A dual-layer composite lubricating coating composition and a method of making the same, and lubricating medical puncturing instruments
Patent Information
- Application Number
- CN202611324126.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-08-28
- Publication Date
- 2026-09-29
AI Technical Summary
在穿刺过程中，涂层极易发生迁移、剥落或被擦拭，导致润滑失效
[0017]实验结果表明，涂覆本申请所述双层涂层组合物的医用穿刺器械的最大穿刺力仅为0.738N，平均穿刺阻力仅为0.059N。
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Abstract
Description
Technical Field
[0001] This application relates to the field of medical device coating technology, and in particular to a double-layer composite lubricating coating composition and its preparation method, and a lubricating medical puncture instrument. Background Technology
[0002] Disposable sterile injection and puncture instruments are widely used in critical medical procedures such as clinical surgery, drug infusion, and blood sample collection. To reduce puncture resistance, alleviate patient pain, and improve the ease of operation, a lubricating coating is usually applied to the needle surface. Currently, siloxane materials, due to their excellent low surface energy properties, have become the most widely used lubricating media in this field. However, existing silicon-based lubricating coating technologies face a technical dilemma in practical applications: it is difficult to balance adhesion and lubricity.
[0003] Traditional non-reactive polydimethylsiloxane (PDMS), while providing excellent initial lubrication, exhibits only weak physical adsorption with the metal substrate. During puncture, the coating is prone to migration, peeling, or wiping, leading to lubrication failure. Furthermore, the detached silicone oil tends to accumulate at the puncture site, affecting the instrument's appearance and posing a risk of introducing foreign bodies, making it difficult to meet long-term stable clinical needs. Reactive silicone oils containing amino and alkoxy functional groups can form strong interfacial bonds with the metal surface through hydrogen bonds or covalent bonds, significantly improving the coating's peel resistance. However, chemical modification often involves changes in molecular chain polarity, leading to a decrease in the coating's surface smoothness and an increased coefficient of friction, which in turn affects the smoothness of puncture and patient experience. In addition, studies have shown that with the increase of polar groups such as amino groups, the coating's biocompatibility may be impaired, posing a potential risk of inducing local tissue irritation or allergic reactions, limiting its application in sensitive clinical settings.
[0004] In conclusion, developing a composite coating system that combines high adhesion with excellent lubrication and durability remains a key technological bottleneck that urgently needs to be overcome in the field of sterile puncture instruments. Summary of the Invention
[0005] In view of this, this application provides a double-layer composite lubricating coating composition and its preparation method, as well as a lubricating medical puncture instrument. The medical puncture instrument coated with the coating composition of this application has both high adhesion strength and excellent lubricity, while achieving low resistance and high stability throughout the puncture process.
[0006] This application provides a two-layer composite lubricating coating composition, including a primer composition and a topcoat composition; The primer composition comprises an alkoxy-containing reactive silicone oil of formula (I) and a high molecular weight non-reactive silicone oil of formula (II); The topcoat composition comprises a low molecular weight nonreactive silicone oil of formula (III); Formula (I); Formula (II); Formula (III); In formula (I), R1 to R5 are each independently selected from one of C1 to C20 straight-chain alkyl and C1 to C20 branched alkyl; R6 is selected from C1 to C20 alkyl containing amino or imino; R7 to R8 are each independently selected from C1 to C20 alkoxy; m is an integer from 60 to 500. In equation (II), R9~R 16 Each is independently selected from one of C1-C20 straight-chain alkyl groups and C1-C20 branched alkyl groups; p is an integer from 300 to 2000; In equation (III), R 17 ~R 24 Each is independently selected from one of C1-C20 straight-chain alkyl and C1-C20 branched alkyl; q is an integer from 5 to 100.
[0007] In some specific implementations, in formula (I), R1 to R5 are each independently selected from one of C1 to C10 straight-chain alkyl and C1 to C10 branched alkyl; R6 is selected from C1 to C10 alkyl containing amino or imino; R7 to R8 are each independently selected from C1 to C10 alkoxy; m is an integer from 100 to 450; In equation (II), R9~R 16 Each is independently selected from one of C1-C10 straight-chain alkyl groups and C1-C10 branched alkyl groups; p is an integer from 500 to 1500; In equation (III), R 17 ~R 24 Each is independently selected from one of C1-C10 straight-chain alkyl and C1-C10 branched alkyl; q is an integer from 10 to 90.
[0008] In some specific implementations, in formula (I), R1 to R5 are each independently selected from one of C1 to C6 straight-chain alkyl and C1 to C6 branched alkyl; R6 is γ-aminopropyl or N-(β-aminoethyl)-γ-aminopropyl; R7 to R8 are each independently selected from C1 to C6 alkoxy; m is an integer from 150 to 400; In equation (II), R9~R 16 Each is independently selected from one of C1-C6 straight-chain alkyl groups and C1-C6 branched alkyl groups; p is an integer from 800 to 1300; In equation (III), R 17~R 24 Each is independently selected from one of C1-C6 straight-chain alkyl groups and C1-C6 branched alkyl groups; q is an integer from 40 to 80.
[0009] In some specific implementations, the alkoxy-containing reactive silicone oil, high molecular weight non-reactive silicone oil, and low molecular weight non-reactive silicone oil have the specific structures shown in formulas (IV) to (VI): Formula (IV); Formula (V); Formula (VI); In equation (IV), m is 300; In equation (V), p is 1000; In equation (VI), q is 50.
[0010] In some specific implementations, the mass ratio of the alkoxy-containing reactive silicone oil to the high molecular weight non-reactive silicone oil is (0.5~3):1.
[0011] In some specific implementations, the composition further includes a diluent; The diluent is selected from one or more of chlorinated hydrocarbons, aliphatic hydrocarbons, aromatic hydrocarbons, esters, ketones, ethers, fatty alcohols, and volatile siloxanes.
[0012] Furthermore, this application also provides a lubricated medical puncture instrument, including a medical puncture instrument substrate and a double-layer composite lubricating coating applied to the surface of the medical puncture instrument. The dual-layer composite lubricating coating is obtained by curing the above-described coating composition.
[0013] In some specific implementations, the medical puncture instrument substrate is selected from one or more of the following: injection needles, infusion needles, blood collection needles, biopsy needles, and indwelling needles.
[0014] Furthermore, this application also provides a method for preparing the above-mentioned medical puncture instrument, the specific preparation steps of which include: The primer composition is applied to the surface of the medical puncture instrument substrate and cured for the first time. Then, the top coat composition is applied to the cured medical puncture instrument substrate surface and cured for the second time to obtain the medical puncture instrument.
[0015] In some specific implementations, the coating method is selected from one or more of immersion, wiping, or spraying; The temperature for the first curing is 40℃~90℃; The first curing time is 5 min to 60 min; The temperature for the second curing is 40℃~90℃; The second curing time is 5 to 60 minutes.
[0016] This application provides a two-layer composite lubricating coating composition, including a primer composition and a topcoat composition; the primer composition includes an alkoxy-containing reactive silicone oil of formula (I) and a high molecular weight non-reactive silicone oil of formula (II); the topcoat composition includes a low molecular weight non-reactive silicone oil of formula (III); the alkoxy-containing reactive silicone oil of this application achieves chemical anchoring of the bottom layer on the metal substrate through Si-OM covalent bonds formed by the hydrolysis of alkoxy groups and the condensation of hydroxyl groups on the metal surface, while the high molecular weight non-reactive silicone oil and reactive silicone oil segments entangle to form an interpenetrating physical network, constructing a dual stable structure with both chemical bonding and physical entanglement, significantly enhancing the coating's anti-peeling and wear resistance during dynamic puncture; the low molecular weight non-reactive silicone oil acts as a lubricating phase covering the surface of the bottom coating, maintaining extremely low puncture resistance while achieving long-term stable retention of the lubricating phase through the physical constraint of the bottom network, avoiding the migration and peeling of traditional silicone oil coatings; medical puncture instruments coated with the coating composition of this application have both high adhesion strength and lubricity, while significantly reducing puncture resistance.
[0017] Experimental results show that the maximum puncture force of the medical puncture instrument coated with the double-layer coating composition described in this application is only 0.738N, and the average puncture resistance is only 0.059N. Attached Figure Description
[0018] Figure 1 This is a schematic diagram of the double-layer composite lubricating coating of this application; Figure 2 This is the puncture force curve of Example 1; Figure 3 This is the puncture force curve of Comparative Example 1; Figure 4 This is the puncture force curve of Comparative Example 2; Figure 5 This is a comparison chart of the average puncture resistance between Examples 1-3 and Comparative Examples 1-2; Figure 6 This is a comparison chart of the average maximum puncture force of Examples 1, 4, 5 and Comparative Examples 1-2; Figure 7 This is a comparison diagram of the puncture effects of Example 1 and Comparative Example 3. Detailed Implementation
[0019] It should be understood that the expression “one or more of…” individually includes each of the objects described after the expression, as well as various different combinations of two or more of the described objects, unless otherwise understood from the context and usage. The expression “and / or” combined with three or more described objects should be understood to have the same meaning, unless otherwise understood from the context.
[0020] The terms “including,” “having,” or “containing,” including the use of their grammatical synonyms, should generally be understood as open-ended and non-restrictive, for example, not excluding other unstated elements or steps, unless otherwise specifically stated or understood from the context.
[0021] It should be understood that the order of steps or the sequence of actions is not important as long as this application remains operational. Furthermore, two or more steps or actions can be performed simultaneously.
[0022] This application provides a two-layer composite lubricating coating composition, comprising a primer composition and a topcoat composition; the primer composition comprises an alkoxy-containing reactive silicone oil of formula (I) and a high molecular weight non-reactive silicone oil of formula (II); the topcoat composition comprises a low molecular weight non-reactive silicone oil of formula (III); Formula (I); Formula (II); Formula (III); In formula (I), R1 to R5 are each independently selected from one of C1 to C20 straight-chain alkyl and C1 to C20 branched alkyl; R6 is selected from C1 to C20 alkyl containing amino or imino; R7 to R8 are each independently selected from C1 to C20 alkoxy; m is an integer from 60 to 500. In this application, the alkoxy-containing reactive silicone oil and the high molecular weight non-reactive silicone oil together constitute the underlayer coating. This underlayer coating is firmly bonded to the substrate and can provide the necessary lubrication performance under high friction conditions. The alkoxy-containing reactive silicone oil is reactive, and its terminal alkoxy group can hydrolyze on the metal surface during the curing process to form silanol groups, which then form covalent bonds with the hydroxyl groups on the metal surface, constructing a stable structure similar to a molecular brush on the substrate surface. In equation (II), R9~R 16 Each is independently selected from one of C1-C20 straight-chain alkyl groups and C1-C20 branched alkyl groups; p is an integer from 300 to 2000; in this application, the high molecular weight non-reactive silicone oil and the alkoxy-containing reactive silicone oil are entangled to form an interpenetrating network; the high molecular weight non-reactive silicone oil helps to improve the overall strength of the coating and provides effective lubrication when the interfacial friction is large; In equation (III), R 17 ~R 24 Each is independently selected from one of straight-chain alkyl groups and branched alkyl groups of C1 to C20; q is an integer from 5 to 100; in this application, the low molecular weight non-reactive silicone oil can partially penetrate into the bottom layer and entangle with it, thereby providing excellent lubricity when the interfacial friction is small and effectively reducing sliding resistance.
[0023] In some specific implementations, preferably, in formula (I), R1~R5 are each independently selected from one of C1~C10 straight-chain alkyl and C1~C10 branched alkyl; R6 is selected from C1~C10 alkyl containing amino or imino; R7~R8 are each independently selected from C1~C10 alkoxy; m is an integer from 100 to 450; in formula (II), R9~R 16 Each is independently selected from one of C1-C10 straight-chain alkyl and C1-C10 branched alkyl; p is an integer from 500 to 1500; in formula (III), R 17 ~R 24 Each is independently selected from one of C1-C10 straight-chain alkyl and C1-C10 branched alkyl; q is an integer from 10 to 90.
[0024] In some specific implementations, more preferably, in formula (I), R1~R5 are each independently selected from one of C1~C6 straight-chain alkyl and C1~C6 branched alkyl; R6 is γ-aminopropyl or N-(β-aminoethyl)-γ-aminopropyl; R7~R8 are each independently selected from C1~C6 alkoxy; m is an integer from 150 to 400; in formula (II), R9~R 16 Each is independently selected from one of C1-C6 straight-chain alkyl groups and C1-C6 branched alkyl groups; p is an integer from 800 to 1300; in formula (III), R 17 ~R 24 Each is independently selected from one of C1-C6 straight-chain alkyl groups and C1-C6 branched alkyl groups; q is an integer from 40 to 80.
[0025] In some embodiments, the alkoxy-containing reactive silicone oil, high molecular weight non-reactive silicone oil, and low molecular weight non-reactive silicone oil have the specific structures shown in formulas (IV) to (VI): Formula (IV); Formula (V); Formula (VI); In equation (IV), m is 300; In equation (V), p is 1000; In equation (VI), q is 50.
[0026] In some specific implementations, the mass ratio of the alkoxy-containing reactive silicone oil to the high molecular weight non-reactive silicone oil is (0.5~3):1, preferably (1~2):1, and more preferably 0.5:1, 1:1 or 2:1.
[0027] In some specific implementations, the composition further includes a diluent; the diluent is selected from one or more of chlorinated hydrocarbons, aliphatic hydrocarbons, aromatic hydrocarbons, esters, ketones, ethers, fatty alcohols, and volatile siloxanes; the chlorinated hydrocarbons are preferably one or more of dichloromethane and chloroform; the aliphatic hydrocarbons are preferably one or more of butane, pentane, and hexane; the aromatic hydrocarbons are preferably one or more of benzene, toluene, and xylene; the esters are preferably one or more of ethyl acetate and butyl acetate; the ketones are preferably methyl isobutyl ketone; the ethers are preferably one or more of tetrahydrofuran, butyl ether, and dioxane; the fatty alcohols are preferably one or more of methanol, ethanol, and isopropanol; and the volatile siloxanes are preferably one or more of polydimethylsiloxane and linear volatile silicone oil, more preferably hexamethyldisiloxane.
[0028] This application does not impose specific limitations on the preparation method of the coating composition, which can be carried out according to the following steps:
[0029] The primer composition is obtained by mixing alkoxy-containing reactive silicone oil, high molecular weight non-reactive silicone oil, and diluent. In some specific implementations, the type of diluent is as described above, and will not be repeated here. The mixing method is stirring. The mixing time is 10 min to 30 min, preferably 20 min. In the primer composition, the mass concentration of alkoxy-containing reactive silicone oil and high molecular weight non-reactive silicone oil is 3% to 9%, preferably 5% to 8%, and more preferably 6%.
[0030] This application describes the preparation of a topcoat composition by mixing a low molecular weight non-reactive silicone oil and a diluent. In some specific implementations, the mixing method is stirring, and the mixing time is 5 min to 20 min, preferably 10 min. In the topcoat composition, the mass concentration of the low molecular weight non-reactive silicone oil is 3% to 9%, preferably 3% to 7%, more preferably 3%, 5%, or 7%.
[0031] Furthermore, this application also provides a lubricated medical puncture device, comprising a medical puncture device substrate and a double-layer composite lubricating coating applied to the surface of the medical puncture device; the double-layer composite lubricating coating is obtained by curing the above-mentioned coating composition; in some specific implementations, the medical puncture device substrate is selected from one or more of injection needles, infusion needles, blood collection needles, biopsy needles and indwelling needles.
[0032] Furthermore, this application also provides a method for preparing the above-mentioned medical puncture instrument, the specific preparation steps of which include: The primer composition is applied to the surface of the medical puncture instrument substrate and cured for the first time. Then, the topcoat composition is applied to the cured medical puncture instrument substrate surface and cured for the second time to obtain the medical puncture instrument.
[0033] In some specific implementations, the coating method is selected from one or more of immersion, wiping, or spraying, preferably immersion; the temperature of the first curing is 40℃~90℃, preferably 60℃~80℃, more preferably 70℃; the time of the first curing is 5min~60min, preferably 10min~30min, more preferably 15min; the temperature of the second curing is 40℃~90℃, preferably 60℃~80℃, more preferably 70℃; the time of the second curing is 5min~60min, preferably 10min~30min, more preferably 15min.
[0034] Figure 1 This is a schematic diagram of the double-layer composite lubricating coating of this application, as shown below. Figure 1 As described above, during the high-friction initial stage when the needle tip first enters the tissue, the high-molecular-weight non-reactive silicone oil in the bottom layer provides immediate lubrication through physical entanglement, reducing the initial puncture force. In the stage where the needle continues to penetrate and friction is relatively low, the low-molecular-weight non-reactive silicone oil in the top layer, with its excellent surface mobility and low surface energy, further reduces sliding friction, thereby achieving optimized control of the resistance curve throughout the puncture process. This staged, intelligent lubrication mechanism significantly improves the smoothness and controllability of the puncture operation.
[0035] This application provides a two-layer composite lubricating coating composition, including a primer composition and a topcoat composition; the primer composition includes an alkoxy-containing reactive silicone oil of formula (I) and a high molecular weight non-reactive silicone oil of formula (II); the topcoat composition includes a low molecular weight non-reactive silicone oil of formula (III); the alkoxy-containing reactive silicone oil of this application achieves chemical anchoring of the bottom layer on the metal substrate through Si-OM covalent bonds formed by the hydrolysis of alkoxy groups and the condensation of hydroxyl groups on the metal surface, while the high molecular weight non-reactive silicone oil and reactive silicone oil segments entangle to form an interpenetrating physical network, constructing a dual stable structure with both chemical bonding and physical entanglement, significantly enhancing the coating's anti-peeling and wear resistance during dynamic puncture; the low molecular weight non-reactive silicone oil acts as a lubricating phase covering the surface of the bottom coating, maintaining extremely low puncture resistance while achieving long-term stable retention of the lubricating phase through the physical constraint of the bottom network, avoiding the migration and peeling of traditional silicone oil coatings; medical puncture instruments coated with the coating composition of this application have both high adhesion strength and lubricity, while significantly reducing puncture resistance.
[0036] Experimental results show that the maximum puncture force of the medical puncture instrument coated with the double-layer coating composition described in this application is only 0.738N, and the average puncture resistance is only 0.059N.
[0037] The present application is further illustrated below with reference to embodiments. The scope of protection of the present application is not limited to the following embodiments.
[0038] Example 1
[0039] 1. Main ingredients: Formula (IV); Formula (V); Formula (VI); Alkyl-containing reactive silicone oil: degree of polymerization m=300; High molecular weight non-reactive silicone oil: degree of polymerization p=1000; Low molecular weight non-reactive silicone oil: degree of polymerization q=50; 2. Preparation method: 1) Take 3g of alkoxy-containing reactive silicone oil and 3g of high molecular weight non-reactive silicone oil (the mass ratio of alkoxy-containing reactive silicone oil to high molecular weight non-reactive silicone oil is 1:1), dissolve them in 94g of hexamethyldisiloxane (the concentration of alkoxy-containing reactive silicone oil is 3%, and the concentration of high molecular weight non-reactive silicone oil is 3%), stir at room temperature for 20min to obtain a primer composition; take 3g of low molecular weight non-reactive silicone oil, dissolve it in 97g of hexamethyldisiloxane (the concentration of low molecular weight non-reactive silicone oil is 3%), stir at room temperature for 10min to obtain a topcoat composition. 2) Immerse the blood collection needle in the primer composition, remove excess liquid from the needle cavity and surface, and then cure it in a 70°C oven for 15 minutes; then immerse the cured blood collection needle in the top coating composition, remove excess liquid, and cure it in a 70°C oven for 15 minutes. After curing, remove the needle and cool it at room temperature to obtain a blood collection needle with a double-layer composite lubricating coating.
[0040] Figure 2 This is the puncture force curve of Example 1, as shown below. Figure 2 As shown, the blood collection needle coated with a double-layer composite lubricating coating has a maximum puncture force of only 0.738N and an average puncture resistance of 0.059N. This indicates that the double-layer design achieves intelligent matching of lubrication function at different puncture stages, thereby obtaining comprehensive and excellent lubrication performance while ensuring adhesion strength.
[0041] Example 2
[0042] The difference between this embodiment and Example 1 is that the concentration of low molecular weight non-reactive silicone oil is adjusted from 3% to 5%, while the other raw materials and preparation methods are exactly the same.
[0043] Example 3
[0044] The difference between this embodiment and Example 1 is that the concentration of low molecular weight non-reactive silicone oil is adjusted from 3% to 7%, while the other raw materials and preparation methods are exactly the same.
[0045] Example 4
[0046] The difference between this embodiment and Example 1 is that the mass ratio of alkoxy-containing reactive silicone oil to high molecular weight non-reactive silicone oil is adjusted from 1:1 to 2:1 (that is, the concentration of alkoxy-containing reactive silicone oil is adjusted from 3% to 4%, and the concentration of high molecular weight non-reactive silicone oil is adjusted from 3% to 2%). The other raw materials and preparation methods are exactly the same.
[0047] Example 5
[0048] The difference between this embodiment and Example 1 is that the mass ratio of alkoxy-containing reactive silicone oil to high molecular weight non-reactive silicone oil is adjusted from 1:1 to 0.5:1 (that is, the concentration of alkoxy-containing reactive silicone oil is adjusted from 3% to 2%, and the concentration of high molecular weight non-reactive silicone oil is adjusted from 3% to 4%). The other raw materials and preparation methods are exactly the same.
[0049] Comparative Example 1
[0050] The difference between this comparative example and Example 1 is that the blood collection needle was coated with only the top coating composition instead of the base coating composition. All other raw materials and preparation methods were exactly the same.
[0051] Figure 3 The diagram shows the puncture force curve for Comparative Example 1. The results indicate that the puncture force of the blood collection needle coated only with the top coating is 1.215 N, and the average resistance during puncture is as high as 0.296 N. This is mainly because the top low molecular weight silicone oil coating lacks chemical interaction with the metal substrate and relies solely on physical adsorption, resulting in weak coating adhesion. During puncture, the coating is prone to displacement or local detachment, failing to form a stable and continuous lubrication interface.
[0052] Comparative Example 2
[0053] The difference between this comparative example and Example 1 is that the blood collection needle was not coated with a top coating composition, but only with a base coating composition. All other raw materials and preparation methods were exactly the same.
[0054] Figure 4The diagram shows the puncture force curve for Comparative Example 2. The results indicate that the maximum puncture force of the blood collection needle coated only with the bottom layer is 0.814 N, significantly lower than that with only the top layer. This is because the alkoxy-containing reactive silicone oil in the bottom layer can form covalent bonds with the metal surface through hydrolysis, ensuring strong adhesion. Simultaneously, the interpenetrating network composed of high-molecular-weight non-reactive silicone oil provides effective lubrication under high-friction conditions. However, the average resistance of this structure during the sustained puncture phase still reaches 0.16 N, indicating that the lubrication performance of a single bottom layer coating in low-friction areas remains limited.
[0055] Comparative Example 3
[0056] 1. Main ingredients: Alkyl-containing reactive silicone oil: degree of polymerization m=300; High molecular weight non-reactive silicone oil: degree of polymerization p=1000; Low molecular weight non-reactive silicone oil: degree of polymerization q=50; Formula (IV); Formula (V); Formula (VI); 2. Preparation method: 1) Take 3g of alkoxy-containing reactive silicone oil, 3g of high molecular weight non-reactive silicone oil and 3g of low molecular weight non-reactive silicone oil, dissolve them in 91g of hexamethyldisiloxane, stir at room temperature for 20min to obtain a coating composition. 2) Immerse the blood collection needle in the coating composition, blow off the excess liquid in the needle cavity and on the surface, and then place it in a 70°C oven to cure for 15 minutes. After curing, remove it and cool it at room temperature to obtain a blood collection needle with a single-layer composite lubricating coating.
[0057] Figure 7The figures show a comparison of the puncture effects of Example 1 and Comparative Example 3. The results show that both the single-layer coating and the double-layer coating of this application significantly reduce the puncture force compared to the uncoated needle. However, the maximum puncture force and average puncture resistance of the double-layer coating of this invention are lower than those of the single-layer mixed coating. This is because in the single-layer coating, low-molecular-weight silicone oil is blended with reactive and high-molecular-weight silicone oils. Some of the low-molecular-weight silicone oil is embedded within the coating, and its lubrication depends on "permeation" from within the coating to the surface. This process requires overcoming interfacial resistance during the initial puncture stage, resulting in a higher maximum puncture force. During the continuous penetration stage, the permeation rate of the low-molecular-weight silicone oil may gradually decrease, causing the sliding resistance to rise slowly, making it difficult to maintain stable lubrication. In contrast, this invention sets the low-molecular-weight silicone oil as a separate top layer, initially exposed to the coating surface. It immediately provides lubrication when the needle tip contacts the tissue and directly provides stable, ultra-low sliding friction throughout the puncture process, without relying on a permeation mechanism. Therefore, the double-layer coating of this invention exhibits superior performance in both maximum puncture force and average puncture resistance, with a smoother puncture resistance curve.
[0058] Performance testing: The lubrication effect of puncture instruments was tested according to the test method of GB 15811-2016. The testing equipment was a medical injection needle tip puncture force performance tester (ZC7864-D, Shanghai Heng Instrument Factory Co., Ltd.). The test was conducted in a constant temperature and humidity environment (22℃±2℃), using a polyurethane film with a thickness of 0.35mm±0.05mm and a Shore A hardness of 85±10 as the simulated skin material. Before the test, the sample and film should be conditioned under the above conditions for no less than 24 hours. During the test, the film was tension-free clamped in a special fixture, exposing a circular puncture area with a diameter of 10mm. The needle under test was vertically mounted on the testing device, with its axis aligned with the center of the puncture area, and punctured the film vertically at a constant speed of 100mm / min. The force changes during the puncture process were recorded, and the maximum peak force and resistance were taken as the puncture force results. Each needle could only perform one effective puncture in the unused area of the film. The final puncture force is the average of the test results of no less than 30 needles from the same batch.
[0059] Figure 5 The figures show a comparison of the average puncture resistance of Examples 1-3 and Comparative Examples 1-2. The results show that Comparative Examples 1 and 2, which are coated with only a single layer, maintain a high level of puncture resistance. However, in Examples 1-3, which use a double-layer structure, the puncture resistance shows a slight decreasing trend as the concentration of silicone oil in the top layer composition increases from 3% to 7%, but the change is not significant, indicating that the improvement in the lubrication performance of the top layer is limited within this concentration range. It is worth noting that when the concentration increases to 7%, a small amount of local accumulation of silicone oil is observed on the needle surface after puncture. This may be due to the slightly higher content of low molecular weight non-reactive silicone oil on the surface, which exceeds the ideal entanglement capacity with the bottom layer network.
[0060] Figure 6 This is a comparison chart of the average maximum puncture force of Examples 1, 4, 5 and Comparative Examples 1-2. Comparative Example 1 has the highest maximum puncture force, while Comparative Example 2 shows a significant decrease, which confirms the key role of the bottom coating in improving adhesion through chemical bonding. Examples 1 and 4-5 both adopt a double-layer design, and their maximum puncture force is further reduced, demonstrating the synergistic effect of the double layers. As the proportion of non-reactive silicone oil in the bottom layer gradually increases, the maximum puncture force shows a trend of first decreasing and then slightly increasing, indicating that an excessively high proportion of non-reactive silicone oil may lead to a loose network structure, affecting the coating's load-bearing and lubrication efficiency in the initial stage of puncture.
[0061] The above description is merely a preferred embodiment of this application, but the scope of protection of this application is not limited thereto. Any equivalent substitutions or modifications made by those skilled in the art within the scope of the technology disclosed in this application, based on the technical solution and application concept of this application, should be included within the scope of protection of this application.
Claims
1. A two-layer composite lubricating coating composition, characterized in that, include: Primer composition and topcoat composition; The primer composition comprises an alkoxy-containing reactive silicone oil of formula (I) and a high molecular weight non-reactive silicone oil of formula (II); The topcoat composition comprises a low molecular weight nonreactive silicone oil of formula (III); Formula (I); Formula (II); Formula (III); In formula (I), R1 to R5 are each independently selected from one of C1 to C20 straight-chain alkyl and C1 to C20 branched alkyl; R6 is selected from C1 to C20 alkyl containing amino or imino; R7 to R8 are each independently selected from C1 to C20 alkoxy; m is an integer from 60 to 500. In equation (II), R9~R 16 Each is independently selected from one of C1-C20 straight-chain alkyl groups and C1-C20 branched alkyl groups; p is an integer from 300 to 2000; In equation (III), R 17 ~R 24 Each is independently selected from one of C1-C20 straight-chain alkyl and C1-C20 branched alkyl; q is an integer from 5 to 100.
2. The coating composition according to claim 1, characterized in that, In the formula (I), R1 to R5 are each independently selected from one of C1 to C10 straight-chain alkyl and C1 to C10 branched alkyl; R6 is selected from C1 to C10 alkyl containing amino or imino; R7 to R8 are each independently selected from C1 to C10 alkoxy; m is an integer from 100 to 450. In equation (II), R9~R 16 Each is independently selected from one of C1-C10 straight-chain alkyl groups and C1-C10 branched alkyl groups; p is an integer from 500 to 1500; In equation (III), R 17 ~R 24 Each is independently selected from one of C1-C10 straight-chain alkyl and C1-C10 branched alkyl; q is an integer from 10 to 90.
3. The coating composition according to claim 2, characterized in that, In the formula (I), R1 to R5 are each independently selected from one of C1 to C6 straight-chain alkyl and C1 to C6 branched alkyl; R6 is γ-aminopropyl or N-(β-aminoethyl)-γ-aminopropyl; R7 to R8 are each independently selected from C1 to C6 alkoxy; m is an integer from 150 to 400; In equation (II), R9~R 16 Each is independently selected from one of C1-C6 straight-chain alkyl groups and C1-C6 branched alkyl groups; p is an integer from 800 to 1300; In equation (III), R 17 ~R 24 Each is independently selected from one of C1-C6 straight-chain alkyl groups and C1-C6 branched alkyl groups; q is an integer from 40 to 80.
4. The coating composition according to claim 3, characterized in that, The specific structures of the alkoxy-containing reactive silicone oil, high molecular weight non-reactive silicone oil, and low molecular weight non-reactive silicone oil are shown in formulas (IV) to (VI): Formula (IV); Formula (V); Formula (VI); In equation (IV), m is 300; In equation (V), p is 1000; In equation (VI), q is 50.
5. The coating composition according to claim 1, characterized in that, The mass ratio of the alkoxy-containing reactive silicone oil to the high molecular weight non-reactive silicone oil is (0.5~3):
1.
6. The coating composition according to any one of claims 1 to 5, characterized in that, It also includes diluents; The diluent is selected from one or more of chlorinated hydrocarbons, aliphatic hydrocarbons, aromatic hydrocarbons, esters, ketones, ethers, fatty alcohols, and volatile siloxanes.
7. A lubricated medical puncture instrument, characterized in that, It includes a medical puncture instrument substrate and a double-layer composite lubricating coating applied to the surface of the medical puncture instrument; The dual-layer composite lubricating coating is obtained by curing the coating composition according to any one of claims 1 to 6.
8. The medical puncture instrument according to claim 7, characterized in that, The substrate of the medical puncture instrument is selected from one or more of the following: injection needle, infusion needle, blood collection needle, biopsy needle, and indwelling needle.
9. A method for preparing a medical puncture instrument as described in claim 7 or 8, characterized in that, The specific preparation steps include: The primer composition is applied to the surface of the medical puncture instrument substrate and cured for the first time. Then, the top coat composition is applied to the cured medical puncture instrument substrate surface and cured for the second time to obtain the medical puncture instrument.
10. The preparation method according to claim 9, characterized in that, The coating method is selected from one or more of immersion, wiping, or spraying; The temperature for the first curing is 40℃~90℃; The first curing time is 5 min to 60 min; The temperature for the second curing is 40℃~90℃; The second curing time is 5 to 60 minutes.