An antibacterial bioactive glass coating for sutures and a method of making the same
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- SHANDONG MIANYITONG MEDICAL TECHNOLOGY CO LTD
- Filing Date
- 2026-07-02
- Publication Date
- 2026-08-04
AI Technical Summary
[0006]本发明的目的是提供一种用于缝合线的抗菌生物活性玻璃涂层及其制备方法，旨在根本性地解决现有医用缝合线在临床应用中面临的感染风险、组织损伤以及愈合缓慢等核心挑战
[0019] (3) Outer coating: Mix nano-bioactive glass, antibacterial agent and sodium hyaluronate, add deionized water and ultrasonically disperse to form an outer coating liquid; use a high-pressure spraying device to uniformly spray the outer coating liquid onto the surface of the inner coating, and dry it in a vacuum drying oven at 40℃ for 2-3 hours after spraying to obtain a double-layer composite coating suture.
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Figure CN122499345A_ABST
Abstract
Description
Technical Field
[0001] This invention belongs to the field of bioactive coating technology, specifically referring to an antibacterial bioactive glass coating for sutures and its preparation method. Background Technology
[0002] In surgical procedures, sutures serve as crucial medical consumables for connecting and supporting the healing of damaged tissues. Their performance directly impacts surgical success rates, wound healing quality, and the probability of postoperative complications. With the continuous advancement of modern medicine and patients' increasing demands for medical quality, the requirements for sutures in terms of biocompatibility, mechanical strength, ease of handling, and biofunctionality are becoming increasingly stringent. This has prompted medical materials science to continuously explore novel suture technologies that integrate multiple advantages.
[0003] In traditional medical practice, sutures made of various materials, such as catgut, polyester, and polylactic acid, are widely used in clinical practice. These sutures play an irreplaceable role in providing basic mechanical support and tissue closure. To address the common and serious complication of postoperative infection, early improvements focused primarily on enhancing a single function. Specifically, to address the risk of infection caused by bacterial adhesion, existing technologies have attempted to modify the suture surface using antibacterial agents such as silver ions. Silver ions, due to their broad-spectrum antibacterial properties and relatively mature preparation process, have shown some effectiveness in inhibiting various pathogenic bacteria. Furthermore, to address friction between the suture and tissue during suturing and potential postoperative inflammatory responses, some research focuses on introducing hydrophilic polymers such as polyethylene glycol (PEG) to improve suture surface lubricity, aiming to reduce puncture resistance and minimize tissue damage. Meanwhile, to actively promote wound tissue repair, especially for patient groups with impaired healing abilities (such as the elderly and diabetic patients), bioactive substances such as collagen have been introduced into suture coatings. These substances, as core components of the extracellular matrix (ECM), induce cell adhesion and proliferation, and support tissue regeneration. These single-function-oriented improvements have demonstrated their technical rationality and application value in specific periods and for specific problems.
[0004] However, with the continuous development of related technologies and the increasingly stringent and comprehensive requirements placed on suture performance indicators in clinical applications, the inherent characteristics of existing technologies based on single-function enhancement have gradually revealed deep and non-obvious limitations when addressing the challenges of multifunctional synergy. The underlying reason lies in the fact that simply stacking multiple functional components or carrying them in a single uniform coating often creates irreconcilable contradictions between material chemical compatibility, maintenance of bioactivity, and long-term functional stability. Specifically, to achieve highly effective antibacterial action, potent antibacterial agents such as silver ions often need to be continuously released to maintain local antibacterial concentrations; however, this continuous high-concentration release, while inhibiting bacterial growth, can also easily produce significant cytotoxicity to host cells (such as fibroblasts and endothelial cells), thereby interfering with the normal wound healing process and even causing tissue damage or delay. Furthermore, attempting to enhance the antibacterial effect simply by increasing the amount of antibacterial agent will exacerbate the potential cytotoxicity risk, leading to a fundamental inherent conflict between the two core functions of "antibacterial" and "promoting healing."
[0005] Meanwhile, lubricating coatings (such as those based on polyethylene glycol) typically rely on dynamic conformational changes in their hydrophilic polymer segments to reduce the coefficient of friction. However, the interfacial bonding between these materials and the hydrophobic polymer suture substrate is often weak. After being subjected to high shear forces during suturing or prolonged immersion in bodily fluids, the coating is highly susceptible to peeling or dissolution, thus losing its intended lubricating properties and potentially forming free microparticles in vivo, triggering new biological reactions. Conversely, introducing strong cross-linking agents or dense structures to enhance adhesion may sacrifice the coating's flexibility and the release efficiency of bioactive components. Furthermore, although collagen coatings exhibit excellent performance in promoting cell growth, as a natural biomolecule, they are easily degraded in the in vivo environment and lack inherent antibacterial capabilities. Without proper modification or binding, their effectiveness in infected wound areas will be significantly reduced, and they may even become a breeding ground for bacteria. Summary of the Invention
[0006] The purpose of this invention is to provide an antibacterial bioactive glass coating for sutures and its preparation method, aiming to fundamentally solve the core challenges faced by existing medical sutures in clinical applications, such as infection risks, tissue damage, and slow healing. The technical solution of this invention, through ingenious structural design and component synergistic mechanisms, ensures that the coating can continuously and stably exert multiple functions in the biological environment, including long-lasting antibacterial action, efficient lubrication, active healing promotion, and excellent biocompatibility, thereby significantly improving the overall performance of the suture and promoting safe and rapid wound healing. This invention, through a rational coating structure design, organically combines the healing-promoting function of bioactive glass, the nutritional supply function of collagen, the antibacterial function of antibacterial agents, and the friction-reducing function of lubricants, achieving a triple synergistic effect and solving the problem of single function in existing sutures. Simultaneously, the selected bioactive glass and collagen are both biocompatible materials that can be gradually degraded and absorbed in vivo without cytotoxicity; the antibacterial agent adopts a low-concentration compounding scheme, avoiding the damage to normal tissues caused by traditional high-concentration antibacterial agents; the coating of this invention is applicable to sutures of various materials, and the coating thickness and component ratio can be adjusted according to different surgical needs, making it suitable for a wide range of scenarios.
[0007] To achieve the above objectives, the present invention adopts the following technical solution: an antibacterial bioactive glass coating for sutures and a method for preparing the same, wherein the glass coating comprises a bonding layer (inner layer) and a functional layer (outer layer).
[0008] Furthermore, the binding layer (inner layer) uses type I collagen as the main structural matrix and is uniformly dispersed in bioactive glass micropowder with a mass fraction ranging from 5% to 10%.
[0009] Furthermore, the collagen is derived from medical-grade animal tissue extracts that have undergone rigorous purification and virus inactivation treatment. Its molecular weight ranges from 100kDa to 300kDa, and it has a complete amino acid sequence and a highly stable triple helix structure, thereby preserving its cell recognition sites and biological activity.
[0010] Furthermore, the particle size range of the bioactive glass micropowder is precisely controlled within the range of 50 nm to 100 nm, and its main components include silicon oxide, calcium oxide, and phosphorus pentoxide.
[0011] Furthermore, the functional layer (outer layer) is directly composited onto the outer surface of the bonding layer, and its design aims to achieve multiple synergistic functions.
[0012] Furthermore, the outer layer uses nanoscale bioactive glass as the core functional component. The particle size range of the nanoscale bioactive glass is precisely controlled between 10 nm and 30 nm. Its chemical composition is similar to that of the inner layer bioactive glass micropowder, but due to the nanoscale effect, its surface area / volume ratio is significantly increased, thereby possessing a faster ion release rate and higher bioactivity.
[0013] Furthermore, the mass fraction of the nanoscale bioactive glass accounts for 50% to 80% of the total mass of the outer layer. The outer layer is compounded with an antibacterial agent with a mass fraction ranging from 2% to 5%.
[0014] Preferably, the antibacterial agent is one or more of chitosan quaternary ammonium salt and zinc oxide nanoparticles.
[0015] Furthermore, the outer layer also contains a lubricant with a mass fraction ranging from 1% to 3%, preferably medical-grade sodium hyaluronate with a molecular weight range of 800 kDa to 2000 kDa.
[0016] The present invention also provides a method for preparing an antibacterial bioactive glass coating for sutures, the method comprising the following steps:
[0017] (1) Suture pretreatment: Place the suture in a 5%-8% NaOH solution and soak it at 60-70℃ for 1-2 hours to remove surface impurities and introduce hydroxyl groups; then rinse with deionized water until neutral and dry in a vacuum drying oven at 60℃ for 2-3 hours for later use.
[0018] (2) Inner layer coating: Prepare a collagen solution, add nano-bioactive glass powder to it, and disperse it by ultrasonication to form an inner layer coating solution; immerse the pretreated suture in the coating solution, soak it under a negative pressure of 0.05-0.1MPa for 30-60s, take it out and dry it in a constant temperature oven at 37℃ for 1-2h to form an inner layer coating.
[0019] (3) Outer coating: Mix nano-bioactive glass, antibacterial agent and sodium hyaluronate, add deionized water and ultrasonically disperse to form an outer coating liquid; use a high-pressure spraying device to uniformly spray the outer coating liquid onto the surface of the inner coating, and dry it in a vacuum drying oven at 40℃ for 2-3 hours after spraying to obtain a double-layer composite coating suture.
[0020] The beneficial effects of the present invention using the above structure are as follows: (1) The present invention, through reasonable coating structure design, organically combines the healing-promoting function of bioactive glass, the nutritional supply function of collagen, the antibacterial function of antibacterial agent and the friction-reducing function of lubricant, to achieve a triple synergistic effect and solve the problem of single function of existing sutures; (2) The bioactive glass and collagen selected in the present invention are both biocompatible materials that can be gradually degraded and absorbed in the body without cytotoxicity; the antibacterial agent adopts a low-concentration compound scheme to avoid damage to normal tissues caused by traditional high-concentration antibacterial agents; (3) The coating of the present invention can be applied to sutures of various materials, and the coating thickness and component ratio can be adjusted according to different surgical needs, making it applicable to a wide range of scenarios. Attached Figure Description
[0021] Figure 1 Antimicrobial rate of an antimicrobial bioactive glass coating for use in sutures.
[0022] The accompanying drawings are provided to further illustrate the invention and form part of the specification. They are used together with the embodiments of the invention to explain the invention and do not constitute a limitation thereof. Detailed Implementation
[0023] The technical solutions of the present invention will be clearly and completely described below with reference to the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. All other embodiments obtained by those skilled in the art based on the embodiments of the present invention without creative effort are within the scope of protection of the present invention.
[0024] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those familiar to those skilled in the art. Furthermore, any methods and materials similar to or equivalent to those described herein may be applied to this invention. The preferred embodiments and materials described herein are for illustrative purposes only and do not limit the scope of this application.
[0025] Unless otherwise specified, the experimental methods used in the following examples are conventional methods; unless otherwise specified, the experimental materials and test strains used in the following examples were purchased from commercial channels.
[0026] Example 1
[0027] An antibacterial bioactive glass coating for sutures and its preparation method
[0028] The glass coating includes a bonding layer (inner layer) and a functional layer (outer layer).
[0029] The binding layer (inner layer) uses type I collagen as the main structural matrix and is uniformly dispersed in 5% by mass of bioactive glass micropowder.
[0030] The collagen is derived from medical-grade animal tissue extracts that have undergone rigorous purification and virus inactivation treatment. It has a molecular weight of 300 kDa, a complete amino acid sequence, and a highly stable triple helix structure, thereby preserving its cell recognition sites and biological activity.
[0031] The bioactive glass micropowder has a particle size of 50 nm and its main components include silicon oxide, calcium oxide and phosphorus pentoxide.
[0032] The functional layer (outer layer) is directly composited onto the outer surface of the bonding layer, and its design aims to achieve multiple collaborative functions.
[0033] The outer layer uses nanoscale bioactive glass as its core functional component. The particle size of the nanoscale bioactive glass is precisely controlled within the range of 10 nm to 30 nm. Its chemical composition is similar to that of the inner layer bioactive glass micropowder, but due to the nanoscale effect, its surface area / volume ratio is significantly increased, thereby exhibiting a faster ion release rate and higher bioactivity.
[0034] The nanoscale bioactive glass accounts for 50% of the total mass of the outer layer. The outer layer is coated with zinc oxide nanoparticles with a mass fraction of 5%.
[0035] The outer layer also contains a 1% (by mass) lubricant, preferably medical-grade sodium hyaluronate with a molecular weight of 2000 kDa.
[0036] The present invention also provides a method for preparing an antibacterial bioactive glass coating for sutures, the method comprising the following steps:
[0037] (1) Suture pretreatment: Place the suture in a 5%-8% NaOH solution and soak it at 60-70℃ for 1-2 hours to remove surface impurities and introduce hydroxyl groups; then rinse with deionized water until neutral and dry in a vacuum drying oven at 60℃ for 2-3 hours for later use.
[0038] (2) Inner layer coating: Prepare a collagen solution, add nano-bioactive glass powder to it, and disperse it by ultrasonication to form an inner layer coating solution; immerse the pretreated suture in the coating solution, soak it under a negative pressure of 0.05-0.1MPa for 30-60s, take it out and dry it in a constant temperature oven at 37℃ for 1-2h to form an inner layer coating.
[0039] (3) Outer coating: Mix nano-bioactive glass, antibacterial agent and sodium hyaluronate, add deionized water and ultrasonically disperse to form an outer coating liquid; use a high-pressure spraying device to uniformly spray the outer coating liquid onto the surface of the inner coating, and dry it in a vacuum drying oven at 40℃ for 2-3 hours after spraying to obtain a double-layer composite coating suture.
[0040] Example 2
[0041] An antibacterial bioactive glass coating for sutures and its preparation method
[0042] The glass coating includes a bonding layer (inner layer) and a functional layer (outer layer).
[0043] The binding layer (inner layer) uses type I collagen as the main structural matrix and is uniformly dispersed in 10% by mass of bioactive glass micropowder.
[0044] The collagen is derived from medical-grade animal tissue extracts that have undergone rigorous purification and virus inactivation treatment. It has a molecular weight of 100kDa, a complete amino acid sequence, and a highly stable triple helix structure, thereby preserving its cell recognition sites and biological activity.
[0045] The bioactive glass micropowder has a particle size of 100 nm and its main components include silicon oxide, calcium oxide and phosphorus pentoxide.
[0046] The functional layer (outer layer) is directly composited onto the outer surface of the bonding layer, and its design aims to achieve multiple collaborative functions.
[0047] The outer layer uses nanoscale bioactive glass as its core functional component. The nanoscale bioactive glass has a particle size of 10 nm and its chemical composition is similar to that of the inner layer of bioactive glass micropowder. However, due to the nanoscale effect, its surface area / volume ratio is significantly increased, thus exhibiting a faster ion release rate and higher bioactivity.
[0048] The nanoscale bioactive glass accounts for 80% of the total mass of the outer layer. The outer layer is coated with zinc oxide nanoparticles with a mass fraction of 2%.
[0049] The outer layer also contains a 3% (by mass) lubricant, preferably medical-grade sodium hyaluronate with a molecular weight range of 800 kDa.
[0050] The present invention also provides a method for preparing an antibacterial bioactive glass coating for sutures, wherein the preparation method is performed in accordance with Example 1.
[0051] Example 3
[0052] An antibacterial bioactive glass coating for sutures and its preparation method
[0053] The glass coating includes a bonding layer (inner layer) and a functional layer (outer layer).
[0054] The binding layer (inner layer) uses type I collagen as the main structural matrix and is uniformly dispersed in 8% by mass of bioactive glass micropowder.
[0055] The collagen is derived from medical-grade animal tissue extracts that have undergone rigorous purification and virus inactivation treatment. It has a molecular weight of 200 kDa, a complete amino acid sequence, and a highly stable triple helix structure, thereby preserving its cell recognition sites and biological activity.
[0056] The bioactive glass micropowder has a particle size of 80 nm and its main components include silicon oxide, calcium oxide, and phosphorus pentoxide.
[0057] The functional layer (outer layer) is directly composited onto the outer surface of the bonding layer, and its design aims to achieve multiple collaborative functions.
[0058] The outer layer uses nanoscale bioactive glass as its core functional component. The nanoscale bioactive glass has a particle size of 20 nm and its chemical composition is similar to that of the inner layer bioactive glass micropowder. However, due to the nanoscale effect, its surface area / volume ratio is significantly increased, thus exhibiting a faster ion release rate and higher bioactivity.
[0059] The nanoscale bioactive glass comprises 65% by mass. The outer layer is coated with 3% by mass of chitosan quaternary ammonium salt.
[0060] The outer layer also contains a 2% (by mass) lubricant, preferably medical-grade sodium hyaluronate with a molecular weight of 1600 kDa.
[0061] The present invention also provides a method for preparing an antibacterial bioactive glass coating for sutures, wherein the preparation method is performed in accordance with Example 1.
[0062] Experimental Example 1
[0063] Antimicrobial test of an antimicrobial bioactive glass coating for sutures
[0064] The antibacterial bioactive glass-coated sutures prepared in Examples 1-3 were used as experimental materials and labeled as Group 1, Group 2, and Group 3. The control group used uncoated ordinary polyester sutures. Each group had three replicates. Each suture sample (2 cm in length) was placed in a centrifuge tube containing 5 mL of sterile physiological saline, and 100 μL of a 1×10⁻⁶ solution was added to each tube.7 Mix the bacterial culture with CFU / mL by shaking. Incubate at 37°C with shaking for 24 hours, then serially dilute 100 μL of the culture (10⁻¹-10⁻¹). 5 ), take 100 μL of bacterial suspension at different dilutions and spread it on MH agar medium. After incubation at 37℃ for 24 h, count the number of colonies and calculate the inhibition rate according to the formula: Inhibition rate (%) = (number of colonies in control sample - number of colonies in test sample) / number of colonies in control sample × 100%.
[0065] Results analysis: such as Figure 1 As shown, the antibacterial rates of groups 1-3 in Examples 1-3 were all higher than those of the control group, with the antibacterial rate of group 3 in Example 3 being the highest.
[0066] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.
[0067] The present invention and its embodiments have been described above. This description is not restrictive, and the accompanying drawings are only one embodiment of the present invention; the actual structure is not limited thereto. In conclusion, if those skilled in the art are inspired by this description and design similar structures and embodiments without departing from the spirit of the invention, such designs should fall within the protection scope of the present invention.
Claims
1. An antibacterial bioactive glass coating for sutures, characterized by: The glass coating includes a bonding layer (inner layer) and a functional layer (outer layer).
2. The antibacterial bioactive glass coating for sutures according to claim 1, characterized in that: The binding layer (inner layer) uses type I collagen as the main structural matrix and uniformly disperses bioactive glass micropowder with a mass fraction ranging from 5% to 10%.
3. The antibacterial bioactive glass coating for sutures according to claim 2, characterized in that: The collagen is derived from medical-grade animal tissue extracts that have been purified and inactivated by viruses. Its molecular weight ranges from 100kDa to 300kDa, and it has a complete amino acid sequence and a highly stable triple helix structure.
4. The antibacterial bioactive glass coating for sutures according to claim 3, characterized in that: The particle size range of the bioactive glass micropowder is precisely controlled between 50 nm and 100 nm, and its main components include silicon oxide, calcium oxide and phosphorus pentoxide.
5. The antibacterial bioactive glass coating for sutures according to claim 4, characterized in that: The functional layer (outer layer) is directly bonded to the outer surface of the bonding layer.
6. The antibacterial bioactive glass coating for sutures according to claim 5, characterized in that: The particle size range of the nanoscale bioactive glass is precisely controlled between 10 nm and 30 nm.
7. The antibacterial bioactive glass coating for sutures according to claim 6, characterized in that: The nanoscale bioactive glass accounts for 50% to 80% of the total mass of the outer layer. The outer layer is compounded with an antibacterial agent with a mass fraction ranging from 2% to 5%.
8. The antibacterial bioactive glass coating for sutures according to claim 7, characterized in that: The antibacterial agent is one or more of chitosan quaternary ammonium salt and zinc oxide nanoparticles.
9. The antibacterial bioactive glass coating for sutures according to claim 8, characterized in that: The outer layer also contains a lubricant with a mass fraction ranging from 1% to 3%, preferably medical-grade sodium hyaluronate with a molecular weight range of 800 kDa to 2000 kDa.
10. A method for preparing an antibacterial bioactive glass coating for sutures according to claim 9, characterized in that: The preparation method includes the following steps: (1) Suture pretreatment: Place the suture in a 5%-8% NaOH solution and soak it at 60-70℃ for 1-2 hours to remove surface impurities and introduce hydroxyl groups; then rinse with deionized water until neutral and dry in a vacuum drying oven at 60℃ for 2-3 hours for later use. (2) Inner layer coating: Prepare a collagen solution, add nano-bioactive glass powder to it, and disperse it by ultrasonication to form an inner layer coating solution; immerse the pretreated suture in the coating solution, soak it under a negative pressure of 0.05-0.1MPa for 30-60s, take it out and dry it in a constant temperature oven at 37℃ for 1-2h to form an inner layer coating. (3) Outer coating: Mix nano-bioactive glass, antibacterial agent and sodium hyaluronate, add deionized water and ultrasonically disperse to form an outer coating liquid; use a high-pressure spraying device to uniformly spray the outer coating liquid onto the surface of the inner coating, and dry it in a vacuum drying oven at 40℃ for 2-3 hours after spraying to obtain a double-layer composite coating suture.