JP2006149936A - Fixing member for sterilization bag storage object - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide technique for a sterilization bag which stores medical equipment with sharp tip ends and can effectively suppress generation of undesired accidents of opening and breaking of the bag by a contact with the sharp tip end parts even when sterilization is performed with high temperature. <P>SOLUTION: A fixing member 4 made of a mesh structure body and/or a resin foam body is used by being stored in the sterilization bag 1. The medical equipment, etc., are inserted to the fixing member 4 so as to be fixed. <P>COPYRIGHT: (C)2006,JPO&NCIPI

Description

  The present invention relates to a fixing member such as a medical instrument housed in a sterilization bag.

  Instruments used for surgery and treatment must be sterilized before use, and when the contents to be stored are tangible solids such as machine parts and various instruments, they are peeled off and opened. Peel-open method and easy-cleavage film bags are used. For example, as a sterilization method carried out in a hospital or the like, an object to be sterilized such as tweezers, a scalpel, and forceps is placed in a sterilization bag having an area that is at least gas permeable and incapable of passing bacteria, and is sealed. And sterilization using high-temperature steam, plasma, ethylene oxide gas (EOG), and the like. The instrument after sterilization is stored in this packaging bag until it is used for surgery or the like, and is opened and used when used for surgery or treatment. Therefore, the sterilization packaging bag is a thin body such as two rectangular sheets or films (hereinafter referred to as “film”) so that it can be easily opened even if doctors or practitioners use gloves in the hospital. Is peelable, or is manufactured using an easily tearable (easier to tear open) film. When opening, a tearing method or a so-called peel-open method for peeling two films is used. It is common that

  Conventionally, after sterilizing a sterile bag such as tweezers, scalpels, and forceps with a sharp tip or medical device with irregularities, the tip of the bag is placed in a container such as a forceps stand for easy use. Often used for standing. As described above, a sterilization bag is generally heat-sealed so that two films can be peeled off. For this reason, when storing such a medical device in a sterilization bag, or packaging after sterilization. When the body is put into the forceps stand, there is a problem that the tip part comes into contact with the heat fusion part near the lower end of the sterilization bag, and the heat fusion part is peeled off and opened.

  In addition, as the film constituting the sterilization bag, it is necessary to use a film made of paper or non-woven fabric that is gas permeable and bacteria cannot pass through. However, sharp tips and irregularities such as large tweezers and forceps are used. When inserting a medical device, the tip of the paper or non-woven fabric may get caught in the gaps, or irregularities may be pierced, causing pinholes to open and making it impossible to use a sterilization bag. is there.

As a bag for sterilization of an object to be sterilized having such a sharp tip, Patent Literature 1 discloses a sterilization bag in which a bottom portion is formed by a synthetic resin boat-shaped bottom film. Patent Document 2 discloses a sterilization bag having a specific bulging portion at the lower end. Patent Document 3 discloses a sterilization bag having a protective member for protecting a gas permeable substrate at the lower end.
JP-A-8-168518 JP 2004-73723 A JP 2004-121838 A

  However, the technique of Patent Document 1 cannot be expected to protect the tip of a medical instrument having a sharp tip such as tweezers, a scalpel, or forceps. Further, in the techniques of Patent Documents 2 and 3, since the medical instrument cannot be fixed, it is difficult to completely prevent an undesired opening or breakage accident due to a sharp tip contact.

  The object of the present invention is to store a medical instrument having a sharp tip such as tweezers (particularly large tweezers), a knife, forceps, etc. It is an object of the present invention to provide a technique for a sterilization bag that can effectively suppress the occurrence of unopened or broken accidents.

  The present invention relates to a sterilization bag container fixing member made of a mesh structure and / or a resin foam, and a sterilization bag provided with the fixing member. The present invention also relates to a sterilization bag kit including the fixing member of the present invention and a sterilization bag. The present invention also relates to a method for accommodating and sterilizing a medical instrument in a sterilization bag in a state of being fixed by the fixing member of the present invention. Furthermore, this invention relates to the method of sterilizing a medical device using the sterilization bag of the said this invention.

  According to the fixing member of the present invention, when a medical instrument having a sharp tip such as tweezers (particularly large tweezers), a scalpel, forceps or the like is stored in a sterilization bag and sterilized by applying temperature, the sharp tip portion It is possible to effectively suppress the occurrence of an undesired opening or breakage accident due to the contact of.

  In the present invention, a mesh structure or a resin foam is used as the fixing member. When sterilizing a medical instrument, the distal end of the medical instrument is fixed to the protective member in such a manner that the distal end of the medical instrument is inserted into the sterilization bag, such as a gas permeable substrate, a synthetic resin film, a gas. Suppressing contact with the adhesive portion between the permeable substrate and the synthetic resin film, etc., and preventing the sterilization bag from being damaged. Further, the fixing member also functions as a cushioning material, and prevents not only the sterilization bag from being damaged but also the medical device tip from being damaged due to impact during transportation.

  The network structure constituting the fixing member of the present invention is a so-called three-dimensional loofah fiber three-dimensional network structure in which filament yarns are heat-sealed at their contact points, or a three-dimensional knitted fabric It is preferable that Moreover, it is preferable that it is flat form.

Moreover, it is preferable that the network structure can hold 15% or more of the original thickness when a load of 70 g / cm ² is applied from the thickness direction, and more preferably 20% or more of the original thickness.

The basis weight of the mesh structure 200 to 2000 g / m ^2, further 400~1000g / m ² is preferred.

Further, the elasticity of the mesh structure means that when a load of 70 g / cm ² is applied in the thickness direction for 5 minutes and then the load is removed and left for 5 minutes, it returns to 80% or more of the original thickness. It has an elastic compression recovery rate.

  The network structure of the present invention preferably uses fibers or filament yarns as constituent members. Here, the fibers are relatively short, the filament yarns are substantially endless and elongated, and both are made of natural or man-made materials. From the viewpoint of maintaining appropriate elasticity, a filament yarn is preferable. Here, the filament yarn refers to a monofilament yarn. In the present invention, a yarn in which a plurality of filament yarns are bundled (multifilament yarn) can also be used.

  The filament yarn may be made of any material as long as the mesh structure is non-water-absorbing, and a synthetic resin is preferable from the viewpoint of processability and cost. Examples of the synthetic resin include polyolefins such as polyethylene and polypropylene, polyesters such as polyethylene terephthalate, polymer compounds such as nylon, polyurethane, and polyvinyl chloride. Olefin resins and polyester resins are preferred from the standpoints of safety, processability, and price. Two or more kinds of synthetic resins can also be used. In the present invention, the filament yarn itself is preferably non-absorbent.

  The diameter of the filament yarn forming the network structure is preferably 0.1 to 2 mm, more preferably 0.2 to 1 mm, and particularly preferably 0.3 to 0.8 mm.

  The network structure of the present invention is a filter-like structure in addition to a filament yarn heat-sealed, a three-dimensional knitted fabric, and the like, and has a mesh made of fibers such as a nonwoven fabric, a woven fabric, a knitted fabric, and paper. A structure having air permeability can also be used. Of these, polypropylene (PP) non-woven fabric and polyethylene terephthalate (PET) non-woven fabric are preferred from the viewpoint of heat resistance and cost.

  On the other hand, the resin foam is a so-called sponge-like structure obtained by foaming a synthetic resin, and any material and structure can be used as long as it has a softness or void enough to insert a medical device. Specific examples include PP foam, PET foam, urethane foam, phenol foam, urea foam, melamine foam, and the like. Examples of the polyurethane foam include polyurethane foams obtained from polyols, polyisocyanates, foaming agents, and polyurethane isocyanurate foams. Phenol foam, urea foam, and melamine foam refer to condensation-bonded foams of phenol, urea, melamine, and formaldehyde, respectively. In the present invention, PP foam and PET foam are preferred from the viewpoint of heat resistance.

  The sterilization bag of the present invention is a sterilization bag formed by adhering the side edge portion and the lower end portion of the gas permeable base material and the synthetic resin film, leaving an opening in the upper portion, and inside the sterilization bag. The thing provided with the fixing member of this invention is mentioned.

  Although the fixing member of the present invention depends on the material and shape of the sterilization bag, it is preferable that the fixing member has a thickness of 2 to 10 mm, more preferably 3 to 8 mm, regardless of whether it is composed of a mesh structure or a resin foam. Moreover, it is preferable that it is sufficiently thick with respect to the thickness of the sterilization bag, and the thickness of the fixing member is 13 to 70 times, more preferably 20 to 55 times with respect to the thickness 1 of the sterilization bag before the fixing member is installed. preferable. Note that the thickness of the sterilization bag is the total thickness of the bag accommodating portion in the unaccommodated state, and the planar shape of the fixing member having such a thickness may be appropriately adjusted according to the sterilization bag. Further, when the fixing member and the sterilization bag include a heat-sealable material, both can be integrated by heat-seal.

  As a sterilization bag as an object of the present invention, one side film is composed of a base material such as gas permeable paper or nonwoven fabric (hereinafter referred to as sterilized paper as appropriate), and the other side film is a synthetic resin film. What is comprised is preferable at the point which is excellent in sterilization efficiency and adhesiveness. From the viewpoint of the visibility of the object to be sterilized, the synthetic resin film is preferably transparent.

  As a preferred embodiment of the sterilization bag according to the present invention, the sterilized paper that is the two side films and the synthetic resin film are detachably bonded, and the adhesion between the two base film is at least This is easily achieved by using a synthetic resin film having heat-fusibility as one side film. In order to control the adhesive strength and peelability more reliably, an easy peel (easy peel) adhesive is used, or a thermoplastic non-woven fabric is used as the gas permeable base material. Combine the two using a transparent plastic synthetic resin film that develops, or stack a seal layer on sterilized paper without impairing gas permeability, and heat-seal them together for heat-bonding It is possible to adopt a known method such as.

  The sterilized paper, which is a gas-permeable base material used in the sterilization bag according to the present invention, is an active ingredient of these because sterilization is usually performed using high-temperature water vapor, ethylene oxide gas (EOG), plasma, or the like. It needs to be made of a material that allows gas (gas) to permeate and does not allow bacteria to permeate. As a material for such sterilized paper, paper may be used, but it is preferable to select and use a non-moisture-adsorbing material such as polyester, polyvinyl chloride, polyethylene, polypropylene, and fluorine. Examples of the material include gas permeable polyethylene or polypropylene nonwoven fabric.

  Further, as the side film facing the gas permeable substrate, a synthetic resin film obtained by molding a synthetic resin by melt extrusion, casting, calendering or the like is used from the viewpoint of cost, strength, and visibility of contents. Although these synthetic resin films are not particularly limited, preferred synthetic resins include synthetic resins having heat-fusible properties because they are easy to operate at the time of bonding. Therefore, polyolefins such as polyethylene (PE) and polypropylene (PP) and polyvinyl chloride are preferable. The synthetic resin film does not necessarily have a single layer structure, and may have a multilayer structure depending on the purpose. For example, when the side film is constituted by the synthetic resin film having the above heat-fusible property, the side film only needs to have the heat-fusible property on one side, so that the other side has polyethylene terephthalate (PET), It is preferable to laminate a biaxially stretched film such as nylon (trademark: polyamide) or PP because the strength against piercing and impact is improved. Two or more biaxially stretched films may be laminated. The thickness of the synthetic resin side film can be appropriately selected according to the purpose, but is generally in the range of 30 to 100 μm.

  As the sterilization bag according to the present invention, a sterilization bag provided with a specific bulging portion at the lower end as described in JP-A-2004-73723, or as described in JP-A-2004-121838 A sterilization bag having a protective member for protecting the gas permeable substrate at the lower end can also be used. Moreover, the thing of the shape like what is called a standing pouch which the bottom part can open and becomes independent may be sufficient.

  FIG. 1 shows a schematic view of a sterilization bag having a fixing member of the present invention inside. 1A is a schematic view from the front, and FIG. 1B is a schematic cross-sectional view taken along the line AA in FIG. The gas permeable substrate (side film) 2 of the sterilization bag 1 is made of sterilized paper. The side film 3 as the other substrate is made of a synthetic resin. The upper end of the sterilization bag 1 is opened to store an object to be sterilized, and the periphery including the lowermost end portion is sealed with the sterilized paper 2 and the synthetic resin film 3 by the heat fusion part 5. A fixing member 4 is accommodated in the sterilization bag 1. In this sterilization bag, the fixing member 4 is made of a heat-sealable plastic (for example, PP nonwoven fabric, PP foam, etc.), and is heat-sealed with the synthetic resin film 3, thereby being fixed inside. In the sterilization bag 1 of the present invention configured as described above, the medical instrument can be fixed by inserting the distal end of the medical instrument into the fixing member 4. For this reason, it is possible to completely prevent an undesired opening or breakage accident due to the sharp tip contact during or after sterilization.

Example 1
Gas permeable substrate made of sterilized paper made of paper having a length of 350 mm × width of 75 mm × thickness of 90 μm and a basis weight of 70 g / m ^2, a biaxially stretched PET film having a thickness of 12 μm and a PP of 30 μm in thickness, the same dimensions as the substrate. The synthetic resin film laminated with the film was used for the production of a sterilization bag. A PP spunbonded nonwoven fabric (basis weight 200 g / m ² ) having a length of 30 mm, a width of 50 mm, and a thickness of 5 mm was used as the fixing member. The fixing member is heat-sealed at a position 10 mm from the lower end of the synthetic resin film, and then the synthetic resin film and the gas-permeable base material are heat-sealed at a lower end and a left and right end width of 5 mm, and the fixing member is placed inside. A sterilized bag as shown in FIG. 1 was obtained.

  Open the open end of the obtained sterilization bag by hand, make it slant, sharp tip, weight 80g, length 25cm large tweezers are inserted from the opening, the tweezers tip is inserted into the 20mm fixing member I stopped there. The sterilization bag was not damaged by this charging.

Example 2
A sterilization bag was obtained in the same manner as in Example 1 except that a PP foam (basis weight: 300 g / m ² ) having a length of 30 mm, a width of 50 mm, and a thickness of 5 mm was used as the fixing member.

  Open the open end of the obtained sterilization bag by hand, tilt it, sharpen the tip, put a large tweezers with a weight of 80 g and a length of 25 cm through the opening, and the tip of the tweezers is inserted into a 12 mm fixing member I stopped there. The sterilization bag was not damaged by this charging.

It is the schematic which shows an example of the sterilization bag provided with the fixing member of this invention.

Explanation of symbols

1: Sterilization bag 2: Gas permeable substrate (side film)
3: Synthetic resin film 4: Fixing member

Claims (7)

  A fixing member for a sterilized bag container, comprising a mesh structure and / or a resin foam.   The fixing member according to claim 1, wherein the container is one or more medical instruments selected from the group consisting of a knife, tweezers, forceps, and a scissors.   The fixing member according to claim 1 or 2, wherein the container is fixed by inserting a sharp portion of the container.   A sterilization bag provided with the fixing member according to any one of claims 1 to 3.   The sterilization bag kit comprised including the fixing member of any one of Claims 1-3, and a sterilization bag.   A method of sterilizing a medical instrument in a sterilization bag in a state of being fixed with a fixing member made of a mesh structure and / or a resin foam.   A method for sterilizing a medical instrument using the sterilization bag according to claim 4.

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