JP3190332B2

JP3190332B2 - Perfusion catheter

Info

Publication number: JP3190332B2
Application number: JP51098591A
Authority: JP
Inventors: ウィジェイ、バンデュラ; アンジェリニ、パオロ
Original assignee: シメッドライフシステムズ，インコーポレイテッド
Priority date: 1991-05-23
Filing date: 1991-05-23
Publication date: 2001-07-23
Anticipated expiration: 2016-07-23
Also published as: JPH06511394A; WO1992020398A1; EP0586371A1; EP0586371A4

Description

【発明の詳細な説明】産業上の利用分野本発明は灌流カテーテル、特に血管形成術に適した灌
流カテーテルに関する。Description: TECHNICAL FIELD The present invention relates to a perfusion catheter, and more particularly to a perfusion catheter suitable for angioplasty.

発明の背景冠状血管形成術を行うには狭窄を拡大することにより
血液の流路を浄化しようとして動脈路でバルーンを膨張
させることが必要である。バルーンが収縮すると、動脈
路での有効な血流断面積が増大する。血管形成術が抱え
る問答点はバルーンの膨張時に血液循環が遮断されるこ
とである。この場合、虚血及び心電的変化に至ることが
ある。冠状血管形成中またはその直後に見られる他の現
象は、血管形成後に動脈路を再び遮断するように、狭窄
が元通りになる部位で突然に再び遮断が起こることであ
る。あるいは、狭窄部位が一端で緩み血液の流路を遮断
することもある。これは脈管内膜弁として知られてい
る。こうした状態は明らかにすべて緊急事態となり、す
ぐに処置しないと重大な結果になる可能性がある。BACKGROUND OF THE INVENTION Performing coronary angioplasty requires inflating the balloon in the arterial tract in an attempt to purify the blood flow path by expanding the stenosis. As the balloon contracts, the effective blood flow cross-section in the arterial tract increases. The problem with angioplasty is that blood circulation is interrupted when the balloon is inflated. This can lead to ischemia and electrocardiographic changes. Another phenomenon seen during or shortly after coronary angioplasty is the sudden re-obstruction at the site where the stenosis is restored, such as re-obstructing the arterial tract after angioplasty. Alternatively, the stenosis site may be loosened at one end to block the blood flow path. This is known as an intimal valve. All of these conditions are obviously emergency situations and can have serious consequences if not addressed immediately.

虚血、心電的及びST部分の変化の兆候を抑えるために
用いられてきた方法の１つは、バルーン膨張時に血管形
成カテーテルの管腔内に血液を灌流することであった。
血液の灌流により膨張したバルーンの末端部において動
脈路の虚血及びST部分の変化をなくし、関係する心筋を
保護するのに好結果を生む。灌流については、膨張時に
バルーンに接触している脈管内膜部分のみが、そしてそ
こで関係する支脈が虚血反応の原因となる。One method that has been used to reduce the signs of ischemia, electrocardiographic and ST segment changes has been to perfuse blood into the lumen of an angioplasty catheter upon balloon inflation.
The perfusion of blood eliminates ischemia and ST segment changes in the arterial tract at the distal end of the inflated balloon, which is successful in protecting the involved myocardium. For perfusion, only the portion of the intima that is in contact with the balloon during inflation, and the tributaries involved there, cause an ischemic response.

狭窄部位に進めるようにカテーテルは可能な限り小さ
くしておくことが有利であるということも分かってい
る。また、血管形成カテーテルは小型であることが好ま
しいが、狭窄部分まで進むのに十分な推進力及びトルク
性反応を示すような柱強度を備える必要がある。It has also been found advantageous to keep the catheter as small as possible so that it can be advanced to the stenosis. Also, the angioplasty catheter is preferably small, but must have sufficient column strength to provide propulsion and torque response to advance to the stenosis.

従来、バルーンの膨張時に血液灌流を行おうと様々な
血液ポンプが開発されてきた。こうしたポンプの大部分
は出力が水銀圧60プシーを上限とするかなりの低圧のも
のだった。これらは主に膜型ポンプ及びローラ型ポンプ
であった。Conventionally, various blood pumps have been developed for performing blood perfusion during inflation of the balloon. Most of these pumps were of fairly low pressure, with outputs up to 60 psi of mercury. These were mainly membrane pumps and roller pumps.

径内に末端部で約0.020インチの中央部の管腔を備え
た小型カテーテルの出現は、所望量の約60cc/分を圧出
するためには、そうしたポンプはより高圧にすることが
必要となるということである。約130〜140cmの概ねの全
長に対し約0.032インチの中央部の管腔を備えたカテー
テルでさえ、中央部の管腔の逓減率が約0.020インチま
で下がっても、必要量の約60cc/分を灌流するためには
約125〜200プシーの圧力が必要だった。末端部で逓減率
を伴うそのような典型的なカテーテルが、これらの出願
人による米国特許第4,921,483号である。The advent of small catheters with a central lumen about 0.020 inches in diameter at the end requires the pumps to be higher pressure to pump the desired amount of about 60 cc / min. It is to become. Even with a catheter having a central lumen of about 0.032 inches for an approximate total length of about 130-140 cm, the required amount of about 60 cc / min, even if the tapering rate of the central lumen drops to about 0.020 inches Required a pressure of about 125-200 psi to perfuse. One such exemplary catheter with a taper at the distal end is US Pat. No. 4,921,483 to these applicants.

血液を高圧に圧出すれば溶血を引き起こし小型化効果
を低下させた。Pumping blood to a high pressure caused hemolysis and reduced the miniaturization effect.

血圧をそうしたレベルに上げることなく、且つ小型カ
テーテルが使用でき、必要とする血液量を灌流する方法
を開発することが望ましい。It would be desirable to develop a method for perfusing the required blood volume without raising blood pressure to such a level and using a small catheter.

先行技術で特に興味深いのはカリフォルニア州マウン
テンビュウー（Mountain View）にあるACS社（ACS Corp
oration）に譲渡された米国特許第4,790,315及び4.661,
094号である。これらの特許は全長にわたり中央部の管
腔内まで穿孔されたカテーテルを示している。これらの
カテーテルは狭窄の先端部の患者の血圧を利用すること
により灌流する。狭窄の先端部の患者の血圧は開口を通
りカテーテル末端部の外へと血液を押し流す。そのよう
なカテーテルを還流に利用することの重大な問題点の１
つは、患者が血管形成を必要とするときに患者は血圧が
かなり低く、またはAVブロックの状態にあり、患者の心
室駆出分が低いことである。これらの要素は米国特許第
4,790,315及び4,661,094号に示されている血液を開口の
中へ押し流す駆動力を構成する。′315特許に示すカテ
ーテルの別の欠点は、主たるカテーテルとして使用でき
ないまでに際立つ大きさであることである。その代わり
に′315特許のカテーテルを使用する前に、まず狭窄を
拡大するためにより細身のカテーテルが狭窄に挿入され
なければならない。′094特許のカテーテルは灌流方法
を示しているが、バルーン式カテーテルではない。その
代わりに′094特許のカテーテルは灌流が狭窄を越えら
れるように注意深く狭窄に押し込まれなければならな
い。どちらの特許でも、最良の状態で約４プシーの範囲
内でしか得られない圧力で必要とする流出率を得ること
は困難である。患者自身の血圧を利用することでは非常
に低い起動圧力しか得られないため、相当な圧力低下を
起こさずに中央部の管腔へ接近するために数多くの穴を
備える必要がある。中央部の管腔の数多くの開口を利用
すると、そこで開示されているカテーテルの柱強度及び
推進力にも影響を与える。Of particular interest in the prior art is ACS Corp. in Mountain View, California.
oration) U.S. Patent Nos. 4,790,315 and 4.661,
No. 094. These patents show a catheter pierced the entire length into the central lumen. These catheters perfuse by utilizing the patient's blood pressure at the tip of the stenosis. The blood pressure of the patient at the tip of the stenosis pushes the blood through the opening and out of the distal end of the catheter. One of the major problems of using such a catheter for perfusion is
First, when the patient needs angiogenesis, the patient has significantly lower blood pressure, or is in an AV block, and has lower ventricular ejection. These elements are
No. 4,790,315 and 4,661,094 constitute the driving force to force blood into the opening. Another disadvantage of the catheters shown in the '315 patent is that they are so large that they cannot be used as primary catheters. Instead, prior to using the catheter of the '315 patent, a thinner catheter must first be inserted into the stenosis to enlarge the stenosis. The catheter of the '094 patent illustrates a perfusion method, but is not a balloon catheter. Instead, the catheter of the '094 patent must be carefully pushed into the stenosis so that the perfusion can cross the stenosis. With both patents, it is difficult to obtain the required effluent rate at pressures that can only be obtained within the range of about 4 psi at best. Utilizing the patient's own blood pressure results in very low starting pressures, requiring numerous holes to access the central lumen without significant pressure drop. The use of multiple openings in the central lumen also affects the column strength and propulsion of the disclosed catheter.

発明の要約案内カテーテルの中に挿入できる、小型血管形成カテ
ーテルが開示される。血管形成カテーテルは２つのバル
ーンを備える。末端部のバルーンは狭窄を膨張させる。
先端部のバルーンは別個に膨張でき、血管形成カテーテ
ルと案内カテーテルとの間の環状通路を選択的に遮断す
る。血管形成カテーテルは中央部の管腔から環状通路を
密閉するバルーンの先端部の環状通路に至る液体伝達を
可能にする、一連の開口を備えた中央部の管腔を備え
る。狭窄を膨張させるために第一のバルーンは膨張され
るが、案内カテーテルの管腔（複数の場合もある）を経
て動脈源から血液を引き出し、血管形成カテーテルと案
内カテーテルとの間の環状通路へ血液を圧出できる。血
液はその後、先端部のバルーンに隣接する開口を経てPT
CAカテーテルの中央部管腔へ向かい、狭窄の末端部にお
いて患者の血液環状を保持するため、血液は血管形成カ
テーテルの末端部の先へ流れる。SUMMARY OF THE INVENTION A miniature angioplasty catheter that can be inserted into a guiding catheter is disclosed. An angioplasty catheter comprises two balloons. The distal balloon inflates the stenosis.
The distal balloon can be separately inflated to selectively block the annular passage between the angioplasty catheter and the guide catheter. The angioplasty catheter includes a central lumen with a series of apertures that allow fluid communication from the central lumen to the annular passage at the distal end of the balloon sealing the annular passage. The first balloon is inflated to dilate the stenosis, but draws blood from the arterial source through the lumen (s) of the guiding catheter and into the annular passage between the angioplasty catheter and the guiding catheter. Can express blood. The blood then passes through the opening adjacent to the balloon at the tip,
Towards the central lumen of the CA catheter, blood flows beyond the distal end of the angioplasty catheter to maintain the patient's blood ring at the distal end of the stenosis.

図面の簡単な説明図１は本発明のカテーテルアッセンブリの断面図で、
膨張した位置におけるバルーンを示している。BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a cross-sectional view of the catheter assembly of the present invention.
Figure 4 shows the balloon in an inflated position.

図２は本発明の案内カテーテルアッセンブリの先端部
近傍の断面図である。FIG. 2 is a cross-sectional view of the guide catheter assembly of the present invention in the vicinity of the distal end.

図３は図１に示す両方のバルーンの先端部における血
管形成カテーテルの断面図である。FIG. 3 is a cross-sectional view of the angioplasty catheter at the distal ends of both balloons shown in FIG.

発明の詳細な説明装置Ａを図１に示す。案内カテーテル13は基端部に隣
接して接合された案内カテーテルと一体の外部被覆８を
備える。案内カテーテル13はハブ６を末端とする。図２
に示すように被覆８は複数の管腔20,21及び22を備え
る。管腔20は患者の動脈（図示しない）の圧力を監視す
るのに使用できる。末端部11から管腔20を経て接合部７
に至る液体伝達により患者の血圧が感知できる開口末端
部11を管腔20は末端とする。適正な圧力変換器が接合部
７に接続され、バルーン17の膨張時に患者の血圧を絶え
間なく監視する。血液吸引のために管腔21及び22が追加
されている。膨張した末端部のバルーン17の先端部にお
ける動脈の患者の血液は、開口した末端部12を通り管腔
21及び22を経て、案内カテーテルハブ６から延びる接合
部29に引き入れられる。接合部29はポンプ28用の吸引接
合部である。ポンプ28の排出部は吐血接合部５の側面排
出口である接合部９に取り付けられている。また、案内
カテーテルハブ６と吐血接合部５は一体化できる。DETAILED DESCRIPTION OF THE INVENTION Apparatus A is shown in FIG. The guiding catheter 13 has an outer coating 8 integral with the guiding catheter joined adjacent the proximal end. The guide catheter 13 terminates at the hub 6. FIG.
The coating 8 comprises a plurality of lumens 20, 21 and 22, as shown in FIG. Lumen 20 can be used to monitor the pressure in a patient's arteries (not shown). Junction 7 from distal end 11 through lumen 20
The lumen 20 is the end of the open end 11 where the blood pressure of the patient can be sensed by the transmission of fluid to the end. A suitable pressure transducer is connected to the junction 7 to constantly monitor the patient's blood pressure when the balloon 17 is inflated. Lumens 21 and 22 have been added for blood aspiration. The arterial patient's blood at the distal end of the inflated distal balloon 17 passes through the open distal end 12 and through the lumen.
Via 21 and 22, it is drawn into the joint 29 extending from the guide catheter hub 6. The joint 29 is a suction joint for the pump 28. The discharge part of the pump 28 is attached to the joint part 9 which is a side discharge port of the blood bleeding joint part 5. Further, the guide catheter hub 6 and the blood-emesis junction 5 can be integrated.

図１に示すように、PTCAカテーテル14は案内カテーテ
ル13の中を延び、PTCAカテーテル14と案内カテーテル13
との間に環状通路30を形成している。複数の開口部15は
管腔26（図３参照）と環状通路30との間の血液伝達を可
能にしている。ポンプ28は接合部９に排出し、接合部９
は環状通路30と血液伝達をしており、次に環状通路30が
開口部15を経て管腔26と血液伝達をしている。基端部の
バルーン16は選択的に膨張されて環状通路30を密閉でき
る。基端部のバルーン16は、基端部のバルーン16から接
合部３におけるカテーテルの基端部に延びている基端部
のバルーン膨張管腔24を経て膨張される。バルーン16を
選択的に膨張または収縮させるために接合部３に適正な
媒体が注入される。同様に、末端部のバルーン17は、ほ
ぼカテーテルの全長にわたり、接合部４にまで延びる末
端部のバルーン膨張管腔25と血液伝達をしている。末端
部のバルーン17は接合部４に適正な媒体を注入したり、
接合部４から適正な媒体を引き抜いたりすることにより
選択的に膨張または収縮させることができる。PTCAカテ
ーテル14の先端部は案内ワイヤ引出し口２を備え、PTCA
カテーテル14の長手方向の軸にほぼ一致する中央線を有
し、案内ワイヤ１が完全に管腔26を貫きPTCAの末端開口
部18の外部に出られるようにしており、案内ワイヤ１の
先端部19の延びる様子が示されている。PTCAカテーテル
14の柱強度及び推進力を高めるべく、管腔26内に管27を
選択的に設置できる。案内ワイヤ１は管27の内部を貫通
できる。管27はPTCAカテーテル14の全長にわたり開口部
15に隣接位置にまで延びているのが好ましい。管27の代
用に剛性ロッドを用いることができ、管腔24または25に
備えるのが好ましい。As shown in FIG. 1, a PTCA catheter 14 extends through a guiding catheter 13 and includes a PTCA catheter 14 and a guiding catheter 13.
To form an annular passage 30. The plurality of openings 15 allow blood communication between the lumen 26 (see FIG. 3) and the annular passage 30. The pump 28 discharges to the joint 9 and the joint 9
Communicates with the annular passage 30, which in turn communicates with the lumen 26 via the opening 15. The proximal balloon 16 can be selectively inflated to seal the annular passage 30. The proximal balloon 16 is inflated via a proximal balloon inflation lumen 24 that extends from the proximal balloon 16 to the proximal end of the catheter at the junction 3. A suitable medium is injected into the joint 3 to selectively inflate or deflate the balloon 16. Similarly, the distal balloon 17 is in blood communication with the distal balloon inflation lumen 25 extending to the junction 4 over substantially the entire length of the catheter. The balloon 17 at the distal end injects the proper medium into the joint 4,
It is possible to selectively expand or contract by pulling out an appropriate medium from the joint 4. The distal end of the PTCA catheter 14 has a guide wire outlet 2
The guidewire 1 has a centerline substantially coincident with the longitudinal axis of the catheter 14 so that the guidewire 1 can pass completely through the lumen 26 and out of the distal opening 18 of the PTCA. 19 are shown. PTCA catheter
A tube 27 can be selectively installed within the lumen 26 to increase the column strength and thrust of the fourteen. The guide wire 1 can pass through the inside of the tube 27. Tube 27 has an opening over the entire length of PTCA catheter 14.
Preferably it extends to a position adjacent to 15. A rigid rod can be used in place of tube 27 and is preferably provided in lumen 24 or 25.

一般的には基端部のバルーン16の中央部から末端部の
バルーン17の中央部までは約15〜25cmである。PTCAカテ
ーテル14の全長は約130〜140cmである。Generally, the distance from the center of the balloon 16 at the proximal end to the center of the balloon 17 at the distal end is about 15 to 25 cm. The overall length of the PTCA catheter 14 is about 130-140 cm.

使用時には案内カテーテル13は標準的な0.032〜0.035
インチの案内ワイヤ上を大腿動脈から大動脈根まで押し
進められ、適正な冠状動脈に配置される。その後、PTCA
カテーテル14は案内ワイヤ１上を案内カテーテル13を通
り、末端部のバルーン17が狭窄に達するまで押し進めら
れる。その後、バルーン17は膨張される。末端部の血液
灌流を必要とする場合には、バルーン16を膨張させて流
路30を密閉する。すると環状通路30は効果的に遮断され
る。膨張したバルーン17の基端部における動脈路は管腔
21及び22の末端部12と血液伝達をしている。ポンプ28の
作動により、患者の血液は、膨張したバルーン17の基端
側における動脈から接合部９へ戻り、環状通路30を経
て、開口部15を介してPTCAカテーテル14の管腔26へ戻
り、バルーン17の先端側のPTCAカテーテル14の末端開口
部18へと圧出される。血液の圧出前に管腔26を経てカテ
ーテルの基端部に塩水を注入し、開口部15を通過する血
液がカテーテルの基端部に向かわないよう、血液圧出
中、塩水は管腔26内に保持されていることが重要であ
る。言い替えれば、開口部15に至る管腔26の基端部はま
ず塩水で満たされ、前記管腔26の基端部は遮断される。
このように、血液が開口部15中を圧出される場合には、
血液は基端方向には移動できないが、突端18においてカ
テーテル14の先端部から先端方向に移動する。即座に明
白である本機構の利点の１つは、圧力変換器（図示して
いない）が接続された接合部７と血液伝達している開口
部11を通じて絶え間なく患者の血圧が感知できるため、
患者の血圧は途切れることなく監視できることである。
更に、カテーテル14のほぼ全長に対して得られる有効な
断面積は中央部の管腔26中ではなく、カテーテル14の外
側に血液を圧出することにより劇的に拡大する。一般的
な案内カテーテルの内径は0.080インチで、ここに記載
のPTCAカテーテルの外径は0.045インチである。その結
果得られる環状通路30の断面積は約0.01375平方インチ
であり、末端部の血液灌流に対する一般的なPTCAカテー
テルにおいて得られる最大面積よりもはるかに広い。一
般的なカテーテルは直径約0.032インチで、その結果得
られる面積は約0.0008平方インチである。このように、
通常約130〜140cmのPTCAカテーテルのほぼ全長に対する
流路断面積は、全長にわたりPTCAカテーテル14の管腔26
中に血液を灌流するよりも約17倍広い。その結果、溶血
が生じる可能性は小さくなる。血液を灌流するために得
られる断面積の拡大により、ポンプ28において必要とさ
れる圧力が低くなる、というのは約15〜25cmにすぎない
流路が約0.020インチというより小さな直径を備えた中
央部の管腔を通っているためである。ポンプのデザイン
はより簡潔になって経済的になり、生じさせる必要があ
る吐出圧力の低下により、より長い時間にわたってバッ
テリー駆動のポンプが使用できる。本発明で開示される
カテーテルアッセンブリの別の利点は、灌流中に案内ワ
イヤが管腔26内の定位置に留まることができることであ
る。管腔26中を血液が灌流されねばならない先行技術に
おいては、案内ワイヤが存在することで血流を多大に阻
害し、ポンプ28が発生させねばならない必要な圧力が増
大した。従ってこの問題に対処するために、医師は灌流
中に血流抵抗を弱めるべく案内ワイヤを引き戻したり、
さらには引き出したりした。In use, guide catheter 13 is standard 0.032-0.035
The femoral artery is pushed over the inch guidewire from the femoral artery to the aortic root and placed in the appropriate coronary artery. Then PTCA
Catheter 14 is advanced over guidewire 1 through guide catheter 13 until distal balloon 17 reaches stenosis. Thereafter, the balloon 17 is inflated. If distal perfusion is required, the balloon 16 is inflated to seal the flow path 30. Then, the annular passage 30 is effectively shut off. The arterial tract at the proximal end of the inflated balloon 17 is a lumen
It communicates with the distal end 12 of 21 and 22. With the operation of the pump 28, the patient's blood returns from the artery proximal to the inflated balloon 17 to the junction 9, via the annular passage 30 and back to the lumen 26 of the PTCA catheter 14 via the opening 15, The balloon 17 is pressed out to the distal opening 18 of the PTCA catheter 14 on the distal side. Before the blood is pumped, saline is injected into the proximal end of the catheter via the lumen 26, and during the blood pumping, the saline is injected into the lumen 26 so that the blood passing through the opening 15 does not go to the proximal end of the catheter. It is important that the In other words, the proximal end of the lumen 26 leading to the opening 15 is first filled with saline, and the proximal end of the lumen 26 is blocked.
Thus, when blood is pumped through the opening 15,
The blood cannot move in the proximal direction, but moves from the distal end of the catheter 14 at the tip 18 in the distal direction. One of the advantages of the mechanism, which is immediately obvious, is that the patient's blood pressure can be continuously sensed through the junction 7 to which the pressure transducer (not shown) is connected and the blood-communicating opening 11,
The patient's blood pressure can be monitored without interruption.
Further, the effective cross-sectional area available for substantially the entire length of the catheter 14 is dramatically increased by pumping blood outside the catheter 14, rather than in the central lumen 26. A typical guide catheter has an inner diameter of 0.080 inches, and the PTCA catheter described herein has an outer diameter of 0.045 inches. The resulting cross-sectional area of the annular passage 30 is about 0.01375 square inches, which is much larger than the maximum area available in a typical PTCA catheter for distal blood perfusion. A typical catheter is about 0.032 inches in diameter and the resulting area is about 0.0008 square inches. in this way,
The cross-sectional area of the flow passage for almost the entire length of the PTCA catheter, usually about 130 to 140 cm, is equal to the lumen 26 of the PTCA catheter 14 over the entire length.
During blood is about 17 times wider than perfusing. As a result, the possibility of hemolysis is reduced. The increased cross-sectional area available to perfuse the blood reduces the pressure required in the pump 28, since the channel, which is only about 15-25 cm, has a smaller diameter of about 0.020 inch This is because it passes through the lumen of the part. The design of the pump is simpler and more economical, and the reduced discharge pressure that needs to be produced allows a longer time to use a battery-powered pump. Another advantage of the catheter assembly disclosed in the present invention is that the guidewire can remain in place within lumen 26 during perfusion. In the prior art, where blood must be perfused through lumen 26, the presence of the guidewire greatly impeded blood flow and increased the required pressure that pump 28 had to generate. Therefore, to address this problem, physicians may pull back the guidewire during perfusion to reduce blood flow resistance,
I even pulled it out.

案内ワイヤを定位置に置くことは、カテーテルを押し
進めたり、適正な位置にカテーテルを置き換えるのを容
易にするので常に重要なことである。案内ワイヤ１及び
灌流用に別個の管腔を備えることは本発明の範囲内にあ
るということに留意せねばならない。本発明の装置Ａの
別の利点は、案内カテーテル13が被覆８と組付けられて
いるため、要求に答えるべく患者の体の中にカテーテル
を追加して配置する必要なしに、開口部11中の圧力測定
を可能にし、血液が開口部12中に吸引されることであ
る。本発明の装置はコンパクトに設計されているため患
者に対する外傷を減らすことが可能になる。または本発
明の趣旨から逸脱することなく管27中に補強ワイヤを用
いることができることを当業者は理解できよう。この用
途では補強管27は補強ロッドも有する。本願出願人によ
る米国同時係属特許出願第07/347,406号に示すような血
液ポンプも図１に示すポンプ28として用いることができ
る。これは脈動緩衝装置を備えたピストン型ポンプであ
り、静止点がないように設計されている。しかし、この
ポンプが発生させる圧力、例えば約200プシーは、本発
明の装置Ａの流路断面積を甚だしく拡大させることを鑑
みて、必ずしも必要ではない。開口部15の先端部におけ
る流路断面積が、従来の小型なものにおける有効断面積
の約17〜20倍に拡大したため、開口部18を経てバルーン
17の末端部において約60cc/分を吐き出すには、ポンプ
圧力は約50〜100プシーで十分である。Positioning the guidewire in place is always important as it facilitates pushing the catheter and replacing it in place. It should be noted that providing separate lumens for guidewire 1 and perfusion is within the scope of the present invention. Another advantage of the device A according to the invention is that, since the guiding catheter 13 is assembled with the sheath 8, it is not necessary to place an additional catheter in the patient's body in order to meet the requirements, so that The blood is drawn into the opening 12. The device of the present invention is designed to be compact so that trauma to the patient can be reduced. Alternatively, those skilled in the art will recognize that a reinforcing wire can be used in tube 27 without departing from the spirit of the invention. In this application, the reinforcing tube 27 also has a reinforcing rod. A blood pump, such as that shown in commonly assigned U.S. patent application Ser. No. 07 / 347,406, may also be used as the pump 28 shown in FIG. This is a piston pump with a pulsation damper and is designed to have no resting point. However, the pressure generated by the pump, for example, about 200 psi, is not necessary in view of the fact that the flow cross-sectional area of the device A of the present invention is greatly increased. Since the cross-sectional area of the flow path at the tip of the opening 15 has been increased to about 17 to 20 times the effective cross-sectional area of the conventional small one, the balloon has passed through the opening 18
A pump pressure of about 50-100 psi is sufficient to deliver about 60 cc / min at the 17 end.

米国特許第4.921,483号において本願発明者が開示し
たタイプのカテーテルは本発明の装置Ａに利用できる。
そのような特許により開示された記載及び明細は、米国
特許出願第07/347、406号、発明の名称「血液ポンプ」
において本願出願人が開示しているように、十分に示さ
れたが如く本明細書中に記載されているものとする。本
出願人はまた、米国特許第4,884,573号、発明の名称
「操作可能且つ取り外し可能な案内ワイヤの使用に耐え
る小型血管形成バルーン式カテーテル」、米国同時係属
出願第442,157号、発明の名称「小型カテーテル」及び
米国特許第4,921,483号と同特許に至る出願、特に1985
年12月19日出願の米国特許出願第811,162号の記載内容
を、十分に示されたが如く本明細書中に記載されている
ものとする。A catheter of the type disclosed by the present inventor in U.S. Pat. No. 4,921,483 can be used in device A of the present invention.
The description and specification disclosed by such patent is found in U.S. patent application Ser. No. 07 / 347,406, entitled "Blood Pump".
In this regard, as disclosed by the applicant of the present invention, it is assumed that the present invention is fully described herein. Applicant also discloses in U.S. Pat.No. 4,884,573, entitled "Small Angioplasty Balloon Catheter Resistant to Use of Operable and Detachable Guide Wire," U.S. Pat. And U.S. Pat.No. 4,921,483 and applications leading to that patent, particularly 1985.
No. 811,162, filed Dec. 19, is hereby incorporated by reference as if fully set forth.

本発明の前記開示及び記載は例示的なものであり、本
発明の趣旨から逸脱することなく、例示した構造の詳細
と同様に寸法、形状及び材質においても様々な変更が可
能である。The above disclosure and description of the invention is illustrative, and various changes may be made in dimensions, shapes, and materials as well as details of the illustrated structures without departing from the spirit of the invention.

───────────────────────────────────────────────────── フロントページの続き (72)発明者アンジェリニ、パオロアメリカ合衆国 77099 テキサス州ヒューストンカービードライブ 1568 (56)参考文献特開平３−63059（ＪＰ，Ａ) 特開平２−193676（ＪＰ，Ａ) 特表平２−500888（ＪＰ，Ａ) 米国特許4790315（ＵＳ，Ａ) 米国特許4771777（ＵＳ，Ａ) 米国特許3572979（ＵＳ，Ａ) 米国特許3426743（ＵＳ，Ａ) (58)調査した分野(Int.Cl.⁷，ＤＢ名) A61M 39/00 A61M 25/00 A61M 25/00 405 A61M 29/02 ────────────────────────────────────────────────── ─── Continued on the front page (72) Inventor Angelini, Paolo United States 77099 Houston Kirby Drive, Texas 1568 (56) References JP-A-3-63059 (JP, A) JP-A-2-193676 (JP, A) Japanese Patent No. 2-500888 (JP, A) US Patent 4,790,315 (US, A) US Patent 4,771,777 (US, A) US Patent 3,729,791 (US, A) US Patent 3,426,743 (US, A) (58) (Int.Cl. ⁷ , DB name) A61M 39/00 A61M 25/00 A61M 25/00 405 A61M 29/02

Claims

(57) [Claims]

1. An apparatus for perfusing fluid across a passageway created in a blood vessel of a patient during catheter insertion, comprising: an elongated catheter having a proximal end and a distal end; and extending through the distal end of the catheter. At least one first lumen; guiding means provided for guiding the catheter through the blood vessel, covering at least a portion of the catheter and forming an annular passage therebetween; and the proximal end And valve means provided on the catheter between the distal end and the valve to selectively close the annular passage; and that the lumen communicates with the annular passage at a position close to the valve means; and the valve The catheter and guide means are disposed in communication with the vessel at the proximal end of the means and with the annular passage at the proximal end of the valve means. Perfusion means for drawing blood from a tube and pumping it into the annular passage; and, based on the selective operation of the valve means, for perfusing fluid outside the catheter through the annular passage and between them. A perfusion device that is perfused into the lumen via communication and is capable of perfusing outside the catheter beyond a circulatory disorder of the patient.

2. The catheter further comprising: means for selectively expanding the passage in a vessel in which the catheter is located to remove an obstruction in the passage; and wherein the expanding means is a proximal end of the guiding means. 2. The apparatus of claim 1 further comprising: being disposed on the catheter at, and means for actuating the expansion means from a proximal end of the catheter.

3. The valve means is mounted on a catheter at a proximal end of the expansion means and further actuated from the proximal end of the catheter to the valve means to selectively excite the valve means from its proximal end. 3. The apparatus of claim 2, comprising means connected in series.

4. The invention as defined in claim 3 wherein said guide means is coaxial with said catheter above said valve means and extends from a proximal end of said catheter, said proximal end of said expansion means being a terminator. apparatus.

5. The operating means of the expansion means is a second lumen in the catheter, extending from near the proximal end to the expansion means, the excitation means is a third lumen of the catheter, 5. The device of claim 4, wherein said device extends from said proximal end to said valve means.

6. The apparatus of claim 5, wherein said first lumen is larger in cross-sectional area than said second or third lumen.

7. The apparatus of claim 5 wherein said dilatation means and valve means are balloons individually and selectively dilatable through said second and third lumens, respectively, and said guiding means is a guiding catheter. .

8. The apparatus of claim 7, wherein said guiding means further comprises a covering means to allow flow in and out of the blood vessel in which said catheter and said guiding means are located.

9. The covering means is further provided between the covering means and the guiding means, and is substantially parallel to the guiding means so that a part of the length of the guiding means can draw blood from the passage. At least one first groove extending; and pump means included in the perfusion means, communicating with the first groove and the annular passage, for pumping a patient's blood into the lumen of the catheter via the passage. The apparatus of claim 8, comprising:

10. The blood vessel, a proximal end of the catheter, and the guide means are provided on the covering means and communicate with the proximal end of the pressure measuring means. The device of claim 9 further comprising at least one second groove that allows for continuous measurement of pressure.

11. The apparatus of claim 1 further comprising a covering means provided on said guiding means to allow flow in and out of the vessel in which said catheter and guiding means are located.

12. At least one of said guide means is provided between said covering means and said guide means, wherein a portion of said guide means extends substantially parallel to said guide means to allow blood to be drawn from said blood vessel. Pump means included in the perfusion means, communicating with the first groove and the annular passage, and for pumping a patient's blood through the passage into the lumen of the catheter. 12. The device of claim 11, comprising the device.

13. The blood vessel, a proximal end of the catheter and the guide means are provided on the covering means so as to communicate with the guide means, and a pressure measuring means is provided to communicate with the proximal end. 13. The device of claim 12, further comprising at least one second groove that allows for continuous measurement of pressure.

14. The catheter further comprising: means for selectively dilating the blood vessel to remove an obstruction in the blood vessel in which the catheter is located; and wherein the dilating means comprises the catheter at a proximal end of the guiding means. 14. The device of claim 13, comprising: a top and a means for actuating the expansion means from a proximal end of the catheter.

15. The valve means is mounted on a catheter at a proximal end of the expansion means and is operatively connected to the valve means from the proximal end to selectively excite the valve means from a proximal end of the catheter. Claims comprising means
14 devices.

16. The invention as defined in claim 15 wherein said guide means is coaxial with said catheter above said valve means and extends from the proximal end of said catheter, with the proximal end of said dilation means as its termination. apparatus.

17. The operating means of the expansion means is a second lumen in the catheter, extending from near the proximal end to the expansion means, the excitation means is a third lumen of the catheter, 17. A valve extending from the vicinity of the base end to the valve means.
Equipment.

18. The method according to claim 18, wherein said first lumen is larger in cross-sectional area than said second or third lumen, and reinforcing means is provided to strengthen said proximal end of said catheter. 18. The device of claim 17, wherein a removable guidewire disposed within the lumen is selectively extendable through the first lumen.

19. The apparatus of claim 17, wherein said expansion means and valve means are individually selectively expandable balloons through said second and third lumens, respectively, and said guide means is a guide catheter. .

20. The apparatus of claim 20, wherein said annular passage is at least one of said lumens.
When the catheter has a cross-sectional area of 10 times or more, and the catheter has a length of about 140 cm which can be subjected to a pressure not exceeding 100 psi by the pumping means, the pumping means communicating with the annular passage is moved from the tip of the lumen
The device of claim 1 wherein 60 cc / min of blood is pumped.