JPH0316152B2 - - Google Patents

Info

Publication number
JPH0316152B2
JPH0316152B2 JP62275655A JP27565587A JPH0316152B2 JP H0316152 B2 JPH0316152 B2 JP H0316152B2 JP 62275655 A JP62275655 A JP 62275655A JP 27565587 A JP27565587 A JP 27565587A JP H0316152 B2 JPH0316152 B2 JP H0316152B2
Authority
JP
Japan
Prior art keywords
inner diameter
catheter
securing
securing device
body cavity
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 - Lifetime
Application number
JP62275655A
Other languages
Japanese (ja)
Other versions
JPH01119266A (en
Inventor
Hisanobu Ishida
Fumiaki Harada
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Terumo Corp
Original Assignee
Terumo Corp
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Terumo Corp filed Critical Terumo Corp
Priority to JP62275655A priority Critical patent/JPH01119266A/en
Priority to PCT/JP1988/001029 priority patent/WO1989003197A1/en
Priority to US07/477,843 priority patent/US5201901A/en
Priority to DE3855725T priority patent/DE3855725T2/en
Priority to EP88908753A priority patent/EP0380668B1/en
Priority to AU25309/88A priority patent/AU623100B2/en
Publication of JPH01119266A publication Critical patent/JPH01119266A/en
Publication of JPH0316152B2 publication Critical patent/JPH0316152B2/ja
Priority to AU10837/92A priority patent/AU638886B2/en
Granted legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0019Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • A61F2210/0023Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply
    • A61F2210/0042Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol operated at different temperatures whilst inside or touching the human body, heated or cooled by external energy source or cold supply using a fluid, e.g. circulating
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Description

【発明の詳細な説明】 [産業上の利用分野] 本発明は、血管、消化管もしくは気管等の管状
器官内腔に内径確保器具を留置、あるいは回収す
る体腔の内径確保用システムに関する。
DETAILED DESCRIPTION OF THE INVENTION [Field of Industrial Application] The present invention relates to a system for securing the inner diameter of a body cavity in which an instrument for securing the inner diameter is placed in or retrieved from the inner lumen of a tubular organ such as a blood vessel, digestive tract, or trachea.

[従来の技術] 従来、例えば冠動脈の狭搾部を血管拡張カテー
テルで拡張して留置した後、その部分の再狭搾を
防止する等のために、管状器官の内腔の内径を確
保する内径確保器具(ステント)が提案されてい
る。
[Prior Art] Conventionally, for example, after dilating and indwelling a narrowed part of a coronary artery with a vasodilator catheter, the inner diameter of the inner lumen of a tubular organ is secured to prevent re-narrowing of the narrowed part of the coronary artery. A securing device (stent) has been proposed.

従来の内径確保器具として、特公昭61−6655号
公報に記載のものは、Ti−Ni系合金からなる一
方向性形状記憶合金を用い、これを予め正常な血
管内径と略等しい内径をもつ管状に成形してこの
形状を記憶させ、これをさらに血管内への挿入を
容易とすべく外径を小さく変形して血管の所望位
置に導入後、温水等にて加熱して記憶形状に拡張
復元して用いるようになつている。
As a conventional inner diameter securing device, the one described in Japanese Patent Publication No. 61-6655 uses a unidirectional shape memory alloy made of Ti-Ni alloy, which is pre-shaped into a tubular shape with an inner diameter approximately equal to the normal blood vessel inner diameter. The shape is memorized by molding it into a shape, and then the outside diameter is changed to a smaller size to make it easier to insert it into the blood vessel. After being introduced into the desired position of the blood vessel, it is expanded and restored to the memorized shape by heating with hot water, etc. It has come to be used as such.

[発明が解決しようとする問題点] ところで、上記従来の一方向性形状記憶合金か
らなる内径確保器具を例えば血管の目的部位に留
置する作業は、まず血管内にガイデイングカテー
テルを留置し、その後内径確保器具を上記ガイデ
イングカテーテル内に通しつつ該内径確保器具を
目的部位にまで進めていくのが通常である。しか
しながら、上記の場合、内径確保器具を狭いガイ
デイングカテーテル内にむき出しにて通しつつ進
めるため、内径確保器具が途中で引つかかつたり
変形してしまう等が問題となる。さらに、一般的
にガイデイングカテーテルは剛性が大きく血管末
梢端の屈曲部を通過することができないため、目
的部位が屈曲部より先にある場合は、内径確保器
具はそれを装着したカテーテルとともに血管内に
むきだしにて通しつつ進めるため、内径確保器具
は途中で引つかかつたり変形してしまう問題、ま
たは内径確保器具を径方向に収縮維持するため、
大量の冷却水を注入しなければならない問題等が
あつた。
[Problems to be Solved by the Invention] Incidentally, the work of indwelling the conventional inner diameter securing device made of a unidirectional shape memory alloy at a target site of a blood vessel, for example, involves first placing a guiding catheter in the blood vessel, and then Normally, the inner diameter securing device is advanced to the target site while being passed through the guiding catheter. However, in the above case, since the inner diameter securing device is advanced through the narrow guiding catheter while being exposed, there are problems such as the inner diameter securing device getting caught or deformed midway through the guiding catheter. Furthermore, guiding catheters are generally too rigid to pass through bends at the distal end of blood vessels, so if the target area is beyond the bend, the inner diameter securing device is inserted into the blood vessel along with the catheter attached to it. Since the inner diameter securing device is forced to pass through the material exposed, there is a problem that the inner diameter securing device may get caught or deform during the process, or in order to maintain the inner diameter securing device contracted in the radial direction.
There were problems such as having to inject a large amount of cooling water.

また、本発明者らがすでに提案している二方向
性形状記憶合金からなる内径確保器具、すなわち
「ある変態温度を境に高温側と低温側の2つの記
憶形状を可逆的に発現する二方向性形状記憶合金
により、体温または体温近傍では径方向に拡張し
て血管等の内径を確保し、体温または体温近傍よ
り低い温度では径方向に収縮して血管等の内部を
移動できる特性」を備えた内径確保器具は、留置
位置の変更、回収ができる内径確保器具として画
期的である。しかしながら、この内径確保器具に
あつては、内径確保器具を狭いガイデイングカテ
ーテル内にむきだしにて通しつつ進めるため、内
径確保器具は途中で引つかかつたり変形してしま
う等が問題となる。さらに、この内径確保器具に
あつては、内径確保器具をガイデイングカテーテ
ル内に通しつつ進める時、該内径確保器具を径方
向に収縮維持するため、大量の冷却水を注入しな
ければならない。また、一方向性形状記憶合金の
場合と同様に、ガイデイングカテーテルは剛性が
大きく、血管末梢端の屈曲部を通過することがで
きないため、目的部位が屈曲部より先にある場合
は、内径確保器具はそれを装着したカテーテルと
ともに血管内にむきだしにて通しつつ進めるた
め、内径確保器具は途中で引つかかつたり変形し
てしまう問題、または内径確保器具を径方向に収
縮維持するため、大量の冷却水を注入しなければ
ならない問題等があつた。
In addition, the present inventors have already proposed an inner diameter securing device made of a bidirectional shape memory alloy, that is, a bidirectional shape memory alloy that reversibly develops two memory shapes, one on the high temperature side and one on the low temperature side, with a certain transformation temperature as the boundary. The shape memory alloy has the property of expanding radially at or near body temperature to secure the inner diameter of blood vessels, etc., and contracting radially at or below body temperature to move inside blood vessels, etc. This internal diameter securing device is revolutionary as an internal diameter securing device that can be repositioned and retrieved. However, with this device for securing the inner diameter, since the device for securing the inner diameter is advanced through the narrow guiding catheter while being exposed, there is a problem that the device for securing the inner diameter gets caught or deforms on the way. Furthermore, in the case of this inner diameter securing device, a large amount of cooling water must be injected in order to keep the inner diameter securing device contracted in the radial direction when advancing the inner diameter securing device while passing it through the guiding catheter. In addition, as with unidirectional shape memory alloys, guiding catheters have high rigidity and cannot pass through bends at the distal end of blood vessels, so if the target area is beyond the bend, the inner diameter must be secured. Because the device and the attached catheter are passed through the blood vessel exposed, there are problems with the internal diameter securing device being caught or deformed on the way, or a large amount of work is required to maintain the internal diameter securing device contracted in the radial direction. There were problems such as having to inject cooling water.

本発明は、内径確保器具を管状器管内にて円滑
かつ容易に移動できるようにすることを目的とす
る。
An object of the present invention is to enable smooth and easy movement of an inner diameter securing device within a tubular vessel.

[問題点を解決するための手段] 本発明の第1は、温度変化にともなつて径方向
に寸法変化をし得る形状記憶合金にて実質的に筒
状体に形成された内径確保器具を体腔内に留置す
るための体腔の内径確保用装置であつて、先端部
近傍の内径確保器具装着部の外周面に前記内径確
保器具を装着し得るカテーテルと、両端部が開口
しその内腔に、前記内径確保器具を装着した上記
カテーテルを収納し得るカテーテルシースからな
るようにしたものである。
[Means for Solving the Problems] The first aspect of the present invention is to provide an inner diameter securing device formed into a substantially cylindrical body made of a shape memory alloy whose dimensions can change in the radial direction as the temperature changes. A device for securing the inner diameter of a body cavity to be indwelled in the body cavity, which includes a catheter to which the inner diameter securing device can be attached to the outer circumferential surface of an inner diameter securing device attachment part near the distal end, and a catheter having both ends open and connected to the inner diameter of the body cavity. , a catheter sheath capable of accommodating the catheter equipped with the inner diameter securing device.

本発明の第2は、温度変化にともなつて径方向
に寸法変化をし得る二方向性形状記憶合金にて実
質的に筒状に形成された内径確保器具を体腔内に
留置、あるいは回収するための体腔の内径確保用
装置であつて、先端部近傍の内径確保器具装着部
の外周面に前記内径確保器具を装着し得るカテー
テルと、両端部が開口しその内腔に、収縮した前
記内径確保器具を装着した上記カテーテルを収納
し得、かつ拡張した前記内径確保器具の外径に較
べ内径が等しいか、あるいは小さいカテーテルシ
ースとからなるようにしたものである。
The second aspect of the present invention is to indwell or retrieve an inner diameter securing device formed into a substantially cylindrical shape made of a bidirectional shape memory alloy that can change dimensions in the radial direction with temperature changes in a body cavity. A device for securing the inner diameter of a body cavity, the catheter having an inner diameter securing device attached to the outer circumferential surface of an inner diameter securing device mounting portion near the distal end, and a catheter having both ends open and having the contracted inner diameter inserted into the inner lumen. The catheter sheath is capable of housing the catheter equipped with the securing device and has an inner diameter equal to or smaller than the outer diameter of the expanded inner diameter securing device.

[作用] (内径確保器具が一方向性形状記憶合金からなる
システム) 本発明において、内径確保器具を一方向性形状
記憶合金にて形成する場合には、体温近傍におい
て留置すべき管状器官の内径と同等かやや大きな
外径を記憶しているコイル状あるいは網目状等の
実質的に筒状の内径確保器具が用いられる。
[Function] (System in which the inner diameter securing device is made of a unidirectional shape memory alloy) In the present invention, when the inner diameter securing device is made of a unidirectional shape memory alloy, the inner diameter of the tubular organ to be indwelled near body temperature is A substantially cylindrical inner diameter securing device, such as a coil or mesh shape, is used, which has an outer diameter equal to or slightly larger than the diameter of the tube.

体温より実質的に低い温度(変態温度以下)に
おいては、内径確保器具は自由に変形できるた
め、カテーテル先端部近傍の内径確保器具装着部
に巻き付ける如くに装着されて、カテーテルシー
ス内に収納される。このようにして、カテーテル
に装着された内径確保器具をカテーテルシース内
に収納した組合わせを、管状器官に導入すること
により内径確保器具を目的部位に容易に留置でき
る。
Since the inner diameter securing device can be freely deformed at temperatures substantially lower than body temperature (below the transformation temperature), it is attached so as to wrap around the inner diameter securing device mounting portion near the catheter tip and stored within the catheter sheath. . In this way, by introducing the combination of the inner diameter securing device attached to the catheter and housed within the catheter sheath into the tubular organ, the inner diameter securing device can be easily indwelled at the target site.

すなわち、内径確保器具を留置すべき管状器官
に一般的な手技によりガイドワイヤを通過させ、
これに沿つて上記組合わせを導入することによ
り、内径確保器具を容易に目的部位に導入し得
る。この時、本発明によれば、カテーテルシース
の存在により、内径確保器具は管状器官に対しむ
き出しにならず、途中で引つかかつたり変形して
しまうおそれがない。また、カテーテルシースは
柔軟性を有しているので血管屈曲部を、内径確保
器具とカテーテルとともに容易に通過することが
できる。
That is, a guide wire is passed through the tubular organ in which the inner diameter securing device is to be placed using a common procedure,
By introducing the above combination along this line, the inner diameter securing instrument can be easily introduced to the target site. At this time, according to the present invention, due to the presence of the catheter sheath, the inner diameter securing device is not exposed to the tubular organ, and there is no risk of it being caught or deformed on the way. Further, since the catheter sheath is flexible, it can easily pass through the bending part of the blood vessel together with the inner diameter securing device and the catheter.

上記の如くにて目的部位に導入された内径確保
器具は、カテーテルに装着された状態でカテーテ
ルシースから突き出された後、体温にて加温され
て拡径し、管状器官の目的部位に留置される。
The inner diameter securing device introduced into the target site as described above is inserted into the catheter and pushed out from the catheter sheath, then heated by body temperature to expand its diameter, and placed in the target site of the tubular organ. Ru.

なお、上記一方向性形状記憶合金からなる内径
確保器具の導入時にはカテーテルシースから冷却
水を供給し、またその留置時にはカテーテルシー
スから温水を供給することもできる、また、本発
明の好適な実施態様においては、カテーテルに基
端部から少なくとも先端部近傍にまで延びる流路
と該流路を先端部近傍の内径確保器具装着部外面
に連通する連通口を設け、この連通口から上記冷
却水、温水を供給することができる。
In addition, it is also possible to supply cooling water from the catheter sheath when introducing the inner diameter securing device made of the unidirectional shape memory alloy, and to supply warm water from the catheter sheath when the device is indwelled. In this method, the catheter is provided with a flow channel extending from the proximal end to at least the vicinity of the distal end, and a communication port that communicates the flow channel with the outer surface of the inner diameter securing device attachment part near the distal end, and the above-mentioned cooling water and hot water are supplied from the communication port. can be supplied.

ここで、一方向性形状記憶合金とは、熱弾性型
マルテンサイト変態を生じ、逆変態開始温度以上
になると母相の予め記憶させていた形状に変化す
るものをいい、変態温度以下では自由に変形で
き、逆変態開始温度以上となり記憶形状に復元す
るとその後変態温度以下になつても外力を加えな
い限り記憶形状を維持するものをいう。
Here, the unidirectional shape memory alloy refers to an alloy that undergoes thermoelastic martensitic transformation and changes to the pre-memorized shape of the matrix when the temperature exceeds the reverse transformation start temperature, and freely changes below the transformation temperature. A material that can be deformed, and once it reaches a temperature higher than the reverse transformation start temperature and restores its memorized shape, it maintains its memorized shape even if the temperature drops below its transformation temperature, unless external force is applied.

(内径確保器具が二方向性形状記憶合金からなる
システム) 本発明において、内径確保器具を二方向性形状
記憶合金にて形成する場合には、体温より実質的
に低い温度において留置すべき管状器官の内腔よ
り小さな外径を記憶しているコイル状あるいは網
目状等の実質的に筒状の内径確保器具が用いられ
る。また、この二方向性形状記憶合金からなる内
径確保器具は、体温または体温近傍で拡張し留置
すべき管状器官の内径と同等かやや大きな外径を
記憶している。この内径確保器具はカテーテルに
装着された状態で、カテーテルシース内に収納さ
れ、この組合せを管状器官に導入することにより
内径確保器具を目的部位に容易に留置し、かつ回
収できる。
(System in which the inner diameter securing device is made of a bidirectional shape memory alloy) In the present invention, when the inner diameter securing device is formed of a bidirectional shape memory alloy, a tubular organ that is to be indwelled at a temperature substantially lower than body temperature is used. A substantially cylindrical inner diameter securing device, such as a coil or mesh type, is used, which has an outer diameter smaller than the inner cavity of the tube. Further, the inner diameter ensuring device made of this bidirectional shape memory alloy expands at or near body temperature and stores an outer diameter that is equal to or slightly larger than the inner diameter of the tubular organ to be indwelled. The inner diameter securing device is housed in the catheter sheath while attached to the catheter, and by introducing this combination into the tubular organ, the inner diameter securing device can be easily placed at the target site and retrieved.

すなわち、内径確保器具を留置すべき管状器官
に一般的な手技によりガイドワイヤを通過させ、
これに沿つて上記組合せを導入することにより、
内径確保器具を容易に目的部位に導入し得る。こ
の時、本発明によれば、カテーテルシースの存在
により、内径確保器具はカテーテルに装着された
状態でシース内に確実に保持されるから、カテー
テルに間隙なく巻き突ける如くに縮径維持すべく
大量の冷却水を供給する必要がなく、患者に対す
る負担を軽減できる。また、カテーテルシースの
存在により、内径確保器具は管状器官に対しむき
出しにならず、途中で引つかかつたり変形してし
まうおそれがない。また、カテーテルシースは柔
軟性を有しているので血管屈曲部を、内径確保器
具とカテーテルとともに容易に通過することがで
きる。
That is, a guide wire is passed through the tubular organ in which the inner diameter securing device is to be placed using a common procedure,
By introducing the above combination in line with this,
The inner diameter securing device can be easily introduced into the target site. At this time, according to the present invention, due to the presence of the catheter sheath, the inner diameter securing device is reliably held within the sheath while attached to the catheter, so that the diameter can be maintained so as to be wrapped around the catheter without any gaps. There is no need to supply large amounts of cooling water, reducing the burden on patients. Further, due to the presence of the catheter sheath, the inner diameter securing device is not exposed to the tubular organ, and there is no risk of it being caught or deformed on the way. Further, since the catheter sheath is flexible, it can easily pass through the bending part of the blood vessel together with the inner diameter securing device and the catheter.

上記の如くにて目的部位に導入された内径確保
器具は、カテーテルシースから冷却水を供給され
てカテーテルに巻き突けられる状態で、カテーテ
ルシースから突き出された後、冷却水を止めるこ
とにより、体温にて加温されて拡張し、管状器官
の目的部位に留置される。
The inner diameter securing device introduced into the target site as described above is supplied with cooling water from the catheter sheath and wound around the catheter. After being pushed out from the catheter sheath, the cooling water is stopped and the device is cooled to body temperature. The tube is heated, expanded, and placed at the desired site in the tubular organ.

さらに、上記の如くに目的部位に留置された内
径確保器具の回収は、ガイドワイヤを内径確保器
具の留置部に通過させ、これに沿つてカテーテル
とカテーテルシースの組合わせを該留置部にまで
導入する。その後、カテーテルシースからカテー
テルの先端部を突き出し、カテーテルシースから
冷却水を供給することにより内径確保器具を縮径
させてカテーテルの内径確保器具装着部に巻き付
け、巻き付けられた内径確保器具をカテーテルと
ともにカテーテルシース内に引き込み回収でき
る。この場合にも、冷却水は小量で足り、さらに
カテーテルシースに内径確保器具を引き込んだ後
には該内径確保器具の引つかかり、変形のおそれ
がなく確実に回収できる。
Furthermore, in order to retrieve the inner diameter securing device indwelled at the target site as described above, the guide wire is passed through the indwelling portion of the inner diameter securing device, and the combination of the catheter and catheter sheath is introduced along this into the indwelling portion. do. After that, the distal end of the catheter is protruded from the catheter sheath, and cooling water is supplied from the catheter sheath to reduce the diameter of the inner diameter securing device, and it is wrapped around the catheter's inner diameter securing device attachment part, and the wrapped inner diameter securing device is attached to the catheter together with the catheter. It can be pulled into the sheath and recovered. In this case as well, a small amount of cooling water is sufficient, and furthermore, after the inner diameter securing device is drawn into the catheter sheath, the inner diameter securing device can be reliably recovered without the risk of getting caught or deformed.

なお、本発明の好適な実施態様においては、カ
テーテルに基端部から少なくとも先端部近傍にま
で延びる流路と該流路を先端部近傍の内径確保器
具装着部外面に連通する連通口を設け、上記二方
向性形状記憶合金からなる内径確保器具の導入
時、回収時に供給すべき冷却水を上記連通口から
供給することができる。
In a preferred embodiment of the present invention, the catheter is provided with a flow path extending from the proximal end to at least the vicinity of the distal end, and a communication port that communicates the flow path with the outer surface of the inner diameter securing device mounting portion near the distal end, When the inner diameter ensuring device made of the bidirectional shape memory alloy is introduced, the cooling water to be supplied during recovery can be supplied from the communication port.

ここで、二方向性形状記憶合金とは、ある変態
温度を境に、高温側と低温側においてそれぞれ予
め形状を記憶しており、温度変化によりこの形状
を可逆的に発言できるものである。
Here, a bidirectional shape memory alloy is one that memorizes a shape in advance on both the high temperature side and the low temperature side after a certain transformation temperature, and can reversibly change this shape depending on temperature changes.

なお、本発明の実施に用いられる形状記憶合金
としては、例えばTi−Ni系合金(組成:Ni50〜
53原子%、好ましくはNi50〜51原子%、変態温
度:Af30〜45℃、M′f10〜30℃)が好適である。
In addition, as the shape memory alloy used for carrying out the present invention, for example, Ti-Ni alloy (composition: Ni50~
53 atomic %, preferably Ni 50-51 atomic %, transformation temperature: Af 30-45°C, M'f 10-30°C).

[実施例] 第1図は本発明の第1実施例に係る内径確保用
システムを示す断面図、第2図A、Bは内径確保
器具を示す側面図、第3図はカテーテルを示す側
面図、第4図はカテーテルシースを示す側面図、
第5図A〜Eは内径確保器具の導入、留置過程を
示す模式図である。
[Example] Fig. 1 is a sectional view showing an inner diameter securing system according to the first embodiment of the present invention, Figs. 2 A and B are side views showing an inner diameter securing device, and Fig. 3 is a side view showing a catheter. , FIG. 4 is a side view showing the catheter sheath,
FIGS. 5A to 5E are schematic diagrams showing the process of introducing and indwelling the inner diameter securing device.

内径確保用システム1は、内径確保器具(ステ
ント)10、カテーテル20、カテーテルシース
30の組合せにて構成される。
The inner diameter securing system 1 is configured by a combination of an inner diameter securing device (stent) 10, a catheter 20, and a catheter sheath 30.

ステント10は、第2図A,Bに示す如くの扁
平な二方向性形状記憶合金線条体、(例えばNi−
Ti系、Cu−Al−Ni系、Cu−Zn−Al系合金から
なる)を実質的に筒状をなす螺線状に成型したも
のからなる。このステント10は体温または体温
近傍(例えば30〜35℃)では第2図Bの如く径方
向に拡張した形状を保ち、体温より実質的に低い
温度(例えば15〜25℃)では第2図Aに示す如く
径方向に縮小した形状を保つ。本実施例に使用し
たステント(Ti−Ni系二方向性形状記憶合金、
Ni約51原子%、肉厚0.03mm、幅1mm)においては
20℃以下でφ1.6mm、32℃以上でφ2.8mmの径変化を
生じた。
The stent 10 is made of a flat bidirectional shape memory alloy filament (for example, Ni-
Ti alloy, Cu-Al-Ni alloy, Cu-Zn-Al alloy) is molded into a substantially cylindrical spiral shape. The stent 10 maintains a radially expanded shape as shown in FIG. 2B at or near body temperature (e.g., 30 to 35°C), and at a temperature substantially lower than body temperature (e.g., 15 to 25°C), as shown in FIG. 2A. It maintains a radially reduced shape as shown in . The stent used in this example (Ti-Ni bidirectional shape memory alloy,
Ni approximately 51 atomic%, wall thickness 0.03 mm, width 1 mm)
The diameter changed by 1.6 mm at temperatures below 20°C and by 2.8 mm at temperatures above 32°C.

ステント10の径、長さ等は目的とする管状器
官の留置部の内径、長さに応じて適宜選択され
る。すなわち、ステント10の径は拡張時に留置
されるべき血管等の管状器官の内径と一致させる
ことができ、縮径時にはその留置部にまで導入す
るに充分な細さとすることができればよい。
The diameter, length, etc. of the stent 10 are appropriately selected depending on the inner diameter and length of the intended indwelling portion of the tubular organ. That is, the diameter of the stent 10 can be made to match the inner diameter of a tubular organ such as a blood vessel in which it is to be indwelled when it is expanded, and can be made thin enough to be introduced into the indwelling part when it is contracted.

ここで、ステントの形状は上記螺線状に限ら
ず、実質的に筒状をなす例えば網目状、渦巻き状
等の形状であつてもよい。
Here, the shape of the stent is not limited to the above-mentioned spiral shape, but may be substantially cylindrical, for example, a mesh shape, a spiral shape, or the like.

さらに、ステント10は筒状体の少なくとも一
部にX線不透過マーカー11を備えるものである
ことが望ましい。
Furthermore, it is desirable that the stent 10 includes an X-ray opaque marker 11 on at least a portion of the cylindrical body.

カテーテル20は、両端が開口したカテーテル
チユーブ21(例えばポリエチレン、EVA、
PVC等の熱可塑性樹脂からなる)と、このカテ
ーテルチユーブ21の基端に、カテーテルチユー
ブ21の基端部から先端部にまで延びるルーメン
(内腔)と連通するように設けられた中空状のハ
ブ部22(例えばポリカーボネート、ポリプロピ
レン等からなる)とからなつている。カテーテル
20は、カテーテルチユーブ21の先端部近傍の
ステント装着部23の外周面に前記ステント10
を装着し得る。
The catheter 20 has a catheter tube 21 (for example, polyethylene, EVA,
(made of thermoplastic resin such as PVC), and a hollow hub provided at the proximal end of the catheter tube 21 so as to communicate with a lumen extending from the proximal end to the distal end of the catheter tube 21. 22 (for example, made of polycarbonate, polypropylene, etc.). The catheter 20 has the stent 10 attached to the outer peripheral surface of the stent attachment part 23 near the distal end of the catheter tube 21.
can be installed.

また、カテーテル20は、カテーテルチユーブ
21のルーメンとハブ部20の内腔にて流路24
を形成し、かつ該24を外面に連通させる多数の
側孔状の連通口25をカテーテルチユーブ21の
上記ステント装着部23に設けており、流路24
に供給されたステント冷却液がこの連通口25か
ら放射状に排出できるようになつている。なお、
上記連通口はスリツト状であつてもよい。
The catheter 20 also has a flow path 24 between the lumen of the catheter tube 21 and the inner lumen of the hub portion 20.
The stent mounting portion 23 of the catheter tube 21 is provided with a large number of side hole-like communication ports 25 that form a flow path 24 and communicate with the outer surface.
The stent cooling liquid supplied to the stent can be discharged radially from this communication port 25. In addition,
The communication port may be in the form of a slit.

さらにカテーテル20は、この連通口25を設
けてあるステント装着部23の基端部側に、ステ
ント装着部23に装着されたステント10の外径
よりも大きな外径を持つ膨出部26を備えている
のが望ましい。これはステント10の回収時にス
テント10をステント装着部23に巻き付けてカ
テーテルシース30の内部に引き込む時、ステン
ト10がカテーテルシース30の先端に引つかか
るのを防ぐためである。なお、上記膨出部はステ
ント装着部23の基端部側および先端部側の両部
位に設けられるものであつてもよい。
Further, the catheter 20 includes a bulging portion 26 having an outer diameter larger than the outer diameter of the stent 10 attached to the stent attachment portion 23 on the proximal end side of the stent attachment portion 23 in which the communication port 25 is provided. It is desirable that This is to prevent the stent 10 from getting caught on the distal end of the catheter sheath 30 when the stent 10 is wound around the stent attachment part 23 and pulled into the catheter sheath 30 when the stent 10 is retrieved. In addition, the said bulge part may be provided in both the proximal end side and the distal end side of the stent attachment part 23.

さらにカテーテル20は、カテーテルチユーブ
21の先端近傍にX線不透過マーカー27(例え
ば金、白金等からなる)を備えるものであること
が望ましい。これによりX線透視下においてのカ
テーテル20の位置確認、およびステント10、
シース30との位置関係の確認が可能になる。
Further, the catheter 20 preferably includes an X-ray opaque marker 27 (for example, made of gold, platinum, etc.) near the tip of the catheter tube 21. As a result, the position of the catheter 20 can be confirmed under X-ray fluoroscopy, and the stent 10,
The positional relationship with the sheath 30 can be confirmed.

カテーテル20のハブ部22は第3図に示す如
く、直線状筒状部22Aとこの中間部から分岐す
る分岐部22Bとからなつている。直線状筒状部
22Aはガイドワイヤの導入口となるものであ
り、そのため血液等の漏れを防止するための逆止
弁28(例えばシリコーンゴム等の柔軟材料から
なる)がその基端開口部近傍に設けられている。
なお、分岐部22Bは冷却液等の導入に用いられ
るもので三方活栓29を有する。
As shown in FIG. 3, the hub portion 22 of the catheter 20 consists of a linear cylindrical portion 22A and a branch portion 22B branching from the intermediate portion thereof. The straight cylindrical portion 22A serves as an introduction port for the guide wire, and therefore a check valve 28 (for example, made of a flexible material such as silicone rubber) for preventing leakage of blood etc. is provided near the proximal opening of the straight cylindrical portion 22A. It is set in.
Note that the branch portion 22B is used for introducing cooling liquid and the like, and has a three-way stopcock 29.

カテーテルシース30は、両端が開口したシー
スチユーブ21(例えばPVC、ポリエチレン、
フツ素系樹脂からなる)と、このシースチユーブ
31の後端にシースチユーブ31のルーメン(内
腔)に連通するようにして設けられた中空状のシ
ースハブ部32(例えばポリプロピレン、ポリカ
ーボネート等からなる)とからなる。カテーテル
シース30はステント10を装着したカテーテル
20をそのルーメンに収納し得る。
The catheter sheath 30 has a sheath tube 21 (for example, PVC, polyethylene,
a hollow sheath hub portion 32 (made of polypropylene, polycarbonate, etc.) provided at the rear end of the sheath tube 31 so as to communicate with the lumen of the sheath tube 31; It consists of. Catheter sheath 30 may accommodate catheter 20 with stent 10 mounted thereon in its lumen.

カテーテルシース30は、シースチユーブ31
の材質中にX線透視下で位置確認ができるようX
線造影剤が配合されているのが望ましい。あるい
は、カテーテリシース30はシースチユーブ31
の先端部近傍に少なくとも1つのX線不透過マー
カーを具備するものであつてもよい。
The catheter sheath 30 includes a sheath tube 31
There is an X in the material so that the position can be confirmed under X-ray fluoroscopy.
It is desirable that a radiographic contrast agent is included. Alternatively, the catheter sheath 30 may include a sheath tube 31
At least one radiopaque marker may be provided near the tip of the marker.

カテーテルシース30のシースチユーブ31の
内径はステント10が拡張した時の径よりも小さ
いことが望ましい。これはステント10の導入時
にステント10、カテーテル20、シース30の
組合わせで導入するが、シース30の内径よりス
テント10が広がろうとするためシース30の内
側にステント10が固定されるからである。これ
により留置部手前までステント10、カテーテル
20、シース30の組合わせを導入する時、冷却
水を流しステント10をカテーテル20に巻き付
けておく必要がなくなり確実に導入することが可
能になる。さらにこれにより冷却水の注入量を少
なくすることができ、患者に対する負担を非常に
軽減することができる。
It is desirable that the inner diameter of the sheath tube 31 of the catheter sheath 30 is smaller than the diameter when the stent 10 is expanded. This is because the stent 10 is introduced as a combination of the stent 10, the catheter 20, and the sheath 30, but the stent 10 tends to expand beyond the inner diameter of the sheath 30, so the stent 10 is fixed inside the sheath 30. . This eliminates the need to run cooling water and wrap the stent 10 around the catheter 20 when introducing the combination of the stent 10, catheter 20, and sheath 30 up to the front of the indwelling site, making it possible to introduce the stent 10 reliably. Furthermore, this allows the amount of cooling water to be injected to be reduced, greatly reducing the burden on the patient.

カテーテルシース30のシースハブ部32はこ
れを介しカテーテル20が入るため、血液等の漏
れを防ぐための逆止弁33を備えている。さらに
シースハブ部32には造影剤等の注入のためのシ
ースポート34が設けられている。
The sheath hub portion 32 of the catheter sheath 30, through which the catheter 20 enters, is provided with a check valve 33 to prevent leakage of blood or the like. Further, the sheath hub portion 32 is provided with a sheath port 34 for injecting a contrast agent or the like.

次に、上記実施例の作用について説明する。 Next, the operation of the above embodiment will be explained.

上記内径確保用システム1は、ステント10を
二方向性形状記憶合金にて形成するものであり、
このステント10は体温より実質的に低い温度に
おいて留置すべき管状器官の内腔より小さな外径
を記憶している。また、このステント10は、体
温または体温近傍で拡張し留置すべき管状器官の
内径と同等かやや大きな外径を記憶している。こ
のステント10はカテーテル20に装着される状
態で、カテーテルシース30の内部に収納され、
この組合わせを管状器官に導入することによりス
テント10を目的部位に容易に留置し、かつ回収
できる。
In the system 1 for securing the inner diameter, the stent 10 is made of a bidirectional shape memory alloy,
The stent 10 has an outer diameter that is smaller than the lumen of the tubular organ in which it is to be placed at temperatures substantially below body temperature. Furthermore, the stent 10 expands at or near body temperature and has an outer diameter that is equal to or slightly larger than the inner diameter of the tubular organ to be indwelled. This stent 10 is housed inside the catheter sheath 30 while being attached to the catheter 20,
By introducing this combination into a tubular organ, the stent 10 can be easily placed in the target site and retrieved.

すなわち、ステント10を留置すべき管状器官
に一般的な手技によりガイドワイヤを通過させ、
これに沿つて上記組合わせを導入することによ
り、ステント10を容易に目的部位に導入し得る
(第5図A参照)。
That is, a guide wire is passed through a tubular organ in which the stent 10 is to be placed using a common procedure,
By introducing the above combination along this line, the stent 10 can be easily introduced into the target site (see FIG. 5A).

この時、本発明によれば、カテーテルシース3
0の存在により、ステント10はカテーテル20
に装着された状態でシース30の内部に確実に保
持されるから、カテーテル20に間隙なく巻き付
ける如くに縮径維持すべく大量の冷却水を供給す
る必要がなく、患者に対する負担を軽減できる。
また、カテーテルシース30の存在により、ステ
ント10が管状器官に対しむき出しにならず、途
中で引つかかつたり、変形してしまうおそれがな
い。
At this time, according to the present invention, the catheter sheath 3
0, the stent 10 is connected to the catheter 20
Since the catheter 20 is securely held inside the sheath 30 while being attached to the catheter 20, there is no need to supply a large amount of cooling water to maintain the diameter reduction so that the catheter 20 is wrapped tightly around the catheter 20, thereby reducing the burden on the patient.
Further, due to the presence of the catheter sheath 30, the stent 10 is not exposed to the tubular organ, and there is no risk of it being caught or deformed midway.

上記の如くにて目的部位に導入されたステント
10は、カテーテルシース30およびまたはカテ
ーテル20の連通口25から冷却水を供給されて
カテーテル20に巻き付けられる状態で(第5図
B参照)、カテーテルシース30から突き出され
た後(第5図C参照)、冷却水を止めることによ
り、体温にて加温されて拡張し(第5図D参照)、
管状器官の目的部位に留置される(第5図E参
照)。
The stent 10 introduced into the target site as described above is supplied with cooling water from the catheter sheath 30 and/or the communication port 25 of the catheter 20 and is wound around the catheter 20 (see FIG. 5B). 30 (see Figure 5 C), by stopping the cooling water, it is heated by body temperature and expands (see Figure 5 D).
It is placed at the target site in the tubular organ (see Figure 5E).

さらに、上記の如くに目的部位に留置されたス
テント10の回収は、ガイドワイヤをステント1
0の留置部に通過させ、これに沿つてカテーテル
20とカテーテルシース30の組合わせを該留置
部にまで導入する。その後、カテーテルシース3
0からカテーテル20の先端部を突き出し、カテ
ーテルシース30およびまたはカテーテル20の
連通口25から冷却水を供給することによりステ
ント10を縮径させてカテーテル20のステント
装着部23に巻き付け、巻き付けられたステント
10をカテーテル20とともにカテーテルシース
30の内部に引き込み回収できる。この場合に
も、冷却水は少量で足り、さらにカテーテルシー
ス30にステント10を引き込んだ後には該ステ
ント10の引つかかり、変形のおそれがなく確実
に回収できる。
Furthermore, in order to retrieve the stent 10 that has been placed in the target site as described above, the guide wire is inserted into the stent 10.
0, and the combination of catheter 20 and catheter sheath 30 is introduced along this into the indwelling section. Then catheter sheath 3
The distal end of the catheter 20 is protruded from the catheter 20, and cooling water is supplied from the catheter sheath 30 and/or the communication port 25 of the catheter 20 to reduce the diameter of the stent 10 and wrap it around the stent attachment part 23 of the catheter 20, thereby forming the wrapped stent. 10 can be drawn into the catheter sheath 30 together with the catheter 20 and recovered. In this case as well, a small amount of cooling water is sufficient, and furthermore, after the stent 10 is drawn into the catheter sheath 30, there is no risk of the stent 10 getting caught or deformed, and it can be reliably recovered.

なお、本発明の実施において、内径確保器具を
一方向性形状記憶合金にて形成する場合には、体
温近傍において留置すべき管状器官の内径と同等
かやや大きな外径を記憶しているコイル状あるい
は網目状等の実質的に筒状の内径確保器具が用い
られる。
In carrying out the present invention, when the inner diameter securing device is made of a unidirectional shape memory alloy, a coiled shape having an outer diameter equal to or slightly larger than the inner diameter of the tubular organ to be indwelled near body temperature may be used. Alternatively, a substantially cylindrical inner diameter securing device such as a mesh-like device is used.

体温より実質的に低い温度(変態温度以下)に
おいては、内径確保器具は自由に変形できるた
め、カテーテル先端部近傍の内径確保器具装着部
に巻き付ける如くに装着されて、カテーテルシー
ス内に収納される。このようにして、カテーテル
に装着された内径確保器具をカテーテルシース内
に収納した組合わせを、管状器官に導入すること
により内径確保器具を目的部位に容易に留置でき
る。
Since the inner diameter securing device can be freely deformed at temperatures substantially lower than body temperature (below the transformation temperature), it is attached so as to wrap around the inner diameter securing device mounting portion near the catheter tip and stored within the catheter sheath. . In this way, by introducing the combination of the inner diameter securing device attached to the catheter and housed within the catheter sheath into the tubular organ, the inner diameter securing device can be easily indwelled at the target site.

すなわち、内径確保器具を留置すべき管状器官
に一般的な手技によりガイドワイヤを通過させ、
これに沿つて上記組合わせを導入することによ
り、内径確保器具を容易に目的部位に導入し得
る。この時、本発明によれば、カテーテルシース
の存在により、内径確保器具は管状器官に対しむ
き出しにならず、途中で引つかかつたり変形して
しまうおそれがない。
That is, a guide wire is passed through the tubular organ in which the inner diameter securing device is to be placed using a common procedure,
By introducing the above combination along this line, the inner diameter securing instrument can be easily introduced to the target site. At this time, according to the present invention, due to the presence of the catheter sheath, the inner diameter securing device is not exposed to the tubular organ, and there is no risk of it being caught or deformed on the way.

上記の如くにて目的部位に導入された内径確保
器具は、カテーテルに装着された状態でカテーテ
ルシースから突き出された後、体温にて加温され
て拡径し、管状器官の目的部位に留置される。
The inner diameter securing device introduced into the target site as described above is inserted into the catheter and pushed out from the catheter sheath, then heated by body temperature to expand its diameter, and placed in the target site of the tubular organ. Ru.

なお、上記一方向性形状記憶合金からなる内径
確保器具の導入時にはカテーテルシースから冷却
水を供給し、またその留置時にはカテーテルシー
スから温水を供給することもできる。また、本発
明の好適な実施態様においては、カテーテルに基
端部から少なくとも先端部近傍にまで延びる流路
と該流路を先端部近傍の内径確保器具装着部外面
に連通する連通口を設け、この連通口から上記冷
却水、温水を供給することができる。
Note that cooling water can be supplied from the catheter sheath when the inner diameter ensuring device made of the unidirectional shape memory alloy is introduced, and hot water can also be supplied from the catheter sheath when the device is indwelled. Further, in a preferred embodiment of the present invention, the catheter is provided with a flow path extending from the proximal end to at least the vicinity of the distal end, and a communication port that communicates the flow path with the outer surface of the inner diameter securing device mounting portion near the distal end, The cooling water and hot water can be supplied from this communication port.

以下、本発明の具体的実施結果について説明す
る。
Hereinafter, specific implementation results of the present invention will be explained.

実施例 1 二方向性形状記憶合金からなるステントについ
て、以下の器具を用いて留置および回収を行なつ
た。
Example 1 A stent made of a bidirectional shape memory alloy was placed and retrieved using the following instrument.

ステントの材質はTi−Ni(Ni約51原子%)と
した。ステントの形状は肉厚t=0.03mm、幅w=
1mmの素材を第2図の如く螺線状にした。ステン
トは20℃以下でφ1.6mm、32℃以上でφ2.8mmに径変
化する。ステントの両端に金マーカー(肉厚t=
0.02mm、w=1.0mm)2個を固定した。
The material of the stent was Ti-Ni (approximately 51 atomic percent Ni). The shape of the stent is wall thickness t=0.03mm, width w=
A 1 mm material was made into a spiral shape as shown in Figure 2. The diameter of the stent changes from 1.6 mm at temperatures below 20°C to 2.8 mm at temperatures above 32°C. Gold markers at both ends of the stent (thickness t=
0.02mm, w=1.0mm) were fixed.

カテーテルの材質はポリエチレン−EVAのブ
レンド品とした。カテーテルの形状は第3図に示
す如くとした。
The material of the catheter was a polyethylene-EVA blend. The shape of the catheter was as shown in FIG.

カテーテルシースの材質はBi2O3の配合のPVC
とした。シースの形状は第4図に示す如くとし
た。
The material of the catheter sheath is PVC with Bi 2 O 3 compound.
And so. The shape of the sheath was as shown in FIG.

以下の手順にてステントの留置回収を行なつ
た。
The stent was placed and retrieved using the following procedure.

雑犬(17Kg)に術前日、当日aspirin(80mg)
dipyridamole(50mg)経口投与。
Aspirin (80mg) for a mixed dog (17Kg) on the day before surgery and on the day of surgery
dipyridamole (50 mg) orally.

全身麻酔下、常法により大腿動脈にイントロ
デユーサー留置後ヘパリン化(200/U/Kg) 常法により交換用ガイドワイヤを目的とする
血管に導入する。この場合においては右浅頸動
脈を選択した。
Under general anesthesia, an introducer is placed in the femoral artery using the standard method, followed by heparinization (200/U/Kg). A replacement guide wire is introduced into the target blood vessel using the standard method. In this case, the right superficial carotid artery was selected.

ステント、カテーテル、シースのセツトした
組合わせ(第1図参照)をガイドワイヤに沿つ
て留置位置直前まで導入する。
The set combination of stent, catheter, and sheath (see FIG. 1) is introduced along the guide wire until just before the indwelling position.

カテーテル側孔部(連通口)より冷却水(氷
冷生食)を30ml/〓で流しステントを収縮させ
る。
Cooling water (ice-cold saline) is flowed through the catheter side hole (communication port) at a rate of 30ml/ml to deflate the stent.

シースよりカテーテルを押し出しステントを
留置位置まで進め、冷却水を止めステントを拡
張させ留置し、カテーテル、シースを抜去す
る。
The catheter is pushed out from the sheath, the stent is advanced to the indwelling position, the cooling water is turned off, the stent is expanded and indwelled, and the catheter and sheath are removed.

30分後、ガイドワイヤに沿つてカテーテル、
シースのセツトをステント留置部手前まで進
め、さらにカテーテルのみ留置部に進め冷却水
を流す。
After 30 minutes, insert the catheter along the guide wire,
Advance the sheath set to the front of the stent indwelling site, then advance only the catheter to the indwelling site and flow cooling water.

ステントがカテーテルに巻き付いたのを確認
後、カテーテル、ステントをシース内に引き込
み冷却水を止め、シースごと抜去し回収を完了
する。
After confirming that the stent is wrapped around the catheter, pull the catheter and stent into the sheath, turn off the cooling water, and remove the sheath to complete recovery.

なお、〜はX線透視下で行なわれた。 Note that ~ was performed under X-ray fluoroscopy.

以上の手順によりステントの留置、回収を容易
に行ない得ることが認められた。
It was confirmed that the above procedure allowed easy placement and retrieval of the stent.

実施例 2 一方向性形状記憶合金ステントについて、以下
の器具、手順にて容易に留置が行ない得た。
Example 2 A unidirectional shape memory alloy stent was easily indwelled using the following instruments and procedures.

ステントは実施例1と同様の寸法、組成にて形
成し、42℃以上でφ2.8mmの形状を記憶させた。
The stent was formed with the same dimensions and composition as in Example 1, and the shape of 2.8 mm was memorized at 42° C. or higher.

カテーテルおよびカテーテルシースは実施例1
におけるものと同一のものを用いた。
Catheter and catheter sheath are Example 1
The same one as in was used.

雑犬右浅頸動脈に実施例1と同様にしてガイ
ドワイヤを留置し、上記ステントをカテーテル
に巻き付けこれにシースを組合わせたものをガ
イドワイヤに沿つて留置部まで導入する。
A guide wire is placed in the right superficial carotid artery of a mongrel dog in the same manner as in Example 1, and the above-mentioned stent is wrapped around a catheter and combined with a sheath, which is introduced along the guide wire to the indwelling site.

留置部でカテーテル、ステントを突き出し、
カテーテル側孔より45℃に暖めた生理食塩水を
注入する。これによりステントは拡張し留置し
得た。
The catheter and stent are pushed out at the indwelling site.
Inject physiological saline warmed to 45°C through the catheter side hole. This allowed the stent to expand and deploy.

[発明の効果] 以上のように、本発明の第1は、温度変化にと
もなつて径方向に寸法変化をし得る形状記憶合金
にて実質的に筒状体に形成された内径確保器具を
体腔内に留置するための内径確保用装置であつ
て、先端部近傍の内径確保器具装着部の外周面に
前記内径確保器具を装着し得るカテーテルと、両
端部が開口しその内腔に、前記内径確保器具を装
着した上記カテーテルを収納し得るカテーテルシ
ースとからなるようにしたものである。したがつ
て、内径確保器具を管状器官の目的部位に留置す
るに際し、カテーテルシースの存在により、内径
確保器具が管状器官に対しむき出しにならず、途
中で引つかかつたり変形してしまうおそれがな
い。
[Effects of the Invention] As described above, the first aspect of the present invention is to provide an inner diameter securing device formed into a substantially cylindrical body made of a shape memory alloy whose dimensions can change in the radial direction as the temperature changes. An internal diameter securing device for indwelling in a body cavity, which includes a catheter to which the internal diameter securing device can be mounted on the outer circumferential surface of an internal diameter securing device mounting portion near the distal end, and a catheter whose both ends are open and into which the internal diameter securing device is attached. It consists of a catheter sheath capable of housing the above-mentioned catheter equipped with an inner diameter securing device. Therefore, when the device for securing the inner diameter is indwelled at the target site of the tubular organ, the presence of the catheter sheath prevents the device for securing the inner diameter from being exposed to the tubular organ, and there is no risk of the device getting caught or deformed on the way. .

また、本発明の第2は、温度変化にともなつて
径方向に寸法変化をし得る二方向性形状記憶合金
にて実質的に筒状に形成された内径確保器具を体
腔内に留置、あるいは回収するための体腔の内径
確保用装置であつて、先端部近傍の内径確保器具
装着部の外周面に前記内径確保器具を装着し得る
カテーテルと、両端部が開口しその内腔に、収縮
した前記内径確保器具を装着した上記カテーテル
を収納し得、かつ拡張した前記内径確保器具の外
径に較べ内径が等しいか、あるいは小さいカテー
テルシースとからなるようにしたものである。し
たがつて、内径確保器具を管状器官の目的部位に
留置し、あるいは留置回収するに際し、カテーテ
ルシースの存在により、内径確保器具はカテーテ
ルに装着された状態でシース内に確実に保持され
るから、カテーテルに間隙なく巻き付く如くに縮
径維持すべく大量の冷却水を供給する必要がな
く、患者に対する負担を軽減できる。また、カテ
ーテルシースの存在により、内径確保器具は管状
器官に対しむき出しにならず、途中で引つかかつ
たり変形してしまうおそれがない。
In addition, the second aspect of the present invention is to indwell in a body cavity an inner diameter securing device formed into a substantially cylindrical shape made of a bidirectional shape memory alloy that can change dimensions in the radial direction with temperature changes, or The device is a device for securing the inner diameter of a body cavity for recovery, and includes a catheter to which the inner diameter securing device can be attached to the outer circumferential surface of the inner diameter securing device attachment part near the distal end, and a catheter having both ends open and having a contracted catheter attached to the inner diameter of the body cavity. The catheter sheath is capable of housing the catheter equipped with the inner diameter securing device and has an inner diameter equal to or smaller than the outer diameter of the expanded inner diameter securing device. Therefore, when the device for securing the inner diameter is placed in the target site of the tubular organ or withdrawn, the catheter sheath ensures that the device for securing the inner diameter is held within the sheath while attached to the catheter. There is no need to supply a large amount of cooling water to maintain the diameter reduction so that the catheter is wrapped around the catheter without any gaps, and the burden on the patient can be reduced. Further, due to the presence of the catheter sheath, the inner diameter securing device is not exposed to the tubular organ, and there is no risk of it being caught or deformed on the way.

したがつて、本発明の第1および第2によれ
ば、内径確保器具を管状器官内にて円滑かつ容易
に移動できる。
Therefore, according to the first and second aspects of the present invention, the inner diameter securing device can be moved smoothly and easily within the tubular organ.

【図面の簡単な説明】[Brief explanation of the drawing]

第1図は本発明の第1実施例に係る内径確保用
システムを示す断面図、第2図A,Bは内径確保
器具を示す側面図、第3図はカテーテルを示す側
面図、第4図はカテーテルシースを示す側面図、
第5図A〜Eは内径確保器具の導入、留置過程を
示す模式図である。 1……内径確保用システム、10……内径確保
器具(ステント)、11……X線不透過マーカー、
20……カテーテル、21……カテーテルチユー
ブ、22……ハブ部、23……ステント装着部、
24……流路、25……連通口、26……膨出
部、27……X線不透過マーカー、28……逆止
弁、30……カテーテルシース、31……シース
チユーブ、32……シースハブ部、33……逆止
弁。
FIG. 1 is a sectional view showing an inner diameter securing system according to a first embodiment of the present invention, FIGS. 2A and B are side views showing an inner diameter securing device, FIG. 3 is a side view showing a catheter, and FIG. 4 is a side view showing the catheter sheath;
FIGS. 5A to 5E are schematic diagrams showing the process of introducing and indwelling the inner diameter securing device. 1...Inner diameter securing system, 10...Inner diameter securing device (stent), 11...X-ray opaque marker,
20... Catheter, 21... Catheter tube, 22... Hub portion, 23... Stent attachment portion,
24... Channel, 25... Communication port, 26... Bulging portion, 27... X-ray opaque marker, 28... Check valve, 30... Catheter sheath, 31... Sheath tube, 32... Sheath hub section, 33...Check valve.

Claims (1)

【特許請求の範囲】 1 温度変化にともなつて径方向に寸法変化をし
得る形状記憶合金にて実質的に筒状体に形成され
た内径確保器具を体腔内に留置するための体腔の
内径確保用装置であつて、先端部近傍の内径確保
器具装着部の外周面に前記内径確保器具を装着し
得るカテーテルと、両端部が開口しその内腔に、
前記内径確保器具を装着した上記カテーテルを収
納し得るカテーテルシースとからなる体腔の内径
確保用装置。 2 前記カテーテルは、基端部から少なくとも先
端部近傍にまで延びる流路を備え、かつ該流路を
カテーテル外面と連通させる側孔あるいはスリツ
ト状の連通口を先端部近傍の内径確保器具装着部
に備えてなる特許請求の範囲第1項記載の体腔の
内径確保用装置。 3 前記カテーテルは、先端部近傍の内径確保器
具装着部の基端部側および先端部側の両外径ある
いは基端部側の外径が、該内径確保器具装着部に
装着された内径確保器具の外径以上の外径を持つ
特許請求の範囲第1項または第2項記載の体腔の
内径確保用装置。 4 前記カテーテルは、基端部から少なくとも基
端部近傍にまで延びるカテーテル内腔を備えると
ともに、基端部に該カテーテル内腔と連通するよ
うにして設けられる中空状のハブ部を備え、該カ
テーテル内腔と該ハブ部内腔にて前記流路を形成
する特許請求の範囲第2項または第3項記載の体
腔の内径確保用装置。 5 前記ハブ部は、2つのポートを具備した分岐
ハブからなり、その一方のポートに逆止弁が設け
られる特許請求の範囲第4項記載の体腔の内径確
保用装置。 6 前記カテーテルは、先端部近傍に少なくとも
1つのX線不透過マーカーを具備している特許請
求の範囲第1項〜第5項のいずれかに記載の体腔
の内径確保用装置。 7 前記カテーテルシースは、材質中にX線不透
過物質を配合するか、あるいは先端部近傍に少な
くとも1つのX線不透過マーカーを具備している
特許請求の範囲第1項〜第6項のいずれかに記載
の体腔の内径確保用装置。 8 前記カテーテルシースは、両端部間に延びる
シース内腔を備えるとともに、基端部に該シース
内腔と連通するように設けられる中空状のハブ部
を備え、該ハブ部に逆止弁が設けられる特許請求
の範囲第1項〜第7項のいずれかに記載の体腔の
内径確保用装置。 9 温度変化にともなつて径方向に寸法変化をし
得る二方向性形状記憶合金にて実質的に筒状に形
成された内径確保器具を体腔内に留置、あるいは
回収するための体腔の内径確保用装置であつて、
先端部近傍の内径確保器具装着部の外周面に前記
内径確保器具を装着し得るカテーテルと、両端部
が開口しその内腔に、収縮した前記内径確保器具
を装着した上記カテーテルを収納し得、かつ拡張
した前記内径確保器具の外径に較べ内径が等しい
か、あるいは小さいカテーテルシースとからなる
体腔の内径確保用装置。 10 前記カテーテルは、基端部から少なくとも
先端部近傍にまで延びる流路を備え、かつ該流路
をカテーテル外面と連通させる側孔あるいはスリ
ツト状の連通口を先端部近傍の内径確保器具装着
部に備えてなる特許請求の範囲第9項記載の体腔
の内径確保用装置。 11 前記カテーテルは、先端部近傍の内径確保
器具装着部付近の外径が、前記内径確保器具の収
縮時の内径に等しいかあるいは僅かに大きい外径
を持ち、体温より実質的に低い温度において前記
内径確保器具を装着し得る特許請求の範囲第9項
または10項記載の体腔の内腔確保用装置。 12 前記カテーテルは、基端部から少なくとも
基端部近傍にまで延びるカテーテル内腔を備える
とともに、基端部に該カテーテル内腔と連通する
ようにして設けられる中空状のハブ部を備え、該
カテーテル内腔と該ハブ部内腔にて前記流路を形
成する特許請求の範囲第10項または第11項記
載の体腔の内径確保用装置。 13 前記ハブ部は、2つのポートを具備した分
岐ハブからなり、その一方のポートに逆止弁が設
けられる特許請求の範囲第12項記載の体腔の内
径確保用装置。 14 前記カテーテルは、先端部近傍の内径確保
器具装着部の基端部側および先端部側の両外径あ
るいは基端部側の外径が、該内径確保器具装着部
に装着された内径確保器具の外径以上の外径を持
つ特許請求の範囲第9項〜第13項のいずれかに
記載の体腔の内径確保用装置。 15 前記カテーテルは、先端部近傍に少なくと
も1つのX線不透過マーカーを具備している特許
請求の範囲第9項〜第14項のいずれかに記載の
体腔の内径確保用装置。 16 前記カテーテルシースは、材質中にX線不
透過物質を配合するか、あるいは先端部近傍に少
なくとも1つのX線不透過マーカーを具備してい
る特許請求の範囲第9項〜第15項のいずれかに
記載の体腔の内径確保用装置。 17 前記カテーテルシースは、両端部間に延び
るシース内腔を備えるとともに、基端部に該シー
ス内腔と連通するように設けられる中空状のハブ
部を備え、該ハブ部に逆止弁が設けられる特許請
求の範囲第9項〜第16項のいずれかに記載の体
腔の内径確保用装置。
[Scope of Claims] 1. The inner diameter of a body cavity for indwelling an inner diameter securing device formed into a substantially cylindrical body made of a shape memory alloy that can change dimensions in the radial direction with temperature changes. The securing device includes a catheter to which the inner diameter securing device can be attached to the outer peripheral surface of the inner diameter securing device mounting portion near the distal end, and a catheter whose both ends are open and into the inner lumen thereof.
A device for securing the inner diameter of a body cavity, comprising a catheter sheath capable of accommodating the catheter equipped with the inner diameter securing device. 2. The catheter is provided with a flow path extending from the proximal end to at least the vicinity of the distal end, and a side hole or a slit-shaped communication port that communicates the flow path with the outer surface of the catheter is provided in the inner diameter securing device mounting portion near the distal end. A device for securing the inner diameter of a body cavity according to claim 1. 3. The catheter has an inner diameter securing device attached to the inner diameter securing device mounting portion such that both outer diameters of the proximal end side and distal end side of the inner diameter securing device mounting portion near the distal end or the outer diameter of the proximal end side of the inner diameter securing device mounting portion near the tip end thereof are The device for securing an inner diameter of a body cavity according to claim 1 or 2, having an outer diameter greater than or equal to an outer diameter of . 4. The catheter includes a catheter lumen extending from the proximal end to at least the vicinity of the proximal end, and a hollow hub portion provided at the proximal end so as to communicate with the catheter lumen; The device for securing an inner diameter of a body cavity according to claim 2 or 3, wherein the flow path is formed by the inner cavity and the inner cavity of the hub portion. 5. The device for securing an inner diameter of a body cavity according to claim 4, wherein the hub portion is a branch hub having two ports, one of which is provided with a check valve. 6. The device for securing the inner diameter of a body cavity according to any one of claims 1 to 5, wherein the catheter is provided with at least one radiopaque marker near the distal end. 7. Any one of claims 1 to 6, wherein the catheter sheath contains an X-ray opaque substance in its material or has at least one X-ray opaque marker near its tip. The device for securing the inner diameter of a body cavity as described in . 8. The catheter sheath includes a sheath lumen extending between both ends, and a hollow hub portion provided at the proximal end so as to communicate with the sheath lumen, and the hub portion is provided with a check valve. A device for securing an inner diameter of a body cavity according to any one of claims 1 to 7. 9 Securing the inner diameter of a body cavity for indwelling or retrieving an inner diameter securing device formed into a substantially cylindrical shape made of a bidirectional shape memory alloy that can change dimensions in the radial direction with temperature changes. A device for
A catheter capable of mounting the inner diameter securing device on the outer circumferential surface of the inner diameter securing device mounting portion near the tip portion, and a catheter having both ends open and having the contracted inner diameter securing device mounted thereon in the lumen thereof, and a catheter sheath whose inner diameter is equal to or smaller than the outer diameter of the expanded inner diameter securing device. 10 The catheter is provided with a flow path extending from the proximal end to at least the vicinity of the distal end, and a side hole or a slit-shaped communication opening that communicates the flow path with the outer surface of the catheter is provided in the inner diameter securing device mounting portion near the distal end. An apparatus for securing an inner diameter of a body cavity according to claim 9. 11. The catheter has an outer diameter near the distal end portion where the inner diameter securing device is attached, which is equal to or slightly larger than the inner diameter of the inner diameter securing device when it is contracted, and the catheter has an outer diameter that is equal to or slightly larger than the inner diameter of the inner diameter securing device when it is contracted, and the catheter 11. The device for securing the internal cavity of a body cavity according to claim 9 or 10, to which an internal diameter securing instrument can be attached. 12 The catheter includes a catheter lumen extending from the proximal end to at least the vicinity of the proximal end, and a hollow hub portion provided at the proximal end so as to communicate with the catheter lumen; The device for securing an inner diameter of a body cavity according to claim 10 or 11, wherein the flow path is formed by the inner cavity and the inner cavity of the hub portion. 13. The device for securing the inner diameter of a body cavity according to claim 12, wherein the hub portion is a branch hub having two ports, one of which is provided with a check valve. 14. The catheter has an inner diameter securing device attached to the inner diameter securing device mounting portion such that both outer diameters of the proximal end side and distal end side of the inner diameter securing device mounting portion near the distal end or the outer diameter of the proximal end side of the inner diameter securing device mounting portion near the tip end thereof are The device for securing an inner diameter of a body cavity according to any one of claims 9 to 13, having an outer diameter greater than or equal to an outer diameter of . 15. The device for securing an inner diameter of a body cavity according to any one of claims 9 to 14, wherein the catheter is provided with at least one radiopaque marker near the distal end. 16. Any one of claims 9 to 15, wherein the catheter sheath contains an X-ray opaque substance in its material or has at least one X-ray opaque marker near its tip. The device for securing the inner diameter of a body cavity as described in . 17 The catheter sheath includes a sheath lumen extending between both ends, and a hollow hub portion provided at the proximal end so as to communicate with the sheath lumen, and the hub portion is provided with a check valve. An apparatus for securing an inner diameter of a body cavity according to any one of claims 9 to 16.
JP62275655A 1987-10-08 1987-11-02 Appliance for securing cavity bore Granted JPH01119266A (en)

Priority Applications (7)

Application Number Priority Date Filing Date Title
JP62275655A JPH01119266A (en) 1987-11-02 1987-11-02 Appliance for securing cavity bore
PCT/JP1988/001029 WO1989003197A1 (en) 1987-10-08 1988-10-07 Instrument and apparatus for securing inner diameter of lumen of tubular organ
US07/477,843 US5201901A (en) 1987-10-08 1988-10-07 Expansion unit and apparatus for expanding tubular organ lumen
DE3855725T DE3855725T2 (en) 1987-10-08 1988-10-07 INSTRUMENT AND DEVICE FOR MAINTAINING THE INNER LUMEN DIAMETER OF A TUBULAR ORGAN
EP88908753A EP0380668B1 (en) 1987-10-08 1988-10-07 Instrument and apparatus for securing inner diameter of lumen of tubular organ
AU25309/88A AU623100B2 (en) 1987-10-08 1988-10-07 Instrument and apparatus for securing inner diameter of lumen of tubular organ
AU10837/92A AU638886B2 (en) 1987-10-08 1992-02-07 Expansion unit and apparatus for expanding tubular organ lumen

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
JP62275655A JPH01119266A (en) 1987-11-02 1987-11-02 Appliance for securing cavity bore

Publications (2)

Publication Number Publication Date
JPH01119266A JPH01119266A (en) 1989-05-11
JPH0316152B2 true JPH0316152B2 (en) 1991-03-04

Family

ID=17558490

Family Applications (1)

Application Number Title Priority Date Filing Date
JP62275655A Granted JPH01119266A (en) 1987-10-08 1987-11-02 Appliance for securing cavity bore

Country Status (1)

Country Link
JP (1) JPH01119266A (en)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5683451A (en) * 1994-06-08 1997-11-04 Cardiovascular Concepts, Inc. Apparatus and methods for deployment release of intraluminal prostheses
EP2431009B1 (en) * 2009-08-03 2016-09-14 Terumo Kabushiki Kaisha Stent delivery system
US8616467B1 (en) * 2010-12-17 2013-12-31 Gary Leavitt Sprinkler head cover
WO2015141408A1 (en) * 2014-03-19 2015-09-24 テルモ株式会社 Medical instrument
US11504734B1 (en) 2014-11-11 2022-11-22 Gary Leavitt Sprinkler head cover
US10758928B1 (en) 2014-11-11 2020-09-01 Gary Leavitt Sprinkler head cover
EP3588433A1 (en) * 2018-06-28 2020-01-01 Koninklijke Philips N.V. Stent positioning

Also Published As

Publication number Publication date
JPH01119266A (en) 1989-05-11

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