JP3201927B2 - Puncture-resistant medical material and puncture-resistant medical tubular structure - Google Patents
Puncture-resistant medical material and puncture-resistant medical tubular structureInfo
- Publication number
- JP3201927B2 JP3201927B2 JP10350795A JP10350795A JP3201927B2 JP 3201927 B2 JP3201927 B2 JP 3201927B2 JP 10350795 A JP10350795 A JP 10350795A JP 10350795 A JP10350795 A JP 10350795A JP 3201927 B2 JP3201927 B2 JP 3201927B2
- Authority
- JP
- Japan
- Prior art keywords
- puncture
- resistant medical
- tubular structure
- olefin
- elastomer
- 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.)
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Description
【０００１】[0001]
【産業上の利用分野】本発明は、頻回穿刺が行われる部
位において使用され穿刺耐性、および生体適合性を有す
る医療用材料および穿刺耐性医療用管状構造体に関す
る。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a puncture-resistant, biocompatible medical material and a puncture-resistant medical tubular structure used at a site where frequent punctures are performed.
【０００２】[0002]
【従来の技術】従来、穿刺を必要とし、かつ生体と接触
する部位に使用される医療材料としては、ポリウレタン
やシリコーンゴム、あるいはダクロンからなる織り編み
物やフェルト、あるいはテフロンからなる延伸物、フェ
ルトなどが用いられてきた。2. Description of the Related Art Conventionally, medical materials used for sites requiring puncture and coming into contact with a living body include woven or knitted fabrics or felts made of polyurethane, silicone rubber, or Dacron, stretched materials made of Teflon, felts, and the like. Has been used.
【０００３】[0003]
【発明が解決しようとする課題】しかしながらこれらの
医用材料は、穿刺耐性、生体適合性が好ましくなく長期
間生体と接触する部位に使用すると種々の問題が発生す
る。例えば、透析用シャントグラフトでは、頻回の穿刺
により血液漏出が認められたり、細菌感染の温床となり
潰瘍が形成され、あるいは慢性炎症が持続することによ
り機能が発揮できず、しかたなく抜去したり、再手術を
行う等などの問題が生じて患者の受ける肉体的、経済的
負担は計り知れなく大きいものであった。However, these medical materials have various problems when they are used for a site which is not preferable in terms of puncture resistance and biocompatibility and is in contact with a living body for a long period of time. For example, in shunt grafts for dialysis, blood leaks are observed due to frequent punctures, ulcers are formed as a hotbed of bacterial infection, or chronic inflammation persists, the function can not be exhibited due to persistent, inevitable removal, The physical and economic burden on the patient due to problems such as reoperation has been enormous.
【０００４】[0004]
【課題を解決するための手段】本発明者らは、頻回の穿
刺に耐えられ、しかも生体適合性に優れる医療材料に関
して鋭意検討した結果、以下の本発明を完成するに至っ
た。本発明は、スチレン系エラストマーおよび／または
オレフィン系エラストマー１００重量部に対してスクワ
ランを２０重量部以上混合した樹脂からなる層に、オレ
フィン系エラストマー不織布から構成される層が積層さ
れていることを特徴とする穿刺耐性医療用材料である。
また本発明は、多層構造を有する管状構造体において、
内層側にスチレン系エラストマーおよび／またはオレフ
ィン系エラストマー１００重量部に対してスクワランを
２０重量部以上混合した樹脂からなる層、外層側にオレ
フィン系エラストマー不織布から構成される層が設けら
れていることを特徴とする穿刺耐性医療用管状構造体で
ある。Means for Solving the Problems The present inventors have made intensive studies on medical materials that can withstand frequent punctures and have excellent biocompatibility, and as a result, have completed the present invention described below. The present invention relates to a squeeze based on 100 parts by weight of a styrene-based elastomer and / or an olefin-based elastomer.
A puncture-resistant medical material characterized in that a layer composed of an olefin-based elastomer nonwoven fabric is laminated on a layer composed of a resin in which 20 or more parts by weight of a run are mixed.
The present invention also provides a tubular structure having a multilayer structure,
A layer made of a resin obtained by mixing 20 parts by weight or more of squalane with respect to 100 parts by weight of a styrene-based elastomer and / or an olefin-based elastomer on the inner layer side, and a layer made of an olefin-based elastomer nonwoven fabric on the outer layer side. It is a puncture resistant medical tubular structure characterized by the following.
【０００５】以下、本発明の穿刺耐性医療用材料および
穿刺耐性医療用管状構造体を実施態様に基づき順次詳細
に説明する。本発明に使用するスチレン系エラストマー
は、スチレンを主成分とする部分と、ブタジエンおよび
／またはイソプレンおよび／またはそれらの水素添加物
からなる部分から構成された共重合体を主成分とするも
のである。具体的には、市販されているもので、クレイ
トン，カリフレックス（シェル化学）、タフプレン，タ
フテック（旭化成工業）、アロンＡＲ（アロン化成）、
ラバロン（三菱油化）、ＪＳＲ−ＴＲ，ＪＳＲ−ＳＩ
Ｓ，ダイナロン（日本合成ゴム）、セプトン（クラレ）
などが挙げられる。また、オレフィン系エラストマー
は、エチレンとプロピレンの共重合体や、それに第三成
分としてα−オレフィンやジエンモノマーを添加したも
のなどで、具体的には、ミラストマー，タフマー（三井
石油化学）、住友ＴＰＥ（住友化学工業）、サーモラン
（三菱油化）などが挙げられる。Hereinafter, the puncture resistant medical material and the puncture resistant medical tubular structure of the present invention will be sequentially described in detail based on embodiments. The styrene-based elastomer used in the present invention is mainly composed of a copolymer composed of a portion composed mainly of styrene and a portion composed of butadiene and / or isoprene and / or a hydrogenated product thereof. . Concretely, it is commercially available and includes Clayton, Kaliflex (Shell Chemical), Tufprene, Tuftec (Asahi Kasei Kogyo), Aron AR (Aron Kasei),
Lavalon (Mitsubishi Yuka), JSR-TR, JSR-SI
S, Dynalon (Japanese synthetic rubber), Septon (Kuraray)
And the like. The olefin-based elastomer is a copolymer of ethylene and propylene, or a product obtained by adding an α-olefin or a diene monomer as a third component to the olefin elastomer. Specific examples thereof include milastomer, tuffmer (Mitsui Petrochemical), and Sumitomo TPE. (Sumitomo Chemical Industries), Thermolan (Mitsubishi Yuka) and the like.
【０００６】本発明においてスクワランを混合させると
硬度の低下、およびゴム弾性の向上がえられる。その量
は２０重量部以上混合させることが好ましい。In the present invention, when squalane is mixed, hardness is reduced and rubber elasticity is improved. Preferably, the amount is 20 parts by weight or more.
【０００７】本発明において、スチレン系エラストマー
および／またはオレフィン系エラストマー１００重量部
に対してスクワランを２０重量部以上混合した樹脂から
なる層は、穿刺針や留置針などの医療用針の頻回の穿刺
にも耐えられる穿刺耐性層であるため、無孔性層である
ことが望ましい。その加工方法はシート材など得るため
の既知の方法により行うことができ、例えば、上述した
材料を混合して熱プレス機によってシート状にすること
によって得られる。また管状構造体として得るときは、
シート状に成形したものを芯棒に巻き付け熱処理する方
法や、一般的な押し出し成形、コンプレーション成形等
により得られる。また、この層の厚さは厚い程穿刺耐性
は良いが、通常の医療用針の使用に耐えるには０.１〜
０.５mm程度あれば良い。In the present invention, a layer made of a resin in which squalane is mixed in an amount of 20 parts by weight or more with respect to 100 parts by weight of a styrene-based elastomer and / or an olefin-based elastomer, comprises a medical needle such as a puncture needle or an indwelling needle. Since it is a puncture resistant layer that can withstand frequent punctures, a non-porous layer is desirable. The processing method can be performed by a known method for obtaining a sheet material or the like. For example, it can be obtained by mixing the above-described materials and forming a sheet by a hot press. When obtaining as a tubular structure,
It can be obtained by a method in which a sheet-shaped material is wound around a core rod and heat-treated, or by general extrusion molding, compilation molding or the like. In addition, although the puncture resistance is better as the thickness of this layer is larger, it is 0.1 to 0.1 to withstand the use of ordinary medical needles.
It may be about 0.5 mm.
【０００８】本発明において不織布に用いるオレフィン
系エラストマーとしては、特に限定しないが、具体的に
は、ミラストマー，タフマー（三井石油化学）などが挙
げられる。オレフィン系エラストマー不織布は、溶出物
がなく安全であることから、炎症性が低く早期に不織布
内に線維芽細胞が侵入する。それによって、穿刺後良好
な止血性が得られる。オレフィン系エラストマー不織布
の加工方法は、スパンボンド法、メルトブローン法、フ
ラッシュ紡糸法、カード法など既知の方法により行うこ
とができる。また不織布の線維径は、０.１から１００
μm、好ましくは１μmから２０μmの範囲が望ましい。
１μm以下であると強度の面から問題があり、また２０
μm以上であると生体と接触するには硬すぎ物理的に炎
症を惹起しやすくなる。また、この層の厚さは、組織を
侵入させることができ、かつ出来るだけ薄いことが好ま
しく０.１〜０.５mmが望ましい。In the present invention, the olefin elastomer used for the nonwoven fabric is not particularly limited, but specific examples thereof include Mirastomer and Tuffmer (Mitsui Petrochemical). Since the olefin-based elastomer nonwoven fabric is safe without eluting substances, fibroblasts infiltrate into the nonwoven fabric early with low inflammatory properties. Thereby, good hemostasis after puncture is obtained. The olefin elastomer nonwoven fabric can be processed by a known method such as a spun bond method, a melt blown method, a flash spinning method, and a card method. The fiber diameter of the nonwoven fabric is 0.1 to 100.
μm, preferably in the range of 1 μm to 20 μm.
If it is 1 μm or less, there is a problem in terms of strength.
If it is more than μm, it is too hard to come into contact with the living body and easily causes physical inflammation. Further, the thickness of this layer is preferably as thin as possible, which allows tissue to penetrate, and desirably 0.1 to 0.5 mm.
【０００９】また本発明の穿刺耐性医療用材料および穿
刺耐性医療用管状構造体においては上述した層以外に
も、生体適合性に優れた材料からなる層、物理的強度に
優れた材料からなる層等を設けても良い。なお、得られ
た各層間の複合化は、各種バインダーを用いる方法や熱
による融着など既知の方法により接着は可能であるが、
安全性の面から熱による融着が望ましい。In the puncture-resistant medical material and the puncture-resistant medical tubular structure of the present invention, in addition to the above-mentioned layers, a layer made of a material excellent in biocompatibility and a layer made of a material excellent in physical strength are provided. May be provided. In addition, although the composite of each obtained layer can be bonded by a known method such as a method using various binders or fusion by heat,
From the viewpoint of safety, fusion by heat is desirable.
【００１０】本発明の穿刺耐性医療用材料および穿刺耐
性医療用管状構造体は、長期的に生体と接触する医療用
具、例えば、透析用グラフトなどの人工血管や、ＩＩＳ
ポート部、あるいは埋没型人工心臓やそのエネルギー供
給ルートとなるカテーテルなどの医療用具に有効に使用
でできる。The puncture-resistant medical material and the puncture-resistant medical tubular structure of the present invention can be used for medical devices that come into contact with a living body for a long period of time, such as artificial blood vessels such as dialysis grafts and IIS.
It can be effectively used for a medical device such as a port or an implantable artificial heart or a catheter serving as an energy supply route thereof.
【００１１】[0011]
【実施例】本発明をより詳細に説明するため以下に実施
例をあげて説明する。 （実施例１）スチレン系エラストマーであるタフプレン
（旭化成製）１００ｇとスクアラン（クラレ製）２０ｇ
をビーカーに取り、薬匙で良くかき混ぜ一晩放置して熟
成した後、江藤製作所製ミキシングロールを１６０℃に
して３分間混合した。その後江藤製作所製熱プレス機を
１６０℃にして、厚み０.４mmのプレスシート（Ａ）を
得た。次にオレフィン系エラストマーであるミラストマ
ー（三井石油化学社製）をノードソン株式会社製ホット
メルトアプリケーターシステム（ノズル：HMG-19-UF、
アプリケーター：HM-3100）にて線径約１０から１５μm
の細線維から構成される厚さ０.２mmの不織布（Ｂ）を
得た。次にプレスシート（Ａ）及び不織布（Ｂ）を重ね
た後オーブンで１２０℃、５分間加熱処理し熱融着させ
て、本発明の穿刺耐性医療用材料（Ｃ）を得た。The present invention will be described in more detail with reference to the following examples. Example 1 100 g of a styrene elastomer, tufprene (manufactured by Asahi Kasei) and 20 g of squalane (manufactured by Kuraray)
Was placed in a beaker, mixed well with a spoon, left to stand overnight, and aged, and then mixed at 160 ° C. for 3 minutes with a mixing roll manufactured by Eto Seisakusho. Thereafter, a hot press machine manufactured by Eto Seisakusho was set at 160 ° C. to obtain a pressed sheet (A) having a thickness of 0.4 mm. Next, Mirastomer (Mitsui Petrochemical Co., Ltd.), an olefin-based elastomer, was converted to a hot melt applicator system (Nozzle: HMG-19-UF, manufactured by Nordson Corporation).
Applicator: HM-3100) wire diameter about 10 to 15μm
A non-woven fabric (B) having a thickness of 0.2 mm and comprising fine fibers was obtained. Next, the press sheet (A) and the nonwoven fabric (B) were stacked, and then heated in an oven at 120 ° C. for 5 minutes and heat-sealed to obtain a puncture-resistant medical material (C) of the present invention.
【００１２】（実施例２）スチレン系エラストマーであ
るクレイトン（シェル化学社製）１００ｇとスクアラン
（クラレ社）３０ｇを実施例１と同様に混合した後、押
し出し成形機により内径５mm、長さ６cmのチューブ状に
加工し、チューブ（Ｄ）を得た。次に、実施例１と同じ
不織布を作製した後、チューブ（Ｄ）の外側へ不織布層
を熱融着させることにより本発明の穿刺耐性医療用管状
構造体（Ｅ）を得た。Example 2 100 g of a styrene elastomer, Clayton (manufactured by Shell Chemical Co., Ltd.) and 30 g of squalane (Kuraray Co., Ltd.) were mixed in the same manner as in Example 1. It was processed into a tube to obtain a tube (D). Next, after preparing the same nonwoven fabric as in Example 1, the nonwoven fabric layer was heat-sealed to the outside of the tube (D) to obtain a puncture-resistant medical tubular structure (E) of the present invention.
【００１３】（試験例１）本発明の穿刺耐性医療用管状
構造体（Ｅ）について、透析用グラフト（Ｇｏｒｅ−Ｔ
ｅｘ（ゴア・テックス社））を比較対照に用いて、流量
２００ml/分、水圧１２０mmHg下で、それぞれ１７ゲー
ジのＡＦＶ針（テルモ社製）にて１０回の穿刺を行い漏
水量を測定した。その結果、Ｇｏｒｅ−Ｔｅｘの漏水量
が９２.０ml/分であったのに対し、穿刺耐性医療用管状
構造体（Ｅ）の漏水量は１２.０ml/分であり優れた穿刺
耐性を示した。(Test Example 1) The puncture-resistant medical tubular structure (E) of the present invention was used for a dialysis graft (Gore-T).
ex (Gore-Tex Corporation)) was used as a control and punctured 10 times with a 17-gauge AFV needle (manufactured by Terumo Corporation) at a flow rate of 200 ml / min and a water pressure of 120 mmHg to measure the amount of water leakage. As a result, while the water leakage of Gore-Tex was 92.0 ml / min, the water leakage of the puncture-resistant medical tubular structure (E) was 12.0 ml / min, indicating excellent puncture resistance. .
【００１４】（試験例２）実施例２で得られたチューブ
（Ｄ）、本発明の穿刺耐性医療用管状構造体（Ｅ）につ
いて、対照として２液性シリコンレジン（サイラスティ
ックス（ダウコーニング社製））によりチューブ（Ｓ
ｉ）を作製し、さらに得られたチューブ（Ｓｉ）にテフ
ロンフェルト（メアドックス社製）を外周囲に巻き付け
たチューブ（ＳｉＴ）、ダクロンフェルト（メアドック
ス社製）を外周囲に巻き付けたチューブ（ＳｉＤ）、お
よび、チューブ（Ｄ）にテフロンフェルトを熱融着し巻
き付けたチューブ（ＤＴ）、ダクロンフェルトを巻き付
けたチューブ（ＤＤ）を、それぞれを犬の大腿動脈に吻
合し、１週間に１日、１日につき１０回１７ゲージの針
で穿刺し血液の漏出状況について観察した。また、その
後３ヶ月後に取り出し周囲組織治癒状態について比較観
察した。結果を表１に示す。Test Example 2 The tube (D) obtained in Example 2 and the puncture-resistant medical tubular structure (E) of the present invention were used as controls for a two-part silicone resin (Silastics (Dow Corning Co., Ltd.) Tube) (S
i) was prepared, and a tube (SiT) in which Teflon felt (made by Meadox) was wound around the obtained tube (Si), and a tube (SiD) in which Dacron felt (made by Meadox) was wound around the outside. And a tube (DT) obtained by heat-sealing Teflon felt to the tube (D) and a tube (DD) wound by Dacron felt were anastomosed to the femoral artery of a dog, and were anesthetized one day a week. Puncture was performed 10 times a day with a 17 gauge needle to observe the state of blood leakage. Three months later, the tissue was taken out, and the surrounding tissue healing state was compared and observed. Table 1 shows the results.
【００１５】[0015]
【表１】 [Table 1]
【００１６】本発明の穿刺耐性医療用管状構造体（Ｅ）
の内腔面には顕著な血栓の付着はなく、また新生内膜の
形成が認められたが、他の物では新生内膜は生体血管と
の吻合部に限局して見られるだけであった。また、外周
ではＳｉＴ、ＳｉＤ、ＤＴ、ＤＤのテフロンフェルトお
よびダクロンフェルト内に異物巨細胞中心の強い炎症反
応が観察された。一方、本発明の穿刺耐性医療用管状構
造体（Ｅ）では、外周の不織布内に著明な線維芽細胞の
侵入と、コラーゲン産生が認められ、良好な組織修復が
見られた。The puncture-resistant medical tubular structure of the present invention (E)
No significant thrombus adhesion was observed on the luminal surface, and neointimal formation was observed, but in other cases, the neointima was found only in the anastomosis with the living blood vessels. . In the outer periphery, a strong inflammatory reaction of the giant cell center of the foreign body was observed in Teflon felt and Dacron felt of SiT, SiD, DT and DD. On the other hand, in the puncture-resistant medical tubular structure (E) of the present invention, remarkable infiltration of fibroblasts and collagen production were recognized in the outer nonwoven fabric, and favorable tissue repair was observed.
【００１７】結果が示す通り、血液の漏れがなく、かつ
良好な組織結合性を有するのは、本発明の穿刺耐性医療
用管状構造体（Ｅ）のみであった。つまり、スチレン系
エラストマーおよび／またはオレフィン系エラストマー
に対してイソプレン誘導体を２０重量部以上混合した樹
脂は血液の漏れ防止に優れており、かつオレフィン系エ
ラストマー不織布を積層することにより良好な組織結合
性が得られる。As can be seen from the results, the absence of blood leakage and good tissue binding are the reasons for the puncture resistant medical treatment of the present invention.
Use tubular structure (E) was only. That is, a resin obtained by mixing an isoprene derivative in an amount of 20 parts by weight or more with a styrene-based elastomer and / or an olefin-based elastomer is excellent in preventing blood leakage, and has a good tissue binding property by laminating an olefin-based elastomer nonwoven fabric. can get.
【００１８】[0018]
【発明の効果】本発明の穿刺耐性医療用材料および穿刺
耐性医療用管状構造体は、穿刺耐性、生体適合性に優れ
ており、透析用グラフトなどの人工血管や、ＩＩＳポー
ト部、あるいは埋没型人工心臓やそのエネルギー供給ル
ートとなるカテーテルなどの医療用具に有効に使用でき
る。Industrial Applicability The puncture-resistant medical material and the puncture-resistant medical tubular structure of the present invention are excellent in puncture resistance and biocompatibility, and can be used for artificial blood vessels such as dialysis grafts, IIS ports, or implantable blood vessels. It can be used effectively for medical devices such as artificial hearts and catheters serving as energy supply routes.
───────────────────────────────────────────────────── フロントページの続き (58)調査した分野(Int.Cl.7，ＤＢ名) A61L 27/00 - 33/18 ──────────────────────────────────────────────────続 き Continued on the front page (58) Field surveyed (Int.Cl. 7 , DB name) A61L 27/00-33/18
Claims (2)
レフィン系エラストマー１００重量部に対してスクワラ
ンを２０重量部以上混合した樹脂からなる層に、オレフ
ィン系エラストマー不織布から構成される層が積層され
ていることを特徴とする穿刺耐性医療用材料。1. A squala based on 100 parts by weight of a styrene elastomer and / or an olefin elastomer.
A puncture-resistant medical material, wherein a layer composed of an olefin-based elastomer nonwoven fabric is laminated on a layer composed of a resin in which 20 parts by weight or more of the olefin-based elastomer is mixed.
層側にスチレン系エラストマーおよび／またはオレフィ
ン系エラストマー１００重量部に対してスクワランを２
０重量部以上混合した樹脂からなる層、外層側にオレフ
ィン系エラストマー不織布から構成される層が設けられ
ていることを特徴とする穿刺耐性医療用管状構造体。2. A tubular structure having a multilayer structure, wherein squalane is added on the inner layer side to 100 parts by weight of a styrene elastomer and / or an olefin elastomer.
A puncture-resistant medical tubular structure, wherein a layer made of a resin mixed with 0 part by weight or more and a layer made of an olefin elastomer nonwoven fabric are provided on the outer layer side.
Priority Applications (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10350795A JP3201927B2 (en) | 1995-04-27 | 1995-04-27 | Puncture-resistant medical material and puncture-resistant medical tubular structure |
| US08/637,478 US5904967A (en) | 1995-04-27 | 1996-04-25 | Puncture resistant medical material |
| DE1996618271 DE69618271T2 (en) | 1995-04-27 | 1996-04-26 | Puncture-proof medical material |
| EP19960400903 EP0742021B1 (en) | 1995-04-27 | 1996-04-26 | Puncture resistant medical material |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP10350795A JP3201927B2 (en) | 1995-04-27 | 1995-04-27 | Puncture-resistant medical material and puncture-resistant medical tubular structure |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH08294529A JPH08294529A (en) | 1996-11-12 |
| JP3201927B2 true JP3201927B2 (en) | 2001-08-27 |
Family
ID=14355895
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP10350795A Expired - Fee Related JP3201927B2 (en) | 1995-04-27 | 1995-04-27 | Puncture-resistant medical material and puncture-resistant medical tubular structure |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3201927B2 (en) |
-
1995
- 1995-04-27 JP JP10350795A patent/JP3201927B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH08294529A (en) | 1996-11-12 |
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