Anesthesia breathing circuit and preparation method thereof

Abstract

The anesthesia breathing circuit comprises a circuit body, and the circuit body is of a multi-layer structure and comprises a base material layer, a transition layer, a functional coating and a sealing layer from inside to outside; the base material layer is composed of medical-grade polycarbonate or polyether-ether-ketone; the transition layer is a microporous structure layer; the functional coating is a composite gradient coating composed of nano-silver and titanium dioxide, the functional coating comprises an inner layer and an outer layer, the inner layer is made of titanium dioxide, and the outer layer is made of nano-silver; the inner layer is in contact with the transition layer, and the outer layer is in contact with the sealing layer; and the sealing layer is a zwitterionic polymer capable of covering the functional coating. The anesthetic breathing circuit can actively defend, enhance the disinfection effect, prolong the service life, improve the safety and retain the reuse advantage, and the anesthetic breathing circuit meets the requirements that the antibacterial rate is larger than 99.9%, the anesthetic breathing circuit can tolerate 134 DEG C high-pressure sterilization is larger than or equal to 100 times, and the cost is lower than that of a disposable circuit by 60%.

Description

Technical Field

[0001] This invention relates to the field of anesthesia breathing circuits, and more specifically to anesthesia breathing circuits and their preparation methods. Background Technology

[0002] The anesthesia breathing circuit is a key component connecting the patient to the anesthesia machine and ventilator, responsible for delivering anesthetic gases and expelling waste gases. Due to its cost-effectiveness and environmental advantages, reusable types made of silicone or rubber are widely used globally. However, reuse carries the risk of nosocomial infection, as it comes into contact with substances containing microorganisms, such as the patient's respiratory secretions, potentially becoming a source of cross-infection, especially threatening immunocompromised individuals. Traditional reuse processes require disassembly, cleaning, disinfection, and drying, but these methods have limitations such as biofilm formation, disinfection blind spots, disinfectant limitations, human error, secondary contamination, material aging, and time and resource consumption.

[0003] While disposable circuits eliminate the risk of infection, they have limitations, such as high long-term costs, significant medical waste, inconsistent material properties, and reliance on supply. To address the infection control challenges and extended lifespan requirements of reusable breathing circuits, while retaining their cost and environmental advantages, a solution is needed.

[0004] This invention introduces nano-antibacterial coating technology into the field and constructs a nano-level functional coating with long-lasting, broad-spectrum, and highly efficient antibacterial activity on the key inner surface of a reusable breathing circuit. Compared with the existing technology, which can withstand a maximum of 50 sterilization cycles, this invention can improve the efficiency by 300% and reduce the cost by 60%. Summary of the Invention

[0005] The purpose of this invention is to provide an anesthesia breathing circuit and its preparation method.

[0006] To achieve the above objectives, the present invention provides the following technical solution: An anesthesia breathing circuit includes a circuit body, which has a multi-layer structure, comprising a substrate layer, a transition layer, a functional coating layer, and a sealing layer from the inside out; the substrate layer is composed of medical-grade polycarbonate or polyetheretherketone; the transition layer is a microporous structure layer; The functional coating is a composite gradient coating composed of nano-silver and titanium dioxide. The functional coating includes an inner layer and an outer layer. The inner layer is made of titanium dioxide and the outer layer is made of nano-silver. The inner layer is in contact with the transition layer and the outer layer is in contact with the sealing layer. The sealing layer is composed of a zwitterionic polymer and completely covers the surface of the functional coating.

[0007] Preferably, the transition layer has a pore size of 5-20 μm and a depth of 50-100 μm.

[0008] A method for preparing an anesthesia breathing circuit includes the following steps: S1: Substrate pretreatment, medical grade polycarbonate (PC) or polyetheretherketone (PEEK) tube body is etched with oxygen plasma for 5-10 minutes, with a power of 100W; S2: Gradient coating deposition to prepare a composite gradient coating, including magnetron sputtering deposition of a TiO2 layer, with the TiO2 layer as the inner layer and a thickness of 200-300 nm; electrochemical deposition of an AgNPs layer, with the AgNPs layer as the outer layer and a thickness of 100-150 nm; and forming a composite gradient structure by alternating deposition of the TiO2 layer and the AgNPs layer three times. S3: Sealing layer coating, dipped in 0.5% zwitterionic polymer solution, and cured at 60℃.

[0009] Preferably, the zwitterionic polymer is sulfobetaine.

[0010] Preferably, the inner layer contains 80% TiO2 by weight and has a particle size of 20-50 nm.

[0011] Preferably, the outer layer contains 60% AgNPs by weight and has a particle size of 10-30 nm. Beneficial effects

[0012] By introducing a nanoscale functional coating, this invention achieves the following effects: 1. Active defense: The coating itself has the ability to kill or inhibit the attachment and growth of microorganisms. Even between two disinfection sessions or when there are slight omissions in the disinfection process, it can provide an additional protective barrier and significantly reduce the risk of biofilm formation.

[0013] 2. Enhance disinfection effect: Works synergistically with existing disinfection processes to improve the efficiency of killing residual microorganisms.

[0014] 3. Extend service life: Slows down material aging by reducing microbial erosion and potentially reducing the frequency or intensity of use of powerful disinfectants.

[0015] 4. Improve safety: Reduce the risk of cross-infection caused by patients using reused circuits from the source.

[0016] 5. Retain the advantages of reuse: Do not change the economic and environmentally friendly nature of reusable circuits.

[0017] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, the preferred embodiments of the present invention are described in detail below with reference to the accompanying drawings. Attached Figure Description

[0018] Figure 1 This is a schematic diagram of the main structure of the present invention; Figure 2This is a schematic diagram of the main layered structure of the present invention; Figure 3 This is a schematic diagram of the main functional coating of the present invention; In the diagram: 1-Circuit body; 101-Sealing layer; 102-Functional coating; 1021-Outer layer; 1022-Inner layer; 103-Transition layer; 104-Substrate layer. Detailed Implementation

[0019] The technical solution of the present invention will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0020] In the description of this invention, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are used only for the convenience of describing the invention and for simplifying the description, and do not indicate or imply that the device or element referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on the invention. Furthermore, the terms "first," "second," and "third" are used for descriptive purposes only and should not be construed as indicating or implying relative importance.

[0021] In the description of this invention, it should be noted that, unless otherwise explicitly specified and limited, the terms "installation," "connection," and "linking" should be interpreted broadly. For example, they can refer to a fixed connection, a detachable connection, or an integral connection; they can refer to a mechanical connection or an electrical connection; they can refer to a direct connection or an indirect connection through an intermediate medium; and they can refer to the internal connection of two components. Those skilled in the art can understand the specific meaning of the above terms in this invention based on the specific circumstances.

[0022] Furthermore, the technical features involved in the different embodiments of the present invention described below can be combined with each other as long as they do not conflict with each other.

[0023] like Figures 1-3As shown, an anesthesia breathing circuit includes a circuit body 1, which has a multi-layer structure, comprising a substrate layer 104, a transition layer 103, a functional coating 102, and a sealing layer 101 from the inside out. The substrate layer 104 is composed of medical-grade polycarbonate (PC) or polyether ether ketone (PEEK). The transition layer 103 is a microporous structure layer treated with plasma. The functional coating 102 is a composite gradient coating composed of nano-silver (AgNPs) and titanium dioxide (TiO2). The functional coating 102 includes an inner layer 1022 and an outer layer 1021. The inner layer 1022 is made of titanium dioxide (TiO2), and the outer layer 1021 is made of nano-silver (AgNPs). The inner layer 1022 is in contact with the transition layer 103, and the outer layer 1021 is in contact with the sealing layer 101. The sealing layer 101 is composed of a zwitterionic polymer and completely covers the surface of the functional coating 102.

[0024] Preferably, the transition layer 103 has a pore size of 5-20 μm and a depth of 50-100 μm.

[0025] A method for preparing an anesthesia breathing circuit includes the following steps: S1: Substrate pretreatment, medical grade polycarbonate (PC) or polyether ether ketone (PEEK) tube body is etched with oxygen plasma for 5-10 minutes, with a power of 100W.

[0026] S2: Gradient coating deposition to prepare a composite gradient coating, including magnetron sputtering deposition of a TiO2 layer, the TiO2 layer being the inner 1022 layer with a thickness of 200-300 nm; electrochemical deposition of an AgNPs layer, the AgNPs layer being the outer 1021 layer with a thickness of 100-150 nm, and the composite gradient structure being formed by alternating deposition of the TiO2 layer and the AgNPs layer three times.

[0027] S3: The sealing layer 101 is coated with a 0.5% zwitterionic polymer solution and cured at 60°C.

[0028] Preferably, the zwitterionic polymer is sulfobetaine.

[0029] Preferably, the inner layer 1022 contains 80% TiO2 by weight and has a particle size of 20-50 nm, which can provide photocatalytic antibacterial properties.

[0030] Preferably, the outer layer 1021 contains 60% AgNPs by weight and has a particle size of 10-30 nm, which can provide contact sterilization. Example

[0031] The test data of this invention are shown in Table 1: Table 1 Test Report .

[0032] Comparative experiment: Experiments were conducted on the silicone circuit of the commercially available brand FlexiCare. After 50 sterilization cycles, cracks appeared and the antibacterial rate dropped to 85%. However, the circuit of this invention showed no visible damage after 100 sterilization cycles, and the antibacterial rate remained above 99.9%.

[0033] In summary, this invention solves the problem of coating peeling at high temperatures by designing a gradient coating structure, and by designing a microporous transition layer 103, which can improve coating adhesion. After 100 sterilization cycles, the peel strength is >5N / cm, which is higher than the national standard YY / T0681 of 3N / cm. It also enables photocatalytic contact and sterilization to work synergistically, reducing the release of silver ions (<0.1ppm) and avoiding cytotoxicity.

[0034] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0035] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. An anaesthetic breathing circuit, characterised in that, The application relates to a circuit main body which is a multilayer structure and comprises, from inside to outside, a substrate layer, a transition layer, a functional coating layer and a sealing layer; the substrate layer is composed of medical-grade polycarbonate or polyether ether ketone; the transition layer is a microporous structure layer; The functional coating layer is a composite gradient plating layer composed of nano-silver and titanium dioxide, and the functional coating layer comprises an inner layer and an outer layer; the inner layer is made of titanium dioxide, and the outer layer is made of nano-silver; the inner layer is in contact with the transition layer, and the outer layer is in contact with the sealing layer; the sealing layer is composed of a zwitterionic polymer and completely covers the surface of the functional coating layer.

2. An anaesthetic breathing circuit as claimed in claim 1, characterised in that, The pore diameter of the transition layer is 5-20 mu m, and the depth is 50-100 mu m.

3. A method of preparing an anaesthetic breathing circuit, characterised in that, The application further discloses a preparation method of the circuit main body. S1: substrate pretreatment, medical-grade polycarbonate or polyether ether ketone pipe body is subjected to oxygen plasma etching for 5-10 min, wherein the power is 100 W; S2: gradient plating layer deposition, a composite gradient plating layer is prepared, including magnetron sputtering deposition of a TiO2 layer, the TiO2 layer is an inner layer and has a thickness of 200-300 nm; electrochemical deposition of an AgNPs layer, the AgNPs layer is an outer layer and has a thickness of 100-150 nm, and the composite gradient structure is formed by alternately depositing the TiO2 layer and the AgNPs layer for three times; S3: sealing layer coating, 0.5% of a zwitterionic polymer solution is immersed and coated, and 60 DEG C solidification is adopted.

4. A method of preparing an anaesthetic breathing circuit as claimed in claim 1, characterised in that, The zwitterionic polymer is a sulfobetaine.

5. A method of preparing an anaesthetic breathing circuit as claimed in claim 1, characterised in that, The TiO2 in the inner layer accounts for 80% by weight and has a particle size of 20-50 nm.

6. A method of preparing an anaesthetic breathing circuit as claimed in claim 1, characterised in that, The AgNPs in the outer layer account for 60% by weight and have a particle size of 10-30 nm.

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