Antimicrobial sterile container

DE102014215353B4Inactive Publication Date: 2025-03-06AESCULAP AG
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Patent Information

Application Number
DE102014215353
Authority / Receiving Office
DE · DE
Patent Type
Patents
Current Assignee / Owner
Filing Date
2014-08-04
Publication Date
2025-03-06
Estimated Expiration
Not applicable · inactive patent

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Abstract

Sterile container (1) for medical purposes with a lower part (3) and a lid part (2) which can be sealed onto it, characterized in that the sterile container (1) has at least one antimicrobial agent, wherein the outer surface of the sterile container (1) has the at least one antimicrobial agent, wherein the lower part (3) and / or lid part (2) has a material which is selected from the group consisting of aluminium, aluminium alloys, anodised and combinations thereof, the sterile container (1) furthermore has an alkali-resistant coating (4) in which at least one antimicrobial agent is contained, the coating (4) having a proportion of the at least one antimicrobial agent of 0.001 wt.% to 0.1 wt.%.- % based on the total weight of the coating (4), and at least one antimicrobial agent is a metal or metal alloy selected from the group consisting of platinum, iridium, gold, silver, mercury, copper, zinc and alloys thereof.
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Description

Area of ​​application and state of the art

[0001] The invention relates to a sterile container for medical purposes.

[0002] Sterile containers of this type are known, for example, from the applicant's publications DE 1 972 38 57 A1, EP 1 140 221 B1, and WO 99 / 30630 A1. Such containers are used in everyday clinical practice primarily for the sterile storage, transport, and provision of surgical instruments and surgical implants.

[0003] Sterile containers made of polyphenylene sulfone (PPSU) and with a compartment with antimicrobial effect are also known (http: / / www.kometdental.de / fileadmin / user_upload / pdfs / pdf_pis / 405051V0_0410_D_Angle-Modulation.pdf).

[0004] Furthermore, a sterile container system with a germ barrier is known. Due to its geometry, this creates different flow velocities, thus separating the air flow from the germs. While filtered air enters the interior of the container, germs are retained. Antimicrobially treated medical devices such as implants and medical instruments are known from DE 10 2005 044 361 A1, DE 103 23 597 A1, and DE 10 2007 012 253 A1.

[0005] A container for holding a liquid, the inside of the container having at least partially a biocidal coating, is known from DE 10 2012 202 861 A1.

[0006] EP 0 677 989 B1 relates to an antimicrobial coating and an antimicrobially shaped polymer article which can be designed, inter alia, as a container.

[0007] Antiseptically coated medical devices are known from WO 02 / 082907 A1.

[0008] Furthermore, a composite coating made of a polymer and aluminum oxide, which is characterized, among other things, by corrosion resistance, is known (http: / / www.webarchive.org on 21.06.2008).

[0009] Furthermore, the production of anodic aluminum oxide for corrosion protection is known, which partially has a crystalline structure (JM RUNGE; M. SUNG: A technology for corrosion protection - In: Aluminium International Today-Vol. 23, 2011, No. 6, pp. 23-26).

[0010] US 5,730,530 A discloses a container which can be impregnated with a disinfectant substance in the case of storing medical instruments.

[0011] After cleaning, the sterile containers and their contents are usually sterilized using hot steam. A problem is that the sterile containers are often not used immediately after sterilization, which creates the risk of recontamination with pathogens, especially on the outer surface of the container. Task and solution

[0012] The present invention was therefore based on the object of providing a sterile container which prevents the spread of germs, in particular of resistant germs, or at least significantly reduces the risk of germ spread.

[0013] This object is achieved by a sterile container having the features of independent claim 1. A preferred embodiment of the sterile container is defined in dependent claim 2. The wording of all claims is hereby incorporated into the present description by express reference.

[0014] The invention proposes a sterile container for medical purposes, in particular for the storage, transport and / or provision of surgical instruments, operating room instruments (surgical instruments) and / or surgical implants.

[0015] The sterile container has a base and a lid. The lid fits tightly onto the base.

[0016] Compared to generic sterile containers, the sterile container according to the invention is particularly distinguished by the fact that it contains at least one antimicrobial active ingredient.

[0017] In other words, the invention proposes a sterile container that is antimicrobially equipped, i.e. one that has at least one antimicrobial active ingredient added to it.

[0018] For the purposes of the present invention, an antimicrobial agent is understood to mean an agent that reduces the replication capacity or infectivity of pathogens, in particular germs, i.e., harmful microorganisms such as bacteria, fungi, and / or viruses, or kills or inactivates them. According to this definition, the at least one antimicrobial agent can comprise, for example, an antiseptic, anti-infective, and / or disinfectant, which will be discussed in more detail below.

[0019] For the purposes of the present invention, the term "at least one antimicrobial agent" can define one type of antimicrobial agent or a plurality of different types of antimicrobial agents, particularly in the form of a mixture. Suitable types of agents will be discussed in more detail below.

[0020] The at least one antimicrobial agent particularly advantageously hinders or prevents pathogen contamination of the sterile container and preferably of the sterile container contents, particularly after opening the container, for example, in the operating room. This, in turn, hinders or prevents the spread of germs, especially hospital-acquired germs, and in particular the occurrence of nosocomial infections.

[0021] The bottom and / or cover part comprises or is formed from a material selected from the group consisting of aluminum, aluminum alloys, anodizing, and combinations thereof.

[0022] The outer surface of the sterile container, in particular the bottom and / or lid part, has at least one antimicrobial active ingredient.

[0023] For example, only the outer surface of the sterile container, in particular the bottom and / or lid part, can contain the at least one antimicrobial agent. This embodiment has the advantage that it requires smaller amounts of the at least one antimicrobial agent while still achieving the desired antimicrobial effect. This advantage is greater the more expensive the at least one antimicrobial agent is.

[0024] The sterile container, in particular the bottom and / or lid part, also has a coating.

[0025] From a corrosion perspective, it may be advantageous for the coating to be alkali-resistant, such as a silicate-containing coating. Such a coating is particularly advantageous if the sterile container, in particular the base and / or lid, is made at least partially of aluminum and alkaline treatment of the sterile container, in particular the base and / or lid, is desired.

[0026] The at least one antimicrobial active ingredient is contained in the coating. The coating has a proportion of the at least one antimicrobial active ingredient of 0.001 wt.% to 0.1 wt.%, based on the total weight of the coating.

[0027] In a further embodiment, the coating has a layer thickness of 1 µm to 50 µm, in particular 1 µm to 10 µm, preferably 4 µm to 10 µm.

[0028] The coating described in the previous embodiment can cover the outer surface of the sterile container, in particular the bottom and / or lid part, in principle partially, in particular only partially, or completely, ie over the entire surface or continuously.

[0029] Furthermore, it can be provided according to the invention that the at least one antimicrobial active ingredient is present in particulate form, ie in the form of particles, in particular with a diameter of 1 µm to 100 µm, preferably of 1 µm to 10 µm or of 10 µm to 100 µm.

[0030] The at least one antimicrobial agent is a metal or metal alloy selected from the group consisting of platinum, iridium, gold, silver, mercury, copper, zinc, and alloys thereof. Silver is particularly preferred.

[0031] Further features and advantages of the invention will become apparent from the following description of preferred embodiments in the form of a figure, along with a corresponding description of the figure, an exemplary embodiment, and the subclaims. Individual features can be implemented individually or in combination with one another. The preferred embodiments serve merely to further explain and improve understanding of the invention, without limiting it thereto. Figure description The Fig.Figure 1 schematically shows a sterile container 1 according to the invention. The sterile container 1 has a lower part 3 and a lid part 2. The lid part 2 can be placed sealingly onto the lower part 3.

[0032] The sterile container 1 is made of aluminum and has a silicate-containing coating 4 on its outer surface to enable alkaline treatment of the sterile container 1.

[0033] To prevent contamination of the sterile container 1 and its contents with pathogens, the coating 4 contains an antimicrobial agent, such as silver. Example 1. Production of a sterile container by powder coating and subsequent silver coating (not according to the invention)

[0034] For pretreatment, a stainless steel sterile container, consisting of a base and a lid, was sandblasted to remove oil, grease, and contaminants. The sandblasting pretreatment also roughened the surface of the sterile container, facilitating subsequent powder coating with polyetheretherketone (PEEK).

[0035] In preparation for powder coating, the sterile container was preheated to a temperature above the melting point of polyetheretherketone for a period of several minutes.

[0036] The base and lid of the preheated sterile container were then exposed to a fluidized polyetheretherketone powder for a period of a few seconds. The polyetheretherketone particles melted onto the surfaces of the base and lid. After cooling, the base and lid exhibited a uniform coating of polyetheretherketone on their outer and inner surfaces.

[0037] The powder-coated parts of the sterile container were then transferred to a vacuum chamber for ion beam-assisted deposition (IBAD). There, the sterile container parts were vapor-deposited with silver while simultaneously bombarded with argon ions. The coating process continued until the outer and inner surfaces of the sterile container parts had a silver layer approximately 0.1 µm thick. 2. Production of a sterile container by powder coating and subsequent silver doping (not according to the invention)

[0038] For pretreatment, a stainless steel sterile container, consisting of a base and a lid, was sandblasted to remove oil, grease, and contaminants. The sandblasting pretreatment also roughened the surface of the sterile container, facilitating subsequent powder coating with polyetheretherketone (PEEK).

[0039] In preparation for powder coating, the sterile container was preheated to a temperature above the melting point of polyetheretherketone for a period of several minutes.

[0040] The base and lid of the preheated sterile container were then exposed to a fluidized polyetheretherketone powder for a period of a few seconds. The polyetheretherketone particles melted onto the surfaces of the base and lid. After cooling, the base and lid exhibited a uniform coating of polyetheretherketone on their outer and inner surfaces.

[0041] The powder-coated parts of the sterile container were then transferred to a suitable implantation system for ion implantation. There, silver ions were generated and implanted into the powder-coated sterile container parts. After the ion implantation, the sterile containers were doped with silver. 3. Production of a sterile container using antimicrobial powder coating (not according to the invention)

[0042] For pretreatment, a stainless steel sterile container, consisting of a base and a lid, was sandblasted to remove oil, grease, and contaminants. The sandblasting pretreatment also roughened the surface of the sterile container, facilitating subsequent powder coating. The powder coating was applied using polyetheretherketone (PEEK) with silver particles added.

[0043] In preparation for powder coating, the sterile container was preheated to a temperature above the melting point of polyetheretherketone for a period of several minutes.

[0044] The base and lid of the preheated sterile container were then exposed to a fluidized polyetheretherketone powder for a period of a few seconds. The silver-added polyetheretherketone particles melted onto the surfaces of the base and lid. After cooling, the base and lid exhibited a uniform coating of silver-added polyetheretherketone on their outer and inner surfaces.

Claims

[1] Sterile container (1) for medical purposes with a lower part (3) and a lid part (2) which can be placed on the lower part in a sealing manner, characterized bythat the sterile container (1) has at least one antimicrobial active ingredient, wherein the outer surface of the sterile container (1) has the at least one antimicrobial active ingredient, wherein the lower part (3) and / or lid part (2) has a material which is selected from the group consisting of aluminum, aluminum alloys, anodizing and combinations thereof, the sterile container (1) further has an alkali-resistant coating (4), the at least one antimicrobial active ingredient is contained in the coating (4), the coating (4) has a proportion of the at least one antimicrobial active ingredient of 0.001 wt.% to 0.1 wt.%, based on the total weight of the coating (4), and the at least one antimicrobial active ingredient is a metal or a metal alloy selected from the group consisting of platinum, iridium, gold, silver, mercury, copper, zinc and alloys thereof. [2] Sterile container (1) according to claim 1, characterized by that only the outer surface of the sterile container (1) has the at least one antimicrobial active ingredient.

Citation Information

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