Anus stenosis silver needle with antibacterial coating and threading method thereof

By applying antibacterial coating on the surface of the silver needle and design a simplified thread penetration method, the problems of risk of silver needle infection and operation complexity in the prior art are solved, and safer and more efficient treatment of anal stenosis are achieved.

CN119236189AInactive Publication Date: 2025-01-03WEIHAI FANDEQIANG TRADITIONAL CHINESE MEDICINE ANORECTAL MEDICAL CO LTD
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Patent Information

Application Number
CN202411404726.1
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Filing Date
2024-10-10
Publication Date
2025-01-03
Estimated Expiration
Not applicable · inactive patent

AI Technical Summary

Technical Problem

The lack of antibacterial treatment of existing silver needles in the treatment of anal stenosis leads to a high risk of infection, improper operation can easily lead to treatment failure or increase patient pain, and the line penetration method lacks systematic step guidance.

Method used

Silver needles made of silver with a purity of no less than 99%, are coated with antibacterial coatings, including chitosan, zinc oxide, nanosilver particles and other components, and ensure the uniformity of the coating through electrolytic polishing, plasma spraying and other technologies. and stability, while designing simplified threading methods, including sterile treatment, lubricant use and synchronous propulsion.

Benefits of technology

It significantly reduces the risk of infection, improves the antibacterial performance of silver needles and the safety and reliability of penetration, improves the treatment experience of patients, simplifies operating steps, and improves penetration efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The invention relates to the technical field of medical instruments, in particular to an anal stenosis silver needle with an antibacterial coating and a threading method thereof.The silver needle is made of silver with the purity not lower than 99%, the diameter of the silver needle is 1-3 mm, the length of the silver needle is 10-15 cm, and the surface of the silver needle is coated with the antibacterial coating. The antibacterial coating comprises the following raw materials in percentage by weight: 1-5% of chitosan, 2-4% of zinc oxide, 1-3% of nano-silver particles, 5-10% of polydimethylsiloxane, 1-3% of ethylene glycol, 2-5% of silicon dioxide and the balance of a solvent. According to the invention, the surface of the silver needle is coated with the antibacterial coating, and simplified and reasonable threading operation steps are designed, so that the infection risk in the threading process is reduced, the discomfort of a patient is reduced, and the operation safety and efficiency are improved.
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Description

Technical Field

[0001] The invention relates to the technical field of medical devices, in particular to anal stenosis silver needles with antibacterial coatings and a thread penetration method thereof. Background Art

[0002] Anal stenosis is a common anorectal disease, usually caused by chronic inflammation, surgical trauma or other anorectal diseases, which leads to proliferation of tissues around the anus and contraction of connective tissue, thereby causing the anal caliber to narrow. In severe cases, it can lead to difficulty in defecation and severe pain. For patients with severe anal stenosis, physical dilation methods are often used for treatment. Among them, silver needles, as a medical device, are widely used in the treatment of anal stenosis dilation. The traditional silver needle threading method is to pass the silver needle through the narrow part and then guide the medical thread. However, in actual operation, due to the easy breeding of bacteria in the anal area, there is a high risk of infection. At the same time, due to the narrowness of the narrow part, the threading operation is often accompanied by a great degree of discomfort for the patient.

[0003] Silver needles in the prior art are often not treated with antibacterial agents, or the coating is uneven, and the antibacterial effect is limited, which makes patients prone to infection during and after the threading process. In addition, the existing threading operation method lacks systematic step-by-step guidance, which can easily lead to treatment failure or increase the patient's pain due to improper operation. Therefore, it is of great clinical significance to develop a silver needle with an antibacterial coating for anal stenosis and design a simpler threading method that reduces patient discomfort. Summary of the invention

[0004] Based on the above purpose, the present invention provides an anal stenosis silver needle with an antibacterial coating and a thread penetration method thereof.

[0005] Anal stenosis silver needle with antibacterial coating, the silver needle is made of silver with a purity of not less than 99%, the diameter of the silver needle is 1-3mm, the length is 10-15cm, the surface of the silver needle is coated with antibacterial coating, the antibacterial coating comprises the following raw materials in weight percentage: chitosan 1-5%, zinc oxide 2-4%, nano silver particles 1-3%, polydimethylsiloxane 5-10%, ethylene glycol 1-3%, silicon dioxide 2-5% and solvent, the solvent is the balance to make the total amount reach 100%; The specific preparation of the silver needle comprises the following steps: S1: Surface treatment of the prepared silver needles, removing surface impurities and rough spots by electrolytic polishing; S2: Clean the silver needle to remove the oil and tiny particles remaining on the surface; S3: Pre-treat the silver needles and use plasma spraying technology to form a microscopic rough structure on the surface of the silver needles; S4: preparing antibacterial coating raw materials, and preparing the coating raw materials into antibacterial coating solutions according to a formula; S5: evenly coating the antibacterial coating solution on the surface of the silver needle to form an antibacterial coating on the surface of the silver needle; S6: curing the coated silver needles to ensure that the coating adheres firmly; S7: The solidified silver needles are sealed and packaged to ensure that the prepared silver needles are not contaminated during storage and transportation.

[0006] Optionally, the S4 specifically includes: S41: preparing various components of the antibacterial coating according to a predetermined ratio for standby use; S42: adding all components into a mixing tank and stirring using a high-speed stirring device, with the stirring speed controlled at 800-1200 rpm for 30 minutes; S43: Filter the prepared antimicrobial coating solution through a filter with a pore size of 0.2-0.5 microns to remove any undissolved particles or impurities.

[0007] Optionally, the voltage of the electrolytic polishing in S1 is controlled at 5-15V, and the polishing time is 10-20 minutes.

[0008] Optionally, the frequency of ultrasonic cleaning in S2 is 40-60 kHz, the cleaning time is 5-10 minutes, and the cleaning liquid used is ethanol.

[0009] Optionally, the gas pressure of the plasma spraying in S3 is 0.1-0.5 MPa, and the processing time is 3-8 minutes.

[0010] Optionally, the coating thickness in S5 is controlled at 0.1-0.3 mm, and the specific coating process is carried out by spraying, and the spraying air pressure is controlled at 0.2-0.6 MPa.

[0011] Optionally, the temperature of the curing treatment in S6 is 50-80° C., and the curing time is 20-40 minutes.

[0012] Optionally, the sealed packaging of the silver needles in S7 is vacuum packaging, the vacuum degree is controlled at 0.01-0.05MPa during packaging, and the sealing material is a medical grade sterile material.

[0013] The method of threading an anal stenosis with a silver needle having an antibacterial coating comprises the following steps: Step 1: Prepare the silver needle and medical thread with antibacterial coating, and ensure that the silver needle and thread are sterile. The medical thread should be antibacterial suture thread; Step 2: Thoroughly clean and disinfect the patient's anal area, ensure the operation area is sterile, and apply medical lubricant to the narrow part of the anus; Step 3: Slowly insert the silver needle into the narrow part of the anus, keep the needle parallel to the anal tissue, and guide the silver needle through the narrow part. Note that the advancement of the needle should be synchronized with the patient's breathing rhythm; Step 4: After the silver needle passes through the narrow part, fix the medical thread to the connection hole at the end of the silver needle to ensure that the thread is firmly wrapped; Step 5: Slowly withdraw the silver needle. During the process of withdrawing the silver needle, the medical thread will smoothly pass through the narrow part and be pulled to the predetermined position; Step 6: After threading is completed, cut off or fix the excess part of the silver needle and thread end, and cover the operation site with sterile gauze.

[0014] Beneficial effects of the present invention: The present invention effectively solves the infection problem caused by bacterial growth during the threading process by coating the silver needle with an antibacterial coating. The coating adopts antibacterial components such as chitosan, zinc oxide, and nano-silver particles, has a broad-spectrum antibacterial effect, and can significantly reduce the risk of infection during and after surgery. At the same time, the silver needle undergoes fine surface treatment and coating technology to ensure the uniformity and stability of the coating, which greatly improves the antibacterial performance of the silver needle and makes it safer and more reliable during the threading process.

[0015] The present invention, through the designed threading method, simplifies the operating steps and combines the use of lubricants, can effectively reduce the friction during threading and the patient's discomfort, improve the patient's treatment experience, and the steps are closely connected with clear logic, which is easier for operators to master and execute. The threading efficiency is significantly improved, and the present invention is suitable for promotion and application in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] In order to more clearly illustrate the technical solutions in the present invention or the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are only for the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative work.

[0017] Figure 1 Schematic diagram of a method for preparing silver needles for anal stenosis according to an embodiment of the present invention; Figure 2 Schematic diagram of the thread penetration method of silver needles for anal stenosis according to an embodiment of the present invention. DETAILED DESCRIPTION

[0018] The present invention is described in detail below in conjunction with the accompanying drawings and specific embodiments. At the same time, it is explained here that in order to make the embodiments more detailed, the following embodiments are the best and preferred embodiments, and those skilled in the art may also adopt other alternatives to implement some known technologies; and the accompanying drawings are only for more specific description of the embodiments, and are not intended to specifically limit the present invention.

[0019] It should be noted that the references to "one embodiment", "embodiment", "exemplary embodiments", "some embodiments" and the like in the specification indicate that the embodiments described may include specific features, structures or characteristics, but not every embodiment may include the specific features, structures or characteristics. In addition, when a specific feature, structure or characteristic is described in conjunction with an embodiment, it should be within the knowledge of a person skilled in the art to implement such feature, structure or characteristic in conjunction with other embodiments (whether or not explicitly described).

[0020] In general, a term can be understood, at least in part, from its use in context. For example, depending, at least in part, on the context, the term "one or more" as used herein can be used to describe any feature, structure, or characteristic in the singular sense, or can be used to describe a combination of features, structures, or characteristics in the plural sense. Additionally, the term "based on" can be understood as not necessarily intended to convey an exclusive set of factors, but can instead, depending, at least in part, on the context, allow for the presence of other factors that are not necessarily explicitly described.

[0021] Example 1 like Figure 1 As shown, an anal stenosis silver needle with an antibacterial coating is made of silver with a purity of not less than 99%, the diameter of the silver needle is 1.5 mm, the length is 12 cm, the surface of the silver needle is coated with an antibacterial coating, and the antibacterial coating includes the following raw materials in percentage by weight: 3% chitosan, 3% zinc oxide, 2% nano silver particles, 7% polydimethylsiloxane, 3% ethylene glycol, 3% silicon dioxide and solvent, and the solvent is the balance to make the total amount reach 100%; The specific preparation of the silver needle comprises the following steps: S1: Surface treatment of the prepared silver needles is performed by removing surface impurities and rough spots through electrolytic polishing to ensure that the surface of the needle body is smooth; S2: Clean the silver needle to remove the residual oil and tiny particles on the surface to ensure the surface is clean; S3: Pre-treat the silver needles by using plasma spraying technology to form a microscopic rough structure on the surface of the silver needles to enhance the stability of the coating; S4: preparing antibacterial coating raw materials, and preparing the coating raw materials into antibacterial coating solutions according to a formula; S5: evenly coating the antibacterial coating solution on the surface of the silver needle to form an antibacterial coating on the surface of the silver needle; S6: curing the coated silver needles to ensure that the coating adheres firmly; S7: The solidified silver needles are sealed and packaged to ensure that the prepared silver needles are not contaminated during storage and transportation.

[0022] The antibacterial coating solution prepared according to the formula in S4 specifically includes: S41: preparing various components of the antibacterial coating according to a predetermined ratio for standby use; S42: Add all components into a mixing tank and stir using a high-speed stirring device at a stirring speed of 1000 rpm for 30 minutes to ensure complete dissolution and uniform mixing; S43: Filter the prepared antimicrobial coating solution through a filter with a pore size of 0.3 micrometers to remove any undissolved particles or impurities to ensure that the coating quality meets the requirements.

[0023] The voltage of electrolytic polishing in S1 was controlled at 10 V, and the polishing time was 15 minutes.

[0024] The frequency of ultrasonic cleaning in S2 is 50 kHz, the cleaning time is 8 minutes, and the cleaning solution used is ethanol.

[0025] The gas pressure of the plasma spraying in S3 was 0.3 MPa, and the processing time was 5 minutes.

[0026] The coating thickness in S5 is controlled at 0.2 mm, and the specific coating process adopts spraying method, and the spraying air pressure is controlled at 0.4 MPa.

[0027] The temperature of the curing treatment in S6 is 60° C. and the curing time is 30 minutes.

[0028] The sealed packaging of the silver needles in S7 is vacuum packaging. The vacuum degree is controlled at 0.03MPa during packaging, and the sealing material is medical grade sterile material.

[0029] like Figure 2 As shown, the method for threading an anal stenosis with an antibacterial coating silver needle comprises the following steps: Step 1: Prepare the silver needle and medical thread with antibacterial coating, and ensure that the silver needle and thread are sterile. The medical thread should be antibacterial suture to reduce the risk of infection; Step 2: Thoroughly clean and disinfect the patient's anal area to ensure that the operation area is sterile, and apply medical lubricant to the narrow part of the anus to reduce operating friction; Step 3: Slowly insert the silver needle into the narrow part of the anus, keep the needle parallel to the anal tissue, and guide the silver needle through the narrow part. Note that the advancement of the needle should be synchronized with the patient's breathing rhythm to reduce discomfort; Step 4: After the silver needle passes through the narrow part, fix the medical thread to the connection hole at the end of the silver needle to ensure that the thread is firmly wrapped; Step 5: Slowly withdraw the silver needle. During the process of withdrawing the silver needle, the medical thread will smoothly pass through the narrow part and be pulled to the predetermined position; Step 6: After threading, cut off or fix the excess part of the silver needle and thread end, cover the operation site with sterile gauze, and give necessary antibacterial treatment to prevent infection.

[0030] Example 2 S1: Preparation of silver needles, using silver material with a purity of 99.9%, a diameter of 1 mm and a length of 10 cm, and surface treatment of the prepared silver needles, with the voltage of electrolytic polishing set to 5 V and the polishing time set to 10 minutes to remove surface impurities and rough spots; S2: Silver needle cleaning: After electrolytic polishing, the silver needle is cleaned using an ultrasonic device with a frequency of 40kHz for 5 minutes. The cleaning liquid is ethanol to ensure that there is no oil stain and tiny particles on the surface. S3: Pretreatment of silver needles: using plasma spraying equipment with an air pressure of 0.1 MPa to treat the silver needles for 3 minutes to form a microscopic rough structure on the surface of the silver needles to increase the adhesion of the antibacterial coating; S4: Preparation of antibacterial coating solution, first prepare the raw materials of antibacterial coating, including 1% chitosan, 2% zinc oxide, 1% nano silver particles, 5% polydimethylsiloxane, 1% ethylene glycol, 2% silicon dioxide, and the rest is solvent; then add all the raw materials into a stirring tank, stir at a speed of 800 rpm with a high-speed stirrer for 30 minutes, and then filter the solution with a filter with a pore size of 0.2 microns to remove undissolved particles; S5: Antibacterial coating coating: spray the prepared antibacterial coating solution on the surface of the silver needle, the coating thickness is controlled at 0.1 mm, and the spraying pressure is set to 0.2 MPa; S6: Coating curing. After coating, the silver needle is placed in a 50°C environment for curing for 20 minutes to ensure that the coating is firmly attached. S7: Finally, the cured silver needles are vacuum packed with the vacuum degree controlled at 0.01MPa and sealed with medical-grade sterile packaging materials to ensure that the silver needles are not contaminated during storage and transportation.

[0031] Example 3 S1: Preparation of silver needles, using silver material with a purity of 99.9%, a diameter of 3 mm and a length of 15 cm, and surface treatment of the prepared silver needles, with the voltage of electrolytic polishing set to 15 V and the polishing time set to 20 minutes to remove surface impurities and rough spots; S2: Silver needle cleaning: After electrolytic polishing, the silver needle is cleaned using an ultrasonic device with a frequency of 60kHz for 10 minutes. The cleaning liquid is ethanol to ensure that there is no oil stain and tiny particles on the surface. S3: Pretreatment of silver needles: using plasma spraying equipment with an air pressure of 0.5 MPa to treat the silver needles for 8 minutes to form a microscopic rough structure on the surface of the silver needles to increase the adhesion of the antibacterial coating; S4: Preparation of antibacterial coating solution, first prepare the raw materials of antibacterial coating, including 5% chitosan, 4% zinc oxide, 3% nano silver particles, 10% polydimethylsiloxane, 3% ethylene glycol, 5% silicon dioxide, and the rest is solvent; then add all the raw materials into a stirring tank, stir at a speed of 1200 rpm with a high-speed stirrer for 30 minutes, and then filter the solution with a filter with a pore size of 0.5 microns to remove undissolved particles; S5: Antibacterial coating coating: spray the prepared antibacterial coating solution on the surface of the silver needle, the coating thickness is controlled at 0.3 mm, and the spraying pressure is set to 0.6 MPa; S6: Coating curing. After coating, the silver needle is placed in an environment of 80°C for curing for 40 minutes to ensure that the coating is firmly attached. S7: Finally, the cured silver needles are vacuum-packed with the vacuum degree controlled at 0.05MPa and sealed with medical-grade sterile packaging materials to ensure that the silver needles are not contaminated during storage and transportation.

[0032] Table 1 Comparison of performance parameters of finished narrow silver needles project Example 1 Example 2 Example 3 Surface roughness(nm) 100 120 180 Coating thickness(mm) 0.2 0.1 0.3 Antibacterial effect (%) 99.9 95 98 Coating Adhesion(MPa) 0.8 0.3 0.7 Silver needle strength (MPa) 230 180 220 Corrosion resistance (%) 99.5 95 99 Yield rate (%) 98 90 92 As can be seen from Table 1 above, the performance indicators of Example 1 are all the best, among which the surface roughness is 100nm, indicating that the silver needle surface treatment effect is the best, which is conducive to the adhesion of the antibacterial coating; the coating thickness is 0.2mm, and the moderate thickness ensures the effectiveness and stability of the coating; the antibacterial effect is 99.9%, showing the best antibacterial performance; the coating adhesion is 0.8MPa, and the highest coating adhesion ensures the coating stability in long-term use; the silver needle strength is 230MPa, and the higher mechanical strength ensures the durability of the silver needle; the corrosion resistance is 99.5%, which has the strongest corrosion resistance and is suitable for long-term use; the finished product rate is 98%, and the high finished product rate indicates the reliability of the production process. Therefore, Example 1 shows the best performance in all items and is the most ideal.

[0033] The present invention covers any substitution, modification, equivalent method and scheme made on the essence and scope of the present invention. In order to make the public have a thorough understanding of the present invention, specific details are described in detail in the following preferred embodiments of the present invention, but those skilled in the art can fully understand the present invention without the description of these details. In addition, in order to avoid unnecessary confusion about the essence of the present invention, well-known methods, processes, procedures, components and circuits are not described in detail.

[0034] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and modifications can be made without departing from the principle of the present invention. These improvements and modifications should also be regarded as the scope of protection of the present invention.

Claims

1. Anal stenosis silver needle with antibacterial coating, characterized in that: The silver needle is made of silver with a purity of not less than 99%, with a diameter of 1-3 mm and a length of 10-15 cm. The surface of the silver needle is coated with an antibacterial coating, which includes the following raw materials by weight percentage: 1-5% chitosan, 2-4% zinc oxide, 1-3% nano silver particles, 5-10% polydimethylsiloxane, 1-3% ethylene glycol, 2-5% silicon dioxide and a solvent, wherein the solvent is the remainder so that the total amount reaches 100%; The specific preparation of the silver needle comprises the following steps: S1: Surface treatment of the prepared silver needles, removing surface impurities and rough spots by electrolytic polishing; S2: Clean the silver needle to remove the oil and tiny particles remaining on the surface; S3: Pre-treat the silver needles and use plasma spraying technology to form a microscopic rough structure on the surface of the silver needles; S4: preparing antibacterial coating raw materials, and preparing the coating raw materials into antibacterial coating solutions according to a formula; S5: evenly coating the antibacterial coating solution on the surface of the silver needle to form an antibacterial coating on the surface of the silver needle; S6: curing the coated silver needles to ensure that the coating adheres firmly; S7: The solidified silver needles are sealed and packaged to ensure that the prepared silver needles are not contaminated during storage and transportation.

2. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The S4 specifically includes: S41: preparing various components of the antibacterial coating according to a predetermined ratio for standby use; S42: adding all components into a mixing tank and stirring using a high-speed stirring device, with the stirring speed controlled at 800-1200 rpm for 30 minutes; S43: Filter the prepared antimicrobial coating solution through a filter with a pore size of 0.2-0.5 microns to remove any undissolved particles or impurities.

3. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The voltage of the electrolytic polishing in S1 is controlled at 5-15V, and the polishing time is 10-20 minutes.

4. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The frequency of ultrasonic cleaning in S2 is 40-60kHz, the cleaning time is 5-10 minutes, and the cleaning liquid used is ethanol.

5. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The gas pressure of the plasma spraying in S3 is 0.1-0.5 MPa, and the processing time is 3-8 minutes.

6. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The coating thickness in S5 is controlled at 0.1-0.3 mm, and the specific coating process adopts a spraying method, and the spraying air pressure is controlled at 0.2-0.6 MPa.

7. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The temperature of the curing treatment in S6 is 50-80° C., and the curing time is 20-40 minutes.

8. The anal stenosis silver needle with antibacterial coating according to claim 1, characterized in that: The sealed packaging of the silver needles in the S7 is vacuum packaging, the vacuum degree is controlled at 0.01-0.05MPa during packaging, and the sealing material is medical grade sterile material.

9. A method for threading anal stenosis with a silver needle having an antibacterial coating, characterized in that: The following steps are involved: Step 1: Prepare the silver needle and medical thread with antibacterial coating, and ensure that the silver needle and thread are sterile. The medical thread should be antibacterial suture thread; Step 2: Thoroughly clean and disinfect the patient's anal area, ensure the operation area is sterile, and apply medical lubricant to the narrow part of the anus; Step 3: Slowly insert the silver needle into the narrow part of the anus, keep the needle parallel to the anal tissue, and guide the silver needle through the narrow part. Note that the advancement of the needle should be synchronized with the patient's breathing rhythm; Step 4: After the silver needle passes through the narrow part, fix the medical thread to the connection hole at the end of the silver needle to ensure that the thread is firmly wrapped; Step 5: Slowly withdraw the silver needle. During the process of withdrawing the silver needle, the medical thread will smoothly pass through the narrow part and be pulled to the predetermined position; Step 6: After threading is completed, cut off or fix the excess part of the silver needle and thread end, and cover the operation site with sterile gauze.