Medical endoscope antifogging agent and application thereof

Abstract

The application discloses a medical endoscope antifogging agent and application thereof, and belongs to the medical instrument field. The medical endoscope antifogging agent is composed of cellulose, a zwitterionic polymer, deionized water and ethanol, wherein the weight percentage of the cellulose is 0.001wt%-10wt%; the weight percentage of the zwitterionic polymer is 0.001wt%-10wt%; the weight percentage of the ethanol is 40wt%-90wt%; and the rest is the deionized water. The cellulose can form a film on the surface of the medical endoscope, and the zwitterionic polymer can resist the adhesion of biological components in the body. The medical endoscope antifogging agent combines the cellulose and the zwitterionic polymer, can play a long-time antifogging role, can significantly reduce the adhesion of biological components in the body to the endoscope, can keep the endoscope in the body with a high light transmittance during the operation, can keep the visual field clear during the operation, and can improve the operation accuracy. The application solves the technical problems that the existing medical endoscope antifogging agent has a short antifogging time and is easy to adhere to biological components in the body.

Description

Technical Field

[0001] This disclosure relates to the field of medical devices, and more specifically, to an anti-fogging agent for medical endoscopes and its application. Background Technology

[0002] With the continuous development of minimally invasive surgical techniques, the use of rigid endoscopes in various surgeries is becoming increasingly common. Successful surgery requires not only advanced surgical skills but also a clear field of vision. During the procedure, the endoscope uses a cold light source for illumination. The temperature difference between the endoscope and the body's internal environment causes water vapor in the body cavity to fog up when it encounters the cold endoscope lens, affecting diagnostic and treatment efficiency.

[0003] Current routine clinical practices for defogging endoscopes include: preheating the lens with hot water, wiping with the greater omentum, and wiping with povidone-iodine. However, these methods have relatively short defogging times and cannot achieve prolonged defogging. Currently, the average fogging time for endoscopes using existing methods in medical institutions is 4–6 minutes, while a surgical endoscopic procedure takes approximately 26–90 minutes, and some complex procedures can last several hours. Therefore, current defogging methods require frequent removal of the endoscope lens from the patient during surgery to repeatedly wipe away the fog, severely impacting the progress and smoothness of the procedure. Furthermore, existing defogging methods easily lead to the adhesion of blood, tissue fluid, bacteria, and other biological components to the endoscope, causing contamination and reducing its light transmittance, affecting the clarity of the surgical field and consequently the accuracy of the procedure. In addition, bacterial adhesion to the endoscope surface also increases the risk of postoperative infection.

[0004] Therefore, providing a medical endoscope anti-fogging agent and its application, which can solve or alleviate at least one of the above-mentioned technical problems, would be of great significance. Summary of the Invention

[0005] In view of the above-mentioned technical problems, this disclosure provides a medical endoscope antifog agent and its application, which can achieve long antifog time, high light transmittance and reduce the adhesion of biological components such as blood, tissue fluid and bacteria on the endoscope, so as to solve or at least alleviate at least one of the technical problems existing in the above-mentioned endoscope antifog.

[0006] According to specific embodiments of this disclosure, in a first aspect, this disclosure provides a medical endoscope antifogging agent, composed of cellulose, a zwitterionic polymer, deionized water and ethanol, wherein the weight percentage of cellulose is 0.001wt% to 10wt%; the weight percentage of the zwitterionic polymer is 0.001wt% to 10wt%; the weight percentage of ethanol is 40wt% to 90wt%; and the remainder is deionized water. The cellulose is used to form a film on the surface of the medical endoscope, and the zwitterionic polymer is used to resist the adhesion of biological components in the body.

[0007] Furthermore, in the medical endoscope antifogging agent, the weight percentage of cellulose is 0.002wt%~5wt%; the weight percentage of zwitterionic polymer is 0.002wt%~5wt%; the weight percentage of ethanol is 65wt%~80wt%; and the remainder is deionized water.

[0008] Further, cellulose is one or more of cellulose acetate, cellulose triacetate, cellulose butyrate, cellulose phthalate, cellulose nitrate, cellulose sulfate, cellulose phosphate, cellulose propionate, cellulose acetate butyrate, ethyl cellulose, ethyl methyl cellulose, benzyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, ethyl hydroxyethyl cellulose, and carboxyethyl cellulose.

[0009] Furthermore, the zwitterionic polymer is one or more of polymethacryloylethyl sulfobetaine, poly2-methacryloyloxyethyl phosphoric acid choline, polymethacryloylethyl carboxylic acid betaine, and polymethacryloylethyl trifluoropropyl carboxylic acid betaine.

[0010] Furthermore, the molecular weight of cellulose is 20,000 to 500,000 Da.

[0011] Furthermore, the molecular weight of cellulose is 20,000-100,000 Da.

[0012] Furthermore, the molecular weight of the zwitterionic polymer is 10,000-100,000 Da.

[0013] Furthermore, the molecular weight of the zwitterionic polymer is 20,000-50,000 Da.

[0014] Furthermore, cellulose, zwitterionic polymers, deionized water, and ethanol all meet the requirements of YY / T 0640-2016 "General Requirements for Passive Surgical Implants".

[0015] Furthermore, the light transmittance of the anti-fogging agent for medical endoscopes after film formation is 90%–100%.

[0016] Furthermore, under conditions of temperature of 22℃~25℃ and relative humidity of 20%~40%, the water contact angle of the medical endoscope anti-fogging agent is 25°~35°.

[0017] Furthermore, the anti-fogging time of the medical endoscope anti-fogging agent in the body is greater than or equal to 120 minutes.

[0018] According to a specific embodiment of this disclosure, in a second aspect, this disclosure provides the application of any of the aforementioned medical endoscope antifogging agents in clinical surgery.

[0019] Compared with the prior art, the above-described solutions of this disclosure have at least the following beneficial effects:

[0020] (1) The antifogging agent for medical endoscopes provided in this disclosure is composed of cellulose, zwitterionic polymer, deionized water and ethanol. Cellulose has good film-forming properties and can quickly form a film on the endoscope surface in deionized water and ethanol solvents, which can prevent the formation of small water droplets on the endoscope surface, so that the antifogging agent has good transparency, thereby ensuring the light transmittance of the medical endoscope, achieving a good antifogging effect, and ensuring long-term antifogging. Moreover, after the cellulose film is formed, it can also effectively protect the medical endoscope and prevent the intrusion of external pollution, oxidation and moisture. At the same time, the zwitterionic polymer has excellent anti-biofouling properties, such as anti-adhesion of proteins, blood, tissue fluid and bacteria, which can reduce the adhesion of biological components such as blood, tissue fluid and bacteria in the body to the medical endoscope.

[0021] Therefore, the medical endoscope anti-fogging agent disclosed herein combines cellulose and zwitterionic polymers. While providing a continuous and stable anti-fogging effect, it significantly reduces the adhesion of biological components such as blood, tissue fluid, and bacteria to the endoscope, allowing the endoscope to maintain high light transmittance in the internal environment such as the thoracic and abdominal cavities during surgery. This results in a clear surgical field and improved surgical accuracy. Reducing bacterial adhesion to the endoscope also lowers the risk of postoperative infection. Furthermore, the reduced adhesion of biological components such as blood, tissue fluid, and bacteria to the endoscope further extends the anti-fogging time of the endoscope.

[0022] (2) The weight percentage of cellulose in the medical endoscope antifogging agent disclosed herein is 0.001wt%~10wt%; the weight percentage of zwitterionic polymer is 0.001wt%~10wt%; the weight percentage of ethanol is 40wt%~90wt%; and the remainder is deionized water. By rationally setting the weight percentage of each component and ensuring synergistic effects among them, the anti-fogging agent for medical endoscopes forms a stable film on the endoscope surface, guaranteeing a long-lasting anti-fogging effect while maintaining high light transmittance during use. It ensures that the anti-fogging agent absorbs fog and forms a stable hydration layer, effectively preventing the adhesion of biological components within the antibody system. It also prevents the anti-fogging agent from absorbing large amounts of fog and forming droplets, thus avoiding leaching and ensuring the durability of its anti-fogging effect. Furthermore, it allows the anti-fogging agent to evaporate and form a film quickly on the endoscope surface, reducing surgical preparation time and improving efficiency. It also prevents cellulose dissolution, resulting in a uniform film formation of the anti-fogging agent on the endoscope surface.

[0023] (3) The cellulose, zwitterionic polymer, deionized water and ethanol in the medical endoscope antifogging agent provided in this disclosure are all medical grade, meet YY / T 0640-2016 "General Requirements for Passive Surgical Implants", and have high biocompatibility and biodegradability, and have no impact on health.

[0024] (4) The anti-fogging agent for medical endoscopes provided in this disclosure has an anti-fogging time of 120 minutes or more in the body, and can achieve no fogging within 120 minutes, which is something that existing anti-fogging agents for medical endoscopes cannot achieve.

[0025] (5) The light transmittance of the medical endoscope antifog agent provided in this disclosure can reach 90% to 100%, which is better than the conventional clinical antifog agents, such as medical iodine tincture, and will not affect the clarity of the medical endoscope.

[0026] (6) The antifogging agent for medical endoscopes provided in this disclosure has a water contact angle of 25°~35° at room temperature. The small water contact angle is conducive to the rapid film formation of the antifogging agent on the surface of the medical endoscope, thus delaying the fogging of the medical endoscope.

[0027] (7) The anti-fogging agent for medical endoscopes provided in this disclosure enables the medical endoscope to maintain a clear surgical field within the body, thereby improving the efficiency and quality of the surgeon's operation, reducing surgical risks and complications, and enhancing the safety of endoscopic surgery. The anti-fogging agent for medical endoscopes provided in this disclosure has a long anti-fogging time, eliminating the need for frequent removal of the endoscope to apply the anti-fogging agent during surgery, thus shortening the surgical time. This significantly reduces the amount of medication required during general anesthesia, alleviates the burden on the patient's liver and kidneys, helps maintain stable vital signs during surgery, and shortens the postoperative recovery period. Reducing surgical time delays also maximizes the utilization of operating room resources.

[0028] (8) The components of the anti-fogging agent for medical endoscopes provided in this disclosure are simple and readily available, and the cost is low; moreover, the method of using the anti-fogging agent for medical endoscopes provided in this disclosure is simple. Attached Figure Description

[0029] The accompanying drawings, which are incorporated in and form part of this specification, illustrate embodiments consistent with this disclosure and, together with the description, serve to explain the principles of this disclosure. It is obvious that the drawings described below are merely some embodiments of this disclosure, and those skilled in the art can obtain other drawings based on these drawings without any inventive effort. In the drawings:

[0030] Figure 1 The bar chart shows the water contact angle of the medical endoscope antifog agent of Examples 4-7 of this disclosure, the medical iodine antifog agent of Comparative Example 1, and the bare glass slide.

[0031] Figure 2 The transmittance bar charts are for the medical endoscope antifog agents of Examples 4-7 of this disclosure and the medical iodine antifog agent of Comparative Example 1.

[0032] Figure 3 The image shows bar charts of the transmittance of the medical endoscope antifogging agent of Examples 1, 3, and 5 of this disclosure, the medical iodine tincture of Comparative Example 1, and the bare glass slide before and after adding blood.

[0033] Figure 4 The above are bar charts showing the transmittance of the medical endoscope antifogging agent of Examples 2, 4, 6, and 8 of this disclosure, the medical iodine tincture of Comparative Example 1, and the bare glass slide before and after adding tissue fluid.

[0034] Figure 5 The images are scanning electron microscope images of the medical endoscope antifogging agent of Examples 5 and 6 of this disclosure, the medical iodine tincture of Comparative Example 1, and the Escherichia coli culture solution after being dropped onto a bare glass slide;

[0035] Figure 6 The images show the anti-fogging test results of an endoscope coated with the anti-fogging agent of Embodiment 6 of this disclosure and an endoscope without the anti-fogging agent.

[0036] Figure 7 The images show the anti-fogging test results of an endoscope coated with the anti-fogging agent of Embodiment 6 of this disclosure and an endoscope without the anti-fogging agent in the abdominal cavity of a rabbit. Detailed Implementation

[0037] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to the accompanying drawings. Obviously, the described embodiments are only a part of the embodiments of this invention, and not all of them. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs; the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit this disclosure.

[0039] It should also be noted that in the description of the embodiments of the present invention, the symbol “~” represents the data of the two endpoints before and after “~” and all data between the two endpoints. For example, A~B represents all data that is greater than or equal to A and less than or equal to B.

[0040] In this disclosure, the reference to "embodiment" means that a particular feature, structure, or characteristic described in connection with an embodiment may be included in at least one embodiment of this disclosure. The appearance of this phrase in various places throughout the specification does not necessarily refer to the same embodiment, nor is it a separate or alternative embodiment mutually exclusive with other embodiments. It will be explicitly and implicitly understood by those skilled in the art that the embodiments described in this disclosure can be combined with other embodiments.

[0041] With the continuous development of minimally invasive surgical techniques, the use of endoscopes in various surgeries is becoming increasingly common. Successful surgery requires not only advanced surgical skills but also a clear field of vision. Therefore, the anti-fogging time, light transmittance, and cleanliness of the medical endoscope directly affect the surgical procedure. Current routine clinical practices for defogging medical endoscopes include: preheating the lens with hot water, wiping with the greater omentum, and wiping with povidone-iodine.

[0042] However, the inventors discovered through research that existing defogging methods for medical endoscopes suffer from a short defogging time, requiring frequent removal of the endoscope lens from the patient during surgery to repeatedly wipe away the fog, severely impacting the progress and smoothness of the procedure. Furthermore, existing defogging methods easily lead to the adhesion of biological components such as blood, tissue fluid, and bacteria to the endoscope, contaminating it and reducing its light transmittance, thus affecting the clarity of the surgical field. Additionally, bacterial adhesion to the endoscope surface increases the risk of postoperative infection for the patient.

[0043] This disclosure provides a medical endoscope antifogging agent, which is composed of cellulose, zwitterionic polymer, deionized water and ethanol. The weight percentage of cellulose is 0.001wt% to 10wt%; the weight percentage of zwitterionic polymer is 0.001wt% to 10wt%; the weight percentage of ethanol is 40wt% to 90wt%; and the remainder is deionized water. Cellulose can form a film on the surface of the medical endoscope, and zwitterionic polymer can resist the adhesion of biological components in the body.

[0044] The cellulose, zwitterionic polymer, deionized water and ethanol in this disclosure must all meet the requirements of YY / T 0640-2016 "General Requirements for Passive Surgical Implants" to meet the standards for application in the human body.

[0045] In some preferred embodiments, the medical endoscope antifogging agent contains 0.002wt% to 5wt% cellulose; 0.002wt% to 5wt% zwitterionic polymer; 65wt% to 80wt% ethanol; and the remainder is deionized water.

[0046] Cellulose is hydrophilic and has good film-forming properties, enabling it to rapidly form a film on the surface of medical endoscopes. Preferred, but not limited to, cellulose acetate, cellulose triacetate, cellulose butyrate, cellulose phthalate, cellulose nitrate, cellulose sulfate, cellulose phosphate, cellulose propionate, cellulose acetate butyrate, ethyl cellulose, ethyl methyl cellulose, benzyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, ethyl hydroxyethyl cellulose, and carboxyethyl cellulose are one or more of these.

[0047] The weight percentage of cellulose in the anti-fogging agent for medical endoscopes is 0.001 wt% to 10 wt%. If the weight percentage of cellulose is too small, for example, less than 0.001 wt%, it is difficult to ensure the formation of a stable film on the surface of the medical endoscope, thus making it difficult to guarantee a long-term anti-fogging effect, resulting in an anti-fogging effect of less than 10 minutes. If the weight percentage of cellulose is too large, for example, greater than 10 wt%, it is easy to aggregate on the surface of the medical endoscope, forming small aggregates, affecting light transmittance and thus affecting the surgical field of view. Preferably, the weight percentage of cellulose is 0.002 wt% to 5 wt%.

[0048] The molecular weight of cellulose can be selected according to actual needs. Preferably, the molecular weight of cellulose is 20,000 to 500,000 Da. If the molecular weight of cellulose is too small, for example, less than 20,000 Da, it is easily washed away by the water film formed by the absorbed mist, making it difficult to guarantee the durability of the anti-fogging effect, and the anti-fogging time is usually less than 15 minutes. If the molecular weight of cellulose is too large, for example, greater than 500,000 Da, it is easy to cause the solution viscosity to be too high. On the one hand, it is difficult to form a stable and uniform film on the endoscope surface, and on the other hand, it is easy to agglomerate and form small aggregates, affecting the light transmittance of the endoscope and the clarity of the surgical field. More preferably, the molecular weight of cellulose is 20,000 to 100,000 Da.

[0049] The zwitterionic polymer can be a betaine-based zwitterionic polymer. Preferably, but not limited to, the zwitterionic polymer is one or more of polymethacryloylethyl sulfobetaine, poly2-methacryloyloxyethyl phosphoric acid choline, polymethacryloylethyl carboxylic acid betaine, and polymethacryloylethyl trifluoropropyl carboxylic acid betaine.

[0050] The zwitterionic polymer has a weight percentage of 0.001 wt% to 10 wt%. If the weight percentage of the zwitterionic polymer is too small, for example, less than 0.001 wt%, it is difficult to guarantee the formation of a stable hydration layer after absorbing mist, and it is difficult to guarantee effective resistance to the adhesion of biological components such as blood and tissue fluid. If the weight percentage of the zwitterionic polymer is too large, for example, greater than 10 wt%, due to its superhydrophilicity, it easily absorbs a large amount of mist and forms droplets, leading to the elution of the anti-fogging agent, thus making it difficult to guarantee the durability of the anti-fogging effect, and the anti-fogging time is usually less than 15 minutes. Preferably, the weight percentage of the zwitterionic polymer is 0.002 wt% to 5 wt%.

[0051] The molecular weight of the zwitterionic polymer can be selected according to actual needs. Preferably, the molecular weight of the zwitterionic polymer is 10,000 to 100,000 Da. If the molecular weight of the zwitterionic polymer is too small, for example, less than 10,000 Da, it is difficult to form a hydration layer of sufficient strength, thus making it difficult to ensure effective resistance to the adhesion of biological components such as blood and tissue fluid; if the molecular weight of the zwitterionic polymer is too large, for example, greater than 100,000 Da, the zwitterionic polymer with an excessively large molecular weight is slowly absorbed in the body, and the excessively large molecular weight is difficult to be metabolized and excreted by the kidneys. More preferably, the molecular weight of the zwitterionic polymer is 20,000 to 50,000 Da.

[0052] Ethanol and deionized water are miscible, which facilitates the deposition of cellulose and zwitterionic polymers on the surface of medical endoscopes, thereby improving the light transmittance of the anti-fogging agent. Furthermore, both ethanol and deionized water can be used as medical-grade solvents in the human body without affecting human health. Preferably, the weight percentage of ethanol is 40wt% to 90wt%. If the weight percentage of ethanol is too low, for example, less than 40wt%, the anti-fogging agent will evaporate and form a film slowly on the surface of the medical endoscope, prolonging surgical preparation time and reducing efficiency. If the weight percentage of ethanol is too high, for example, greater than 90wt%, it will affect the dissolution of the cellulose component, causing it to separate and precipitate, making it difficult to form a uniform film on the surface of the medical endoscope. More preferably, the weight percentage of ethanol is 65wt% to 80wt%.

[0053] Cellulose possesses excellent film-forming properties, capable of forming a uniform, transparent, and flexible film that reduces light scattering, prevents the formation of small water droplets, and ensures the transparency of the endoscope, thus achieving an anti-fogging effect. Furthermore, the cellulose film effectively protects the endoscope from external contamination, oxidation, and moisture intrusion. Simultaneously, zwitterionic polymers exhibit excellent anti-biofouling properties, such as resistance to adhesion of proteins, blood, tissue fluid, and bacteria. The medical endoscope anti-fogging agent disclosed herein combines cellulose and zwitterionic polymers, providing a continuous and stable anti-fogging effect while significantly reducing the adhesion of biological components such as blood, tissue fluid, and bacteria in the human body to the medical endoscope. This allows the endoscope to maintain high light transmittance in the internal environment such as the thoracic and abdominal cavities during surgery, resulting in a clear surgical field and improved surgical accuracy. Reducing bacterial adhesion to the endoscope also lowers the risk of postoperative infection. Moreover, the reduced adhesion of biological components such as blood, tissue fluid, and bacteria to the endoscope further extends the anti-fogging time of the endoscope.

[0054] According to some embodiments of this disclosure, the application of any of the above-described medical endoscope antifogging agents in clinical surgery is also provided.

[0055] The method of using the medical endoscope anti-fogging agent disclosed herein includes the following steps: Before use, apply the medical endoscope anti-fogging agent of this disclosure evenly to the endoscope lens using a cotton swab, but not limited to this method. Alternatively, apply the medical endoscope anti-fogging agent of this disclosure evenly to the endoscope lens using a cotton swab, and allow it to dry before use. During use, after the medical endoscope anti-fogging agent has been evenly applied to the endoscope lens and dried, avoid wiping it again to prevent damage to the anti-fogging layer of the endoscope and reduction of its anti-fogging effect.

[0056] The following describes in more detail the medical endoscope antifogging agent and its application, with reference to specific embodiments and test results. Example 1:

[0057] The anti-fogging agent for medical endoscopes in this embodiment is composed of hydroxypropyl methylcellulose, polymethacryloyl ethyl sulfobetaine, ethanol, and deionized water. Specifically, the hydroxypropyl methylcellulose has a molecular weight of 20,000 Da and a weight percentage of 1 wt%; the polymethacryloyl ethyl sulfobetaine has a molecular weight of 20,000 Da and a weight percentage of 0.5 wt%; the ethanol has a weight percentage of 75 wt%; and the deionized water has a weight percentage of 23.5 wt%. Example 2:

[0058] The anti-fogging agent for medical endoscopes in this embodiment is composed of hydroxyethyl methylcellulose, polymethacryloyl ethyl sulfobetaine, ethanol, and deionized water. Specifically, the hydroxyethyl methylcellulose has a molecular weight of 50,000 Da and a weight percentage of 0.5 wt%; the polymethacryloyl ethyl sulfobetaine has a molecular weight of 50,000 Da and a weight percentage of 10 wt%; the ethanol has a weight percentage of 70 wt%; and the deionized water has a weight percentage of 19.5 wt%. Example 3:

[0059] The anti-fogging agent for medical endoscopes in this embodiment is composed of cellulose acetate, poly(2-methacryloyloxyethyl)phosphocholine, ethanol, and deionized water. Specifically, cellulose acetate has a molecular weight of 30,000 Da and a weight percentage of 2.5 wt%; poly(2-methacryloyloxyethyl)phosphocholine has a molecular weight of 30,000 Da and a weight percentage of 3.5 wt%; ethanol has a weight percentage of 80 wt%; and deionized water has a weight percentage of 14 wt%. Example 4:

[0060] The anti-fogging agent for medical endoscopes in this embodiment is composed of hydroxypropyl methylcellulose, cellulose acetate, poly(2-methacryloyloxyethyl phosphocholine), ethanol, and deionized water. Specifically, the hydroxypropyl methylcellulose has a molecular weight of 50,000 Da and a weight percentage of 1.5 wt%; the cellulose acetate has a molecular weight of 60,000 Da and a weight percentage of 1.5 wt%; the poly(2-methacryloyloxyethyl phosphocholine) has a molecular weight of 20,000 Da and a weight percentage of 1.5 wt%; the ethanol has a weight percentage of 75 wt%; and the deionized water has a weight percentage of 20.5 wt%. Example 5:

[0061] The anti-fogging agent for medical endoscopes in this embodiment is composed of ethyl hydroxyethyl cellulose, carboxyethyl cellulose, poly-2-methacryloyloxyethyl phosphocholine, polymethacryloylethyl carboxylate betaine, ethanol, and deionized water. Specifically, ethyl hydroxyethyl cellulose has a molecular weight of 40,000 Da and a weight percentage of 1 wt%; carboxyethyl cellulose has a molecular weight of 80,000 Da and a weight percentage of 3 wt%; poly-2-methacryloyloxyethyl phosphocholine has a molecular weight of 20,000 Da and a weight percentage of 1.2 wt%; polymethacryloylethyl carboxylate betaine has a molecular weight of 10,000 Da and a weight percentage of 0.8 wt%; ethanol has a weight percentage of 75 wt%; and deionized water has a weight percentage of 19 wt%. Example 6:

[0062] The anti-fogging agent for medical endoscopes in this embodiment is composed of cellulose sulfate, carboxyethyl cellulose, poly(2-methacryloyloxyethyl)phosphocholine, poly(methacryloylethyl)carboxylate betaine, ethanol, and deionized water. Specifically, the molecular weight of cellulose sulfate is 40,000 Da, and its weight percentage is 1 wt%; the molecular weight of carboxyethyl cellulose is 80,000 Da, and its weight percentage is 3 wt%; the molecular weight of poly(2-methacryloyloxyethyl)phosphocholine is 20,000 Da, and its weight percentage is 1.2 wt%; the molecular weight of poly(methacryloylethyl)carboxylate betaine is 10,000 Da, and its weight percentage is 0.8 wt%; the weight percentage of ethanol is 75 wt%; and the weight percentage of deionized water is 19 wt%. Example 7:

[0063] The anti-fogging agent for medical endoscopes in this embodiment is composed of cellulose sulfate, carboxyethyl cellulose, polymethacryloylethyl trifluoropropyl carboxylate betaine, ethanol, and deionized water. Specifically, the cellulose sulfate has a molecular weight of 40,000 Da and a weight percentage of 1 wt%; the carboxyethyl cellulose has a molecular weight of 80,000 Da and a weight percentage of 3 wt%; the polymethacryloylethyl trifluoropropyl carboxylate betaine has a molecular weight of 20,000 Da and a weight percentage of 1.2 wt%; the polymethacryloylethyl carboxylate betaine has a molecular weight of 10,000 Da and a weight percentage of 0.8 wt%; the ethanol has a weight percentage of 75 wt%; and the deionized water has a weight percentage of 19 wt%. Example 8:

[0064] The anti-fogging agent for medical endoscopes in this embodiment is composed of ethyl hydroxyethyl cellulose, cellulose phosphate, poly(2-methacryloyloxyethyl phosphocholine), poly(methacryloylethyl trifluoropropyl carboxylate betaine), ethanol, and deionized water. Specifically, ethyl hydroxyethyl cellulose has a molecular weight of 40,000 Da and a weight percentage of 1 wt%; cellulose phosphate has a molecular weight of 80,000 Da and a weight percentage of 3 wt%; poly(2-methacryloyloxyethyl phosphocholine) has a molecular weight of 20,000 Da and a weight percentage of 1.2 wt%; poly(methacryloylethyl trifluoropropyl carboxylate betaine) has a molecular weight of 10,000 Da and a weight percentage of 0.8 wt%; ethanol has a weight percentage of 75 wt%; and deionized water has a weight percentage of 19 wt%. Example 9:

[0065] The anti-fogging agent for medical endoscopes in this embodiment is composed of nitrocellulose, benzyl cellulose, poly(2-methacryloyloxyethyl)phosphocholine, poly(methacryloylethyl)trifluoropropylcarboxylate betaine, ethanol, and deionized water. Specifically, nitrocellulose has a molecular weight of 60,000 Da and a weight percentage of 1.5 wt%; benzyl cellulose has a molecular weight of 80,000 Da and a weight percentage of 3.5 wt%; poly(2-methacryloyloxyethyl)phosphocholine has a molecular weight of 20,000 Da and a weight percentage of 1.5 wt%; poly(methacryloylethyl)trifluoropropylcarboxylate betaine has a molecular weight of 10,000 Da and a weight percentage of 0.5 wt%; ethanol has a weight percentage of 75 wt%; and deionized water has a weight percentage of 18 wt%.

[0066] Example 10:

[0067] The anti-fogging agent for medical endoscopes in this embodiment is composed of hydroxypropyl methylcellulose, cellulose acetate, carboxyethyl cellulose, polymethacryloylethyl sulfobetaine, poly-2-methacryloyloxyethyl phosphocholine, ethanol, and deionized water. Specifically, the molecular weight of hydroxypropyl methylcellulose is 50,000 Da, and its weight percentage is 1.5 wt%; the molecular weight of cellulose acetate is 60,000 Da, and its weight percentage is 1.5 wt%; the molecular weight of carboxyethyl cellulose is 50,000 Da, and its weight percentage is 1.5 wt%; the molecular weight of polymethacryloylethyl sulfobetaine is 20,000 Da, and its weight percentage is 1.5 wt%; the molecular weight of poly-2-methacryloyloxyethyl phosphocholine is 20,000 Da, and its weight percentage is 4 wt%; the weight percentage of ethanol is 75 wt%; and the weight percentage of deionized water is 15 wt%.

[0068] Comparative Example 1:

[0069] In this comparative example, medical iodine tincture (Shandong Lierkang Medical Technology Co., Ltd.) was used as the anti-fogging agent for medical endoscopes.

[0070] The performance of the medical endoscope anti-fogging agents of Examples 1-10 and the medical iodine anti-fogging agent of Comparative Example 1 were tested below. The test methods and test results are as follows:

[0071] Contact angle test:

[0072] Water contact angle tests were performed on the medical endoscope antifogging agents of Examples 4-7, the medical iodine solution of Comparative Example 1, and bare glass slides. Specifically, the medical endoscope antifogging agents of Examples 4-7 and the medical iodine solution of Comparative Example 1 were uniformly coated onto different glass slides, and thin films were prepared using a solvent evaporation method. Contact angle measurements were performed using a DSA 10mk2 (Kruss) system under room temperature (22-25°C) and relative humidity (20-40%) conditions. To avoid cross-contamination, a disposable syringe was used for each test liquid. A 2 µL droplet from the syringe was placed on the sample surface, and a static contact angle image was captured using a charge-coupled device (CCD) camera after the droplet had been stationary for 120 seconds. The contact angle was calculated by the system software. Each sample experiment was repeated 5 times. Please refer to [link to relevant documentation]. Figure 1 The bar chart shows the water contact angle of the medical endoscope antifog agent of Examples 4-7, the medical iodine antifog agent of Comparative Example 1, and the bare glass slide.

[0073] from Figure 1 It can be seen that the water contact angle of the medical endoscope anti-fogging agents in Examples 4-7 is approximately 30°, indicating that the medical endoscope anti-fogging agents in Examples 4-7 have good hydrophilicity. This proves that water vapor can form a uniform water film on the endoscope surface coated with the medical endoscope anti-fogging agents of Examples 4-7, thus laying the foundation for anti-fogging. From Figure 1 It can also be seen that the water contact angles of the medical endoscope antifogging agents in Examples 4-7 are all lower than those of the medical iodine solution in Comparative Example 1, indicating that the hydrophilicity of the antifogging agents in Examples 4-7 is superior to that of the medical iodine solution in Comparative Example 1. Figure 1 It can also be seen that the water contact angle of the medical endoscope antifog agent in Examples 4-7 is much lower than that of the bare glass slide, indicating that the medical endoscope antifog agent in Examples 4-7 can significantly improve the hydrophilicity of the glass slide, and thus significantly improve the hydrophilicity of the endoscope, achieving the antifog effect.

[0074] Light transmittance test:

[0075] The transmittance of the medical endoscope anti-fogging agents of Examples 4-7 and the medical iodine tincture in Comparative Example 1 was tested. Specifically, the medical endoscope anti-fogging agents of Examples 4-7 and the medical iodine tincture anti-fogging agent in Comparative Example 1 were uniformly coated onto glass slides, and thin films were prepared using a solvent evaporation method. Then, the transmittance was tested using a transmittance meter (DR82). Please refer to [link to relevant documentation]. Figure 2 The bar chart shows the light transmittance of the anti-fogging agents for medical endoscopes in Examples 4-7 and the anti-fogging agent for medical iodine tincture in Comparative Example 1.

[0076] from Figure 2 As can be seen, the light transmittance of the medical endoscope antifog agents in Examples 4-7 is all higher than 95%, which is significantly better than that of medical iodine tincture, and helps to ensure a clear surgical field of vision.

[0077] Anti-blood adhesion test:

[0078] Anti-blood adhesion tests were conducted on the anti-fogging agents for medical endoscopes in Examples 1, 3, and 5, the medical iodine solution in Comparative Example 1, and the bare glass slides. Specifically, the anti-fogging agents for medical endoscopes in Examples 1, 3, and 5, and the medical iodine solution in Comparative Example 1, were coated onto different glass slides. After wetting the slides and the bare glass slides with physiological saline, freshly collected rat blood was dropped onto the surface and allowed to drip naturally. The transmittance was then measured using a transmittance meter (DR82) to analyze the effect of surface blood adhesion on transmittance. Please refer to [link to relevant documentation]. Figure 3 The graph shows the transmittance of the medical endoscope antifogging agent in Examples 1, 3, and 5, the medical iodine solution in Comparative Example 1, and the bare glass slide before and after blood was added.

[0079] from Figure 3 It can be seen that the anti-fogging agents for medical endoscopes in Examples 1, 3, and 5, even after being contaminated with blood, still maintained a light transmittance of over 85%, while the light transmittance of the medical iodine and bare glass slide in Comparative Example 1 decreased significantly after being contaminated with blood, both falling below 30%. This indicates that the anti-blood adhesion performance of the medical endoscope anti-fogging agent disclosed herein is significantly better than that of medical iodine, which is beneficial for ensuring a clear field of vision during surgery.

[0080] Anti-tissue fluid adhesion test:

[0081] Anti-tissue adhesion tests were conducted on the anti-fogging agents for medical endoscopes in Examples 2, 4, 6, and 8, the medical iodine solution in Comparative Example 1, and bare glass slides. Specifically, the anti-fogging agents from Examples 2, 4, 6, and 8, and the medical iodine solution from Comparative Example 1, were coated onto different glass slides. After wetting the slides and bare glass slides with physiological saline, rat liver tissue homogenate was dropped onto the surface and allowed to drip naturally. The transmittance was then measured using a transmittance meter (DR82) to analyze the effect of surface tissue fluid adhesion on transmittance. Please refer to [link to relevant documentation]. Figure 4 The graph shows the transmittance of the medical endoscope antifogging agent in Examples 2, 4, 6, and 8, the medical iodine solution in Comparative Example 1, and the bare glass slide before and after the addition of tissue fluid droplets.

[0082] from Figure 4 It can be seen that the anti-fogging agents for medical endoscopes in Examples 2, 4, 6, and 8 can still maintain a light transmittance of over 80% after being contaminated with tissue fluid, while the light transmittance of the medical iodine and bare glass slide in Comparative Example 1 is significantly reduced after being contaminated with tissue fluid, both falling below 30%. This indicates that compared to medical iodine, the anti-fogging agent for medical endoscopes provided in this disclosure can significantly enhance the anti-tissue adhesion ability of medical endoscopes, which is beneficial to ensuring a clear surgical field.

[0083] Antibacterial fluid adhesion test:

[0084] Antibacterial adhesion tests were conducted on the medical endoscope antifogging agents in Examples 5 and 6, the medical iodine solution in Comparative Example 1, and the bare glass slides. Specifically, the medical endoscope antifogging agents in Examples 5 and 6 and the medical iodine solution in Comparative Example 1 were coated onto different glass slides. After wetting the slides and bare glass slides with physiological saline, Escherichia coli culture solution was dropped onto the surface and allowed to drip naturally. The antibacterial adhesion ability of the medical endoscope antifogging agents in Examples 5 and 6, the medical iodine solution in Comparative Example 1, and the bare glass slides was qualitatively analyzed using scanning electron microscopy. Please refer to [link to relevant documentation]. Figure 5 The images are scanning electron microscope images of the medical endoscope antifogging agent in Examples 5 and 6, the medical iodine tincture in Comparative Example 1, and the bare glass slide after adding Escherichia coli culture medium.

[0085] from Figure 5 As can be seen, no E. coli adhesion was detected in the field of view of the medical endoscope antifogging agents of Examples 5 and 6, while obvious E. coli adhesion was observed on the bare glass slide and the medical iodine solution of Comparative Example 1. This indicates that compared with medical iodine solution and bare glass slide, the medical endoscope antifogging agent of this disclosure can significantly reduce bacterial adhesion, thereby helping to reduce the risk of infection.

[0086] External anti-fog effect test:

[0087] The external anti-fogging effect of the medical endoscope anti-fogging agent in Example 6 was tested under simulated operating room environmental conditions, including temperature, relative humidity, instrument temperature before use, and instrument temperature during use. The test environment temperature was 26℃, and the relative humidity was 40-60%. The test steps are as follows:

[0088] (1) Set the temperature of the constant temperature water bath to 90℃ and press the start button;

[0089] (2) Immediately after treating the endoscope with the anti-fogging agent from Example 6, move the endoscope above the observation port of the constant temperature water bath, with the endoscope's contact surface with the water vapor 5 cm away from the water level, allowing the water vapor to impact the endoscope, and record the data using the system's built-in recording function; then, use the same method to test the endoscope without the anti-fogging agent. The test results are as follows: Figure 6 As shown, the endoscope lens treated with the anti-fogging agent of Example 6 did not fog up and affect the field of vision, and could clearly capture the image below; conversely, the endoscope without anti-fogging treatment fogged up quickly, resulting in a blurred field of vision. This indicates that the anti-fogging agent of the medical endoscope provided in this embodiment has a better anti-fogging effect in vitro.

[0090] Rabbit abdominal cavity anti-fogging effect test:

[0091] A New Zealand rabbit pneumoperitoneum model was constructed to test the in vivo anti-fogging effect of the medical endoscope anti-fogging agent in Example 6. The test results are as follows: Figure 7 As shown. From Figure 7 It can be seen that the endoscope without anti-fogging agent fogs up rapidly after entering the abdominal cavity through the trocar, causing blurred surgical vision; while the endoscope treated with the medical endoscope anti-fogging agent of Example 6 can maintain a clear surgical vision throughout the procedure. This indicates that the medical endoscope anti-fogging agent provided in this embodiment has a better anti-fogging effect in vivo.

[0092] Comparative experiment on anti-fogging effect in pig abdominal cavity:

[0093] Experimental site: Tianjin Cardiovascular Disease Research Institute

[0094] Laboratory animals: Guangxi Bama miniature pigs

[0095] Experimental Summary: Based on the principles of similarity, reliability, and economy, miniature pigs with body temperatures close to those of humans were selected as experimental subjects, and this experiment was conducted using simulated laparoscopic surgery.

[0096] Experimental Design: Three simulated operating rooms were prepared, each equipped with two sets of endoscopic surgical equipment. Six miniature pigs were randomly selected and numbered P1-P6. The endoscope lenses of the three miniature pigs numbered P1, P2, and P3 were wiped with medical iodine solution from Comparative Example 1; the lenses of the three miniature pigs numbered P4, P5, and P6 were coated with the medical endoscope anti-fogging agent from Example 6.

[0097] Experimental Procedure: The operating room temperature was simulated at 22℃, and the expected anesthesia time for miniature pigs was 120 minutes. Medical personnel applied medical iodine solution (Comparative Example 1) and anti-fogging agent for medical endoscopes (Example 6) to the endoscope lens before performing the surgical procedure. Monopolar and bipolar probes were used normally during the procedure, along with electro-dissection and electro-cutting of the pig's internal tissues. The time it took for fogging to form on the endoscope lens due to the high temperature and humidity environment inside the pig was recorded. After each recording, the lens was wiped and the corresponding reagent was applied, and the recording was restarted. A total of 8 records were made. Experimental data can be found in Table 1.

[0098] Criteria for judging fogging: The general clinical experience for judging fogging of endoscope lenses is that fogging occurs when a quarter of the visible area is blurred or only a small part of the central area is blurred.

[0099]

[0100] The comparison of experimental data in Table 1 shows that the endoscope using the medical iodine solution in Comparative Example 1 fogged up more frequently and for a longer period, while the endoscope using the medical endoscope anti-fogging agent of Example 6 of this disclosure did not fog up at all during the 120-minute experiment. Therefore, compared with existing medical iodine solution anti-fogging agents, the medical endoscope anti-fogging agent of Example 6 of this disclosure significantly improves the anti-fogging time of medical endoscopes.

[0101] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this disclosure, and not to limit them. Although this disclosure has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. These modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of this disclosure, and they should all be covered within the scope of the claims and specification of this disclosure. In particular, as long as there is no structural conflict, the various technical features mentioned in the various embodiments can be combined in any way. This disclosure is not limited to the specific embodiments disclosed herein, but includes all technical solutions falling within the scope of the claims.

Claims

1. A medical endoscope anti-fogging agent, characterized in that, Composed of cellulose, a zwitterionic polymer, deionized water, and ethanol, wherein the weight percentage of cellulose is 0.001 wt% to 10 wt%; the weight percentage of the zwitterionic polymer is 0.001 wt% to 10 wt%; the weight percentage of ethanol is 40 wt% to 90 wt%; and the remainder is deionized water. The cellulose is used to form a film on the surface of a medical endoscope, the zwitterionic polymer is used to resist the adhesion of biological components in vivo, and the ethanol and deionized water are miscible, which is beneficial for the adhesion of cellulose and the zwitterionic polymer to the medical endoscope. The surface of the endoscope is coated to improve the light transmittance of the medical endoscope anti-fogging agent. The zwitterionic polymer is one or more of polymethacryloylethyl sulfobetaine, poly2-methacryloyloxyethyl phosphoric acid choline, polymethacryloylethyl carboxylic acid betaine, and polymethacryloylethyl trifluoropropyl carboxylic acid betaine. The light transmittance of the medical endoscope anti-fogging agent after film formation is 90% to 100%. Under the conditions of temperature of 22°C to 25°C and relative humidity of 20% to 40%, the water contact angle of the medical endoscope anti-fogging agent is 25° to 35°.

2. The anti-fogging agent for medical endoscopes according to claim 1, characterized in that, The cellulose comprises 0.002 wt% to 5 wt% by weight; the zwitterionic polymer comprises 0.002 wt% to 5 wt% by weight; the ethanol comprises 65 wt% to 80 wt% by weight; and the remainder is deionized water.

3. The anti-fogging agent for medical endoscopes according to claim 1, characterized in that, The cellulose is one or more of cellulose acetate, cellulose butyrate, cellulose phthalate, cellulose nitrate, cellulose sulfate, cellulose phosphate, cellulose propionate, cellulose acetate butyrate, ethyl cellulose, ethyl methyl cellulose, benzyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxyethyl methyl cellulose, hydroxypropyl methyl cellulose, ethyl hydroxyethyl cellulose, and carboxyethyl cellulose.

4. The anti-fogging agent for medical endoscopes according to claim 1, characterized in that, The molecular weight of the cellulose is 20,000 to 500,000 Da.

5. The anti-fogging agent for medical endoscopes according to claim 1, characterized in that, The molecular weight of the zwitterionic polymer is 10,000 to 100,000 Da.

6. The anti-fogging agent for medical endoscopes according to any one of claims 1 to 5, characterized in that, The anti-fogging agent for medical endoscopes has an anti-fogging time of 120 minutes or more inside the body.

7. The application of a medical endoscope antifog agent as described in any one of claims 1 to 5 in clinical surgery.

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