JPS63206254A - Medical member - Google Patents
Medical memberInfo
- Publication number
- JPS63206254A JPS63206254A JP62039194A JP3919487A JPS63206254A JP S63206254 A JPS63206254 A JP S63206254A JP 62039194 A JP62039194 A JP 62039194A JP 3919487 A JP3919487 A JP 3919487A JP S63206254 A JPS63206254 A JP S63206254A
- Authority
- JP
- Japan
- Prior art keywords
- balloon
- fluorine
- containing polyurethane
- catheter
- wire
- 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
- 229920002635 polyurethane Polymers 0.000 claims description 27
- 239000004814 polyurethane Substances 0.000 claims description 27
- 229910052731 fluorine Inorganic materials 0.000 claims description 24
- 239000011737 fluorine Substances 0.000 claims description 24
- YCKRFDGAMUMZLT-UHFFFAOYSA-N Fluorine atom Chemical compound [F] YCKRFDGAMUMZLT-UHFFFAOYSA-N 0.000 claims description 22
- 239000008280 blood Substances 0.000 claims description 5
- 210000004369 blood Anatomy 0.000 claims description 5
- 150000002009 diols Chemical class 0.000 claims description 5
- 239000004970 Chain extender Substances 0.000 claims description 4
- 125000005442 diisocyanate group Chemical group 0.000 claims description 3
- 125000006551 perfluoro alkylene group Chemical group 0.000 claims description 3
- 238000005086 pumping Methods 0.000 claims description 3
- RTZKZFJDLAIYFH-UHFFFAOYSA-N ether Substances CCOCC RTZKZFJDLAIYFH-UHFFFAOYSA-N 0.000 claims description 2
- 238000000034 method Methods 0.000 description 17
- 239000000243 solution Substances 0.000 description 7
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 6
- 238000000465 moulding Methods 0.000 description 6
- 239000002904 solvent Substances 0.000 description 6
- -1 polyoxytetramethylene Polymers 0.000 description 5
- 230000002785 anti-thrombosis Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- FXHOOIRPVKKKFG-UHFFFAOYSA-N N,N-Dimethylacetamide Chemical compound CN(C)C(C)=O FXHOOIRPVKKKFG-UHFFFAOYSA-N 0.000 description 3
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 3
- 230000000704 physical effect Effects 0.000 description 3
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 description 2
- 239000004698 Polyethylene Substances 0.000 description 2
- 239000000853 adhesive Substances 0.000 description 2
- 230000001070 adhesive effect Effects 0.000 description 2
- 210000000709 aorta Anatomy 0.000 description 2
- 239000011248 coating agent Substances 0.000 description 2
- 238000000576 coating method Methods 0.000 description 2
- 150000004985 diamines Chemical class 0.000 description 2
- 238000007598 dipping method Methods 0.000 description 2
- 150000002221 fluorine Chemical class 0.000 description 2
- 239000011521 glass Substances 0.000 description 2
- 230000004217 heart function Effects 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 229920000573 polyethylene Polymers 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- XIPFCPIAMUDJIS-UHFFFAOYSA-N 2,2,3,3,4,4,5,5-octafluoro-1,6-diisocyanatohexane Chemical compound O=C=NCC(F)(F)C(F)(F)C(F)(F)C(F)(F)CN=C=O XIPFCPIAMUDJIS-UHFFFAOYSA-N 0.000 description 1
- 206010007556 Cardiac failure acute Diseases 0.000 description 1
- 206010011878 Deafness Diseases 0.000 description 1
- PIICEJLVQHRZGT-UHFFFAOYSA-N Ethylenediamine Chemical compound NCCN PIICEJLVQHRZGT-UHFFFAOYSA-N 0.000 description 1
- 206010019280 Heart failures Diseases 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- SECXISVLQFMRJM-UHFFFAOYSA-N N-Methylpyrrolidone Chemical compound CN1CCCC1=O SECXISVLQFMRJM-UHFFFAOYSA-N 0.000 description 1
- 229920002396 Polyurea Polymers 0.000 description 1
- 239000004830 Super Glue Substances 0.000 description 1
- 208000007536 Thrombosis Diseases 0.000 description 1
- 238000004026 adhesive bonding Methods 0.000 description 1
- 238000004220 aggregation Methods 0.000 description 1
- 230000002776 aggregation Effects 0.000 description 1
- 239000003146 anticoagulant agent Substances 0.000 description 1
- 229940127219 anticoagulant drug Drugs 0.000 description 1
- 125000004432 carbon atom Chemical group C* 0.000 description 1
- 230000008602 contraction Effects 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 125000004427 diamine group Chemical group 0.000 description 1
- FGBJXOREULPLGL-UHFFFAOYSA-N ethyl cyanoacrylate Chemical compound CCOC(=O)C(=C)C#N FGBJXOREULPLGL-UHFFFAOYSA-N 0.000 description 1
- 210000001105 femoral artery Anatomy 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 150000002334 glycols Chemical class 0.000 description 1
- 230000010370 hearing loss Effects 0.000 description 1
- 231100000888 hearing loss Toxicity 0.000 description 1
- 208000016354 hearing loss disease Diseases 0.000 description 1
- GNOIPBMMFNIUFM-UHFFFAOYSA-N hexamethylphosphoric triamide Chemical compound CN(C)P(=O)(N(C)C)N(C)C GNOIPBMMFNIUFM-UHFFFAOYSA-N 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 125000002887 hydroxy group Chemical group [H]O* 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 238000003780 insertion Methods 0.000 description 1
- 230000037431 insertion Effects 0.000 description 1
- 230000010354 integration Effects 0.000 description 1
- CWEFIMQKSZFZNY-UHFFFAOYSA-N pentyl 2-[4-[[4-[4-[[4-[[4-(pentoxycarbonylamino)phenyl]methyl]phenyl]carbamoyloxy]butoxycarbonylamino]phenyl]methyl]phenyl]acetate Chemical compound C1=CC(CC(=O)OCCCCC)=CC=C1CC(C=C1)=CC=C1NC(=O)OCCCCOC(=O)NC(C=C1)=CC=C1CC1=CC=C(NC(=O)OCCCCC)C=C1 CWEFIMQKSZFZNY-UHFFFAOYSA-N 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000004417 polycarbonate Substances 0.000 description 1
- 229920000515 polycarbonate Polymers 0.000 description 1
- 229920005862 polyol Polymers 0.000 description 1
- 150000003077 polyols Chemical class 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 239000004810 polytetrafluoroethylene Substances 0.000 description 1
- 229920001343 polytetrafluoroethylene Polymers 0.000 description 1
- 229920003226 polyurethane urea Polymers 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 229920001059 synthetic polymer Polymers 0.000 description 1
- 239000001993 wax Substances 0.000 description 1
Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.
Description
【発明の詳細な説明】
［産業上の利用分野］
本発明は、急性心不全等の治療法である大動脈内バルー
ンポンピング法に用いるバルーンカテーテルなどの血液
に接触するバルーン部分を有する医療用部材に関するも
のである。Detailed Description of the Invention [Field of Industrial Application] The present invention relates to a medical device having a balloon portion that comes into contact with blood, such as a balloon catheter used in intra-aortic balloon pumping, which is a treatment method for acute heart failure, etc. It is.
［従来の技術］
大動脈内バルーンポンピング法（以下ＩＡＢＰ法と略す
）とは、心不全等による左心機能低下時の治療のため、
大動脈内に合成高分子からなるバルーン（風船）を挿入
し、心臓の拍動にあわせて、バルーンを膨張、収縮させ
るという補助循環法である。１９Ｈ年Ｋａｎｔｒｏｗｉ
ｔｚらによって臨床応用され（Ｊｏｕｒｎａｌ ｏｆ
ｔｈｅ Ａｍｅｒｉｃａｎにｅｄｉｃａｌ Ａｓ５ｏｃ
ｉａｔｉｏｎ ２０３； １１３（１９１３８））心機
能補助の効果が確認されて以来１世界的に普及した。特
に、米国特許４，２１３１．３３９および４，３２７゜
７０９に示されるように、バルーンを支持部材に巻きつ
けて径を小さくし、経皮的に挿入することが可能になり
、手技的に簡便であることと、患者らに与える侵聾が少
なくなったことにより、現在では最も広く用いられつつ
ある補助循理法である。[Prior Art] Intra-aortic balloon pumping method (hereinafter abbreviated as IABP method) is a method for treating decreased left heart function due to heart failure, etc.
This is an auxiliary circulation method in which a balloon made of synthetic polymer is inserted into the aorta, and the balloon is inflated and deflated in accordance with the heart's beats. 19H Kantorowi
Clinically applied by tz et al. (Journal of
the American ni edical As5oc
tion 203; 113 (19138)) It has become popular worldwide since its effectiveness in supporting cardiac function was confirmed. In particular, as shown in U.S. Pat. This method is now becoming the most widely used assisted circulation method because it causes less hearing loss to patients.
［発明の解決しようとする問題点］
しかしながら、現在市販されているバルーンカテーテル
に使用されている材料は、カルジオサン（商品名）もし
くは、必ずしも構造は明確ではないが、バイオマー（商
品名）タイプの炭化水素系のポリウレタンからできてお
り、バルーンカテーテルに要求される物性を満足してい
るとは言い難い、前者は、抗血栓性は比較的良好である
ものの、強度の点で不十分であり、耐久性に不安が残り
、後者は逆に強度の点では充分であるが、抗血栓性はや
や劣る。[Problems to be Solved by the Invention] However, the materials currently used in balloon catheters on the market are either Cardiosan (trade name) or carbonized Biomer (trade name), although the structure is not necessarily clear. It is made of hydrogen-based polyurethane, and it cannot be said that it satisfies the physical properties required for balloon catheters.The former has relatively good antithrombotic properties, but is insufficient in terms of strength and durability. However, while the latter is strong enough, its antithrombotic properties are somewhat inferior.
同様に、上記ＩＡＢＰ用バルーンカテーテル以外の血液
に接触するバルーン部分を有する医療用部材（たとえば
他の用途のバルーンカテーテル）においても、抗血栓性
と強度に優れた材料が求められている。Similarly, materials with excellent antithrombotic properties and strength are also required for medical members having balloon portions that come into contact with blood (for example, balloon catheters for other uses) other than the IABP balloon catheter described above.
［問題点を解決するための手段］
本発明は、前述の問題点を解決すべくなされたものであ
り、血液に接触するバルーン部分を有する医療用部材に
おいて、少なくともバルーン部分が含フッ素ポリウレタ
ンからなることを特徴とする医療用部材を提供するもの
である。[Means for Solving the Problems] The present invention has been made to solve the above-mentioned problems, and provides a medical device having a balloon portion that comes into contact with blood, in which at least the balloon portion is made of fluorine-containing polyurethane. The present invention provides a medical member characterized by the following.
本発明における、含フッ素ポリウレタンとは、＃公開８
０−４１９５０号公報に示される親木性部位と疎水性部
位がともに主鎖に規則的に組込まれたポリウレタン、ポ
リウレタンウレアおよびポリウレア型から選ばれる結合
様式を有するブロック重合体である。この含フッ素ポリ
ウレタンは、 ０ＣＮＧＨｚ−Ｒｆ−ＣＨ２ＮＣ：０で
表わされる含フッ素ジイソシアネートを用いて得られる
ものが好ましい（Ｒｆは、炭素数１〜２０、エーテル結
合数０〜ｌＯのパーフルオロアルキレン基を表わす）、
この含フッ素ジイソシアネートと反応させてポリウレタ
ンを形成するポリオールとしては分子量４００〜ｔｏ、
ｏｏｏのジオールが好ましい。In the present invention, the fluorine-containing polyurethane refers to #Publication 8
It is a block polymer having a bonding mode selected from polyurethane, polyurethane urea, and polyurea types in which both lignophilic sites and hydrophobic sites are regularly incorporated into the main chain as shown in Japanese Patent No. 0-41950. This fluorine-containing polyurethane is preferably one obtained using a fluorine-containing diisocyanate represented by 0CNGHz-Rf-CH2NC:0 (Rf represents a perfluoroalkylene group having 1 to 20 carbon atoms and 0 to 10 ether bonds. ),
The polyol that is reacted with this fluorine-containing diisocyanate to form polyurethane has a molecular weight of 400 to
ooo diols are preferred.
ジオールとしては、ポリオキシテトラメチレングリコー
ルやポリオキシプロピレングリコールなどのポリオキシ
アルキレングリコールが好ましい、また、ポリウレタン
は、これらとともに鎖延長剤を用いて得られるものが好
ましい、鎖延長剤としては、分子量４００未満のジオー
ルやジアミンが遠出であり、特に分子量２００以下のジ
オールあるいはジアミンが好ましい、最も好ましくは、
２，２，３，３，４，４，５．５−オクタフルオロへキ
サメチレンジイソシアネート、分子量６００〜４０００
のポリオキシテトラメチレングリコール、および分子量
２００以下のフルキレンジアミンを用いて得られる含フ
ッ素ポリウレタンである。As the diol, polyoxyalkylene glycols such as polyoxytetramethylene glycol and polyoxypropylene glycol are preferred.As for the polyurethane, those obtained by using these together with a chain extender are preferred.The chain extender has a molecular weight of 400 Diols and diamines with a molecular weight of less than 200 are particularly preferable, and most preferably,
2,2,3,3,4,4,5.5-octafluorohexamethylene diisocyanate, molecular weight 600-4000
This is a fluorine-containing polyurethane obtained using polyoxytetramethylene glycol and fullkylene diamine having a molecular weight of 200 or less.
含フッ素ポリウレタンはプレポリマー法やワンショット
法、その他の方法で製造されるが、斉一なブロック重合
体を得るにはプレポリマー法の使用が好ましい、得られ
る含フッ素ポリウレタンは、上記好ましい原料を用いプ
レポリマー法で製造された場合、次のような分子構造を
有する。Fluorine-containing polyurethane is produced by a prepolymer method, a one-shot method, or other methods, but it is preferable to use a prepolymer method to obtain a uniform block polymer. When produced by the prepolymer method, it has the following molecular structure.
−Ｅ Ｒ’−ＮＨＣＯＮＨ（ＣＨ２−Ｒｆ−ＣＨ２ＮＨ
ＧＯＯ−Ａ−ＯＣＯＮＨ）−ＣＨ２−Ｒｆ−ＣＨ２ＮＨ
ＯＣ：ＯＮＨＦＲｆ：パーフルオロアルキレン基
Ａ：分子量４００以上のジオールの水酸基を除いた残基
Ｒ′ニジアミン系鎖延長剤の７ミノ基を除いた残基
ｍ、整数（ただし、 １〜８が好ましい）ｎ：整数
本発明における含フッ素ポリウレタンは、高い抗血栓性
を有するとともに１機械的強度が高い、従って、膨張と
縮少をくり返しても物性の低下が少なく、血液に接触す
るバルーン部分の材料として最も適している。-ER'-NHCONH(CH2-Rf-CH2NH
GOO-A-OCONH)-CH2-Rf-CH2NH
OC: ONHFRf: Perfluoroalkylene group A: Residue of a diol with a molecular weight of 400 or more, excluding the hydroxyl group R' Residue of a diamine chain extender excluding the 7-mino group m, an integer (preferably 1 to 8) n: integer The fluorine-containing polyurethane of the present invention has high antithrombotic properties and high mechanical strength.Therefore, even after repeated expansion and contraction, there is little deterioration in physical properties, making it suitable as a material for the balloon portion that comes into contact with blood. most suitable.
ＩＡＢＰ法用のバルーンカテーテルは、基本的には、図
１に示すようにバルーン部分（１）とカテーテル部分（
２）に分けることができる。バルーンとカテーテルを含
フッ素ポリウレタンで一体成形することも可能であるが
、各々に要求される物性が異なるためバルーン部分（１
）を含フッ素ポリウレタンで成形し、カテーテル部分（
２）は、ポリエチレン、ポリ塩化ビニル、硬質ポリウレ
タン、ＰＴＦＥ等のフッ素樹脂のような固いチューブの
表面を含フッ素ポリウレタンでコートして作製した後、
一体化することが望ましい、バルーンの成形は、溶融成
形、ディッピング成形などどのような方法でも可能であ
るが、成形の容易さ、最終製品の性能の安定性などから
考え、含フッ素ポリウレタン溶液からのディッピングに
よる成形が好ましい、含フッ素ポリウレタンの溶媒とし
ては、溶解能のあるものなら何でも構わないが、例えば
、Ｎ、Ｎ−ジメチルホルムアミド、Ｎ、Ｎ−ジメチルア
セトアミド、Ｎ−メチル−ピロリドン、ジメチルスルホ
キシド、ヘキサメチルホスホリックトリアミド、ｌ−ク
レゾールなどを挙げることができる。A balloon catheter for the IABP method basically consists of a balloon part (1) and a catheter part (1) as shown in Figure 1.
It can be divided into 2). It is also possible to integrally mold the balloon and catheter from fluorine-containing polyurethane, but since the physical properties required for each are different, the balloon part (1
) is molded from fluorine-containing polyurethane, and the catheter part (
2) is made by coating the surface of a hard tube such as polyethylene, polyvinyl chloride, hard polyurethane, fluororesin such as PTFE with fluorine-containing polyurethane, and then
Balloons, which are desirable to be integrated, can be molded by any method such as melt molding or dipping molding, but from the viewpoint of ease of molding and stability of the performance of the final product, it is preferable to mold the balloon using a fluorine-containing polyurethane solution. The solvent for fluorine-containing polyurethane, which is preferably molded by dipping, may be any solvent as long as it has a dissolving power, such as N,N-dimethylformamide, N,N-dimethylacetamide, N-methyl-pyrrolidone, dimethylsulfoxide, Examples include hexamethylphosphoric triamide and l-cresol.
予め、成形時の変形を推測した、金属、ガラスもしくは
ワックスで型を作り、含フッ素ポリウレタン溶液にディ
ップし、均一に膜ができるよう回転しながら溶媒を留去
して表面に膜を形成させる。金属、ガラスの場合には、
形成膜を型から剥離することで、ワックスの場合には、
ワックスを熱または含フッ素ポリウレタンを溶かさない
溶媒で溶かし出すことによって、目的とするバルーンを
得ることができる。A mold made of metal, glass, or wax is made in advance to estimate the deformation during molding, and the mold is dipped in a fluorine-containing polyurethane solution, and the solvent is distilled off while rotating to form a uniform film on the surface. In the case of metal and glass,
By peeling the formed film from the mold, in the case of wax,
The desired balloon can be obtained by dissolving the wax with heat or a solvent that does not dissolve the fluorine-containing polyurethane.
カテーテル部分は基材となるチューブの表面に、同様な
方法でコート皮膜を形成させればよい。For the catheter portion, a coating film may be formed on the surface of the tube serving as the base material using a similar method.
このようにして成形した。バルーン部とカテーテル部を
一体化するには゛、熱融着、接着剤による接着などが考
えられるが、接着強度を大きくするためには、含フッ素
ポリウレタン溶液を接着剤として用い、溶媒を留去して
一体化する方法が好ましい。It was molded in this way. To integrate the balloon part and the catheter part, heat fusing, adhesive bonding, etc. can be considered, but in order to increase the adhesive strength, a fluorine-containing polyurethane solution is used as the adhesive and the solvent is distilled off. A method of integrating the two is preferable.
このようにして成形されたバルーンカテーテルは、治療
に使用され易いように、どのような付属品をもつけるこ
とが可能である０例えば、先端にＸ線不透過のチップ（
４）をつけたワイヤー（３）を、バルーンカテーテルに
差し込み支持体とすると同時に、このワイヤーを前述の
米国特許４，２８１，３３９および４，３２７，７０９
に示されるようなカテーテル側に取付けたラフピングノ
ブ（５）により回転し、バルーンをワイヤーの回りに巻
きつけて、経皮的に侵入し易くすることも可能である。The balloon catheter formed in this way can be attached with any kind of accessories to make it easier to use for treatment. For example, a radiopaque tip (
4) is inserted into the balloon catheter to serve as a support, and at the same time, this wire is attached to the wire (3) as described in the above-mentioned US Pat.
It is also possible to rotate the balloon around the wire by means of a luffing knob (5) attached to the catheter side, as shown in Figure 1, to facilitate percutaneous entry.
また、ワイヤーの代りに、Ｘ線不透過のチップをつけた
細い中空のチューブを差し込んでダブルルーメンとする
ことも可能である。It is also possible to create a double lumen by inserting a thin hollow tube with an X-ray opaque tip in place of the wire.
［実施例］
実施例１
■バルーンの成形
長さ２７７ｍｍ、先端部の径２．２ｍｍ、バルーン部分
の径１？、５ｍｍ 、カテーテル部分の径３．５ａ＋ｗ
の金型を用いた。含フッ素ポリウレタン（平均分子量約
１０００のポリオキシテトラメチレングリコールと０Ｃ
ＮＧ）１２Ｃ４ＦａＣ）１２ＮＧＯから得られたプレポ
リマーを、エチレンジアミンにより鎖延長したもの）１
６部を、Ｎ、Ｎ−ジメチルアセトアミド８４部に溶解し
た溶液（約５，０００ｃｐｓ）に上記金型を浸清し、６
０°Ｃに調節した回転成型機に直立させて回転しながら
８０分熱風乾燥した。同様の操作をもう一度繰り返した
後、形成膜を金型から２１１敲し、７０°Ｃで２０時間
真空乾燥器で溶媒を留去して膜厚約１２０ルの紡錘状の
バルーン部分を得た。[Example] Example 1 ■Balloon molding length: 277 mm, tip diameter: 2.2 mm, balloon portion diameter: 1? , 5mm, diameter of catheter part 3.5a+w
A mold was used. Fluorine-containing polyurethane (polyoxytetramethylene glycol with an average molecular weight of about 1000 and 0C
NG) 12C4FaC) 12 Prepolymer obtained from NGO is chain-extended with ethylenediamine) 1
The above mold was immersed in a solution (approximately 5,000 cps) in which 6 parts of N,N-dimethylacetamide was dissolved in 84 parts of N,N-dimethylacetamide.
It was placed upright in a rotary molding machine adjusted to 0°C and dried with hot air for 80 minutes while rotating. After repeating the same operation once more, the formed film was removed from the mold, and the solvent was distilled off in a vacuum dryer at 70°C for 20 hours to obtain a spindle-shaped balloon portion with a film thickness of about 120 l.
■カテーテル部の作製
外径３．５ｍｍ 、内径３．０ｍｍ 、長さ８０ｃｍの
ポリエチレン製チューブの外面に上記含フッ素ポリウレ
タンをコートした。(2) Preparation of Catheter Portion The outer surface of a polyethylene tube having an outer diameter of 3.5 mm, an inner diameter of 3.0 mm, and a length of 80 cm was coated with the above-mentioned fluorine-containing polyurethane.
■バルーン部とカテーテル部の一体化
バルーンの切口部へ■で作製したカテーテルを差し込み
、上記含フッ素ポリウレタン溶液にて接着し、７０°Ｃ
で２時間熱風乾燥した。■Integration of balloon part and catheter part Insert the catheter made in step (■) into the cut part of the balloon, glue it with the above fluorine-containing polyurethane solution, and heat it at 70°C.
It was dried with hot air for 2 hours.
以上のようにして成形したバルーンカテーテルのバルー
ン部分の長さは２３０＋ａ＋１１、径は、１５．５ｍｍ
であり、容量は３Ｂ＋ａＪＬであった。The length of the balloon part of the balloon catheter formed as above is 230+a+11, and the diameter is 15.5mm.
The capacity was 3B+aJL.
■ワイヤーの挿入
予め製造、洗浄したＸ線不透過チップ付のワイヤーのチ
ップ部分に含フッ素ポリウレタン溶液をコートし、７０
℃ ６０分熱風乾燥した。一方、バルーンの先端突起部
を先端より２ｍ１Ｉｌ切り、■で一体化したカテーテル
側よりワイヤーをチップ側から入れ、バルーンの突起部
ヘワイヤ先端のチップを差し込んだ、差し込んだ部分だ
け含フッ素ポリウレタン溶液へ浸漬した後、７０℃で２
時間熱風乾燥した。■Insertion of the wire Coat the tip part of the wire with the prefabricated and cleaned X-ray opaque tip with a fluorine-containing polyurethane solution.
It was dried with hot air at ℃ for 60 minutes. On the other hand, cut the protrusion at the tip of the balloon by 2 ml from the tip, insert the wire from the tip side from the integrated catheter side in (■), and insert the tip of the wire into the protrusion of the balloon. Only the inserted part is immersed in the fluorine-containing polyurethane solution. After that, heat at 70℃ for 2
Dry with hot air for an hour.
■ラッピングノブの接着
予め射出成形したポリカーボネート製ラッピングノブの
中へ■でワイヤーを挿入したバルーンカテーテルのカテ
ーテル部を入れ、バルーンに捩れのないことを確認した
上でシアノアクリレート接着剤で充填結合した。■ Adhesion of the wrapping knob The catheter part of the balloon catheter with the wire inserted in ■ was inserted into the polycarbonate wrapping knob that had been injection molded in advance, and after confirming that the balloon was not twisted, it was filled and bonded with cyanoacrylate adhesive.
以上のように成形、一体化し、付属品を取りつけたバル
ーンカテーテルを、３７℃の生理食塩水中で、膨張−収
縮をくり返す駆動試験を行った。１分間に７０回の繰返
しで約３ケ月間（１０７回に相当）駆動させたが、別々
に作製した３木とも全く破損はなかった。The balloon catheter molded and integrated as described above and attached with accessories was subjected to a drive test in which it was repeatedly inflated and deflated in physiological saline at 37°C. Although the drive was repeated 70 times per minute for about 3 months (equivalent to 107 times), there was no damage to any of the three separately produced trees.
実施例２
実施例１の金型寸法を長さ２４０ｍｍ 、バルーン部分
の径１１．５＋＋＋ｍとした以外は全く同様の方法でバ
ルーンカテーテルを作製した。出来上りは、バルーン部
の長さ２００１ＩＩ１１、径１ｏｌｌＩ層であり、容量
は １７ＬＩｌ父であった。Example 2 A balloon catheter was produced in exactly the same manner as in Example 1 except that the mold dimensions were 240 mm in length and the diameter of the balloon portion was 11.5+++ m. The completed balloon part had a length of 2001II11, a diameter of 1 layer, and a capacity of 17LI1.
このバルーンを、犬の大腿動脈より、外科的手術により
、大動脈へ挿入し、抗凝固剤なしで２０時間駆動した。This balloon was surgically inserted into the dog's aorta through the femoral artery and operated for 20 hours without anticoagulant.
終了後取り出したバルーン表面には、血栓の付着はほと
んどなく、走査型電子顕微鏡による所見でも、所々に血
小板の凝集が観察できる程度であった。There was almost no thrombus adhering to the surface of the balloon, which was taken out after the completion of the procedure, and findings using a scanning electron microscope showed that aggregation of platelets could be observed here and there.
第１図は、本発明の一実施例を示す側面図である。 １：バルーン部分、２：カテーテル部分、３：ワイヤー FIG. 1 is a side view showing one embodiment of the present invention. 1: Balloon part, 2: Catheter part, 3: Wire
Claims (3)
において、少なくともバルーン部分が含フッ素ポリウレ
タンからなることを特徴とする医療用部材。(1) A medical device having a balloon portion that comes into contact with blood, wherein at least the balloon portion is made of fluorine-containing polyurethane.
ルーンカテーテルである特許請求の範囲第１項の部材。(2) The member according to claim 1, wherein the medical member is a balloon catheter for intra-aortic balloon pumping.
てもよいパーフルオロアルキレン基を有するジイソシア
ネート、分子量４００以上のジオール、および鎖延長剤
を反応して得られる含フッ素ポリウレタンである、特許
請求の範囲第１項の部材。(3) Claims that the fluorine-containing polyurethane is a fluorine-containing polyurethane obtained by reacting a diisocyanate having a perfluoroalkylene group which may have an ether bond, a diol having a molecular weight of 400 or more, and a chain extender. Components of Paragraph 1.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62039194A JPS63206254A (en) | 1987-02-24 | 1987-02-24 | Medical member |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP62039194A JPS63206254A (en) | 1987-02-24 | 1987-02-24 | Medical member |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| JPS63206254A true JPS63206254A (en) | 1988-08-25 |
Family
ID=12546309
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP62039194A Pending JPS63206254A (en) | 1987-02-24 | 1987-02-24 | Medical member |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPS63206254A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5447152A (en) * | 1992-08-13 | 1995-09-05 | Terumo Kabushiki Kaisha | Endotracheal tube and the method of manufacturing it |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5841563A (en) * | 1981-09-04 | 1983-03-10 | 旭硝子株式会社 | Anti-coagulant material of blood |
| JPS59155432A (en) * | 1983-02-22 | 1984-09-04 | Rikagaku Kenkyusho | Surface-modified polymer having molecular chain of large mobility |
| JPS60241448A (en) * | 1984-05-15 | 1985-11-30 | 鐘淵化学工業株式会社 | Production of medical instrument |
-
1987
- 1987-02-24 JP JP62039194A patent/JPS63206254A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS5841563A (en) * | 1981-09-04 | 1983-03-10 | 旭硝子株式会社 | Anti-coagulant material of blood |
| JPS59155432A (en) * | 1983-02-22 | 1984-09-04 | Rikagaku Kenkyusho | Surface-modified polymer having molecular chain of large mobility |
| JPS60241448A (en) * | 1984-05-15 | 1985-11-30 | 鐘淵化学工業株式会社 | Production of medical instrument |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5447152A (en) * | 1992-08-13 | 1995-09-05 | Terumo Kabushiki Kaisha | Endotracheal tube and the method of manufacturing it |
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