JPS62217968A - Production of base material for artificial blood vessel - Google Patents
Production of base material for artificial blood vesselInfo
- Publication number
- JPS62217968A JPS62217968A JP61052353A JP5235386A JPS62217968A JP S62217968 A JPS62217968 A JP S62217968A JP 61052353 A JP61052353 A JP 61052353A JP 5235386 A JP5235386 A JP 5235386A JP S62217968 A JPS62217968 A JP S62217968A
- Authority
- JP
- Japan
- Prior art keywords
- base material
- artificial blood
- tubular
- blood vessel
- solvent
- 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.)
- Granted
Links
- 239000000463 material Substances 0.000 title claims description 46
- 210000004204 blood vessel Anatomy 0.000 title claims description 23
- 239000002473 artificial blood Substances 0.000 title claims description 20
- 238000004519 manufacturing process Methods 0.000 title claims description 12
- 229920001971 elastomer Polymers 0.000 claims description 14
- 239000000806 elastomer Substances 0.000 claims description 14
- 239000011148 porous material Substances 0.000 claims description 14
- 239000002904 solvent Substances 0.000 claims description 13
- 150000003839 salts Chemical class 0.000 claims description 9
- 239000002253 acid Substances 0.000 claims description 4
- 238000000034 method Methods 0.000 description 11
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 9
- WYURNTSHIVDZCO-UHFFFAOYSA-N Tetrahydrofuran Chemical compound C1CCOC1 WYURNTSHIVDZCO-UHFFFAOYSA-N 0.000 description 8
- 238000005452 bending Methods 0.000 description 8
- 239000004721 Polyphenylene oxide Substances 0.000 description 7
- 229920000570 polyether Polymers 0.000 description 7
- 229920002635 polyurethane Polymers 0.000 description 7
- 239000004814 polyurethane Substances 0.000 description 7
- 239000000047 product Substances 0.000 description 7
- VTYYLEPIZMXCLO-UHFFFAOYSA-L Calcium carbonate Chemical compound [Ca+2].[O-]C([O-])=O VTYYLEPIZMXCLO-UHFFFAOYSA-L 0.000 description 6
- 238000000576 coating method Methods 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 239000011248 coating agent Substances 0.000 description 5
- 238000001125 extrusion Methods 0.000 description 5
- 239000002245 particle Substances 0.000 description 5
- YLQBMQCUIZJEEH-UHFFFAOYSA-N tetrahydrofuran Natural products C=1C=COC=1 YLQBMQCUIZJEEH-UHFFFAOYSA-N 0.000 description 4
- ZMXDDKWLCZADIW-UHFFFAOYSA-N N,N-Dimethylformamide Chemical compound CN(C)C=O ZMXDDKWLCZADIW-UHFFFAOYSA-N 0.000 description 3
- 208000007536 Thrombosis Diseases 0.000 description 3
- 239000008280 blood Substances 0.000 description 3
- 210000004369 blood Anatomy 0.000 description 3
- 229910000019 calcium carbonate Inorganic materials 0.000 description 3
- 239000000395 magnesium oxide Substances 0.000 description 3
- CPLXHLVBOLITMK-UHFFFAOYSA-N magnesium oxide Inorganic materials [Mg]=O CPLXHLVBOLITMK-UHFFFAOYSA-N 0.000 description 3
- AXZKOIWUVFPNLO-UHFFFAOYSA-N magnesium;oxygen(2-) Chemical compound [O-2].[Mg+2] AXZKOIWUVFPNLO-UHFFFAOYSA-N 0.000 description 3
- 229920003226 polyurethane urea Polymers 0.000 description 3
- UIIMBOGNXHQVGW-UHFFFAOYSA-M Sodium bicarbonate Chemical compound [Na+].OC([O-])=O UIIMBOGNXHQVGW-UHFFFAOYSA-M 0.000 description 2
- QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 description 2
- 230000003872 anastomosis Effects 0.000 description 2
- 230000015572 biosynthetic process Effects 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 239000010954 inorganic particle Substances 0.000 description 2
- 239000007788 liquid Substances 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 229920005573 silicon-containing polymer Polymers 0.000 description 2
- 239000002002 slurry Substances 0.000 description 2
- 206010002329 Aneurysm Diseases 0.000 description 1
- 239000004604 Blowing Agent Substances 0.000 description 1
- 229920004934 Dacron® Polymers 0.000 description 1
- UFHFLCQGNIYNRP-UHFFFAOYSA-N Hydrogen Chemical compound [H][H] UFHFLCQGNIYNRP-UHFFFAOYSA-N 0.000 description 1
- GRYLNZFGIOXLOG-UHFFFAOYSA-N Nitric acid Chemical compound O[N+]([O-])=O GRYLNZFGIOXLOG-UHFFFAOYSA-N 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 230000036772 blood pressure Effects 0.000 description 1
- 230000001112 coagulating effect Effects 0.000 description 1
- 230000006866 deterioration Effects 0.000 description 1
- 238000007598 dipping method Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000001704 evaporation Methods 0.000 description 1
- 239000000835 fiber Substances 0.000 description 1
- 239000012467 final product Substances 0.000 description 1
- 239000001257 hydrogen Substances 0.000 description 1
- 229910052739 hydrogen Inorganic materials 0.000 description 1
- 229920001477 hydrophilic polymer Polymers 0.000 description 1
- VTHJTEIRLNZDEV-UHFFFAOYSA-L magnesium dihydroxide Chemical compound [OH-].[OH-].[Mg+2] VTHJTEIRLNZDEV-UHFFFAOYSA-L 0.000 description 1
- 239000000347 magnesium hydroxide Substances 0.000 description 1
- 229910001862 magnesium hydroxide Inorganic materials 0.000 description 1
- 239000000155 melt Substances 0.000 description 1
- 238000002844 melting Methods 0.000 description 1
- 230000008018 melting Effects 0.000 description 1
- 239000012528 membrane Substances 0.000 description 1
- 238000000465 moulding Methods 0.000 description 1
- 229910017604 nitric acid Inorganic materials 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 239000005020 polyethylene terephthalate Substances 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 229910000030 sodium bicarbonate Inorganic materials 0.000 description 1
- 235000017557 sodium bicarbonate Nutrition 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000758 substrate 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、人工血管用基材の製造方法に関し、とりわり
小口径の人工血管用基材に適したポリウレタン系の人工
血管用基材の製造方法に関する。Detailed Description of the Invention (Industrial Application Field) The present invention relates to a method for producing a base material for an artificial blood vessel, and in particular to a method for producing a base material for an artificial blood vessel made of polyurethane, which is suitable for a base material for an artificial blood vessel with a small diameter. Regarding the manufacturing method.
（従来技術その問題点）
人工血管用基材としては、ダクロンなどの繊維を管状に
編組したものや、テフロン系、例えばボアテックスの多
孔性物質によるものが公知である。(Problems with Prior Art) Known base materials for artificial blood vessels include those made of fibers such as Dacron braided into a tubular shape, and those made of porous materials such as Teflon, such as Votex.
この種の基材を人工血管として生体中に使用するときに
は、中空管状の基材の内壁に予め血栓を形成し、その内
面上に偽内膜を形成させて、その内側を血液が流れるよ
うな態様で使用されており、この点から管径を小さくす
ると、血栓そのもので、人工血管用基材を閉塞に到らし
める慣れがある。When this type of base material is used as an artificial blood vessel in a living body, a thrombus is formed on the inner wall of the hollow tubular base material in advance, and a pseudointima is formed on the inner surface of the base material to allow blood to flow inside. If the tube diameter is made small from this point of view, the blood clot itself tends to cause occlusion of the artificial blood vessel substrate.
このため、従来より汎用されているこれらの人工血管用
基材は、内径５Ｍ程度以下の微小口径の血管の代替とし
ては適さないとされている。For this reason, these base materials for artificial blood vessels, which have been widely used in the past, are not suitable as a substitute for blood vessels with minute diameters of about 5M or less.
一方、人工血管用基材の内壁に親水性のポリマーなどを
グラフトすることによって内壁への血栓の生成を防止す
る方法が提案されており、この方法によれば小口径の人
工血管も可能となるが、基材自体には当然ながら、生体
適合性、屈曲に対する耐性、可撓性、吻合適合性などが
要求され、これらの性能が満足される基材は未だ開発さ
れていない。On the other hand, a method has been proposed to prevent the formation of blood clots on the inner wall of the base material for artificial blood vessels by grafting a hydrophilic polymer onto the inner wall, and this method makes it possible to create small-diameter artificial blood vessels. However, the base material itself is naturally required to have biocompatibility, resistance to bending, flexibility, anastomosis compatibility, etc., and a base material that satisfies these properties has not yet been developed.
特に、人工血管用基材は湾曲させて使用されることが多
いので、ある程度曲げた状態で基材が閉塞されることが
ない性質、すなわち耐屈曲性を有することが必要となる
。In particular, since the base material for artificial blood vessels is often used in a curved state, it is necessary that the base material has the property of not being occluded even when bent to a certain extent, that is, has bending resistance.
管の肉厚を増すことによってこの性質は改善されるが、
単純に肉厚を増しただけでは断面積が大きくなりすぎて
血圧の変化による管径の変化が宿主血管のそれとの差が
大きくなり、宿主血管にスｊ・レスを与え、動脈瘤や吻
合部の同突などの結果を引き起すおそれがある。このた
めには実質断面積を増加することなく見掛は断面積を大
きくする多孔質化が有効な手段となる。This property can be improved by increasing the wall thickness of the tube, but
If the wall thickness is simply increased, the cross-sectional area will become too large, and changes in tube diameter due to changes in blood pressure will have a large difference from that of the host blood vessel, causing damage to the host blood vessel and causing aneurysms and anastomoses. There is a risk that this could lead to a collision between two vehicles. For this purpose, an effective means is to make the material porous, which increases the apparent cross-sectional area without increasing the actual cross-sectional area.
多孔質化により良好な耐屈曲性を発現させるには、管の
外層から内層迄気孔が連なった連続気孔が望ましく、発
泡剤を添加した独立性気泡構造は好ましくない。In order to develop good bending resistance by making the tube porous, it is preferable that the tube has continuous pores from the outer layer to the inner layer, and a closed cell structure in which a blowing agent is added is not preferable.
また、人工血管用基材として血液をよどむことなく流通
させ、且つその漏洩を防ぐためには、内面に極く薄い平
滑膜を形成することが望ましい。Furthermore, in order to allow blood to flow without stagnation and prevent leakage as a base material for an artificial blood vessel, it is desirable to form an extremely thin smooth membrane on the inner surface.
ところで、生体適合性に優れたエラストマー材料として
ポリエーテル−ポリウレタンによる人工血管用基材が特
開昭５７−１５０９５４号公報に開示されている。この
公報に示されている人工血管用基材の製造方法は、塩粒
子を含まないスラリーと含むスラリーをマンドレル（心
棒）上にディッピング、コーティング、ドクタリングな
どによって複数のゾーンを形成し、しかる後このマンド
レル上のコーティングを乾燥して溶媒を除去し、次いで
水浴中で塩または炭酸水素ナトリウム粒子を除去して多
孔質の管状物を得る方法である。By the way, as an elastomer material with excellent biocompatibility, an artificial blood vessel base material made of polyether-polyurethane is disclosed in Japanese Patent Laid-Open No. 150954/1983. The method for producing the base material for artificial blood vessels described in this publication involves forming multiple zones on a mandrel by dipping, coating, doctoring, etc. a slurry that does not contain salt particles and a slurry that contains salt particles, and then The coating on the mandrel is dried to remove the solvent and then the salt or sodium bicarbonate particles are removed in a water bath to obtain a porous tube.
しかし、この方法では、スラリー状のものをマンドレル
上にコーティングするため、ゾーン毎に均一の厚さにす
るには、薄いコーティングを複数回に分けて行なうこと
になるので、周方向、＠方向の双方に均一にコーティン
グすることが難しく、かなりの工数を必要とし、生産性
、均一性の点で問題がある。However, in this method, a slurry-like material is coated on the mandrel, so thin coatings must be applied multiple times in order to achieve a uniform thickness in each zone. It is difficult to uniformly coat both surfaces, requiring a considerable number of man-hours, and there are problems in terms of productivity and uniformity.
一方、単に多孔性のエラストマーによる管状材を得るに
は、特開昭５９−２２５０５３号に示されているごとく
、弾性体ポリマーを溶媒に溶解し、さらに貧溶媒を添加
して、これをノズルから管状に押出し水などの凝固液に
よって内外層から同時に凝固させる方法があるが、この
場合は気孔は微細となり、また液面に直接する側には、
スキン層と呼ばれる非常に微細な孔径を持った層が生じ
、内部にいくに従って孔径が大きくなることや、耐屈曲
性の点で問題がある。On the other hand, in order to simply obtain a tubular material made of a porous elastomer, as shown in JP-A No. 59-225053, an elastic polymer is dissolved in a solvent, a poor solvent is added, and this is passed through a nozzle. There is a method in which the inner and outer layers are coagulated simultaneously using a coagulating liquid such as extruded water in a tubular shape, but in this case, the pores are fine, and the side facing directly to the liquid surface has
A layer with very fine pores called a skin layer is formed, and there are problems in that the pores become larger as they go deeper into the layer and in terms of bending resistance.
本発明は叙上の問題点に鑑みてなされたものであって、
エラストマーによって平滑な内層と連続気孔を有する外
層とからなる人工血管用基材の新規な製造方法を提供す
ることを目的とする。The present invention has been made in view of the above problems, and
The object of the present invention is to provide a novel method for producing a base material for an artificial blood vessel, which is made of an elastomer and has a smooth inner layer and an outer layer having continuous pores.
（発明の構成）
上記の目的を達成するための本発明の構成は、エラスト
マー材料を溶媒に溶解して、これに無機塩類を添加混合
し粘度を適宜調整した後、これを押出機に供給して所定
形状のダイより環状に押出した後所定長に切断する管状
物の製造工程と：この掛に前記管状物の溶媒を除去して
乾燥固化した後、その内面にエラストマー材料の溶液を
層状にコーティングした後に溶媒を除去して平滑な表面
を有する内層の形成工程と；
さらにこの後に酸で前記無機塩類を溶出して前記管状物
に連続気孔を有する外層を形成する気孔形成工程とから
なることを特徴とする。(Structure of the Invention) The structure of the present invention to achieve the above object is to dissolve an elastomer material in a solvent, add and mix inorganic salts thereto, adjust the viscosity as appropriate, and then supply this to an extruder. A manufacturing process of a tubular product in which the tubular product is extruded into a ring shape through a die of a predetermined shape and then cut into a predetermined length: In this process, the solvent of the tubular product is removed and the tubular product is dried and solidified, and then a solution of an elastomer material is layered on the inner surface of the tubular product. After coating, the method comprises a step of removing the solvent to form an inner layer having a smooth surface; and a pore forming step of eluting the inorganic salts with an acid to form an outer layer having continuous pores in the tubular article. It is characterized by
本発明の管状物製造工程と内層の成形工程で使用される
エラストマー材料としては、ポリウレタン、ポリウレタ
ンウレアあるいはこれらとシリコーンポリマーとのブレ
ンド物、シリコーンポリマーなどがあげられ、ポリウレ
タンあるいはポリウレタンウレアは生体内での耐久性の
面からポリエーテル型のものが、さらに好ましくはポリ
エーテルセグメント化ポリウレタンあるいはポリエーテ
ルセグメント化ポリウレタンウレアなどが挙げられる。The elastomer materials used in the tubular product manufacturing process and the inner layer molding process of the present invention include polyurethane, polyurethaneurea, blends of these with silicone polymers, and silicone polymers. From the viewpoint of durability, polyether type materials are more preferred, and polyether segmented polyurethane and polyether segmented polyurethane urea are more preferred.
また、本発明に使用できる溶媒は、エラストマー材料が
ポリエーテルセグメント化ポリウレタンもしくはポリエ
ーテルセグメント化ポリウレタンウレアに対しては、テ
トラヒドロフラン、ジメチルホルムアミドなどが挙げら
れる。Further, solvents that can be used in the present invention include tetrahydrofuran, dimethylformamide, etc. when the elastomer material is polyether segmented polyurethane or polyether segmented polyurethane urea.
添加混合される無１ｆｆｆｊｕ類としては、炭酸カルシ
ウム、酸化マグネシウム、水酸化マグネシウムなどがあ
げられ、事後において塩酸、硫酸、硝酸などの酸によっ
て溶出可能なものであればよく、添加量は連続気孔を形
成させる点からエラストマー１００重世部に対して５０
０重量部以上が望ましい。Examples of the non-1ffjus to be added and mixed include calcium carbonate, magnesium oxide, magnesium hydroxide, etc., as long as they can be eluted with acids such as hydrochloric acid, sulfuric acid, nitric acid, etc., and the amount added is such that continuous pores are maintained. From the point of formation, 50 to 100 parts of elastomer
0 parts by weight or more is desirable.
本発明に用いる押出様は、最終製品の形状に相応した環
状のダイを有するスクリュ一式の押出機、あるいはラム
式押出機などが好適であり、これらの押出機による押出
成形に適した粘度となるように供給する材料の粘度を、
溶媒を揮発させるなどの方法で調整する。また内層の形
成工程は、エラストマー溶液を管状物の内部へコーティ
ングすることにより行なうが、内管部が内径５Ｍ程度以
下であり、溶液も比較的粘稠であるような時は、管状物
の下端を溶液に浸し上端を吸引して溶液を下から上に吸
上げる方式や、ある程度の液圧で管状物中に溶液を満た
す方法などが、均一な塗膜を作る上から好ましい。As for the extrusion mode used in the present invention, a screw set extruder having an annular die corresponding to the shape of the final product or a ram type extruder are suitable, and the viscosity is suitable for extrusion molding with these extruders. The viscosity of the material to be supplied as,
Adjust by evaporating the solvent, etc. In addition, the process of forming the inner layer is performed by coating the inside of the tubular object with an elastomer solution, but if the inner tube has an inner diameter of approximately 5M or less and the solution is relatively viscous, the lower end of the tubular object may be coated with the elastomer solution. From the standpoint of creating a uniform coating, it is preferable to immerse the tube in a solution and suck up the solution from the bottom to the top by suctioning the upper end, or to fill the solution into a tubular object with a certain amount of hydraulic pressure.
（実施例） 以下に本発明の好適な実施例について説明する。(Example) Preferred embodiments of the present invention will be described below.
まず、ポリエーテルセグメント化ポリウレタン１００重
邑部をテトラヒドロフラン６００重量部に溶解し、粘稠
なポリマー溶液を得る。次にこれに平均粒径１．７μの
軽質炭酸カルシウム４５０重社部と、平均粒径２μの酸
化マグネシウム９０重量部とを加えて混練し、テトラヒ
ドロフランの一部を揮散させて、後述する測定法による
流出量が１．２５１／１０分程度の粘度のペースト状物
となし、これをスクリュ一式の押出１１ｉ１に供給して
内径３ ｔｒｙ ％外径４ｍの環状のダイ２より押出し
て、これを引取機３により引取りつつ、約５０〜６０ｃ
ｒｒｒの長さに切断した管状物Ａを製造する。そして管
状物Ａを、第２図に示すように水槽４に浸漬して脱溶媒
して固化し、さらにこれを充分乾燥させた。First, 100 parts by weight of polyether segmented polyurethane is dissolved in 600 parts by weight of tetrahydrofuran to obtain a viscous polymer solution. Next, 450 parts by weight of light calcium carbonate with an average particle size of 1.7 μm and 90 parts by weight of magnesium oxide with an average particle size of 2 μm are added and kneaded, and a part of the tetrahydrofuran is volatilized. A paste-like material with a viscosity of about 1.251/10 minutes is formed, and this is fed to an extruder 11i1 with a set of screws, extruded through an annular die 2 with an inner diameter of 3% and an outer diameter of 4m, and collected. Approximately 50~60c while being picked up by machine 3
A tubular article A cut to a length of rrr is manufactured. Then, the tubular material A was immersed in a water tank 4 to remove the solvent and solidify as shown in FIG. 2, and was then thoroughly dried.
第３図は管状物Ａの内面に内層７を形成する工程を示し
ており、この工程では管状物へ両端を切除した後、ポリ
エーテルセグメント化ポリウレタンをテトラヒドロフラ
ンに溶解した濃度５％の溶液５を収納した槽６中に、一
端を浸漬して立設状態に保持した後、他端を吸引するこ
とによって、下方から溶液５を上界させる操作を３回繰
返して、厚みが約５０μの内層７を形成した。FIG. 3 shows the process of forming an inner layer 7 on the inner surface of the tubular body A, in which, after cutting both ends of the tubular body, a solution 5 of polyether segmented polyurethane dissolved in tetrahydrofuran at a concentration of 5% is applied. The inner layer 7 with a thickness of approximately 50 μm was prepared by repeating the operation of immersing one end in the stored tank 6 and holding it in an upright state, and then sucking the other end to cause the solution 5 to flow upward from below three times. was formed.
しかる後、この管状物Ａの一端を水流アスピレータに約
５分間接続して内層７を乾燥した。次いでこの管状物Ａ
を外周を密閉して塩酸を満たした容器に浸漬し、減圧下
で無機塩（炭酸カルシウム及び酸化マグネシウム）と塩
酸との反応による水素の発生が見られなくなる迄処理し
無機塩を溶出させた。この後希塩酸で数回すすぎ、さら
に水洗して塩酸や無機物を洗滌除去した後、その多孔質
形状を保つために真空凍結乾燥法によって頁空度２ ｔ
ｎｍ Ｈｇ以下で１２時間乾燥した。Thereafter, one end of the tube A was connected to a water aspirator for about 5 minutes to dry the inner layer 7. Then this tubular object A
The sample was immersed in a container filled with hydrochloric acid with its outer periphery sealed, and treated under reduced pressure until hydrogen was no longer generated due to the reaction between the inorganic salts (calcium carbonate and magnesium oxide) and the hydrochloric acid, and the inorganic salts were eluted. After this, it was rinsed several times with diluted hydrochloric acid, and then washed with water to remove hydrochloric acid and inorganic substances, and then vacuum freeze-dried to maintain its porous shape with a page vacancy of 2 tons.
Dry for 12 hours below nm Hg.
このようにして得た多孔質状の人工血管用基材は内径的
３＃、外径的３．８６１ＩＩ＋で内径側には厚み約５０
μの実質的に無孔の内層７と、平均孔径が６〜１０μで
気孔率が８０％の外層８とから構成されていた。The porous artificial blood vessel base material thus obtained has an inner diameter of 3#, an outer diameter of 3.861II+, and a thickness of approximately 50mm on the inner diameter side.
It consisted of a substantially non-porous inner layer 7 of μ and an outer layer 8 with an average pore size of 6 to 10 μ and a porosity of 80%.
なお、押出機１に投入する前のペースト状原料の粘度は
、比較的粘度が高く、回転式粘度計などによっては測定
が困難であるので通常プラスチックの溶融指数の測定に
使用されるメルト・インディフサ−を用い、常温下で測
定した。シリンダー径９．５５Ｍ１オリフィス径２．０
９６ｍ、オリフィス長さ８．００ｍのものを用い、荷重
２１６０ｇ、８５５０ｇで測定した場合、感覚的に（イ
）やわらかい（ロ）少しやわらかい（ハ）硬いの３通り
の粘度の異なるサンプルについて第１表の結果が得られ
た。Note that the viscosity of the paste raw material before being fed into the extruder 1 is relatively high and difficult to measure using a rotational viscometer, so a melt indiffsaner, which is usually used to measure the melting index of plastics, is used. - was measured at room temperature. Cylinder diameter 9.55M1 Orifice diameter 2.0
Table 1 shows samples with three different viscosities: (a) soft, (b) slightly soft, and (c) hard, when measured at loads of 2,160 g and 8,550 g using a sample with an orifice length of 96 m and an orifice length of 8.00 m. The results were obtained.
この結果よりダイ２より押出して管状物Ａを１ｑるには
、２１６０ｇの荷重で２．０ｇ／１０分程度から８８５
０ｇ荷重で２．０ｇ／１０分程度が望ましい。From this result, in order to extrude 1q of tubular material A from die 2, it takes 885 to 2.0g/10 minutes at a load of 2160g.
Approximately 2.0 g/10 minutes at 0 g load is desirable.
上記の実施例で１与られた人工血管用基材の耐屈曲性は
、折り曲げによって管の内部が閉塞する曲げ直径が４０
ｍｍで実用上要求される値を満足するものであった。The bending resistance of the artificial blood vessel base material given in Example 1 above is such that the bending diameter at which the inside of the tube is occluded by bending is 40 mm.
mm, which satisfied the practically required value.
（発明の作用、効果）
以上詳細に説明したように本発明による多孔質人工血管
用基材の製造方法は、■ラストマー材料に溶媒および所
定量の無機粒子を添加してこれを押出成形する方法によ
るので、内径、外径の精度が良好なものが得られ、これ
に所要の厚みの平滑層を形成させるごとくエラストマー
溶液をコーティングさせるので、比較的容易に血液の漏
洩を防ぐ作用をなす内層が形成でき、しかる後無機粒子
を酸により溶出して外層の多孔質層を形成するので、気
孔は外層から内層側へ連続したものとなり、この人工血
管用基材を折り曲げても、圧縮側あるいは引張側への応
力が気孔部で分散するためか閉塞が起こりにくくなって
耐屈曲性の向上した基材が得られる。(Operations and Effects of the Invention) As explained above in detail, the method for manufacturing the porous artificial blood vessel base material according to the present invention is: (1) A method of adding a solvent and a predetermined amount of inorganic particles to a lastomer material and extrusion molding the same. As a result, a product with good accuracy in inner and outer diameters can be obtained, and since it is coated with an elastomer solution to form a smooth layer of the required thickness, it is relatively easy to form an inner layer that prevents blood leakage. After that, the inorganic particles are eluted with acid to form the outer porous layer, so the pores are continuous from the outer layer to the inner layer. Possibly because the stress on the sides is dispersed in the pores, blockage is less likely to occur, resulting in a base material with improved bending resistance.
また、押出成形にあたっては、特に熱を使用しないので
、エラストマー基材の変質もなく、また、押出装置の費
用あるいはエネルギーコストの削減もできる。Furthermore, since no heat is used during extrusion molding, there is no deterioration of the elastomer base material, and the cost of extrusion equipment or energy cost can be reduced.
第１図から第３図は本発明による人工血管用基材の製造
工程の一例を順に示す概略図、第４図は同製造方法によ
って得られた基材の部分断面模式１・・・押出機
２・・・ダ イ３・・・引取機 ４・
・・水 槽７・・・内 層 ８・・・外 層
Ａ・・・管状物
第 １ 図 ｆ、剥＊りＰ４Ｆ
第３図
第２図
第４図Figures 1 to 3 are schematic diagrams sequentially showing an example of the manufacturing process of the base material for artificial blood vessels according to the present invention, and Figure 4 is a partial cross-sectional schematic diagram of the base material obtained by the same manufacturing method 1...Extruder
2...Die 3...Collection machine 4.
...Water tank 7...Inner layer 8...Outer layer A...Tubular material Fig. 1 f, peeling P4F Fig. 3 Fig. 2 Fig. 4
Claims (1)
添加混合し粘度を適宜調整した後、これを押出機に供給
して所定形状のダイより環状に押出した後所定長に切断
する管状物の製造工程と；この後に前記管状物の溶媒を
除去して乾燥固化した後、その内面にエラストマー材料
の溶液を層状にコーティングした後に溶媒を除去して平
滑な表面を有する内層の形成工程と； さらにこの後に酸で前記無機塩類を溶出して前記管状物
に連続気孔を有する外層を形成する気孔形成工程とから
なることを特徴とする人工血管用基材の製造方法。[Claims] The elastomer material is dissolved in a solvent, inorganic salts are added and mixed to suitably adjust the viscosity, and then the solution is fed to an extruder and extruded into a circular shape through a die of a predetermined shape to a predetermined length. After that, the solvent of the tubular material is removed, the tubular material is dried and solidified, and the inner surface of the tubular material is coated with a layer of a solution of the elastomer material, and the solvent is removed to form an inner layer with a smooth surface. A method for producing a base material for an artificial blood vessel, comprising: a forming step; and a pore forming step of eluting the inorganic salts with an acid to form an outer layer having continuous pores in the tubular article.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61052353A JPH074420B2 (en) | 1986-03-12 | 1986-03-12 | Method for manufacturing base material for artificial blood vessel |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP61052353A JPH074420B2 (en) | 1986-03-12 | 1986-03-12 | Method for manufacturing base material for artificial blood vessel |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS62217968A true JPS62217968A (en) | 1987-09-25 |
| JPH074420B2 JPH074420B2 (en) | 1995-01-25 |
Family
ID=12912444
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP61052353A Expired - Lifetime JPH074420B2 (en) | 1986-03-12 | 1986-03-12 | Method for manufacturing base material for artificial blood vessel |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JPH074420B2 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2005080927A (en) * | 2003-09-09 | 2005-03-31 | Jms Co Ltd | Production method of medical porous body |
| JP2006521907A (en) * | 2002-10-23 | 2006-09-28 | ザ バイオメリックス コーポレーション | Aneurysm treatment device and method |
| JP2007268239A (en) * | 2006-03-07 | 2007-10-18 | National Cardiovascular Center | Artificial blood vessel |
-
1986
- 1986-03-12 JP JP61052353A patent/JPH074420B2/en not_active Expired - Lifetime
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2006521907A (en) * | 2002-10-23 | 2006-09-28 | ザ バイオメリックス コーポレーション | Aneurysm treatment device and method |
| JP2005080927A (en) * | 2003-09-09 | 2005-03-31 | Jms Co Ltd | Production method of medical porous body |
| JP2007268239A (en) * | 2006-03-07 | 2007-10-18 | National Cardiovascular Center | Artificial blood vessel |
Also Published As
| Publication number | Publication date |
|---|---|
| JPH074420B2 (en) | 1995-01-25 |
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