Classifications

• • 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/26—Accessories or devices or components used for biocidal treatment
• • 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/04—Heat
  • A61L2/06—Hot gas
• • 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/04—Heat
  • A61L2/06—Hot gas
  • A61L2/07—Steam
• • 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
  • A61L2/14—Plasma, i.e. ionised gases
• • 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/20—Gaseous substances, e.g. vapours
  • A61L2/204—Formaldehyde
• • 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
  • A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
  • A61L2/16—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using chemical substances
  • A61L2/20—Gaseous substances, e.g. vapours
  • A61L2/206—Ethylene oxide
• • 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
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/10—Apparatus features
  • A61L2202/12—Apparatus for isolating biocidal substances from the environment
  • A61L2202/122—Chambers for sterilisation
• • 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
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/10—Apparatus features
  • A61L2202/15—Biocide distribution means, e.g. nozzles, pumps, manifolds, fans, baffles, sprayers
• • 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
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/10—Apparatus features
  • A61L2202/18—Aseptic storing means
  • A61L2202/181—Flexible packaging means, e.g. permeable membranes, paper
• • 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
  • A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
  • A61L2202/20—Targets to be treated
  • A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps

Definitions

• the invention relates to the sterilization of medical and other equipment.
• the subject matter of the invention is a sterilization package, a sterilization filter, the use thereof and a sterilization method.
• n fe t i ' or.s ⁇ is essenially,-- important- in medical procedures, and this substantially includes the pre-use sterilization of the instruments to be used.
• the sterilization must be carried out in a reliable manner and the instruments that have undergone the sterilization process must be easily distinguishable.
• the process should be cost-effective and the storage of the sterilized instruments easily arrangeable.
• the instruments to be sterilized mus-t be enclosed-. in sterilization packages. Their purpose is to let through a sterilization agent during sterilization as well as to maintain the sterility of the instrument until Use.
• the terili ation- a kages should be able to protect the instrument to be steri- ⁇ lized from mechanical damages, allow the visual inspection of the instrument without opening the- package and be easily handleable in different stages of the instrument maintenance process.
• Steriliza ⁇ tion wraps are made of a non-transparent fiber material which is wrapped directly around the instrument to be sterilized, or the instrument is first enclosed in a protective case and then enclosed in the wrap.
• Sterilization bags are made of paper or other fiber mate- rial on one side and of a transparent plastic film (e.g. Tyvek®) on the other side.
• the instruments are placed in the bag as such or as packed in a protective case, and the bag is then closed by heat sealing.
• large or vulnerable instruments can alternatively be packed using durable aluminum containers, the lid (and optionally the bottom) of which has one or more openings, the purpose of which is to let through a sterilization agent and which can be covered with a sterilization filter.
• EP 0513614 Al and' US -5372787 disclose durable sterilization packages having a lid and- openings covered with a sterilization.- ' filter on the sides .
• Publication WO 2010/073152 A2 discloses- a disposable container for sterilization of medical instruments with a lid that is fastened with a lock mechanism and that is provided with a sterilization filter. Also publication US 2012/0189508 Al discloses a similar disposable sterilization container, the lid of which is fastened to the container with a lock mechanism and has an opening to be covered with a sterilization filter.
• the known sterilization packages for medical instruments have, for instance, the following problems: Disposable sterilization wraps and bags are easily torn during handling and especially sharp instruments may puncture them, in which case the instruments must be re-sterilized. This increases the instrument maintenance workload and costs. In addition, the packages do not protect the instruments much against blows during the treatment, so vulnerable instruments may be damaged if dropped or hit- on something. In addition, the shape of the sterilization wraps and bags varies as to their content, so they occupy a great deal of space when stacked for storage, and the above"- mentioned risk of damage is also increased. Some of these problems may be alleviated by first enclosing the instruments in a durable plastic package.
• a problem that is common to all the above-mentioned sterilization packages is also the ineffective utilization of the sterilization " capacity.
• the -packages must be placed in the sterilization device in siich a way that the sterilization agent has access into each package. This prevents the effective stacking of the packages or their placement closely side by side, thus reducing the capacity of the ' steri- lization device and increasing the number of the ster ⁇ ilization runs required.
• the objective of the invention is to disclose a novel sterilization package that enhances the steri ⁇ lization and protects the product to be sterilized.
• the objective of the invention is to solve at least one of the above-mentioned problems.
• the sterilization package according to the invention is characterized by the features presented in claim 1.
• the sterilization method according :to. the in- vention is characterized by the features presented in claim 13.
• the sterilization package according to the invention is shaped substantially as a polyhedron and at least two sides of the sterilization package have an opening which can be covered with a ⁇ sterilization filter that is permeable to a sterilization agent.
• the polyhedron is a regular or irregular polyhedron that omprises at least 4 sides.
• the sterilization package is substantially a hexahedron.
• all sides of the sterilization package have an opening which can be covered with a sterilization filter that is permea- ble to a sterilization agent.
• the openings of the sterilization package and the ' sterilization filter that covers them may be of any shape.
• the opening and the filter are polygonal, such as rectangular quadrilaterals or squares, or substantially circular or elliptical. More than one opening may be provided on each side, in which case they can be closed with one or more steri ⁇ lization filters.
• the sterilization filter is larger than the opening.
• the shape of the sterilization fil- ter may differ from that of the opening.
• the material of the sterilization package according to the invention may be any material that withstands the steri ⁇ lization conditions.
• the sterilization package is manufactured from a plastic-, pulp- and/or glass-based packaging material or their combination material.
• the plastic material may encompass thermoplastic polymer, for example poly- olefin such as polyethylene and polypropylene, polyester such as polyethylene terephthalate, .polystyrene, polyamide, or polycarbonate, polymer that contains halogen such as polyvinyl chloride or any other plastic material generally used as a packaging material and/or their mixture.
• the pulp-based material may encompass for example finished or unfinished paper, pa- perboard, dissolving pulp -based film material or other cellulose-based material. Further, the material may be formed of a laminate of the above-mentioned or oth ⁇ er known packaging materials or of another combination material. The material may also be coated.
• the sterilization package is manufactured from polypropylene, polyethylene, polystyrene, polyethylene terephthalate, polyvinyl chloride, polycarbonate or their mixtures.
• the ster- ilization package is manufactured from a substantially transparent plastic material.
• the openings of the sterilization package can be covered with a sterilization filter.
• the steriliza ⁇ tion filter comprises a filter material, which materi- al is selected from materials known in the art so as to be suitable for the sterilization device to be used and for the sterilization agent used therein.
• the filter material of the sterilization filter means herein a material that is permeable to the sterilization agent but not to bacteria, their spores, viruses or other pathogens.
• the material may encompass thermoplastic polymer fiber such as polyolefin or polyester.
• the material is a nonwoven fabric material, such as spinbound polyolefin, for example polypropylene or high-density polyethylene (HDPE) , or polyester.
• the sterilization package is manufactured from a single piece of material except for one side, and said one side is closed in connection with the use of the sterilization package.
• the sterilization package according to the invention may be manufactured by methods known in the art for example by leaving one side of the polyhedron open, and the other sides form a trough.
• the open side may be covered with a plastic film which can be air- tightly fastened to the edges of the trough for example by glue, heat sealing or another method suitable for fastening a film.
• the open side may also be closed with a lid having a glue or lock mechanism to ensure airtightness and prevent accidental opening of the package.
• the film or lid for closing may have an opening which can be covered with a sterilization filter that is permeable to a sterilization agent.
• the trough, plastic film and lid may be manufactured from the same or different materials.
• the open side may also be entirely covered with a sterilization filter.
• the sterilization filter may be fastened to the sterilization package for example by gluing, heat sealing or another method known in the art in such a way that air is only able to flow into the package through the sterilization filter.
• the side of the sterilization package to be closed in connection with the use is an airtightly closable plastic film.
• the side of the sterilization package to be closed in connection with the use is an airtightly closable lid.
• the side of the sterilization package to be closed in connec- tion with the use is a sterilization filter that is permeable to a sterilization agent.
• the sterilization filter with which the openings of the steri- lization package are covered is larger than the . open- ing to be covered and it is fastened to the steriliza ⁇ tion package by means of a glue line that substantially follows the contours of the opening to be covered, heat sealing, pressure or other such fastening method that provides a tight seam.
• the sterilization filter comprises a filter material encircled with a layer of glue.
• the sterilization filter is used in the sterilization package according to the invention.
• the sterilization filter may be fastened by any generally used fastening method such as a glue or heat sealing method.
• the size difference between the opening to be covered and the sterilization filter may vary. The larger the sterilization filter is relative to the opening, the easier and quicker it is to be fastened over the opening, but material is spent to a greater degree.
• glue is used for closing, it may be ready on the package or on the sterilization filter to be fastened.
• the glue surface may be covered with a film that protects the glue surface before fastening and can be removed just before covering the Opening with the sterilization filter.
• the sterilization filters may also be fastened during the manufacture of the packages, in which case the packages are ready for Use when delivered to the users.
• the sterilization filter may be fastened on the external or the internal surface of the sterilization package.
• the sterilization package according to the invention is designed for use in a variety of sterilization devices that use high temperatures (the so-called dry heat sterilization) , water vapor, a chemical substance (e.g. ethylene oxide) or gas plasma or another such sterilizing agent.
• the sterilizing agent has access into the package through the openings on at least two sides of the package.
• the openings also allow the movement of the sterilization agent between sterilization packages disposed against one another. If openings are provided on all sides of the sterili- zation package in the form of a hexahedron, the packages can be stacked into towers disposed closely against one another.
• the sterilization agent is able to flow into all sterilization packages irrespective of their position.
• the sterilization package according to the invention is used in steam sterilization, hot air sterilization, low temperature hydrogen peroxide sterilization, hydrogen peroxide plasma sterilization, ethylene oxide sterilization, ionizing radiation sterilization and/or steam/formaldehyde sterilization.
• the size of the openings of the sterilization packages may be selected over a wide range.
• the most important factors that have an effect on the size are sufficiently fast movement of the sterilization gas into the sterilization package and easy placement of adjoining sterilization packages side by side with sufficient accuracy (the larger the opening, the less attention must be paid to the alignment of the openings.)
• the robustness of the package is of importance because a smaller opening reinforces the sterilization package.
• the openings in the sterilization package which can be covered with the sterilization filter that is permeable to the sterilization agent make up approximately 5-95 % of the surface area of a side, preferably approximately 10-70 %, most preferably 20-60 %.
• At least one of the openings in the sterilization package which can be covered with the sterilization filter that is permeable to the sterilization agent makes up 100 % of the surface area of a side.
• one of the sides entirely consists of the sterilization filter.
• the bottom and the lid or two of the sides of the sterilization filter are entirely made of the sterilization filter materi- al .
• the size and proportions of the package have an essential effect on the solution in each case. Medical instruments come in a variety of sizes and shapes, which is why the ster 11 ization packages may also differ in size and proportions.
• the dimensions of the sterilization package are at least approximately 50 mm x 30 mm ⁇ 10 mm and at most approximately 800 mm ⁇ 600 mm x 400 mm.
• the sterilization package may contain one or more holders for the instrument to be sterilized to reduce or prevent the movement of the instrument to be sterilized in the sterilization package.
• the holder may be shaped from the same piece during the manufacture of the sterilization package or added from a sep ⁇ arate piece of material.
• the sterilization package may contain an indicator that indicates the effectiveness of the sterilization, such as a biological spore ampoule, or a process indicator, which indicates the exposure to sterilization conditions for example by changing color.
• the indicator may be fastened to the sterilization package by glue or by means of a holder for that purpose .
• the sterilization packages according to the invention are three-dimensionally stacked in the sterilization device so that the sterilization agent is able to access the sterilization packages through the sterilization filters and the sterilization packages are sterilized.
• the sterilization packages are closely abutting each other and the openings on the sides of the sterilization packages which can be covered with the. st.eriliza- tion filter that is permeable to the sterilization agent form an air passage between the sterilization packages .
• the sterilization method according to the invention may be steam sterilization, hot air sterili- zation, low temperature hydrogen peroxide sterilization, hydrogen peroxide plasma sterilization, ethylene oxide sterilization, ionizing radiation sterilization or steam/formaldehyde sterilization or another ⁇ suitable sterilization method.
• the use of the sterilization packages according to the invention may enhance the instrument maintenance process because the number of the sterilization runs required may be reduced as a function of the extent to which the capacity of the sterilization device can be utilized. This may reduce both energy consumption and time spent on the sterilization process.
• the extent to which it is possible to enhance the sterilization process depends on the number of sides on which the openings of the sterilization pack- age that can be covered with the sterilization filter that is permeable to the sterilization agent are provided. If the openings are provided on all sides of the sterilization package shaped substantially as a hexahedron, the packages may be stacked on top of one another and closely side by side in all directions and a three-dimensional air passage is formed between the sterilization packages. If the openings are provided on two opposed sides of the sterilization package, the sterilization packages can still be stacked and the space of the sterilization device thus be effectively utilized but the sterilization agent must go through a relatively longer distance from the outermost package to the innermost one.
• the sterilization package according to the invention enhances the throughput _P.f the_. sterilization process and thus lowers the operating costs and environmental load of the sterilization device as the required number of runs is reduced.
• the sterilization package is stackable and if an opening which can be covered with a sterilization filter that is permeable to a sterilization agent is also provided on the sides of the sterilization package, the sterilization packages may also be placed closely side by side.
• the sterilization package according to the invention speeds up working because the sterilization package as such protects vulnerable instruments and , additional packaging steps are not required to protect them.
• the sterilization package also extends the lifetime of vulnerable instruments. The process loss in sterilization is reduced as the sterilization packages are not broken and thus the instruments need not be re- sterilized.
• the sterilization packages are transparent which facilitates the inspection of the instruments before opening the package.
• the sterilization package according to the invention also re- prises the time spent on washing, maintenance and post- use processing of the sterilization packages and thus reduces the costs of the instrument maintenance pro ⁇ cess as compared to durable packages.
• the use of the storage space is enhanced as the boxes can be easily and firmly stacked on the storage shelves. In addition, it is easy to make permanent markings on the sterilization packages.
• FIGURES Fig. 1A is a schematic representation of the sterilization package according to the invention. Only the surfaces that are visible from one direction are shown in the figure . . .
• Fig. IB is a schematic representation of the sterilization package according to Fig. 1A. All surfaces of the sterilization package are shown in the figure and the invisible sides are indicated in dashed lines .
• Fig. 1C is a schematic representation of one opening of the sterilization package according to Fig. 1A and IB which can be covered with a sterilization film, with the film is disposed in its place.
• the figure is a cross section.
• Fig. ID is a schematic representation of the sterilization filter according to the invention encircled with a layer of glue for fastening the sterilization filter to the sterilization package according to the invention.
• Fig. 2 is a schematic representation of the sterilization package according to the invention. In the figure, the openings are covered with sterilization filters.
• Fig. 3A is a schematic representation of the sterilization package according to the invention. In the figure, the openings are covered with sterilization filters.
• Fig. 3B is a schematic representation of stacked sterilization packages illustrated in Fig. 3A.
• Fig. 4A is a schematic representation of the sterilization package according to the invention, wherein the sterilization package is manufactured from a single piece of material except for one side, and said one side is closed in connection with the use of the sterilization package.
• Fig. 4B is a schematic representation of the sterilization package according to Fig. 4A.
• Fig. 1A illustrates a sterilization package 1 for sterilization of medical instruments.
• the sterilization package 1 consists of six sides 2, the adjoin- ing sides 2 being perpendicular to each other.
• the material of the sides of the sterilization package 1 is packaging material that withstands the sterilization conditions, such as the temperature of above 120 °C and the pressure of steam sterilization, e.g. polypro- pylene.
• polypro- pylene e.g. polypro- pylene.
• other polyolefins, polyterephthalate or other polyester that satisfy the requirements of standards concerning the sterilization of medical devices for example SFS-EN-868) or their combination and/or mixture may be used.
• the sterilization package 1 consists of openings 3 which are provided on the sides of the sterilization package and which can be closed with sterilization filters 4 such as those illustrated in Fig. 1C and ID which can be glued with a layer of glue 5 along the edge of the openings 3 of a -side.
• the material of the sterilization filter 4 is high-density polyethylene (HDPE) such as Tyvek.
• the glue to be used is non-toxic and withstands the steri ⁇ lization conditions as well as several months of storage. The glue forms a strong seam and makes the steri- lization package 1 sealed.
• one of the sides 2 of the sterilization package 1 is hot pressed to the package with a tight seam.
• the filter material 4' of the sterilization filter 4 and the glue to be used may also be some other material or glue that sat- isfy the requirements of standards concerning the sterilization of medical devices (e.g. said SFS-EN- 868) .
• the size of an opening 3 of the sterilization package 1 Ls approximately 2.0.%. of .the. _ surface area of a side 2, but it can be smaller or larger depending on the sterilization method.
• Fig. IB illustrates holders 6 fastened to the internal surface of a side 2 of the sterilization package 1.
• the upper edge of the holders 6 can be shaped according to the shape of the instruments to be sterilized for example in a wavy manner in such a way that one or more instruments can be firmly placed in the parts of the holder 6 of the sterilization package 1 shaped according to the instrument by virtue of the shaping.
• Fig. 1C illustrates a sterilization filter 4 of the sterilization package 1 with a glue line formed by a layer of glue 5 so as to extend along the edges thereof.
• the width of the glue line is typically approximately 0.1-1 cm, but the width may be smaller or greater, for example 0.05-3 cm depending on the size of the sterilization filter 4 and the glue to be used.
• the sterilization filter 4 is placed over the openings 3 of a side 2 in such a way that the filter material 4' covers the openings 3 and the layer of glue 5 is glued along the edges of the openings on the side material, forming a tight and continuous seam that satisfies the strength requirements.
• Fig. ID is a top view of the sterilization filter 4.
• the figure illustrates the continuous glue line formed by a layer of glue 5, on the inside of which an opening 3 of the sterilization package 1 is provided .
• Fig. 2. optionally illustraterates a . sterilization, package 1 for sterilization of medical instruments.
• the sterilization package 1 consists of six sides 2, the adjoining sides 2 being perpendicular to each other. Further, the sterilization package 1 consists of three openings 3 on each of the four long sides 2 and, re- spectively, of a total of four sterilization filters 4.
• the openings on two short sides of the sterilization package may be similar or for example as those illustrated in Fig. 1. They are not shown in the figure for clarity purposes.
• the sterilization filters 4 are placed over the openings 3 of the sides 2 so that the filter material 4' covers the openings 3 and a layer of glue 5 is glued along the edges of the openings 3 on the side material, forming a tight continuous seam.
• the opening structure according to ' Fig. 2 makes the sterilization package 1 permeable to the sterilization agent and the structure of the sterilization package 1 strong, so the sterilization packages 1 withstand the stacking well.
• the material of the sterilization package 1, the filter material 4' of the sterilization filter 4 and the glue to be used encompass packaging material and glue which satisfy the re ⁇ quirements of standards concerning the sterilization of medical devices.
• Fig. 3A illustrates a sterilization package 1 shaped as a regular hexahedron, of which each of the six sides 2 has an opening 3 covered with a steriliza ⁇ tion filter 4.
• the sterilization filters 4 are glued or heat sealed on the sides 2 over the openings 3.
• the size of an opening 3 of the sterilization package 1 is approximately 50 % of the surface area of a side.
• the sterilization packages 1 are three- dimensionally stacked in the sterilization device in such a way that the vertical sides.2.. of the .steriliza- tion packages 1 closely abut each other and the openings 3 covered with sterilization filters 4 on the sides 2 are disposed opposite each other and form between the sterilization packages 1 an air passage through which the sterilization agent, for example ethylene oxide, is able to access all sterilization packages 1 and sterilizes the sterilization packages 1 and their content (Fig. 3B) .
• the sterilization agent for example ethylene oxide
• Sterilization packages may also be stacked in the sterilization de ⁇ vice with different-sized sides against each other. In this case, it should be ensured that the openings 3 covered with the sterilization filter 4 are provided against each other in such a way that they form an air passage that carries the sterilization agent to all sterilization packages 1.
• Fig. 4A illustrates a sterilization package 1 according to the invention consisting of a trough 7 manufactured from a single piece of plastic and of a plastic film 8 to be fastened thereto by heat sealing.
• the trough 7 is formed by five sides 2, four of which are slightly outwardly oriented but may also be sub ⁇ stantially perpendicular to the fifth side 2 and to each other.
• An edge 9 of the trough manufactured as part of the trough is provided on the upper rim of the trough 7 for fastening the plastic film 8 thereto by heat sealing.
• the trough 7 and the plastic film 8 have openings 3 covered with sterilization filters 4.
• Fig. 4B illustrates a sterilization package 1 according to the invention wherein the plastic film 8 is fastened to the trough 7 by heat sealing.
• the trough 7 and the plastic film 8 form substantially a hexahedron in which the surface area of the side 2 covered with .the plastic film.8 is. larger than that of the opposite side 2 that forms the bottom and the other sides 2 are not perpendicular to the side 2 that forms the bottom.
• the airtight seam 10 formed by heat sealing is illustrated on the edge 9 of the trough 7.
• EXAMPLE 1 - A sterilization package for sterilization of an endoscopic surgery optics device. The instrument is vulnerable to blows e.g. as it contains optical lenses.
• the length of the optical instrument is approximately 20 cm, so the sterilization package is manufactured to have a length of 25-30 cm, a width of 5-10 cm and a height of 5-10 cm.
• the optics is disposed as centrally as possible in the package.
• the sterilization package is manufactured from polypropylene and the instrument stays in place by virtue of- the shaped holders of the sterilization package and is not subject to immediate blows on the edges of the box.
• the device may be sterilized by steam or low temperature sterilization (such as hydrogen peroxide) or ethylene oxide.
• the sterilization package is manufactured from a single cast piece of plastic shaped as a hexa ⁇ hedron with rounded edges. One large side is left open and the sides of the sterilization package adjacent to this side are outwardly bent so as to provide for ex- ample an approximately 10 mm wide edge around the side in parallel to the open side.
• the optical instru ⁇ ment is placed into the sterilization package, the in ⁇ strument is placed in the holders on the center of the box. Then, the sterilization package is moved into a heat sealing device and a film of which all sides are approximately one centimeter larger than the open side of the package and which is manufactured form a suitable material such as spinbound high-density polyethylene fiber (e.g.
• Tyvek ⁇ is placed over it and tightly sealed to the sterilizat on, package .
• the - film- may have a tag that facilitates opening and prompts the opening direction to be such that the instrument is always taken the right way out from the package while making the opening movement similar every time.
• the sterilization package and the film for closing it may be delivered to the user with the sterilization filters already provided in place or the user may fasten the sterilization filters themselves. If the user fastens the sterilization filters, the glue surface for fastening may be ready on the sterilization package or on the sterilization filters.
• the glue surface is covered by an easily removable plastic or paper cover. After removal of the cover, the sterilization filter is carefully placed against the sterilization package in such a way that an airtight seam is provided. To this end, the so-called self seal seams are known in the art.
• EXAMPLE 2 A sterilization package for ster ⁇ ilization of batteries in orthopedic drills etc. In proportion to their size, batteries are relatively heavy and break almost without exception if they are dropped.
• the sterilization package for the sterilization of batteries has a size of for example approxi ⁇ mately 15 cm x 15 cm x 15 cm and comprises a holder shaped for the battery so that the battery may be pressed therein in such a way that it stays in place in a normal instrument maintenance process. The holder also absorbs the blow from falling so that the battery may remain operational .
• the invention is not limited merely to the above embodiment examples; instead, many modifications are possible within the scope of the inventive idea defined by the c.aims.
• the features of the invention disclosed in the embodiment examples above may also be used in other embodiment examples to create new embodiments.
• the scope of the claims is also meant to encompass all such modifications and new embodiments.

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• 2013
  • 2013-03-12 FI FI20135238A patent/FI20135238L/sv not_active Application Discontinuation
• 2014
  • 2014-03-07 WO PCT/FI2014/050171 patent/WO2014140421A1/en active Application Filing
• 2015
  • 2015-10-08 FI FIU20154180U patent/FI11048U1/sv active IP Right Grant

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