TWI336236B - Packaged antimicrobial medical device and method of preparing same - Google Patents

Description

DESCRIPTION OF THE INVENTION (1) The interaction of the Lishen case is the temporary application of the US-specific serial number 60/416,114, which was filed on October 4, 2002. February 2, 2015 U.S. Patent No. 67,497, the entire disclosure of which is incorporated herein by reference. FIELD OF THE INVENTION [0002] Anti-microbial medical devices and their manufacture are related to a method. Background of Love • Patients in the United States perform multiple surgical operations each year. Based on current data, approximately 27, 〇〇〇, 〇〇〇 times of surgery are performed each year. All surgeries The incidence of infection ("ssls") after surgery or surgery is about 2 to the total number of SSIs that occur each year is more than 675, 〇〇〇 case. The occurrence of SSIs is usually associated with bacteria that are propagated on implantable surgical devices. During surgery, bacteria from the surrounding environment can enter the surgical site and attach to the medical device. In particular, bacteria can invade their surrounding tissues using implanted medical devices. This bacterium that is propagated on the medical device can cause the patient's money and trauma. @This, SSIs will increase the patient's medical costs. This film or implantable medical device containing an antimicrobial agent has been disclosed and/or exemplified in the art. An embodiment of this device has been disclosed in Europe

Shen 6 Qing Case No. 761 761 243 ^ The physical devices exemplified in the application include the French Percuflex catheter. The catheter was impregnated within 2 nights of coating with 2,4,4,-trichloro-2,-perylene-benzene mystery [Cibajiaji Irgasan (Dp3〇〇)] and other additives. The catheter was then sterilized with ethyiene oxide and stored for 5 30 days. The catheter coated with the liquid has an antimicrobial effect after storage for 3 days, i.e., it can be produced when it is placed in a medium and attacked by microorganisms. Sterilization temperatures, storage of coated catheters are technically not difficult. 〇 After the implantable medical device is manufactured and sterilized, most of the plutonium is placed in the package before being used for surgery. During the surgical procedure, after disassembling the package containing the packaging member, the medical device is exposed to the environment of the operating room, and thus bacteria in the air may be introduced. The packaging having antimicrobial properties, as well as the packaging member, substantially avoids bacterial contamination on the packaging and packaging components after unpacking. The anti-micro$ bio-packaging and packaging components can be used to ensure the antimicrobial environment of the sterilized medical device after being combined with the antimicrobial properties on the medical device. 20 p The present invention relates to a packaged antimicrobial medical device and a method of making the tear packaging medical device. According to a specific embodiment of the invention, the surface of the device is exposed to an antimicrobial agent. The medical device is placed within a 裴 or placed within a packaging member such as a sealed chamber within the package and, under appropriate conditions, a portion of the antimicrobial agent can be delivered from the medical device to the package and/or sealed chamber. The amount of delivery of the antimicrobial agent can be sufficient to inhibit the growth of bacteria on the medical device, package, and/or sealed cavity. -4 - 丄336236 A7 V. INSTRUCTIONS (3) Specific examples of the packaged antimicrobial medical device include a package in which an antimicrobial agent is placed on at least one of its inner surfaces, the antimicrobial agent being selected from a halogenated hydroxy bond Acyloxydiphenyl ethers, or a combination thereof, in an amount sufficient to substantially inhibit the growth of bacteria on the package; and at least one medical device placed in the package 5 having one or both of the antimicrobial agent disposed thereon The plurality of surfaces, the antimicrobial agent being selected from the group consisting of hydroxy oxime, oxyphenylene diphenyl ether, or a combination thereof, in an amount sufficient to substantially inhibit the growth of bacteria on the medical device. Printed by the Intellectual Property Office of the Ministry of Economic Affairs, the Consumers' Cooperatives, and the specific examples of the packaged antimicrobial medical device include a package having an inner surface and a sealed cavity in which the medical device is placed and placed in the package. In this embodiment, the antimicrobial agent is placed on at least one surface of the sealed chamber and in an amount sufficient to substantially inhibit the growth of bacteria on the sealed chamber. In another embodiment, the antimicrobial agent is placed on the inner surface of the package and the surface of the sealed cavity in an amount sufficient to substantially inhibit growth of the bacteria 15 on the package and the sealed cavity. The packaged medical device also includes At least one medical device placed in a sealed chamber. The medical device also has one or more surfaces on which the antimicrobial agent is placed. The amount of antimicrobial agent on the medical device is sufficient to substantially inhibit the growth of bacteria on the medical device. The antimicrobial agent on the packaging, sealed cavity and medical device may be selected from the group consisting of halogenated hydroxy ethers, decyloxydiphenyl ethers, and antimicrobial compounds of the combination. Another specific example includes an antimicrobial suture assembly having one or more sealed cavities on the surface of the antimicrobial agent, the antimicrobial agent being selected from the group consisting of a toothed hydroxy ether, a nonoxydiphenyl ether, and the like The combination is sufficient to substantially inhibit the growth of bacteria on the sealed cavity; and a paper placed in the sealed cavity is applicable to the Chinese National Standard (CNS) A4 specification (210x297 mm) 1336236 A7 5. Inventive Note (4) — The suture comprises a plurality of surfaces having an antimicrobial agent disposed thereon, the antimicrobial agent being selected from the group consisting of a toothed hydroxy ether, a decyloxy 2^ bond, and combinations thereof. Sufficient to substantially inhibit the bacteria on the suture, the invention also indicates a method of preparing, packaged antimicrobial medical device, the steps comprising providing a package and/or a substantially chamber-free sealed cavity; The device is placed in a packaging or sealed chamber. The medical device includes one or more surfaces on which the antimicrobial agent is placed. The antimicrobial agent is selected from the group consisting of a self-containing hydroxyether, a nonoxydiphenyl ether, and The set 10 is such that the conditions of the bag and/or the sealed cavity and the medical device are sufficient to deliver the first portion of the antimicrobial agent from the medical device to the package and/or the sealed cavity while retaining the second portion of the antimicrobial agent on the surface of the medical device Thus, the growth of bacteria on the medical device, the package and/or the sealed cavity can be substantially inhibited'. A brief description of the 15 suppression mode is shown in Fig. 1 to illustrate the transfer of the antimicrobial agent from the medical device to the seal at a time function of 55 °c. The graphics of the cavity. Printed by the Ministry of Economic Affairs Intellectual Property Office Staff Consumer Cooperatives Figure 2 is a photograph of a sealed cavity placed on a TSA plate by Staphylococcus aureus. 20 Figure 3 is a photograph of a suture placed on a TSA plate with Staphylococcus epidermidis. Figure 4 is a scanning electron microscope ("SEM") image of a suture coated with an antimicrobial component exposed to an anti-penicillin-resistant Staphylococcus epidermidis. Figure 5 is a view of a scanning electron microscope ("SEM") of a suture of an uncoated antimicrobial component exposed to anti-penicillin-6 - 1336236 A7 B7 5. Inventive Note (5) Staphylococcus epidermidis. BRIEF DESCRIPTION OF THE INVENTION The packaged antimicrobial device 5 A specific example of a packaged antimicrobial medical device includes at least one package having an inner surface. The inner surface includes an antimicrobial agent disposed thereon in an amount sufficient to substantially inhibit the growth of bacteria on the package. The packaged medical device also includes at least one medical device disposed within the package. The medical device also has one or more surfaces on which the antimicrobial agent is placed. The medical device 10 is provided with an anti-microbial agent in an amount sufficient to substantially inhibit the growth of bacteria on the medical device. The antimicrobial agent on the packaging and medical device can be selected from the group consisting of halogenated hydroxy ethers, decyloxydiphenyl ethers, or combinations thereof. Ministry of Economic Affairs Intellectual Property Office Staff Consumer Cooperative Printed In another embodiment, the packaged medical device includes a package having an inner surface and a sealed cavity in which the medical device is secured and placed within the package. In this particular embodiment, the antimicrobial agent is placed on at least one surface of the sealed chamber and is present in an amount sufficient to substantially inhibit the growth of bacteria on the sealed chamber. In another embodiment, the antimicrobial agent is placed on the inner surface of the package and at least one surface of the sealed cavity' and in an amount sufficient to substantially inhibit growth of the bacteria on the package and the sealed cavity. The packaged medical device also includes up to 20 medical devices placed in a sealed chamber. The medical device also has one or more surfaces on which the antimicrobial agent is placed. The amount of antimicrobial agent on the medical device is sufficient to substantially inhibit the growth of bacteria on the medical device. The antimicrobial agent on the package, seal cavity, and medical device can be selected from the group consisting of halogenated hydroxy ethers, decyloxy diphenyl ethers, and combinations thereof. 1336236 A7 B7 V. INSTRUCTION DESCRIPTION (6) Another specific example includes an antimicrobial suture assembly having one or more sealed cavities on the surface of which an antimicrobial agent is selected, the antimicrobial agent being selected from the group consisting of i-containing hydroxy ethers, a decyl diphenyl ether, and combinations thereof, in an amount sufficient to substantially inhibit the growth of bacteria on the sealed cavity; and a suture placed within the sealed cavity 5 'this suture includes having an antimicrobial agent placed thereon The one or more surfaces on the antimicrobial agent are selected from the group consisting of halogenated hydroxy ethers, decyloxydiphenyl ethers, and combinations thereof, in an amount sufficient to substantially inhibit bacterial growth on the suture. The medical devices described herein generally refer to implantable medical devices including, but not limited to, single and multi-fiber constructions, surgical meshes such as hernia repair nets, hernia plugs, and close seed spacers. Brachy seed spacers, suture clips, suture anchors, anti-adhesive screens and films, and seam clips. It also includes implantable medical devices that are absorbable and non-absorbable. An absorbable polymer is defined as a polymer that is decomposed and absorbed by the body 15 after exposure to a physiological environment for a period of time. Absorbable medical devices can be prepared from conventional methods. [Amenable absorbent polymers include, but are not limited to, glycolide, lactide, glycolic acid copolymers, or mixtures of polymers, such as Polydioxanone, polycaprolactone and their equivalents. Preferred polymers include those selected from the group consisting of greater than about 70% polyglycolic acid; greater than about 70% polylactic acid; polymeric i, 4-di. Cacao-2-ketone; greater than about 70% polypeptide; glycolic acid and lactic acid copolymer; greater than about 7% by weight of the polymeric material of the cellulose plastic and cellulose plastic derivative groups. Examples of absorbable medical devices include single and multi-fiber constructions. The multi-fiber construction includes stitches woven from a plurality of fibers. Examples of non-absorbable medical devices include single and multi-fiber-8 - this paper scale applies to China National Standard (CNS) A4 specifications (210x297 public) d. - ordered. Ministry of Economic Affairs Intellectual Property Bureau employee consumption cooperative printed 1336236 A7 __B7_ V. INSTRUCTIONS (7) Dimensional sutures, surgical meshes such as hernia repair meshes, hernia plugs, and close-range spacers, which may be polymeric or non-polymeric. Suitable antimicrobial agents can be selected from, but not limited to, hydroxyl hydroxy, acyloxydiphenyl ethei^s, or combinations thereof. 5 In particular, the antimicrobial agent may be a halogenated 2-hydroxydiphenyl ether and/or a halogenated bismuthoxydiphenyl ether, as described in U.S. Patent No. 3,629,477, and the following formula: r 10 5. 6* 6 5

4 '(Hal), 15 Ministry of Economic Affairs, Intellectual Property Office, Staff Consumer Cooperative Printed 20 In the above formula, Hal represents the same or different fangs atom, z represents hydrogen or a brewing group, and w represents a positive integer of 1 to 5' and Preferably, ring A in each of the loops may also contain one or more low alkyl groups, which may be halides, low oxy groups, propyl groups, cyano groups, amine groups, or low chain s. Preferred useful lower alkyl and lower alkyl groups are the substituents of the methyl or methoxy group in the phenyl ring, respectively. — Preferably, the halogenated lower alkyl group or the trifluorofluorenyl group is used. In practical applications, it is also attempted to use a partially or fully hydrolyzed 〇-mercapto derivative similar to the antimicrobial activity of the above-mentioned dentate 〇 经 经 二 ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ ❶ Dimercaptocarbamic acid, benzoic acid, gas, acid, methanesulfonic acid and gas methylsulfonic acid. 9 - The paper size applies to the national standard (CNS) A4 specification (210x297 mm) 1336236 A7 B7 V. Description of invention (8) The specific preferred antimicrobial agent in the above formula is commonly known as Tri-gas (Tricl〇san) 2,4,4,-Trichloro-2,-hydroxydiphenyl ether (manufactured by Ciba Specialty Chemicals, trade name Irgasan DP300 or Irgacare MP). Sanchensheng is a broad-spectrum antimicrobial agent used on many products and is effective against many microorganisms commonly associated with SSIs. The microorganism includes '; </ RTI> is not limited to, Staphylococcus, Staphylococcus epidermidis, Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus aureus, and combinations thereof. The Ministry of Economic Affairs, the Intellectual Property Office, and the Employees' Cooperatives Co., Ltd. can use the coating composition commonly used in general preparation medical devices as the carrier 10 to deliver the antimicrobial agent to the surface of the medical device, such as, for example, absorbable and non-absorbable multi-fiber structures. . Examples of medical devices and coatable films can be found in U.S. Patent Nos. 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 and 5,972,008, all of which are 15 columns. This is hereby incorporated by reference. The coating composition disclosed in U.S. Patent No. 4,201,216 may comprise a film-forming polymer and a water-insoluble salt of a C6 or higher fatty acid. As another embodiment, an absorbable film component for an absorbable medical device includes a poly(lean smoke oxide) whose alkylene moiety is a mixture of C6 or C4 to Ci2 glycols, such as U.S. Patent No. 4,105,034 discloses the application of a solvent solution to a medical device. The coating composition of the present invention may comprise a polymer or copolymer as an adhesive, which includes lactic acid and glycolic acid. The coating composition may also contain g as a stearic acid stearic acid series, and an antimicrobial agent. This film can be dreamed by, for example, 'dip coating method, spray coating method, or hanging drop coating method, or other conventional-10 - this paper scale applies Chinese National Standard (CNS) A4 specification (210 X 297 mm). ) 1336236 A7 B7

The known coating method applies it to the device. Absorbable medical devices are extremely sensitive to moisture, that is, they are prone to decomposition when exposed to the outside air or the wet environment of the body. Those having ordinary skill in the art are well aware that exposure of the medical device made of the absorbable polymer to the water vapor prior to surgical use will result in deterioration of the quality and loss of strength. For example, sutures will quickly lose their 'tensile strength' that can be maintained in the body after exposure to a humid environment for a period of time prior to use. Therefore, it is preferred that the absorbable medical device be a completely sealed package. A fully sealed package as used herein means a package made of a material that blocks sterilized air and air, i.e., a material that avoids or substantially limits the ingress of moisture and air. The Ministry of Economic Affairs, the Intellectual Property Office, the Employees' Consumer Cooperative, which prints the packaging materials for absorbable medical devices, including, for example, single-layer and multi-layered metal foils, commonly referred to as heat-sealable aluminum foils. These types of aluminum foil products are disclosed in US patents. No. 3,815,315, which is hereby incorporated by reference. Another applicable aluminum foil product is a laminated foil film known in the art as a peelable foil film. An example of such a peelable foil film and substrate is disclosed in U.S. Patent No. 5,623,810, the disclosure of which is incorporated herein by reference. If desired, a conventional non-metallic film may be added to or substituted for the metal foil = a package for making an absorbable medical device. Such films are a polymer and may contain conventional polyenes, polyesters, acrylics and the like, combinations and laminates thereof. These polymeric films can substantially inhibit moisture and oxygen; they can be coated with conventional coatings, for example, a metal film that reduces gas intrusion. The package may comprise a combination of a polymer and a metal foil, in particular a multilayer polymer/metal foil mixture.疋-11 - This paper size is applicable to China National Standard (CNS) A4 specification (210 X 297 mm) A7 B7 10 15 Ministry of Economic Affairs Intellectual Property Bureau employee consumption cooperative printing 20 V. Invention description (10) Any of the above materials may be used Packaging non-soluble medical devices Non-soluble medical silk packaging is more often able to block the sterilized material = such as 'medical boring (four) _, or - kind of permeable water ^ air polymerization _, such as DuPont (Dup (10)) company TYVEK® film made from high density poly. Fiber surgical needles, sutures, and packages containing a combination of sutures and surgical needles typically have a suture tray as their sealed cavity for securing sutures or surgical needles to surgical needles and / or the type of sealing cavity of the suture is a pleated pack made of tough medical paper. - The pleated bag has a stagnation and a hanging sag and a hanging bag. A pleated package of surgical needles and sutures is described and disclosed in the following patents, which are incorporated herein by reference in their entirety by U.S. Patent Nos. 4,126,221, 4,120,395 and 5,555,976. Another conventionally known sealing chamber for surgical needles and/or sutures is a molded plastic disk having a central layer surrounded by an outer winding groove such as an elliptical groove to receive and secure the suture. The sealed chamber may further comprise a medical paper or plastic sheet that can be attached to the winding groove, or a molded fixing member for fixing the suture in the groove. The molded plastic disk can be made of a thermoplastic material selected from the group consisting of polyester 'polyethylene gas, polypropylene, polystyrene and polyethylene. A sealed chamber having a wraparound groove is described in the following patents, which are incorporated herein by reference in their entirety: U.S. Patent Nos. 4,967,902, 5,213,210 and 5,230,424. The most common microorganism in the surgically infected site associated with the device is the genus Staphylococcus. Staphylococcus aureus and Staphylococcus epidermidis are most commonly present in the skin of a patient, and therefore, the wound is susceptible to infection by the above bacteria. 2,4,4,- -12 - This paper scale applies to China National Standard (CNS) A4 specification (210 297 mm) 1336236 A7 B7 V. Description of invention (11) Trichloro-2,-hydroxydiphenyl ether One of the most effective antimicrobial agents for staphylococci. The minimum inhibitory wave (MIC) of this compound against S. aureus is 0.01 ppm, which is in a suitable medium according to the method described by Bhargava, H. et al., June 1986, 1982-218. The measurements performed. The specific antimicrobial agent against a particular microorganism is defined as the minimum concentration of antimicrobial agent that prevents growth of that particular microorganism in a suitable medium, thus making the medium unsuitable for growth of the microorganism, i.e., the lowest concentration at which the growth of the microorganism is inhibited. As used herein, "a sufficient dose that substantially inhibits bacterial growth" is defined as the minimum inhibitory concentration of S. aureus or its 10 other bacteria. The MIC can be illustrated by the sensitivity measurement of the paper tray diffusion method. A filter paper tray or other item that is impregnated with a specific antimicrobial agent is placed in a loam medium inoculated with the test microorganism. The antimicrobial agent can begin to diffuse in the medium and the susceptible microorganism cannot grow at a circumferential extent 15 where the antimicrobial concentration is above the minimum inhibitory concentration (MIC). This distance is called the suppression zone. It is assumed that the antimicrobial agent has a certain diffusion rate in the medium. If the inhibition zone appears around the paper tray impregnated with the antimicrobial agent, it means that there is an anti-Ministry of the Ministry of Economic Affairs, the Intellectual Property Bureau, the consumer cooperative, the printed microbial agent, or the microorganism. Can continue to grow. The diameter of the zone of inhibition is inversely proportional to the MIC. 20 Alternatively, the concentration of three gasses on the surface of a medical device such as a coated suture may be greater than about 0.01 ppm (coating weight/weight) or between about 3 〇 ppm to 5,000 ppm (suture weight/weight). . The concentration of triclosan on the surface of the package or sealed cavity can range from about 5 ppm to 5, 〇〇〇 ppm (package or density/weight). However, other specific applications can utilize higher levels of anti-micro- 13 -

1336236 A7 B7 V. INSTRUCTIONS (I2 Biological Agents, and which are still considered to be within the scope of the present invention. The various methods according to the invention of the packaged antimicrobial therapeutic device provide initially substantially no antimicrobial 5 doses of packaging and sealing cavity, ie no antimicrobial agent on the surface of the packaging or sealing cavity. The medical device with the antimicrobial agent placed in the packaging or sealing cavity. Thereafter, when using this packaging, the sealing cavity And the medical device is such that its time, temperature and pressure conditions are sufficient to vaporize a portion of the antimicrobial agent from the medical device to the packaging and/or the sealed chamber. 10 Transferring, for example, three gas to the packaging and/or sealed chamber from the medical device Anti-micro tl Ministry of Economic Affairs Intellectual Property Bureau Employees Cooperatives Printed biotransport rate is dependent on the time, temperature and pressure conditions of processing, storage and transportation of the package with sealed chamber and medical device. For example, Figure 1 illustrates When the temperature is maintained at 55 ° c - period of time, three gas is transferred from the suture to the sealed chamber (in a sealed bottle under atmospheric pressure). Effective gasification 15 transmission The conditions of the three-dimensional antimicrobial agent include a sealed environment, atmospheric pressure, temperature of more than 40 ° C, and a time of about 4 to 8 hours, which also includes making the partial pressure of the antimicrobial agent equal or greater than the above conditions. Any combination of pressure and temperature divided and combined with a period of time sufficient to produce an effective amount or concentration of the antimicrobial agent on the package and/or seal cavity, i.e., a concentration that is less than 20 concentrations (MIC). It is well known to those skilled in the art that if the pressure is reduced, the temperature can be lowered simultaneously to achieve the same effective partial pressure. Or, when the right 'reduced pressure and the temperature remains constant, the effect is effective on the package and/or the seal cavity. The amount of time or concentration of the antimicrobial agent may be shorter. A portion of the antimicrobial agent is delivered to the package during processing -

V. INSTRUCTIONS INSTRUCTIONS 13 10 15 The Ministry of Economic Affairs' Intellectual Property Office staff consumption cooperative prints 20 σ/or sealed chambers while the second part remains on the surface of the medical device. Because: after delivery, the medical device and the anti-agent contained in the packaging and/or sealed cavity can reach a sterilized medical device that substantially inhibits the bacteria growing on or near it. The creature that is attached to it. Specifically, 'sterilization in this field means maintaining a sterile concentration of 1〇.6. Examples of sterilizing treatments are described in Ice IMS, 3, _, 864, 3, 767, 362, 5, 464, 58, 5, 128, 2, and 5, 868, 244, respectively, which are incorporated herein by reference. In particular, absorbable medical devices may be extremely sensitive to radiation and heat. Therefore, sterilization of such devices can be carried out using a general disinfecting gas or a disinfectant such as ethylene oxide gas. Since the time, temperature and pressure conditions in the sterilization of ethylene oxide are sufficient to allow a portion of the antimicrobial agent to be vaporized from the medical device to the package and/or the sealed chamber, the sterilization process of the epoxy oxime is described below. However, the time, temperature and pressure conditions at which the athlete's foot can transport the antimicrobial agent from the medical device to the package and/or the sealed chamber may be singly or by other types of sterilization, and it is not limited to ethylene oxide alone. Sterilization or general sterilization. As noted above, absorbable medical devices are very sensitive to moisture and are therefore typically packaged in a completely sealed package such as (4) paper. However, the sealant also prevents the entry of disinfectant gas. In order to solve this problem and utilize this aluminum foil package in the ethylene sterilization process, it has been developed to utilize the venting or previously described pores (for example, TYVEK polymer) 15 specifications (210x297 mm) 1336236 A7 B7 V. INSTRUCTIONS (Μ) 10 15 The Ministry of Economic Affairs' Intellectual Property Office staff consumption cooperative prints 20 foil packaging processes. The venting holes are disposed at one end of the package opening and allow access to the interior of the package by air, water vapor, and ethylene oxide. After the sterilizing treatment is completed, the package is sealed close to the venting opening to separate the venting opening from the sealed package, and the venting opening is cut or otherwise removed, so that a hermetic sealed package can be prepared. Another type of aluminum foil package is a venting opening in a bag-like package having a venting opening at the end of the package, wherein the venting opening is sealed to one side of the package to create a venting zone. After the sterilization process is completed, the package is sealed close to the venting zone and the sealed package is then cut away from the venting zone. The packaging and sealing chamber is substantially free of antimicrobial agents prior to delivery of the antimicrobial agent from the medical device to the packaging and/or sealing chamber, and is preferably completely free of antimicrobial agents. The medical device is placed in a sealed chamber if necessary and then placed in a package. After the surrounding seal and side seals are formed in the package, the packaged medical device is placed in a conventional epoxy-based sterilization device. If it is (4) package, the venting hole can be used. The internal temperature of the sterilization device can be heated to about the time before the cycle begins. The sterilization equipment is maintained at about 2 to 37 C throughout the humidification and sterilization cycle. The receiver's extracted the air from the sterilizing equipment to a vacuum of about 1.8 • king b.U kpa. In the wetness job, steam is injected to provide the water-based source of the product. The packaged medical device can be exposed to a sterilization setting for about 60 to 90 minutes. However, depending on the type of sterilization required: 2 times vary. After the humidification cycle, a dry inert gas pressurized to 48 kPa, for example, nitrogen, may be introduced by (iv). -曰1,%1 The required level is -16 - The paper size is applicable to China's national ii^(CNS)A4 specification (210 X 297 mm). Order 1336236 V. Invention description 5 10 15 Ministry of Economic Affairs Intellectual Property Bureau Staff Consumption Cooperative After printing 20, the device can be used to treat pure epoxy (10) until the pressure reaches about %. This epoxy (iv) can be maintained for a period of time sufficient for the packaged medical device to achieve the effect of killing. For example, the surgical suture is maintained in the g-eliminating device for a duration of about _ minutes. The sterilization time of other medical devices varies depending on the type of product and packaging. In order to remove residual moisture and ethylene oxide from the medical device, the omega is extracted from the sterilization apparatus and maintained at a pressure of about 0 〇7 kpa for about 150 to 300 minutes. The pressure in the sterilization unit can then be restored to atmospheric pressure. The following are the processing steps for the drying cycle. The packaged medical device can be dried by exposure to a plurality of dry nitrogen and vacuum cycles sufficient to effectively remove moisture and water vapor from the armored device to a predetermined level. During these cycles, the packaged medical device can undergo a number of pressurization and depressurization processes at temperatures greater than room temperature. In particular, the sleeve temperature of the drying chamber can be maintained at 53C to 57 throughout the drying cycle. (: Between. However, it is also possible to use higher temperatures, for example, sutures can use temperatures of about 65 to 7 〇〇c, and higher temperatures can be used depending on the medical device to be sterilized. Typical drying cycles The steps include increasing the pressure of the nitrogen to about 100 Kpa, withdrawing the chamber pressure to about 0.07 kPa in 18 to 24 minutes, reintroducing the nitrogen to a pressure of 1 kPa and then circulating the nitrogen for about 90 minutes 'at about 240 to The chamber pressure is drawn to about 0. 01 kPa in 360 minutes and then maintained at a pressure of no more than 0.005 kPa for about 4 to 96 hours. At about the end of the humidification, sterilization, and drying cycle, which typically takes about 24 hours, dry nitrogen is required. The container is returned to the external pressure. Once the drying is completed to the predetermined humidity, the container can be taken out of the drying chamber. -17 - The paper size is applicable to the Chinese National Standard (CNS) A4 specification (210x297 mm) 1336236 A7 ____B7 V. Invention &quot; installed medical device and stored in a storage area under humidity control. After the sterilization process is completed, the antimicrobial medical device, the packaging and/or the sealed cavity with the antimicrobial agent may have substantially Inhibition of the proliferation of bacteria on or near the packaging and/or sealing cavity of the antimicrobial disruption. Example 10 15 Ministry of Economic Affairs Intellectual Property Bureau Staff Consumer Cooperative Print 20 Apply 2% of the three gas-coated coatings Cloth - series USP (usp) standard size 5_〇 film pQly fine in 91 () suture so that the seam ^ contains about 23 · 2 micrograms of tri-gas before sterilization. The coated suture Placed in a package containing a sealed chamber as described above, i.e., a tray that secures the suture and the paper assembly that covers the suture within the disc. The seal cavity and the suture within the package are sterilized as described above. It has been determined that the suture contains about 5 micrograms of tris, the tray contains about 0.2 micrograms of triclosan, the paper component contains about 2.3 micrograms of tris, and the heat seal coated package contains about i 5 micrograms. The second gas is about 13.7 micrograms after the sterilization. After the trichlorobenzene is sterilized from the medical device under the time function of 55 ° C, the paper is tested by the suppression ring test as described below and the sterilization package is used. The antimicrobial properties of the tray. The inhibition method of the bacterial strain can be effectively used for the determination of diffusible substances. When the method is outwardly diffused, the concentration is decreased by the S number: the substance is used in the disc The size of the ring of beneficial and soil growth determines the age of the microbial agent against the microbial agent. The degree of weaving 'that is, 25 contains the packaging of the conventional commercial suture without triclosan _=, the comparative example can also As a preparation and measurement of antimicrobial properties, the ratio is -18 - This paper scale applies to the Chinese National Standard (CNS) A4 specification (210 X 297 mm). V. Description of invention (17) Figure 2 shows Staphylococcus aureus The attack is placed on a photo of the suppression circle of the biological packaging tray. The results of the suppression test of micro-paper, components and trays are listed in the table or:: The trays and paper components are all suppressed: = all treated components are Staphylococcus aureus and Staphylococcus aureus The suppression of i-untreated components has no suppression loop. Table h packaging component suppression circle detection 10 treated packaging group supply · 押 表 表 葡萄 葡萄 菡 菡 菡 菡 菡 菡 菡 13 13 13 13 13 13 13 13 13 13 13 13 j j j j j j j j j j j j j j j j j j j j j j j 〇&quot; 15 20 f Example &amp; Day j implementation (4) - a 24-hour water-based test. In this test, the effect of measuring humidity on the antimicrobial properties of different size suture materials will contain or contain 1% of the three gas-coated points/, the USP size of 2-0, in the absence of (4). 3-0, 4-0, and 5_〇 sterilized suture cuts 5, a small length of the knife. Place the half-cut suture in a sterile glass dish and place it in a dry atmosphere for 24 hours (dry lining). The other half of the suture was placed in q '85% sterile saline under sterile operation and placed at 37 ° for 24 hours (wet suture). After drying, the wet and wet sutures are placed in separate sterilizations under aseptic operation. 19 - (210x297 ~ 1336236 A7 V. Inventive Note (18) Glass, Service:: Skilled 1 〇 °ml with 1 () 5 colony forming units (CFU) Inoculum of Staphylococcus aureus or Staphylococcus epidermidis. Each of the two bacteria and dry and wet sample groups has a repeat of each size of the suture. Pour the TSA into each glass dish and allow it to The plate was cultured at 37T: 5 48 hours. After the completion of the culture, the glass dish was inspected with a dark field colony counter, and the size of the inhibition zone was measured. The results of the inhibition circle test are listed in the table. The film was found to have a restraining ring on the P〇lyglaCtin 910 suture. The dry and wet samples showed obvious inhibition circles. The film p〇lyglaetin 91 quilting line had no 10 suppression ring for the Zhao (4). The typical suppression circle is illustrated in Figure 3. *, Table 2·. 24-hour water-based immersion test: Diameter of the suppression circle Ministry of Economic Affairs Intellectual Property Bureau Staff Consumption Cooperative Printed suture material stomach size 2-0~ —— average inhibition circle diameter (Millies, Staphylococcus epidermis Portuguese glass chain --- _ damp dry and humid + DP300 10 9 10 9 control group 0 0 〇 size 3-0 _^ +DP300 10 10 10 8 control group 0 0 0 0 size 4-0 + DP300 10 ----- 3 ~Το Ί 2 Control group 0 0 0 0 size 5-0 ---_____ + DP300 10 3 10 2 Control group 0 0 0 0 Moderate ruler paper standard

I PCT 97 Ministry of Economic Affairs Intellectual Property Bureau Staff Consumer Cooperative Printed 1336236 A7 B7 V. Invention Description (I9 All suture samples are from different batches. The average suppression circle diameter is based on repeated three glass dishes. As shown, the area of the quilt line of the p含lyglaetin 91 containing the second gas can be seen in the area where the growth of the bacteria is inhibited, while the suture without the three-gas control has no obvious growth inhibition area. Staphylococci (shown), Staphylococcus aureus, MRSA, and MRSE also had similar responses, and there were consistent changes in sutures of various sizes.10 Example 4 This example is a 7-day aqueous impregnation test. The purpose of this test is to determine whether the antimicrobial effect after three-gas treatment can be maintained for 7 days in a buffered aqueous environment. 15 usp of 1%, 2%, and 3% triclosan coating solution, respectively. Dimensional coated polyglactin 910 suture, and Epoxy sterilized USP size 2-0 coated p〇iygiactin suture was cut into 5 cm segments under aseptic processing. Samples were grouped on day 7 Test on the first day At the same time, each of the suture materials was placed in 3 separate glass dishes and co-cultured with 0.1 ml of challenge bacteria containing about 104 CFU. TSA was poured into each glass dish and allowed to cure. A small section of the remaining suture material was placed in 100 ml of 0.85% phosphate buffered saline (PBS). For each of the next 6 days, various sizes of suture material-21 -

This paper scales the financial standard (CNS) A4 specifications (10) 297 297 public) 1336236 A7 ___B7_____ ___ V. Description of the invention (2〇) 3 small pieces of material are taken out from PBS, and cultured, inverted gossip protein medium (TSA) inside the glass dish. All glass dishes were incubated at 37 ° C for 48 hours, after which the presence or absence of the inhibition zone was examined. The test results of this dipping for 7 days are shown in Table 4. Triclosan-containing film ' 5 Pdyghctin 910 sutures produce a ring of inhibition after each bacterial challenge. The control group without the three-dimensional film p〇lyglactin 91 quilt line did not produce growth inhibition. Table 4. 7-day aqueous impregnation test: average diameter of inhibition ring diameter 圏 diameter (mm) Tri-gas coating liquid day 1 2 3 4 5 6 7 1% 20 18 20 20 19 21 2〇2% 24 20 22 21 24 24 23 3 °/〇27 25 15 25 27 30 Bu 2 7 Control group (0%) 0 0 0 0 0 0 Ministry of Economic Affairs Intellectual Property Bureau employee consumption cooperative printing

5 IX ruler paper All stitch samples are from different batches. The average suppression ring diameter is based on repeated three glass phoenixes.

SOL This example illustrates the effect of antimicrobial sutures, which are separated from the sutured human simulated aqueous buffer for 7 days. The sample of the normal suture and the antimicrobial suture of the present invention is taken out every day, and placed in a tryptic bean medium (recognized) glass 22 which has been inoculated with iq4 colony forming unit (cpu) m. staphylococcus. 210X297 public meal) 1336236 A7 B7 V. Invention description ο). As shown in Table 4, the antimicrobial suture of the present invention can form a restraining ring on the glass dish even after 7 days of dipping, and the concentration of the antimicrobial agent on and around the antimicrobial suture of the present invention is still in the MIC. On the other hand, the general suture treated in the same way does not form a restraining ring, that is, the bacteria can still grow on the general suture and around from the root. Example 5 This example relates to a scanning electron microscope. A scanning electron microscope (SEM) image was prepared using sutures immersed in the broth culture solution of MRSE. 10 The 6-inch single-strand USP size 2-0 coated 0.5% three-gas coating solution coated polygalctin 910 suture was placed in different tubes containing 30 ml of sterile TSB, and inoculated with 0.1 ml in TSB. 24 hours of challenge bacteria. The Polysorb (woven lactomer 9-1) suture, which was obtained from the American Surgery Company without a three-gas, 6-inch single-strand USP size 2_0, was also prepared in the same manner as described above. The tubes were incubated at 37 ° C for 24 hours. After the cultivation, the suture which was examined by SEM was prepared in the following manner. Printed by the Intellectual Property Office of the Ministry of Economic Affairs, the consumer cooperatives. Take the sutures of each strand from the broth culture solution and wash them in 100 ml of sterile physiological saline for 10 minutes. The washed suture was mixed in 10% buffered formalin for 5 minutes. This mixed suture was dewatered using continuous exposure to 50%, 70%, 85% '95% and 100% alcohol for 5 minutes. The final dehydration was carried out by exposure to hexamethylene disilazane for 5 minutes. kind

This was air dried before SEM. SEM -23 for the image of bacteria - This paper scale applies to China National Standard (CNS) A4 specification (210x297 mm) 1336236 A7 I---B7 V. Description of invention (22 10 15 Ministry of Economic Affairs Intellectual Property Bureau employee consumption cooperative Print 20 is a JE〇L (Japanese Electronics and Optical Laboratory) JSM-5900LV scanning electron microscope. Figures 4 and 5 illustrate the difference between the three-air treated suture (a) or the untreated suture (b). The growth of bacteria is rarely found on the triclosan-treated suture, while the untreated sutures are evenly densely packed with the growing bacteria. The above data show that the polyglactin 910 suture containing the three gas-like coatings is resistant to golden yellow in vivo. Antimicrobial activity of Staphylococcus and Staphylococcus epidermidis. This activity can be found in many different sizes of sutures. It retains its antimicrobial activity even when exposed to buffered aqueous solutions for a prolonged period of time. Contains low wave diclosan Polyglactin 910 can still inhibit the anti-penicillin strains of Staphylococcus aureus and Staphylococcus epidermidis after 24 hours of aqueous extraction. The suture only needs to contain a low amount of three gas to be sufficient under scanning electron microscopy. According to the group, the number of bacteria on the suture was significantly reduced. These data are sufficient to prove that the p〇lyglactin 91 quilt line containing the three gas is in the production; the effect of inhibiting the growth of Staphylococcus aureus and Staphylococcus epidermidis is concluded. In addition, the covered medical device can be stably stored for a long period of time. During storage, the laminating device can maintain a sufficient content of triclosan for the desired antimicrobial effect. It can be determined by a standard accelerated aging test. The antimicrobial properties of the following articles. After the accelerated aging test, the three-air-coated coating seams showed inhibition circles against Staphylococcus aureus and Staphylococcus epidermidis. Membrane sutures can be exposed to 5 &&gt;c for the day. This exposure is sterilized in the suture through ethylene oxide and placed in a heating room.

This paper size applies to the National Standard (CNS) A4 specification (21〇 X 297 mm)

A7 Five invention description B7 5

ο 1X Ministry of Economic Affairs Intellectual Property Bureau employees consumption cooperatives printed after Ϊ such as: j for the anti-microbial color of the grape ball / 7 ^ after the exposure of the suture, from the side of the exposure can be found to fight against the golden Its confrontation. Although no concentration can be obtained as r _ under these test conditions, higher trigastric growth is known to be free of S. lactis. Important people should pay attention to the standard accelerating the old, old and non-hospital real storage conditions, which are only in the worst case of reaction. Therefore, the three-air-coated coated suture can be quite long under normal storage conditions. stability. Table 6. 2-〇 dyeing Vicry quilting line at 50 after being placed in an ethylene oxide sterilized and heated room for 3 days. (: Loss of three gas in the case of 1% in 50 ° C 2% solution 3% solution - Irgacare 1 50eC - Irgacare ^ 50 °C Irgacare -^PP.m Η - Day _ ppm Day ppm 0 200 0 — 295 0 333 3 127 3 216 0 266 3 132 3 235 0 291 3 156 3 230 0 291 11 94 11 163 11 227 11 — 91 11 163 11 213 18 89 18 140 Γ 8 189 32 69 Wide 32 120 32 155 5 8 58 58 108 58 164 157 59 157 118 157 130 157 39 157 79 157 101 -25 This paper size applies to the Chinese National Standard (CNS) A4 specification (21〇χ297 public) 1336236 A7 B7 V. Description of invention (24) Table 7.2 -0 staining of Vicry quilting line after 157 days of exposure to 50 ° C. Three-gas film concentration (%) on the suture. Three gas generation (ppm) on the suture Storage condition / sterilization cycle inhibition ring (with/without) Staphylococcus aureus 丨N. lactis | epidermis ί S. coli 24 hours 48 hours 24 hours 48 hours 24 hours 48 hours no no no no no nos. 1.0 39 50. The next 157 days / N cycle with or without 2.0 79 There are 157 days/N cycles under 50 〇C. There are 3.0 101 at 50 °C/157 cycles/N cycles. 0 59 157 days/N cycle at 50 °C with or without 2.0 118 50 〇C under 157 days/N cycle with or without 3.0 130 50 ° C under 157 days / N cycle with or without the Ministry of Economic Affairs The Intellectual Property Bureau employee consumption cooperative printed this paper scale applies the Chinese National Standard (CNS) A4 specification (210x297 mm)

Claims (1)

1336236 耕)/: ;A8 B8 C8 ”D8 Patent Application Patent Application No. 95274417 ROC Patent Appln, No. 95127417 Revised Patent Application Scope Text-Annex (II) Amended Claims in Chinese - Enel. II (Submitted on March 6, 2009) 1. An antimicrobial suture combination comprising: a sealed chamber having one or more surfaces on which an antimicrobial agent is placed, the antimicrobial agent being selected from the group consisting of halogenated hydroxy ethers And a combination of decyloxydiphenyl ether, and a combination thereof, in an amount sufficient to substantially inhibit growth of the fine bacteria on the sealed chamber; and a suture disposed within the sealed cavity, the suture comprising an antimicrobial agent disposed thereon The one or more surfaces are selected from the group consisting of halogenated hydroxy ethers, nonoxydiphenyl ethers, and combinations thereof in an amount sufficient to substantially inhibit the growth of bacteria on the suture. 10 2. The combination of sutures of claim 1 wherein the suture has a polymeric film comprising an antimicrobial agent. 3. The suture combination of claim 2, wherein the suture is formed from a plurality of polymeric fibers. 4. For the suture combination of claim 1 of the patent scope, wherein the suture is a fifteen single fiber suture. 5. The combination of sutures of claim 3, wherein the plurality of fibers form a woven construction. Printing by the Intellectual Property Office of the Ministry of Economic Affairs, Employees' Cooperatives 6. In the case of the suture combination of claim 5, the majority of the fibers are formed by absorbable materials under physiological conditions. 20 7. The suture combination of claim 6 of the patent scope further comprising a needle. B. The suture combination of claim 1, wherein the sealing cavity further comprises a winding groove or a fixing element for fixing the suture. 9. For the suture combination of Article 8 of the patent application, which is further included in -27 - This paper scale applies the Chinese National Standard (CNS) A4 specification (210 X297 mm) J:\menu\pending-92\92511 -doc. doc 1336236 A8 B8 C8 D8 6. A paper or plastic covering on a winding groove or fixing element of the patent application, wherein the covering has one or more surfaces on which the antimicrobial agent is placed, the antimicrobial agent It is selected from the group consisting of a hydroxylated ether, a nonoxydiphenyl ether, and a combination thereof in an amount sufficient to substantially inhibit the growth of bacteria on the cover. 10. A packaged suture having antimicrobial properties, comprising: an inner surface having an outer packaging having an antimicrobial agent disposed thereon, the antimicrobial agent being selected from the group consisting of halogenated hydroxy ethers, decyloxydiphenyl ethers And combinations thereof, in an amount sufficient to substantially inhibit growth of bacteria on the inner surface 10 of the outer package; and a suture combination comprising: a sealed cavity having one or more surfaces on which an antimicrobial agent is placed, the resistance The microbial agent is selected from the group consisting of ifiylated hydroxy ethers, decyloxydiphenyl ethers, and combinations thereof, in an amount sufficient to substantially inhibit the growth of fine bacteria on the sealed cavity; and printed by the Ministry of Economic Affairs, Intellectual Property Office, Staff Consumer Cooperative a suture disposed within the sealed cavity, the suture comprising one or more surfaces having an antimicrobial agent disposed thereon, the antimicrobial agent being selected from the group consisting of halogenated hydroxy ethers, nonoxydiphenyl ethers, and The combination is in an amount sufficient to substantially inhibit the growth of bacteria on the suture. 20 11. An antimicrobial suture combination comprising: one or more surfaces having between about 5 ppm and 5,000 ppm of 2,4,4'-trichloro-2'-hydroxydiphenyl ether disposed thereon a sealed chamber that substantially inhibits the growth of bacteria on the sealed chamber; and an elongated braided suture placed within the sealed cavity, the elongated braided suture -28 - the paper size applies to the Chinese National Standard (CNS) A4 specification (210x297) PCT) 1336236 VI. Patent Application A8 B8 C8 D8 10 15 Ministry of Economic Affairs Intellectual Property Office Staff Consumer Cooperative Printed 20 Formed and included on a majority of fibers containing more than about 70% polyglycolic acid polymeric material Having one or more surfaces of a film comprising a film-forming absorbable polymer, a substantially water-insoluble fatty acid salt, and at about 30 ppm and 5, 〇〇〇ppm substantially inhibiting the woven seam 2,4,4'-tris-2'-mono-diphenyl hydrazine on the growth of bacteria on the line. 12. A packaged antimicrobial suture prepared according to the following steps: providing a sealed cavity substantially free of antimicrobial agent; placing the suture in a sealed cavity, the suture comprising a layer having an antimicrobial agent disposed thereon Or a plurality of surfaces, the antimicrobial agent being selected from the group consisting of: a phthalic acid-containing diphenyl ether, and a combination thereof; the sealing chamber containing the suture is placed in an outer package; and the outer packaging is made The time, temperature and pressure conditions of the sealed chamber and the suture are sufficient to vaporize an effective amount of the antimicrobial agent from the suture to the sealed chamber while retaining an effective amount of the antimicrobial agent on the suture, thereby substantially inhibiting the suture And the growth of bacteria on the sealed cavity. A method of making a packaged antimicrobial suture comprising the steps of: providing a sealed cavity substantially free of antimicrobial agent; placing a suture in a sealed cavity, the suture comprising an antimicrobial agent disposed thereon The one or more surfaces, the antimicrobial agent is selected from the group consisting of a halogenated test, a decyl diphenyl ether, and combinations thereof; the sealed cavity containing the suture is placed in an outer package; Time, temperature and pressure of outer packaging, sealing cavity and suture 13. -29 - This paper size is applicable to Chinese national standard. Your specifications are 2 〇χ 〇χ 297 public) 1336236 A8 B8 C8 6. The scope of patent application is sufficient for sewing gas. An effective amount of the antimicrobial agent is delivered to the sealed chamber' while retaining an effective amount of the antimicrobial agent on the strand, thereby substantially inhibiting the growth of bacteria on the suture and the sealed cavity. 14. A method of preparing a packaged antimicrobial suture 5 according to claim 13 wherein the antimicrobial agent is vaporized to deliver an effective amount of the antimicrobial agent to the sealed chamber during the sterilization of the ethylene oxide. 15. The method of preparing a packaged antimicrobial suture according to claim 13 wherein the step of allowing the outer package, the sealing cavity and the suture to be sufficiently vaporized to deliver an effective amount of the antimicrobial agent comprises: 10 having a sealed cavity The outer packaging and the suture therein are placed in the sterilization device; the sterilization device is heated to the first temperature; the pressure in the sterilization device is adjusted to the first pressure value; the preparation is injected into the pain-relieving device to make the outer packaging and seal The cavity and the slit 15 are exposed to water vapor during the first phase; the pressure in the sterilization device is adjusted to the second pressure value; the chemical fungicide is introduced into the sterilization device; the Ministry of Economic Affairs Intellectual Property Bureau employee consumption cooperative prints the sterilization The chemical sterilant in the equipment maintains a second stage of time to produce an amount sufficient to kill bacteria in the package; 20 remove residual moisture and chemical sterilant from the suture; and dry the packaged antimicrobial suture to the desired humidity . 16. The method of preparing a packaged anti-staple suture according to the scope of claim 15 wherein the step of introducing a chemical bactericide comprises introducing ethylene epoxide into the sterilizing apparatus. -30 - This paper size applies to China National Standard (CNS) A4 specification (210 X 297 public) 1336236 A8 B8 C8 D8 VI. Patent application scope 17. A wide range of packaged medical devices with antimicrobial properties, including: At least one completely sealed package having an antimicrobial agent disposed on an inner surface thereof, the antimicrobial agent being selected from the group consisting of a toothed hydroxy ether, a decyloxydiphenyl ether, and combinations thereof, in an amount sufficient to substantially inhibit the package 5 the growth of the bacteria; and at least one implantable medical device placed in the at least one fully sealed package, the medical device having one or more surfaces on which the antimicrobial agent is placed, the antimicrobial agent being selected Self-containing halogenated hydroxy ethers, decyloxydiphenyl ethers, and combinations thereof, in an amount sufficient to substantially inhibit the growth of bacteria on the medical device. 18. The packaged medical device of claim 17, wherein the medical device has a polymeric film comprising an antimicrobial agent. 19. The packaged medical device of claim 18, wherein the medical device is formed from a plurality of fibers. 15 20, The packaged medical device of claim 19, wherein the medical device formed from the plurality of fibers is a braided suture. 21. The packaged medical device of claim 20, wherein the 1⁄4 woven thread is a suture that is absorbable under physiological conditions. Printed by the Ministry of Economic Affairs, Intellectual Property Office, Staff Consumer Cooperatives 22. For a packaged medical device of the '17th patent application scope, the 20 device is a single fiber suture. 23. The packaged medical device of claim 22, wherein the single fiber suture is formed from a polymeric material that is absorbable under physiological conditions. 24. For the packaged medical device of claim 17 of the patent scope, the -31 - paper scale applies to the Chinese National Standard (CNS) A4 specification (210x297 mm) 1336236 A8 B8 C8 D8 VI. The patented medical device is It is selected from the group consisting of surgical mesh and membrane, hernia plug, brachy seed spacer and surgical suture. 25. A packaged medical device having antimicrobial properties, comprising: 5 at least one package having an antimicrobial agent disposed on an inner surface thereof, the antimicrobial agent being selected from the group consisting of halogenated hydroxy ethers, decyloxydiphenyl ethers And a combination thereof in an amount sufficient to substantially inhibit growth of bacteria on the package; and at least one implantable medical device disposed within the at least one package, the medical device being selected from the group consisting of sutures, surgery a mesh, a hernia plug, a close seed septum, a suture clip, a suture anchor, a release screen and a film, and a group of sewn clips; and the medical device has one or more antimicrobial agents placed thereon The antimicrobial agent is selected from the group consisting of a hydroxylated ether, a nonoxydiphenyl ether, and combinations thereof, 15 in an amount sufficient to substantially inhibit the growth of bacteria on the medical device. 26. The packaged medical device of claim 25, wherein the medical device is selected from the group consisting of a surgical mesh and a membrane, a hernia plug, a proximal seed septum, and a surgical stapling clip. Printed medical device prepared according to the following steps: 20 A packaged medical device whose inner surface is substantially free of antimicrobial agent; a medical device placed in the package, the medical device The device comprises one or more surfaces having an antimicrobial agent disposed thereon, the antimicrobial agent being selected from the group consisting of halogenated hydroxy ethers, decyloxydiphenyl ethers, and combinations thereof; and -32 - the paper size is applicable to China National Standard (CNS) A4 Specification (210x297 mm) D8 t, the scope of patent application is such that the time, temperature and pressure conditions of the package and medical device are sufficient to vaporize an effective amount of antimicrobial agent from the medical device to the inner surface of the package, An effective amount of the antimicrobial agent is retained on the medical device and the inner surface of the package, thereby substantially inhibiting the growth of bacteria on the surface of the medical device and the interior of the package 5. 28. A method of making a packaged medical device comprising the steps of: providing a package having an inner surface substantially free of antimicrobial agent; placing the medical device in a package, the medical device comprising 10 antimicrobial agent The one or more surfaces disposed thereon, the antimicrobial agent being selected from the group consisting of a toothed hydroxy ether, a decyl diphenyl ether, and combinations thereof; and time, temperature, and pressure conditions of the package and medical device Sufficient to vaporize an effective amount of the antimicrobial agent from the medical device to the surface of the package 15 while retaining an effective amount of the antimicrobial agent on the medical device, thereby substantially inhibiting the growth of bacteria on the medical device and the inner surface of the package. This paper size applies to the Chinese National Standard (CNS) A4 specification (210x297 mm)