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WO2008035535A1 - Capsule incluant un agent antibactérien et joint artificiel auquel la capsule est fixée - Google Patents

Capsule incluant un agent antibactérien et joint artificiel auquel la capsule est fixée Download PDF

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Publication number
WO2008035535A1
WO2008035535A1 PCT/JP2007/066352 JP2007066352W WO2008035535A1 WO 2008035535 A1 WO2008035535 A1 WO 2008035535A1 JP 2007066352 W JP2007066352 W JP 2007066352W WO 2008035535 A1 WO2008035535 A1 WO 2008035535A1
Authority
WO
WIPO (PCT)
Prior art keywords
capsule
drugs
antibacterial
drug
porous
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/JP2007/066352
Other languages
English (en)
Japanese (ja)
Inventor
Takao Hotokebuchi
Iwao Noda
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Saga University NUC
Kyocera Medical Corp
Original Assignee
Saga University NUC
Kyocera Medical Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Saga University NUC, Kyocera Medical Corp filed Critical Saga University NUC
Publication of WO2008035535A1 publication Critical patent/WO2008035535A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • 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
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    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4164—1,3-Diazoles
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    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/425—Thiazoles
    • A61K31/429—Thiazoles condensed with heterocyclic ring systems
    • A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
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    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
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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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    • 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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    • A61L2300/62—Encapsulated active agents, e.g. emulsified droplets

Definitions

  • the present invention relates to a capsule attached to an artificial joint and containing an antibacterial drug, and an artificial joint to which the capsule is attached.
  • Patent Document 1 discloses a method in which hydroxyapatite is deposited on an implant surface and dried to form a hydroxyapatite layer having a large specific surface area, and the hydroxyapatite layer is impregnated with an antibiotic or the like ( Patent Document 1). Since the hydroxyapatite layer deposited on the implant surface contains antibiotics, infection with artificial joint replacement can be suppressed with the antibiotics after the implant is attached to the human body Patent Document 1: Special Table 2005— No. 506879
  • an object of the present invention is to provide an antibacterial agent that can be slowly and slowly released at a desired rate and retain a large amount of drug.
  • the object is to provide a medicine-containing capsule and an artificial joint to which the medicine-containing capsule is attached.
  • the inventors of the present invention made porous capsules containing antibacterial drugs, and contained antibacterial drugs such as antibiotics in the porous capsules.
  • antibacterial drugs such as antibiotics
  • the porous layer By coating the porous layer on the implant and impregnating the porous layer with the antibacterial drug, more drug can be retained, and by controlling the pore diameter and porosity of the porous wall, The present inventors have found that the drug can be released slowly at a desired rate and have completed the present invention.
  • the present invention has been made on the basis of force and knowledge, and the gist of the present invention is a capsule filled with an antibacterial drug, and the capsule is composed of a porous member.
  • An antibacterial drug-containing capsule that is attached to at least a part of an artificial joint and gradually releases the filled antibacterial drug into a joint capsule or bone via the porous member.
  • the member is in an antibacterial drug-containing capsule, wherein the member has an average porosity of 10% to 80%.
  • the average porosity is less than 10%, the pores are in a dispersed state, cannot be in communication with each other, and the antibacterial drug cannot be released from the capsule! /, .
  • the average porosity exceeds 80%, the mechanical strength of the capsule is decreased, which is not preferable. Yes.
  • the average porosity of the porous member of the capsule is 10% to 80%, sustained release in the medium to long term is possible.
  • the porous wall portion of the capsule is preferably made of porous ceramics, porous metal, or porous resin.
  • the antibacterial drug filled in the capsule is a beta-ratata antibacterial agent such as penicillin, an amino darcoside antibacterial agent such as gentamicin, ciprofloxacin fluo Roquinolone antibiotics, macrolide antibiotics such as erythromycin, darcopeptide antibiotics such as ticobranine, lincomycin antibiotics such as clindamycin, tetracycline antibiotics such as tetracycline, ST combination, metronidazole, and ketolide
  • a beta-ratata antibacterial agent such as penicillin, an amino darcoside antibacterial agent such as gentamicin, ciprofloxacin fluo Roquinolone antibiotics, macrolide antibiotics such as erythromycin, darcopeptide antibiotics such as ticobranine, lincomycin antibiotics such as clindamycin, tetracycline antibiotics such as tetracycline, ST combination, metronidazole, and ketolide
  • antibacterial agents include animal drugs such as chitin and chitosan, microbial drugs such as polylysine, enzyme drugs such as lysozyme, plant drugs such as hinokitiol, and metal ions such as silver, copper, and zinc.
  • animal drugs such as chitin and chitosan
  • microbial drugs such as polylysine
  • enzyme drugs such as lysozyme
  • plant drugs such as hinokitiol
  • metal ions such as silver, copper, and zinc.
  • the antibacterial agent is preferably mixed with a gelling agent such as gelatin, agar, carrageenan or pectin.
  • a gelling agent such as gelatin, agar, carrageenan or pectin.
  • the present invention provides an artificial joint to which any one of the antibacterial drug-containing capsules is attached, and the antibacterial agent filled in the capsule when the artificial joint is inserted into a bone.
  • the artificial joint is characterized in that the drug is gradually released into the joint capsule or bone.
  • the capsule is most effective when placed in a joint capsule having a high possibility of infection, and is effective for the growth of bacteria in the joint capsule. Can be suppressed or sterilized.
  • controlled release of the drug can be achieved by controlling the porosity and pore diameter as described above, and controlling the pore diameter, the number of pores and the pore distribution. Since the capsule has a hollow portion inside and has a sufficiently large space, a sufficient amount of drug can be held.
  • inorganic antibacterial agents that could not be effectively retained by the prior art can be retained in an amount sufficient for the prevention and treatment of infection by using the present invention.
  • FIG. 1 is a schematic diagram showing an example of an antibacterial drug-containing capsule according to an embodiment of the present invention.
  • FIG. 2 is a schematic view showing an example of a sustained release capsule attached to a stem.
  • FIG. 3 is a schematic view showing a production process by a green tape laser sintering method.
  • an antibacterial drug-containing capsule according to the present invention and an artificial joint to which the capsule is attached will be described in detail with reference to the drawings.
  • the antibacterial drug-containing capsule according to the present embodiment and the artificial joint to which the capsule is attached are merely examples, and the present invention is not limited to these embodiments.
  • common parts are denoted by the same reference numerals, and redundant description is omitted.
  • the number of arrangement of each component, the arrangement position, and the like can be appropriately set depending on the purpose, application, desired performance, etc. of the capsule containing the antibacterial drug.
  • FIG. 1 is a schematic view showing an example of an antibacterial drug-containing capsule according to an embodiment of the present invention.
  • the antibacterial drug-containing capsule 1 includes a hollow part 2 filled with an antibacterial drug, and a porous wall part 3 covering the hollow part 2.
  • the antibacterial drug-containing capsule 1 is attached to the upper end of the stem 4 and is inserted into the medullary cavity (not shown) of the femur to regenerate the joint capsule. 1 is located in the joint capsule.
  • Stem 4 If it is attached to the lower end of the stem, the stem 4 can be positioned in the medullary cavity of the femur, for example.
  • the capsule containing the antibacterial drug according to the present invention is used, it is antibacterial Since the capsule containing the drug is placed in the joint capsule or in the medullary cavity and bacteria in the joint capsule and in the medullary cavity are sterilized, there is no need for reoperation.
  • a porous hydroxyapatite layer is formed on the implant surface, and more antibacterial drugs can be retained than the conventional type in which antibiotics are impregnated in the hydroxyapatite. It is possible to sterilize bacteria and the like effectively. Insufficient sterilization in infection treatment will not only cause the infection to recur, but also lead to the development of resistant bacteria. Therefore, placing a sufficient amount of antibacterial agent at the site of infection is an important factor in preventing infection and treating infection.
  • the antibacterial drug-containing capsule 1 includes a porous portion at least in part.
  • the porous part is preferably a porous ceramic, a porous metal, or a porous resin.
  • porous ceramics include oxide ceramics such as aluminum oxide (alumina) and zirconium oxide (zircoua), calcium phosphates such as hydroxyapatite (HA), tricalcium phosphate (TCP), and tetracalcium phosphate (TeCP).
  • the sintered body is preferably made of a ceramic ceramic or phosphoric glass ceramic. Further, the porous ceramic may be a sintered body made of these composites.
  • the porous metal is preferably titanium, titanium alloy, zirconium, tantalum, cobalt chromium alloy, or stainless steel, and the porous resin is polyethylene, polyurethane, acrylic resin, or epoxy resin. It is preferable.
  • the shape of the capsule may be any shape.
  • the capsule When the capsule is screwed to the stem using a hand or a wrench, it is preferably a polygonal columnar shape. Further, when the capsule is fitted using a hammer or the like, any shape may be used.
  • the thickness of the capsule wall is preferably 0.5 mm to 2 mm. More preferably, it is Omm. If the thickness is reduced, the sustained release time can be shortened, but the structural strength is lowered. Further, if the thickness is increased, the structural strength is improved, but the sustained release time becomes longer. Therefore, the thickness is preferably 0.5 mm to 1 Omm.
  • the pore size of the pores provided in the capsule is preferably 0.1 ⁇ m to 300 ⁇ m! / ⁇ .
  • the porosity is preferably 10 to 80%.
  • the controlled release period of the antibacterial drug is 1 to 90 days.
  • the capsule is effective not only for short-term infection prevention after artificial joint surgery but also for medium- to long-term infection prevention. Even after all the antibacterial drugs have disappeared, the antibacterial effects can be regained by supplementing the antibacterial drugs or replacing them with new ones.
  • the capsule When the capsule is applied to an artificial hip joint, the capsule may be attached to an artificial hip joint femoral component (stem) or an artificial hip joint acetabular component (cup). It can also be attached to the screw head of the screw, in which case it can be placed on any native bone. In cases where it is difficult to attach to an artificial joint or to a natural bone, it can be fixed to cartilage with a thread or wire.
  • a method for producing the porous ceramic after mixing a ceramic powder with a pore material such as carbon powder and naphthalene powder of a predetermined particle size, after molding by a method such as squeeze molding, extrusion molding, press molding, rubber press molding, Effective methods include firing and grinding, or cutting and firing after forming. Adjust the amount of pore agent added so that the pores communicate with each other. Further, a method using a foaming agent such as hydrogen peroxide or a method of adjusting the sintering temperature to make it porous can be used. In addition, a thin layer of powder material strength is formed, and the layer is irradiated with laser light and instantaneously sintered to form a hardened layer. Fine powders of ceramics, metal, etc.
  • the method for producing an antibacterial drug-containing capsule according to the present invention will be described taking as an example the case of a hydoxy xylate.
  • polyethyleneimine or the like is added as a crosslinkable resin to hydroxyapatite powder, and mixed and crushed using ultrapure water as a dispersion medium to prepare a slurry.
  • a foaming agent at least one selected from polyoxyethylene lauryl ether, lauryl betaine, lauryl sulfate triethanolamine, etc. is added to the slurry and stirred to foam.
  • a crosslinking agent (sorbitol polyglycidyl ether, etc.) is added, the foam slurry is put in a mold, the foam structure is fixed and dried, and then sintered at a temperature of about 1100 ° C to about 1300 ° C. A hydroxyapatite porous sintered body is obtained. This calcination is carried out for 0.5 to 3 hours.
  • a green tape is produced.
  • a slurry 5 is prepared by mixing ceramics and / or metal fine particles, a binder, and a solvent that constitute the capsule.
  • the power that can use any material as ceramics and metal
  • quaternary calcium phosphate (Te CP), calcium phosphate glass ceramic, titanium, titanium alloy, zirconium, tantalum, cobalt chromium alloy, stainless steel, or the like can be used.
  • Te CP quaternary calcium phosphate
  • Ca CP calcium phosphate glass ceramic
  • titanium, titanium alloy, zirconium, tantalum, cobalt chromium alloy, stainless steel, or the like can be used.
  • acrylic resin or styrene resin as the binder and water, ethyl alcohol, butyl alcohol, isopropyl alcohol, or toluene as the solvent.
  • the slurry 5 mixed as described above is formed into a sheet having a constant thickness in the same manner as the doctor blade method. Then by drying this sheet The solvent in the slurry is volatilized and solidified. Thereafter, the sheet is cut into a certain size.
  • one sheet of the sheet cut into a certain size is stacked, and laser light 7 is applied to the sheet 6 according to the 3D CAD data of the capsule. Irradiate to solidify the metal or ceramic in the irradiated part.
  • the second sheet 6 is laminated, and the laser beam 7 is irradiated in the same manner as described above to solidify the metal or ceramic in the irradiated portion.
  • the portion 8 solidified by sintering is taken out from the laminated green tape and processed into a predetermined shape, whereby an antibacterial drug-containing capsule can be produced.
  • the pore diameter and porosity of the produced capsule can be adjusted by adjusting the concentration of the metal or ceramic contained in the green tape, thereby filling the inside. Since the release rate of an antibacterial drug can be adjusted, it is preferably used. In addition, this manufacturing method is preferable because any material can be used and a complicated shape can be manufactured.
  • the antibacterial drug capsule is made of a porous metal body, it can be made using a sintered body of metal powder or metal particles as described above, but the metallic mesh is fixed by sintering. It is easy to make it.
  • the hole diameter, the number of holes, and the hole distribution can be arbitrarily controlled.
  • holes having a diameter of 76 ⁇ m were processed at a pitch interval of 100 ⁇ m using a laser beam on a titanium plate having a thickness of 0.2 mm.
  • sustained release of the drug is preferably carried out by adjusting the porosity and the pore diameter.
  • the size of the antibacterial drug-containing capsule can be increased as long as it does not cause a problem in the function of the artificial joint. If the size is large, a large amount of drug can be held in the force vessel.
  • the capsule is generally composed of two parts, a main body and a lid. This is to store the antibacterial drug in the hollow portion inside the capsule. In the case of a drug with low viscosity and easy impregnation, it can be stored even if the capsule is integrally molded.
  • any of an antibacterial agent, a natural antibacterial agent, an inorganic antibacterial agent, and an organic antibacterial agent may be used. You can use any mixture of two or more of these.
  • antibacterial agent examples include beta-latatam antibacterial agents such as penicillin, amaminodarcoside antibacterial agents such as gentamicin, ciprofloxacin fluoroquinolone antibacterial agents, macrolide antibacterial agents such as erythromycin, Examples include darcopeptide antibiotics such as ticobranine, lincomycin antibiotics such as clindamycin, tetracycline antibiotics such as tetracycline, ST combinations, metronidazole, and ketolide antibiotics.
  • natural antibacterial agents include animal drugs such as chitin and chitosan, microbial drugs such as polylysine, enzyme drugs such as lysozyme, and plant drugs such as hinokitiol.
  • examples of the inorganic antibacterial agent include those in which metal ions such as silver, copper and zinc are supported on a silicate such as zeolite and a phosphate such as zirconium phosphate.
  • organic antibacterial agents include alcoholic agents such as ethyl alcohol, alcoholic agents such as benzenecarboxylic acid, esteric agents such as methylparaben, nitrile agents such as TPN, and Sampras.
  • Halogen drugs pyridin quinoline drugs such as oxine, isothiazolone drugs such as caisson, imidazole thiazole drugs such as TBZ, anilide drugs such as halcarban, biguanide drugs such as clodin hexidine dalconate
  • Examples include thiocarbamate agents such as carbam, surfactant agents such as benzalkonium chloride, and oxine copper.
  • These antibacterial drugs are preferably mixed with a gelling agent. It is possible to adjust the sustained release period of the antibacterial drug by mixing it with the gelling agent and filling it in the capsule according to the present invention. Especially in the case of liquid drugs, mixing with a genolic agent is possible. It is effective.
  • the sustained release period is adjusted by adjusting the content of the gelling agent in the gel. In other words, gels using a large amount of gelling agent do not contain much hard water, so that drug elution is suppressed. On the other hand, when a small amount of gelling agent is used, the gel contains a lot of soft water, so it does not significantly suppress the elution of the drug. By using the gelling agent in this way, it is possible to increase the force 1.5 times to 20 times when the sustained release period of the antibacterial drug is not used.
  • the gelling agent gelatin, agar, carrageenan or pectin is preferably used.
  • a slurry was prepared by mixing hydroxyapatite as a ceramic, a water-soluble acrylic resin as a binder, and pure water as a solvent. Subsequently, the slurry was formed into a 0.2 mm sheet in the same manner as the doctor blade method. Thereafter, the sheet was dried to evaporate and solidify the solvent in the slurry, and then the sheet was cut into a plurality of pieces.
  • the antibacterial drug-containing capsule is composed of two members, a container-like part and a lid part that fits snugly.
  • Penicillin powder (which is gelled with agar) is put into the capsule as an antibacterial agent, and then the container part and the lid part are fitted together, and the stem behind the tapered part of the artificial hip joint stem Screwed into the driving hole.
  • press molding was performed using a mold.
  • the molded body was sintered at 1150 ° C and ground into a capsule shape to produce the container and lid.
  • Gentamicin powder was placed in the container.
  • the porosity of this cabcel material was 40% and the pore diameter was 80-200 m.
  • Capsule containers and lids were made by pouring titanium beads with a diameter of 200 m into capsule-shaped tungsten molds and heat-treating them in a vacuum oven at 1300 ° C for 2 hours.
  • the capsule material had a porosity of 30% and a pore diameter of 20-40 m. This cuff.
  • the cell contained ceramic powder loaded with silver ions, a typical inorganic antibacterial agent, and showed good elution of silver ions in bovine serum.
  • the antibacterial drug-containing capsule is a container that contains an antibacterial drug and can be gradually released.
  • the capsule is attached to a part of an artificial joint, and after the artificial joint is mounted, It is used to suppress and sterilize bacterial growth in the joint capsule and around the stem by slowly releasing the antibacterial agent into the cavity.

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Abstract

La présente invention concerne une capsule incluant un agent antibactérien, ladite capsule étant capable de libérer l'agent lentement à une vitesse désirée et de le retenir en grande quantité. La présente invention concerne également un joint artificiel auquel ladite capsule est fixée. La capsule inclut un agent antibactérien, est composée d'un matériau poreux, et peut être fixée à au moins une partie d'un joint artificiel, afin de libérer lentement l'agent antibactérien qu'elle contient dans une capsule de joint ou un os, à travers le matériau poreux.
PCT/JP2007/066352 2006-09-19 2007-08-23 Capsule incluant un agent antibactérien et joint artificiel auquel la capsule est fixée Ceased WO2008035535A1 (fr)

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Cited By (4)

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WO2013129465A1 (fr) * 2012-02-29 2013-09-06 株式会社ラステック Plaque poreuse pour applications médicales
JP2014221412A (ja) * 2008-08-13 2014-11-27 スメド−ティーエイ／ティーディー・エルエルシー 整形外科インプラントシステム
JP2021519146A (ja) * 2018-03-26 2021-08-10 ワルデマール リンク ゲーエムベーハー ウント ツェーオー．カーゲー 関節インプラントのための活性物質アプリケータおよび活性物質アプリケータを有する関節インプラント
CN116211879A (zh) * 2023-02-07 2023-06-06 湖北省农业科学院畜牧兽医研究所 桧木醇与克林霉素组合物及其在抑制细菌中的应用

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CN101850154B (zh) * 2010-05-04 2012-12-19 武汉理工大学 用于局部给药的多孔生物陶瓷经皮植入装置
US10406263B2 (en) * 2014-03-25 2019-09-10 Orthopaedic Innovation Centre Inc. Antimicrobial articles produced by additive manufacturing
CN110160172A (zh) * 2018-02-05 2019-08-23 青海新东联信息技术有限公司 一种家用雾霾吸收装置

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JP2001259043A (ja) * 2000-03-22 2001-09-25 Mmt:Kk 徐放用容器
JP2004277421A (ja) * 2003-03-12 2004-10-07 Howmedica Osteonics Corp 持続放出鎮痛剤を用いた補綴

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JP2001259043A (ja) * 2000-03-22 2001-09-25 Mmt:Kk 徐放用容器
JP2004277421A (ja) * 2003-03-12 2004-10-07 Howmedica Osteonics Corp 持続放出鎮痛剤を用いた補綴

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2014221412A (ja) * 2008-08-13 2014-11-27 スメド−ティーエイ／ティーディー・エルエルシー 整形外科インプラントシステム
WO2013129465A1 (fr) * 2012-02-29 2013-09-06 株式会社ラステック Plaque poreuse pour applications médicales
JP2021519146A (ja) * 2018-03-26 2021-08-10 ワルデマール リンク ゲーエムベーハー ウント ツェーオー．カーゲー 関節インプラントのための活性物質アプリケータおよび活性物質アプリケータを有する関節インプラント
CN116211879A (zh) * 2023-02-07 2023-06-06 湖北省农业科学院畜牧兽医研究所 桧木醇与克林霉素组合物及其在抑制细菌中的应用
CN116211879B (zh) * 2023-02-07 2024-05-31 湖北省农业科学院畜牧兽医研究所 桧木醇与克林霉素组合物及其在抑制细菌中的应用

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