Medical grade silica gel with antibacterial property

Abstract

The application relates to the technical field of medical materials, in particular to a medical-grade silica gel with antibacterial performance, which comprises an antibacterial functional module and a flexible base material module. The antibacterial functional module is embedded in the flexible base material module and comprises an antibacterial particle group and a flow guide channel group, liquid or gas from the outside is guided through the flow guide channel to activate the antibacterial particle group to release metal ions and inhibit bacterial growth. The outer surface of the flexible base material module is provided with a protective layer containing a reinforcing layer to improve the tensile strength. The application solves the problems of insufficient antibacterial performance, complex process and high cost of traditional medical silica gel by optimizing the structural design, has excellent flexibility, durability and long-lasting antibacterial effect, and is suitable for various medical scenes.

Description

Technical Field

[0001] This invention belongs to the field of medical materials technology, specifically a medical-grade silicone with antibacterial properties. Background Technology

[0002] In the field of medical devices and medical materials, silicone is widely used in medical devices, implants, and care products due to its excellent biocompatibility and softness. However, traditional medical-grade silicone has certain limitations in antibacterial properties, especially during long-term use or contact with bodily fluids, where it is prone to bacterial or microbial growth, increasing the risk of infection. Currently, some technologies exist to improve the antibacterial properties of silicone through surface coatings or the addition of antibacterial agents, but these methods often require complex processes, and the durability of the antibacterial effect is difficult to guarantee. Furthermore, some antibacterial silicone materials require sophisticated equipment during processing, leading to increased production costs and limiting their large-scale application.

[0003] In the prior art, the Chinese utility model patent (application number: CN202123098203.3) discloses "An antibacterial and anti-adhesion silicone rubber for medical devices," which includes a rubber layer; an adsorption layer that is attached to the upper surface of the rubber layer and fixed on the rubber layer; and an antibacterial layer that is attached to the upper surface of the adsorption layer and fixed on the adsorption layer. The rubber layer, adsorption layer, and antibacterial layer are bonded together as an integral structure. This utility model achieves the desired functionality by setting an antibacterial layer on silicone rubber and using an adsorption layer to stably fix the antibacterial layer on the silicone rubber. The aforementioned patent can demonstrate that the prior art has certain room for improvement.

[0004] Therefore, to address the above issues, we propose a medical-grade silicone with antibacterial properties. The aim is to improve the stability and durability of its antibacterial effect by optimizing the material structure design and processing technology, while reducing manufacturing difficulty and cost. Utility Model Content

[0005] The purpose of this invention is to address the limitations of current medical-grade silicone in terms of antibacterial properties, particularly the tendency for bacteria or microorganisms to grow during long-term use or contact with bodily fluids, thereby increasing the risk of infection. Furthermore, it addresses the problems of complex processes, insufficient antibacterial durability, and high manufacturing costs associated with existing technologies that improve antibacterial properties through surface coatings or the addition of antibacterial agents. The invention proposes a medical-grade silicone with antibacterial properties.

[0006] To achieve the aforementioned objectives and address the aforementioned problems, this utility model provides a medical-grade silicone material with antibacterial properties, comprising an antibacterial functional module and a flexible substrate module. The antibacterial functional module is embedded within the flexible substrate module and forms an integral unit with it through a specific connection structure. The antibacterial functional module includes an antibacterial particle group and a flow channel group. The antibacterial particle group is uniformly distributed within the flexible substrate module, and the flow channel group penetrates the flexible substrate module and communicates with its surface, guiding liquids or gases from the external environment into the flexible substrate module to activate the functional properties of the antibacterial particle group. A protective layer is provided on the outer surface of the flexible substrate module, and this protective layer is bonded to the flexible substrate module via a hot-pressing process, protecting the antibacterial functional module while maintaining the flexibility of the flexible substrate module.

[0007] The antibacterial particle assembly comprises multiple antibacterial particle units, each including a core and a coating layer. The core is a metal ion carrier, and the coating layer is a biodegradable polymer material, bonded to the core via chemical bonding. The multiple antibacterial particle units are distributed in a lattice pattern within the flexible substrate module, and their positions are dynamically adjusted by the elastic deformation of the flexible substrate module. The flow channel assembly includes multiple microporous channels, each with its inlet located on the outer surface of the flexible substrate module and its outlet extending to the surrounding area of ​​the antibacterial particle unit. These channels are used to transport liquids or gases from the external environment to the vicinity of the antibacterial particle unit, thereby promoting the release of metal ions from the antibacterial particle unit.

[0008] As a preferred technical solution of this application, the flexible substrate module includes a main layer and a reinforcing layer. The main layer is made of medical-grade silicone material, and the reinforcing layer is made of fiber-reinforced material. The reinforcing layer is embedded inside the main layer and bonded to the main layer through an injection molding process. The thickness of the main layer is 1-5 mm, and the thickness of the reinforcing layer is 0.2-1 mm. The fiber direction of the reinforcing layer is consistent with the tensile direction of the main layer, which is used to improve the tensile strength and durability of the flexible substrate module.

[0009] As a preferred technical solution of this application, the protective layer includes an inner protective film and an outer protective film. The inner protective film is made of a hydrophilic polymer material, and the outer protective film is made of a hydrophobic polymer material. The inner protective film is bonded to the outer surface of the flexible substrate module by a hot-pressing process, and the outer protective film is applied to the outside of the inner protective film by a spraying process. The thickness of the inner protective film is 0.1-0.3 mm, and the thickness of the outer protective film is 0.05-0.1 mm. The inner and outer protective films work together to regulate the permeation rate of external liquids or gases.

[0010] As a preferred technical solution of this application, the core of the antibacterial particle unit is a silver ion carrier, the coating layer is made of polylactic acid material, the thickness of the coating layer is 10-50 micrometers, and the diameter of the core is 50-200 micrometers. The spacing between the antibacterial particle units is 0.5-2 millimeters, and the dot-matrix arrangement ensures that the antibacterial particle units are uniformly distributed within the flexible substrate module, thereby guaranteeing the stability of the antibacterial effect.

[0011] As a preferred technical solution of this application, the diameter of the microporous channel is 50-200 micrometers, the length of the microporous channel is 1-5 millimeters, and the inlet end of the microporous channel is tapered to improve the efficiency of liquid or gas introduction. The inner wall of the microporous channel is provided with a hydrophilic coating made of polyvinyl alcohol to enhance the adsorption capacity of the microporous channel for liquid.

[0012] As a preferred technical solution of this application, the outer surface of the flexible substrate module is provided with a protruding structure. The protruding structure is hemispherical in design, with a height of 0.5-2 mm and a spacing of 1-5 mm between the protruding structures. The protruding structure is integrally formed with the flexible substrate module through injection molding, which increases the surface area of ​​the flexible substrate module, thereby improving the contact efficiency between the antibacterial particle unit and the external environment.

[0013] As a preferred technical solution of this application, the flexible substrate module has a buffer cavity inside, which is located below the antibacterial particle group. The buffer cavity is separated from the antibacterial particle group by a partition, which has multiple through holes with a diameter of 0.1-0.5 mm. The buffer cavity is filled with a moisture-absorbing material made of diatomaceous earth to absorb excess liquid from the external environment, thereby preventing the antibacterial particle group from becoming ineffective due to excessive liquid immersion.

[0014] Compared with the prior art, the beneficial effects of this utility model are as follows:

[0015] In the scheme of this application:

[0016] Through the design of an antibacterial functional module and a flexible substrate module, antibacterial particles are evenly distributed within the flexible substrate module and connected to the external environment via a flow channel group. Liquids or gases from the external environment enter the flexible substrate module through the flow channel group, activating the functional properties of the antibacterial particles and releasing metal ions to inhibit the growth of bacteria or microorganisms. Simultaneously, the protective layer design allows for the regulation of liquids or gases from the external environment without affecting the flexibility of the flexible substrate module, ensuring the stability and durability of the antibacterial effect. Furthermore, the reinforcing layer within the flexible substrate module enhances the tensile strength and durability of the overall structure, maintaining good antibacterial performance even under complex stress or dynamic environments. This invention solves the problems of insufficient antibacterial performance, complex processes, and high manufacturing costs associated with traditional medical-grade silicone, while possessing excellent flexibility and durability, making it suitable for various medical scenarios. Attached Figure Description

[0017] Figure 1 This is a schematic diagram of the overall external structure of this utility model.

[0018] Figure 2 This is a partial enlarged view of the antibacterial functional module of this utility model.

[0019] Figure 3 This is a schematic cross-sectional view of the flexible substrate module of this utility model.

[0020] Figure 4 This is a schematic diagram of the protective layer structure of this utility model.

[0021] Figure 5 This is a schematic diagram of the protruding structure of this utility model.

[0022] The attached figures are labeled as follows:

[0023] 1. Flexible substrate module; 2. Antibacterial functional module; 3. Antibacterial particle group; 4. Flow channel group; 5. Protective layer; 6. Inner protective film; 7. Outer protective film; 8. Reinforcing layer; 9. Raised structure. Detailed Implementation

[0024] This invention provides a medical-grade silicone with antibacterial properties, comprising a flexible substrate module 1, an antibacterial functional module 2, and a protective layer 5. The specific embodiments of this invention are described in detail below with reference to the accompanying drawings.

[0025] First, such as Figure 1As shown, the flexible substrate module 1 is the basic part of the overall structure, and an antibacterial functional module 2 is embedded inside it. The antibacterial functional module 2 forms an integral structure with the flexible substrate module 1 through a specific connection structure. The outer surface of the flexible substrate module 1 is covered with a protective layer 5, which is bonded to the flexible substrate module 1 through a hot-pressing process, thereby forming a physically stable layered structure. The antibacterial functional module 2 consists of an antibacterial particle group 3 and a flow channel group 4. The antibacterial particle group 3 is evenly distributed inside the flexible substrate module 1, while the flow channel group 4 penetrates the flexible substrate module 1 and communicates with the surface, forming a material exchange channel between the internal and external environments.

[0026] Antibacterial particle group 3 consists of multiple antibacterial particle units, each including a core and a coating layer. The core is a metal ion carrier, specifically using silver ions as the antibacterial active substance, and the coating layer is a biodegradable polymer material, preferably polylactic acid. The coating layer is chemically bonded to the core to ensure the stability of the core and control the release rate. Figure 2 As shown, the antibacterial particle units are distributed in a lattice pattern inside the flexible substrate module 1, resulting in a uniform distribution of the antibacterial particle units within the module 1. The specific spacing of the lattice arrangement is 0.5-2 mm, and the core diameter of the antibacterial particle unit is 50-200 micrometers, while the coating layer thickness is 10-50 micrometers. Through this design, the antibacterial particle units can maintain a stable distribution within the flexible substrate module 1 and dynamically adjust their position when the module 1 undergoes elastic deformation, thereby adapting to changes in external stress.

[0027] The flow channel group 4 includes multiple microporous channels, the inlet ends of which are located on the outer surface of the flexible substrate module 1, and the outlet ends extend to the surrounding area of ​​the antibacterial particle unit. For example... Figure 2 As shown, the microporous channels have a diameter of 50-200 micrometers and a length of 1-5 millimeters, with a tapered inlet design to improve the efficiency of liquid or gas introduction. The inner wall of the microporous channels is coated with a hydrophilic coating made of polyvinyl alcohol, which enhances the adsorption capacity of the microporous channels for liquids. When external liquids or gases enter the flexible substrate module 1 through the microporous channels, they come into contact with the antibacterial particle units and activate their function of releasing metal ions, thereby achieving an antibacterial effect.

[0028] The main structure of the flexible substrate module 1 includes a main layer and a reinforcing layer 8, such as... Figure 3As shown, the main body layer is made of medical-grade silicone material with a thickness of 1-5 mm; the reinforcing layer 8 is made of fiber-reinforced material with a thickness of 0.2-1 mm and is embedded inside the main body layer. The fiber direction of the reinforcing layer 8 is consistent with the tensile direction of the main body layer, and it is bonded to the main body layer through injection molding, thereby giving the flexible substrate module 1 high tensile strength and durability. This layered design not only improves the overall mechanical properties of the flexible substrate module 1, but also provides good support and protection for its internal antibacterial functional module 2.

[0029] The protective layer 5 is divided into two parts: an inner protective film 6 and an outer protective film 7, such as... Figure 4 As shown. The inner protective membrane 6 is made of a hydrophilic polymer material with a thickness of 0.1-0.3 mm; the outer protective membrane 7 is made of a hydrophobic polymer material with a thickness of 0.05-0.1 mm. The inner protective membrane 6 is bonded to the outer surface of the flexible substrate module 1 through a hot-pressing process, while the outer protective membrane 7 is coated onto the outside of the inner protective membrane 6 through a spraying process. This double-layer design can regulate the permeation rate of external liquids or gases while maintaining the flexibility of the flexible substrate membrane 1. For example, in practical use, when the flexible substrate module 1 comes into contact with human body fluids, the inner protective membrane 6 allows a suitable amount of liquid to pass through and enter the interior of the flexible substrate module 1, while the outer protective membrane 7 prevents excessive liquid intrusion, thereby avoiding the failure of the antibacterial particle group 3 due to excessive wetting.

[0030] The outer surface of the flexible substrate module 1 is provided with a protruding structure 9, such as Figure 5 As shown. The protruding structure 9 is a hemispherical design with a height of 0.5-2 mm and a spacing of 1-5 mm, and is integrally formed with the flexible substrate module 1 through injection molding. The protruding structure 9 increases the surface area of ​​the flexible substrate module 1, thereby improving the contact efficiency between the antibacterial particle unit and the external environment. In addition, the flexible substrate module 1 also has a buffer cavity inside, located below the antibacterial particle group 3 and separated from it by a partition. The partition has multiple through holes with a diameter of 0.1-0.5 mm, used to guide excess liquid from the external environment into the buffer cavity. The buffer cavity is filled with a moisture-absorbing material, preferably made of diatomaceous earth, which can absorb excess liquid from the external environment, thereby further protecting the antibacterial particle group 3 from the effects of excessive liquid.

[0031] In practical applications, the medical-grade silicone of this invention can be used to manufacture medical devices or implants, such as urinary catheters and artificial organ shells. When the silicone product comes into contact with human tissue or bodily fluids, external liquid enters the flexible substrate module 1 through the control of the protective layer 5, and is then transported to the vicinity of the antibacterial particle unit via the flow channel group 4. At this time, the coating layer of the antibacterial particle unit gradually degrades and releases silver ions from its core. The silver ions diffuse to the surface of the flexible substrate module 1 and come into contact with bacteria or microorganisms, thereby inhibiting their growth and reproduction. At the same time, the presence of the reinforcing layer 8 enables the flexible substrate module 1 to withstand complex stress environments, while the design of the buffer cavity and moisture-absorbing material effectively avoids the problem of the antibacterial particle group 3 failing due to excessive liquid infiltration. Throughout the process, the various components work together to ensure the stability and durability of the antibacterial performance.

[0032] This invention solves the problems of insufficient antibacterial properties, complex processes, and high manufacturing costs of traditional medical-grade silicone through the above-mentioned structural design and material selection. At the same time, it has excellent flexibility and durability and is suitable for a variety of medical scenarios.

[0033] To enable those skilled in the art to fully understand and implement this utility model, the specific implementation principles of this utility model are further explained below in conjunction with specific application scenarios.

[0034] In practical applications, when this medical-grade silicone product is used to manufacture urinary catheters, its operating principle and antibacterial performance are achieved as follows: First, the outer surface of the flexible substrate module 1 comes into contact with human tissue or body fluids through the protective layer 5. The inner protective membrane 6 in the protective layer 5 allows a suitable amount of liquid to pass through and enter the interior of the flexible substrate module 1, while the outer protective membrane 7 effectively prevents excessive liquid intrusion, thereby avoiding the failure of the antibacterial particle group 3 due to over-wetting. At this time, external liquid is transported to the vicinity of the antibacterial particle unit through the microporous channels of the flow channel group 4. The tapered inlet design of the microporous channel improves the liquid introduction efficiency, while the polyvinyl alcohol hydrophilic coating on the inner wall further enhances the liquid adsorption capacity, ensuring that the liquid can smoothly reach the antibacterial particle unit.

[0035] Subsequently, the coating layer of the antibacterial particle unit gradually degrades upon contact with the liquid, releasing silver ions from its core. These silver ions migrate from the interior of the flexible substrate module 1 to the surface via diffusion, contacting bacteria or microorganisms and inhibiting their growth and reproduction. Because the antibacterial particle units are uniformly distributed within the flexible substrate module 1 in a lattice pattern with a spacing of 0.5-2 mm, this design ensures the uniformity of the antibacterial effect throughout the material and on its surface. Furthermore, the antibacterial particle units can dynamically adjust their position when the flexible substrate module 1 undergoes elastic deformation, thereby adapting to changes in external stress and ensuring the stability of the antibacterial performance under complex stress environments.

[0036] Meanwhile, the presence of reinforcing layer 8 significantly improves the overall mechanical properties of the flexible substrate module 1. Reinforcing layer 8 is made of fiber-reinforced material, with its fiber direction aligned with the tensile direction of the main layer. It is embedded within the main layer using an injection molding process and has a thickness of 0.2-1 mm. This layered structure not only enhances the tensile strength and durability of the flexible substrate module 1 but also provides excellent support and protection for its internal antibacterial functional module 2, enabling it to withstand complex stress environments during long-term use.

[0037] The design of the buffer chamber plays a crucial role in the liquid penetration process. Located below the antimicrobial granule group 3 and separated from it by a partition, the buffer chamber has multiple through-holes with a diameter of 0.1-0.5 mm, which guide excess liquid from the external environment into the buffer chamber. The buffer chamber is filled with a moisture-absorbing material, preferably made of diatomaceous earth, which efficiently absorbs excess liquid, thus preventing the antimicrobial performance of the antimicrobial granule group 3 from decreasing due to excessive liquid infiltration. This design ensures the stability and durability of the antimicrobial granule group 3 during long-term use.

[0038] Furthermore, the raised structure 9 on the outer surface of the flexible substrate module 1 further improves the efficiency of antibacterial performance. The raised structure 9 is hemispherical in shape, with a height of 0.5-2 mm and a spacing of 1-5 mm, and is integrally formed with the flexible substrate module 1 through injection molding. This design increases the surface area of ​​the flexible substrate module 1, thereby improving the contact efficiency between the antibacterial particle units and the external environment, allowing the antibacterial performance to be exerted more quickly and comprehensively.

[0039] In summary, this invention achieves stable and durable antibacterial performance through the synergistic effect of the aforementioned components. The protective layer 5 regulates the liquid permeation rate, the flow channel group 4 guides the liquid to the vicinity of the antibacterial particle unit, the antibacterial particle unit releases silver ions to inhibit bacterial growth, the reinforcing layer 8 provides mechanical support, the buffer cavity absorbs excess liquid, and the raised structure 9 increases the contact area. These designs collectively solve the problems of insufficient antibacterial performance, complex processes, and high manufacturing costs associated with traditional medical-grade silicone, while also possessing excellent flexibility and durability, making it suitable for various medical scenarios.

[0040] All content not described in detail in this specification belongs to the prior art known to those skilled in the art, and the material selection and processing technology of each component can be achieved by conventional technical means. Details not mentioned in the technical solution of this utility model are not shown in the figures because they belong to the prior art, and will not be elaborated upon here.

[0041] The above description is only a preferred embodiment of the present utility model and is not intended to limit the present utility model. Any modifications, equivalent substitutions, improvements, etc., made within the spirit and principles of the present utility model should be included within the protection scope of the present utility model.

Claims

1. A medical grade silicone having antibacterial properties, characterized in that, The device includes a flexible substrate module (1), an antibacterial functional module (2), and a protective layer (5). The antibacterial functional module (2) is embedded inside the flexible substrate module (1), and the protective layer (5) covers the outer surface of the flexible substrate module (1). The antibacterial functional module (2) includes an antibacterial particle group (3) and a flow channel group (4). The antibacterial particle group (3) is evenly distributed inside the flexible substrate module (1), and the flow channel group (4) penetrates the flexible substrate module (1) and communicates with the surface of the flexible substrate module (1).

2. The medical grade silicone having an antibacterial property according to claim 1, characterized by, The antibacterial particle group (3) is composed of multiple antibacterial particle units. Each antibacterial particle unit includes a core and a coating layer. The core is a metal ion carrier, and the coating layer is made of a biodegradable polymer material and is chemically bonded to the core. The multiple antibacterial particle units are distributed in a dot matrix arrangement inside the flexible substrate module (1).

3. The medical grade silicone having an antibacterial property according to claim 2, characterized by, The flow channel group (4) includes multiple microporous channels. The inlet end of the microporous channel is located on the outer surface of the flexible substrate module (1), and the outlet end extends to the surrounding area of ​​the antibacterial particle unit. The inlet end of the microporous channel is tapered, and the inner wall of the microporous channel is provided with a hydrophilic coating.

4. The medical-grade silicone with antibacterial properties according to claim 1, characterized in that, The flexible substrate module (1) includes a main layer and a reinforcing layer (8). The main layer is made of medical-grade silicone material, and the reinforcing layer (8) is made of fiber-reinforced material and embedded inside the main layer. The fiber direction of the reinforcing layer (8) is consistent with the stretching direction of the main layer.

5. The medical-grade silicone with antibacterial properties according to claim 1, characterized in that, The protective layer (5) includes an inner protective film (6) and an outer protective film (7). The inner protective film (6) is made of a hydrophilic polymer material and is bonded to the outer surface of the flexible substrate module (1) by a hot pressing process. The outer protective film (7) is made of a hydrophobic polymer material and is coated on the outside of the inner protective film (6) by a spraying process.

6. The medical grade silicone having an antibacterial property according to claim 1, wherein, The outer surface of the flexible substrate module (1) is provided with a protruding structure (9), which is a hemispherical design and is integrally formed with the flexible substrate module (1) through injection molding process.

7. The medical-grade silicone with antibacterial properties according to claim 1, characterized in that, The flexible substrate module (1) has a buffer cavity inside. The buffer cavity is located below the antibacterial particle group (3) and is separated from the antibacterial particle group (3) by a partition. The partition has multiple through holes, and the buffer cavity is filled with moisture-absorbing material.

8. The medical grade silicone having an antibacterial property according to claim 3, wherein, The hydrophilic coating is made of polyvinyl alcohol.

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