CN105326535B - Medical anastomosis nail and preparation method thereof - Google Patents
Medical anastomosis nail and preparation method thereof Download PDFInfo
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- CN105326535B CN105326535B CN201410382354.7A CN201410382354A CN105326535B CN 105326535 B CN105326535 B CN 105326535B CN 201410382354 A CN201410382354 A CN 201410382354A CN 105326535 B CN105326535 B CN 105326535B
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Abstract
The invention relates to a medical anastomosis nail which consists of a substrate, an adhesive layer and a drug coating. The antibacterial drug coated on the surface of the medical anastomosis nail can sterilize and disinfect the periphery of the tissue while connecting the tissue, promote the regeneration of the tissue and effectively promote the healing of the wound. In addition, the medical anastomosis nail can also be coated with corresponding treatment medicines aiming at other pathological changes, such as bleeding, tissue hyperplasia, cancer and the like, and can also obtain good treatment effect.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a medical anastomosis nail.
Background
Medical staples are widely used in various kinds of staplers (staplers) and other products, and these staplers are generally used for anastomosis of surgical tissues such as stomach, lung, liver and intestinal tract. However, in the operation, due to the unclean surgical environment, the anastomotic region may be infected by bacteria, and the tissue is connected and sterilized around the tissue, and if the sterilization effect is not good, the healing of the wound is affected, and even serious lesion is caused, but at present, no method for effectively sterilizing the tissue around the anastomotic stoma exists. In addition, other diseases such as bleeding and tissue hyperplasia can occur near the anastomotic stoma, and no effective prevention and treatment method is found at present.
Disclosure of Invention
The invention aims to provide a staple with an antibacterial drug coating or other drug coatings.
In order to achieve the purpose, the technical scheme adopted by the invention is as follows: the medical staple is characterized by consisting of a substrate, an adhesive layer and a drug coating.
Preferably, the substrate is titanium or stainless steel or degradable magnesium or degradable zinc or a degradable magnesium zinc alloy.
Preferably, the adhesive layer is one or a mixture of two of hyaluronic acid and serum protein.
Preferably, the drug coating comprises poly-l-lysine, and the drug coating further comprises one or more of an antibacterial agent, an anticancer agent, a hemostatic agent, an anti-stenosis agent.
Preferably, the antibacterial agent is one or a mixture of two of nano silver and sulfadiazine.
The invention also provides a preparation method of the medical anastomosis nail, which comprises the following steps:
step (1), pretreating an anastomosis nail substrate: cleaning the surface of an anastomosis nail matrix for coating a coating liquid, mainly polishing the surface of the matrix by using metallographic abrasive paper, and then treating the surface of the matrix by using ultrasonic waves for more than 10 minutes;
step (2) adhesive layer coating treatment: dissolving hyaluronic acid (or serum protein) in water to prepare a 16% -20% solution, and immersing the anastomosis nail in the prepared hyaluronic acid (or serum protein) water solution for 30-40 minutes;
step (3), coating antibacterial drugs (or other drugs): dissolving poly-L-lysine (or other polymers) in water to prepare a 21-25% solution, and mixing the solution according to the weight ratio of nano-silver (or other drugs): adding nano silver (or other medicines) into the solution in a ratio of 1: 1000 to prepare a suspension of the nano silver (or other medicines), immersing the anastomosis nail obtained in the step (2) into the suspension for 5 minutes or more, taking out the anastomosis nail, and naturally drying or drying in a freeze dryer to obtain the anastomosis nail coated with the hyaluronic acid (or serum protein), the poly-L-lysine (or other polymers) and the nano silver (or other medicines).
Preferably, the method further comprises the step (4) of surface anodizing: namely, the anastomosis nail in the step (3) is immersed in an electrolyte solution, an anodic current is applied externally to form an oxide film on the surface of the anastomosis nail, and different dyes are adsorbed in the pore structure of the anodic oxide film to enable the oxide film to have different colors.
The antibacterial drug coated on the surface of the medical anastomosis nail can sterilize and disinfect the periphery of the tissue while connecting the tissue, promote the regeneration of the tissue and effectively promote the healing of the tissue. In addition, the medical anastomosis nail can also be coated with corresponding medicines aiming at other pathological changes, such as bleeding, tissue hyperplasia, cancer and the like, and can also obtain good treatment effect.
Detailed Description
The medical anastomosis nail is generally used in medical instruments such as an under-mirror anastomat, a linear stitching instrument, a linear cutter, a tubular anastomat and the like.
The embodiment of the invention adopts the scheme that the surface of the substrate of the metal anastomosis nail is coated with the adhesive layer and the medicine coating.
The main component of the metal matrix can be titanium, stainless steel, degradable magnesium, degradable zinc or degradable magnesium-zinc alloy, and the like.
In view of the above, the present invention provides a layer of adhesive between the surface of the staple substrate and the drug coating, so that the drug is not easy to fall off and the biocompatibility can be completely met, and the healing of the anastomotic stoma can be positively promoted. Hyaluronic acid, also known as Hyaluronic Acid (HA), is an acidic mucopolysaccharide and a multifunctional matrix, and exhibits a variety of important physiological functions, such as regulating permeability of blood vessel walls, regulating proteins, promoting wound healing, and the like. Serum proteins also have properties similar to hyaluronic acid, and thus, the staples of the present invention employ one or a mixture of hyaluronic acid and serum proteins as an adhesive layer.
Furthermore, the antibacterial drug coating comprises functional drug-loaded nanoparticles, preferably prepared from poly-L-lysine, wherein the poly-L-lysine is a polymer with good biocompatibility, has good nano-balling property, can be used as a good carrier of a drug therapeutic agent, and is more convenient for release and expression of a drug immobilization source. The functional drug-loaded nanoparticles in the antibacterial drug coating can also be polylactic acid, ethyl cellulose, chitosan and the like.
Further, the drug therapeutic agent in the drug coating layer according to the present invention may be an antibacterial agent, an anticancer agent, a hemostatic agent, an anti-stenosis agent, or the like.
The antibacterial agent can be nano silver, namely a metal silver simple substance with the particle size of nano level. The particle size of the nano silver is mostly about 25 nanometers, and the nano silver has strong inhibiting and killing effects on dozens of pathogenic microorganisms such as escherichia coli, gonococcus and the like, and can not generate drug resistance. The antibacterial agent can also be sulfadiazine, and the sulfadiazine has an inhibiting effect on gram-positive bacteria and gram-negative bacteria and belongs to a broad-spectrum antibacterial agent of sulfonamides. The antibacterial agent can also be a mixture of nano silver and sulfadiazine, and can also be rifampicin, chlorhexidine and other antibacterial drugs.
The anticancer agent can be one or more of adriamycin, kaempferol, vincristine, camptothecin, epipodophyllotoxin, taxol, and 5-fluorouracil. The hemostatic agent may be vitamins, etamsylate, carbachol, aminocaproic acid, aminomethyl benzoic acid, blood clotting enzyme, thrombin, pituitrin, Yunnan white drug powder, etc. The anti-stenosis agent may be rapamycin or the like. Further, the drug coating of the present invention may include any corresponding drug that prevents or treats a corresponding condition at the anastomotic site.
Embodiments of the invention may be prepared by the following method:
(1) pretreating an anastomosis nail substrate: cleaning the surface of an anastomosis nail matrix for coating a coating liquid, mainly polishing the surface of the matrix by using metallographic abrasive paper, and then treating the surface of the matrix by using ultrasonic waves for more than 10 minutes;
(2) coating treatment of the bonding layer: dissolving hyaluronic acid (or serum protein) in water to prepare a 16% -20% solution, and immersing the anastomosis nail in the prepared hyaluronic acid (or serum protein) water solution for 30-40 minutes;
(3) antibacterial (or other drug) coating treatment: dissolving poly-L-lysine (or other polymers) in water to prepare a 21-25% solution, and mixing the solution according to the weight ratio of nano-silver (or other drugs): adding nano silver (or other medicines) into the solution in a ratio of 1: 1000 to prepare a suspension of the nano silver (or other medicines), immersing the anastomosis nail obtained in the step (2) into the suspension for 5 minutes or more, taking out the anastomosis nail, and naturally drying or drying in a freeze dryer to obtain the anastomosis nail coated with the hyaluronic acid (or serum protein), the poly-L-lysine (or other polymers) and the nano silver (or other medicines).
Further, the method can also comprise the following steps:
(4) surface anodic oxidation treatment: and (4) immersing the anastomosis nail in the step (3) into an electrolyte solution, forming an oxide film on the surface of the anastomosis nail by applying an anodic current externally, and adsorbing different dyes in a pore structure of the anodic oxide film to enable the oxide film to be colored with different colors.
The antibacterial drug (or other drugs) coated on the surface of the medical anastomosis nail can carry out sterilization treatment (or treatment of other diseases) on surrounding tissues while connecting the tissues, and promote the healing of the tissues.
The metal wire of the above embodiment is in a U shape, and the medical anastomosis nail of the invention can be made into various shapes according to the requirements. The cross-section of the staple may be circular, oval or other such shape.
The above embodiments are illustrative of specific embodiments of the present invention, and those skilled in the art can make various modifications according to the above embodiments, such as making various changes to the shape of the medical staple and making changes to the component ratio of the soaking solution within a reasonable range, and these modifications will all result in medical staples with the surface coated with the drug coating, and all fall within the protection scope of the present invention without departing from the spirit and substance of the present invention.
Claims (2)
1. A medical anastomosis nail is characterized in that the anastomosis nail consists of a substrate, an adhesive layer and a drug coating layer,
the substrate is stainless steel or degradable magnesium or degradable zinc or degradable magnesium-zinc alloy,
the adhesive layer is one or a mixture of two of hyaluronic acid and serum protein,
the drug coating comprises poly-L-lysine, nano-silver and sulfadiazine;
the surface of the anastomosis nail is subjected to anodic oxidation treatment to form an oxidation film with a pore structure, and the oxidation film with the pore structure adsorbs dyes in the anodic oxidation treatment.
2. A method of making a medical staple according to claim 1, comprising the steps of:
step (1), pretreating an anastomosis nail substrate: cleaning the surface of the anastomosis nail substrate for coating a coating liquid, polishing the surface of the substrate by using metallographic abrasive paper, and then treating the surface of the substrate by using ultrasonic waves for more than 10 minutes;
step (2) adhesive layer coating treatment: dissolving the hyaluronic acid in water to prepare a 16-20% solution, and immersing the anastomosis nail in the prepared aqueous solution of the hyaluronic acid for 30-40 minutes;
step (3), coating antibacterial agent: dissolving poly-L-lysine in water to prepare a 21-25% solution, and mixing the solution according to the weight ratio of nano-silver: adding nano silver into the solution in a ratio of 1: 1000 to prepare a nano silver suspension, immersing the anastomosis nail obtained in the step (2) into the suspension for 5 minutes or more, taking out the anastomosis nail, and naturally drying or drying in a freeze dryer to obtain the anastomosis nail with the surface coated with the hyaluronic acid, the poly-L-lysine and the nano silver;
further comprising the step (4) of surface anodic oxidation treatment: and (4) immersing the staple in the step (3) in an electrolyte solution, applying an anodic current to form an oxide film on the surface of the staple, and adsorbing different dyes in the pore structure of the anodic oxide film to make the oxide film have different colors.
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| CN201410382354.7A CN105326535B (en) | 2014-08-06 | 2014-08-06 | Medical anastomosis nail and preparation method thereof |
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| CN201410382354.7A CN105326535B (en) | 2014-08-06 | 2014-08-06 | Medical anastomosis nail and preparation method thereof |
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| CN105326535A CN105326535A (en) | 2016-02-17 |
| CN105326535B true CN105326535B (en) | 2020-08-14 |
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| CN105920683B (en) * | 2016-04-24 | 2019-02-01 | 河北卫崭医疗科技有限公司 | A kind of titanium that can prevent bacterium infection used for gastrointestinal disease is followed closely |
| CN106377290B (en) * | 2016-08-19 | 2018-06-22 | 北京派尔特医疗科技股份有限公司 | A kind of medicine-carried titanium nail and load medicine titanium nail and preparation method thereof |
| CN111378195B (en) * | 2019-08-20 | 2022-07-01 | 北京派尔特医疗科技股份有限公司 | Preparation method of polydopamine film and application of polydopamine film in medical implant material |
| EP4163408A4 (en) | 2020-06-05 | 2023-07-26 | Sichuan Megall Medical Devices Co., Ltd | Degradable magnesium alloy in-situ composite staple and preparation method therefor |
| CN113476668A (en) * | 2021-07-12 | 2021-10-08 | 中山大学附属第六医院 | Biodegradable anastomosis nail and preparation method thereof |
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| CN2778285Y (en) * | 2005-03-28 | 2006-05-10 | 山东百多安医疗器械有限公司 | Antibacterial super slippery urethral catheter |
| CN2843389Y (en) * | 2005-07-15 | 2006-12-06 | 罗劲松 | The bone injury fixing head that resets |
| CN2838562Y (en) * | 2005-08-04 | 2006-11-22 | 林斌 | A kind of orthopaedics implants that is used to prevent and treat the internal fixation of fracture postoperative infection |
| CN1843124A (en) * | 2006-03-17 | 2006-10-11 | 何素梅 | Nano silver coating agent for sterilization and its preparation method |
| EP2257971A4 (en) * | 2008-01-18 | 2012-11-28 | Nanosurface Technologies Llc | Nanofilm protective and release matrices |
| CN103328015B (en) * | 2011-01-24 | 2016-01-06 | 奥林巴斯株式会社 | Biodegradable implant material and manufacture method thereof |
| CN102697531A (en) * | 2012-05-28 | 2012-10-03 | 王学凡 | Titanium nail with hemostatic medicine coating |
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