Method for preparing anastomotic staple and anastomotic staple with acid-resistant repairable drug-loaded coating

Abstract

The present invention discloses a method for preparing an anastomotic staple and an acid-resistant, repairable, drug-loaded anastomotic staple, belonging to the field of medical device technology. The anastomotic staple preparation method comprises the following steps: S1, preparing a magnesium alloy anastomotic staple substrate using magnesium alloy wire; S2, forming a porous oxide layer on the surface of the magnesium alloy anastomotic staple substrate; S3, depositing corrosion-inhibiting drug molecules within the pores of the porous oxide layer; and S4, forming a hydrotalcite coating containing anti-inflammatory drug molecules on the surface of the magnesium alloy anastomotic staple substrate using a hydrothermal method in a reactor. The present invention not only controls the degradation rate of the anastomotic staple but also facilitates anastomotic healing.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a method for preparing anastomotic staples and anastomotic staples with acid-resistant and repairable drug-loaded coatings. Background Art

[0002] A stapler is a medical device that replaces manual suturing. It can quickly suture the surgical site through staples while removing the diseased tissue. The working process is similar to that of a stapler. It is easy to use, can significantly reduce trauma and bleeding, shorten the operation time, and better ensure the safety of the operation.

[0003] Staples are a key component of staplers. Currently, staples are commonly made of titanium, titanium alloys, and stainless steel. These materials offer advantages such as chemical stability and excellent mechanical properties. However, their permanent implantation as a foreign body can cause inflammation in surrounding tissues, impacting the patient's postoperative well-being.

[0004] Therefore, some technicians have used magnesium alloys that can gradually degrade in the human body and have good biocompatibility as anastomotic staple materials. However, the uncontrollable degradation rate of magnesium alloys may lead to premature failure, limiting their scope of use.

[0005] This section provides background information related to the present application which is not necessarily prior art. Summary of the Invention

[0006] The purpose of the present invention is to provide a method for preparing anastomotic staples and anastomotic staples with an acid-resistant and repairable drug-loaded coating, which can not only control the degradation rate of the anastomotic staples but also facilitate the healing of the anastomotic stoma.

[0007] To achieve the above objectives, the following technical solutions are provided:

[0008] The method for preparing anastomotic staples comprises the following steps:

[0009] S1. A magnesium alloy anastomotic staple matrix is ​​prepared by using a magnesium alloy wire;

[0010] S2. forming a porous oxide layer on the surface of the magnesium alloy anastomotic staple substrate;

[0011] S3, depositing corrosion-inhibiting drug molecules into the pores of the porous oxide layer;

[0012] S4. Placing the magnesium alloy anastomotic staple in a reactor and forming a hydrotalcite coating having anti-inflammatory drug molecules on the surface of the magnesium alloy anastomotic staple substrate through a hydrothermal method.

[0013] As an optional solution of the method for preparing anastomotic staples, in step S3, the corrosion-inhibiting drug molecules include one or more of silver thiamine, metronidazole, omeprazole and ketoconazole.

[0014] As an optional solution of the method for preparing anastomotic staples, in step S4, the anti-inflammatory drug molecules include one or more of silver thiamine, metronidazole, omeprazole and ketoconazole.

[0015] As an optional solution of the method for preparing anastomotic staples, in step S2, the porous oxide layer is formed on the surface of the magnesium alloy anastomotic staple substrate by micro-arc oxidation.

[0016] As an optional solution for the method of preparing anastomotic staples, step S3 includes the following steps:

[0017] S31, soaking the magnesium alloy anastomotic staple substrate in a solution containing the corrosion-inhibiting functional drug molecules.

[0018] As an optional solution for the method of preparing anastomotic staples, step S3 includes the following steps:

[0019] S32, placing it in ultrasound for a predetermined period of time and then taking it out.

[0020] As an optional solution for the method of preparing anastomotic staples, step S1 includes the following steps:

[0021] S11, annealing the magnesium alloy wire;

[0022] S12. The magnesium alloy wire is made into a magnesium alloy anastomotic staple matrix through a stamping and cutting process.

[0023] As an optional solution for the preparation method of anastomotic staples, the diameter of the magnesium alloy wire is 0.25-0.38 mm, and / or

[0024] The thickness of the hydrotalcite coating is 5-10 μm, and / or

[0025] The thickness of the porous oxide layer is 2-10 μm, and the diameter of the pores of the porous oxide layer is 0.3-1 μm.

[0026] As an optional solution of the staple preparation method, the staple preparation method further includes:

[0027] S5. Taking out the magnesium alloy anastomotic staple base and performing cleaning, drying and sterilization treatments.

[0028] The acid-resistant, repairable, and drug-loaded anastomosis staple is prepared using the anastomosis staple preparation method described above. The acid-resistant, repairable, and drug-loaded anastomosis staple comprises a magnesium alloy anastomosis staple substrate, a porous oxide layer, and a hydrotalcite coating. The porous oxide layer is disposed on the surface of the magnesium alloy anastomosis staple substrate, and corrosion-inhibiting drug molecules are deposited in the pores of the porous oxide layer. The hydrotalcite coating is disposed on the porous oxide layer, and the hydrotalcite coating contains anti-inflammatory drug molecules.

[0029] Compared with the prior art, the present invention has the following beneficial effects:

[0030] The method for preparing anastomosis staples provided by the present invention adopts magnesium alloy wire to prepare a magnesium alloy anastomosis staple substrate, which has good biocompatibility and is gradually degraded and discharged after fulfilling its function in the human body environment, without the risk of residual in the body. A porous oxide layer is prepared on the surface of the magnesium alloy anastomosis staple substrate, which improves the corrosion resistance and surface roughness of the anastomosis staple, is conducive to improving the adhesion of the hydrotalcite coating, and provides storage space for corrosion-inhibiting functional drug molecules. The corrosion-inhibiting functional drug molecules are deposited in the pores of the porous oxide layer, and the reaction kettle is placed in a hydrothermal method to form a hydrotalcite coating with anti-inflammatory functional drug molecules on the surface of the magnesium alloy anastomosis staple substrate. The outer coating of the magnesium alloy anastomosis staple substrate is a hydrotalcite coating, which has an alkaline pH and can slow down the degradation rate in an acidic environment. The inner coating of the magnesium alloy anastomosis staple substrate is a porous oxide layer, and the porous oxide layer and the hydrotalcite coating are collectively referred to as a composite coating. The composite coating of the present invention combines repair and anti-inflammatory properties. The anti-inflammatory drug molecules intercalated in the interstices of the hydrotalcite can reduce inflammation and promote anastomotic healing. The hydrotalcite coating also has a sustained-release drug function and can be used as a drug carrier for controlled drug release in the biomedical field. The corrosion-inhibiting drug molecules deposited in the porous oxide layer act as corrosion inhibitors. When defects such as cracks and holes appear in the hydrotalcite coating, exposing the porous oxide layer, the corrosion-inhibiting drug molecules in the holes act as inhibitors to form a new protective film at the defect site, thus achieving the self-repair function of the hydrotalcite coating.

[0031] The acid-resistant and repairable drug-loaded anastomotic staple provided by the present invention can not only control the degradation rate of the anastomotic staple, but also facilitate the healing of the anastomotic stoma. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] In order to more clearly illustrate the technical solutions in the embodiments of the present invention, the following briefly introduces the drawings required for use in describing the embodiments of the present invention. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on the contents of the embodiments of the present invention and these drawings without any creative work.

[0033] Figure 1 Flowchart of the method for preparing anastomotic staples in an embodiment of the present invention. DETAILED DESCRIPTION

[0034] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the accompanying drawings of the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Generally, the components of the embodiments of the present invention described and shown in the drawings herein can be arranged and designed in various different configurations.

[0035] In the description of the present invention, it should be noted that the terms "upper", "lower", "left", "right", "vertical", "horizontal", "inside", "outside", etc., indicating the orientation or position relationship, are based on the orientation or position relationship shown in the accompanying drawings, or are the orientation or position relationship in which the product of the invention is usually placed when in use. 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, be constructed and operated in a specific orientation, and therefore cannot be understood as limiting the present invention. In addition, the terms "first", "second", "third", etc. are only used to distinguish the description and cannot be understood as indicating or implying relative importance. In the description of the present invention, unless otherwise specified, "multiple" means two or more.

[0036] In the description of the present invention, it should be noted that, unless otherwise specified or limited, the terms "disposed" and "connected" should be understood in a broad sense. For example, they can refer to fixed connections, detachable connections, or integral connections; they can refer to mechanical connections or electrical connections. Those skilled in the art will understand the specific meanings of the above terms in the present invention based on the specific circumstances.

[0037] The following describes embodiments of the present invention in detail. Examples of the embodiments are shown in the accompanying drawings, wherein the same or similar reference numerals throughout represent the same or similar elements or elements having the same or similar functions. The embodiments described below with reference to the accompanying drawings are exemplary and are intended only to explain the present invention and are not to be construed as limiting the present invention.

[0038] In order to control the degradation rate of the anastomotic staples and facilitate the healing of the anastomotic stoma, this embodiment provides a method for preparing anastomotic staples and an anastomotic staple with an acid-resistant and repairable drug-loaded coating. Figure 1 The specific contents of this embodiment are described in detail.

[0039] like Figure 1 As shown, the method for preparing anastomotic staples in this embodiment includes the following steps: S1, using magnesium alloy wire to prepare a magnesium alloy anastomotic staple substrate; S2, preparing a porous oxide layer on the surface of the magnesium alloy anastomotic staple substrate; S3, depositing corrosion-inhibiting functional drug molecules in the pores of the porous oxide layer; S4, placing the staple in a reactor and forming a hydrotalcite coating with anti-inflammatory functional drug molecules on the surface of the magnesium alloy anastomotic staple substrate through a hydrothermal method.

[0040] In short, the method for preparing the staple provided in this embodiment uses magnesium alloy wire to make a magnesium alloy staple substrate, which has good biocompatibility and is gradually degraded and discharged after fulfilling its function in the human body environment, without the risk of residual in the body. A porous oxide layer is prepared on the surface of the magnesium alloy staple substrate, which improves the corrosion resistance and surface roughness of the staple, helps to improve the adhesion of the hydrotalcite coating, and provides storage space for corrosion-inhibiting functional drug molecules. The corrosion-inhibiting functional drug molecules are deposited in the pores of the porous oxide layer, placed in a reactor, and a hydrotalcite coating with anti-inflammatory functional drug molecules is formed on the surface of the magnesium alloy staple substrate by a hydrothermal method. The outer coating of the magnesium alloy staple substrate is a hydrotalcite coating, which has an alkaline pH and can slow down the degradation rate in an acidic environment. The inner coating of the magnesium alloy staple substrate is a porous oxide layer, and the porous oxide layer and the hydrotalcite coating are collectively referred to as a composite coating. The composite coating of the present invention combines repair and anti-inflammatory properties. The anti-inflammatory drug molecules intercalated in the interstices of the hydrotalcite can reduce inflammation and promote anastomotic healing. The hydrotalcite coating also has a sustained-release drug function and can be used as a drug carrier for controlled drug release in the biomedical field. The corrosion-inhibiting drug molecules deposited in the porous oxide layer act as corrosion inhibitors. When defects such as cracks and holes appear in the hydrotalcite coating, exposing the porous oxide layer, the corrosion-inhibiting drug molecules in the holes act as inhibitors to form a new protective film at the defect site, thus achieving the self-repair function of the hydrotalcite coating.

[0041] Furthermore, in step S3, the corrosion-inhibiting drug molecules include one or more of silver thiamine, metronidazole, omeprazole, and ketoconazole. Corrosion-inhibiting drug molecules are compounds that, while exhibiting their medicinal properties, also inhibit corrosion. Drug molecules such as silver thiamine, metronidazole, omeprazole, and ketoconazole exhibit corrosion inhibition properties through specific mechanisms.

[0042] Furthermore, in step S4, the anti-inflammatory functional drug molecule includes one or more of silver thiamine, metronidazole, omeprazole, and ketoconazole. The anti-inflammatory functional drug molecule refers to a compound with an anti-inflammatory effect. Silver thiamine, metronidazole, omeprazole, and ketoconazole exhibit anti-inflammatory effects under specific circumstances.

[0043] Furthermore, in step S2, a porous oxide layer is formed on the surface of the magnesium alloy staple substrate using micro-arc oxidation. Micro-arc oxidation, a method for creating a ceramic coating on a metal surface through an electrochemical process, is widely used to enhance the wear resistance, corrosion resistance, and insulation properties of materials. When applied to staples, this technology primarily exhibits the following benefits: Formation of a porous oxide layer: Micro-arc oxidation treatment produces a dense and uniform porous structure on the staple surface. This oxide layer not only improves the hardness and wear resistance of the substrate but also significantly enhances corrosion resistance, improving biocompatibility and mechanical properties. For degradable magnesium staples, micro-arc oxidation combined with a polylactic acid (PLLA) coating effectively enhances initial corrosion resistance while maintaining good cellular compatibility. This treatment also ensures the mechanical stability of the staple in physiological environments, meeting clinical requirements. Controlling degradation rate: Micro-arc oxidation treatment helps regulate the degradation rate of degradable materials. For example, in simulated colonic fluid, treated magnesium alloy staples exhibited stable tensile strength and gradually degraded as expected, ultimately being completely absorbed.

[0044] Furthermore, step S3 includes the following steps: S31, immersing the magnesium alloy staple substrate in a solution containing corrosion-inhibiting drug molecules. On the one hand, the corrosion inhibitor can slow down the degradation rate of the magnesium alloy in the physiological environment, prolong the effective support time of the staple, and enhance the corrosion resistance; on the other hand, through surface treatment technologies such as micro-arc oxidation combined with corrosion inhibitors, a protective film can be formed, thereby increasing the hardness and tensile strength of the staple and improving the mechanical properties; on the other hand, certain corrosion inhibitors such as omeprazole may have a slight protective effect on surrounding tissues, helping to reduce inflammatory responses and promote healing.

[0045] Furthermore, step S3 includes the following steps: S32, placing the staple in ultrasonic vibration for a predetermined period of time and then removing the staple. The cavitation effect generated by the ultrasound can enhance the mass transfer process between the liquid and the solid surface, allowing the corrosion inhibitor to be more evenly and quickly adsorbed onto the staple surface, thereby helping to improve the impregnation efficiency.

[0046] Furthermore, step S1 includes the following steps: S11, annealing the magnesium alloy wire; S12, forming the magnesium alloy staple matrix from the magnesium alloy wire through a stamping and shearing process. The magnesium alloy wire is annealed. Low-temperature annealing can remove internal stress generated during processing, stabilize the material size and properties, and eliminate internal stress in the magnesium alloy wire. Complete recrystallization annealing can restore the material's plasticity, facilitate subsequent processing, reduce the effects of cold work hardening, and improve the plasticity and processing properties of the magnesium alloy wire. Annealing can promote grain refinement or homogenization, thereby enhancing the mechanical properties of the magnesium alloy wire. The magnesium alloy wire is formed into a magnesium alloy staple matrix through a stamping and shearing process. The stamping process can efficiently process the magnesium alloy wire into a staple matrix with a specific size and shape to meet the precision requirements of medical applications. The plastic deformation during the stamping process helps improve the mechanical properties of the magnesium alloy, such as strength and stiffness, making it more suitable for medical implants. The stamping process can precisely control material usage, reduce waste generation, and improve resource utilization. This process is suitable for mass production, meeting the large demand for anastomosis staples in the medical field while ensuring the stable quality of each product.

[0047] Optionally, the magnesium alloy wire in this embodiment has a wire diameter of 0.25 mm to 0.38 mm, is annealed at 390° C. to 480° C., and / or the thickness of the hydrotalcite coating is 5 μm to 10 μm, and / or the thickness of the porous oxide layer is 2 μm to 10 μm, and the pore diameter of the porous oxide layer is 0.3 μm to 1 μm.

[0048] Furthermore, the staple preparation method further includes: S5, removing the magnesium alloy staple base and then cleaning, drying, and sterilizing it. Cleaning removes surface grease, dirt, and any remaining chemicals, ensuring the cleanliness of the staple. Drying prevents corrosion or contamination caused by residual moisture and provides good conditions for subsequent operations. Sterilization is a key step, using high-temperature steam or other methods to eliminate microorganisms and prevent infection. This step must strictly adhere to medical standards to ensure the safety of the implant.

[0049] This embodiment also provides an acid-resistant, repairable, and drug-loaded anastomosis staple. The acid-resistant, repairable, and drug-loaded anastomosis staple is produced using the above-mentioned anastomosis staple production method. The acid-resistant, repairable, and drug-loaded anastomosis staple comprises a magnesium alloy anastomosis staple substrate, a porous oxide layer, and a hydrotalcite coating. The porous oxide layer is disposed on the surface of the magnesium alloy anastomosis staple substrate, and corrosion-inhibiting drug molecules are deposited within the pores of the porous oxide layer. The hydrotalcite coating is disposed on the porous oxide layer, and the hydrotalcite coating contains anti-inflammatory drug molecules. The acid-resistant, repairable, and drug-loaded anastomosis staple in this embodiment not only controls the degradation rate of the anastomosis staple but also facilitates anastomotic healing. The uniformly porous porous oxide layer improves the corrosion resistance and surface roughness of the anastomosis staple. The alkaline hydrotalcite coating ensures a low degradation rate in an acidic environment. The anastomosis staple has a certain anti-inflammatory effect and promotes anastomotic healing.

[0050] Note that the above are only preferred embodiments of the present invention and the technical principles employed. Those skilled in the art will understand that the present invention is not limited to the specific embodiments described herein, and that various obvious changes, readjustments, and substitutions can be made by those skilled in the art without departing from the scope of protection of the present invention. Therefore, although the present invention has been described in detail through the above embodiments, the present invention is not limited to the above embodiments and may include many other equivalent embodiments without departing from the concept of the present invention. The scope of the present invention is determined by the scope of the appended claims.

Claims

1. A method for preparing anastomotic staples, characterized in that: The following steps are involved: S1. A magnesium alloy anastomotic staple matrix is ​​prepared by using a magnesium alloy wire; S2. forming a porous oxide layer on the surface of the magnesium alloy anastomotic staple substrate; S3, depositing corrosion-inhibiting drug molecules in the pores of the porous oxide layer, wherein the corrosion-inhibiting drug molecules include one or more of silver thiamine, metronidazole, omeprazole, and ketoconazole; S4. Placing the magnesium alloy anastomosis staple in a reactor and forming a hydrotalcite coating with anti-inflammatory drug molecules on the surface of the magnesium alloy anastomosis staple through a hydrothermal method, wherein the anti-inflammatory drug molecules intercalated in the gaps between the hydrotalcite can play an anti-inflammatory role, and the anti-inflammatory drug molecules include one or more of silver thiamine, metronidazole, omeprazole and ketoconazole.

2. The method for preparing anastomotic staples according to claim 1, wherein: In the step S2, the porous oxide layer is formed on the surface of the magnesium alloy anastomotic staple substrate by micro-arc oxidation.

3. The method for preparing anastomotic staples according to claim 2, wherein: The step S3 comprises the following steps: S31, soaking the magnesium alloy anastomotic staple substrate in a solution containing the corrosion-inhibiting functional drug molecules.

4. The method for preparing anastomotic staples according to claim 3, wherein: The step S3 comprises the following steps: S32, placing it in ultrasound for a predetermined period of time and then taking it out.

5. The method for preparing anastomotic staples according to claim 2, characterized in that: The step S1 comprises the following steps: S11, annealing the magnesium alloy wire; S12. The magnesium alloy wire is made into a magnesium alloy anastomotic staple matrix through a stamping and cutting process.

6. The method for preparing anastomotic staples according to claim 2, characterized in that: The magnesium alloy wire has a wire diameter of 0.25 mm to 0.38 mm, and / or The thickness of the hydrotalcite coating is 5 μm-10 μm, and / or The thickness of the porous oxide layer is 2 μm-10 μm, and the diameter of the pores of the porous oxide layer is 0.3 μm-1 μm.

7. The method for preparing anastomotic staples according to claim 2, characterized in that: The method for preparing the anastomotic staple further comprises: S5. Taking out the magnesium alloy anastomotic staple base and performing cleaning, drying and sterilization treatments.

8. The acid-resistant and repairable drug-loaded coating of the anastomotic staple is characterized by: The anastomosis staple is prepared using the method for preparing the anastomosis staple according to any one of claims 1 to 7. The acid-resistant, repairable, drug-loaded coating anastomosis staple comprises a magnesium alloy anastomosis staple substrate, a porous oxide layer, and a hydrotalcite coating. The porous oxide layer is arranged on the surface of the magnesium alloy anastomosis staple substrate, and the corrosion-inhibiting functional drug molecules are deposited in the pores of the porous oxide layer. The hydrotalcite coating is arranged on the porous oxide layer, and the hydrotalcite coating contains anti-inflammatory functional drug molecules.

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