JP2002238921A - Packaging shape for applicator for biological binding agent - Google Patents
Packaging shape for applicator for biological binding agentInfo
- Publication number
- JP2002238921A JP2002238921A JP2001041895A JP2001041895A JP2002238921A JP 2002238921 A JP2002238921 A JP 2002238921A JP 2001041895 A JP2001041895 A JP 2001041895A JP 2001041895 A JP2001041895 A JP 2001041895A JP 2002238921 A JP2002238921 A JP 2002238921A
- Authority
- JP
- Japan
- Prior art keywords
- syringe
- preparation
- sterilization
- packaging
- bag
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 238000004806 packaging method and process Methods 0.000 title claims abstract description 26
- 239000011230 binding agent Substances 0.000 title 1
- 238000000034 method Methods 0.000 claims abstract description 5
- 230000001954 sterilising effect Effects 0.000 claims description 32
- 238000004659 sterilization and disinfection Methods 0.000 claims description 31
- 238000002360 preparation method Methods 0.000 claims description 20
- 239000000227 bioadhesive Substances 0.000 claims description 9
- 238000002834 transmittance Methods 0.000 claims description 9
- 239000000126 substance Substances 0.000 abstract description 10
- 238000009472 formulation Methods 0.000 abstract description 6
- 239000000203 mixture Substances 0.000 abstract description 6
- 238000007689 inspection Methods 0.000 description 9
- 239000003814 drug Substances 0.000 description 6
- 229940079593 drug Drugs 0.000 description 6
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 239000000243 solution Substances 0.000 description 3
- 239000002699 waste material Substances 0.000 description 3
- 210000004204 blood vessel Anatomy 0.000 description 2
- 230000001066 destructive effect Effects 0.000 description 2
- 239000011347 resin Substances 0.000 description 2
- 229920005989 resin Polymers 0.000 description 2
- 102100033029 Carbonic anhydrase-related protein 11 Human genes 0.000 description 1
- 241000887125 Chaptalia nutans Species 0.000 description 1
- 241000238558 Eucarida Species 0.000 description 1
- 101000867841 Homo sapiens Carbonic anhydrase-related protein 11 Proteins 0.000 description 1
- 101001075218 Homo sapiens Gastrokine-1 Proteins 0.000 description 1
- 230000005540 biological transmission Effects 0.000 description 1
- 238000004040 coloring Methods 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000002439 hemostatic effect Effects 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000004072 lung Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 239000004745 nonwoven fabric Substances 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 238000012856 packing Methods 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000005070 sampling Methods 0.000 description 1
- 238000007789 sealing Methods 0.000 description 1
- 210000003491 skin Anatomy 0.000 description 1
- 238000005507 spraying Methods 0.000 description 1
- 238000003860 storage Methods 0.000 description 1
- 239000003106 tissue adhesive Substances 0.000 description 1
- 238000009423 ventilation Methods 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Landscapes
- Surgical Instruments (AREA)
- Packages (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
Description
【０００１】[0001]
【発明の属する技術分野】本発明は、主に複数成分系製
剤として適用される組織接着剤の塗布用具に関するもの
であり、特に肝臓や肺の切除断端や消化管の縫合部の止
血閉鎖などに好適な、生体の患部に噴霧して塗布するた
めの用具の包装形態に関する。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a device for applying a tissue adhesive which is mainly applied as a multi-component preparation, and more particularly to a hemostatic closure of a cut edge of a liver or a lung or a suture of a digestive tract. The present invention relates to a packaging form of a tool suitable for spraying and applying to an affected part of a living body.
【０００２】[0002]
【従来の技術】生体接着剤調製器は製剤調製用具一式と
製剤塗布用具一式の部材により構成されるのが一般的で
ある。部品点数が多いため、製剤調製器一式と生体塗布
用具一式は別袋に包装し、同一の箱に梱包するのが普通
である。特に製剤塗布用具一式は清潔域（手術室など）
で使用する為、二重包装することが望まれている。 製剤調製用具一式：注射針複数本、シリンジ複数本、通
気針複数本。 製剤塗布用具一式：注射針複数本、シリンジ複数本、プ
ラスチック針複数本、シリンジ固定具1セット、薬液塗
布具１個。2. Description of the Related Art A bioadhesive preparation device is generally composed of a set of a preparation preparation tool and a set of a preparation application tool. Because of the large number of parts, it is common practice to package the pharmaceutical preparation device and the biological application tool in separate bags and pack them in the same box. In particular, a complete set of drug application tools is in a clean area (such as an operating room).
Therefore, it is desired to double-wrap them for use. Formulation preparation kit: multiple injection needles, multiple syringes, multiple ventilation needles. A set of formulation application tools: multiple injection needles, multiple syringes, multiple plastic needles, one syringe fixture, one chemical applicator.
【０００３】本器具は臓器や皮膚、血管に直接接触する
可能性があり、またシリンジ内及び薬液流路から突出し
た薬液は皮膚、血管に接触するために、器具に付着した
異物は大きさにもよるが致命的な欠点となる。このもの
の包装形態は術者の利便性を考慮し透明のブリスタート
レーに白色の樹脂製不織紙を熱溶着したものである。整
然と包装することが可能であり、見た目はよい。しかし
ながら、ブリスター容器は曲面状部分がほとんどである
ために、包装後に製品に異物が付着していないことを確
認する工程が不可能となり、実質上全ての製品の最終検
査を行うことが出来ず、抜き取りによる破壊検査にて異
物の有無の判断をせざるを得なかった。[0003] The device may directly contact organs, skin, and blood vessels, and the drug solution protruding from the syringe and from the drug solution channel contacts the skin and blood vessels. This is a fatal drawback. In this case, a white resin non-woven paper is heat-sealed to a transparent blister tray in consideration of the convenience of the operator. It can be packed neatly and looks good. However, since most of the blister container has a curved surface portion, it is impossible to perform a process of confirming that no foreign matter is attached to the product after packaging, and the final inspection of virtually all products cannot be performed. It was necessary to judge the presence or absence of foreign matter by destructive inspection by sampling.
【０００４】更に、廃棄時はブリスター容器が嵩高く廃
棄物が嵩張ってしまう問題があり、ユーザーから廃棄物
量の削減が強く望まれている。しかしながら本器具は手
術室で使われる製品であり、煩雑な包装形態では輸送中
に部材間で擦れ合い損傷あるいは異物発生の危険性があ
る他、開封時に誤って部材が落下してしまうなどの危険
性があり問題点があるため、整然と包装することが可能
なブリスター容器を使用せざるを得なかった。[0004] Furthermore, at the time of disposal, there is a problem that the blister container is bulky and the waste is bulky, and reduction of the amount of waste is strongly desired by users. However, this device is a product used in the operating room, and in a complicated packaging form, there is a danger of rubbing between the members during transportation and the risk of foreign matter being generated, and the risk of accidentally dropping members when opening. Due to the nature and problems, blister containers that can be packed neatly have to be used.
【０００５】[0005]
【発明が解決しようとする課題】本発明の目的は前述の
問題点即ち、製品包装内への異物の混入の減少と製品梱
包後の異物の有無の確認が可能で、コンパクトに収納で
きる包装形態を提供することである。SUMMARY OF THE INVENTION The object of the present invention is to solve the above-mentioned problems, that is, to reduce the intrusion of foreign substances into the product packaging and to confirm the presence or absence of foreign substances after product packaging, and to provide a compact storage form. It is to provide.
【０００６】[0006]
【課題を解決するための手段】本発明は即ち、（１）製
剤調製用具一式と製剤塗布用具一式をそれぞれ前面が可
視光透過率８０〜１００％のフィルムシートで、背面に
滅菌紙を有する滅菌袋に別個に包装することを特徴とし
た生体接着剤塗布用具の包装形態、（２）製剤塗布用具
一式を前面が可視光透過率８０〜１００％のフィルムシ
ートで、背面面積の５０〜１００％の部分の可視光透過
率が８０〜１００％以上の透明部分を有するフィルムシ
ートである複数の滅菌袋に分割包装した状態で、各滅菌
袋を重ねることなく滅菌袋に包装する（１）記載の生体
接着剤塗布用具の包装形態、（３）製剤塗布用具一式の
うち、シリンジ固定具にシリンジを嵌合した状態で包装
する（１）又は（２）記載の生体接着剤塗布用具の包装
形態、（４）シリンジ固定具にシリンジを嵌合する方法
が、シリンジの先端側をシリンジ固定具のフランジ固定
部に向けて嵌合する（３）記載の生体接着剤塗布用具の
包装形態である。According to the present invention, there are provided (1) a sterilization apparatus comprising a set of a preparation preparation tool and a set of preparation application tool each having a film sheet having a visible light transmittance of 80 to 100% at the front and a sterilization paper at the back. The packaging form of the bioadhesive application tool characterized by being separately packaged in a bag. (2) A set of preparation application tools is a film sheet having a visible light transmittance of 80 to 100% on the front surface and 50 to 100% of the back surface area. (1) is packaged in a sterilization bag without overlapping each sterilization bag in a state of being dividedly packaged in a plurality of sterilization bags which are a film sheet having a transparent portion having a visible light transmittance of 80 to 100% or more. The packaging form of the bioadhesive application tool; (3) the package form of the bioadhesive application tool according to (1) or (2), which is packaged in a state in which the syringe is fitted to the syringe fixture, out of the set of formulation application tools; (4) Siri How to fit the syringe di fixture, the front end side of the syringe is fitted toward the flange fixing portion of the syringe fixture (3) is a packaging form of a bioadhesive applicator according.
【０００７】[0007]
【発明の実施の形態】本発明の包装形態の一実施例を図
１に示す。製剤調製用具一式と製剤塗布用具一式は使用
するタイミングと場所が異なる為にそれぞれ別個の包装
とした方が、術者の使い勝手が良い。最も望ましい形態
は、製剤調製用具一式を滅菌袋（２）で包装し、製剤塗
布用具の一式のうちシリンジ、シリンジ固定具一式、薬
液塗布具を内滅菌袋（３）で包装し、注射針、プラスチ
ック針を別の内滅菌袋（４）で包装する。包装する際に
は、各部材が重なり合わないことが異物検査の観点から
重要であり、注射針等とシリンジ等を別の滅菌袋に分け
ることは部材の重なりを避けるための一手段である。DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS FIG. 1 shows an embodiment of a packaging form according to the present invention. Since the kit for preparing the preparation and the kit for applying the preparation are used at different timings and locations, it is more convenient for the operator to use separate packages. In the most desirable form, a set of preparations is packaged in a sterile bag (2), and a syringe, a set of syringe fixtures, and a drug applicator are packaged in an inner sterilization bag (3) among the set of preparation application tools. The plastic needle is packaged in another inner sterile bag (4). When packaging, it is important from the viewpoint of foreign substance inspection that the components do not overlap with each other, and dividing the injection needle or the like and the syringe or the like into separate sterilization bags is one means for avoiding the overlapping of the components.
【０００８】この内滅菌袋（３）、（４）は背面も可能
な限り透明部分が多いことが望ましいが、ガス滅菌法の
場合には不織紙状の滅菌紙が必要であろうため背面にヒ
ートシールされたリボン状の滅菌紙のあるリボンタイプ
の滅菌袋を使用することが好ましい。最も好ましくはγ
線滅菌法による不織紙の不要な包装袋で背面全てが透明
であることである。ここで言う滅菌紙には樹脂製不織布
も含まれる。内滅菌袋（３）、（４）の透明フィルムは
可視光透過に優れたものが望ましく、好ましくは可視光
透過率８０〜１００％。より好ましくは９０〜１００％
である。It is desirable that the inner sterilization bags (3) and (4) have as many transparent portions as possible on the back surface, but in the case of the gas sterilization method, nonwoven paper-like sterilized paper will be required, so that the back surface is required. It is preferable to use a ribbon-type sterilization bag with a heat-sealed ribbon-shaped sterilization paper. Most preferably γ
It is a packaging bag that does not require the use of non-woven paper by the line sterilization method. The sterilized paper mentioned here includes a nonwoven fabric made of resin. The transparent films of the inner sterilization bags (3) and (4) desirably have excellent visible light transmission, and preferably have a visible light transmittance of 80 to 100%. More preferably 90 to 100%
It is.
【０００９】内滅菌袋（３）、（４）の最も好ましくな
い例は背面全体が滅菌紙の滅菌袋であり、この場合、内
滅菌袋（３）、（４）の背面外側に異物が付着していた
場合には検査が不可能であり、清潔域での開封の際に製
品に異物が移行する可能性があるため好ましくない。ま
た背面全体が滅菌紙の場合には必然的にヒートシール部
が四方に設けられてしまうためコンパクトな包装の面か
らも好ましくない。[0009] The most unfavorable example of the inner sterilization bags (3) and (4) is a sterilization bag made of sterilized paper on the entire back surface. In this case, foreign substances adhere to the outer surfaces of the inner sterilization bags (3) and (4). If this is done, it is not possible to carry out an inspection, and there is a possibility that foreign matter may migrate to the product when opening in a clean area, which is not preferable. When the entire back surface is made of sterile paper, the heat seal portions are necessarily provided on all sides, which is not preferable in terms of compact packaging.
【００１０】そして、この２つの内滅菌袋（３）、
（４）を互いに重ね合わせることなく更に滅菌袋（１）
で包装し二重包装としたうえで２つの内滅菌袋（３）、
（４）の間で二つ折りにする。これを製剤調製用具一式
を包装したものと組み合わせて小箱に包装する。この二
重包装用の滅菌袋（１）の前面は可視光透過率８０〜１
００％の透明フィルムであることが望ましく、好ましく
は可視光透過率９０〜１００％である。背面は全面が白
色基調の滅菌紙であることが望ましく、これにより有色
の異物の検査を容易にする。また、前面の透明フィルム
は異物検査を考慮し、微量の着色を施すことも有効な手
段である。公知の例としては微量な青色に着色した透明
フィルムに背面は全面が白色の滅菌紙とすることにより
異物検査の効率が改善される例があるが、大変好ましい
例の一つである。Then, the two inner sterilization bags (3),
(4) Sterilization bag without overlapping each other (1)
Wrapped in a double wrap and then two inner sterilization bags (3),
Fold in half between (4). This is combined with the packaged preparation preparation and packaged in a small box. The front surface of the sterilization bag (1) for double packaging has a visible light transmittance of 80 to 1
The transparent film is desirably 00%, and preferably has a visible light transmittance of 90 to 100%. It is desirable that the entire back surface is made of white-based sterile paper, thereby facilitating inspection of colored foreign substances. It is also an effective means to apply a slight amount of coloring to the transparent film on the front surface in consideration of foreign substance inspection. As a well-known example, there is an example in which the efficiency of foreign substance inspection is improved by using a small amount of transparent film colored in blue and sterilizing paper with a white back surface on the entire surface, but this is one of the very preferable examples.
【００１１】よりコンパクトな包装梱包形態が望まれる
場合には図１に示す通りに内滅菌袋（３）及び（４）の
ヒートシール部分を折り曲げた後二重包装とした方が望
ましい。また、二重包装される２つの内滅菌袋（３）、
（４）は大きさが異なる場合には小さい方を滅菌袋の取
り出し側に配置した方が、デッドスペースとなる取り出
し側にある開封用の掴み代部分を相殺することが出来、
二つ折りにした場合によりコンパクトにできる。When a more compact packaging form is desired, it is desirable that the heat-sealed portions of the inner sterilization bags (3) and (4) be folded and then double-wrapped as shown in FIG. In addition, two inner sterilization bags (3) that are double wrapped,
(4) If the size is different, it is better to arrange the smaller one on the take-out side of the sterilization bag to offset the opening allowance on the take-out side which is a dead space,
It can be made more compact when folded in two.
【００１２】背面にヒートシール部がある滅菌袋、例え
ばリボンタイプの滅菌袋は一般的には開封時にシール面
に対し垂直方向に袋を裂く為、袋外面が袋内面または内
容物に接触することにより内部が汚染さる可能性がある
が、二重包装した場合は滅菌袋の外側も無菌的であるた
め袋外側が袋内面または内容物に接触しても衛生的に全
く問題は無く、本実施例の内滅菌袋（３）及び（４）も
衛生的に全く問題が無い。また、シリンジ（５）とシリ
ンジ固定具（６）は図２又は３に示すがごとく組立て包
装した方がよりコンパクトに収納することができる。最
も望ましい包装形態は、図２に示すシリンジの先端側を
シリンジ固定具（６）のフランジ固定部（７）に向け嵌
合させる形態である。A sterilization bag having a heat seal portion on the back side, for example, a ribbon-type sterilization bag, generally tears the bag in a direction perpendicular to the sealing surface when opened, so that the outer surface of the bag contacts the inner surface of the bag or the contents. Although the inside of the bag may be contaminated, the outside of the sterile bag is sterile when double-wrapped, so there is no sanitary problem even if the outside of the bag contacts the inside of the bag or the contents. The inner sterilization bags (3) and (4) of the examples also have no hygiene problem. Further, as shown in FIG. 2 or 3, the syringe (5) and the syringe fixture (6) can be housed more compactly by assembling and packaging. The most desirable packaging form is a form in which the distal end side of the syringe shown in FIG. 2 is fitted to the flange fixing part (7) of the syringe fixing tool (6).
【００１３】図３のようにシリンジ（５）をシリンジ固
定具（６）に通常使用する状態で嵌合し包装してもコン
パクトな包装が可能である。しかしながら、シリンジ
（５）のフランジ部分の高さの分嵩が増すことになる上
に、実際に使用するときは一度シリンジを外して薬液を
充填する作業が必要な為、フランジ部分がフランジ固定
部位（７）にしっかりと固定される後者よりは、図２に
示す組立形態で包装する方が好ましい。As shown in FIG. 3, compact packaging is possible even if the syringe (5) is fitted and packaged in the syringe fixture (6) in a state normally used. However, since the height of the flange portion of the syringe (5) is increased and the operation of removing the syringe and filling the drug solution is necessary when actually using the syringe, the flange portion is a flange fixing portion. It is preferable to pack in the assembled form shown in FIG. 2 rather than the latter which is firmly fixed to (7).
【００１４】[0014]
【発明の効果】本発明によると、ブリスターの容器を使
用しないために、熱溶着機の製造ラインから異物が入る
ことはない。また、梱包後に最終的な検査が可能であり
異物の混入の危険が小さい。更に、非破壊の検査であ
り、高価な薬剤や部材を無駄にすることがない。廃棄時
にもかさばらない。また、シリンジとシリンジ固定具を
コンパクトに包装可能であり、更に包装から出した状態
で、部材がまとまっており、使い勝手がよい。According to the present invention, no foreign matter enters from the production line of the heat welding machine because no blister container is used. In addition, final inspection is possible after packing, and there is little risk of foreign matter being mixed. Furthermore, it is a non-destructive inspection and does not waste expensive medicines and members. Not bulky when discarded. Further, the syringe and the syringe fixture can be packaged compactly, and furthermore, the members are assembled in a state of being unpacked, which is convenient.
【図１】 本発明の包装形態の滅菌袋の一例を示す。FIG. 1 shows an example of a sterilized bag in a package form according to the present invention.
【図２】 本発明の包装形態の一例を示す。FIG. 2 shows an example of a packaging form of the present invention.
【図３】 本発明の包装形態の一例を示す。FIG. 3 shows an example of a packaging form of the present invention.
１、２ 滅菌袋 ３、４ 内滅菌袋 ５ シリンジ ６ シリンジ固定具 ７ フランジ固定部位 1, 2 sterilization bag 3, 4 inner sterilization bag 5 syringe 6 syringe fixture 7 flange fixing part
───────────────────────────────────────────────────── フロントページの続き Ｆターム(参考） 3E067 AA21 AB83 AC01 BA12A BB14A CA11 EA06 FA04 FB07 FC01 GC03 4C058 AA14 BB01 BB06 EE13 EE16 KK03 4C060 MM18 ──────────────────────────────────────────────────続 き Continued on the front page F term (reference) 3E067 AA21 AB83 AC01 BA12A BB14A CA11 EA06 FA04 FB07 FC01 GC03 4C058 AA14 BB01 BB06 EE13 EE16 KK03 4C060 MM18
Claims (4)
それぞれ前面が可視光透過率８０〜１００％のフィルム
シートで、背面全面に滅菌紙を有する滅菌袋に別個に包
装することを特徴とした生体接着剤塗布用具の包装形
態。The present invention is characterized in that a set of a preparation preparation and a set of preparation application tools are separately packaged in a sterilization bag having a front surface with a visible light transmittance of 80 to 100% and a sterilization paper on the entire back surface. Packaging form of bioadhesive application tool.
８０〜１００％のフィルムシートで、背面面積の５０〜
１００％の部分の可視光透過率が８０〜１００％以上の
透明部分を有するフィルムシートである複数の滅菌袋に
分割包装した状態で、各滅菌袋を重ねることなく滅菌袋
に包装する請求項１記載の生体接着剤塗布用具の包装形
態。2. A set of the device for applying a preparation is a film sheet having a visible light transmittance of 80 to 100% on the front surface and a rear surface area of 50 to 100%.
2. A package in which a 100% portion is divided and packaged into a plurality of sterilization bags, each of which is a film sheet having a transparent portion having a visible light transmittance of 80 to 100% or more. A packaging form of the bioadhesive application tool according to the above.
具にシリンジを嵌合した状態で包装する請求項１又は２
記載の生体接着剤塗布用具の包装形態。3. A package of a pharmaceutical application tool set, wherein the syringe is fitted to a syringe fixture and packaged.
A packaging form of the bioadhesive application tool according to the above.
法が、シリンジの先端側をシリンジ固定具のフランジ固
定部に向けて嵌合する請求項３記載の生体接着剤塗布用
具の包装形態。4. The packaging form of the bioadhesive application tool according to claim 3, wherein in the method of fitting the syringe to the syringe fixture, the tip of the syringe is fitted to the flange fixing portion of the syringe fixture.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001041895A JP2002238921A (en) | 2001-02-19 | 2001-02-19 | Packaging shape for applicator for biological binding agent |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2001041895A JP2002238921A (en) | 2001-02-19 | 2001-02-19 | Packaging shape for applicator for biological binding agent |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JP2002238921A true JP2002238921A (en) | 2002-08-27 |
Family
ID=18904268
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2001041895A Pending JP2002238921A (en) | 2001-02-19 | 2001-02-19 | Packaging shape for applicator for biological binding agent |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2002238921A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019058587A (en) * | 2017-09-28 | 2019-04-18 | 三井化学株式会社 | Medical material or multiple bag body for medical equipment, and manufacturing method for the same |
-
2001
- 2001-02-19 JP JP2001041895A patent/JP2002238921A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2019058587A (en) * | 2017-09-28 | 2019-04-18 | 三井化学株式会社 | Medical material or multiple bag body for medical equipment, and manufacturing method for the same |
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