CN102423266B - Antimicrobial packaged medical device and method of preparing the same - Google Patents

Antimicrobial packaged medical device and method of preparing the same Download PDF

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Publication number
CN102423266B
CN102423266B CN201110260501.XA CN201110260501A CN102423266B CN 102423266 B CN102423266 B CN 102423266B CN 201110260501 A CN201110260501 A CN 201110260501A CN 102423266 B CN102423266 B CN 102423266B
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China
Prior art keywords
antimicrobial
packaging
treatment device
medical treatment
agent source
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CN201110260501.XA
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Chinese (zh)
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CN102423266A (en
Inventor
H·斯卡佐
J·A·费希尔
R·塞温
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Johnson and Johnson Medical SAS
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Ethicon SAS
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Priority claimed from US10/367,497 external-priority patent/US20040068293A1/en
Priority claimed from US10/603,317 external-priority patent/US20050101993A1/en
Application filed by Ethicon SAS filed Critical Ethicon SAS
Publication of CN102423266A publication Critical patent/CN102423266A/en
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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06114—Packages or dispensers for needles or sutures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/04—Surgical instruments, devices or methods, e.g. tourniquets for suturing wounds; Holders or packages for needles or suture materials
    • A61B17/06—Needles ; Sutures; Needle-suture combinations; Holders or packages for needles or suture materials
    • A61B17/06166—Sutures
    • 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
    • A61L17/00—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters
    • A61L17/005—Materials for surgical sutures or for ligaturing blood vessels ; Materials for prostheses or catheters containing a biologically active substance, e.g. a medicament or a biocide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00889—Material properties antimicrobial, disinfectant
    • 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
    • A61L2300/20—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials
    • A61L2300/202—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices containing or releasing organic materials with halogen atoms, e.g. triclosan, povidone-iodine
    • 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
    • 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
    • A61L2300/60—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a special physical form
    • A61L2300/606—Coatings

Abstract

An antimicrobial suture assembly comprising a containment compartment comprising one or more surfaces having an antimicrobial agent disposed thereon, said antimicrobial agent being selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof, in an amount sufficient to substantially inhibit bacterial colonization on said containment compartment; and a suture positioned within the containment compartment, the suture comprising one or more surfaces having an antimicrobial agent disposed thereon, said antimicrobial agent being selected from the group consisting of halogenated hydroxyl ethers, acyloxydiphenyl ethers, and combinations thereof, in an amount sufficient to substantially inhibit bacterial colonization on the suture; and a method for making.

Description

Medical treatment device of packaged antimicrobial and preparation method thereof
The application is the divisional application of following application: the applying date: on JIUYUE 25th, 2003; Application number: 03825548.0 (PCT/US2003/030598); Denomination of invention: " medical treatment device of packaged antimicrobial and preparation method thereof ".
cross-reference to related applications
The application requires the United States Patent (USP) serial number 10/367 of submitting on February 15th, 2003,497 rights and interests, this United States Patent (USP) requires to be filed in the United States Patent (USP) serial number 10/603 on June 25th, 2003,317 (its requirement is filed in the U.S. Provisional Application number 60/416 on October 04th, 2002,114 rights and interests) rights and interests, the content of described each patent application is incorporated herein by reference.
Technical field
The present invention relates to medical treatment device of antimicrobial medical device and packaged antimicrobial and preparation method thereof.
Background technology
In the U.S., patient will accept a large amount of operation techniques every year.Recent data show is approximately carried out 27,000,000 operation techniques every year.In all cases, about 2 percent to three there will be the rear or surgical site infection (" SSIs ") of performing the operation.Add up to every year and exceed 675,000 routine SSIs.
The appearance of SSIs is conventionally relevant to antibacterial, on the implantable medical device that described antibacterial can be used in operation, forms bacterium colony.In operation process, can enter surgical site and be attached to medical treatment device from the antibacterial of external environment.Particularly, antibacterial can be sent out in tissue around as approach by the medical treatment device of implanting.Described bacterial clump on medical treatment device can cause infection and the wound to patient.Thus, SSIs can increase patient's medical expense significantly.
In this area, openly and/or for example understand the implantable medical device of wherein applying or integrated antimicrobial.The example of described device has been disclosed in European Patent Application No. EP 0 761 243.The actual device of this application illustrated comprises French Percuflex conduit.The dip-coating in the coating pond that comprises 2,4,4 '-tri-chloro-2-dihydroxy diphenyl ethers (Ciba Geigy Irgasan (DP300)) and other additive of this conduit.Then epoxy available ethane carries out sterilizing to this conduit, and it can be preserved 30.The conduit that has been coated with described solution can show antimicrobial property, that is, being placed on while testing in growth medium and with microorganism, it can produce inhibition zone in coating in latter 30 days.This application does not clearly disclose sterilising temp, applies the storage temperature of conduit.
Most of implantable medical devices be produced, sterilizing and being wrapped in packaging, until be opened for operation process.Intra-operative, the packaging of opening, comprising package component, and medical treatment device is exposed in operating room environment, can enter wherein from the antibacterial of air.Give packaging and package component antimicrobial property, can pack after opening, substantially suppress the bacterial clump on packaging and assembly.Packaged antimicrobial and package component, combine give medical treatment device self antimicrobial property will substantially guarantee sterilized medical device antimicrobial environment around.
Summary of the invention
The present invention relates to medical treatment device of antimicrobial medical device and packaged antimicrobial and preparation method thereof.According to embodiment of the present invention, use antimicrobial agent source.Medical treatment device (having or do not have one or more package components) is positioned in packaging, by being placed under sufficient condition, part antimicrobial is transferred to packaging, package component (if use) and medical treatment device from antimicrobial agent source evaporation.The transfer amount of antimicrobial is enough to suppress the bacterial growth on packaging, package component (if use) and medical treatment device.
According to multiple embodiments of the present invention, packaging can comprise antimicrobial agent source, can contain the lip-deep antimicrobial agent source in inside that is attached to packaging, maybe can contain with packaging in one or more package components or with packaging antimicrobial agent source in aggregates itself.Alternatively, medical treatment device can be positioned in packaging, then the packaging that contains medical treatment device be exposed to outside antimicrobial agent source.In these embodiments, medical treatment device is placed in packaging, and this medical treatment device can be initial containing antimicrobial can be maybe initial one or more surfaces that comprise, on described surface, contain antimicrobial.Then packaging, antimicrobial agent source and medical treatment device are placed in and are enough to the antimicrobial of effective dose to be transferred under time surface, inside and the medical treatment device of packaging, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on medical treatment device.
The invention still further relates to the method for preparing antimicrobial medical device, it comprises the following steps: antimicrobial agent source is positioned in the packaging that contains medical treatment device, on the surface, inside of the packaging that antimicrobial agent source is attached to contain medical treatment device, or provide with the packaging that comprises medical treatment device in one or more package components or with packaging antimicrobial agent source in aggregates itself.In these embodiments, be placed on medical treatment device in packaging and can be initial containing antimicrobial can be maybe initial one or more surfaces that comprise, on described surface, arranged antimicrobial.Then packaging, antimicrobial agent source and medical treatment device are placed in and are enough to the antimicrobial of effective dose to be transferred under time medical treatment device, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on medical treatment device.
Brief description of the drawings
Fig. 1 shown at 55 DEG C, and the transfer of antimicrobial from medical treatment device to package component, as time function.
Specific embodiments
the antimicrobial medical device of packaging
Medical treatment device described herein is generally implantable medical device and implant, include but not limited to that monofilament and multifilament sutures, operation net such as hernia repair net, hernia bolt, short circuit kind liner, suture clips, stitching thread anchor, the net that prevents adhesion and film, and sew up toe-in folder.Wherein also comprise the implantable medical device with absorbability and non-absorbability.The definition of absorbability polymer is when be placed in physiological condition lower time, the polymer that can be degraded and absorb by health within a period of time.Absorbable medical devices typically adopts well-known, conventional absorbability polymer to be prepared, described polymer includes but not limited to Acetic acid, hydroxy-, bimol. cyclic ester, lactide, glycolide copolymer, or such as the mixture of the polymer of polydioxanone, polycaprolactone, oxidized regenerated cellulose and equivalent thereof.Preferably, polymer comprises and is selected from the polymerization Acetic acid, hydroxy-, bimol. cyclic ester that is greater than approximately 70%, is greater than approximately 70% polymerization lactide, 1 of polymerization, 4-dioxane-2-ketone, is greater than approximately 70% polypeptide, Acetic acid, hydroxy-, bimol. cyclic ester and lactide copolymer, is greater than approximately 70% cellulose and the polymeric material of cellulose derivative.Preferably, absorbable medical devices is by polydioxanone, poliglecaprone, or Acetic acid, hydroxy-, bimol. cyclic ester/lactide copolymer is made.The example of absorbable medical devices comprises monofilament or multifilament sutures.Multifilament sutures comprises the stitching thread of wherein plurality of silk strands being made to braiding structure.The example of non-absorbable medical devices comprises monofilament or multifilament sutures, and operation net such as hernia is repaired net, hernia bolt and short circuit kind liner, and it can be polymerization or non-polymeric.Non-absorbable medical devices can be all or part ofly made up of polymeric material, and described polymeric material includes, but is not limited to polyolefin such as polypropylene; Polyamide is such as nylon; Chloro and/or fluorohydrocarbon such as material; Or polyester such as synthesizing polyester; Or made by non-cohesive material, described non-cohesive material includes, but is not limited to silk, collagen, rustless steel, titanium, cobalt chromium alloy, Ultimum Ti.Preferably, non-absorbable medical devices is made up of nylon or polypropylene.
Applicable antimicrobial can be selected from (but being not limited to) halogenated hydroxyl ether, acyloxy diphenyl ether or its combination.Particularly, antimicrobial can be halo 2-dihydroxy diphenyl ether and/or halo 2-acyloxy diphenyl ether, as U.S. Patent number 3,629, described in 477, can be expressed as following formula:
In above formula, each Hal represents identical or different halogen atom, and Z represents hydrogen or acyl group; and w represents the positive integer of 1-5, with each phenyl ring, but preferably A ring also can comprise one or several can be by the low alkyl group of halo; lower alkoxy, pi-allyl, cyano group, amino, or low-grade alkane acidyl.Preferably, methyl or methoxy is respectively to can be used as substituent low alkyl group and lower alkoxy in phenyl ring.Preferably junior alkyl halides, trifluoromethyl.
The antimicrobial acivity similar to the adjacent dihydroxy diphenyl ether of the halo of above formula also can be by adopting its O-acyl derivative of part or complete hydrolysis under the condition of actual use to realize.The ester of acetic acid, monoxone, methyl or dimethylamino formic acid, benzoic acid, chlorobenzoic acid, methanesulfonic acid and chloromethyl sulfonic acid is particularly suitable.
Within the scope of above formula, a kind of particularly preferred antimicrobial is 2,4, and 4 '-tri-chloro-2 '-dihydroxy diphenyl ethers are commonly called triclosan (Ciba Geigy manufactures, commodity Irgasan DP300 by name or Irgacare MP).Triclosan is the broad-spectrum antimicrobial agent that has been used to multiple product, the multiple-microorganism that it can effectively resist conventionally and SSIs follows.Described microorganism includes, but is not limited to staphylococcus (Staphylococcus), staphylococcus epidermidis (Staphylococcus epidermidis), staphylococcus aureus (Staphylococcus aureus), methicillin-resistance staphylococcus epidermidis, methicillin-resistant Staphylococcus aureus, and combination.
Antimicrobial can be delivered to medical treatment device from the antimicrobial agent source on the surface, inside that is placed on or is attached to packaging.Particularly, when packaging, antimicrobial agent source and medical treatment device being placed in to time described as follows, temperature and pressure condition lower time, antimicrobial can be transferred to medical treatment device from antimicrobial agent source.For example, antimicrobial agent source can be the band of the sponge of plastic reservoir, load antimicrobial of porous capsule storage, the load antimicrobial of paper storage, the load antimicrobial of load antimicrobial or foam storage, load antimicrobial, or the sheet of load antimicrobial.Alternatively, antimicrobial agent source can be integrated with packaging itself, that is, antimicrobial is merged in packaging itself or on it, such as, but not limited to, directly apply on the surface, inside of packaging.In the time that antimicrobial agent source is paper or plastic reservoir, described storage can with packaging in one or more package components in aggregates.
In addition, on medical treatment device, optionally there is coating, and/or optionally comprise one or more surfaces, any transfer at antimicrobial from antimicrobial agent source to medical treatment device, on described surface, arranged antimicrobial.For example, the surface that the coating composition that wherein contains antimicrobial is applied to medical treatment device is useful.The example of medical treatment device (and can be applicable to its coating) is found in U.S. Patent number 4,201,216,4,027,676,4,105,034,4,126,221,4,185,637,3,839,297,6,260,699,5,230,424,5,555,976,5,868,244, with 5,972,008, above-mentioned each patent is all introduced herein thus in full.As U.S. Patent number 4,201,216 is disclosed, and coating composition can comprise C 6or the film forming polymer of higher fatty acids and water-fast salt substantially.As another example, the absorbability coating composition that can be used for absorbable medical devices can comprise poly-oxalic acid alkylene ester (poly (alkylene oxylates)), and wherein alkylene moiety derives from C 6or C 4-C 12the mixture of glycol, it can be applied to medical treatment device from solvent solution, as U.S. Patent number 4,105, described in 034.Coating composition can comprise polymer or copolymer, and it can comprise lactide and Acetic acid, hydroxy-, bimol. cyclic ester, as bonding agent.Coating composition also can comprise calcium stearate (as lubricant); And antimicrobial.Coating can be by based on solvent coating technique (such as dip coated, spraying coating, or suspended drop coating, or any other coating process) and be applied to device.
Absorbable medical devices has moisture sensitive, when these devices are in the humidity that is placed in environment or health, will be degraded.The medical treatment device of being made up of absorbability polymer if it be known to those skilled in the art that is before use at intra-operative contact steam, and it can go bad and reduce intensity.For example, if stitching thread is exposed to any significant time of dampness before use, stitching thread keeps hot strength desirable characteristics to lose fast in vivo.Therefore, need to adopt hermetically sealed packaging to absorbable medical devices.The definition of hermetically sealed packaging is herein by the packaging of making as the material of sterile barrier and other barrier, that is, described material prevents from or substantially suppress dampness seeing through with other.
For example build, for packaging (, comprising list and the multilamellar common metal paper tinsel goods) material used of absorbable medical devices and be commonly called heat insulation paper tinsel.U.S. Patent number 3,815,315 disclose the paper tinsel goods of these types, and this patent is incorporated herein by reference in full thus.Spendable another kind of paper tinsel goods are foil laminates, and it is called as strippable property paper tinsel in the art.U.S. Patent number 5,623, discloses the example of described strippable property paper tinsel and substrate in 810, and this patent is incorporated herein by reference thus in full.If needed, can be by except metal forming or replace the nonmetal polymeric membrane of routine of metal forming to be used to form the packaging of absorbable medical devices.Described film is polymerism, and it can comprise conventional polyolefin, polyester, acrylate, halogenated hydrocarbons etc., its combination and laminate.These polymeric membrane can substantially suppress dampness or oxygen sees through, and available conventional coating, such as, the mineral and the mineral oxide covering that reduce or reduce gas intrusion are coated with.This packaging can comprise the combination of polymer and metal forming, particularly multiple layer polymer/metal-foil composite, such as polyester/aluminum foil/ethylacrylic acid laminate.
Non-absorbable medical devices can be packed in above-mentioned any material.And, non-absorbable medical devices need to be packed in the packaging of being made up of such material, shown in material as sterile barrier, such as how empty material, that is, medical grade paper, or the polymeric membrane of moisture vapor permeable and gas or fiber, that is, non-woven material, is manufactured and is made up of hdpe fiber by DuPont.Preferably, when making antimicrobial medical device, needs there are at least 6 months, preferably at least 1 year and most preferably when the storage life of at least 2 years, by non-absorbable medical devices packing with absorbable medical devices identical packaging material used, such as hermetically sealed packaging.
Staphylococcus microorganism belonging to genus is allly to infect in relevant organism modal to device dependency surgical site.Staphylococcus aureus and staphylococcus epidermidis are present on patient's skin conventionally, and therefore it is easy to enter in wound.2,4 for staphylococcic effective antimicrobial, 4 '-tri-chloro-2 '-dihydroxy diphenyl ethers.This compound is that (MIC) is 0.01ppm for the minimal inhibitory concentration of staphylococcus aureus, in suitable growth medium, detect, as Bhargava, H. etc. are at American Journal of Infection Control, June 1996, described in pages 209-218.The definition of the MIC of specific antimicrobial and specified microorganisms is in the suitable growth culture medium of this microorganism, in order to make this growth medium be unsuitable for this microorganism, the Cmin of the antimicrobial that must exist in this growth medium, suppresses the Cmin of this growth of microorganism that is." being enough to the amount of anti-bacteria bacterium colony substantially " of term antimicrobial and the definition of " effective dose " (as used herein) are to suppress bacteria concentration or higher for the minimum of staphylococcus aureus.
This MIC can be illustrated in disk diffusion susceptibility test.The filter paper plate soaking into by specific antimicrobial, or other object is applied on the agar culture medium of having inoculated test organism.At antimicrobial through culture medium diffusion part, when the concentration of antimicrobial is during higher than minimal inhibitory concentration (MIC), onboard or its interior insensitivity biology growing of some distance around.This distance is called as inhibition zone.Suppose that antimicrobial has certain diffusion rate in culture medium, exist inhibition zone to show the inhibition of the antimicrobial that organism existed in good growth medium at the panel area that soaks into antimicrobial.Diameter and the MIC of inhibition zone are inverse ratio.
prepare the method for antimicrobial medical device
According to multiple embodiments of the present invention, medical treatment device is directly exposed to antimicrobial, that is, antimicrobial agent source is positioned in the packaging that contains medical treatment device.For example, packaging can comprise antimicrobial agent source, can contain the antimicrobial agent source on the surface, inside that is attached to packaging, or antimicrobial agent source can with packaging in one or more package components or in aggregates with packaging itself.In these embodiments, medical treatment device is placed in packaging, and this medical treatment device can be initial containing antimicrobial can be maybe initial one or more surfaces that comprise, on described surface, contain antimicrobial.Then packaging, antimicrobial agent source and medical treatment device are placed in and are enough to the antimicrobial of effective dose to be transferred under time surface, inside and the medical treatment device of packaging, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on medical treatment device.
Initial containing the antimicrobial in the situation that at medical treatment device, be enough to part antimicrobial to be transferred to time of time, temperature and pressure condition of medical treatment device from antimicrobial agent source evaporation when packaging, antimicrobial and medical treatment device are placed in, antimicrobial can be delivered to medical treatment device from antimicrobial agent source.
One or morely be furnished with in the surperficial situation of biocides on it initial comprising at medical treatment device, time, temperature and pressure condition be enough to by be arranged in each antimicrobial on medical treatment device and antimicrobial agent source can microorganism agent part evaporation be transferred to the surface, inside of packaging, to the antimicrobial of effective dose is remained on medical treatment device, substantially suppress thus the lip-deep bacterial clump in inside of medical treatment device and packaging.In this embodiment, by the amount or the concentration that provide the antimicrobial of interpolation to stablize antimicrobial on medical treatment device in pack environment.
Alternatively, medical treatment device can be placed in packaging, and the packaging that comprises medical treatment device is directly exposed to outside antimicrobial agent source, that is, antimicrobial agent source is positioned at the outside of the packaging that contains medical treatment device.Particularly, antimicrobial agent source and the packaging that contains medical treatment device are placed in is enough to the antimicrobial of effective dose to be transferred under the time, temperature and pressure condition of the medical treatment device packaging from antimicrobial agent source evaporation, substantially suppresses thus the bacterial clump on medical treatment device.In this embodiment, packaging can be made up of the material as sterile barrier, porous material or the polymeric membrane of all moisture vapor permeables in this way of described material and gas, thus make gaseous state antimicrobial agent source see through packaging or to transmit through packaging with steam.For example, the packaging that contains medical treatment device can be placed in sealed environment, and antimicrobial agent source can be comprised in sealed environment or can be imported subsequently in sealed environment.Antimicrobial agent source can be any steam form of antimicrobial.
The speed that antimicrobial such as triclosan is transferred to medical treatment device from antimicrobial agent source evaporation depends on time, temperature and pressure condition substantially, packaging and medical treatment device is processed under this condition, storage and processing.For example, Fig. 1 shown in the time temperature being remained on to 55 DEG C within a period of time, and triclosan can be transferred to package component (sealing bottles, under atmospheric pressure) from stitching thread.The condition of vapor transfer antimicrobial such as triclosan comprises enclosed environment effectively, and atmospheric pressure is greater than the temperature of 40 DEG C, the time of 4-8 hour.Also comprise the combination in any of pressure and temperature (described pressure and temperature give antimicrobial dividing potential drop be equal to or greater than the dividing potential drop given under these conditions), combine the time that is enough to make to have on medical treatment device the effective dose of antimicrobial or concentration (, for the minimal inhibitory concentration (MIC) of staphylococcus aureus or higher).Particularly, it be known to those skilled in the art that if reduce pressure, can reduce temperature to produce identical dividing potential drop.Alternatively, if reduce pressure, and keep temperature constant, can shorten the effective dose or the concentration required time that make to have on medical treatment device antimicrobial.Generally speaking, in antimicrobial agent source, the amount of antimicrobial is at least that the antimicrobial of effective dose is passed to (in the time being exposed to following condition) required amount on medical treatment device.
Medical treatment device conventionally by sterilizing to the microorganism being located thereon cannot be survived substantially.Especially, be asepticly in the art understood to imply 10 -6minimum sterility guarantee grade.U.S. Patent number 3,815, discloses the example of sterilization process in 315,3,068,864,3,767,362,5,464,580,5,128,101 and 5,868,244, and each full patent texts is incorporated herein by reference.Particularly, absorbable medical devices can have radiation and hot sensitivity.Thus, need to adopt conventional sterilizing gas or medicament (for example, ethylene oxide gas) to carry out sterilizing to described device.
Owing to having the time, the temperature and pressure condition that are enough to antimicrobial to be transferred to from antimicrobial agent source evaporation medical treatment device in ethylene oxide sterilizing step, so ethylene oxide sterilizing step is described below.But be enough to by antimicrobial the time from antimicrobial source vapor transfer to medical treatment device, temperature and pressure condition can play a role separately or the sterilization steps of other type, it is not limited to ethylene oxide sterilizing step or general sterilization steps.
As mentioned above, absorbable medical devices has the sensitivity to dampness, is therefore generally packaged in airtight packaging such as sealed foil packaging.But the Foilpac of sealing also cannot see through sterilizing gas.In order to use Foilpac to its compensation and in eo sterilization step, develop the step for example, in employing with the Foilpac (, TYVEK polymer) of gas permeability or gas permeable vents.Gas permeation chamber is placed in an open end of packaging, and gas, steam and oxirane enter package interior by this chamber.After sterilization steps completes, near chamber by package encapsulation, thereby chamber is got rid of effectively outside packing, then by chamber excision or otherwise remove, thereby produce gas impervioursness hermetically sealed packaging.The another kind of Foilpac with chamber is capsule sack-type packaging, and the end of this packaging has chamber, wherein that chamber is one side closed to produce ventilation area what pack.After sterilization steps completes, near ventilation area, by package encapsulation, then will pack from ventilation area and excise.
In one embodiment, antimicrobial agent source is placed in packaging, is attached to the surface, inside of packaging, or with packaging in one or more package components integrate or integrate with packaging itself.When forming after edge seal and side seal in packaging, the medical treatment device of packaging can be placed in to conventional ethylene oxide sterilizing device.If packaging is Foilpac, antimicrobial agent source can be that any above-mentioned antimicrobial agent source or antimicrobial agent source can be the gas permeable vents of load antimicrobial.For example, make antimicrobial such as triclosan be carried on Tyvek gas permeable vents by the solution coat Tyvek band with ethyl acetate and triclosan; By the gas permeable vents of load antimicrobial is mounted to the material of hermetically sealed packaging and is positioned over packaging; Medical treatment device is decided to be in the material of hermetically sealed packaging; With around medical treatment device and make gas enter the mode of material internal that enters hermetically sealed packaging through chamber by the edge seal of the material of hermetically sealed packaging; Be placed in and be enough to the antimicrobial of effective dose to be transferred to the time, temperature and pressure condition of medical treatment device from the gas permeable vents evaporation of load antimicrobial thering is the packaging material of gas permeable vents of load antimicrobial and medical treatment device; Foreclose packaging material are sealed to medical treatment device around medical treatment device and by chamber; Then the chamber of excision is made antimicrobial medical device thus.
In another embodiment, antimicrobial agent source is introduced in the sterilizing or gas device of the outer package that contains medical treatment device.For example, medical treatment device is placed in packaging; The packaging that comprises medical treatment device is exposed to antimicrobial agent source; Be enough to the antimicrobial of effective dose to be transferred under the time, temperature and pressure condition of packaging medical treatment device from antimicrobial agent source evaporation with the packaging that comprises medical treatment device and antimicrobial agent source are placed in, substantially suppress thus the bacterial clump on medical treatment device.Packaging can be made up of the material as sterile barrier, porous material or the polymeric membrane of all moisture vapor permeables in this way of described material and gas, or made by the material that can cause hermetically sealed packaging.
Before circulation starts, bactericidal unit can be heated to internal temperature is about 25 DEG C.During humidification and sterilization cycle, bactericidal unit is maintained at about to 22-37 DEG C.Subsequently, to bactericidal unit evacuation to obtain the vacuum of about 1.8-6.0kPa.In humidification cycle, steam injection is to provide source of water vapor to the product of wanting sterilizing.The medical treatment device of packaging can be exposed to about 60-90 minute in the water vapour in bactericidal unit.But the time can change according to needing the medical treatment device of sterilizing.
After this humidification part of circulation, by importing dry inert gas (such as nitrogen), bactericidal unit is pressurized to the pressure of about 42-48kPa.Once reaching required pressure, pure ethylene oxide can be imported to bactericidal unit until pressure reaches about 95kPa.Oxirane is maintained to certain hour, so that the medical treatment device sterilizing to packaging effectively.For example, for operation suture thread, oxirane can keep about 360-approximately 600 minutes in bactericidal unit.Can change according to the type of product and packaging other medical treatment device sterilizing required time.Then from bactericidal unit, extract oxirane out, device is remained under the vacuum pressure of about 0.07kPa approximately to 150-300 minute to remove residual dampness and oxirane from the medical treatment device of sterilization packaging.Pressure in bactericidal unit can be reduced to atmospheric pressure.The subsequent stage of method step is dry cycle.The dry of the medical treatment device of packaging can be by being exposed to the vacuum of drying nitrogen and multiple circulations to fully residue moisture and water vapour are extremely effectively removed until the level of preliminary election from the medical treatment device of packaging.In these circulations, can be by the medical treatment device of packaging at the temperature higher than room temperature, being placed in multiple pressure increases and reduces.Particularly, during dry cycle, the jacket temperature of hothouse can be remained on to the temperature of about 53 DEG C-57 DEG C.But, also can use higher temperature for stitching thread, all 65 DEG C-70 DEG C according to appointment, also can adopt higher temperature according to the therapy equipment of wanting sterilizing.Typical dry cycle comprises the steps: to increase pressure to about 100kPa with nitrogen, in 180-240 minute, will be vented to pressure to chamber is about 0.07kPa, be 100kPa and about 90 minutes of circulating nitrogen gas then importing nitrogen to pressure, be that then about 0.01kPa keeps 4-96 hour again by the pressure that is greater than 0.005kPa by chamber being vented to pressure in 240-360 minute.In humidification, sterilizing and dry cycle (conventionally needing 24 hours) latter stage, container is reduced to confined pressure with drying nitrogen.Be dried to preselected moisture level once completing, then the medical treatment device that can take out packaging from hothouse is stored in humidity control storage area.
By completing sterilization steps, the amount of the antimicrobial having on antimicrobial medical device, packaging and/or package component can suppress on antimicrobial devices, packaging and/or package component or near bacterial clump effectively substantially.Following examples prove to prepare such antimicrobial medical device, it is after sterilizing and medical device package and before for operation process, but adopt while packing, this antimicrobial medical device can be at least 6 months, preferably at least 1 year and most preferably at least 2 years, have effective dose antimicrobial.
Embodiment 1
By 27 " long stitching thread, specification 5-0 and dyeing (the braiding multifilament sutures that the copolymer of being made up of 90% Acetic acid, hydroxy-, bimol. cyclic ester and 10% lactide forms, it can be commercial available from Ethicon, Inc., this stitching thread is initial not to be basically contained antimicrobial and is placed in polypropylene suture dish) be placed in packaging, in described packaging, place antimicrobial agent source.In these embodiments, package component (, the paper lid of being made up of medical grade kraft paper, respectively nearly weighs 0.45g and is used to cover suture tray) by each lid is immersed in the ethyl acetate solution that comprises 5% triclosan (by weight) and is coated with.Each lid kept about 5 seconds in solution, make its at room temperature air dried overnight, be then positioned in suture tray.Respectively cover the amount of triclosan of existence the chances are the 2-3% (by weight) of dried lid gross weight.(suture assemblies (respectively containing the paper lid of stitching thread, suture tray and load triclosan) is emitted on to strippable Foilpac material, the aluminum foil composite that ethylacrylic acid applies) in the split cavity that forms, being provided with of an open end of packaging material ventilation mouth is to make gas, water vapour and oxirane enter the inside of packaging material middle chamber through it.Then to suture assemblies sterilizing, it is suitable is easily placed in suture assemblies to be enough to effective dose antimicrobial to be transferred to sutural time, temperature and pressure condition from antimicrobial agent source (being the paper lid of load triclosan) evaporation.After sterilization steps completes, wherein contain packing of stitching devices thereby seal each chamber and air-vent is foreclosed to form effectively.Then from packaging, take out stitching thread, be applied to suppress test block.
The data that comprise in following table are available from the inhibition test block that stitching thread is implemented, and described experiment adopts staphylococcus aureus ATCC 6538; Methicillin-resistance staphylococcus epidermidis ATCC 51625, escherichia coli (Escherichia coli) ATCC 8739, Vancomycin-resistant Enterococcus faecium (Enterococcus faecium) ATCC 700221, or streptococcus agalactiae (Streptococcus agatacticae) ATCC 624 (growing 24 hours for 37 DEG C in tryptic soy fluid medium) attacks.Thereby dilute culture in aseptic 0.85% saline, to produce concentration be about 1,000, the inoculum that 000cfu (colony-forming units) is every milliliter.For every kind of challenge organism, stitching thread is cut under aseptic condition to the fragment of 5cm.Fragment is placed in to the sterile petri dish with 0.1mL inoculum separately.Tryptic soy agar is injected to culture dish, then culture dish is hatched 48 hours at 37 DEG C.Read inhibition zone with stitching thread to the distance of visible growth.
Microorganism n Minimum Maximum On average
Embodiment 1 Staphylococcus aureus 8 15 19 16
8 6 9 7
N=experiment sample quantity
Embodiment 2
Except stitching thread is stitching thread is (commercial available from Ethicon, Inc. monofilament polydioxanone stitching thread) and paper lid by outside each lid be immersed in be coated with in the ethyl acetate solution that comprises 10% triclosan (by weight), this embodiment is identical with embodiment 1.
Microorganism n Minimum Maximum On average
Embodiment 2 Streptococcus agalactiae 3 0 4 2
Staphylococcus aureus 3 NCP NCP NCP
Escherichia coli 3 11 20 15
On NCP=culture plate without bacterium colony
Embodiment 3
Except stitching thread is stitching thread is (commercial available from Ethicon, Inc. monofilament polypropylene suture) and paper lid by outside each lid be immersed in be coated with in the ethyl acetate solution that comprises 10% triclosan (by weight), this embodiment is identical with embodiment 1.
Microorganism n Minimum Maximum On average
Embodiment 3 Streptococcus agalactiae 3 0 0 0
Staphylococcus aureus 3 17 20 18
Escherichia coli 3 0 6 2
Embodiment 4-5
Except comprising the triclosan (by weight) of 1.1% (embodiment 4) or 5.6% (embodiment 5), 15% Acetic acid, hydroxy-, bimol. cyclic ester and lactide copolymer (by weight), and the solution that residue is ethyl acetate replaces the paper lid of load triclosan to be used as outside antimicrobial agent source, the preparation of these samples is identical with the preparation of embodiment 1.These solution of 0.5ml are placed at (under each stitching devices) in the chamber separating forming in strippable Foilpac material, then make its at room temperature dried overnight, thereby in embodiment 4, in each chamber, there is 5mg triclosan, and in embodiment 5, in each chamber, there is 25mg triclosan.Then suture assemblies (respectively have in the polypropylene tray of being coiled in and paper using blanketing lid 27 " stitching thread) be placed in chamber, subsequently sterilizing.
Microorganism Experiment 1 Experiment 2 Experiment 3
Embodiment 4 Staphylococcus aureus 5 9 8
Staphylococcus epidermidis 6 6 5
Enterococcus faecalis 0 0 0
Escherichia coli 0 0 0
Streptococcus agalactiae 0 0 0
Embodiment 5 Staphylococcus aureus 16 13 15
Staphylococcus epidermidis 15 20 16
Escherichia coli 1 6 5
Enterococcus faecalis 0 0 0
Streptococcus agalactiae 0 0 0
Embodiment 4 and 5 demonstrates and uses the antimicrobial storage that is arranged in paper tinsel chamber is the method for optimizing that generates such product, and described product can present inhibition zone when with staphylococcus aureus and the attack of epidermis Fructus Vitis viniferae.Following table has shown the data of passing through test available from tissue, adopts the stitching thread of being prepared by step described in embodiment 5 in this test.Particularly, be connected with sterile suture manual pin, then determine through live chickens breast whether triclosan is removed for ten times.Data show is being passed stitching thread after tissue, while attack, still can retain significant inhibition zone with staphylococcus aureus and staphylococcus epidermidis.
Microorganism Experiment 1
Embodiment 5a Staphylococcus aureus 15
Staphylococcus epidermidis 15
Escherichia coli 0
Embodiment 6-7
Except stitching thread is outside stitching thread, the preparation of embodiment 6 is identical with the preparation of embodiment 4, and the preparation of embodiment 7 is identical with the preparation of embodiment 5.
Microorganism Experiment 1 Experiment 2 Experiment 3
Embodiment 6 Staphylococcus aureus 7 7 6
Staphylococcus epidermidis 7 6 6
Escherichia coli 0 0 0
Enterococcus faecalis 0 0 0
Streptococcus agalactiae 0 0 0
Embodiment 7 Staphylococcus aureus 12 14 22
Staphylococcus epidermidis 14 18 18
Escherichia coli 3 1 1
Enterococcus faecalis 0 0 0
Streptococcus agalactiae 0 0 0
Embodiment 6 and 7 demonstrates and uses the antimicrobial storage that is arranged in paper tinsel chamber is the method for optimizing that generates such product, and described product can present inhibition zone when with staphylococcus aureus and the attack of epidermis Fructus Vitis viniferae.Following table has shown the data of passing through test available from tissue, adopts the stitching thread of being prepared by step described in embodiment 7 in this test.Particularly, be connected with sterile suture manual pin, then determine through live chickens breast whether triclosan is removed for ten times.Data show is being passed stitching thread after tissue, while attack, still can retain significant inhibition zone with staphylococcus aureus and staphylococcus epidermidis.
Microorganism Experiment 1
Embodiment 7a Staphylococcus aureus 13
Staphylococcus epidermidis 15
Escherichia coli 5
Embodiment 8-10
Except stitching thread is dyeing plus stitching thread, specification 5-0 (the braiding multifilament antimicrobial suture that the copolymer of being made up of 90% Acetic acid, hydroxy-, bimol. cyclic ester and L-10% lactide forms, triclosan is comprised in the copolymer of Acetic acid, hydroxy-, bimol. cyclic ester and lactide and the coating mixed liquor of calcium stearate and ethyl acetate composition, described stitching thread can be commercial available from Ethicon, Inc.), embodiment 8 contains 1.0% triclosan (by weight) in coating mixed liquor; Embodiment 9 has 2.0%; And embodiment 10 has outside 3.0% (according to the gross weight of coating mixed liquor), these embodiment are identical with embodiment 1.
Microorganism N Minimum Maximum On average
Embodiment 8 Staphylococcus aureus 8 16 19 18
Escherichia coli 8 7 9 8
Embodiment 9 Staphylococcus aureus 8 15 21 18
Escherichia coli 8 7 9 8
Embodiment 10 Staphylococcus aureus 8 15 20 17
Escherichia coli 8 7 10 8
Embodiment 11-12
Except stitching thread is dyeing plus stitching thread (specification 2-0), in coating mixed liquor, triclosan is that outside 2% (by weight), the present embodiment is identical with embodiment 4-5.
Microorganism
Embodiment 11 Staphylococcus aureus 17 14 14
Staphylococcus epidermidis 15 15 15
Escherichia coli 1 1 0
Enterococcus faecalis 0 0 0
Streptococcus agalactiae 0 0 0
Embodiment 7 Staphylococcus aureus ＞25 25 20
Staphylococcus epidermidis ＞25 ＞25 20
Escherichia coli 4 4 6
Enterococcus faecalis 0 0 0
Streptococcus agalactiae 0 0 0
Embodiment 13
Except using stitching thread (specification 2-0 dyeing) and antimicrobial agent source are outside (breathability band), the present embodiment is identical with embodiment 1.The ethyl acetate that one side of Tyvek band can hardened coating comprises 20% triclosan (by weight).Suture assemblies (respectively containing stitching thread, polypropylene suture dish and paper lid) is emitted in the split cavity forming in strippable Foilpac material, in an open end of packaging material load triclosan is installed air permeable belt is to make gas, water vapour and oxirane enter the inside of packaging material middle chamber through it.Then to suture assemblies sterilizing.After sterilization steps completes, thus seal each chamber and by air-vent effectively foreclose form wherein contain stitching devices the packaging of each sealing.Then, from packaging, take out stitching thread and be then placed in inhibition test district.Get three samples from each stitching thread; In the time testing with staphylococcus aureus and staphylococcus epidermidis, all sample standard deviations show inhibition zone.

Claims (1)

1. an antimicrobial suture, it is prepared according to following steps:
Stitching thread and antimicrobial agent source are positioned in packaging, and described antimicrobial is selected from halogenated hydroxyl ether, acyloxy diphenyl ether, and combination; With
Packaging, stitching thread and antimicrobial agent source are placed in and are enough to the antimicrobial of effective dose to be transferred to sutural time, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on stitching thread.
2. an antimicrobial suture device that contains stitching thread and at least one package component, it is prepared according to following steps:
Stitching thread device and antimicrobial agent source are positioned in packaging, and described antimicrobial is selected from halogenated hydroxyl ether, acyloxy diphenyl ether, and combination; With
Packaging, stitching thread device and antimicrobial agent source are placed in and are enough to the antimicrobial of effective dose to be transferred to sutural time, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on stitching thread device.
3. a medical treatment device for packaged antimicrobial, it is prepared according to following steps:
Medical treatment device and antimicrobial agent source are positioned in the packaging that comprises inner surface, and described antimicrobial is selected from halogenated hydroxyl ether, acyloxy diphenyl ether, and combination; With
Packaging, antimicrobial agent source and medical treatment device are placed in and are enough to will have at least the antimicrobial of effect amount and are transferred to the surface, inside of packaging and the time of medical treatment device, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on surface, inside and the medical treatment device of packaging.
4. the medical treatment device of the packaging of claim 3, wherein antimicrobial agent source is the storage of load antimicrobial.
5. the medical treatment device of the packaging of claim 3, wherein antimicrobial agent source is placed in packaging.
6. the medical treatment device of the packaging of claim 3, wherein antimicrobial agent source is positioned on the surface, inside of packaging.
7. the medical treatment device of the packaging of claim 3, wherein one or more package components or pack in aggregates in antimicrobial agent source and packaging.
8. the medical treatment device of the packaging of claim 3, wherein medical treatment device comprises one or more surfaces, on described surface, is furnished with antimicrobial, described antimicrobial is selected from halogenated hydroxyl ether, acyloxy diphenyl ether and combination thereof; When packaging, antimicrobial agent source and medical treatment device being placed in to described time, temperature and pressure condition lower time, being arranged in antimicrobial part evaporation separately in antimicrobial on medical treatment device and antimicrobial agent source transfers on the surface, inside of packaging, and effective dose antimicrobial is retained in medical treatment device, the bacterial clump on surface, inside and the medical treatment device that substantially suppresses thus to pack.
9. a method of preparing antimicrobial suture, it comprises the following steps:
Stitching thread and antimicrobial agent source are positioned in packaging, and described antimicrobial is selected from halogenated hydroxyl ether, acyloxy diphenyl ether, and combination; With
Packaging, stitching thread and antimicrobial agent source are placed in and are enough to the antimicrobial of effective dose to be transferred to sutural time, temperature and pressure condition from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on stitching thread.
10. the method for claim 9, wherein the antimicrobial of effective dose is transferred to the surface, inside of packaging from antimicrobial agent source evaporation, substantially suppresses thus the bacterial clump in packaging.
Prepare the method for antimicrobial medical device for 11. 1 kinds, it comprises the following steps:
Medical treatment device and antimicrobial agent source are positioned in the packaging that comprises inner surface, and described antimicrobial is selected from halogenated hydroxyl ether, acyloxy diphenyl ether, and combination; With
Packaging, antimicrobial agent source and medical treatment device are placed in and are enough to the antimicrobial of effective dose to be transferred to the time, temperature and pressure condition of medical treatment device from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on medical treatment device.
The method of 12. claim 11, wherein the antimicrobial of effective dose is transferred to the surface, inside of packaging from antimicrobial agent source evaporation, substantially suppresses thus the bacterial clump in packaging.
The method of 13. claim 12, wherein antimicrobial agent source is the storage of load antimicrobial.
The method of 14. claim 12, wherein antimicrobial agent source is placed in packaging.
The method of 15. claim 12, wherein antimicrobial agent source is positioned on the surface, inside of packaging.
The method of 16. claim 12, wherein one or more package components or pack in aggregates in antimicrobial agent source and packaging.
Prepare the method for antimicrobial medical device for 17. 1 kinds, it comprises the following steps:
Medical treatment device is exposed to antimicrobial agent source; With
Medical treatment device and antimicrobial agent source are placed in and are enough to the antimicrobial of effective dose to be transferred to the time, temperature and pressure condition of medical treatment device from antimicrobial agent source evaporation, substantially suppress thus the bacterial clump on medical treatment device.
The method of 18. claim 17, the time, the temperature and pressure condition that are wherein enough to the antimicrobial of effective dose to be transferred to medical treatment device from antimicrobial agent source evaporation are the pressure and temperatures that is enough to combating microorganisms agent generation dividing potential drop, described dividing potential drop is equal to or greater than the dividing potential drop for producing under 40 DEG C and atmospheric pressure in temperature, and the time is 4-8 hour.
The medical treatment device of 19. 1 kinds of packaged antimicrobials of preparing according to method described in claim 17, its sterilizing and packaging after, and open and for operation process before, can there are effective dose antimicrobial at least 6 months.
CN201110260501.XA 2002-10-04 2003-09-25 Antimicrobial packaged medical device and method of preparing the same Expired - Lifetime CN102423266B (en)

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US41611402P 2002-10-04 2002-10-04
US60/416114 2002-10-04
US10/367,497 US20040068293A1 (en) 2002-10-04 2003-02-15 Packaged antimicrobial medical device and method of preparing same
US10/367497 2003-02-15
US10/603317 2003-06-25
US10/603,317 US20050101993A1 (en) 2002-10-04 2003-06-25 Antimicrobial packaged medical device and method of preparing same

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