A headgear for permanent pacemaker interventional surgery

Abstract

This invention provides a surgical headgear for permanent pacemaker interventional surgery, relating to the field of medical device technology, and includes the following steps: S1, preparing an MXene-cellulose composite substrate; S2, modifying the surface of the substrate to heterogeneous wettability; S3, coating a gradient porous adsorption coating; S4, laser etching of a microfluidic structure; S5, depositing a nano-silver antibacterial layer; S6, hot-pressing curing treatment; S7, performance parameter testing. This invention achieves rapid moisture absorption, targeted sweat wicking, and efficient evaporation of the surgical headgear during prolonged wear through four core functions of the MXene-cellulose composite substrate: efficient sweat adsorption, heterogeneous wettability gradient transport, gradient porous coating evaporation, and long-lasting antibacterial effect of nano-silver. Simultaneously, hot-pressing curing ensures structural stability (peel strength ≥ 5 N / cm), solving the problems of sweat accumulation, poor breathability, and cross-infection risk associated with traditional headgear.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a headgear for permanent pacemaker interventional surgery. Background Technology

[0002] Permanent pacemaker intervention surgery is an important means of treating heart diseases such as arrhythmia. The procedure must be performed in a strictly sterile environment. At the same time, patients need to wear a head cover for a long time to prevent contaminants from entering the surgical area. As a protective device that comes into direct contact with the head, the comfort, sweat management ability and antibacterial properties of the head cover directly affect the patient's physiological state and surgical safety. Especially during long-term surgery, the head is prone to producing a lot of sweat. If the head cover cannot absorb, transfer and evaporate the sweat in time, it may lead to damp and stuffy skin, and even cause bacterial growth, increasing the risk of cross-infection.

[0003] In existing technologies, traditional surgical head covers mostly use single-layer cotton or non-woven fabric materials, which have limited sweat management capabilities. The substrate has poor hydrophilicity and lacks a directional transport structure, causing sweat to easily accumulate on the skin surface and not quickly diffuse to the outer layer for evaporation. This results in poor wearing comfort, insufficient antibacterial performance, and most head covers do not have a long-lasting antibacterial layer, or have low antibacterial agent loading that is easy to fall off. They are unable to meet the high sterility requirements of the surgical environment, have poor structural stability, low bonding strength between the coating and the substrate, and few washes. After repeated use, problems such as coating peeling and decreased breathability are likely to occur, making it impossible to guarantee performance stability during long-term use.

[0004] Therefore, the present invention aims to provide a head cover for permanent pacemaker interventional surgery to solve the above-mentioned problems. Summary of the Invention

[0005] The purpose of this invention is to overcome the shortcomings of the prior art.

[0006] To achieve the above objectives, the present invention adopts the following technical solution, comprising the following steps:

[0007] S1. Preparation of MXene-cellulose composite matrix;

[0008] S2. Modification of heterogeneous wettability of substrate surface;

[0009] S3. Apply a gradient porous adsorption coating;

[0010] S4, Laser etching of microchannel structures;

[0011] S5, nano-silver antibacterial layer deposition;

[0012] S6. Hot pressing curing treatment;

[0013] S7, Performance Parameter Testing.

[0014] In a preferred embodiment, in step S1, the MXene-cellulose composite substrate is prepared by mixing Ti3C2 MXene nanosheets (50-200 nm in diameter) and medical-grade cellulose fibers (10-20 μm in diameter) at a mass ratio of 3:7. The substrate is then prepared into a base fabric using a wet spinning process, with the spinning speed controlled at 8-12 m / min and the spinning temperature at 85±5℃. The resulting substrate has an areal density of 120±10 g / m³. 2 Tensile strength ≥300N / 5cm, air permeability 80-100L / (m³) 2 ·s);

[0015] The addition of MXene nanosheets gives the substrate excellent hydrophilicity and conductivity. Its layered structure can form a three-dimensional network channel, which significantly improves the liquid transport rate. By controlling the content of MXene at 30%, the mechanical properties of the material are guaranteed, and the instantaneous adsorption capacity of sweat of more than 95% is achieved.

[0016] The Ti3C2 MXene nanosheets were prepared by hydrofluoric acid etching. Ti3AlC2 powder (purity ≥99%) was mixed with 40% hydrofluoric acid at a solid-liquid ratio of 1:20 and stirred at 35±5℃ for 24 hours. Then, the mixture was separated by centrifugation (4000 rpm, 10 minutes), washed with deionized water until pH ≥6.5, and finally ultrasonically exfoliated (300W, 30 minutes) to obtain monolayer or few-layer MXene nanosheets with a sheet thickness ≤5nm.

[0017] The phase composition of MXene nanosheets was characterized by X-ray diffraction (XRD), and a characteristic peak appeared at 2θ=6.1°, indicating that Al atoms had been successfully etched. Atomic force microscopy (AFM) tests showed that the lateral size of the nanosheets was mainly distributed in the range of 50-200 nm, ensuring their uniform dispersion in the cellulose matrix. The etching process must be carried out in a fume hood, and operators must be equipped with anti-corrosion protective equipment.

[0018] In a preferred embodiment, in step S2, the heterogeneous wettability modification of the substrate surface, plasma-enhanced chemical vapor deposition (PECVD) is used to construct a hydrophilic-hydrophobic microarray structure on the substrate surface. The processing power is set to 500-600W, the working pressure is 0.8-1.2Pa, and a mixed gas of hexamethyldisiloxane (HMDSO) and oxygen (volume ratio 1:3) is introduced. The deposition time is 15-20 minutes, forming a wedge pattern distribution with a superhydrophobic region with a contact angle of 120-130° and a superhydrophilic region with a contact angle <10°, with an area ratio of 3:1.

[0019] This biomimetic structure is inspired by the heterogeneous wettability of the vein-membrane structure of a cicada's wing. Through the synergistic effect of wettability gradient and Laplace pressure difference, it enables the directional transfer of sweat from the skin contact surface (superhydrophilic region) to the outer side of the fabric (superhydrophobic region).

[0020] In a preferred embodiment, in step S3, the gradient porous adsorption coating is applied. The coating material consists of 40% polyacrylate emulsion, 35% nano-silica (particle size 20-50nm), 15% polyvinyl alcohol (molecular weight 80000), and 10% glycerol. It is applied to the hydrophobic side of the substrate by electrospinning. The spinning voltage is 18-22kV, the receiving distance is 15-20cm, the coating thickness is controlled at 40±5μm, the porosity reaches 75-80%, and the average pore size is 2-5μm.

[0021] This gradient porous structure adopts a hierarchical design of "small pore-medium pore-large pore". The dense layer with a pore diameter of 2μm and a thickness of 10μm is close to the substrate, the middle layer is a transition pore with a pore diameter of 3μm and a thickness of 20μm, and the outer layer is a large pore structure with a pore diameter of 5μm and a thickness of 10μm.

[0022] The nano-silica undergoes surface modification treatment by reacting it with silane coupling agent KH550 (1% ethanol solution) at 60°C for 2 hours to introduce amino functional groups, thereby increasing the interfacial bonding strength between the nano-silica and the polyacrylate emulsion by 40%, and achieving a water wash resistance of more than 50 times (tested according to ISO6330 standard) while maintaining a porosity of more than 85%.

[0023] The modified nano-silica was verified by Fourier transform infrared spectroscopy (FTIR) at 3300 cm⁻¹. -1 and 1560cm -1 The characteristic absorption peak of amino groups appeared at the point, and the dynamic light scattering (DLS) test showed that the dispersion index (PDI) of the modified nanoparticles decreased from 0.35 to 0.20, which significantly improved the stability of the coating slurry. No obvious sedimentation was observed after 72 hours of standing.

[0024] In a preferred embodiment, in step S4, the microchannel structure laser etching uses a 1064nm wavelength fiber laser to etch micron-level transmission channels on the hydrophilic side of the substrate. The laser power is set to 8-12W, the scanning speed is 300-500mm / s, and the etching depth is 5-8μm, forming a tree-like branched channel network with a width of 100-150μm and a spacing of 500μm. A liquid collection microcavity with a diameter of 500μm is set in the transition area between the end of the channel and the hydrophobic region.

[0025] The microchannel structure adopts a fractal geometry design, with a main channel width of 150μm and branch channel widths gradually decreasing to 100μm, ensuring rapid diversion of sweat under capillary action. Through finite element simulation optimization, the channel network can transfer 90% of local sweat to the collection microcavity within 30 seconds, effectively preventing sweat accumulation on the skin surface. After laser etching, plasma cleaning (oxygen plasma, power 300W, time 5 minutes) is required to remove residues.

[0026] In a preferred embodiment, in step S5, the deposition of the nano-silver antibacterial layer, a chemical reduction method is used to load nano-silver particles onto the coating surface. The fabric is immersed in a 0.5 mmol / L silver nitrate solution, with sodium citrate added as a reducing agent (molar ratio 1:1.2). The reaction is carried out in a water bath at 60±5℃ for 30 minutes to form nano-silver particles with a particle size of 20-30 nm, and the loading is controlled at 0.15-0.2 g / m². 2 It has an antibacterial rate of over 99.9% (against Escherichia coli and Staphylococcus aureus), and the silver ion release is <0.1ppm, meeting the requirements for medical biocompatibility.

[0027] The nano-silver particles are fixed in the porous structure of the coating through coordination bonds, achieving long-lasting antibacterial properties. Accelerated aging tests have verified that the fabric still maintains an antibacterial rate of over 95% after 50 washes, avoiding the risk of cross-infection during surgery. The deposition process requires strict control of the pH value between 8.0 and 8.5 to ensure the uniform distribution of the nano-silver particles.

[0028] In a preferred embodiment, in step S6, hot-press curing, a flatbed hot press is used for composite curing. The temperature is set at 120±5℃, the pressure is 0.8-1.0MPa, and the holding time is 15-20 minutes. During the curing process, the polyacrylate emulsion undergoes a cross-linking reaction to form a three-dimensional network structure, which makes the peel strength between the coating and the substrate reach ≥5N / cm, while maintaining the softness of the fabric (bending stiffness <50mN·m).

[0029] The hot-press curing process uses a gradient heating process (room temperature → 60℃ → 120℃, with a heating rate of 5℃ / min at each stage) to avoid material deformation caused by rapid temperature changes. After curing, the dry friction coefficient of the fabric is 0.35-0.40, and the wet friction coefficient is 0.45-0.50, which ensures both wearing comfort and prevents the headgear from shifting during surgery.

[0030] In a preferred embodiment, the performance parameter testing in step S7 includes the following items: A1, sweat adsorption rate: at 37℃ and 65% relative humidity, the initial adsorption rate is ≥2.5g / m³. 2 •s, reaching saturation adsorption capacity (200g / m³) 2A1. Time < 30s; A2. Directional transmission efficiency: Tested by fluorescence tracer method, the lateral transmission distance of sweat within 30 seconds is ≥ 5cm, and the longitudinal penetration amount is < 5%; A3. Evaporation rate: Under the conditions of 37℃ and air velocity of 0.5m / s, the evaporation rate is ≥ 0.25g / h·cm. 2 A4. Biocompatibility: According to ISO10993-5 standard, the cytotoxicity rating is ≤1, and there is no skin irritation.

[0031] The testing process requires the use of simulated sweat (composition: 0.9% NaCl, 0.5% lactic acid, 0.3% urea, pH 6.0) for performance testing. Ten samples are randomly selected from each batch, and the test results are taken as the average value. The deviation must be controlled within ±5%. For unqualified products, steps S3-S6 must be repeated.

[0032] As a preferred embodiment, it includes: a non-woven fabric outer cover, in which an MXene-cellulose composite head cover is disposed, in which a conductive head cover is disposed, an elastic bandage is disposed at one end of the conductive head cover, a mating plate is disposed on the conductive head cover, a mating ring shell is disposed on the outer surface of the mating plate, a cooling docking device is disposed in the mating ring shell, a conductive mating wire is disposed at one end of the cooling docking device, a master controller is disposed at the end of the conductive mating wire away from the cooling docking device, a transmission line is disposed at one end of the master controller, and an energy storage battery is disposed at the end of the transmission line away from the master controller.

[0033] In a preferred embodiment, the outer surface of the MXene-cellulose composite hood is nested within a non-woven fabric outer cover, the outer surface of the conductive hood is nested within the MXene-cellulose composite hood, the elastic bandage is fixedly connected to the conductive hood, the interface plate is cut out in the conductive hood, the cooling connector is connected to the interface plate, the docking ring shell limits and fixes the cooling connector, one end of the conductive connector is connected to the cooling connector, the end of the conductive connector away from the cooling connector is connected to the main controller, and the two ends of the transmission line are respectively connected between the energy storage battery and the main controller.

[0034] Compared with the prior art, the advantages and positive effects of the present invention are as follows:

[0035] 1. This invention achieves rapid moisture absorption, targeted sweat wicking, and efficient evaporation of the surgical headgear during prolonged wear by utilizing four core functions of the MXene-cellulose composite substrate: efficient sweat adsorption, heterogeneous wettability gradient transport, gradient porous coating evaporation, and long-lasting antibacterial effect of nano-silver. At the same time, the structural stability (peel strength ≥5N / cm) is ensured through hot-press curing, thus solving the problems of sweat accumulation, poor breathability, and cross-infection risk of traditional headgear.

[0036] 2. This invention uses an active heat dissipation system and a multi-layer nested structure to achieve a synergistic effect of active cooling by the cooling dock and passive sweat management by the MXene-cellulose substrate. This results in a 4.2°C reduction in internal temperature after 2 hours of continuous wear at 37°C, an increase in sweat adsorption to 1.14 times that of Example 1, and an antibacterial layer that keeps bacterial growth within a safe range over 24 hours. This significantly improves wearing comfort and safety in high-temperature surgical environments. Attached Figure Description

[0037] Figure 1 This is a schematic diagram of the structure of a headgear for interventional surgery using a permanent pacemaker, provided by the present invention.

[0038] Figure 2 This invention provides a structural disassembly diagram of a headgear for interventional surgery using a permanent pacemaker;

[0039] Figure 3 This invention provides a schematic diagram of the disassembly of the outer cover of a head cover for interventional surgery using a permanent pacemaker;

[0040] Figure 4 This is a schematic diagram showing the disassembly of the conduction headgear for a permanent pacemaker interventional surgery provided by the present invention.

[0041] Legend:

[0042] 1. Non-woven fabric cover; 2. Elastic bandage; 3. Conductive head cover; 4. Interface plate; 5. Docking ring shell; 6. Cooling connector; 7. Conductive connection line; 8. Main controller; 9. Transmission line; 10. Energy storage battery; 11. MXene-cellulose composite head cover. Detailed Implementation

[0043] To make the technical problems, technical solutions, and beneficial effects of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the described embodiments are only a part of the embodiments of this application, not all of them. The specific embodiments described herein are only used to explain the invention and are not intended to limit the invention. Based on the embodiments in this application, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this application.

[0044] It should be further noted that the embodiments of the present invention mainly describe the concept of the present invention. Based on this concept, some specific forms and settings of connection relationships, positional relationships, power mechanisms, power supply systems, hydraulic systems and control systems may not be fully described. However, under the premise that those skilled in the art understand the concept of the present invention, they can implement the above-mentioned specific forms and settings in a well-known manner.

[0045] When a component is referred to as "fixed to" or "set on" another component, it can be directly on or indirectly on that other component. When a component is referred to as "connected to" another component, it can be directly connected to or indirectly connected to that other component.

[0046] The directional terms "inner" and "outer" refer to the inner and outer contours of each component itself. The terms "length," "width," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," and "outer" indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings. They are only for the convenience of describing the present invention and 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 present invention.

[0047] For ease of description, spatial relative terms such as "above," "on top of," "on the upper surface of," "above," etc., are used herein to describe the spatial positional relationship of a device or feature as shown in the figure to other devices or features. It should be understood that spatial relative terms are intended to encompass different orientations in operation. For example, if a device is inverted, a device described as "above" or "on top of" other devices or structures will subsequently be positioned as "below" or "under" other devices or structures. Thus, the exemplary term "above" can include both "above" and "below." The device may also be positioned in other different ways, and the spatial relative descriptions used herein will be interpreted accordingly.

[0048] The terms "first" and "second" are used for descriptive purposes only and should not be construed as indicating or implying relative importance or implicitly specifying the number of technical features indicated. Thus, a feature defined as "first" or "second" may explicitly or implicitly include one or more of that feature. In the description of this invention, "a plurality of" means two or more, and "several" means one or more, unless otherwise explicitly specified.

[0049] The present invention will now describe a head cover for interventional surgery using a permanent pacemaker.

[0050] Example 1

[0051] This invention provides a technical solution: a headgear for permanent pacemaker interventional surgery, comprising the following steps:

[0052] S1. Preparation of MXene-cellulose composite matrix;

[0053] S2. Modification of heterogeneous wettability of substrate surface;

[0054] S3. Apply a gradient porous adsorption coating;

[0055] S4, Laser etching of microchannel structures;

[0056] S5, nano-silver antibacterial layer deposition;

[0057] S6. Hot pressing curing treatment;

[0058] S7. Performance parameter testing;

[0059] In step S1, the MXene-cellulose composite substrate is prepared by mixing Ti3C2 MXene nanosheets (50-200 nm in diameter) and medical-grade cellulose fibers (10-20 μm in diameter) at a mass ratio of 3:7. The substrate is then prepared into a base fabric using a wet spinning process, with the spinning speed controlled at 8-12 m / min and the spinning temperature at 85±5℃. The resulting substrate has an areal density of 120±10 g / m³. 2 Tensile strength ≥300N / 5cm, air permeability 80-100L / (m³) 2 ·s);

[0060] The addition of MXene nanosheets gives the substrate excellent hydrophilicity and conductivity. Its layered structure can form a three-dimensional network channel, which significantly improves the liquid transport rate. By controlling the content of MXene at 30%, the mechanical properties of the material are guaranteed, and the instantaneous adsorption capacity of sweat of more than 95% is achieved.

[0061] Ti3C2 MXene nanosheets were prepared by hydrofluoric acid etching. Ti3AlC2 powder (purity ≥99%) was mixed with 40% hydrofluoric acid at a solid-liquid ratio of 1:20 and stirred at 35±5℃ for 24 hours. Then, the mixture was separated by centrifugation (4000 rpm, 10 minutes), washed with deionized water until pH ≥6.5, and finally ultrasonically exfoliated (300W, 30 minutes) to obtain monolayer or few-layer MXene nanosheets with a sheet thickness ≤5nm.

[0062] The phase composition of MXene nanosheets was characterized by X-ray diffraction (XRD), and a characteristic peak appeared at 2θ=6.1°, indicating that Al atoms had been successfully etched. Atomic force microscopy (AFM) tests showed that the lateral size of the nanosheets was mainly distributed in the range of 50-200 nm, ensuring their uniform dispersion in the cellulose matrix. The etching process must be carried out in a fume hood, and operators must be equipped with anti-corrosion protective equipment.

[0063] In step S2, the heterogeneous wettability modification of the substrate surface is carried out using plasma-enhanced chemical vapor deposition (PECVD) technology to construct a hydrophilic-hydrophobic microarray structure on the substrate surface. The processing power is set to 500-600W, the working pressure is 0.8-1.2Pa, and a mixed gas of hexamethyldisiloxane (HMDSO) and oxygen (volume ratio 1:3) is introduced. The deposition time is 15-20 minutes, forming a wedge pattern distribution with a contact angle of 120-130° and a contact angle of <10°, with an area ratio of 3:1.

[0064] This biomimetic structure is inspired by the heterogeneous wettability of the vein-membrane structure of cicada wings. Through the synergistic effect of wettability gradient and Laplace pressure difference, it enables the directional transfer of sweat from the skin contact surface (superhydrophilic region) to the outer side of the fabric (superhydrophobic region).

[0065] In step S3, the gradient porous adsorption coating is applied. The coating material consists of 40% polyacrylate emulsion, 35% nano silica (particle size 20-50nm), 15% polyvinyl alcohol (molecular weight 80000) and 10% glycerol. It is applied to the hydrophobic side of the substrate by electrospinning. The spinning voltage is 18-22kV, the receiving distance is 15-20cm, the coating thickness is controlled at 40±5μm, the porosity reaches 75-80%, and the average pore size is 2-5μm.

[0066] This gradient porous structure adopts a hierarchical design of "small pore-medium pore-large pore". The dense layer with a pore diameter of 2μm and a thickness of 10μm is close to the substrate, the middle layer is a transition pore with a pore diameter of 3μm and a thickness of 20μm, and the outer layer is a large pore structure with a pore diameter of 5μm and a thickness of 10μm.

[0067] The nano-silica is surface modified by reacting it with silane coupling agent KH550 (1% ethanol solution) at 60°C for 2 hours to introduce amino functional groups, which increases the interfacial bonding strength between nano-silica and polyacrylate emulsion by 40%, and the coating can withstand more than 50 washes (tested according to ISO6330 standard) while maintaining a porosity of more than 85%.

[0068] The modified nano-silica was verified by Fourier transform infrared spectroscopy (FTIR) at 3300 cm⁻¹. -1 and 1560cm -1 The characteristic absorption peak of amino groups appeared at the point. Dynamic light scattering (DLS) test showed that the dispersity index (PDI) of the modified nanoparticles decreased from 0.35 to 0.20, which significantly improved the stability of the coating slurry. No obvious sedimentation was observed after 72 hours of standing.

[0069] In step S4, the microchannel structure is laser etched using a 1064nm wavelength fiber laser to etch micron-level transmission channels on the hydrophilic side of the substrate. The laser power is set to 8-12W, the scanning speed is 300-500mm / s, and the etching depth is 5-8μm, forming a tree-like branched channel network with a width of 100-150μm and a spacing of 500μm. A liquid collection microcavity with a diameter of 500μm is set in the transition area between the end of the channel and the hydrophobic region.

[0070] The microchannel structure adopts a fractal geometry design, with a main channel width of 150μm and branch channel widths gradually decreasing to 100μm, ensuring that sweat is rapidly diverted under capillary action. Through finite element simulation optimization, the channel network can transfer 90% of local sweat to the collection microcavity within 30 seconds, effectively preventing sweat accumulation on the skin surface. After laser etching, plasma cleaning (oxygen plasma, power 300W, time 5 minutes) is required to remove residues.

[0071] In step S5, during the deposition of the nano-silver antibacterial layer, nano-silver particles were loaded onto the coating surface using a chemical reduction method. The fabric was immersed in a 0.5 mmol / L silver nitrate solution, with sodium citrate added as a reducing agent (molar ratio 1:1.2). The reaction was carried out in a water bath at 60±5℃ for 30 minutes, forming nano-silver particles with a particle size of 20-30 nm. The loading amount was controlled at 0.15-0.2 g / m². 2 It has an antibacterial rate of over 99.9% (against Escherichia coli and Staphylococcus aureus), and the silver ion release is <0.1ppm, meeting the requirements for medical biocompatibility.

[0072] The nano-silver particles are fixed in the porous structure of the coating through coordination bonds, achieving long-lasting antibacterial properties. Accelerated aging tests have verified that the fabric still maintains an antibacterial rate of over 95% after 50 washes, avoiding the risk of cross-infection during surgery. The deposition process requires strict control of the pH value between 8.0 and 8.5 to ensure the uniform distribution of the nano-silver particles.

[0073] In step S6, hot-press curing, a flatbed hot press is used for composite curing. The temperature is set at 120±5℃, the pressure is 0.8-1.0MPa, and the holding time is 15-20 minutes. During the curing process, the polyacrylate emulsion undergoes a cross-linking reaction to form a three-dimensional network structure, which makes the peel strength between the coating and the substrate reach ≥5N / cm, while maintaining the softness of the fabric (bending stiffness <50mN·m).

[0074] The hot-press curing process uses a gradient heating process (room temperature → 60℃ → 120℃, with a heating rate of 5℃ / min at each stage) to avoid material deformation caused by rapid temperature changes. After curing, the dry friction coefficient of the fabric is 0.35-0.40, and the wet friction coefficient is 0.45-0.50, which ensures both wearing comfort and prevents the headgear from shifting during surgery.

[0075] Step S7, performance parameter testing, includes the following items: A1, sweat adsorption rate: at 37℃ and 65% relative humidity, the initial adsorption rate is ≥2.5g / m³. 2 •s, reaching saturation adsorption capacity (200g / m³) 2 A1. Time < 30s; A2. Directional transmission efficiency: Tested by fluorescence tracer method, the lateral transmission distance of sweat within 30 seconds is ≥ 5cm, and the longitudinal penetration amount is < 5%; A3. Evaporation rate: Under the conditions of 37℃ and air velocity of 0.5m / s, the evaporation rate is ≥ 0.25g / h·cm. 2 A4. Biocompatibility: According to ISO10993-5 standard, the cytotoxicity rating is ≤1, and there is no skin irritation.

[0076] The testing process requires the use of simulated sweat (composition: 0.9% NaCl, 0.5% lactic acid, 0.3% urea, pH 6.0) for performance testing. Ten samples are randomly selected from each batch, and the test results are taken as the average value. The deviation must be controlled within ±5%. For unqualified products, steps S3-S6 must be repeated.

[0077] In actual use, the surgical head cover prepared in this embodiment has significantly improved breathability, adsorption effect, and durability during surgery compared to existing single-layer cotton and non-woven head covers.

[0078] Example 2

[0079] like Figure 1-4 As shown, the present invention provides a technical solution: a head cover for interventional surgery of a permanent pacemaker, comprising: a non-woven fabric outer cover 1, an MXene-cellulose composite head cover 11 disposed in the non-woven fabric outer cover 1, a conductive head cover 3 disposed in the MXene-cellulose composite head cover 11, a mating interface plate 4 disposed on the conductive head cover 3, a mating ring shell 5 disposed on the outer surface of the mating interface plate 4, a cooling docking device 6 disposed in the mating ring shell 5, a conductive mating wire 7 disposed at one end of the cooling docking device 6, a master controller 8 disposed at the end of the conductive mating wire 7 away from the cooling docking device 6, a transmission line 9 disposed at one end of the master controller 8, and an energy storage battery 10 disposed at the end of the transmission line 9 away from the master controller 8;

[0080] The outer surface of the MXene-cellulose composite head cover 11 is nested in the non-woven fabric cover 1. The outer surface of the conductive head cover 3 is nested in the MXene-cellulose composite head cover 11. The elastic bandage 2 is fixedly connected to the conductive head cover 3. The interface plate 4 is cut out on the conductive head cover 3. The cooling connector 6 is connected to the interface plate 4. The docking ring shell 5 limits and fixes the cooling connector 6. One end of the conductive connector 7 is connected to the cooling connector 6. The end of the conductive connector 7 away from the cooling connector 6 is connected to the main controller 8. The two ends of the transmission line 9 are respectively connected between the energy storage battery 10 and the main controller 8.

[0081] In practical use, the surgical headgear prepared in this embodiment involves medical personnel placing the conductive headgear 3 on the patient's head and wrapping the elastic bandage 2 around the patient's chin. Then, the staff turns on the main controller 8, allowing the energy storage battery 10 to transmit electrical energy to the main controller 8 via the transmission line 9. The energy is then distributed to each cooling connector 6 via the conductive docking line 7 to dissipate heat from the patient's head. During prolonged surgery, sweat produced on the patient's head can be transported to the MXene-cellulose composite headgear 11 via the docking plate 4, and the MXene-cellulose composite headgear 11 will evaporate the sweat, thus further enhancing its practicality in actual use.

[0082] Comparative Example 1

[0083] The method of this comparative example is roughly the same as that of Example 1, the main difference being that: the heterogeneous wettability modification in step S2 was not performed, and the substrate surface remained in its original state.

[0084] The headgear prepared in this comparative example lacks a hydrophilic-hydrophobic microarray structure, resulting in a 60% decrease in the efficiency of directional sweat transmission. The lateral transmission distance within 30 seconds is only 2.1 cm, and obvious sweat accumulation occurs on the skin contact surface.

[0085] Comparative Example 2

[0086] The method of this comparative example is roughly the same as that of Example 1. The main difference is that the coating in step S3 does not use a gradient porous structure, but only a homogeneous coating with a single pore size (5μm).

[0087] The saturated adsorption capacity of the hood prepared in this comparative example was reduced to 120 g / m³. 2 The evaporation rate decreased to 0.15 g / h·cm. 2 Furthermore, due to the lack of a hierarchical porous structure, the antibacterial agent loading is reduced by 35%, and the antibacterial rate drops to 82% after 20 washes.

[0088] Comparative Example 3

[0089] The method of this comparative example is roughly the same as that of Example 2, the main difference being that: the MXene-cellulose composite head cover 11 is not set, and a composite structure of ordinary non-woven fabric cover 1 and conductive head cover 3 is directly used.

[0090] The headgear prepared in this comparative example, after being worn continuously at 37°C for 2 hours, had an internal temperature 4.2°C higher than that of Example 2, and its sweat absorption was only 45% of that of Example 2. Furthermore, due to the lack of a nano-silver antibacterial layer, the bacterial growth rate reached 10 after 24 hours. 5 CFU / cm 2 .

[0091] Performance testing

[0092] Test specimen specifications: The headgear samples prepared in Examples 1-2 and Comparative Examples 1-3 are 20cm×15cm in size. The test environment temperature is 37±1℃ and the relative humidity is 65±5%.

[0093] Test items:

[0094] Sweat adsorption rate: The amount of sweat adsorbed within 30 seconds was measured using simulated sweat (0.9% NaCl, 0.5% lactic acid, 0.3% urea, pH 6.0).

[0095] Directional transport efficiency: Fluorescent tracer method was used to record the lateral transport distance and longitudinal permeation within 30 seconds;

[0096] Antibacterial properties: The antibacterial rate against Escherichia coli (ATCC 25922) was tested according to GB / T 20944.3-2008 standard;

[0097] Wearing comfort: Subjective ratings (1-5 points, with 5 points being the most comfortable) were obtained from 8 healthy volunteers after wearing the garment for 2 hours.

[0098]

[0099] A comparison of the above embodiments and comparative examples shows that:

[0100] Examples 1-2 all demonstrated excellent performance in terms of sweat management, antibacterial properties, and wearing comfort, with Example 2 exhibiting the best overall performance due to its integrated active heat dissipation system.

[0101] Comparative Example 1 demonstrates that heterogeneous wettability modification is key to achieving targeted sweating, and its absence leads to sweat accumulation.

[0102] Comparative Example 2 shows that the gradient porous structure is crucial for improving adsorption-evaporation efficiency, and a single pore size design cannot meet the long-term dryness requirements in surgical scenarios.

[0103] Comparative Example 3 verified the synergistic effect of MXene-cellulose composite substrate and nano-silver antibacterial layer, demonstrating that ordinary textile materials cannot meet the requirements for medical-grade antibacterial and comfort.

[0104] Working principle:

[0105] like Figure 1-4 As shown, the core function of the headgear begins with the efficient sweat management of the MXene-cellulose composite substrate, which is composed of Ti3C2 MXene nanosheets (50-200nm in diameter) are mixed with medical-grade cellulose fibers at a mass ratio of 3:7 and produced by wet spinning. The layered structure of MXene forms a three-dimensional network channel. With a 30% MXene content, it achieves an instant sweat adsorption capacity of over 95%. The substrate surface is constructed with a hydrophilic-hydrophobic microarray using PECVD technology: the superhydrophilic region (contact angle <10°) directly contacts the skin to quickly capture sweat, while the superhydrophobic region (contact angle 120-130°) forms a wettability gradient through a wedge pattern distribution (area ratio 3:1). Combined with the Laplace pressure difference, this drives the directional migration of sweat. The dendritic branched microchannels etched on the hydrophilic side surface (main channel 150μm, branches 100μm, spacing 500μm) use capillary force to divert sweat. Within 30 seconds, 90% of the local sweat can be transferred to the collection microcavity, avoiding accumulation on the skin surface.

[0106] A gradient porous adsorption coating applied to the hydrophobic side further enhances sweat removal capabilities. The coating employs a layered design of "small pores-medium pores-large pores": a 2μm dense layer (10μm thick) near the substrate, a 3μm transition pore layer (20μm thick) in the middle, and a 5μm large pore layer (10μm thick) on the outer layer, achieving a total porosity of 75-80%. This design ensures structural support while providing efficient evaporation channels. Nano-silica is modified with KH550 to introduce amino functional groups, increasing the interfacial bonding strength between the coating and the substrate by 40%. It maintains 85% porosity even after more than 50 washes. The coating surface is loaded with 20-30nm nano-silver particles (loading amount 0.15-0.2g / m²) via chemical reduction. 2 It has an antibacterial rate of 99.9% against Escherichia coli and Staphylococcus aureus, and a silver ion release of <0.1ppm, which takes into account both long-lasting antibacterial effect and biocompatibility, thus avoiding cross-infection during surgery.

[0107] Hot-press curing (120±5℃, 0.8-1.0MPa, 15-20 minutes) crosslinks the polyacrylate emulsion to form a three-dimensional network structure. The peel strength between the coating and the substrate is ≥5N / cm, while maintaining flexibility with a bending stiffness of <50mN·m to ensure wearing comfort. Performance testing verifies the core indicator using simulated sweat (0.9% NaCl, 0.5% lactic acid, 0.3% urea, pH 6.0): initial adsorption rate ≥2.5g / m³. 2• s, lateral transport distance ≥ 5 cm within 30 seconds, evaporation rate ≥ 0.25 g / h·cm 2 With a cytotoxicity rating of ≤1, the headgear achieves an integrated function of "adsorption-transmission-evaporation-antibacterial" through the synergistic effect of each component, meeting the dryness and safety requirements for long-term wear in surgical scenarios.

[0108] The above are merely preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent substitutions, and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

[0109] It should be noted that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the exemplary embodiments according to this application. As used herein, the singular form is intended to include the plural form as well, unless the context clearly indicates otherwise. Furthermore, it should be understood that when the terms "comprising" and / or "including" are used in this specification, they indicate the presence of features, steps, operations, devices, components, and / or combinations thereof.

[0110] Unless otherwise specifically stated, the relative arrangement, numerical expressions, and values ​​of components and steps set forth in these embodiments do not limit the scope of this application. Techniques, methods, and devices known to those skilled in the art may not be discussed in detail, but where appropriate, such techniques, methods, and devices should be considered part of the specification. In all examples shown and discussed herein, any specific values ​​should be interpreted as merely exemplary and not as limitations.

Claims

1. A headgear for permanent pacemaker interventional surgery, characterized in that, Includes the following steps: S1. Preparation of MXene-cellulose composite matrix; S2. Modification of heterogeneous wettability of substrate surface; S3. Apply a gradient porous adsorption coating; S4, Laser etching of microchannel structures; S5, nano-silver antibacterial layer deposition; S6. Hot pressing curing treatment; S7, Performance Parameter Testing.

2. The headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: In step S1, the MXene-cellulose composite substrate is prepared by mixing Ti3C2 MXene nanosheets (50-200 nm in diameter) and medical-grade cellulose fibers (10-20 μm in diameter) at a mass ratio of 3:

7. The substrate is then prepared into a base fabric using a wet spinning process, with the spinning speed controlled at 8-12 m / min and the spinning temperature at 85±5℃. The resulting substrate has an areal density of 120±10 g / m³. 2 Tensile strength ≥300N / 5cm, air permeability 80-100L / (m³) 2 ·s); The addition of MXene nanosheets gives the substrate excellent hydrophilicity and conductivity. Its layered structure can form a three-dimensional network channel, which significantly improves the liquid transport rate. By controlling the content of MXene at 30%, the mechanical properties of the material are guaranteed, and the instantaneous adsorption capacity of sweat of more than 95% is achieved. The Ti3C2 MXene nanosheets were prepared by hydrofluoric acid etching. Ti3AlC2 powder (purity ≥99%) was mixed with 40% hydrofluoric acid at a solid-liquid ratio of 1:20 and stirred at 35±5℃ for 24 hours. Then, the mixture was separated by centrifugation (4000 rpm, 10 minutes), washed with deionized water until pH ≥6.5, and finally ultrasonically exfoliated (300W, 30 minutes) to obtain monolayer or few-layer MXene nanosheets with a sheet thickness ≤5nm. The phase composition of MXene nanosheets was characterized by X-ray diffraction (XRD), and a characteristic peak appeared at 2θ=6.1°, indicating that Al atoms had been successfully etched. Atomic force microscopy (AFM) tests showed that the lateral size of the nanosheets was mainly distributed in the range of 50-200 nm, ensuring their uniform dispersion in the cellulose matrix. The etching process must be carried out in a fume hood, and operators must be equipped with anti-corrosion protective equipment.

3. The headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: In step S2, the heterogeneous wettability modification of the substrate surface, plasma-enhanced chemical vapor deposition (PECVD) technology is used to construct a hydrophilic-hydrophobic microarray structure on the substrate surface. The processing power is set to 500-600W, the working pressure is 0.8-1.2Pa, and a mixed gas of hexamethyldisiloxane (HMDSO) and oxygen (volume ratio 1:3) is introduced. The deposition time is 15-20 minutes, forming a wedge pattern distribution with a superhydrophobic region with a contact angle of 120-130° and a superhydrophilic region with a contact angle of <10°, and the area ratio of the two is 3:

1. This biomimetic structure is inspired by the heterogeneous wettability of the vein-membrane structure of a cicada's wing. Through the synergistic effect of wettability gradient and Laplace pressure difference, it enables the directional transfer of sweat from the skin contact surface (superhydrophilic region) to the outer side of the fabric (superhydrophobic region).

4. The headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: In step S3, the gradient porous adsorption coating is applied. The coating material consists of 40% polyacrylate emulsion, 35% nano-silica (particle size 20-50nm), 15% polyvinyl alcohol (molecular weight 80000), and 10% glycerol. It is applied to the hydrophobic side of the substrate by electrospinning. The spinning voltage is 18-22kV, the receiving distance is 15-20cm, the coating thickness is controlled at 40±5μm, the porosity reaches 75-80%, and the average pore size is 2-5μm. This gradient porous structure adopts a hierarchical design of "small pore-medium pore-large pore". The dense layer with a pore diameter of 2μm and a thickness of 10μm is close to the substrate, the middle layer is a transition pore with a pore diameter of 3μm and a thickness of 20μm, and the outer layer is a large pore structure with a pore diameter of 5μm and a thickness of 10μm. The nano-silica undergoes surface modification treatment by reacting it with silane coupling agent KH550 (1% ethanol solution) at 60°C for 2 hours to introduce amino functional groups, thereby increasing the interfacial bonding strength between the nano-silica and the polyacrylate emulsion by 40%, and achieving a water wash resistance of more than 50 times (tested according to ISO6330 standard) while maintaining a porosity of more than 85%. The modified nano-silica was verified by Fourier transform infrared spectroscopy (FTIR) at 3300 cm⁻¹. -1 and 1560cm -1 The characteristic absorption peak of amino groups appeared at the point, and the dynamic light scattering (DLS) test showed that the dispersion index (PDI) of the modified nanoparticles decreased from 0.35 to 0.20, which significantly improved the stability of the coating slurry. No obvious sedimentation was observed after 72 hours of standing.

5. A headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: In step S4, the microchannel structure laser etching is performed using a 1064nm wavelength fiber laser to etch micron-level transmission channels on the hydrophilic side of the substrate. The laser power is set to 8-12W, the scanning speed is 300-500mm / s, and the etching depth is 5-8μm, forming a tree-like branched channel network with a width of 100-150μm and a spacing of 500μm. A liquid collection microcavity with a diameter of 500μm is set in the transition area between the end of the channel and the hydrophobic region. The microchannel structure adopts a fractal geometry design, with a main channel width of 150μm and branch channel widths gradually decreasing to 100μm, ensuring rapid diversion of sweat under capillary action. Through finite element simulation optimization, the channel network can transfer 90% of local sweat to the collection microcavity within 30 seconds, effectively preventing sweat accumulation on the skin surface. After laser etching, plasma cleaning (oxygen plasma, power 300W, time 5 minutes) is required to remove residues.

6. A headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: In step S5, the deposition of the nano-silver antibacterial layer, a chemical reduction method is used to load nano-silver particles onto the coating surface. The fabric is immersed in a 0.5 mmol / L silver nitrate solution, with sodium citrate added as a reducing agent (molar ratio 1:1.2). The reaction is carried out in a water bath at 60±5℃ for 30 minutes to form nano-silver particles with a particle size of 20-30 nm. The loading is controlled at 0.15-0.2 g / m². 2 It has an antibacterial rate of over 99.9% (against Escherichia coli and Staphylococcus aureus), and the silver ion release is <0.1ppm, meeting the requirements for medical biocompatibility. The nano-silver particles are fixed in the porous structure of the coating through coordination bonds, achieving long-lasting antibacterial properties. Accelerated aging tests have verified that the fabric still maintains an antibacterial rate of over 95% after 50 washes, avoiding the risk of cross-infection during surgery. The deposition process requires strict control of the pH value between 8.0 and 8.5 to ensure the uniform distribution of the nano-silver particles.

7. A headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: In step S6, hot-press curing, a flatbed hot press is used for composite curing. The temperature is set at 120±5℃, the pressure is 0.8-1.0MPa, and the holding time is 15-20 minutes. During the curing process, the polyacrylate emulsion undergoes a cross-linking reaction to form a three-dimensional network structure, which makes the peel strength between the coating and the substrate reach ≥5N / cm, while maintaining the softness of the fabric (bending stiffness <50mN·m). The hot-press curing process uses a gradient heating process (room temperature → 60℃ → 120℃, with a heating rate of 5℃ / min at each stage) to avoid material deformation caused by rapid temperature changes. After curing, the dry friction coefficient of the fabric is 0.35-0.40, and the wet friction coefficient is 0.45-0.50, which ensures both wearing comfort and prevents the headgear from shifting during surgery.

8. A headgear for permanent pacemaker interventional surgery according to claim 1, characterized in that: The performance parameter testing in step S7 includes the following items: A1, sweat adsorption rate: at 37℃ and 65% relative humidity, the initial adsorption rate is ≥2.5g / m³. 2 •s, reaching saturation adsorption capacity (200g / m³) 2 A1. Time < 30s; A2. Directional transmission efficiency: Tested by fluorescence tracer method, the lateral transmission distance of sweat within 30 seconds is ≥ 5cm, and the longitudinal penetration amount is < 5%; A3. Evaporation rate: Under the conditions of 37℃ and air velocity of 0.5m / s, the evaporation rate is ≥ 0.25g / h·cm. 2 A4. Biocompatibility: According to ISO10993-5 standard, the cytotoxicity rating is ≤1, and there is no skin irritation. The testing process requires the use of simulated sweat (composition: 0.9% NaCl, 0.5% lactic acid, 0.3% urea, pH 6.0) for performance testing. Ten samples are randomly selected from each batch, and the test results are taken as the average value. The deviation must be controlled within ±5%. For unqualified products, steps S3-S6 must be repeated.

9. A headgear for permanent pacemaker interventional surgery according to any one of claims 1-8, characterized in that, include: A nonwoven fabric cover (1) is provided with an MXene-cellulose composite head cover (11), a conductive head cover (3) is provided in the MXene-cellulose composite head cover (11), an elastic bandage (2) is provided at one end of the conductive head cover (3), a mating plate (4) is provided on the conductive head cover (3), a mating ring shell (5) is provided on the outer surface of the mating plate (4), a cooling docking device (6) is provided in the mating ring shell (5), a conductive mating wire (7) is provided at one end of the cooling docking device (6), a master controller (8) is provided at the end of the conductive mating wire (7) away from the cooling docking device (6), a transmission line (9) is provided at one end of the master controller (8), and a storage battery (10) is provided at the end of the transmission line (9) away from the master controller (8).

10. A headgear for permanent pacemaker interventional surgery according to claim 9, characterized in that: The outer surface of the MXene-cellulose composite headgear (11) is nested in the non-woven fabric cover (1), the outer surface of the conductive headgear (3) is nested in the MXene-cellulose composite headgear (11), the elastic bandage (2) is fixedly connected to the conductive headgear (3), the interface plate (4) is cut out on the conductive headgear (3), the cooling connector (6) is connected to the interface plate (4), the docking ring shell (5) limits and fixes the cooling connector (6), one end of the conductive connecting wire (7) is connected to the cooling connector (6), the end of the conductive connecting wire (7) away from the cooling connector (6) is connected to the master controller (8), and the two ends of the transmission line (9) are respectively connected between the energy storage battery (10) and the master controller (8).

Images