WO2021223527A1 - 组合物及应用、关节植入物型材、关节植入物及制备方法 - Google Patents

组合物及应用、关节植入物型材、关节植入物及制备方法 Download PDF

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Publication number
WO2021223527A1
WO2021223527A1 PCT/CN2021/081947 CN2021081947W WO2021223527A1 WO 2021223527 A1 WO2021223527 A1 WO 2021223527A1 CN 2021081947 W CN2021081947 W CN 2021081947W WO 2021223527 A1 WO2021223527 A1 WO 2021223527A1
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artificial
infective
porous solid
implant
joint
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PCT/CN2021/081947
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English (en)
French (fr)
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吴世齐
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深圳海思医疗有限公司
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/3094—Designing or manufacturing processes
    • A61F2/30942—Designing or manufacturing processes for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A—HUMAN NECESSITIES
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/4202—Joints for wrists or ankles; for hands, e.g. fingers; for feet, e.g. toes for ankles
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    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/44—Joints for the spine, e.g. vertebrae, spinal discs
    • A61F2/442—Intervertebral or spinal discs, e.g. resilient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/54—Biologically active materials, e.g. therapeutic substances
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30003—Material related properties of the prosthesis or of a coating on the prosthesis
    • A61F2002/3006—Properties of materials and coating materials
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A61F2002/30754—Implants for interposition between two natural articular surfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/10—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing inorganic materials
    • A61L2300/102—Metals or metal compounds, e.g. salts such as bicarbonates, carbonates, oxides, zeolites, silicates
    • A61L2300/104—Silver, e.g. silver sulfadiazine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
    • A61L2300/406—Antibiotics
    • A—HUMAN NECESSITIES
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    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
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    • A61L2430/00—Materials or treatment for tissue regeneration
    • A61L2430/24—Materials or treatment for tissue regeneration for joint reconstruction

Definitions

  • the present invention relates to the technical field of orthopedic implants, in particular to a composition containing ultra-high molecular weight polyethylene and an anti-infective agent and its application in an anti-infective implant.
  • the invention also relates to an anti-infective artificial joint implant profile, an anti-infective artificial joint implant and a preparation method thereof.
  • One way to fight infection is to use antibiotic bone cement to bond joint implants and bone tissue during surgery.
  • the antibiotics in the bone cement are released over time, and the antibacterial properties of antibiotics are used to inhibit bacterial growth to achieve the purpose of anti-infection; Shanghai The Ninth People’s Hospital affiliated to Jiaotong University School of Medicine also invented an anti-infective bone cement.
  • the basic principle is to mix magnesium-based metal particles with bone cement matrix and bone cement monomer to form a new type of anti-infective bone cement.
  • the magnesium-based metal degradation process The formation of antibacterial properties.
  • the present invention provides a composition, an anti-infective artificial joint implant containing the composition, and a preparation method thereof.
  • ultra-high molecular weight polyethylene refers to polyethylene with a viscosity above 2000 mL/g or a tensile stress above 0.2Mpa.
  • composition of the present invention includes ultra-high molecular weight polyethylene and an anti-infective agent.
  • the anti-infective agent may be selected from silver-based antibacterial agents and/or copper-based antibacterial agents.
  • the silver-based antibacterial agent is silver iodide and/or nano silver.
  • Silver-based antibacterial agents have the advantages of broad-spectrum, no drug resistance, and are not affected by pH. However, silver as a heavy metal is harmful to the human body after reaching a certain amount. Therefore, in some cases, antibiotics can be used to replace silver-based antibacterial agents.
  • the antibiotics can be one or a combination of multiple antibiotics commonly used in the medical field, and the specific types of antibiotics are not particularly limited.
  • the antibiotic is selected from vancomycin, gentamicin, amikacin, cefazolin, cefuroxime, cefotaxime, clindamycin, penicillin, erythromycin, tobramycin, any one Species or their combination.
  • the content of the anti-infective agent is 0.01-20%; preferably 0.1-5.0%.
  • the content of the anti-infective agent is 0.01%, 0.05%, 0.1%, 0.5%, 1.0%, 2.0%, 5.0%, 8.0%, 10.0%, 15.0%, 18.0%, 20.0%.
  • the anti-infective agent can be a silver-based anti-bacterial agent, a copper-based anti-bacterial agent or an antibiotic, the content of the anti-infective agent in the composition can be determined according to the material of the anti-infective agent and the actual antibacterial effect.
  • the content of the anti-infective agent can be set according to the material of the anti-infective agent and the anti-infective effect under the condition of ensuring the shaping of the implant. Generally, 0.1-5% is a suitable content range for antibiotics.
  • the present invention also provides the application of a composition comprising ultra-high molecular weight polyethylene and an anti-infective agent in an anti-infective artificial joint implant.
  • the artificial joint is one of an artificial hip joint, an artificial knee joint, an artificial ankle joint, an artificial shoulder joint, an artificial elbow joint, and a spine artificial intervertebral disc joint.
  • the present invention also provides a profile for anti-infective artificial joint implants, which is prepared from a composition comprising ultra-high molecular weight polyethylene and an anti-infective agent.
  • Profiles are precursors for making artificial implants, and cannot be directly implanted into the human body to play an anti-infection effect.
  • the profile has a rod-like or plate-like shape.
  • the profile can also have the shape of an implant suitable for implanting in the human body. After adding an anti-infective agent to the profile, an anti-infective artificial joint implant is prepared.
  • the implant is used as an implant for friction interface components in various artificial joints, such as artificial knee joint gaskets.
  • ultra-high molecular weight polyethylene is used as a friction interface material in various artificial replacement procedures.
  • ultra-high molecular weight polyethylene gaskets containing anti-infective agents as artificial joint implants carry the weight of the body on the one hand, and on the other hand generate movement with the femoral condyle. Due to the relative movement between the two components, the softer side (UHMWPE gasket) will continue to produce wear debris, and the anti-infective agent contained in the wear debris will continue to be released, exerting a long-term and slow anti-infection effect. effect.
  • the present invention provides anti-infective artificial joint implants. The release of anti-infective agents is a slow and continuous process, and thus can provide uniform and long-term infection control effects.
  • the present invention also provides a profile for preparing anti-infective artificial joint implants.
  • the profile is prepared from the raw materials including the composition of the present invention.
  • profiles are often made to serve as the precursors of artificial joint implants.
  • the profiles are the base material for making artificial joint implants. Artificial joint implants suitable for various joints.
  • the profile generally has a rod shape, a plate shape or an implant shape.
  • the profile is processed into various artificial joint implants after cutting, CNC processing and other processes.
  • the present invention also provides a method for preparing the profile.
  • the method includes the following steps:
  • step (12) The mixture material obtained in step (11) is compressed, extruded or injection molded into a profile for manufacturing an implant.
  • ultra-high molecular weight polyethylene powder or ultra-high molecular weight polyethylene particles can be purchased from the market, or can be prepared by oneself.
  • the above method also includes processing the profile obtained in step (12) into an artificial joint implant suitable for implantation in the human body.
  • the present invention also provides another method for preparing anti-infective artificial implant profiles.
  • the method includes the following steps:
  • step (23) Melt and consolidate the porous solid material obtained in step (22) to form an anti-infective artificial implant profile.
  • the contact includes immersing the porous solid material in the solution, so that the anti-infective agent is filled in the pores of the porous solid material.
  • the present invention also provides an anti-infective artificial joint implant, which is processed by including the above-mentioned profile.
  • the profile obtained in step (12) is generally a bar or a sheet. After cutting and CNC processing, the profile is processed into an anti-infective artificial joint implant with a final implant shape and size.
  • the anti-infective artificial joint implant of the present invention is suitable for artificial hip joints, artificial knee joints, artificial ankle joints, artificial shoulder joints, artificial elbow joints and spine artificial intervertebral disc joints.
  • the present invention also provides another method for preparing the anti-infective artificial joint implant as described above, and the method includes the following steps:
  • step (33) The porous solid material obtained in step (32) is melt-consolidated to provide a melt-consolidated material.
  • the porous solid material is prepared by a template filtration method.
  • the specific operation is as follows: mix the ultra-high molecular weight polyethylene powder with high-purity sodium chloride (NaCl), press it into a profile with a mold, then put the profile into deionized water to dissolve and filter out the sodium chloride to obtain a porous solid material .
  • the preparation of anti-infective artificial joint implants is divided into two situations.
  • the first situation is that in step (31), the porous solid material has been made into an implant having a shape and size suitable for implantation in the human body before contacting or infiltrating the solution of the anti-infective agent.
  • the agent penetrates into the pores of the porous solid material, and after melting and consolidation, a finished artificial joint implant suitable for implantation in the human body can be formed.
  • the second situation is that the porous solid material in step (31) is a profile and does not yet have the shape and size of the final implant.
  • the surface of the holes in the porous profile is coated with an anti-infective agent solution, and after melting and consolidation, the profile infiltrated with the anti-infective agent is further processed into an implant with the final implant shape and size.
  • the step of infiltrating the anti-infective agent into the porous solid implant includes putting the porous solid material (which can be a rod-shaped or plate-shaped profile, or a shape and size of the final implant).
  • the profile is immersed in a solution containing an anti-infective agent.
  • the solution is formed by dissolving the anti-infective agent in a solvent.
  • the solvents used to dissolve different anti-infective agents are different, and the specific solvent used can be selected according to the specific anti-infective agent.
  • the anti-infective agent is attached to the pores of the porous solid material.
  • Figure 1 is a schematic diagram of an anti-infective artificial joint implant profile provided by the present invention.
  • Figure 2 is a schematic diagram of an anti-infective artificial knee joint implant gasket provided by the present invention.
  • Fig. 3 is a schematic diagram of an anti-infective artificial intervertebral disc joint implant gasket provided by the present invention.
  • This embodiment provides an ultra-high molecular weight polyethylene anti-infective artificial knee joint gasket implant, which is prepared from the following raw materials: Celanese GUR1020 Ultra-high molecular weight polyethylene and elemental silver.
  • the mass content of ultra-high molecular weight polyethylene is 99.8%, and the mass content of elemental silver is 0.2%.
  • the elemental silver antibacterial agent is a monomer nanosilver solution.
  • Example 2 The difference between this example and Example 2 is that the formulation of the composition is changed to 950 grams of commercially available Celanese GUR1050 ultra-high molecular weight polyethylene powder and 50 grams of vancomycin hydrochloride instead of gentamicin sulfate. Embodiment 2 is the same.
  • the antibacterial effect of artificial joint implants was tested, and the test method is as follows.
  • Staphylococcus epidermidis strain S. epidermidis
  • methicillin-resistant Staphylococcus epidermidis strain MRSE
  • Staphylococcus epidermidis strain ATCC35984
  • a thin sheet with a size of 25mm ⁇ 25mm ⁇ 2mm is taken from the implant or profile as a test sample. After the sample is processed, it is placed in a petri dish, 0.1 mL of the test inoculum is sucked and dropped on the surface of the test sample, a 20mm ⁇ 20mm film is covered on the test inoculum and the inoculum is lightly pressed to disperse the inoculum. Incubate for 24 hours at 37°C ⁇ 1°C and 90% relative humidity. Add 20mL of eluent to elute the test sample 3 times. After diluting the eluent, inoculate the plate and culture in a constant temperature box, and count the viable bacteria. Antibacterial rate.
  • composition formulas and methods are used to prepare anti-infective artificial joint implants, and samples are taken and tested for antibacterial effects using the methods described above.
  • Table 1 shows the antibacterial rate of the sample of the anti-infective artificial implant of the present invention and the antibacterial performance test results of the control group (traditional PMMA bone cement).
  • control group traditional PMMA bone cement
  • the composition containing ultra-high molecular weight polyethylene and an anti-infective agent has a good anti-infective effect.
  • the present invention combines ultra-high molecular weight polyethylene with an anti-infective agent to be used as a material for artificial joint implants. After the artificial joint implants are implanted in the human body, they will continue to stay at the joints as the joints move. Abrasion debris is produced, and the anti-infective agent contained in the abrasion debris is continuously released, exerting a long-term and slow anti-infection effect.
  • the present invention provides anti-infective artificial joint implants, the release of anti-infective agents is a slow and continuous process, and thus can provide uniform and long-term infection control effects.

Abstract

本发明属于材料技术领域并提供了一种包括超高分子量聚乙烯和抗感染剂的组合物。该组合物用在抗感染人工关节植入物中，可以随着关节的运动不断产生磨屑。由于磨屑中含有抗感染剂，而抗感染剂的释放是一个缓慢、持续的过程，因而能够提供均匀且长期的控制感染的效果。本发明还提供了用于制作抗感染人工关节植入物的型材、抗感染人工关节植入物以及它们的制备方法。

Description

组合物及应用、关节植入物型材、关节植入物及制备方法 技术领域
本发明涉及骨科植入物技术领域，具体地涉及包含超高分子量聚乙烯和抗感染剂的组合物及其在抗感染植入物中的应用。本发明还涉及抗感染人工关节植入物型材、抗感染人工关节植入物及其制备方法。
背景技术
随着社会老龄人口的增加、期望寿命延长及生活质量的提高，人工全膝关节置换术、人工全髋关节置换术、人工踝关节置换术、人工肩关节置换术、人工肘关节置换术及人工椎间盘置换术等医疗技术在骨科临床的应用日益广泛。在这些手术中因细菌侵入和生物膜在假体表面的形成而增加感染的风险。临床上初次全髋和全膝置换术后，深部感染的发生率达1％-2％，而因松动进行的关节翻修术则有更高的感染率，达到初次关节置换的2-3倍。骨关节感染可能造成灾难性的后果(如截肢)，病人的死亡率提高、住院时间延长和住院费用大幅增加。因此预防和治疗骨科关节置换手术后感染意义重大。
全身及局部抗生素应用是预防骨关节术后感染的有效途径。术后短期的抗生素极大降低了感染发生的可能性，然而由于感染可能发生在术后的很长一段时间，因此发展长效持久抗感染技术有迫切的临床需求，现在已经有一些这方面的研究与探索。
一种抗感染的方式是在手术中使用抗生素骨水泥粘结关节植入物和骨组织，骨水泥中的抗生素随时间而释放，利用抗生素的抗菌性能抑制细菌生长从而达到抗感染的目的；上海交通大学医学院附属第九人民医院也发明了一种抗感染骨水泥，基本原理是把镁基金属颗粒与骨水泥基质，骨水泥单体混合而成新型抗感染骨水泥，镁基金属降解过程中形成抗菌性能。这些抗感染的骨水泥只能用于骨水泥型人工关节植入物，而目前主流的生物型人工关节植入物均不需要在术中使用骨水泥。此外，骨水泥中的抗生素和镁基金属的释放是从骨水泥的表面开始，随时间的推移，骨水泥中间的抗生素或镁基金属释放出来的量越来越少，或者完全不再释放出抗 菌成分，无法发挥抗感染的作用。因此，有必要开发一种新的人工关节抗感染植入物。
发明内容
为了解决上述问题，本发明提供了一种组合物，以及包含该组合物的抗感染人工关节植入物及其制备方法。
本发明中，超高分子量聚乙烯是指黏数在2000mL/g以上或拉伸应力在0.2Mpa以上的聚乙烯。
具体地，本发明所述的组合物包括超高分子量聚乙烯和抗感染剂。
在本发明的组合物中，所述抗感染剂可以选自银系抗菌剂和/或铜系抗菌剂。优选地，所述银系抗菌剂为碘化银和/或纳米银。
银系抗菌剂具有广谱、无耐药性、不受酸碱值影响等优点但银作为重金属达到一定量后对人体有害。因此，在某些情形下，可以使用抗生素来替代银系抗菌剂。
抗生素可以是医药领域常见的一种或多种抗生素的组合，抗生物的具体种类并不受特别限制。作为示例，抗生素选自万古霉素、庆大霉素、阿米卡星、头孢唑啉、头孢呋辛、头孢噻肟、克林霉素、青霉素、红霉素、妥布霉素、任意一种或它们的组合。
在本发明的组合物中，以所述组合物的质量计，所述抗感染剂的含量为0.01-20％；优选0.1-5.0％。可选地，抗感染剂的含量为0.01％、0.05％、0.1％、0.5％、1.0％、2.0％、5.0％、8.0％、10.0％、15.0％、18.0％、20.0％。由于抗感染剂可以是银系抗菌剂、铜系抗菌剂或抗生素，抗感染剂在组合物中的含量可以根据抗感染剂的材料和实际的抗菌效果确定。另外，当其应用到人工关节植入物时，在确保植入物成形的情况下，可以根据抗感染剂的材料和抗感染效果来设置抗感染剂的含量。一般地，对于抗生素而言，0.1-5％是一个合适的含量范围。
基于上述组合物，本发明还提供了包括超高分子量聚乙烯和抗感染剂的组合物在抗感染人工关节植入物中的应用。具体地，所述人工关节为人工髋关节、人工膝关节、人工踝关节、人工肩关节、人工肘关节和脊柱人工椎间盘关节中的一种。
本发明还提供了一种用于抗感染人工关节植入物的型材，所述型材由包括超高分子量聚乙烯和抗感染剂的组合物制备而得。型材是制作人工植入物的前体，不能直接植入人体内而发挥抗感染作用。可选地，所述型材具有棒状、板状的形状。型材也可以具有适于植入人体的植入物的形状，经过在型材中加入抗感染剂后，制备成抗感染人工关节植入物。
具体地，所述植入物用作各种人工关节中的磨擦界面部件的植入物，例如人工膝关节垫片。
在本发明中，超高分子量聚乙烯作为一种磨擦界面材料被应用于各种人工置换术中。例如，在人工全膝关节置换术中，作为人工关节植入物的含有抗感染剂的超高分子量聚乙烯垫片一方面承载身体的重量，另一方面与股骨髁部件之间产生运动。由于两个部件之间的相对运动，更软的一方(超高分子量聚乙烯垫片)会不断产生磨屑，磨屑包含的抗感染剂不断地被释放出来，发挥长久、缓慢的抗感染的功效。本发明提供抗感染的人工关节植入物，其抗感染剂的释放是一个缓慢、持续的过程，因而能提供均匀且长期的控制感染的效果。
本发明还提供了一种制备用于抗感染人工关节植入物的型材，所述型材由包括本发明所述的组合物的原料制备而得。在制作适于植入人体的人工植入物之前，往往先制作充当人工关节植入物前体的型材，型材是制作人工关节植入物的母材，将型材切割、精加工后，得到具有适配各种关节的人工关节植入物。
在实际应用中，型材一般具有棒状、板状或植入物等形状。型材通过切割、CNC加工等工序后，被加工成各种人工关节植入物。
本发明还提供了一种制备所述型材的方法，该方法包括以下步骤：
(11)将超高分子量聚乙烯粉或超高分子量聚乙烯颗粒与抗感染剂混匀，得到混合物料；
(12)将步骤(11)所得的混合物料压制、挤压或注塑成型为用于制造植入物的型材。
在步骤(11)中，超高分子量聚乙烯粉或超高分子量聚乙烯颗粒可以从市场上购得，也可以自行制备。
进一步地，上述方法还包括将步骤(12)得到的型材加工为适于植入 人体的人工关节植入物。
本发明还提供了另一种制备抗感染人工植入物型材的方法，所述方法包括以下步骤：
(21)通过模板滤取法制备超高分子量聚乙烯多孔固体材料；
(22)用包含至少一种抗感染剂的溶液接触所述多孔固体材料，使所述溶液渗入多孔固体材料的孔隙空间；
(23)将步骤(22)得到的多孔固体材料进行熔融固结，制成抗感染人工植入物型材。
优选地，所述接触包括将所述多孔固体材料浸渍于所述溶液中，以使所述抗感染剂填充在多孔固体材料的孔隙里。
因此，本发明还提供一种抗感染人工关节植入物，所述抗感染人工关节植入物由包括如上所述的型材加工而得。由步骤(12)制得的型材一般为棒料或板料，将型材通过切割、CNC加工后，加工成具有最终植入形状和尺寸的抗感染人工关节植入物。
本发明的抗感染人工关节植入物适用于人工髋关节、人工膝关节、人工踝关节、人工肩关节、人工肘关节和脊柱人工椎间盘关节。
本发明还提供了另一种制备如上所述的抗感染人工关节植入物的方法，所述方法包括以下步骤：
(31)制备超高分子量聚乙烯多孔固体材料；
(32)用包含至少一种抗感染剂的溶液接触所述多孔固体材料，使所述溶液进入所述多孔固体材料的孔隙空间；
(33)将步骤(32)得到的多孔固体材料熔融固结，以提供熔融固结的材料。
在步骤(31)中，多孔固体材料通过模板滤取法来制备。具体操作如下：将超高分子量聚乙烯粉未和高纯度氯化钠(NaCl)混合，用模具压制成型材，然后把型材放入去离子水溶解并滤去氯化钠，从而得到多孔固体材料。
在该方法中，抗感染人工关节植入物的制备分两种情形。第一种情形是，在步骤(31)中，多孔固体材料在接触或渗入抗感染剂的溶液之前就已经制作成具有适于植入人体的外形和尺寸的植入物，只需将抗感染 剂渗入多孔固体材料的孔隙里，经熔融固结后，即可形成适于植入人体的人工关节植入物成品。
第二种情形是，在步骤(31)中的多孔固体材料是型材，还不具有最终植入物的外形和尺寸。在多孔型材中的孔的表面涂覆抗感染剂的溶液，经熔融固结后，将渗入了抗感染剂的型材进一步加工成具有最终植入外形和尺寸的植入物。
在抗感染人工关节植入物的制备方法中，将抗感染剂渗入多孔固体植入物的步骤包括将多孔固体材料(可以是棒状或板状型材，也可以是具有最终植入外形和尺寸的型材)浸渍在含有抗感染剂的溶液中。溶液通过将抗感染剂溶解在溶剂中来形成。使不同抗感染剂溶解所用的溶剂各有不同，具体使用的溶剂可以根据具体的抗感染剂进行选择。在溶液渗入过程中，使抗感染剂附着在多孔固体材料的孔隙里。
附图说明
图1是本发明提供的一种抗感染人工关节植入物型材的示意图；
图2是本发明提供的一种抗感染人工膝关节植入物垫片的示意图；
图3是本发明提供的一种抗感染人工椎间盘关节植入物垫片的示意图。
具体实施方式
下面将结合本发明实施例，对本发明实施例中的技术方案进行清楚、完整地描述，显然，所描述的实施例仅仅是本发明一部分实施例，而不是全部的实施例。基于本发明中的实施例，本领域普通技术人员在没有做出创造性劳动前提下所获得的所有其他实施例，都属于本发明保护的范围。
实施例1
本实施例提供了一种超高分子量聚乙烯抗感染人工膝关节垫片植入物，该超高分子量聚乙烯抗感染人工膝关节垫片植入物由以下原料制备而得：塞拉尼斯GUR1020超高分子量聚乙烯和单质银。超高分子量聚乙烯的质量含量为99.8％，单质银的质量含量为0.2％。单质银抗菌剂为单体纳 米银溶液。
本实施例的人工膝关节垫片植入物的制备方法如下：
将3992克市售塞拉尼斯GUR1020超高分子量聚乙烯粉，含8克单质银的纳米银溶液在洁净容器中充分混合后，装入内腔尺寸为300×300mm的金属模具内，把混合粉末刮平，盖上模具的上模，在100吨液压机上压制成型，制成厚度为47mm左右的板材(图1)，将板材加热至220℃烧结定型。对300mm×300mm×47mm的板材分割成多个70×60×47mm小块，在数控机床上加工为人工膝关节垫片植入物(图2)。
实施例2
将975克市售塞拉尼斯GUR1050超高分子量聚乙烯粉，25克硫酸庆大霉素在洁净容器中充分混合后，把混合物料分成150份，每一份装入内腔尺寸为35mm×25mm的腰形金属模具内，盖上模具的上模，在30吨压机上压制成型为两端凸面的植入物形状(图3)，将植入物部件加热至220℃烧结定型。此植入物经清洗灭菌后即可直接作为脊柱椎间盘人工关节中的磨损部件。
实施例3
将3750克市售塞拉尼斯GUR1020超高分子量聚乙烯粉，250克NaCl(分析纯，99.5％)在洁净容器中充分混合后，装入内腔尺寸为300mm×300mm的金属模具内，把混合粉末刮平，盖上模具上模，在100吨液压机上压制成型，制成厚度为47mm左右的板材(图1)，将板材加热至220℃烧结定型。对300mm×300mm×47mm的板材分割成多个70mm×60mm×47mm小块，把每一小块材料放入盛有去离子水的不锈钢水浴锅中，保持温度45摄氏度震荡24小时，每6小时换一次去离子水，反复清洗后放入干燥箱烘干，把烘干的小块材料放入由去离子水和硫酸庆大霉素混合溶液中浸泡48小时(浸渍法)，把材料取出烘干后放入真空炉中加热至150摄氏度保温2小时后冷却到室温。由此得到的材料可以进一步加工成具有各种不同形状和尺寸的人工关节植入物部件。
实施例4
本实施例与实施例2的不同之处在于，组合物的配方改为950克市售塞拉尼斯GUR1050超高分子量聚乙烯粉和50克盐酸万古霉素代替硫酸庆大霉素，其他部分与实施例2相同。
实施例5
将3800克市售塞拉尼斯GUR1020超高分子量聚乙烯粉，100克硫酸庆大霉素粉剂，100克盐酸万古霉素粉剂在洁净容器中充分混合后，装入内腔尺寸为300×300mm的金属模具内，把混合粉末刮平，盖上模具的上模，在100吨液压机上压制成型厚度为47mm左右的板材(图1)，将板材加热至220℃烧结定型。对300mm×300mm×47mm的板材分割成多个70mm×60mm×47mm小块，在数控机床上加工为人工膝关节垫片植入物(图2)。
实施例6
将3700克市售塞拉尼斯GUR1020超高分子量聚乙烯粉，50克硫酸庆大霉素，50克盐酸万古霉素，50克妥布霉素、50克头孢噻肟、50克克林霉素、50克红霉素粉末在洁净容器中充分混合后，装入内腔尺寸为300×300mm的金属模具内，把混合粉末刮平，盖上模具的上模，在100吨液压机上压制成型厚度为47mm左右的板材(图1)，将板材加热至220℃烧结定型。对300mm×300mm×47mm的板材分割成多个70mm×60mm×47mm小块，在数控机床上加工为人工膝关节垫片植入物(图2)。
对人工关节植入物的抗菌效果进行了测试，测试方法如下。
采用实验菌株：表皮葡萄球菌菌株(S.epidermidis)、甲氧西林耐药的表皮葡萄球菌菌株(MRSE)及购自美国标准细菌库的表皮葡萄球菌菌株(ATCC35984)。抑菌实验按照“JISZ2801：2000《抗菌加工制品-抗菌性试验方法和抗菌效果》、GB/T21510-2008《纳米无机材料抗菌性能检测方法》”等标准规定。
从植入物或型材上取下尺寸为25mm×25mm×2mm的薄片作为测试 样品。样品经处理后置入培养皿，吸取测试接种液0.1mL，滴在测试样品的表面，在测试接种液上覆盖一张20mm×20mm的薄膜并且轻压使接种液散开。在37℃±1℃，相对湿度90％条件下接触培养24小时，加入20mL洗脱液反复洗脱测试样品3次，稀释洗脱液后接种平皿在恒温箱中培养，做活菌培养计数后计算抗菌率。
采用不同的组合物配方和方法制备抗感染人工关节植入物，并采用如上所述的方法采样并测试其抗菌效果。
本发明抗感染人工植入物的采样样品的抗菌率与对照组(传统PMMA骨水泥)的抗菌性能测试的结果见表1。在表1中，标出了不同抗感染人工关节植入物样品以及制备抗感染人工关节植入物所用的组合物的成分。
表1
Figure PCTCN2021081947-appb-000001
注：PMMA-聚甲基丙烯酸甲酯(polymethyl methacrylic)
由表1可知，含有超高分子量聚乙烯和抗感染剂的组合物具有良好的 抗感染效果。更重要的，本发明将超高分子量聚乙烯与抗感染剂结合，用作人工关节植入物的材料，当人工关节植入物植入人体后，随着关节的运行，在关节处会不断产生磨屑，磨屑中包含的抗感染剂不断地被释放出来，发挥长久、缓慢的抗感染的功效。本发明提供抗感染人工关节植入物，其抗感染剂的释放是一个缓慢、持续的过程，因而能够提供均匀且长期的控制感染的效果。

Claims (10)

  1. 一种组合物，其特征在于，所述组合物包括超高分子量聚乙烯和抗感染剂。
  2. 根据权利要求1所述的组合物，其特征在于，所述抗感染剂选自银系抗菌剂和/或铜系抗菌剂；
    优选地，所述银系抗菌剂为碘化银和/或纳米银。
  3. 根据权利要求1所述的组合物，其特征在于，所述抗感染剂为抗生素；
    优选地，所述抗生素为万古霉素、庆大霉素、阿米卡星、头孢唑啉、头孢呋辛、头孢噻肟、克林霉素、青霉素、红霉素、妥布霉素任意一种或它们的组合。
  4. 根据权利要求1至3任一项所述的组合物，其特征在于，以所述组合物的质量计，所述抗感染剂的含量为0.01-20％；优选0.1-5％。
  5. 根据权利要求1至4任一项所述的组合物在抗感染人工关节植入物中的应用；
    优选地，所述人工关节为人工髋关节、人工膝关节、人工踝关节、人工肩关节、人工肘关节和脊柱人工椎间盘关节中的一种。
  6. 一种用于抗感染人工关节植入物的型材，所述型材由包括权利要求1至4任一项所述的组合物的原料制备而得；可选地，所述型材具有棒状、板状或具有适于植入人体的植入物的形状。
  7. 一种制备权利要求6所述的型材的方法，所述方法包括以下步骤：
    (11)将超高分子量聚乙烯粉或超高分子量聚乙烯颗粒与抗感染剂混匀，得到混合物料；
    (12)将步骤(11)得到的混合物料压制、挤压或注塑成型为用于制造植入物的型材；
    进一步地，所述方法还包括将步骤(12)得到的型材加工为适于植入人体的人工关节植入物。
  8. 一种制备权利要求6所述的抗感染人工植入物型材的方法，所述方法包括以下步骤：
    (21)通过模板滤取法制备超高分子量聚乙烯多孔固体材料；
    (22)用包含至少一种抗感染剂的溶液接触所述多孔固体材料，使所 述溶液渗入多孔固体材料的孔隙空间；
    (23)将步骤(22)得到的多孔固体材料进行熔融固结，制成抗感染人工植入物型材；
    优选地，所述接触包括将所述多孔固体材料浸渍于所述溶液中，以使所述抗感染剂填充在多孔固体材料的孔隙里。
  9. 一种抗感染人工关节植入物，其特征在于，所述抗感染人工关节植入物由包括权利要求6所述的型材加工而得；
    优选地，所述抗感染人工关节植入物适用于人工髋关节、人工膝关节、人工踝关节、人工肩关节、人工肘关节和脊柱人工椎间盘关节；
    更优选地，所述人工关节植入物为人工关节垫片。
  10. 一种制备权利要求8所述的抗感染人工关节植入物的方法，所述方法包括以下步骤：
    (31)通过模板滤取法制备超高分子量聚乙烯多孔固体材料；
    (32)用包含至少一种抗感染剂的溶液接触所述多孔固体材料，使所述溶液渗入多孔固体材料的孔隙空间；
    (33)将步骤(32)得到的多孔固体材料进行熔融固结；
    其中，在步骤(31)中，所述多孔固体材料具有适于植入人体的最终外形和尺寸，则步骤(33)得到所述抗感染人工关节植入物；或者，
    在步骤(31)中，所述多孔固体材料是不具有最终植入物的外形和尺寸的型材，所述型材在步骤(33)完成之后进一步加工为具有适于植入人体的最终外形和尺寸的抗感染人工关节植入物；
    优选地，所述接触包括将所述多孔固体材料浸渍于所述溶液中，以使所述抗感染剂填充在多孔固体材料的孔隙里。
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