JP3102921B2 - Medical device and method of manufacturing medical device - Google Patents
Medical device and method of manufacturing medical deviceInfo
- Publication number
- JP3102921B2 JP3102921B2 JP03216386A JP21638691A JP3102921B2 JP 3102921 B2 JP3102921 B2 JP 3102921B2 JP 03216386 A JP03216386 A JP 03216386A JP 21638691 A JP21638691 A JP 21638691A JP 3102921 B2 JP3102921 B2 JP 3102921B2
- Authority
- JP
- Japan
- Prior art keywords
- medical device
- tube
- tubular
- vinyl chloride
- caprolactam
- 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.)
- Expired - Fee Related
Links
- 238000004519 manufacturing process Methods 0.000 title claims description 4
- JBKVHLHDHHXQEQ-UHFFFAOYSA-N epsilon-caprolactam Chemical compound O=C1CCCCCN1 JBKVHLHDHHXQEQ-UHFFFAOYSA-N 0.000 claims description 19
- 239000011347 resin Substances 0.000 claims description 14
- 229920005989 resin Polymers 0.000 claims description 14
- BZHJMEDXRYGGRV-UHFFFAOYSA-N Vinyl chloride Chemical compound ClC=C BZHJMEDXRYGGRV-UHFFFAOYSA-N 0.000 claims description 10
- 239000000853 adhesive Substances 0.000 claims description 9
- 230000001070 adhesive effect Effects 0.000 claims description 9
- 239000004014 plasticizer Substances 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 4
- 230000001954 sterilising effect Effects 0.000 claims description 4
- 238000004659 sterilization and disinfection Methods 0.000 claims description 4
- 230000000052 comparative effect Effects 0.000 description 7
- 239000000243 solution Substances 0.000 description 7
- 239000008280 blood Substances 0.000 description 6
- 210000004369 blood Anatomy 0.000 description 6
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 4
- 239000002904 solvent Substances 0.000 description 4
- 238000012360 testing method Methods 0.000 description 4
- 239000004803 Di-2ethylhexylphthalate Substances 0.000 description 3
- BJQHLKABXJIVAM-UHFFFAOYSA-N bis(2-ethylhexyl) phthalate Chemical compound CCCCC(CC)COC(=O)C1=CC=CC=C1C(=O)OCC(CC)CCCC BJQHLKABXJIVAM-UHFFFAOYSA-N 0.000 description 3
- 238000010438 heat treatment Methods 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- GPZYYYGYCRFPBU-UHFFFAOYSA-N 6-Hydroxyflavone Chemical compound C=1C(=O)C2=CC(O)=CC=C2OC=1C1=CC=CC=C1 GPZYYYGYCRFPBU-UHFFFAOYSA-N 0.000 description 2
- JHIVVAPYMSGYDF-UHFFFAOYSA-N cyclohexanone Chemical compound O=C1CCCCC1 JHIVVAPYMSGYDF-UHFFFAOYSA-N 0.000 description 2
- 238000010828 elution Methods 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- VEXZGXHMUGYJMC-UHFFFAOYSA-M Chloride anion Chemical compound [Cl-] VEXZGXHMUGYJMC-UHFFFAOYSA-M 0.000 description 1
- 241001649081 Dina Species 0.000 description 1
- 229920001944 Plastisol Polymers 0.000 description 1
- 210000001124 body fluid Anatomy 0.000 description 1
- 239000010839 body fluid Substances 0.000 description 1
- 239000012153 distilled water Substances 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 239000004816 latex Substances 0.000 description 1
- 229920000126 latex Polymers 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 230000010355 oscillation Effects 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000004999 plastisol Substances 0.000 description 1
- 238000004062 sedimentation Methods 0.000 description 1
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 1
- 125000000391 vinyl group Chemical group [H]C([*])=C([H])[H] 0.000 description 1
- 229920002554 vinyl polymer Polymers 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Classifications
-
- G—PHYSICS
- G10—MUSICAL INSTRUMENTS; ACOUSTICS
- G10L—SPEECH ANALYSIS TECHNIQUES OR SPEECH SYNTHESIS; SPEECH RECOGNITION; SPEECH OR VOICE PROCESSING TECHNIQUES; SPEECH OR AUDIO CODING OR DECODING
- G10L19/00—Speech or audio signals analysis-synthesis techniques for redundancy reduction, e.g. in vocoders; Coding or decoding of speech or audio signals, using source filter models or psychoacoustic analysis
- G10L2019/0001—Codebooks
- G10L2019/0003—Backward prediction of gain
-
- G—PHYSICS
- G10—MUSICAL INSTRUMENTS; ACOUSTICS
- G10L—SPEECH ANALYSIS TECHNIQUES OR SPEECH SYNTHESIS; SPEECH RECOGNITION; SPEECH OR VOICE PROCESSING TECHNIQUES; SPEECH OR AUDIO CODING OR DECODING
- G10L19/00—Speech or audio signals analysis-synthesis techniques for redundancy reduction, e.g. in vocoders; Coding or decoding of speech or audio signals, using source filter models or psychoacoustic analysis
- G10L2019/0001—Codebooks
- G10L2019/0011—Long term prediction filters, i.e. pitch estimation
Landscapes
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
【０００１】[0001]
【産業上の利用分野】本発明は、血液バッグ、血液回路
等のなどの管状部品同士を接続して構成される塩化ビニ
ル樹脂製医療器具および該医療器具の製造方法に関す
る。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a medical device made of a vinyl chloride resin, which is formed by connecting tubular parts such as a blood bag and a blood circuit, and a method of manufacturing the medical device.
【０００２】[0002]
【従来技術および発明が解決しようとする課題】一般に
血液バッグ、血液回路等のなどの管状部品同士を接続し
て構成される医療器具は、安全性、加工性及び材料費な
どの点から塩化ビニル樹脂から形成されている。2. Description of the Related Art Generally, a medical device constructed by connecting tubular parts such as a blood bag and a blood circuit is made of vinyl chloride in terms of safety, workability and material cost. It is formed from resin.
【０００３】塩化ビニル樹脂製管状部品同士の接続は、
高周波ウェルダ−を用いて管状部品の接続部を融着する
方法や、複雑な構造や径の異なるチュ−ブを挿入して接
続する場合は、塩化ビニル樹脂を溶解させる溶剤とし
て、テトラヒドロフランやシクロヘキサノンが用いられ
ている。The connection between tubular parts made of vinyl chloride resin is as follows:
In the case of connecting a tubular part using a high-frequency welder or connecting a tube having a complicated structure or a different diameter, tetrahydrofuran or cyclohexanone is used as a solvent for dissolving the vinyl chloride resin. Used.
【０００４】しかしながら、高周波ウェルダ−を用いて
接続する方法は、部品同士が管状である場合には、芯金
が挿入できず外部からの高周波の発振のみとなり充分な
溶着強度が得られなかった。また溶剤を用いる方法で
は、溶剤が部品内に残留し、体液と接する場合があるの
で衛生上好ましくない。However, in the method of connecting using a high-frequency welder, when the parts are tubular, the core cannot be inserted, and only high-frequency oscillation from the outside occurs, and sufficient welding strength cannot be obtained. In addition, the method using a solvent is not preferable in terms of hygiene because the solvent may remain in the parts and come into contact with body fluid.
【０００５】また、特開昭６０−６３０６３号公報に開
示されているように、可塑剤を配合してなる塩化ビニル
重合体ペ−ストレジンを管状部品の接続部に充填した
後、熱滅菌により加熱してペ−ストレジンを固化するこ
とによって接続部を接着する方法が提案されているが、
重合体ペ−ストレジンは、塩化ビニルラテックスを可塑
剤を用いて液の中に分散させたプラチゾルが不安定でレ
ジンの沈降が生じやすく調整が困難とか、加熱温度によ
っても接着強度が大きく左右されるという課題があっ
た。そこで本発明者は以上の課題を解決するために鋭意
検討を重ねた結果次の発明に到達した。Further, as disclosed in Japanese Patent Application Laid-Open No. Sho 60-63063, a vinyl chloride polymer paste resin containing a plasticizer is filled into a connection portion of a tubular component, and then heated by heat sterilization. Then, a method of bonding the connection portion by solidifying the paste resin has been proposed,
The adhesive strength of the polymer paste resin is greatly affected by the heating temperature and the difficulty in adjusting the resin because the plastisol in which vinyl chloride latex is dispersed in a liquid using a plasticizer is unstable and sedimentation of the resin is likely to occur. There was a problem that. The inventor of the present invention has made intensive studies in order to solve the above-mentioned problems, and has arrived at the following invention.
【０００６】[0006]
【課題を解決するための手段】図１は、医療器具の該略
図で、接続チュ−ブ２とＹ字管３（いずれも塩化ビニル
樹脂製の管状部材）の接着面にε−カプロラクタムを含
む可塑剤溶液を塗布して、これを加熱滅菌（乾燥）処理
を施して接続したものである（４はε−カプロラクタム
接着剤）。FIG. 1 is a schematic view of a medical device, in which .epsilon.-caprolactam is attached to the connecting surface of a connecting tube 2 and a Y-shaped tube 3 (both are tubular members made of vinyl chloride resin). A plasticizer solution was applied, and this was subjected to heat sterilization (drying) treatment and connected (4 is ε-caprolactam adhesive).
【０００７】[0007]
【実施例１】ε−カプロラクタムをジ−２−エチルヘキ
シルフタレ−トに溶解し５％溶液を調整した。これを接
続チュ−ブ２の接着面に塗布してＹ字管３に挿入した。
その後、蒸気滅菌処理（１２１℃、２０分）を施して接
続した。Example 1 ε-Caprolactam was dissolved in di-2-ethylhexyl phthalate to prepare a 5% solution. This was applied to the adhesive surface of the connection tube 2 and inserted into the Y-tube 3.
After that, steam sterilization (121 ° C., 20 minutes) was performed for connection.
【０００８】[0008]
【実施例２】ε−カプロラクタムをＤＩＮＡ（アジピン
酸ジイソノニル）に溶解し５％溶液を調整した。これを
接続チュ−ブ２の接着面に塗布して針基に挿入した。そ
の後、ギヤ−オ−プン中で加熱処理（１００℃、２０
分）を施して接続した。Example 2 ε-Caprolactam was dissolved in DINA (diisononyl adipate) to prepare a 5% solution. This was applied to the bonding surface of the connection tube 2 and inserted into the needle base. Then, heat treatment (100 ° C., 20 ° C.) in a gear open
Minutes) and connected.
【０００９】比較例１として、ジ−２−エチルヘキシル
フタレ−ト溶液を接続チュ−ブ２の接着面に塗布してＹ
字管３に挿入し、実施例１と同様に処理した。比較例２
として接続チュ−ブ２とＹ字管３をＴＨＦにより接続し
た。各接続部の引張強度を引張試験機を用いて引張速度
２００ｍｍ／ｍｉｎで、接続チュ−ブ２と接続管３をそ
れらの軸方向に引張ることで測定した。その結果を表１
に示す。As Comparative Example 1, a solution of di-2-ethylhexyl phthalate was applied to the bonding surface of the connecting tube 2 and Y
The tube was inserted into the tube 3 and treated in the same manner as in Example 1. Comparative Example 2
The connection tube 2 and the Y-shaped tube 3 were connected by THF. The tensile strength of each connecting portion was measured by pulling the connecting tube 2 and the connecting pipe 3 in their axial direction at a pulling speed of 200 mm / min using a tensile tester. Table 1 shows the results.
Shown in
【００１０】[0010]
【表１】 [Table 1]
【００１１】表１の結果により、本発明の実施例１、２
は溶剤接着（比較例２）と同レベルの引張強度を有する
ことがわかる。可塑剤のみ（比較例１）では若干の引張
強度を保持することができるが、手で引き抜けない程度
の実用強度（３Kgf)には至らなかった。According to the results shown in Table 1, Examples 1 and 2 of the present invention are shown.
Has the same level of tensile strength as that of the solvent adhesion (Comparative Example 2). The plasticizer alone (Comparative Example 1) could maintain a slight tensile strength, but did not reach a practical strength (3 kgf) such that it could not be pulled out by hand.
【００１２】なお、本発明の管状部品の接着面にε−カ
プロラクタムを含む可塑剤溶液を塗布して密着させた後
の加熱処理条件は、７０℃で１０から３０分または１０
０から１２０℃で２から１０分の範囲であれば、３Kgf
以上の実用強度をうることができることが確認できた。
また温度を１２０℃以上にしても引張強度は高くならな
いが、バラツキが少なく安定した強度を得ることができ
る。The heat treatment after applying a plasticizer solution containing ε-caprolactam to the adhesive surface of the tubular component of the present invention and bringing the solution into close contact is performed at 70 ° C. for 10 to 30 minutes or 10 minutes.
3Kgf if it is in the range of 2 to 10 minutes at 0 to 120 ° C
It was confirmed that the above practical strength could be obtained.
Further, even if the temperature is set to 120 ° C. or higher, the tensile strength does not increase, but a stable strength with little variation can be obtained.
【００１３】さらに本発明の安全性を確認するために溶
出物試験を行った。溶出物試験は接続チュ−ブ２とＹ字
管３を接続したもので、比較例として接着剤を使用しな
いものを使用した。試料として、接着剤を全く用いてい
ないＹ字管（比較例３）、ε−カプロラクタムで接着し
たＹ字管（実施例３）を用いた。Further, an eluate test was conducted to confirm the safety of the present invention. The eluate test was performed by connecting the connecting tube 2 and the Y-shaped tube 3 and using no adhesive as a comparative example. As samples, a Y-tube without any adhesive (Comparative Example 3) and a Y-tube bonded with ε-caprolactam (Example 3) were used.
【００１４】試験方法は、生物学的製剤基準の塩化ビニ
ル樹脂製血液セット基準、注射用蒸留水による溶出物試
験に順じ、試験項目は、ＰＨ差、ＫＭn Ｏ4 差について
行った。ＫＭn Ｏ4 差の試験方法は、日局プラ容器の試
験方法に順じ、基準は上記の塩化ビニル樹脂製血液セッ
ト基準（２ｍｌ未満）に準じた。その結果を表２に示
す。The test method was in accordance with the standard for biological products, the standard for blood sets made of vinyl chloride resin, and the test for elution with distilled water for injection. The test items were PH difference and KM n O 4 difference. The method of testing KM n O 4 Sa is Ji order the test methods Japanese Pharmacopoeia Plastic containers, criteria were according to the above-mentioned vinyl resin blood set reference chloride (less than 2 ml). Table 2 shows the results.
【００１５】[0015]
【表２】 [Table 2]
【００１６】表２の結果より、本発明の実施例３は比較
例３と同様に、ＰＨ差、ＫＭn Ｏ4差はいずれも基準内
で安全上問題なく医療用途に適合することが確認でき
た。[0016] than the results in Table 2, Example 3 of the present invention is similar to Comparative Example 3, PH difference, KM n O 4 difference confirmed to meet medical applications without safety problems in both the reference Was.
【００１７】本発明の実施例では、管状部品として、Ｙ
字管、接続チュ−ブ、針基を掲げたが必ずしもこれらに
限定されるものではない。また可塑剤として、ジ−２−
エチルヘキシルフタレ−ト、アジピン酸ジイソノニルを
掲げたが必ずしもこれらに限定されるものではない。In an embodiment of the present invention, the tubular component is Y
Although the pipe, the connecting tube, and the needle base are listed, they are not necessarily limited to these. As a plasticizer, di-2-
Ethylhexyl phthalate and diisononyl adipate are listed, but are not necessarily limited thereto.
【００１８】[0018]
【発明の効果】 本発明では管状部品同士の接続を充
分に保持でき、溶出物も少なく衛生的なので安心して使
用することができる。可塑剤溶液の調整と管状部品同
士への塗布、接着が容易なので組立が容易である。According to the present invention, the connection between the tubular parts can be sufficiently maintained, the elution is small, and the sanitary parts can be used safely. Assembly is easy because adjustment of the plasticizer solution and application and adhesion between the tubular parts are easy.
【図１】本発明の医療器具の概略図FIG. 1 is a schematic view of a medical device of the present invention.
１ 医療器具 ２ 接続チュ−ブ ３ Ｙ字管 ４ ε−カプロラクタム接着剤 DESCRIPTION OF SYMBOLS 1 Medical device 2 Connection tube 3 Y-shaped tube 4 ε-caprolactam adhesive
Claims (2)
ビニル樹脂製医療器具であって、前記管状部品の接着面
にε−カプロラクタムを含む可塑剤溶液を塗布したこと
を特徴とする医療器具。1. A medical device made of a vinyl chloride resin constituted by connecting tubular parts, wherein a plasticizer solution containing ε-caprolactam is applied to an adhesive surface of the tubular part. .
具の製造方法であって、前記管状部品の接着面にε−カ
プロラクタムを含む可塑剤溶液を塗布して密着させ、加
熱滅菌処理を施すことにより前記管状部品同士を接続す
ることを特徴とする医療器具の製造方法。2. The method for producing a medical device made of a vinyl chloride resin according to claim 1, wherein a plasticizer solution containing ε-caprolactam is applied to and adhered to the adhesive surface of the tubular component, and subjected to heat sterilization. A method for manufacturing a medical device, comprising connecting the tubular components to each other.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP03216386A JP3102921B2 (en) | 1991-08-02 | 1991-08-02 | Medical device and method of manufacturing medical device |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP03216386A JP3102921B2 (en) | 1991-08-02 | 1991-08-02 | Medical device and method of manufacturing medical device |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH0615006A JPH0615006A (en) | 1994-01-25 |
| JP3102921B2 true JP3102921B2 (en) | 2000-10-23 |
Family
ID=16687758
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP03216386A Expired - Fee Related JP3102921B2 (en) | 1991-08-02 | 1991-08-02 | Medical device and method of manufacturing medical device |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3102921B2 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH071820U (en) * | 1993-06-14 | 1995-01-13 | 株式会社日研 | Writing tool storage box |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP3585097B2 (en) | 1998-06-04 | 2004-11-04 | セイコーエプソン株式会社 | Light source device, optical device and liquid crystal display device |
| JP4288553B2 (en) | 2000-07-25 | 2009-07-01 | 富士フイルム株式会社 | Camera strobe device |
| KR100804653B1 (en) | 2003-06-16 | 2008-02-20 | 미쓰비시덴키 가부시키가이샤 | Planar light source device and display device using the same |
| WO2006003913A1 (en) | 2004-07-06 | 2006-01-12 | Asagicreate Co., Ltd. | Surface light source and electrically illuminated signboard |
-
1991
- 1991-08-02 JP JP03216386A patent/JP3102921B2/en not_active Expired - Fee Related
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH071820U (en) * | 1993-06-14 | 1995-01-13 | 株式会社日研 | Writing tool storage box |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH0615006A (en) | 1994-01-25 |
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