JPS6037735B2 - 人工血管 - Google Patents

人工血管

Info

Publication number
JPS6037735B2
JPS6037735B2 JP53128695A JP12869578A JPS6037735B2 JP S6037735 B2 JPS6037735 B2 JP S6037735B2 JP 53128695 A JP53128695 A JP 53128695A JP 12869578 A JP12869578 A JP 12869578A JP S6037735 B2 JPS6037735 B2 JP S6037735B2
Authority
JP
Japan
Prior art keywords
tube
porous
artificial blood
blood vessel
anticoagulant
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
Application number
JP53128695A
Other languages
English (en)
Other versions
JPS5554951A (en
Inventor
弘 真野
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sumitomo Electric Industries Ltd
Original Assignee
Sumitomo Electric Industries Ltd
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Sumitomo Electric Industries Ltd filed Critical Sumitomo Electric Industries Ltd
Priority to JP53128695A priority Critical patent/JPS6037735B2/ja
Priority to GB7935248A priority patent/GB2033232B/en
Priority to IT50513/79A priority patent/IT1128744B/it
Priority to AU51695/79A priority patent/AU528494B2/en
Priority to DE19792941281 priority patent/DE2941281A1/de
Priority to BE0/197601A priority patent/BE879356A/fr
Priority to NL7907532A priority patent/NL7907532A/nl
Priority to SE7908446A priority patent/SE443288B/sv
Priority to CA000337441A priority patent/CA1140705A/en
Priority to FR7925494A priority patent/FR2439005A1/fr
Priority to US06/084,323 priority patent/US4321711A/en
Publication of JPS5554951A publication Critical patent/JPS5554951A/ja
Publication of JPS6037735B2 publication Critical patent/JPS6037735B2/ja
Expired legal-status Critical Current

Links

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
    • A61L33/00—Antithrombogenic treatment of surgical articles, e.g. sutures, catheters, prostheses, or of articles for the manipulation or conditioning of blood; Materials for such treatment
    • A61L33/0005—Use of materials characterised by their function or physical properties
    • A61L33/0011—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate
    • A61L33/0029—Anticoagulant, e.g. heparin, platelet aggregation inhibitor, fibrinolytic agent, other than enzymes, attached to the substrate using an intermediate layer of polymer
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/14—Macromolecular materials
    • A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/507—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials for artificial blood vessels
    • 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
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L27/56—Porous materials, e.g. foams or sponges

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Transplantation (AREA)
  • Epidemiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Medicinal Chemistry (AREA)
  • Dermatology (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Surgery (AREA)
  • Hematology (AREA)
  • Materials Engineering (AREA)
  • Dispersion Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Pulmonology (AREA)
  • Cardiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Materials For Medical Uses (AREA)
  • Prostheses (AREA)

Description

【発明の詳細な説明】 本発明はポリテトラフルオロェチレン（以下ＰＴＦＥと
略記する）多孔質チューブを主体とする人工血管に関す
るもので、特にその内腔面のみ抗凝血性能を高めると共
に、出血の防止と強度の向上及び外表面の生体組織結合
性の改善を目的とするものである。
延伸法により製造されたＰＴＦＥ多孔質チューブが人工
血管として臨床的に使用し得ることは多く報告されてお
り、従来の編物、織物から成る人工血管より優れたもの
であるとされている。
延伸処理を受けたＰＴＦＥチューブは非常に細い繊維と
その繊維により互に連結された結節とから成るミクロ構
造を有しており、この繊維の径は延伸処理条件によって
変化するが、上述の編物、織物用の綾維よりもはるかに
小さくすることが出来る。しかもその径と気孔率は自由
に変化し得るため、人工血管として使用される場合には
、柔軟で血栓を生じることもほとんどなく、内腔面に於
ける新生内膜形成性も良好で、周囲の組織への為害性も
認められないことから、最も優れた人工血管の１つであ
るとされている。しかしこの延伸により製造されたＰＴ
ＦＥ多孔質チューブでも血栓を生じないものではなく、
更に改善が望まれている。
また人工血管として生体と吻合する際に縫合針や縫合糸
がチューブを引裂いてしまう傾向にあることが問題とさ
れている。またＰＴＦＥ多孔質チューブの弾性のみでは
縫合孔の自然閉塞も困難であり、吻合後も出血が認めら
れることがある。更にＰＴＦＥ多孔質チューブの外表面
と周囲の生体組織との結合性が低いことも問題となつて
いる。本発明はこれらの問題を解決したもので、抗凝血
性物質を含有するＰＴＦＥ多孔質チューブの外表面に、
該抗凝血性物質に対する阻害物質を含有する多孔質ェラ
ストマー被覆が結合して成る人工血管を提供するもので
ある。
本発明の人工血管は抗凝血性物質を含有するため内腔面
に血栓を生じることがなく、多孔質ェラストマー被覆に
よりチューブの裂けの問題もなくまたその弾性により縫
合孔は自然閉塞するに加え万一縫合部等から出血しても
被覆部分に含有される阻害物質により止血される。この
阻害物質は更に抗凝血性物質の漏れに伴う出血をも防止
することになる。更に周囲の生体組織との結合性も多孔
質ェラストマー被覆により高められたものである。本発
明が対象とするＰＴＦＥ多孔質チューブは、特公昭４２
−１３５６０に記載の方法により製造される。
先ずＰＴＦＥ禾暁続粉末に液状潤滑剤を混和しラム式押
出機によってチューブ状に押出す。このチューブから液
状潤滑剤を除去しあるいは除去せずしてチューブを少な
くとも１軸万向に延伸する。収縮が起らないように固定
しながら暁結温度の３２７０以上に加熱して、延伸、膨
張した構造を焼結固定すると強度の向上したチューブが
得られる。このようにして得られるＰＴＦＥ多孔質チュ
ーブは非常に細い繊維とその繊維により互に連結された
結節とから成るミクロ構造を有しており、その繊維径と
長さ、結節の大きさやそれらの数は延伸と焼結の条件に
より変化させ得るため、得られる多孔質体の孔径と気孔
率も自由に決定し得る。人工血管としてのこのチューブ
の適当な孔径と気孔率の範囲は、平均孔径が２〜数十仏
の、気孔率が７０％以上、チューブの肉厚が０．３〜１
．仇肋であることが臨床的に確認されている。本発明の
好ましいミクロ繊維構造は繊維方向が１方向のみに分布
したものより放射状に分布したものである。
このような繊維構造はＰＴＦＥチューブの２鞠延伸良Ｐ
ち管軸万向への延伸及び径の膨張を行なうことにより得
られるものである。径の膨張は加熱下でチューブの外表
面を減圧するか内腔面を加圧することによって、あるい
は両方法を同時に行なうことで達成される。また適当な
形状の物体をチューブ内腔に挿入通過させて機械的な径
の拡大を行なっても達成される。このチューブの管軸方
向への延伸と径の膨張は同時に、あるいは逐次的に行な
われる。また最後の焼結過程と同時に行なうことも可能
である。この２鞠延伸法により得られるＰＴＦＥ多孔質
チューブは、管軸方向のみの延伸により得られるＰＴＦ
Ｅ多孔質チューブに比べ繊維方向が管融方向だけでなく
あらゆる方向に放射状に分布しているため、非常に柔軟
でしかもチューブの縦裂けも起り難くなっているが、人
工血管として使用するには一層の改善が望まれる。本発
明の多孔質ェラストマ−被覆は、チューフの裂けの防止
、縫合孔の自然閉塞による止血、周囲の生体組織との結
合性向上等を目的とするものである。
ェラストマーとしては生体に対する為害性の低いもので
あれば特に限定されないが、その例としては、弗素ゴム
、シリコンゴム、ウレタンゴム、アクリルゴム、天然ゴ
ム等が挙げられる。通常ェラストマーは架橋して用いら
れるが、本発明に於いても生体内での劣化を防ぐ意味で
架橋したものである方が好ましい。人工血管としては、
多孔質ェラストマー被覆の平均孔径は数十〜数百仏肌の
範囲が適当であり、また被覆層の厚さはＰＴＦＥ多孔質
チューブの肉厚と同程度かそれ以下で充分である。
ＰＴＦＥ多孔質チューブの外表面に多孔費ェラストマ−
被覆を形成するには、予め多孔質としたェラストマーの
シートを巻付けて接着する方法、発泡剤を含むェラスト
マー配合物溶液を塗布して発泡剤を分解させる方法、可
溶性物質を分散させたェラストマー配合物溶液を塗布し
て溶出により多孔質とする方法、ェラストマー配合物を
溶媒と非溶媒の混合系に溶解させて塗布後乾燥過程で多
孔質化させる方法、あるいはェラストマー配合物溶液を
塗布後非溶媒俗に浸潰したり溶媒の沸点以上の温度に加
熱して残留溶媒を抜出すことにより多孔質とする方法等
を適用することが可能であるがＰＴＦＥ多孔質チューブ
の外表面にェラストマー配合物溶液を塗布し、乾燥前に
チューブ内腔から気体又は液体により加圧して発泡させ
、その後架橋することにより多孔質ェラストマー被覆を
形成させる方法が本発明の目的には最も適当であった。
ここでェラストマー配合物とはェラストマーに架橋剤等
を配合したものを言う。このようにして得られたＰＴＦ
Ｅ多孔質チューフの外表面に多孔質ェラストマー被覆が
結合した構造物に於て、本発明ではＰＴＦＥ多孔質チュ
ーブ部分は抗凝血性物質を含有し、多孔質ェラストマー
被覆部分は該抗凝血性物質に対する阻害物質を含有する
。
抗凝血性物質はＰＴＦＥ多孔質チューブの内腔面の抗凝
血性能を一段と高め、血栓の生じない高い開存率を示す
人工血管とするためのものであり、ＰＴＦＥ多孔質チュ
ーブの多孔性空間内に設けられる。抗凝血性物質はＰＴ
ＦＥ多孔質チューフの多孔性空間内全体にわたって均一
に設けてもよいが、好ましくはチューブ内腔面のみに設
けるのがよい。抗凝血怪物質の例としてはへパリン又は
その誘導体、コンドロィチン硫酸、カロニン硫酸等の多
糖類硫酸ェステル類やクエン酸等の有機酸類が挙げられ
るが、最も効果が大きく入手も容易なものはへパリンナ
トリゥムである。抗凝血性物質をＰＴＦＥ多孔質チュー
ブの多孔性空間内に設けるには、直接チューブに抗凝血
性物質の溶液を合浸して乾燥させる方法でもよく、また
多孔性空間内に高分子ゲル等を設けてそれに保持させる
方法でもよい。抗凝血性能の持続性に関しては一般に後
者の方法が良好な結果を与える。高分子ゲルに用いられ
る材料の例としては、ポリビニルアルコール、ポリエチ
レンオキシド、ポリエチレングリコール、ポリビニルピ
ロリドン、ポリアクリル酸等の合成水溶性高分子や、セ
ルロース誘導体、ペクチン、アルギン酸等の天然親水性
高分子が挙げられる。抗凝血性物質はこれらの高分子溶
液中に混入し、ＰＴＦＥ多好質チューブの多孔性空間内
に合浸した後、それぞれの高分子に応じた方法でゲル化
固定することによりチューブに保持させられる。更に高
分子としてポリエチレンィミン、ポリビニルアミン等の
アミン類を用い、その溶液をＰＴＦＥ多孔質チューブの
多孔性空間内に含浸後架橋固定し、第四級化反応を行な
い、それとへパリンナトリウム溶液等を接触させてイオ
ン結合させる方法も有効であった。イオン結合によりへ
パリン等を結合したものは他の結合方法に比べその抗凝
血効果が優れ、しかも長期間効果が持続するという特徴
が見出されており、本発明に於てもこの結合方法が最も
効果的であった。抗凝血性物質を保持させるに於てこの
ような親水性高分子を用いると、溌水性の強いＰＴＦＥ
表面に、親水性部分をも設けたことになり、溌水性と親
水性のバランスによる抗凝血効果をも示すことになり、
抗凝血性物質の作用と相まって優れた特性を有する人工
血管を提供することになる。ＰＴＦＥ多孔質チューフに
含浸される高分子溶液の濃度は通常１０％以下で充分で
あり、また抗凝血性物質の濃度は例えばへパリンナトリ
ウムの場合０．２〜５％の範囲が適当であった。含浸の
操作はＰＴＦＥ多孔質チューブの内腔面からのみ行なう
方がチューブ内腔面のみ抗凝血性能が高められて好都合
である。本発明の抗凝血性物質に対する阻害物質は、多
孔質ェラストマー被覆部分に含有されて、出血防止の役
割を持つものである。
ここでの阻害物質とは、チューブ内腔面の抗凝血性物質
とは逆の作用を示す物質、あるいはその機能を低下させ
るか無効にする物質を含むものである。阻害物質の例と
しては、シリカ、アルミナ、カーボンブラック、活性炭
等の無機あるいは有機の凝血性物質や抗凝血性物質に対
する桔抗剤を挙げられる。へバリンに対する桔抗剤とし
ては、プロタミン又はその誘導体貝０ち硫酸プロタミン
、プロタミン亜鉛等がその代表例である。これらの阻害
物質はェラストマー中に混入して、即ちェラストマーの
充填剤として用いてもよく、また多孔質ェラストマー被
覆の多孔性空間内に設けてもよい。ヱラストマー中に混
入する場合にはェラストマー重量の１０％以下の量で充
分であり、またェラストマ−の多孔性空間内に設ける場
合には更に少量でよいが、抗凝血性物質の全量を無効に
する必要な量よりは多く使用するのが望ましい。以上詳
述した如く本発明の人工血管はＰＴＦＥ多孔質チューブ
を主体とする人工血管を改良すると共に更に高度の機能
をも付与したもので従来にない特性を有するものである
。

Claims (1)

  1. 【特許請求の範囲】 １ 抗凝血性物質を含有するポリテトラフルオロエチレ
    ン多孔質チユーブの外表面に、該抗凝血性物質に対する
    阻害物質を含有する多孔質エラストマー被覆が結合して
    成る人工血管。 ２ 抗凝血性物質がヘパリン又はその誘導体である特許
    請求の範囲第１項記載の人工血管。 ３ 阻害物質が無機あるいは有機の凝血性物質である特
    許請求の範囲第１項記載の人工血管。 ４ 阻害物質がヘパリン拮抗剤である特許請求の範囲第
    １項記載の人工血管。 ５ ヘパリン拮抗剤がプロタミン又はその誘導体である
    特許請求の範囲第４項記載の人工血管。
JP53128695A 1978-10-18 1978-10-18 人工血管 Expired JPS6037735B2 (ja)

Priority Applications (11)

Application Number Priority Date Filing Date Title
JP53128695A JPS6037735B2 (ja) 1978-10-18 1978-10-18 人工血管
GB7935248A GB2033232B (en) 1978-10-18 1979-10-10 Vascular prosthesis
IT50513/79A IT1128744B (it) 1978-10-18 1979-10-10 Protesi vascolare in tubo di polite trafluoro-etilene
AU51695/79A AU528494B2 (en) 1978-10-18 1979-10-11 A vascular prosthesis
DE19792941281 DE2941281A1 (de) 1978-10-18 1979-10-11 Gefaessprothese
BE0/197601A BE879356A (fr) 1978-10-18 1979-10-11 Prothese vasculaire
NL7907532A NL7907532A (nl) 1978-10-18 1979-10-11 Vaatprotese.
SE7908446A SE443288B (sv) 1978-10-18 1979-10-11 Vaskuler protes
CA000337441A CA1140705A (en) 1978-10-18 1979-10-12 Vascular prosthesis
FR7925494A FR2439005A1 (fr) 1978-10-18 1979-10-12 Prothese vasculaire
US06/084,323 US4321711A (en) 1978-10-18 1979-10-12 Vascular prosthesis

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JP53128695A JPS6037735B2 (ja) 1978-10-18 1978-10-18 人工血管

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JPS6037735B2 true JPS6037735B2 (ja) 1985-08-28

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AU (1) AU528494B2 (ja)
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CA (1) CA1140705A (ja)
DE (1) DE2941281A1 (ja)
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GB (1) GB2033232B (ja)
IT (1) IT1128744B (ja)
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SE443288B (sv) 1986-02-24
IT1128744B (it) 1986-06-04
FR2439005A1 (fr) 1980-05-16
NL7907532A (nl) 1980-04-22
DE2941281A1 (de) 1980-04-24
AU528494B2 (en) 1983-04-28
US4321711A (en) 1982-03-30
GB2033232B (en) 1983-03-02
JPS5554951A (en) 1980-04-22
AU5169579A (en) 1980-04-24
GB2033232A (en) 1980-05-21
SE7908446L (sv) 1980-04-19
FR2439005B1 (ja) 1984-11-30
CA1140705A (en) 1983-02-08
IT7950513A0 (it) 1979-10-10
BE879356A (fr) 1980-02-01

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