laser surface includes the following steps: step one: use the picosecond laser to mark the color on the surface of a needle; step two: use a cutter to cut the needle; step three: use Ultrasonic pickling the surface of the needle to remove the oxide film on the surface of the needle; Step four: Perform a surface treatment on the needle; Step five: Wash and dry the needle; Step six: Place the needle and a needle seat Glue each other to assemble an injection device; Step 7: Vacuum encapsulate the injection device and perform optical inspection on the needle; and Step 8: Perform a sterilization treatment on the needle; Wherein, when performing the picosecond laser processing of Step 1 The tube of the needle is filled with a constant temperature liquid to maintain the processing temperature of the material of the needle. The method for processing the color of the needle picosecond laser surface as described in item 1 of the scope of the patent application, in which the first step is to use three-dimensional computer drawing (3D CAD) software to draw the surface of the three color positions and dimensions of the needle surface; input The computer of the picosecond laser processing machine composes the processing path program, and the path program is simulated to confirm its color position, modify the file header and file tail of the path program, and finally set the relevant color-coded processing conditions for color Marked processing steps. The color processing method of the needle picosecond laser surface as described in item 2 of the patent application scope, wherein the setting range and items of the processing parameters of the picosecond laser in step 1 are as follows: (1). Color depth h (μm ), 10μm±10μm, (2). Speed s (mm/sec), 25mm/s-125mm/s, (3). Spot size Φ (μm), 0.025mm-0.03mm, (4). Optical focal length f (mm), 20mm-30mm, (5). Processing power W (W), 7W-19W automatic adjustment, (6). Pulse frequency Hz (kHz), 400kHz-715kHz, (7). Pulse energy w(μ) 10μ-40μ, (8). Pulse width B(ns), 3ns-80ns, (9). Picosecond laser wavelength of three colors λ/( nm) are: green 755nm, yellow 532nm-755nm and red 532nm, (10). Material surface temperature T (℃), 200℃-350℃. The method for processing the color of the needle picosecond laser surface as described in item 2 of the scope of the patent application, in which the second step is to add the cut to the position (right side) in front of the picosecond laser processing chuck and the laser head When the picosecond laser finishes the color of the needle surface, the cutter is used to cut the needle. The method for processing the color of the laser surface of the needle picosecond as described in item 1 of the scope of the patent application, wherein in step 3, the needle will vibrate with the same frequency as the sound wave, and the liquid in the cleaning tank will also be continuously generated Negative pressure phenomenon, at this time, the liquid will produce cavitation and shock wave of cracking; the cleaning fluid in the cleaning tank will generate shock waves similar to positive and negative alternating waves after receiving ultrasonic vibration energy. This process can obtain cavitation The liquid bubble group, the bubble group will invade the surface of the needle, and this bubble will repeatedly shrink and expand, and clean the fine chips or dirt hidden in the slits or deep holes, in this way, and Combined with pickling liquid to remove the fine debris or dirt generated by the needle after picosecond laser processing. The method for processing the color of the laser surface of the needle skin second as described in item 1 of the scope of the patent application, wherein the chemical formula of the ultrasonic pickling to remove the oxide film in step 3 is a mixture of 5% dilute sulfuric acid and 95% deionized water, The operation control temperature is between 25°C-30°C, the time is controlled to 10-15 minutes; finally rinse with deionized water several times and dry. The method for processing the color of the laser surface of the needle picosecond as described in item 1 of the scope of the patent application, wherein the surface treatment of the needle in step 4 is to simultaneously perform electrolytic polishing and passivation treatment using a Hastelloy groove. The method for processing the color of the laser surface of the needle picosecond as described in item 7 of the patent application scope, wherein the electrolytic polishing treatment is to connect the needle to the anode and the reduced metal to the cathode, the two are placed in the electrolyte , The DC power supply is connected, and the agitator at the lower part of the Hastelloy tank is started, which is beneficial to the Control of the uniformity of the electrolyte and temperature of the process; the role of the electrolytic polishing process is to use the principle of reverse electroplating and the concentrated effect of the electric field to produce a dissolving effect and make the surface of the needle flat, glossy, and improved The processing technology with anti-corrosion ability compatible with body tissue, in which, after glossing, the surface of the needle can reach the mirror gloss of Ra=0.15-0.55μm. The method for processing the color of the needle picosecond laser surface as described in item 8 of the patent application scope, wherein the total content of the electrolytic polishing liquid used in the electrolytic polishing process added to deionized water is 150 ml, and the electrolytic polishing liquid The chemical formula is: (1), the concentration of phosphoric acid solution is 10%; (2), the concentration of sulfuric acid solution is 40%; (3), the concentration of chromium trioxide solution is 5%; (4), deionized water and The concentration of other additives is 45%; and the temperature of the electrolyte is controlled to 80-100°C, the voltage is controlled to 12V±5V, and the time is controlled to 1-2 hours; wherein, the additive includes ethylene glycol; wherein, the needle is made of Made of stainless steel, through the electrolytic polishing process to remove the iron atoms of the surface layer of the needle, and retain the chromium atoms of the surface layer of the needle, so that the surface of the needle is filled with the chromium atoms. The method for processing the color of the needle picosecond laser surface as described in item 7 of the scope of the patent application, wherein the passivation treatment is to passivate the right-angle edge of the needle after the picosecond laser processing into a rounded edge to prevent When the needle enters the body tissue, it destroys the inner wall layer of the blood vessel. The method for processing the color of the laser surface of the needle skin second as described in item 10 of the patent application range, wherein the passivation liquid used for the passivation treatment contains a total content of 100 ml of liquid added with deionized water; the chemical formula of the passivation liquid And the dosage includes: (1) The concentration of potassium dichromate solution is 20%; (2), the concentration of sodium hydroxide solution is 4%; (3), the deionized water solution is 76%; and its (acid value) PH value is controlled to 6-7, and the operation time is controlled at 30-55 minutes. The method for processing the color of the laser surface of the needle picosecond as described in item 1 of the patent scope, wherein the cleaning and drying in step 5 is to rinse the needle several times with deionized water and dry the needle with a blower to remove The surface chemical substances remaining after performing Steps 3 and 4 facilitate the subsequent execution of the steps of the sterilization process. The method for processing the color of the laser surface of the needle picosecond as described in item 1 of the scope of the patent application, wherein in step 6 the needle and the needle holder are glued together and assembled, the needle is placed in the needle holder, and after the fixing is completed, The adhesive is penetrated at the joint, and then dried to be glued to assemble the injection device. The method for processing the color of the laser surface of the needle picosecond as described in item 1 of the scope of the patent application, wherein the vacuum packaging of step 7 is to put the injection device into a plastic protective shell and affix protection on the plastic protective shell Stickers; Among them, the plastic protective shell is made of PE, the protective sticker is waterproof and low permeability paper, both of which are materials suitable for EO sterilization; the optical detection is used to measure the needle After the picosecond laser processing, whether the color position and the length measurement of the surface of the needle meet a preset range. The method for processing the color of the laser surface of the needle skin second as described in item 1 of the patent scope, wherein the sterilization treatment in step 8 is used to destroy microorganisms such as bacterial propagules, spores, viruses and molds, so that the needle A sterile state is presented; wherein, the sterilization treatment uses ethylene oxide EO for sterilization, the use temperature includes 60°C, and the aeration time is 8 hours.

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