JP3508416B2 - Dilatation catheter - Google Patents
Dilatation catheterInfo
- Publication number
- JP3508416B2 JP3508416B2 JP23960996A JP23960996A JP3508416B2 JP 3508416 B2 JP3508416 B2 JP 3508416B2 JP 23960996 A JP23960996 A JP 23960996A JP 23960996 A JP23960996 A JP 23960996A JP 3508416 B2 JP3508416 B2 JP 3508416B2
- Authority
- JP
- Japan
- Prior art keywords
- tubular member
- adapter
- polyethylene
- tubular
- balloon
- 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
Landscapes
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
Description
【０００１】[0001]
【発明の属する技術分野】本発明は拡張操作を目的とす
る手術に使用される拡張カテーテルに関するもので、特
に血管拡張用カテーテルに関するものである。BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a dilatation catheter used in a surgical operation for dilation, and more particularly to a vasodilation catheter.
【０００２】[0002]
【従来の技術】拡張カテーテルは、主に狭窄、又は閉塞
した血管に対しての血管形成治療に用いられている。一
般に拡張カテーテル、特にオーバーザワイヤー方式と称
されているカテーテルは本発明を示す図１に示されるよ
うに、内部に複数のルーメンを有するチューブ状のカテ
ーテルシャフトの先端部に、圧力流体を供給する拡張用
ルーメンに連通したバルーンを有するとともに、基端部
に各ルーメンに連通したポートを有するアダプターを接
続した構造のものであり、通常の状態では、前記バルー
ンはカテーテルシャフトに対して折り畳まれている。そ
して、この治療においては拡張カテーテルのバルーン部
は患者の動脈を経て狭窄部位中に挿入され、そこで圧力
流体をバルーンの内部に導入することにより拡張され、
狭窄、又は閉塞した患部を拡げる。Dilatation catheters are mainly used for angioplasty treatment of stenotic or occluded blood vessels. As shown in FIG. 1 showing the present invention, a dilatation catheter, which is generally called an over-the-wire system, is a dilatation catheter that supplies pressure fluid to the distal end of a tubular catheter shaft having a plurality of lumens therein. It has a structure in which a balloon communicating with the working lumen is provided and an adapter having a port communicating with each lumen is connected to the proximal end portion, and in a normal state, the balloon is folded with respect to the catheter shaft. Then, in this treatment, the balloon portion of the dilatation catheter is inserted through the artery of the patient into the stenosis site, where it is expanded by introducing pressure fluid into the balloon,
Expand the stenosis or obstruction.
【０００３】拡張カテーテルは、主に治療対象の体内通
路に挿入され、治療箇所で内圧を導入されることで拡張
治療が行われるため、求められる機能的性質としては拡
張に必要な圧力を導入した際にバルーンが破壊されない
ように充分な強度を有すること、また所望の拡張サイズ
に安全に制御可能なことである。また、体内通路は屈曲
している場合が多くみられることから特に拡張カテーテ
ルの先端部分は屈曲体内通路に対して追随性が良いよう
に柔軟性が、手元部分は先端への力の伝達性がよいよう
にある程度の強度が求められる。加えて、通常、内部に
ガイドワイヤーを通して使用されるためガイドワイヤー
との摩擦が少ないことも重要な性質の一つである。The dilatation catheter is mainly inserted into the body passage to be treated, and the dilatation treatment is performed by introducing the internal pressure at the treatment site. Therefore, the pressure required for dilatation is introduced as the required functional property. It should have sufficient strength to prevent the balloon from breaking during this process and be safely controllable to the desired expansion size. In addition, since the body passage is often bent, the distal end of the dilatation catheter is particularly flexible so that it can follow the bent body passage, and the hand portion has a property of transmitting force to the tip. Some strength is required to be good. In addition, since it is usually used by passing a guide wire inside, it is one of the important properties that there is little friction with the guide wire.
【０００４】また、安全面においてはカテーテル自体が
体内組織や血液と長時間触れあい、またカテーテル内部
を通った造影剤、薬剤等が体内に注入されるため、それ
を構成する材料自体にも充分な安全性が求められる。更
に、使用時における破壊、脱落の危険が予想されること
からそれらを予防した構造にすることが望ましい。In terms of safety, the catheter itself is in contact with internal tissues and blood for a long time, and the contrast agent, drug, etc. that have passed through the inside of the catheter are injected into the body. Safety is required. Furthermore, it is desirable to have a structure that prevents them from the risk of breakage or falling off during use.
【０００５】拡張カテーテルにこれまで使用、又は提案
されている材料としては、ポリエチレンテレフタレー
ト、ポリエチレン、ポリビニルアセテート、アイオノマ
ー、ポリ塩化ビニール、ポリアミド、ポリアミドエラス
トマー、ポリカーボネート、ポリジメチルシロキサン、
ポリイミド、ポリアリレート、ポリサルホン、ポリプロ
ピレン等があるまた、特にアダプター部の素材として
は、その強度、寸法安定性の利点からポリカーボネート
がほとんどの拡張カテーテルに使用されている。また一
部ではポリアミドがアダプター部の材料に使用された場
合もあった。Materials used or proposed for dilatation catheters are polyethylene terephthalate, polyethylene, polyvinyl acetate, ionomers, polyvinyl chloride, polyamides, polyamide elastomers, polycarbonates, polydimethylsiloxanes,
Polyimide, polyarylate, polysulfone, polypropylene, etc. are also used. In particular, as a material for the adapter part, polycarbonate is used for most dilatation catheters because of its strength and dimensional stability. In some cases, polyamide was used as the material for the adapter part.
【０００６】上記の原材料はカテーテルを含む医療用具
用として実績があるが、拡張カテーテルに適用するにあ
たっては注意が必要であった。即ち、拡張カテーテルの
滅菌にはエチレンオキサイドガス（以下ＥＯＧと略記）
が最も頻繁に使用されているが、材料によってＥＯＧの
抜けが悪く、拡張カテーテルの残留ＥＯＧが多いという
問題である。残留ＥＯＧによる障害は、皮膚、粘膜への
刺激、溶血などが良く知られているが、その許容値は現
在の所、公的には決められてはいない。しかし、血液又
は組織と長時間接触する物は２５ｐｐｍ以下が安全と考
えられている。これまでのＥＯＧ滅菌された市販の拡張
カテーテルは、滅菌日からの経時にもよるが残留ＥＯＧ
が数ｐｐｍから数十ｐｐｍのオーダーで存在しており、
ＥＯＧが完全に抜けきっていないことがわかった。Although the above-mentioned raw materials have a track record for medical devices including catheters, caution has been required when applied to dilatation catheters. That is, ethylene oxide gas (hereinafter abbreviated as EOG) is used to sterilize the dilatation catheter.
Is most frequently used, but there is a problem that the EOG does not escape easily depending on the material and there is a large amount of residual EOG in the dilatation catheter. Disorders due to residual EOG are well-known such as irritation to skin and mucous membranes, hemolysis, etc., but the permissible value thereof has not been officially determined at present. However, 25 ppm or less of substances that are in contact with blood or tissues for a long time are considered to be safe. Conventional EOG sterilized commercially available dilatation catheters have residual EOG depending on the time elapsed from the sterilization date.
Exists in the order of several ppm to several tens of ppm,
It turned out that the EOG was not completely removed.
【０００７】また、一般に拡張カテーテルは、バルー
ン、複数のチューブ、アダプター等の部材から構成され
ており、上記の材料はそのそれぞれの部材に適用されて
いるそれぞれの構成部材が組み立てられてカテーテルは
作られるが、拡張カテーテルの破損、脱落を避け安全性
を確保するためには部材間の接合の信頼性が高くなけれ
ばならない。その接合方法には熱溶着、接着剤が多く使
われおり、特に異種材料間の接合には熱溶着を用いるこ
とが難しいため接着剤が頻繁に用いられる。しかし、医
療用具用によく用いられるシアノアクリレート系及びエ
ポキシ系、ウレタン系の接着剤は水分の影響や反応の進
行等の要因で接着性に経時的変化を受けやすいため、ま
た熱溶着と異なり接着剤の硬化時間が長いためカテーテ
ル組立工程を管理するのが難しいという欠点があった。Further, the dilatation catheter is generally composed of members such as a balloon, a plurality of tubes and adapters, and the above materials are applied to the respective members. The respective constituent members are assembled to form a catheter. However, in order to prevent damage and dropout of the dilatation catheter and ensure safety, the joint between the members must be highly reliable. A heat welding method and an adhesive agent are often used for the joining method. Especially, it is difficult to use the heat welding method for joining different kinds of materials, and thus the adhesive agent is frequently used. However, cyanoacrylate-based, epoxy-based, and urethane-based adhesives that are often used for medical devices are susceptible to changes over time in adhesiveness due to factors such as the influence of water and the progress of reactions. There is a drawback that it is difficult to control the catheter assembly process due to the long curing time of the agent.
【０００８】[0008]
【発明が解決しようとする課題】本発明が前述の状況に
鑑み、解決しようとするところは、従来問題であったＥ
ＯＧ滅菌後の拡張カテーテル中の残留ＥＯＧを少なく
し、しかも使用時の破壊、脱落の危険性が低減された拡
張カテーテルを提供することにある。In view of the above situation, the present invention is to solve the problem E which has been a conventional problem.
An object of the present invention is to provide a dilatation catheter in which the residual EOG in the dilatation catheter after OG sterilization is reduced and the risk of breakage or drop during use is reduced.
【０００９】[0009]
【課題を解決するための手段】本発明者らは、まず種々
の材料をＥＯＧの抜け易さという観点でスクリーニング
及び抽出した。そこで選んだ材料について先述したよう
な拡張カテーテルに求められる性質、チューブ部材には
強度、操作性、低摩擦性、アダプター部材には強度、寸
法安定性等を、更に操作時に起こりうる危険の回避を考
慮に入れて鋭意研究した結果、本発明に至った。[Means for Solving the Problems] First, the present inventors screened and extracted various materials from the viewpoint of ease of EOG removal. Therefore, the properties required for the dilatation catheter as described above for the material selected, strength, operability, low friction for the tube member, strength, dimensional stability, etc. for the adapter member, and avoiding the danger that may occur during operation As a result of earnest research with due consideration, the present invention has been achieved.
【００１０】本発明による拡張カテーテルは、複数のチ
ューブ状部材とそれが接続されたアダプター部材から構
成された拡張カテーテルにおいて、チューブ状部材の主
材料がポリエチレンであり、アダプター部材の材料がポ
リメチルペンテンであることを特徴とした拡張カテーテ
ルである。The dilatation catheter according to the present invention is a dilatation catheter composed of a plurality of tubular members and an adapter member connected to the tubular members, wherein the main material of the tubular member is polyethylene and the material of the adapter member is polymethylpentene. It is a dilatation catheter characterized in that
【００１１】そして、複数のポレエンチレ製のチューブ
状部材を先端部から手元部分にかけて同心状に多層に接
合してカテーテルシャフトを構成し、拡張カテーテルの
先端部分は屈曲体内通路に対して追随性が良いように柔
軟性を付与し、手元部分は先端への力の伝達性がよいよ
うにある程度の強度を付与している。Further, a plurality of tube-shaped members made of polyethylene are joined concentrically in multiple layers from the tip portion to the proximal portion to form a catheter shaft, and the tip portion of the dilatation catheter has a good followability with respect to the passage in the bent body. As described above, flexibility is imparted to the proximal portion, and a certain amount of strength is imparted to the proximal portion so that the force transmission to the distal end is good.
【００１２】[0012]
【００１３】本発明による拡張カテーテルは、主構成材
料がポリエチレン、又はポリメチルペンテンという他の
高分子材料と比較して化学的に安定で生体への影響が少
ない医療用への使用実績の確立されている材料を用いた
ため、生体に悪影響を与えると考えられる物質が存在、
発生する可能性が全くなく、滅菌方法にＥＯＧを用いた
場合の残留ＥＯＧが極めて少ないことから生物学的な安
全性が極めて高いカテーテルであり、かつ、バルーンが
チューブから一体成形されているため、また拡張カテー
テル先端チューブが基端部のチューブと熱溶着されてい
るため使用時の脱落の危険が低減されたカテーテルであ
る。The dilatation catheter according to the present invention has a proven record of use in medical applications where the main constituent material is chemically stable compared to other polymer materials such as polyethylene or polymethylpentene and has little effect on the living body. Since there are materials that are used, there are substances that are thought to adversely affect the living body,
There is no possibility of occurrence, and the residual EOG when using EOG in the sterilization method is extremely small, so it is a catheter with extremely high biological safety, and since the balloon is integrally molded from the tube, Further, since the distal end tube of the dilatation catheter is heat-welded to the tube at the proximal end, the risk of dropping out during use is reduced.
【００１４】[0014]
【発明の実施の形態】次に、本発明の拡張カテーテルの
実施形態を図１及び図２に基づいて更に説明する。本発
明の拡張カテーテルは、ポリエチレン製のチューブ状部
材１とそのチューブ状部材の一端から一体的に成形され
たバルーン１Ａを有し、チューブ状部材１がチューブ状
部材１より比較的大きい引っ張り弾性率を有するポリエ
チレン製のチューブ状部材２と同心的に接合されてお
り、チューブ状部材１と２の内側にポリエチレン製のチ
ューブ状部材３が配置さており、チューブ状部材３がチ
ューブ状部材１のバルーン１Ａが成形された端でチュー
ブ状部材１と同心的に接合されており、チューブ状部材
３上でバルーン１Ａと重なる位置にＸ線による造影を目
的とした金又は白金の環状部材１Ｂが固定されており、
チューブ状部材３の内側ルーメンがポリメチルペンテン
製のアダプターのポート１０と連通しており、チューブ
状部材１、２の内側とチューブ状部材３の外側のルーメ
ンがアダプターのポート１１と連通している構造であ
る。BEST MODE FOR CARRYING OUT THE INVENTION Next, an embodiment of the dilatation catheter of the present invention will be further described with reference to FIGS. The dilatation catheter of the present invention has a tubular member 1 made of polyethylene and a balloon 1A integrally formed from one end of the tubular member, and the tubular member 1 has a relatively higher tensile elastic modulus than the tubular member 1. Is joined concentrically with the tubular member 2 made of polyethylene, and the tubular member 3 made of polyethylene is arranged inside the tubular members 1 and 2, and the tubular member 3 is a balloon of the tubular member 1. 1A is joined concentrically with the tubular member 1 at the molded end, and a gold or platinum annular member 1B for X-ray imaging is fixed on the tubular member 3 at a position overlapping with the balloon 1A. And
The inner lumen of the tubular member 3 communicates with the port 10 of the adapter made of polymethylpentene, and the inner lumens of the tubular members 1 and 2 and the outer lumen of the tubular member 3 communicate with the port 11 of the adapter. It is a structure.
【００１５】更に、前記カテーテルのチューブ状部材２
のチューブ状部材１と接合していない方の一端にチュー
ブ状部材２の外径より大きい内径を有したポリエチレン
製チューブ状部材４を重ね合わせて接合したうえで円錐
状にフレア加工した部分４Ａと末端がフレア状加工され
たポリエチレン製チューブ状部材５のフレアー部分５Ａ
を重ね合わせた部分を、ポリメチルペンテン製のアダプ
ターの本体６とポリメチルペンテン製のアダプターキャ
ップ７のネジを締めることによって挟み込んで固定し、
アダプター本体６とキャップ７を超音波溶着によって接
続している。また、チューブ状部材３の内径、外径はチ
ューブ状部材１と接合している側が他端の内径、外径よ
り小さくなるように連続的に一体成形されている。更
に、チューブ状部材１と接合していない方の一端にチュ
ーブ状部材３の外径より大きい内径を有したポリエチレ
ン製チューブ状部材８を重ね合わせて接合したうえで円
錐状にフレア加工した部分８Ａをアダプター本体６とポ
リメチルペンテン製のアダプターキャップ９のネジを締
めることによって挟み込んで固定し、アダプター本体６
とキャップ９を超音波溶着によって接続している。Further, the tubular member 2 of the catheter
And a portion 4A that is flared into a conical shape after superposing a polyethylene tubular member 4 having an inner diameter larger than the outer diameter of the tubular member 2 on one end that is not joined to the tubular member 1. Flare portion 5A of polyethylene tubular member 5 having a flared end
The overlapped part is clamped and fixed by tightening the screws of the main body 6 of the adapter made of polymethylpentene and the adapter cap 7 made of polymethylpentene,
The adapter body 6 and the cap 7 are connected by ultrasonic welding. Further, the inner diameter and the outer diameter of the tubular member 3 are continuously integrally formed so that the side joined to the tubular member 1 is smaller than the inner diameter and the outer diameter of the other end. Further, a portion 8A in which a polyethylene tubular member 8 having an inner diameter larger than the outer diameter of the tubular member 3 is superposed and joined to one end not joined to the tubular member 1 and then flared into a conical shape Is fastened by tightening the screws of the adapter body 6 and the adapter cap 9 made of polymethylpentene.
And the cap 9 are connected by ultrasonic welding.
【００１６】このように、本発明の拡張カテーテルのカ
テーテルシャフトは、バールン１Ａを有する先端部分か
らアダプター６を接続した手元部分へかけてチューブ状
部材の積層数が増した構造である。即ち、先端部分はチ
ューブ状部材１と３の二層同心構造部であり、それより
手元部分へかけて順次チューブ状部材２、４、５が積層
されて三層同心構造部、四層同心構造部、五層同心構造
部となっている。それにより、拡張カテーテルの先端部
分は柔軟性があって屈曲体内通路に対して追随性が良
く、また手元部分は曲げ強度、圧縮強度が高くなって先
端への力の伝達性が良いようになっている。As described above, the catheter shaft of the dilatation catheter of the present invention has a structure in which the number of laminated tubular members is increased from the distal end portion having the balun 1A to the proximal portion to which the adapter 6 is connected. That is, the tip portion is a two-layer concentric structure portion of the tubular members 1 and 3, and the tubular members 2, 4, and 5 are sequentially laminated from there to the proximal portion to form a three-layer concentric structure portion and a four-layer concentric structure portion. Section, five-layer concentric structure section. As a result, the distal end of the dilatation catheter is flexible and has good conformability to the passage in the bent body, and the proximal part has high bending strength and compressive strength, so that the force transmission to the distal end is good. ing.
【００１７】[0017]
【実施例】以下の実施例で本発明によって作製された拡
張カテーテルの一例を示し、また比較例によって従来の
方法、材質で作製した比較カテーテル、市販の拡張カテ
ーテルと比較された本発明の優れた特性を説明する。Examples The following examples show examples of dilatation catheters made according to the present invention, and comparative examples show comparative catheters made by conventional methods and materials, and the superiority of the present invention compared with commercially available dilatation catheters. The characteristics will be described.
【００１８】（実施例）密度０．９５９ｇ／ｃｍ3 、融
点１３２℃、メルトフローレート（以下ＭＦＲと略）
０．７ｇ／１０分のポリエチレンと密度０．９１８ｇ／
ｃｍ3 、融点１０７℃、ＭＦＲ０．３ｇ／１０分のポリ
エチレンと密度０．９３０ｇ／ｃｍ3 、融点１１７℃、
ＭＦＲ１．５ｇ／１０分のポリエチレンを重量比で３：
２．５：４．５の割合で混合した物を押出成形機によっ
て押出し、バルーンに成形されるのに適切な直径、肉厚
（内径約０．７ｍｍ、外径０．９ｍｍ〜１．２ｍｍ）で
あるチューブに成形した。更に、チューブを電子線照射
装置によってバルーンに成形されるのに適切な電子線量
を照射し架橋を導入した。そのチューブを金型内に配置
し、加熱し、軸方向へ延伸した後、内部に圧力流体を導
入し、バルーン形状にブロー成形した。そのバルーンを
含むチューブをバルーンの両端で予め計算された適切な
長さに切断した（チューブ状部材１）。このように作製
されたチューブ状部材１の軸方向の引張弾性率は約３０
０ＭＰａであった。(Example) Density 0.959 g / cm 3 , melting point 132 ° C., melt flow rate (hereinafter abbreviated as MFR)
0.7g / 10min polyethylene and density 0.918g /
cm 3 , melting point 107 ° C., MFR 0.3 g / 10 min polyethylene and density 0.930 g / cm 3 , melting point 117 ° C.,
MFR 1.5 g / 10 min polyethylene in a weight ratio of 3:
A mixture having a ratio of 2.5: 4.5 is extruded by an extruder, and has a diameter and wall thickness suitable for forming a balloon (inner diameter: about 0.7 mm, outer diameter: 0.9 mm to 1.2 mm). Was molded into a tube. Furthermore, the tube was irradiated with an electron dose appropriate for forming a balloon into a balloon by an electron beam irradiation device to introduce crosslinking. The tube was placed in a mold, heated and stretched in the axial direction, and then a pressure fluid was introduced into the mold to blow-mold it into a balloon shape. The tube containing the balloon was cut at both ends of the balloon to an appropriate length pre-calculated (Tubular member 1). The axial elastic modulus of the tubular member 1 thus manufactured is about 30.
It was 0 MPa.
【００１９】密度０．９６１ｇ／ｃｍ3 、融点１３５
℃、ＭＦＲ１．０ｇ／１０分のポリエチレンを押出成形
機によって押出し、内径約０．９５ｍｍ、外径約１．２
ｍｍのチューブに成形した。そのチューブをクリーンオ
ーブン内にチューブの軸方向に約０．１Ｎのテンション
がかかるように配置し、１２０℃で２時間熱処理を行っ
た後、予め計算された適切な長さに切断した（チューブ
状部材２）。このように作製されたチューブ状部材２の
軸方向の引張弾性率は約８００ＭＰａであった。このチ
ューブ状部材２の末端にステンレス製の芯材を入れ、密
度０．９３０ｇ／ｃｍ3 、融点１１７℃、ＭＦＲ１．５
ｇ／１０分のポリエチレンを押し出し機により内径をチ
ューブ状部材２の外径より大きくするように押出成形し
たチューブを予め計算された道切な長さに切断した物
（チューブ状部材４）を被せ、更にその上にシリコン製
の外周保持材を被せて電磁誘導加熱装置で芯材を加熱し
両ポリエチレンチューブを熱溶着させた。その溶着させ
た部分を熱せられたフレアー金型に押しつけてフレアー
部分２Ａ，４Ａを成形した。Density 0.961 g / cm 3 , melting point 135
C., polyethylene having an MFR of 1.0 g / 10 min is extruded by an extruder to give an inner diameter of about 0.95 mm and an outer diameter of about 1.2.
It was molded into a mm tube. The tube was placed in a clean oven so that a tension of about 0.1 N was applied in the axial direction of the tube, heat-treated at 120 ° C. for 2 hours, and then cut into an appropriate length calculated in advance (tube shape). Member 2). The tensile elastic modulus in the axial direction of the tubular member 2 thus manufactured was about 800 MPa. A stainless steel core material was placed at the end of the tubular member 2 to have a density of 0.930 g / cm 3 , a melting point of 117 ° C., and an MFR of 1.5.
g / 10 min of polyethylene was extruded by an extruder so that the inner diameter was made larger than the outer diameter of the tubular member 2, and a tube (tube-shaped member 4) cut into a cut length calculated in advance was covered, Further, a silicon outer peripheral holding material was covered thereon, and the core material was heated by an electromagnetic induction heating device to heat-weld both polyethylene tubes. The welded portion was pressed against a heated flare mold to form flare portions 2A and 4A.
【００２０】密度０．９５９ｇ／ｃｍ3 、融点１３２
℃、ＭＦＲ０．７ｇ／１０分のポリエチレンの内径をチ
ューブ状部材４の外径より大きくなるように押し出し成
形したチューブ状部材５を予め計算された適切な長さに
切断し、その末端を熱せられたフレアー金型に押しつけ
てフレアー部分５Ａを形成した。チューブ状部材２と４
を重ね合わせフレアー加工した部分２Ａ，４Ａとチュー
ブ状部材５のフレアー部分５Ａを重ね合わせた部分を、
ＭＦＲ２６ｇ／１０分、オルゼン剛性６０００ｋｇ／ｃ
ｍ2 、ロックウェル硬度６０、熱変形温度８５℃のポリ
メチルペンテンを射出成形して作製したアダプター本体
６と、ＭＦＲ２２ｇ／１０分、オルゼン剛性３９００ｋ
ｇ／ｃｍ2 、ロックウェル硬度３５、熱変形温度８０℃
のポリメチルペンテンを射出成形して作製したキャップ
７で挟み込み、本体６とキャップ７間のネジを締めるこ
とで各部材間を固定した。更に、ネジの締め込み後、キ
ャップ７と本体６を超音波溶着機を用いて溶着した。Density 0.959 g / cm 3 , melting point 132
The tubular member 5 extruded so that the inner diameter of polyethylene having a MFR of 0.7 g / 10 min and the outer diameter of the tubular member 4 was cut to an appropriate length calculated in advance, and its end was heated. The flare portion 5A was formed by pressing it against the flare mold. Tubular members 2 and 4
The flared portions 2A, 4A and the flared portion 5A of the tubular member 5 are overlapped,
MFR 26g / 10min, Olsen rigidity 6000kg / c
m 2, Rockwell hardness 60, the adapter body 6 polymethylpentene heat distortion temperature 85 ° C. was prepared by injection molding, MFR22g / 10 min, Olsen stiffness 3900k
g / cm 2 , Rockwell hardness 35, heat distortion temperature 80 ° C
The polymethylpentene of (3) was sandwiched by the caps 7 produced by injection molding, and the screws between the main body 6 and the caps 7 were tightened to fix the respective members. Further, after tightening the screws, the cap 7 and the main body 6 were welded using an ultrasonic welding machine.
【００２１】チューブ状部材２のフレアー部分２Ａと反
対側の端に、チューブ状部材１のバルーン１Ａが成形さ
れていない方の端を挿入し、両者の重ね代部分の内部に
スチンレス製の芯材を配置、外部にシリコン製の外周保
護材を取り付け、電磁誘導加熱装置で芯材を加熱し、両
部材を熱溶着した。The end of the tubular member 1 on which the balloon 1A is not formed is inserted into the end of the tubular member 2 opposite to the flare portion 2A, and the core material made of stainless steel is inserted into the overlapping portion of the two. , A silicon outer peripheral protective material was attached to the outside, the core material was heated by an electromagnetic induction heating device, and both members were heat-welded.
【００２２】密度０．９６１ｇ／ｃｍ3 、融点１３５
℃、ＭＦＲ１．０ｇ／１０分のポリエチレンにフタロシ
アニンブルーを重量比で０．３部の割合で混合した後、
押出成形機によって比較的小径的な部分（内径約０．４
２ｍｍ、外径約０．５６ｍｍ）とそこから連続的、一体
的に変化した比較的大径的な部分（内径約０．５０ｍ
ｍ、外径約０．６７ｍｍ）を有したチューブを押出成形
した。そのチューブをクリーンオーブン内にチューブの
軸方向に約０．０５Ｎのテンションがかかるように配置
し、８０℃で１時間熱処理を行った後、予め計算された
適切な長さに切断した（チューブ状部材３）。このチュ
ーブ状部材３の比較的大径な方の末端にステンレス製の
芯材を入れ、密度０．９３０ｇ／ｃｍ3 、融点１１７
℃、ＭＦＲ１．５ｇ／１０分のポリエチレンを押し出し
機により内径をチューブ状部材３の外径より大きくする
ように押出成形したチューブを予め計算された薄切な長
さに切断した物（チューブ状部材８）を被せ、更にその
上にシリコン製の外周保持材を被せて電磁誘導加熱装置
で芯材を加熱し両ポリエチレンチューブを熱溶着させ
た。その溶着させた部分を熱せられたフレアー金型に押
しつけてフレアー部分３Ａ，８Ａを成形した。また、チ
ューブ状部材３のフレアー部分３Ａの反対側にステンレ
ス製の芯材を挿入し、予め計算された位置に金製の環状
部材１Ｂを配置し、更にその環状部材１Ｂの両端に、密
度０．９２０ｇ／ｃｍ3 、融点１２９℃、ＭＦＲ１．６
ｇ／１０分のポリエチレンを内径約０．６２ｍｍ、外径
０．７２ｍｍに押し出したチューブを長さ約０．５ｍｍ
に切断したものを配置し、その部分をシリコンシートに
よる圧迫下において熱風により加熱、金製環状部材１Ｂ
の両端に配置されたポリエチレンを溶かすことによって
チューブ状部材３に金製環状部材１Ｂを固定した。上記
金製環状部材１Ｂが固定され、一端がフレア加工された
チューブ状部材３をフレア加工されていない方から前記
アダプター本体６内とそれに接続されたチューブ状部材
２、１内に通して配置し、フレアー部分３Ａ，８Ａをア
ダプター本体６とＭＦＲ２６ｇ／１０分、オルゼン剛性
１００００ｋｇ／ｃｍ2 、ロックウェル硬度８５、熱変
形温度９０℃のポリメチルペンテンを射出成形して作製
したキャップ９により挟み込み、本体６とキャップ９間
のネジを締めることで各部材間を固定した。更に、ネジ
の締め込み後、キャップ９と本体６を超音波溶着機を用
いて溶着した。Density 0.961 g / cm 3 , melting point 135
After mixing phthalocyanine blue in a weight ratio of 0.3 parts with polyethylene having a MFR of 1.0 g / 10 min,
A relatively small diameter part (inner diameter 0.4
2 mm, outer diameter of about 0.56 mm) and a relatively large-diameter portion that continuously and integrally changed from there (inner diameter of about 0.50 m)
m, outer diameter of about 0.67 mm) was extruded. The tube was placed in a clean oven so that a tension of about 0.05 N was applied in the axial direction of the tube, heat-treated at 80 ° C. for 1 hour, and then cut into an appropriate length calculated in advance (tube shape). Member 3). A stainless steel core material was placed at the end of the tubular member 3 having a relatively large diameter to give a density of 0.930 g / cm 3 and a melting point of 117.
A tube obtained by extruding polyethylene having an MFR of 1.5 g / 10 min at a temperature of MFR of 1.5 g / 10 by an extruder so as to have an inner diameter larger than the outer diameter of the tubular member 3 and cut into a pre-calculated thin length (the tubular member 8 ) Was further covered, and a silicon outer peripheral holding material was further covered thereon, and the core material was heated by an electromagnetic induction heating device to heat-weld both polyethylene tubes. The welded portion was pressed against a heated flare mold to form flare portions 3A and 8A. Further, a stainless core material is inserted on the opposite side of the flared portion 3A of the tubular member 3, a gold annular member 1B is arranged at a pre-calculated position, and a density of 0 is provided on both ends of the annular member 1B. 0.920 g / cm 3 , melting point 129 ° C., MFR 1.6
A tube made by extruding polyethylene of g / 10 min to an inner diameter of about 0.62 mm and an outer diameter of 0.72 mm has a length of about 0.5 mm.
The cut piece is placed and heated by hot air while being pressed by the silicon sheet, the annular member 1B made of gold.
The gold annular member 1B was fixed to the tube-shaped member 3 by melting polyethylene disposed at both ends of the. The gold annular member 1B is fixed, and the tubular member 3 having one end flared is placed through the inside of the adapter body 6 and the tubular members 2 and 1 connected thereto from the unflared side. , Flare parts 3A and 8A are sandwiched between adapter body 6 and MFR 26 g / 10 minutes, Olsen rigidity 10000 kg / cm 2 , Rockwell hardness 85, polymethyl pentene having a heat distortion temperature of 90 ° C. and injection molded cap 9 Each member was fixed by tightening the screw between 6 and the cap 9. Further, after tightening the screws, the cap 9 and the main body 6 were welded using an ultrasonic welding machine.
【００２３】上記まで組み立てられた後、キャップ９か
らチューブ状部材３の内部を通して芯材を貫通させた状
態で、チューブ状部材３とチューブ状部材１の端部の重
なった部分を熱風により加熱、加熱部を両端方向に引っ
張り、両チューブ状部材１，３を実質上減径させるとと
もに同心円的に溶着させた。また、溶着部を所定の長さ
に切断、ラッピングフィルムシートを用いて最先端部を
より減径するように研磨した。After the above-mentioned assembly, the overlapping portion of the ends of the tubular member 3 and the tubular member 1 is heated with hot air in a state where the core material is penetrated from the cap 9 through the inside of the tubular member 3. The heating part was pulled toward both ends to substantially reduce the diameters of both tubular members 1 and 3 and weld them concentrically. Further, the welded portion was cut into a predetermined length, and the tip end portion was polished with a wrapping film sheet so as to further reduce the diameter.
【００２４】チューブ状部材３の内部にへキサンに溶解
されたポリジメチルシロキサンを塗布した後、へキサン
を蒸散させる方法でポリジメチルシロキサンをコーティ
ング、更にバルーン１Ａを含むチューブ状部材１部分を
ポリジメチルシロキサンを直接塗布することでコーティ
ングした。After coating polydimethylsiloxane dissolved in hexane on the inside of the tubular member 3, polydimethylsiloxane is coated by a method of evaporating hexane, and the tubular member 1 portion including the balloon 1A is coated with polydimethylsiloxane. Coating was done by direct application of siloxane.
【００２５】バルーン１Ａをチューブ状部材３の周囲に
折り畳み、その折り畳まれた直径より若干大きい内径を
有するポリエチレン製のチューブに内に形状を保持させ
ながら挿入し、その折り畳まれたバルーン部分のみを約
６５℃〜７０℃、１０分程度加熱して折り癖を持たせ
た。尚、加熱温度を約６５℃〜７０℃としたのは、バー
ルン部分のサイズによって最適な加熱温度が異なるため
である。The balloon 1A is folded around the tubular member 3 and inserted into the polyethylene tube having an inner diameter slightly larger than the folded diameter while maintaining its shape, and only the folded balloon portion is approx. 65 degreeC-70 degreeC was heated for about 10 minutes, and it was made to have a crease. The heating temperature is set to about 65 ° C. to 70 ° C. because the optimum heating temperature differs depending on the size of the balun portion.
【００２６】以上に示すように作製された本発明の拡張
カテーテルは、それを構成する部材間の接合、固定に接
着剤を使用せず、構成部材間の熱溶着によって組み立て
が達成された。特に、アダプター部のネジ締め付けによ
るチューブの固定では実施例中に示したようにアダプタ
ー本体に対してそれぞれ異なった硬度を有したキャップ
を用いることで良好な締め付け性が得られるように調整
した。上記実施例による拡張カテーテルは、バルーン近
傍の部分に引張弾性率が比較的小さいチューブ状部材１
と、アダプター近傍部分に引張弾性率が比較的大きいチ
ューブ状部材２を有しているので、手元の力がアダプタ
ーからバルーン方向へ伝わり易い、操作性に比較的優れ
た拡張カテーテルであった。また、使用時にはガイドワ
イヤ一が内部を通過するチューブ状部材３は、アダプタ
ー近傍の内径が比較的大きいのと同時に、内部にポリジ
メチルシロキサンがコーティングされていることによ
り、ガイドワイヤーとの摩擦が少なく操作性が優れた拡
張カテーテルであった。The dilatation catheter of the present invention produced as described above was assembled by heat welding between the constituent members without using an adhesive for joining and fixing the members constituting the same. In particular, in fixing the tube by tightening the screw of the adapter portion, as shown in the examples, caps having different hardness were used for the adapter body so that good tightening performance was obtained. The dilatation catheter according to the above embodiment has a tubular member 1 having a relatively small tensile elastic modulus in the vicinity of the balloon.
Since the tubular member 2 having a relatively large tensile elastic modulus is provided in the vicinity of the adaptor, the dilatation catheter is relatively excellent in operability, and the force at hand is easily transmitted from the adaptor to the balloon. In addition, the tubular member 3 through which the guide wire 1 passes during use has a relatively large inner diameter in the vicinity of the adapter, and at the same time, since it is coated with polydimethylsiloxane, friction with the guide wire is reduced. It was a dilatation catheter with excellent operability.
【００２７】（比較例）本発明による拡張カテーテル
と、比較例として市販の拡張カテーテルに典型的な材料
構成、接着剤を使用して作製したカテーテル及び市販の
拡張カテーテルを対象としてＥＯＧ滅菌後の残留ＥＯＧ
量を評価した。比較例として以下の３例を示す。比較例
１は、本発明と同等のサイズのポリエチレン製チューブ
及び同じ金型を使用して成形したポリカーボネート製の
アダプターから構成され、チューブとアダプターの接着
にはポリウレタン系の接着剤を用いて組み立てた拡張カ
テーテルである。比較例２は、本発明と同等のサイズの
ポリアミド（ナイロン１２）製チューブ及び別成形され
たポリアミド（ナイロン１２）製のバルーン及び同じ金
型を使用して成形したポリアミド（ナイロン１２）製の
アダプターから構成され、チューブとバルーンの接着に
はシアノアクリレート系接着剤を、アダプターの接着に
はポリウレタン系の接着剤を用いて組み立てられた拡張
カテーテルである。比較例３は、ポリエチレン製チュー
ブとポリカーボネート製のアダプターから構成されてお
り、チューブとアダプターの接着は充填材としてタルク
を含むポリウレタン系の接着剤によってされている市販
の拡張カテーテルである。(Comparative Example) Residue after EOG sterilization for the dilatation catheter according to the present invention, as a comparative example, a material composition typical of commercially available dilatation catheters, a catheter made using an adhesive and a commercially available dilatation catheter EOG
The amount was evaluated. The following three examples are shown as comparative examples. Comparative Example 1 is composed of a polyethylene tube of the same size as the present invention and a polycarbonate adapter molded by using the same mold, and the tube and the adapter are assembled by using a polyurethane adhesive. It is a dilatation catheter. Comparative Example 2 is a polyamide (nylon 12) tube of the same size as the present invention, a separately molded polyamide (nylon 12) balloon, and a polyamide (nylon 12) adapter molded using the same mold. The dilatation catheter is constructed by using a cyanoacrylate adhesive for bonding the tube and the balloon and a polyurethane adhesive for bonding the adapter. Comparative Example 3 is a commercially available dilatation catheter which is composed of a polyethylene tube and a polycarbonate adapter, and the tube and the adapter are adhered by a polyurethane adhesive containing talc as a filler.
【００２８】本発明品と比較例１、２のＥＯＧ滅菌はＥ
ＯＧ２０％、炭酸ガス８０％の混合ガスを用い、ガス濃
度６００ｍｇ／Ｌ、温度５０〜６０℃、湿度４０〜７５
％ＲＨ、圧力１ｋｇ／ｃｍ2 、処理時間６時間の条件で
行い、ガス抜きはエアーレーション５回で行った。処理
後はガス抜き期間として１６日以上室温で保存した物を
測定した。また、比較例３の市販品の滅菌条件、滅菌日
からの正確な期間は不明であったが滅菌月の表示から約
４カ月であると推定された。残留エチレンオキサイドの
定量は日本医療器材協会の残留エチレンオキサイドの定
量法によって行った。測定結果を以下の表に示す。EOG sterilization of the product of the present invention and Comparative Examples 1 and 2 is E
Using a mixed gas of 20% OG and 80% carbon dioxide, gas concentration 600 mg / L, temperature 50 to 60 ° C., humidity 40 to 75
% RH, the pressure was 1 kg / cm 2 , the treatment time was 6 hours, and degassing was performed by aeration 5 times. After the treatment, as a degassing period, a product stored at room temperature for 16 days or more was measured. The sterilization condition of the commercial product of Comparative Example 3 and the exact period from the sterilization date were unknown, but it was estimated from the indication of the sterilization month that it was about 4 months. Quantitative determination of residual ethylene oxide was carried out by the quantitative method of residual ethylene oxide of Japan Medical Equipment Association. The measurement results are shown in the table below.
【００２９】[0029]
【表１】 [Table 1]
【００３０】表に示されるように本発明による拡張カテ
ーテルは、滅菌終了から測定までの期間が最も短いにも
関わらず残留ＥＯＧの量は最も少なかった。この結果は
先述した本発明の優れた安全性の一端を示すものであ
る。As shown in the table, the dilatation catheter according to the present invention had the smallest amount of residual EOG despite the shortest period from completion of sterilization to measurement. This result shows a part of the above-mentioned excellent safety of the present invention.
【００３１】[0031]
【発明の効果】本発明による拡張カテーテルは、主構成
材料がポリエチレン、及びポリメチルペンテンという他
の高分子材料と比較して化学的に安定で生体への影響が
少ない医療用への使用実績の確立されている材料を用
い、更に各部材間の接合に接着剤を用いていないため生
体に悪影響を与えると考えられる物質が存在、発生する
可能性が全くなく、滅菌方法にＥＯＧを用いた場合の残
留ＥＯＧが極めて少ないことから生物学的な安全性が極
めて高い。INDUSTRIAL APPLICABILITY The dilatation catheter according to the present invention is chemically stable as compared with other polymer materials whose main constituent materials are polyethylene and polymethylpentene, and has a proven record of use in medical applications with less influence on the living body. When EOG is used for the sterilization method, since there is no possibility that a substance that may adversely affect the living body exists and does not occur because the established material is used and no adhesive is used for joining the members. The biological safety is extremely high because the residual EOG of is extremely small.
【図１】本発明の拡張カテーテルの全体を示す一部省略
側面図である。FIG. 1 is a partially omitted side view showing the entire dilatation catheter of the present invention.
【図２】本発明の拡張カテーテルのチューブ部とアダプ
ター部の接合部を示す部分断面図である。FIG. 2 is a partial cross-sectional view showing a joint portion between a tube portion and an adapter portion of the dilatation catheter of the present invention.
１ チューブ状部材 ２ チューブ状部材 ３ チューブ状部材 ４ チューブ状部材 ５ チューブ状部材 ６ アダプター本体 ７ アダプターキャップ ８ チューブ状部材 ９ アダプターキャップ １０ ポート １１ ポート 1 tubular member 2 tubular members 3 tubular members 4 tubular members 5 tubular members 6 Adapter body 7 Adapter cap 8 tubular members 9 Adapter cap 10 ports 11 ports
───────────────────────────────────────────────────── フロントページの続き (56)参考文献 特開 平10−16053（ＪＰ，Ａ) 特開 平６−15004（ＪＰ，Ａ) 特開 平６−343691（ＪＰ，Ａ) (58)調査した分野(Int.Cl.7，ＤＢ名) A61L 29/00 - 29/18 A61M 25/00 - 25/18 ─────────────────────────────────────────────────── ─── Continuation of the front page (56) References JP-A-10-16053 (JP, A) JP-A-6-15004 (JP, A) JP-A-6-343691 (JP, A) (58) Field (Int.Cl. 7 , DB name) A61L 29/00-29/18 A61M 25/00-25/18
Claims (3)
たアダプター部材から構成された拡張カテーテルにおい
て、チューブ状部材の主材料がポリエチレンであり、ア
ダプター部材の材料がポリメチルペンテンであることを
特徴とした拡張カテーテル。1. A dilatation catheter composed of a plurality of tubular members and an adapter member connected to the tubular members, wherein the main material of the tubular member is polyethylene and the material of the adapter member is polymethylpentene. Dilated catheter.
のチューブ状部材の一端から一体的に成形されたバルー
ン１Ａを有し、チューブ状部材１がチューブ状部材１よ
り比較的大きい引っ張り弾性率を有するポリエチレン製
のチューブ状部材２と同心的に接合されており、チュー
ブ状部材１と２の内側にポリエチレン製のチューブ状部
材３が配置されており、チューブ状部材３がチューブ状
部材１のバルーン１Ａが成形された端でチューブ状部材
１と同心的に接合されており、チューブ状部材３上でバ
ルーン１Ａと重なる位置にＸ線による造影を目的とした
金または白金の環状部材１Ｂが固定されており、チュー
ブ状部材３の内側ルーメンがポリメチルペンテン製のア
ダプターのポート１０と連通しており、チューブ状部材
１、２の内側とチューブ状部材３の外側のルーメンがア
ダプターのポート１１と連通している構造の請求項１記
載の拡張カテーテル。2. A tubular member (1) made of polyethylene and a balloon (1A) integrally formed from one end of the tubular member, the tubular member (1) having a relatively higher tensile elastic modulus than the tubular member (1). It is concentrically joined to the polyethylene tubular member 2, and a polyethylene tubular member 3 is arranged inside the tubular members 1 and 2, and the tubular member 3 is a balloon 1A of the tubular member 1. Is joined concentrically with the tubular member 1 at the molded end, and a gold or platinum annular member 1B for X-ray imaging is fixed on the tubular member 3 at a position overlapping with the balloon 1A. The inner lumen of the tubular member 3 is in communication with the port 10 of the adapter made of polymethylpentene, and the inner lumen of the tubular members 1 and 2 is The dilatation catheter according to claim 1, wherein the outer lumen of the tube-shaped member (3) communicates with the port (11) of the adapter.
ューブ状部材１と接合していない方の一端にチューブ状
部材２の外径より大きい内径を有したポリエチレン製チ
ューブ状部材４を重ね合わせて接合したうえで円錐状に
フレア加工した部分と末端がフレア状加工されたポリエ
チレン製チューブ状部材５のフレアー部分を重ね合わせ
た部分をポリメチルペンテン製のアダプターの本体６と
ポリメチルペンテン製のアダプターのキャップ７のネジ
を締めることによって挟み込んで固定し、アダプター本
体６とキャップ７を超音波溶着によって接続し、また、
チューブ状部材３の内径、外径がチューブ状部材１と接
合している側が他端の内径、外径より小さくなるように
連続的に一体成形されており、チューブ状部材１と接合
していない方の一端にチューブ状部材３の外径より大き
い内径を有したポリエチレン製チューブ状部材８を重ね
合わせて接合したうえで円錐状にフレア加工した部分を
アダプターの本体６とポリメチルペンテン製のアダプタ
ーのキャップ９のネジを締めることによって挟み込んで
固定し、アダプター本体６とキャップ９を超音波溶着に
よって接続した構造をとっている請求項１又は２記載の
拡張カテーテル。3. A polyethylene tubular member 4 having an inner diameter larger than the outer diameter of the tubular member 2 is superposed and joined to one end of the tubular member 2 of the catheter which is not joined to the tubular member 1. After that, the conical flared portion and the flared portion of the polyethylene tubular member 5 having the flared end are overlapped to form a polymethylpentene adapter body 6 and a polymethylpentene adapter. Tighten the screw of the cap 7 to fix it, and connect the adapter body 6 and the cap 7 by ultrasonic welding.
The tubular member 3 is continuously and integrally molded so that the inner diameter and outer diameter of the tubular member 3 are smaller than the inner diameter and outer diameter of the other end. At one end, a tubular member 8 made of polyethylene having an inner diameter larger than the outer diameter of the tubular member 3 is superposed and joined, and a conical flare portion is formed on the adapter body 6 and an adapter made of polymethylpentene. 3. The expansion catheter according to claim 1, wherein the cap 9 is sandwiched and fixed by tightening the screw, and the adapter body 6 and the cap 9 are connected by ultrasonic welding.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23960996A JP3508416B2 (en) | 1996-09-10 | 1996-09-10 | Dilatation catheter |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP23960996A JP3508416B2 (en) | 1996-09-10 | 1996-09-10 | Dilatation catheter |
Related Child Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2003377833A Division JP2004041790A (en) | 2003-11-07 | 2003-11-07 | Dilation catheter |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPH1080473A JPH1080473A (en) | 1998-03-31 |
| JP3508416B2 true JP3508416B2 (en) | 2004-03-22 |
Family
ID=17047297
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP23960996A Expired - Fee Related JP3508416B2 (en) | 1996-09-10 | 1996-09-10 | Dilatation catheter |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP3508416B2 (en) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100900701B1 (en) * | 2008-01-03 | 2009-06-05 | 최길운 | The manufacturing method of the balloon catheter for kyphoplasty which using of thermoplastic poly urethane |
| EP2254645B1 (en) | 2008-03-13 | 2014-04-16 | Cook Medical Technologies LLC | Method of forming a cutting balloon with connector and dilation element |
| US10543354B2 (en) | 2017-09-27 | 2020-01-28 | Becton, Dickinson And Company | Peripheral intravenous catheters having flow diverting features |
| BR112020016424B1 (en) * | 2018-02-26 | 2023-10-17 | Cti Vascular Ag | SELECTABLE CATHETER BY USEFUL LENGTH TO TREAT VASCULAR PATHOLOGIES |
-
1996
- 1996-09-10 JP JP23960996A patent/JP3508416B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| JPH1080473A (en) | 1998-03-31 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| AU764958B2 (en) | Enhanced balloon dilatation system | |
| JP3583460B2 (en) | Over-the-wire catheter and method of manufacturing the same | |
| EP0409427B1 (en) | Catheter apparatus | |
| EP0650740B1 (en) | Interventional catheter | |
| JP3813112B2 (en) | Catheter and medical tubing | |
| US7022104B2 (en) | Facilitated balloon catheter exchange | |
| EP1681075B1 (en) | Suction catheter | |
| JPWO2006016491A1 (en) | catheter | |
| US20110208284A1 (en) | Protective sleeve for a medical device, system comprising a protective sleeve and a medical device, and a method for the production thereof | |
| WO1999047203A1 (en) | Balloon catheter | |
| JP2010524572A (en) | Catheter with multi-layer soft tip that can be easily bonded | |
| JPH09508557A (en) | Rapid delivery drug delivery catheter and inflatable drug delivery catheter | |
| JPH10513382A (en) | Esophageal dilatation balloon catheter with flexible nitinol wires | |
| JP2011161260A (en) | Balloon catheter and method of manufacturing the same | |
| US20140276401A1 (en) | Catheter Shaft and Method of Forming Same | |
| CA2494206A1 (en) | Suction catheter | |
| JP5473443B2 (en) | catheter | |
| JP4833039B2 (en) | catheter | |
| JP2008110132A (en) | Catheter | |
| JP4914281B2 (en) | catheter | |
| JP3508416B2 (en) | Dilatation catheter | |
| US7332689B2 (en) | Tacking method and apparatus | |
| JP4914282B2 (en) | Catheter with pushability | |
| JP4397072B2 (en) | Spiral balloon catheter and method for manufacturing the same | |
| JP2004041790A (en) | Dilation catheter |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20031215 |
|
| S533 | Written request for registration of change of name |
Free format text: JAPANESE INTERMEDIATE CODE: R313533 |
|
| R350 | Written notification of registration of transfer |
Free format text: JAPANESE INTERMEDIATE CODE: R350 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20090109 Year of fee payment: 5 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20090109 Year of fee payment: 5 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20100109 Year of fee payment: 6 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20100109 Year of fee payment: 6 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20110109 Year of fee payment: 7 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20120109 Year of fee payment: 8 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20120109 Year of fee payment: 8 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20130109 Year of fee payment: 9 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20130109 Year of fee payment: 9 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20140109 Year of fee payment: 10 |
|
| S531 | Written request for registration of change of domicile |
Free format text: JAPANESE INTERMEDIATE CODE: R313531 |
|
| FPAY | Renewal fee payment (event date is renewal date of database) |
Free format text: PAYMENT UNTIL: 20140109 Year of fee payment: 10 |
|
| R350 | Written notification of registration of transfer |
Free format text: JAPANESE INTERMEDIATE CODE: R350 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |
|
| LAPS | Cancellation because of no payment of annual fees |