JP4490559B2

JP4490559B2 - Balloon catheter

Info

Publication number: JP4490559B2
Application number: JP2000188642A
Authority: JP
Inventors: 正年渡辺
Original assignee: Kawasumi Laboratories Inc
Current assignee: Kawasumi Laboratories Inc
Priority date: 2000-06-23
Filing date: 2000-06-23
Publication date: 2010-06-30
Anticipated expiration: 2020-06-23
Also published as: JP2002000736A

Description

【０００１】
【発明の属する技術分野】
本発明は例えば経皮的冠状動脈血管形成術（ＰＴＣＡ）等に使用するバルーンカテーテルの改良に関するものであり、特にシャフト内に配置される補強材の取付形態の改良に関する。
【０００２】
【従来の技術及び発明が解決しようとする課題】
心筋梗塞や狭心症等の虚血性疾患の治療としてＰＴＣＡが行われる。ＰＴＣＡにはＰＴＣＡバルーンカテーテルが使用され、ガイドワイヤーをシャフトチューブの途中から挿入できるラピッドエクスチェンジ（モノレール）タイプの使用頻度が高い。
モノレールタイプのカテーテルでは、シャフトの剛性を上げるため、ステンレスパイプ等の金属管をシャフトに用い、ガイドワイヤー挿入部のキンク防止のため補強体としてステンレス製のコアワイヤーをバルーンとシャフト（金属管）との間に配置されるプラスチックチューブ内に装着している製品が多い（例えば特許公表公報、平成９年第５１１１５９号（シャフトを構成する剛性の基端部（シャフトパイプ）の先端にさらに別部材からなる補強用の芯材を溶接したバルーンカテーテルが開示されている）参照）。
しかし、コアワイヤーは基端部が金属管に接合されているが、先端部はプラスチックチューブに接着されずチューブ内腔に置かれているため、トルクの伝達性が悪く狭窄部の通過性に問題が生じていた。
そこで本発明者は以上の課題を解決するために鋭意検討を重ねた結果次の発明に到達した。
【０００３】
【課題を解決するための手段】
［１］本発明は、シャフト（２）とバルーン（５）とを有し、前記シャフト（２）と前記バルーン（５）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記長手方向の前方から後方に向けて、前記バルーン（５）、前記シャフト（２）の順に配置し、
前記シャフト（２）と前記バルーン（５）は、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記シャフト（２）は、可とう性の前方部（２Ｆ）と、剛性の基端部（２Ｂ）とを有し、
前記前方部（２Ｆ）と前記基端部（２Ｂ）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記前方部（２Ｆ）と前記基端部（２Ｂ）とは、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記前方部（２Ｆ）の近位端に、前記基端部（２Ｂ）の遠位端を装着し、
前記前方部（２Ｆ）の遠位端に、前記バルーン（５）の近位端を装着し、
前記シャフト（２）の前方部（２Ｆ）の内腔に、ガイドワイヤー用チューブ（４）を配置し、当該ガイドワイヤー用チューブ（４）は、内腔にガイドワイヤールーメン（６）を有し、
当該ガイドワイヤールーメン（６）は、先端開口部（９Ｆ）と、後端開口部（９Ｂ）とを有し、
前記先端開口部（９Ｆ）は、前記バルーン（５）の内腔を経て前記バルーン（５）の遠位端に配置され、
前記後端開口部（９Ｂ）は、前記前方部（２Ｆ）の内腔を経て当該前方部（２Ｆ）の側部に配置され、
前記前方部（２Ｆ）の内壁面と前記ガイドワイヤー用チューブ（４）の外壁面との間に形成される流体ルーメン（７）内に、補強体（３）を配置し、
当該補強体（３）は、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記補強体（３）は、前記長手方向の前方から後方に向けて、前方部（３Ｆ）、中間部（３Ｍ）及び基端部（３Ｂ）を順に配置し、
前記補強体（３）は、当該基端部（３Ｂ）から前記前方部（３Ｆ）方向に向けて、先細りテーパー状に形成されたコアワイヤーであり、
前記補強体（３）は、前記基端部（３Ｂ）の近位端を、前記シャフト（２）の基端部（２Ｂ）の遠位端に直接接着することなく、前記前方部（２Ｆ）の近位側の内壁面に接着して配置し、
前記補強体（３）は、前記前方部（３Ｆ）の側部を、前記ガイドワイヤー用チューブ（４）の外周壁面及び前記前方部（２Ｆ）の内壁面に接着したバルーンカテーテル（１）を提供する。
［２］本発明は、シャフト（２）とバルーン（５）とを有し、前記シャフト（２）と前記バルーン（５）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記長手方向の前方から後方に向けて、前記バルーン（５）、前記シャフト（２）の順に配置し、
前記シャフト（２）と前記バルーン（５）は、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記シャフト（２）は、可とう性の前方部（２Ｆ）と、剛性の基端部（２Ｂ）とを有し、
前記前方部（２Ｆ）と前記基端部（２Ｂ）は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、
前記前方部（２Ｆ）と前記基端部（２Ｂ）とは、それぞれ前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記前方部（２Ｆ）の近位端に、前記基端部（２Ｂ）の遠位端を装着し、
前記前方部（２Ｆ）の遠位端に、前記バルーン（５）の近位端を装着し、
前記シャフト（２）の前方部（２Ｆ）の内腔に、ガイドワイヤー用チューブ（４）を配置し、当該ガイドワイヤー用チューブ（４）は、内腔にガイドワイヤールーメン（６）を有し、
当該ガイドワイヤールーメン（６）は、先端開口部（９Ｆ）と、後端開口部（９Ｂ）とを有し、
前記先端開口部（９Ｆ）は、前記バルーン（５）の内腔を経て前記バルーン（５）の遠位端に配置され、
前記後端開口部（９Ｂ）は、前記前方部（２Ｆ）の内腔を経て当該前方部（２Ｆ）の側部に配置され、
前記前方部（２Ｆ）の内壁面と前記ガイドワイヤー用チューブ（４）の外壁面との間に形成される流体ルーメン（７）内に、補強体（１３）を配置し、
当該補強体（１３）は、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有し、
前記補強体（１３）は、前記長手方向の前方から後方に向けて、前方部（１３Ｆ）、中間部（１３Ｍ）及び基端部（１３Ｂ）を順に配置し、
前記補強体（１３）は、当該基端部（１３Ｂ）から前記前方部（１３Ｆ）方向に向けて、先細りテーパー状に形成されたコアワイヤーであり、
前記補強体（１３）は、前記基端部（１３Ｂ）の近位端より、前記シャフト（２）の基端部（２Ｂ）側に向けて細径部（１３Ｅ）を延設し、当該細径部（１３Ｅ）を前記基端部（２Ｂ）の遠位端に直接接着することなく、
前記前方部（２Ｆ）の近位端から、前記基端部（２Ｂ）の遠位端の内部空間わたって配置し、
前記補強体（１３）は、前記シャフト（２）の前記前方部（２Ｆ）から前記基端部（２Ｂ）内に亘って形成される前記流体ルーメン（７）内に配置し、
前記補強体（１３）は、前記前方部（１３Ｆ）の側部を、前記ガイドワイヤー用チューブ（４）の外壁面及び前記前方部（２Ｆ）の内壁面に接着し、前記基端部（１３Ｂ）の側部を、前記前方部（２Ｆ）の遠位端側の内壁面に接着したバルーンカテーテル（１１）を提供する。
【０００４】
【発明の実施の形態】
図１はいわゆるラピッドエクスチェンジタイプといわれる本発明のバルーンカテーテル１の一例を示す概略図（断面図、なお、コネクタ８付近の断面図は前方部２Ｆ付近の断面図より縮小化して記載されている）である。図２は本発明のバルーンカテーテルのその他の実施例を示す概略図（断面図）である。
バルーンカテーテル（１、１１）はシャフト２の先端にバルーン５を装着し、シャフト２は少なくとも可とう性の前方部２Ｆと少なくとも剛性の基端部２Ｂ（シャフトパイプともいう）より構成されている。そして先端と後端にそれぞれ開口部９Ｆ、９Ｂを形成しかつガイドワイヤールーメン６を有するガイドワイヤー用チューブ４を前記前方部２Ｆの側面からバルーン５内を経てバルーン５の先端に至るまで配置している。
さらに前記前方部２Ｆ内及びガイドワイヤー用チューブ４外周の間に形成される流体ルーメン７内に補強体（３、１３）を配置するとともに補強体（３、１３）の基端部（３Ｂ、１３Ｂ）の後端を前記基端部２Ｂの先端に直接接着することなく、該補強体（３、１３）の側部を前記ガイドワイヤー用チューブ４の側部（外壁面）及び前方部２Ｆの側部（内壁面）に接着している（図１、図２中でＢは接着部である）。
換言すれば、バルーンカテーテル（１、１１）は、シャフト２とバルーン５とを有し、シャフト２とバルーン５は、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有する。
長手方向の前方から後方に向けて、バルーン５、シャフト２の順に配置し、シャフト２とバルーン５は、それぞれ長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有する。
シャフト２は、可とう性の前方部２Ｆと、剛性の基端部２Ｂとを有し、前方部２Ｆと基端部２Ｂは、それぞれ長手方向と、当該長手方向と略垂直に交わる側部方向とを有する。
前方部２Ｆと基端部２Ｂとは、それぞれ長手方向の前方側に遠位端を有し、かつ長手方向の後方側に近位端を有する。
前方部２Ｆの近位端に、基端部２Ｂの遠位端を装着し、前方部２Ｆの遠位端に、バルーン５の近位端を装着している。
シャフト２の前方部２Ｆの内腔に、ガイドワイヤー用チューブ４を配置し、当該ガイドワイヤー用チューブ４は、内腔にガイドワイヤールーメン６を有し、
当該ガイドワイヤールーメン６は、先端開口部９Ｆと、後端開口部９Ｂとを有し、先端開口部９Ｆは、バルーン５の内腔を経てバルーン５の遠位端に配置されている。
後端開口部９Ｂは、前方部２Ｆの内腔を経て当該前方部２Ｆの側部に配置され、前方部２Ｆの内壁面とガイドワイヤー用チューブ４の外壁面との間に形成される流体ルーメン７内に、補強体（３、１３）を配置している。
補強体（３、１３）は、長手方向と、当該長手方向と略垂直に交わる側部方向とを有し、前記長手方向の前方側に遠位端を有し、かつ前記長手方向の後方側に近位端を有する。
補強体（３、１３）は、長手方向の前方から後方に向けて、前方部（３Ｆ、１３Ｆ）、中間部（３Ｍ、１３Ｍ）及び基端部（３Ｂ、１３Ｂ）を順に配置している。
【０００５】
本発明で「接着」とはヒート（熱）シール、接着剤等による接着またはこれらと実質的に同等の接着手段を意味する。
また本発明で補強体３（１３）の側部を前記ガイドワイヤー用チューブ４の側部（外壁面）及び前方部２Ｆの側部（内壁面）に接着するとは、図１及び図２のように補強体３（１３）の前方部３Ｆ（１３Ｆ）の側部をガイドワイヤー用チューブ４の側部（外壁面）に部分的に接着するとともに基端部３Ｂ（１３Ｂ）の側部を前方部２Ｆの側部（内壁面）に部分的に接着しても良いし、その他に前方部３Ｆ（１３Ｆ）から基端部３Ｂ（１３Ｂ）のいずれかの二箇所以上の側部とガイドワイヤー用チューブ４の側部（外壁面）から前方部２Ｆの側部（内壁面）のいずれかの二箇所以上を部分的に接着しても良いことを意味する。
【０００６】
本発明に使用される補強体（３、１３）としては、例えば図１及び図２に示すように基端部（３Ｂ、１３Ｂ）から先端部（３Ｆ、１３Ｆ）方向へ向けて先細りテーパー状に形成されたコアワイヤーが使用されるが、これらのコアワイヤーと実質的に同様の機能を果たすものであれば、何でも使用することができる。
図１のバルーンカテーテル１では、補強体３の基端部３Ｂ後端はシャフト２の先端に直接接着することなく、軽く接触する程度かあるいは若干の隙間（約１ｍｍ程度）をあけて配置される。
さらに詳述すれば、補強体３は、長手方向の前方から後方に向けて、前方部３Ｆ、中間部３Ｍ及び基端部３Ｂを順に配置している。
補強体３は、基端部３Ｂの近位端を、シャフト２の基端部（２Ｂ）の遠位端に直接接着することなく、前方部２Ｆの近位側の内壁面に接着して配置している。
補強体３は、前方部３Ｆの側部を、ガイドワイヤー用チューブ４の外周壁面及び前方部２Ｆの内壁面に接着している。
図２のバルーンカテーテル１１では補強体１３の基端部１３Ｂ後端はシャフト２の先端と隙間をあけて配置され、前記補強体１３の基端部１３Ｂの後方に細径部１３Ｅを延設し、細径部１３Ｅを基端部２Ｂに直接接着することなく前方部２Ｆから基端部２Ｂの前方内に形成される流体ルーメン７内に亘って配置している。
さらに詳述すれば、補強体１３は、基端部１３Ｂの近位端より、シャフト２の基端部２Ｂ側に向けて細径部１３Ｅを延設し、細径部１３Ｅを基端部２Ｂの遠位端に直接接着することなく、前方部２Ｆの近位端から、基端部２Ｂの遠位端の内部空間わたって配置している。
補強体１３は、シャフト２の前方部２Ｆから基端部２Ｂ内に亘って形成される流体ルーメン７内に配置している。
補強体１３は、前方部１３Ｆの側部を、前記ガイドワイヤー用チューブ４の外壁面及び前記前方部２Ｆの内壁面に接着し、基端部１３Ｂの側部を、前方部２Ｆの遠位端側の内壁面に接着している。
【０００７】
本発明で前記可とう性の前方部２Ｆの構成材料は、例えばポリアミド、ポリアミドエラストマー、ポリエステル、ポリエチレン、ポリイミド、ＰＥＴ等の合成樹脂を使用することができる。
本発明で前記剛性の基端部２Ｂの構成材料は、例えばステンレス、Ｎｉ−Ｔｉ、Ｃｕ−Ｍｎ−Ａｌ系合金等の金属を使用することができる。前記可とう性の前方部２Ｆと剛性の基端部２Ｂは、例えば接着剤、ヒートシール等の手段により接続することができる。
また剛性の基端部２Ｂの後方部はコネクタ８前方の管状体８ａ内に配置され、管状体８ａの内周と剛性の基端部２Ｂの外周の間に接着剤１０を充填することにより固定されている。あるいは剛性の基端部２Ｂの後方部とコネクタ８はインサート成形により固定することができる。コネクタ８後方の管状体８ｂの後端にはバルーンの拡張用流体を導入するための開口部８Ｂが形成されている。
【０００８】
【発明の作用効果】
本発明のバルーンカテーテル１（１１）は血管に押し込む際に、シャフト２の基端部２Ｂに加わった力が補強体３（１３）（コアワイヤー）を介して、前方部２Ｆ、ガイドワイヤー用チューブ４に直接、直線的に伝達されるためカテーテルの押し込み性、狭窄部における通過性が飛躍的に向上する。
さらに本発明のバルーンカテーテル１１では、補強体１３の基端部１３Ｂの後方に細径部１３Ｅを延設し、細径部１３Ｅを基端部２Ｂに直接接着することなく前方部２Ｆから基端部２Ｂ内に亘って形成される流体ルーメン７内に亘って配置しているので前方部２Ｆと基端部２Ｂ間のキンクの発生が皆無となり、またバルーンカテーテル１よりも基端部２Ｂから前方部２Ｆ及びガイドワイヤー用チューブ４へのトルク伝達性がさらに向上する。
【図面の簡単な説明】
【図１】本発明のバルーンカテーテルの概略図（断面図）
【図２】本発明のバルーンカテーテルのその他の実施例を示す概略図（断面図）
【符号の説明】
１、１１バルーンカテーテル
２シャフト
２Ｆ前方部
２Ｂ基端部
３、１３補強体
３Ｆ、１３Ｆ前方部
３Ｍ、１３Ｍ中間部
３Ｂ、１３Ｂ基端部
１３Ｅ細径部
４ガイドワイヤー用チューブ
５バルーン
６ガイドワイヤールーメン
７流体ルーメン
８コネクタ
８Ｂ開口部（コネクタ）
８ａ、８ｂ管状体
９Ｆ、９Ｂ開口部（ガイドワイヤー用チューブ）
１０接着剤
Ｂ接着部[0001]
BACKGROUND OF THE INVENTION
The present invention relates to an improvement of a balloon catheter used for, for example, percutaneous coronary angioplasty (PTCA), and more particularly to an improvement of a mounting form of a reinforcing member disposed in a shaft.
[0002]
[Prior art and problems to be solved by the invention]
PTCA is performed as a treatment for ischemic diseases such as myocardial infarction and angina. A PTCA balloon catheter is used for PTCA, and a rapid exchange (monorail) type in which a guide wire can be inserted from the middle of a shaft tube is frequently used.
In the monorail type catheter, a metal tube such as a stainless steel pipe is used for the shaft in order to increase the rigidity of the shaft, and a stainless steel core wire is used as a reinforcement to prevent kinking of the guide wire insertion portion between the balloon and the shaft (metal tube). Many products are mounted in a plastic tube placed between the two (for example, Patent Publication No. 1997-11511 (from another member at the distal end of the rigid base end (shaft pipe) constituting the shaft). A balloon catheter in which a reinforcing core material is welded is disclosed).
However, the base end of the core wire is bonded to the metal tube, but the distal end is not bonded to the plastic tube, but is placed in the tube lumen. Has occurred.
Therefore, as a result of intensive studies to solve the above problems, the present inventor has reached the following invention.
[0003]
[Means for Solving the Problems]
[1] The present invention includes a shaft (2) and a balloon (5), and the shaft (2) and the balloon (5) each have a longitudinal direction and a side portion direction substantially perpendicular to the longitudinal direction. And
From the front in the longitudinal direction toward the rear, the balloon (5) and the shaft (2) are arranged in this order,
The shaft (2) and the balloon (5) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction;
Before Symbol shaft (2) has front portion of the flexible and (2F), the proximal end portion of the rigidity and (2B),
The front part (2F) and the base end part (2B) each have a longitudinal direction and a side part direction that intersects the longitudinal direction substantially perpendicularly.
The front part (2F) and the base end part (2B) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
At the proximal end of the front part (2F), the distal end of the base end part (2B) is attached,
Attach the proximal end of the balloon (5) to the distal end of the front part (2F);
A guide wire tube (4) is disposed in the lumen of the front portion (2F) of the shaft (2), and the guide wire tube (4) has a guide wire lumen (6) in the lumen;
The guide wire lumen (6) has a front end opening (9F) and a rear end opening (9B),
The tip opening (9F) is disposed at the distal end of the balloon (5) through the lumen of the balloon (5);
The rear end opening (9B) is disposed on the side of the front part (2F) through the lumen of the front part (2F),
A reinforcing body (3) is disposed in a fluid lumen (7) formed between the inner wall surface of the front portion (2F) and the outer wall surface of the guide wire tube (4),
The reinforcing body (3) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and on the rear side in the longitudinal direction. Has a proximal end,
The reinforcing body (3) is arranged with a front part (3F), an intermediate part (3M) and a base end part (3B) in order from the front in the longitudinal direction to the rear,
The reinforcing body (3) is a core wire formed in a tapered shape from the base end portion (3B) toward the front portion (3F),
The reinforcing body (3) is configured such that the proximal end of the base end portion (3B) is not directly bonded to the distal end of the base end portion (2B) of the shaft (2), and the front portion (2F) Adhering to the inner wall of the proximal side of
The reinforcing body (3) provides a balloon catheter (1) in which the side portion of the front portion (3F) is bonded to the outer peripheral wall surface of the guide wire tube (4) and the inner wall surface of the front portion (2F). To do.
[2] The present invention includes a shaft (2) and a balloon (5), and the shaft (2) and the balloon (5) each have a longitudinal direction and a side portion direction substantially perpendicular to the longitudinal direction. And
From the front in the longitudinal direction toward the rear, the balloon (5) and the shaft (2) are arranged in this order,
The shaft (2) and the balloon (5) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction;
The shaft (2) has a flexible front part (2F) and a rigid base end part (2B),
The front part (2F) and the base end part (2B) each have a longitudinal direction and a side part direction that intersects the longitudinal direction substantially perpendicularly.
The front part (2F) and the base end part (2B) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
At the proximal end of the front part (2F), the distal end of the base end part (2B) is attached,
Attach the proximal end of the balloon (5) to the distal end of the front part (2F);
A guide wire tube (4) is disposed in the lumen of the front portion (2F) of the shaft (2), and the guide wire tube (4) has a guide wire lumen (6) in the lumen;
The guide wire lumen (6) has a front end opening (9F) and a rear end opening (9B),
The tip opening (9F) is disposed at the distal end of the balloon (5) through the lumen of the balloon (5);
The rear end opening (9B) is disposed on the side of the front part (2F) through the lumen of the front part (2F),
A reinforcing body (13) is disposed in a fluid lumen (7) formed between the inner wall surface of the front portion (2F) and the outer wall surface of the guide wire tube (4),
The reinforcing body (13) has a longitudinal direction and a side direction intersecting with the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and on the rear side in the longitudinal direction. Has a proximal end,
The reinforcing body (13) has a front part (13F), an intermediate part (13M) and a base end part (13B) arranged in order from the front in the longitudinal direction to the rear,
The reinforcing body (13) is a core wire formed in a tapered shape from the base end portion (13B) toward the front portion (13F),
The reinforcing body (13) has a narrow diameter portion (13E) extending from the proximal end of the base end portion (13B) toward the base end portion (2B) of the shaft (2). Without directly bonding the diameter (13E) to the distal end of the proximal end (2B),
From the proximal end of the front portion (2F) to the inner space of the distal end of the proximal end portion (2B);
The reinforcing body (13) is disposed in the fluid lumen (7) formed from the front part (2F) of the shaft (2) to the base end part (2B),
The reinforcing body (13) has the side portion of the front portion (13F) adhered to the outer wall surface of the guide wire tube (4) and the inner wall surface of the front portion (2F), and the base end portion (13B). ) Is adhered to the inner wall surface on the distal end side of the front portion (2F) .
[0004]
DETAILED DESCRIPTION OF THE INVENTION
FIG. 1 is a schematic view showing an example of a balloon catheter 1 of the present invention called a so-called rapid exchange type (a cross-sectional view, where the cross-sectional view in the vicinity of the connector 8 is shown in a smaller scale than the cross-sectional view in the vicinity of the front portion 2F). It is. FIG. 2 is a schematic view (cross-sectional view) showing another embodiment of the balloon catheter of the present invention.
The balloon catheter (1, 11) has a balloon 5 attached to the tip of the shaft 2, and the shaft 2 is composed of at least a flexible front portion 2F and at least a rigid base end portion 2B (also referred to as a shaft pipe). A guide wire tube 4 having openings 9F and 9B at the front and rear ends and having a guide wire lumen 6 is disposed from the side surface of the front portion 2F to the front end of the balloon 5 through the inside of the balloon 5. Yes.
Further, a reinforcing body (3, 13) is disposed in the fluid lumen 7 formed in the front portion 2F and the outer periphery of the guide wire tube 4, and the base end portion (3B, 13B ) of the reinforcing body (3, 13). ) Without directly adhering the rear end to the distal end of the base end portion 2B, the side portions of the reinforcing bodies (3, 13) are connected to the side portion (outer wall surface) of the guide wire tube 4 and the front portion 2F side. It adheres to the part (inner wall surface) (B in FIG. 1 and FIG. 2 is an adhesive part).
In other words, the balloon catheter (1, 11) includes the shaft 2 and the balloon 5, and the shaft 2 and the balloon 5 each have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly.
The balloon 5 and the shaft 2 are disposed in this order from the front to the rear in the longitudinal direction. The shaft 2 and the balloon 5 each have a distal end on the front side in the longitudinal direction and close to the rear side in the longitudinal direction. It has a position end.
The shaft 2 has a flexible front portion 2F and a rigid base end portion 2B, and the front portion 2F and the base end portion 2B each have a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly. And have.
Each of the front portion 2F and the base end portion 2B has a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction.
The distal end of the base end 2B is attached to the proximal end of the front part 2F, and the proximal end of the balloon 5 is attached to the distal end of the front part 2F.
A guide wire tube 4 is arranged in the lumen of the front portion 2F of the shaft 2, and the guide wire tube 4 has a guide wire lumen 6 in the lumen.
The guide wire lumen 6 has a front end opening 9F and a rear end opening 9B, and the front end opening 9F is disposed at the distal end of the balloon 5 through the lumen of the balloon 5.
The rear end opening 9B is disposed on the side of the front part 2F through the lumen of the front part 2F, and is a fluid lumen formed between the inner wall surface of the front part 2F and the outer wall surface of the guide wire tube 4. 7, the reinforcing bodies (3, 13) are arranged.
The reinforcing body (3, 13) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and is on the rear side in the longitudinal direction. Has a proximal end.
Reinforcing bodies (3, 13) have a front portion (3F, 13F), an intermediate portion (3M, 13M), and a base end portion (3B, 13B) arranged in this order from the front to the rear in the longitudinal direction.
[0005]
In the present invention, “adhesion” means adhesion by heat sealing, adhesive or the like, or adhesion means substantially equivalent thereto.
In the present invention, the side part of the reinforcing body 3 (13) is bonded to the side part (outer wall surface) of the guide wire tube 4 and the side part (inner wall surface) of the front part 2F as shown in FIGS. The side part of the front part 3F (13F) of the reinforcing body 3 (13) is partially adhered to the side part (outer wall surface) of the guide wire tube 4 and the side part of the base end part 3B (13B) is attached to the front part. It may be partially bonded to the side (inner wall surface) of 2F, and in addition, any two or more sides from the front part 3F (13F) to the base end part 3B (13B) and the guide wire tube It means that any two or more locations from the side portion (outer wall surface) 4 to the side portion (inner wall surface) of the front portion 2F may be partially bonded.
[0006]
As the reinforcing bodies (3, 13) used in the present invention, for example, as shown in FIGS. 1 and 2, the taper is tapered from the base end (3B, 13B) toward the tip (3F, 13F). The formed core wires are used, but anything can be used as long as it performs substantially the same function as these core wires.
In the balloon catheter 1 of FIG. 1, the rear end of the base end portion 3B of the reinforcing body 3 is arranged so as to be in light contact or with a slight gap (about 1 mm) without directly adhering to the tip of the shaft 2. .
More specifically, the reinforcing body 3 has a front portion 3F, an intermediate portion 3M, and a base end portion 3B arranged in this order from the front to the rear in the longitudinal direction.
The reinforcing body 3 is arranged by adhering the proximal end of the base end portion 3B to the inner wall surface on the proximal side of the front portion 2F without directly adhering to the distal end of the base end portion (2B) of the shaft 2. is doing.
The reinforcing body 3 adheres the side portion of the front portion 3F to the outer peripheral wall surface of the guide wire tube 4 and the inner wall surface of the front portion 2F.
In the balloon catheter 11 of FIG. 2, the rear end of the base end portion 13B of the reinforcing body 13 is arranged with a gap from the tip end of the shaft 2, and a small diameter portion 13E extends behind the base end portion 13B of the reinforcing body 13. The narrow-diameter portion 13E is disposed from the front portion 2F to the fluid lumen 7 formed in the front of the base end portion 2B without directly adhering to the base end portion 2B.
More specifically, the reinforcing body 13 has a small diameter portion 13E extending from the proximal end of the base end portion 13B toward the base end portion 2B side of the shaft 2, and the small diameter portion 13E is connected to the base end portion 2B. Without being directly bonded to the distal end of the base portion 2F, it is arranged from the proximal end of the front portion 2F to the inner space of the distal end of the base end portion 2B.
The reinforcing body 13 is disposed in the fluid lumen 7 formed from the front portion 2F of the shaft 2 to the base end portion 2B.
The reinforcing body 13 adheres the side portion of the front portion 13F to the outer wall surface of the guide wire tube 4 and the inner wall surface of the front portion 2F, and the side portion of the base end portion 13B is connected to the distal end of the front portion 2F. Bonded to the inner wall of the side.
[0007]
As the constituent material of the flexible front portion 2F in the present invention, for example, a synthetic resin such as polyamide, polyamide elastomer, polyester, polyethylene, polyimide, or PET can be used.
In the present invention, as the constituent material of the rigid base end portion 2B, for example, a metal such as stainless steel, Ni—Ti, or Cu—Mn—Al alloy can be used. The flexible front portion 2F and the rigid base end portion 2B can be connected by means such as an adhesive or heat seal.
The rear portion of the rigid base end portion 2B is disposed in the tubular body 8a in front of the connector 8, and is fixed by filling the adhesive 10 between the inner periphery of the tubular body 8a and the outer periphery of the rigid base end portion 2B. Has been. Alternatively, the rear portion of the rigid base end 2B and the connector 8 can be fixed by insert molding. At the rear end of the tubular body 8b behind the connector 8, an opening 8B for introducing a balloon expansion fluid is formed.
[0008]
[Effects of the invention]
When the balloon catheter 1 (11) of the present invention is pushed into the blood vessel, the force applied to the proximal end portion 2B of the shaft 2 is passed through the reinforcing body 3 (13) (core wire) to the front portion 2F, the guide wire tube. 4 is transmitted directly and linearly, so that the pushability of the catheter and the passage through the stenosis are greatly improved.
Furthermore, in the balloon catheter 11 of the present invention, the narrow diameter portion 13E is extended behind the base end portion 13B of the reinforcing body 13, and the base end portion 2E is not directly bonded to the base end portion 2B without directly bonding the small diameter portion 13E to the base end portion 2B. Since the fluid lumen 7 formed over the portion 2B is disposed over the fluid lumen 7, there is no kinking between the front portion 2F and the base end portion 2B, and the front end portion 2B is more forward than the balloon catheter 1. Torque transmission to the portion 2F and the guide wire tube 4 is further improved.
[Brief description of the drawings]
FIG. 1 is a schematic view (cross-sectional view) of a balloon catheter of the present invention.
FIG. 2 is a schematic view (cross-sectional view) showing another embodiment of the balloon catheter of the present invention.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1, 11 Balloon catheter 2 Shaft 2F Front part 2B Base end part 3, 13 Reinforcing body 3F, 13F Front part 3M, 13M Intermediate part 3B, 13B Base end part 13E Small diameter part 4 Guide wire tube 5 Balloon 6 Guide wire lumen 7 Fluid Lumen 8 Connector 8B Opening (Connector)
8a, 8b Tubular bodies 9F, 9B Openings (tubes for guide wires)
10 Adhesive B Bonding part

Claims

A shaft (2) and a balloon (5), each of the shaft (2) and the balloon (5) has a longitudinal direction and a side direction intersecting the longitudinal direction substantially perpendicularly;
From the front in the longitudinal direction toward the rear, the balloon (5) and the shaft (2) are arranged in this order,
The shaft (2) and the balloon (5) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction;
Before Symbol shaft (2) has front portion of the flexible and (2F), the proximal end portion of the rigidity and (2B),
The front part (2F) and the base end part (2B) each have a longitudinal direction and a side part direction that intersects the longitudinal direction substantially perpendicularly.
The front part (2F) and the base end part (2B) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
At the proximal end of the front part (2F), the distal end of the base end part (2B) is attached,
Attach the proximal end of the balloon (5) to the distal end of the front part (2F);
A guide wire tube (4) is disposed in the lumen of the front portion (2F) of the shaft (2), and the guide wire tube (4) has a guide wire lumen (6) in the lumen;
The guide wire lumen (6) has a front end opening (9F) and a rear end opening (9B),
The tip opening (9F) is disposed at the distal end of the balloon (5) through the lumen of the balloon (5);
The rear end opening (9B) is disposed on the side of the front part (2F) through the lumen of the front part (2F),
A reinforcing body (3) is disposed in a fluid lumen (7) formed between the inner wall surface of the front portion (2F) and the outer wall surface of the guide wire tube (4),
The reinforcing body (3) has a longitudinal direction and a side direction that intersects the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and on the rear side in the longitudinal direction. Has a proximal end,
The reinforcing body (3) is arranged with a front part (3F), an intermediate part (3M) and a base end part (3B) in order from the front in the longitudinal direction to the rear,
The reinforcing body (3) is a core wire formed in a tapered shape from the base end portion (3B) toward the front portion (3F),
The reinforcing body (3) is configured such that the proximal end of the base end portion (3B) is not directly bonded to the distal end of the base end portion (2B) of the shaft (2), and the front portion (2F) Adhering to the inner wall of the proximal side of
The balloon catheter, wherein the reinforcing body (3) has a side portion of the front portion (3F) bonded to an outer peripheral wall surface of the guide wire tube (4) and an inner wall surface of the front portion (2F). (1).

A shaft (2) and a balloon (5), each of the shaft (2) and the balloon (5) has a longitudinal direction and a side direction intersecting the longitudinal direction substantially perpendicularly;
From the front in the longitudinal direction toward the rear, the balloon (5) and the shaft (2) are arranged in this order,
The shaft (2) and the balloon (5) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction;
The shaft (2) has a flexible front part (2F) and a rigid base end part (2B),
The front part (2F) and the base end part (2B) each have a longitudinal direction and a side part direction that intersects the longitudinal direction substantially perpendicularly.
The front part (2F) and the base end part (2B) each have a distal end on the front side in the longitudinal direction and a proximal end on the rear side in the longitudinal direction,
At the proximal end of the front part (2F), attach the distal end of the base part (2B),
Attach the proximal end of the balloon (5) to the distal end of the front part (2F);
A guide wire tube (4) is disposed in the lumen of the front portion (2F) of the shaft (2), and the guide wire tube (4) has a guide wire lumen (6) in the lumen;
The guide wire lumen (6) has a front end opening (9F) and a rear end opening (9B),
The tip opening (9F) is disposed at the distal end of the balloon (5) through the lumen of the balloon (5);
The rear end opening (9B) is disposed on the side of the front part (2F) through the lumen of the front part (2F),
A reinforcing body (13) is disposed in a fluid lumen (7) formed between the inner wall surface of the front portion (2F) and the outer wall surface of the guide wire tube (4),
The reinforcing body (13) has a longitudinal direction and a side direction intersecting with the longitudinal direction substantially perpendicularly, has a distal end on the front side in the longitudinal direction, and on the rear side in the longitudinal direction. Has a proximal end,
The reinforcing body (13) has a front part (13F), an intermediate part (13M) and a base end part (13B) arranged in order from the front in the longitudinal direction to the rear,
The reinforcing body (13) is a core wire formed in a tapered shape from the base end portion (13B) toward the front portion (13F),
The reinforcing body (13) has a narrow diameter portion (13E) extending from the proximal end of the base end portion (13B) toward the base end portion (2B) of the shaft (2). Without directly bonding the diameter (13E) to the distal end of the proximal end (2B),
From the proximal end of the front portion (2F) to the inner space of the distal end of the proximal end portion (2B);
The reinforcing body (13) is disposed in the fluid lumen (7) formed from the front part (2F) of the shaft (2) to the base end part (2B),
The reinforcing body (13) has the side portion of the front portion (13F) adhered to the outer wall surface of the guide wire tube (4) and the inner wall surface of the front portion (2F), and the base end portion (13B). The balloon catheter (11) is bonded to the inner wall surface on the distal end side of the front portion (2F).