Preparation process of poly (lactic-co-glycolic acid) degradable acupuncture needle

Abstract

According to the construction process, a hopper feeding device, a transmission system, a heating extrusion device, a cooling shaping device, a cutting device, a thread rolling device, a traction device, a grinding device and a sterilization device are arranged. The acupuncture needle prepared from the poly (lactic-co-glycolic acid) material has good non-toxic biodegradability, the acupuncture needle prepared from the poly (lactic-co-glycolic acid) material has good in-vivo biocompatibility, degradation products of lactic acid and glycolic acid can participate in metabolism of a human body, and finally carbon dioxide and water are formed and discharged out of the body. Meanwhile, the material is degraded by organisms and microorganisms in the natural world in the natural environment; by adding the traditional Chinese medicine pigment and adding a small amount of surfactant (phenol polyethylene glycol solvent or zinc naphthenate), the finished acupuncture needle has excellent weather resistance, light resistance, chemical corrosion resistance and ultraviolet resistance.

Description

Technical Field

[0001] This invention relates to the field of acupuncture needle preparation technology, specifically a process for preparing a poly(ethylene lactide) biodegradable acupuncture needle. Background Technology

[0002] The earliest prototype of acupuncture needles was the needle stone. In the oracle bone inscriptions of the Yin and Shang dynasties, acupuncture and moxibustion were described as a person holding a sharp instrument to treat patients with abdominal diseases. In the preparation of acupuncture needles, poly(ethylene glycol) lactide is used as a raw material. Poly(ethylene glycol) lactide is a non-toxic biodegradable polymer with good biocompatibility in the body. Its degradation products, lactic acid and glycolic acid, can participate in human metabolism and are eventually excreted as carbon dioxide and water. It is widely used in the biomedical field, such as surgical sutures, fracture fixation, drug sustained release, and tissue engineering.

[0003] The existing acupuncture needle manufacturing process does not reduce environmental pollution. Existing acupuncture needles contain non-degradable substances that cannot be broken down by organisms and microorganisms in nature. When discharged into rivers and lakes, they can easily disrupt the ecological balance, causing the death of fish and other aquatic organisms and polluting the environment. Therefore, it is necessary to improve the process. Summary of the Invention

[0004] The purpose of this invention is to provide a process for preparing poly(ethylene lactide) biodegradable acupuncture needles to solve the problems mentioned in the background art.

[0005] To achieve the above objectives, the present invention provides the following technical solution:

[0006] A process for preparing biodegradable poly(ethylene lactide) acupuncture needles includes the following steps: hopper feeding device → transmission system → heating extrusion device → cooling and shaping device → cutting device → tooth-rolling device → traction device → grinding device → sterilization device. The main components are: poly(ethylene lactide) (PGLA) granules and traditional Chinese medicine color paste.

[0007] Step 1: According to the acupuncture needle preparation requirements, the weighed raw materials are loaded into the hopper feeding device. The hopper feeding device is equipped with a "U"-shaped hopper device with a spiral mixing rod and a tamping rod. On this basis, a double-layer mixing mechanism with a circular stirring mechanism and a vertically moving forced tamping machine is added to forcibly loosen the polyethylene lactide (PGLA) particles entering the "U"-shaped hopper device, so as to achieve forced feeding and mixing. A color paste addition port is opened at the bottom of the hopper feeding device, so that traditional Chinese medicine color paste can be added to the polyethylene lactide.

[0008] Step 2: The transmission system consists of a main motor, a pair of sprockets, and two counter-rotating twin screws. The main motor is the primary power source, connecting to the pair of sprockets. The sprockets reduce the rotational speed by four times before transmitting the power to the central shaft of the two screws.

[0009] Step 3: The heating extrusion device consists of a screw barrel, an electromagnetic core, and a sliding diaphragm control system. Through electromagnetic induction, eddy currents are generated within the screw barrel to heat the poly(ethylene glycol) lactide (PGLA) particles. Simultaneously, the main motor drives the counter-rotating twin screws to rotate, shearing and compressing the PGLA entering from the hopper feeder. Under the control of the sliding diaphragm control system, the PGLA is rapidly heated to a molten state and mixed with the colorant. While the electromagnetic core is heating, the main motor pressurizes the screw barrel, and this, combined with the rotation of the counter-rotating twin screws, generates an axial thrust along the barrel direction, extruding the molten PGLA from the die.

[0010] Step 4: The ceramic cooling plate is added to the outside of the die in Step 3 to form a cold end. The hot and cold ends are each composed of two ceramic plates. The extruded poly(ethylene glycol) lactide (PGLA) is cooled and shaped by the cold end.

[0011] Step 5: The polyethylene glycol (PGLA) extruded from the cooling and shaping device will be cut into small segments of the same size using a circular saw (driven by a main motor).

[0012] Step Six: The small segments of poly(ethylene lactide) (PGLA) cut to the same specifications are fed into the hopper of the thread rolling machine. The small segments are pushed into the track by a pusher plate with a thickness slightly smaller than that of the small segments of PGLA and then conveyed to the thread rolling plate for thread processing. The two thread rolling plates with the same tooth shape go back and forth once, and the thread processing of the outer surface of the small segments of PGLA is completed.

[0013] Step 7: The tracked traction mechanism is used. After the thread rolling is completed, the small segments of poly(ethylene lactide) (PGLA) threads fall onto the tracked traction mechanism. Double-layer timed directional opening and closing baffles are installed on both sides during the transmission. The small segments of poly(ethylene lactide) (PGLA) threads are aligned and regulated in batches at two different transmission positions and finally conveyed to the grinding device.

[0014] Step 8: The small segments of poly(ethylene lactide) (PGLA) are conveyed to a semi-circular track by a conveyor belt. The grinding disc and grinding wheel are rotated and ground by a motor. The grinding disc grinds the small segments of PGLA to the corresponding thickness of the acupuncture needle, and the grinding wheel grinds the tip of the acupuncture needle into a pine needle shape. The grinding and polishing process of the acupuncture needle is completed.

[0015] Step Nine: The acupuncture needles, after being ground and polished in Step Eight, are conveyed to a high-pressure steam sterilizer via a conveyor belt. Once a certain amount has been collected, the sterilizer is turned off, and the needles are sterilized using high-pressure steam.

[0016] Preferably, the acupuncture needles made of polyethylene lactide (PEL) material have good non-toxic biodegradability. The acupuncture needles made of PEL material have good biocompatibility in the body, and the degradation products lactic acid and glycolic acid can participate in human metabolism, eventually forming carbon dioxide and water which are excreted from the body. At the same time, they are degraded by organisms and microorganisms in the natural environment, without causing pollution to the environment, thus improving the environmental protection performance of acupuncture needles.

[0017] Preferably, by opening a color paste addition port below the hopper feeding device, color paste can be added to polyethylene lactide. The color paste can be used to modify the color of acupuncture needles. The semi-finished color paste, which is made by dispersing Chinese herbal pigments in a liquid carrier, can facilitate better dispersion of pigments in paint. At the same time, the addition of a small amount of surfactant (polyethylene glycol solvent or zinc naphthenate) can give the finished acupuncture needles excellent weather resistance, light resistance, chemical corrosion resistance and UV resistance.

[0018] Preferably, the ceramic cooling chip is powered by the main motor to provide the energy required for the electron flow. After the power is turned on, the electrons start from the negative electrode, first pass through the P-type semiconductor, where they absorb heat, and then release heat when they reach the N-type semiconductor. Each time the electrons pass through an NP module, heat is sent from one side to the other side, creating a temperature difference and forming a hot and cold end.

[0019] Compared with the prior art, the beneficial effects of the present invention are as follows: Acupuncture needles made from poly(ethylene lactide) material possess excellent non-toxic biodegradability. These needles exhibit good biocompatibility in vivo, and their degradation products, lactic acid and glycolic acid, participate in human metabolism, ultimately forming carbon dioxide and water which are excreted. Simultaneously, they are degraded by organisms and microorganisms in the natural environment, causing no pollution and improving the environmental performance of the acupuncture needles. Furthermore, by opening a color paste addition port below the hopper feeding device, color paste can be added to the poly(ethylene lactide). This color paste, made from traditional Chinese medicine pigments dispersed in a liquid carrier, facilitates better dispersion of pigments in the acupuncture needle raw materials. The addition of a small amount of surfactant (polyethylene glycol solvent or zinc naphthenate) further enhances the finished acupuncture needle's excellent weather resistance, light resistance, chemical corrosion resistance, and UV resistance. Attached Figure Description

[0020] Figure 1 This is a flowchart illustrating the manufacturing process of the poly(ethylene lactide) biodegradable acupuncture needles according to the present invention. Detailed Implementation

[0021] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this invention, it should be noted that the terms "upper," "lower," "inner," "outer," "front end," "rear end," "both ends," "one end," and "the other end," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing this invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this invention. Furthermore, the terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0023] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installed," "equipped with," "connected," etc., should be interpreted broadly. For example, "connection" can be a fixed connection, a detachable connection, or an integral connection; it can be a mechanical connection or an electrical connection; it can be a direct connection or an indirect connection through an intermediate medium; it can be a connection within two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0024] Example 1

[0025] Please see Figure 1 The present invention provides an embodiment of a process for preparing a biodegradable poly(ethylene lactide) acupuncture needle. The process includes a hopper feeding device → transmission system → heating extrusion device → cooling and shaping device → cutting device → tooth-rolling device → traction device → grinding device → sterilization device. Its main components are: poly(ethylene lactide) (PGLA) granules and traditional Chinese medicine color paste.

[0026] Step 1: According to the acupuncture needle preparation requirements, the weighed raw materials are loaded into the hopper feeding device. The hopper feeding device is equipped with a "U"-shaped hopper device with a spiral mixing rod and a tamping rod. On this basis, a double-layer mixing mechanism with a circular stirring mechanism and a vertically moving forced tamping machine is added to forcibly loosen the poly(ethylene lactide) (PGLA) particles entering the "U"-shaped hopper device, so as to achieve forced feeding and mixing. The feeding speed is adjusted by adjusting the speed of the double-layer mixing mechanism. The acupuncture needle preparation speed is adjusted by adjusting the feeding speed, which is convenient to adjust the preparation speed according to the needs of acupuncture needle preparation and improves the flexibility of acupuncture needle preparation speed. A color paste addition port is opened at the bottom of the hopper feeding device, so that traditional Chinese medicine color paste can be added to the poly(ethylene lactide).

[0027] Step 2: The transmission system consists of a main motor, a pair of sprockets, and two counter-rotating twin screws. The main motor is the primary power source, connected to the pair of sprockets. The sprockets reduce the rotational speed by four times before transmitting it to the central shaft of the two screws. Bearings are installed at both ends of the central shaft of the screws to bear the axial force and ensure the load-bearing capacity of the counter-rotating twin screws.

[0028] Step 3: The heated extrusion unit consists of a screw barrel, electromagnetic cores, and a sliding diaphragm control system. The inner wall of the screw barrel is equipped with multiple electromagnetic cores, each with individually controllable temperature. Each electromagnetic core contains two excitation coils. Through electromagnetic induction, eddy currents are generated within the screw barrel to heat the poly(ethylene glycol) lactide (PGLA) particles. Simultaneously, the main motor drives the counter-rotating twin-screw to rotate, shearing and compressing the PGLA entering from the hopper feeder. Under the control of the sliding diaphragm control system, the PGLA is rapidly heated to a molten state and mixed with the colorant. While the electromagnetic cores are heating, the main motor pressurizes the screw barrel, and this, combined with the rotation of the counter-rotating twin-screw, generates an axial thrust along the barrel direction, extruding the molten PGLA from the die.

[0029] Step 4: Add ceramic cooling plates to the outside of the die from Step 3 to form a cold end. The hot and cold ends are each composed of two ceramic plates. The extruded poly(ethylene glycol) lactide (PGLA) is cooled and shaped by the cold end. Cooling and shaping by the cold end can quickly shape the acupuncture needle, effectively reducing the deformation rate of the acupuncture needle, thereby improving the quality of acupuncture needle preparation.

[0030] Step 5: Cut the poly(ethylene glycol) lauryl lactide (PGLA) extruded from the cooling and shaping device into small segments of the same size using a circular saw (driven by a main motor).

[0031] Step Six: Cut small segments of poly(ethylene lactide) (PGLA) of the same specifications and feed them into the hopper of the thread rolling machine. The small segments are pushed into the track by a pusher plate with a thickness slightly smaller than that of the PGLA segments and then conveyed to the thread rolling plate for thread processing. The two thread rolling plates with the same tooth shape go back and forth once, and the thread processing of the outer surface of the PGLA segments is completed.

[0032] Step 7: Using a tracked traction mechanism, the small segments of poly(ethylene lactide) (PGLA) threads after the thread rolling is completed fall onto the tracked traction mechanism. Double-layer timed directional opening and closing baffles are installed on both sides during the transmission process. The small segments of poly(ethylene lactide) (PGLA) threads are aligned and regulated in batches at two different transmission positions and finally conveyed to the grinding device.

[0033] Step 8: The small segments of poly(ethylene lactide) (PGLA) are conveyed to a semi-circular track using a conveyor belt. A grinding disc is fixed at the center of the track, and a grinding wheel at a certain angle is fixed in front of the track. The grinding disc and the grinding wheel are rotated by a motor to grind the small segments of PGLA to the corresponding acupuncture needle thickness. The grinding wheel grinds the tip of the acupuncture needle into a pine needle shape, thus completing the grinding and polishing process of the acupuncture needle. The grinding disc and the grinding wheel are rotated simultaneously by a motor, thereby completing the grinding and polishing process of the acupuncture needle at the same time. This simplifies the acupuncture needle preparation process and improves the efficiency of acupuncture needle preparation.

[0034] Step 9: The acupuncture needles that have been ground and polished in Step 8 are conveyed to the high-pressure steam sterilizer via a conveyor belt. After a certain amount has been collected, the sterilizer is turned off. The high-pressure steam sterilization method is used to raise the pressure to 103.4 kPa (1.05 kg / cm2) and the temperature to 121.3℃. Sterilization is completed after maintaining this temperature for 15 to 30 minutes.

[0035] Example 2

[0036] Please see Figure 1Acupuncture needles made from poly(ethylene lactide) material possess excellent non-toxic biodegradability. These needles exhibit good biocompatibility in the body, and their degradation products, lactic acid and glycolic acid, participate in human metabolism, ultimately forming carbon dioxide and water which are excreted. Furthermore, they are naturally degraded by organisms and microorganisms, causing no environmental pollution and enhancing the environmental friendliness of the acupuncture needles. The feeding speed is adjusted by regulating the speed of the double-layer stirring mechanism, thereby controlling the acupuncture needle preparation speed. This allows for adjustments based on the specific needs of acupuncture needle preparation, increasing the flexibility of the preparation process. Additionally, a feeding device located below the hopper further enhances the process. The color paste addition port allows for the addition of color paste to polyethylene lactide. Color pastes made from traditional Chinese medicine can be used to modify the color of acupuncture needles. The semi-finished color paste, composed of traditional Chinese medicine pigments dispersed in a liquid carrier, facilitates better dispersion of pigments in paints. Simultaneously, the addition of a small amount of surfactant (polyethylene glycol solvent or zinc naphthenate) gives the finished acupuncture needle excellent weather resistance, light resistance, chemical corrosion resistance, and UV resistance. Furthermore, the ceramic cooling chip receives the energy required for electron flow from the main motor. After power is applied, electrons originate from the negative electrode, first passing through the P-type semiconductor where they absorb heat, and then releasing heat upon reaching the N-type semiconductor. Each time an NP module is passed, heat is transferred from one side to the other, creating a temperature difference and forming hot and cold ends.

[0037] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above, and that the invention can be implemented in other specific forms without departing from its spirit or essential characteristics. Therefore, the embodiments should be considered in all respects as exemplary and non-limiting, and the scope of the invention is defined by the appended claims rather than the foregoing description. Thus, all variations falling within the meaning and scope of equivalents of the claims are intended to be included within the present invention. No reference numerals in the claims should be construed as limiting the scope of the claims.

Claims

1. A process for preparing biodegradable poly(ethylene lactide) acupuncture needles, comprising the following steps: hopper feeding device → transmission system → heating extrusion device → cooling and shaping device → cutting device → tooth-rolling device → traction device → grinding device → sterilization device. Its main components are: poly(ethylene lactide) (PGLA) granules and traditional Chinese medicine color paste. The characteristic feature is that: It includes the following nine steps: Step 1: According to the acupuncture needle preparation requirements, the weighed raw materials are loaded into the hopper feeding device. The hopper feeding device is equipped with a "U"-shaped hopper device with a spiral mixing rod and a tamping rod. On this basis, a double-layer mixing mechanism with a circular stirring mechanism and a vertically moving forced tamping machine is added to forcibly loosen the poly(ethylene lactide) (PGLA) particles entering the "U"-shaped hopper device, so as to achieve forced feeding and mixing. A color paste addition port is opened at the bottom of the hopper feeding device. Step 2: The transmission system consists of a main motor, a pair of sprockets, and two counter-rotating twin screws. The main motor is the primary power source, connecting to the pair of sprockets. The sprockets reduce the rotational speed by four times before transmitting the power to the central shaft of the two screws. Step 3: The heating extrusion device consists of a screw barrel, an electromagnetic core, and a sliding diaphragm control system. Through electromagnetic induction, eddy currents are generated within the screw barrel to heat the poly(ethylene glycol) lactide (PGLA) particles. Simultaneously, the main motor drives the counter-rotating twin screws to rotate, shearing and compressing the PGLA entering from the hopper feeder. Under the control of the sliding diaphragm control system, the PGLA is rapidly heated to a molten state and mixed with the colorant. While the electromagnetic core is heating, the main motor pressurizes the screw barrel, and this, combined with the rotation of the counter-rotating twin screws, generates an axial thrust along the barrel direction, extruding the molten PGLA from the die. Step 4: The ceramic cooling plate is added to the outside of the die in Step 3 to form a cold end. The extruded poly(ethylene glycol) lactide (PGLA) is cooled and shaped by the cold end. Step 5: The polyethylene glycol (PGLA) extruded from the cooling and shaping device will be cut into small segments of the same size using a circular saw (driven by a main motor). Step 6: The small segments of poly(ethylene lactide) (PGLA) cut into the same specifications are fed into the circular hopper of the thread rolling machine. The small segments of PGLA are pushed into the track by a pusher plate with a thickness slightly smaller than that of the PGLA segments and then conveyed to the thread rolling plate for thread processing. Step 7: The tracked traction mechanism is used to drop the small section of poly(ethylene lactide) (PGLA) thread after the thread rolling is completed onto the tracked traction mechanism and finally convey it to the grinding device. Step 8: The small segments of poly(ethylene lactide) (PGLA) are conveyed to a semi-circular track by a conveyor belt. The grinding disc and grinding wheel are rotated and ground by a motor. The grinding disc grinds the small segments of PGLA to the corresponding thickness of the acupuncture needle, and the grinding wheel grinds the tip of the acupuncture needle into a pine needle shape. The grinding and polishing process of the acupuncture needle is completed. Step Nine: The acupuncture needles, after being ground and polished in Step Eight, are conveyed to a high-pressure steam sterilizer via a conveyor belt. Once a certain amount has been collected, the sterilizer is turned off, and the needles are sterilized using high-pressure steam.

2. The manufacturing process of a poly(ethylene lactide) biodegradable acupuncture needle according to claim 1, characterized in that: The acupuncture needles made of poly(ethylene lactide) material have excellent non-toxic biodegradability. These acupuncture needles have good biocompatibility in the body, and their degradation products, lactic acid and glycolic acid, can participate in human metabolism, ultimately forming carbon dioxide and water which are excreted from the body. At the same time, they are degraded by organisms and microorganisms in the natural environment, without causing pollution to the environment, thus improving the environmental performance of acupuncture needles.

3. The manufacturing process of a poly(ethylene lactide) biodegradable acupuncture needle according to claim 1, characterized in that: The process involves adding a color paste through a port below the hopper feeding device, allowing the addition of color paste to polyethylene lactide. This color paste, derived from traditional Chinese medicine, can be used to modify the color of acupuncture needles. The semi-finished color paste, made by dispersing traditional Chinese medicine pigments in a liquid carrier, facilitates better dispersion of pigments in paint. Furthermore, the addition of a small amount of surfactant (such as phenol-polyethylene glycol solvent or zinc naphthenate) enhances the finished acupuncture needles' excellent weather resistance, light resistance, chemical corrosion resistance, and UV resistance.

4. The manufacturing process of a poly(ethylene lactide) biodegradable acupuncture needle according to claim 1, characterized in that: The ceramic cooling chip is powered by the main motor to provide the energy required for the electron flow. After the power is turned on, the electrons start from the negative electrode, first pass through the P-type semiconductor, where they absorb heat, and then release heat when they reach the N-type semiconductor. Each time the electrons pass through an NP module, heat is sent from one side to the other side, creating a temperature difference and forming a hot and cold end.

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