JPS6187540A - 血管ステント - Google Patents
血管ステントInfo
- Publication number
- JPS6187540A JPS6187540A JP60219016A JP21901685A JPS6187540A JP S6187540 A JPS6187540 A JP S6187540A JP 60219016 A JP60219016 A JP 60219016A JP 21901685 A JP21901685 A JP 21901685A JP S6187540 A JPS6187540 A JP S6187540A
- Authority
- JP
- Japan
- Prior art keywords
- stent
- passageway
- sheath
- wire
- stents
- 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.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2/00—Filters 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
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/0054—V-shaped
Landscapes
- Health & Medical Sciences (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Veterinary Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
- Surgical Instruments (AREA)
- Medicinal Preparation (AREA)
Abstract
(57)【要約】本公報は電子出願前の出願データであるた
め要約のデータは記録されません。
め要約のデータは記録されません。
Description
【発明の詳細な説明】
本発明は、ステントとその挿入方法に関する。
従来技術の説明
様々な状況において、収縮された管腔部分を拡張しある
いは管腔部分をイI過する通路を開いたまま保持するた
めの装置が提供Sれることが好ましい。そのような状況
は例えば動脈硬化症並びに腫扇などとして知られている
血管を通過する白液の流れを制限しあるいは停車させる
ような病気に関連して生じる。チャールズ・トンター傅
+その他は1969年に、犬のひかがみ部の動脈内に置
かれたコイル状にしたステンレス鋼のワイヤのステント
の実験における使用について報告している。
いは管腔部分をイI過する通路を開いたまま保持するた
めの装置が提供Sれることが好ましい。そのような状況
は例えば動脈硬化症並びに腫扇などとして知られている
血管を通過する白液の流れを制限しあるいは停車させる
ような病気に関連して生じる。チャールズ・トンター傅
+その他は1969年に、犬のひかがみ部の動脈内に置
かれたコイル状にしたステンレス鋼のワイヤのステント
の実験における使用について報告している。
コイルは長期間にわたる解放性を示しているが、その内
部の管腔を狭くし、小さなコイルだけしか皮膚を通して
通過することができない。「管腔を通過して配置Xれた
コイルバネの末端動脈の管の接合」 トンターその他、
調査、放射線学、1969.4] 329−332参照
(参考文献l)。最近2つの研究所が形状記憶合金、ニ
チノールによ11製造されたカテーテルを通過するプロ
テーゼの使用を報告している。トンターその他の[管腔
を通過する拡張if能なニチノールコイルステント接合
」、放射線学、198:3年4月、147:259−’
260(参考文献2)、”7ラング・Aその他の「外利
手術によらない動脈の内部プロテーゼの挿入」放用線学
1983年4月;147:261−263 (参8文献
3)参照。こ゛のようなステントは氷水あるいは加熱ご
れた塩水などを必要とするので、使用が複雑になる。同
時にそれらはステントワイヤのトにフイブ・ノンが堆桔
するために管1rケの狭窄を生しる。
部の管腔を狭くし、小さなコイルだけしか皮膚を通して
通過することができない。「管腔を通過して配置Xれた
コイルバネの末端動脈の管の接合」 トンターその他、
調査、放射線学、1969.4] 329−332参照
(参考文献l)。最近2つの研究所が形状記憶合金、ニ
チノールによ11製造されたカテーテルを通過するプロ
テーゼの使用を報告している。トンターその他の[管腔
を通過する拡張if能なニチノールコイルステント接合
」、放射線学、198:3年4月、147:259−’
260(参考文献2)、”7ラング・Aその他の「外利
手術によらない動脈の内部プロテーゼの挿入」放用線学
1983年4月;147:261−263 (参8文献
3)参照。こ゛のようなステントは氷水あるいは加熱ご
れた塩水などを必要とするので、使用が複雑になる。同
時にそれらはステントワイヤのトにフイブ・ノンが堆桔
するために管1rケの狭窄を生しる。
本発明に関連するその他の参照例は、以下の米国特許で
ある。第4.12’4,587吟、第3’、see、9
5e号第4,425,908号、ソI!l!特許第97
8.821号。以下の11行物も含む。C・キアンツル
コその他「新ベナ、サバフィルタ・実験動物の評価」放
射線学、1980づ1:12月、13’7 : 835
−837 (参考文献4)、M・シモンその他「形状記
憶合金を使用したベナ・す/<フィルタ」診断放射線学
、125 : 89−9.1977年10月(参考文献
5)。更にその他のf(1行物は、D・マースその他[
管腔を通過して挿入される血管の内部プロテーゼの放射
線学による追跡調査;拡張スパイラルを使用しての実験
研究」放射線学、1984年、152 : 659−6
63である。
ある。第4.12’4,587吟、第3’、see、9
5e号第4,425,908号、ソI!l!特許第97
8.821号。以下の11行物も含む。C・キアンツル
コその他「新ベナ、サバフィルタ・実験動物の評価」放
射線学、1980づ1:12月、13’7 : 835
−837 (参考文献4)、M・シモンその他「形状記
憶合金を使用したベナ・す/<フィルタ」診断放射線学
、125 : 89−9.1977年10月(参考文献
5)。更にその他のf(1行物は、D・マースその他[
管腔を通過して挿入される血管の内部プロテーゼの放射
線学による追跡調査;拡張スパイラルを使用しての実験
研究」放射線学、1984年、152 : 659−6
63である。
本発明の詳細な説明
本発明の目的は、耐層及び使用が容易で、流れの欠陥、
管腔の狭窄及び閉塞を減少させるステントを提供するこ
とにある。
管腔の狭窄及び閉塞を減少させるステントを提供するこ
とにある。
本発明のステントの1つの実施例は、曲がりにより連結
之れだ閉じて連続した直線部分を含む密接に隣接したし
たジ゛グザグの構造に形成Sれたワイヤを含む。ステン
トは弾力かあってより小さな形状に圧縮可能であり、そ
の形状では通路へ挿入するために直線部分が平行して配
置され相千に密接に隣接している。ステントは弾力によ
り第二の形状に拡張可能であり、その形状では前記直線
部分が通路の壁に抗して押しつけられその通路を開いた
ままに保持し拡大する。
之れだ閉じて連続した直線部分を含む密接に隣接したし
たジ゛グザグの構造に形成Sれたワイヤを含む。ステン
トは弾力かあってより小さな形状に圧縮可能であり、そ
の形状では通路へ挿入するために直線部分が平行して配
置され相千に密接に隣接している。ステントは弾力によ
り第二の形状に拡張可能であり、その形状では前記直線
部分が通路の壁に抗して押しつけられその通路を開いた
ままに保持し拡大する。
図面を参照1.つつ、本発明の詳細な説明する。閉じた
ジグザグの構造に形成されたステンレス鋼のワイヤのワ
イヤ10を含む本発明のステント9の好ましい実施例の
側面図が第1図にある。
ジグザグの構造に形成されたステンレス鋼のワイヤのワ
イヤ10を含む本発明のステント9の好ましい実施例の
側面図が第1図にある。
このワイヤは、閉じた連続構造を作り出すためにワイヤ
の端を溶接あるいは締めつけによりさや11により閉じ
られている。第4図を見ると、直線部分12か相虻に密
接に隣接して配置されたステントか弾力的に圧縮された
第−杉状を示している。
の端を溶接あるいは締めつけによりさや11により閉じ
られている。第4図を見ると、直線部分12か相虻に密
接に隣接して配置されたステントか弾力的に圧縮された
第−杉状を示している。
ステントと直線部分12は比較的鋭い曲がり13により
連結されている。このようにして、本発明の1つの特定
の実施例においては、曲がり13は1パ径は0.2cm
以下である。本発明のこの特定の実施例は、スレンレス
鋼の外径が0.018インチであるワイヤを含む。ステ
ントは弾力性と拡張性があり、第4図の圧縮された第一
形状から第1図、第2図及び第6図に描かれた第二形状
t・と拡張可能であり、ここでは、直線部分12が通路
の壁に抗して通路を開いたままに保持する。第2図はス
テントの拡張した第二形状にある展望図を示している。
連結されている。このようにして、本発明の1つの特定
の実施例においては、曲がり13は1パ径は0.2cm
以下である。本発明のこの特定の実施例は、スレンレス
鋼の外径が0.018インチであるワイヤを含む。ステ
ントは弾力性と拡張性があり、第4図の圧縮された第一
形状から第1図、第2図及び第6図に描かれた第二形状
t・と拡張可能であり、ここでは、直線部分12が通路
の壁に抗して通路を開いたままに保持する。第2図はス
テントの拡張した第二形状にある展望図を示している。
第2図に描かれているように、ステントはその第二の拡
張形状においては環状構造あるいは円筒形の構造を有し
ている。
張形状においては環状構造あるいは円筒形の構造を有し
ている。
本発明の方法を実行するために、ステントは第1O図に
描かれた第一形状に圧縮され、管状カートリッジ15内
に配置される(第1O図)。カートリッジ15はさや2
0のアダプタ17にある凹部16へ挿入yれる。それか
らステントは端の乎らな推進器21の助けによりさや2
0を通過して前進する。このようにして、本発明の1つ
の実施例においては端の平らな推進器は8フレンチポリ
エチレン管から作られるが、端の平らな口f撓性のある
金属棒が好ましい。第4図に示されているように、ステ
ン)10がさやの端に到達すると、端の平らな推進器は
第5図に示されているようにさやが引き抜かれている間
保持される。これによりステントは自由になり、第6図
に示されるように拡張して血管の壁に接近する。特定の
状況のために8侠がある場合は、ステントが追加可能で
あり、I−述と同様の方式で血管内に配置される。この
ようにして、第7図にあるように、追加の2つのステン
トが第一ステントの長さ方向に沿って血管内に配置され
、第8図にあるように4つの重なり合うステントが使用
される場合は第一ステントに他のステントが重なり合う
。
描かれた第一形状に圧縮され、管状カートリッジ15内
に配置される(第1O図)。カートリッジ15はさや2
0のアダプタ17にある凹部16へ挿入yれる。それか
らステントは端の乎らな推進器21の助けによりさや2
0を通過して前進する。このようにして、本発明の1つ
の実施例においては端の平らな推進器は8フレンチポリ
エチレン管から作られるが、端の平らな口f撓性のある
金属棒が好ましい。第4図に示されているように、ステ
ン)10がさやの端に到達すると、端の平らな推進器は
第5図に示されているようにさやが引き抜かれている間
保持される。これによりステントは自由になり、第6図
に示されるように拡張して血管の壁に接近する。特定の
状況のために8侠がある場合は、ステントが追加可能で
あり、I−述と同様の方式で血管内に配置される。この
ようにして、第7図にあるように、追加の2つのステン
トが第一ステントの長さ方向に沿って血管内に配置され
、第8図にあるように4つの重なり合うステントが使用
される場合は第一ステントに他のステントが重なり合う
。
本発明の試験においては、血管内のステントは2つのサ
イズで(完全拡張時には長さ5.5cm×直径4cmと
;完全拡張時には長さ3.0cm×直径2.5cm)で
、ジグザグパターンに形成されたステンレス鋼ワイヤ(
外径0.018インチ)で設計され製造されている。そ
れらは時間の間隔を変化させて5匹の犬の頚動脈、小さ
な静脈、腹部の大動脈に配置され(後述の表を参照)、
使用の容易さ、拡張力、移動、開放性、プロトロンヒン
性、及び局部の血管の変化について評価された。この研
究には5匹の成長した雑種の犬(体@18−27kg)
が使用yれた。これらの犬はi、v、ナトリウムペンド
パルビタール(ネムブタル:3omg/kg)により麻
酔をかけ、頚静脈、大腿部の静脈、大腿部の動脈は外科
手術により分離された。血管に切りこみが入れられ、テ
ーパチップを有する8フレンチテフロンカテーテルを含
む8フレンチテフロンさやが挿入され、対象となってい
る場所への前進を蛍光透視法によりモニタした。ステン
]・は圧縮され、8フレンチさやのアダプタの内部に適
合する8フレンチカートリンジの内部に配置される。8
フレンチカテーテルは除去されカートリッジはさやアダ
プタの内部に配置され、ステントは8フレンチポリエチ
レン管によりさやを通って前進した。ステントがさやの
端に到達すると、ポリエチレン管はさやが引5抜かれて
いる間そのままに保持される。これはステントが拡張し
て血管の壁を支えるために開放yれるためである。一定
の場合においては、複数のステントが1つのステントの
内部に他のステントが配置され、あるいは順次に配置y
れる(表■)。配置の後に続いて、配置直後と1週間後
とに血?6−撮影か行われ、それから1か月の間隔でス
テントの位置と血管解剖が報告Sれた。犬は研究の最後
に深いネムブタルの麻酔をかけられ安楽死ネせられ、完
全な死体解剖が実行された。
イズで(完全拡張時には長さ5.5cm×直径4cmと
;完全拡張時には長さ3.0cm×直径2.5cm)で
、ジグザグパターンに形成されたステンレス鋼ワイヤ(
外径0.018インチ)で設計され製造されている。そ
れらは時間の間隔を変化させて5匹の犬の頚動脈、小さ
な静脈、腹部の大動脈に配置され(後述の表を参照)、
使用の容易さ、拡張力、移動、開放性、プロトロンヒン
性、及び局部の血管の変化について評価された。この研
究には5匹の成長した雑種の犬(体@18−27kg)
が使用yれた。これらの犬はi、v、ナトリウムペンド
パルビタール(ネムブタル:3omg/kg)により麻
酔をかけ、頚静脈、大腿部の静脈、大腿部の動脈は外科
手術により分離された。血管に切りこみが入れられ、テ
ーパチップを有する8フレンチテフロンカテーテルを含
む8フレンチテフロンさやが挿入され、対象となってい
る場所への前進を蛍光透視法によりモニタした。ステン
]・は圧縮され、8フレンチさやのアダプタの内部に適
合する8フレンチカートリンジの内部に配置される。8
フレンチカテーテルは除去されカートリッジはさやアダ
プタの内部に配置され、ステントは8フレンチポリエチ
レン管によりさやを通って前進した。ステントがさやの
端に到達すると、ポリエチレン管はさやが引5抜かれて
いる間そのままに保持される。これはステントが拡張し
て血管の壁を支えるために開放yれるためである。一定
の場合においては、複数のステントが1つのステントの
内部に他のステントが配置され、あるいは順次に配置y
れる(表■)。配置の後に続いて、配置直後と1週間後
とに血?6−撮影か行われ、それから1か月の間隔でス
テントの位置と血管解剖が報告Sれた。犬は研究の最後
に深いネムブタルの麻酔をかけられ安楽死ネせられ、完
全な死体解剖が実行された。
表■:5匹の夫への血管ステントの配置の要約人 ステ
ントサイズ5.5cm、 期間416 使用個
数、5個 1か月血管配置・・・2つ、
1つは内部に、他は腹腔、頭蓋、腸間膜、右の腎臓の動
脈をつなぐ腹部の大動脈(A A)に配置された。
ントサイズ5.5cm、 期間416 使用個
数、5個 1か月血管配置・・・2つ、
1つは内部に、他は腹腔、頭蓋、腸間膜、右の腎臓の動
脈をつなぐ腹部の大動脈(A A)に配置された。
2つ、右の心房のレベルで1つは内部に他は大静脈(S
VC)に配置された。
VC)に配置された。
1つ、両方の腎臓の動脈をつなイ゛小ネい静1ffA(
IVC)に配置された。
IVC)に配置された。
ヌテントサイズ3.0cm、使用個数3個。
面ζi?配置・・・1つ、SvCのl−;8cmの右頚
部に配置きれた。
部に配置きれた。
2つ、1つは内部に、他はS VC(7) 18 c
mノ左9′f1部に配置きれた。
mノ左9′f1部に配置きれた。
犬 ステントサイズ5.5cm、 期間355
使用個数、 3か月1つは、腹腔
、頭蓋、腸間膜、右の腎臓の動脈をつなぐ腹部の大動脈
(AA)に配置された。
使用個数、 3か月1つは、腹腔
、頭蓋、腸間膜、右の腎臓の動脈をつなぐ腹部の大動脈
(AA)に配置された。
2つ、1つは内部に、他は両方の腎臓の動脈をつなぐI
VCに配置された。
VCに配置された。
ステントサイズ3.0cm、使用個数3個。
2つ、1つは内部に、他は右心房のレベルに、そして1
つは右Iu房のト2.3cmのレベルに配置された。
つは右Iu房のト2.3cmのレベルに配置された。
犬 ステントサイズ5.5cm、 期間354
使用個数、2個 4か月血管配置・・
・1つ、頭蓋、腸間膜、両方の腎臓の動脈をつなぐAA
に配置された。
使用個数、2個 4か月血管配置・・
・1つ、頭蓋、腸間膜、両方の腎臓の動脈をつなぐAA
に配置された。
1つ1両方の腎臓の静脈をつなぐIVCに配置された。
犬 ステントす・fズ5.5cm、 期間50
5 使用個数、5個 ′ 5か月血管配置・
・・4つ、順次にダイヤフラム(T11)から始まりL
5で終るAAに配置された。
5 使用個数、5個 ′ 5か月血管配置・
・・4つ、順次にダイヤフラム(T11)から始まりL
5で終るAAに配置された。
1つ、ダイヤフラムのレベルに配置された。
ステントサイズ3.0cm、使用個数3個。
1つ、レベルL4−’L5のAAにある最後の長いステ
ントの内部に配置yれた。
ントの内部に配置yれた。
2つ、順次に肝臓と腎臓の静脈の間にあるIVCの内部
に配置之れだ。
に配置之れだ。
血管ステントを配置することには何の困難も生じなかっ
た。それらは使用か容易で、1つの内部に他を、あるい
は順次に配置することができた。
た。それらは使用か容易で、1つの内部に他を、あるい
は順次に配置することができた。
ステントの拡張の強さはステントの長さ、ステントのワ
イヤの直径、各ステントのワイヤにある折り畳みの数、
ステントの内部に配置されたステントの数に依存するこ
とが判明した。特に、ステ7トの長さが減少し、ステン
トのワイヤの直径が増加し、折り畳みの数が増加し、使
用されるステントの数が増加することにより拡張力は増
加する。
イヤの直径、各ステントのワイヤにある折り畳みの数、
ステントの内部に配置されたステントの数に依存するこ
とが判明した。特に、ステ7トの長さが減少し、ステン
トのワイヤの直径が増加し、折り畳みの数が増加し、使
用されるステントの数が増加することにより拡張力は増
加する。
ステントを使用した血管の撮影によれば、Beれの障害
、管腔の狭窄、あるいは閉塞は見られなかった。ステン
トでつながれた血管は開放されたまま保持され、6か列
後にも狭窄を示すん1拠は発見ごれなかった。配置され
た30個のステントのうち、29個は移動していなかっ
た。頭蓋の小さい静脈に配置された長いステ71−(5
,5cm)1つのみがおよそ2cm、配置後の最初の1
il1間に移動したが、それ以I−の移動は生じること
なく、この移動を原因とする問題は発生しなかった。
、管腔の狭窄、あるいは閉塞は見られなかった。ステン
トでつながれた血管は開放されたまま保持され、6か列
後にも狭窄を示すん1拠は発見ごれなかった。配置され
た30個のステントのうち、29個は移動していなかっ
た。頭蓋の小さい静脈に配置された長いステ71−(5
,5cm)1つのみがおよそ2cm、配置後の最初の1
il1間に移動したが、それ以I−の移動は生じること
なく、この移動を原因とする問題は発生しなかった。
死後の検査では、ステントのワイヤが血管の壁に接触し
た部分の周囲で内皮の増殖が発生しているのが見られた
。配置に続く4週間経過までに、静脈のステントは大部
分(80%)細胞の増殖により覆われ、一方、動脈のス
テントは増殖か始まったばかり(30%)であった。1
2週間までに、ステントのワイヤが面性の壁に接触して
いるところでは、ステントのすべてが内皮細胞により覆
われた。6iJ旧111後でも、分岐につなげられたワ
イヤサイズには成長が見られなかった。加えて、血f6
ム(1′の腐食は見られず、ステントには凝血は全く見
られなかった。
た部分の周囲で内皮の増殖が発生しているのが見られた
。配置に続く4週間経過までに、静脈のステントは大部
分(80%)細胞の増殖により覆われ、一方、動脈のス
テントは増殖か始まったばかり(30%)であった。1
2週間までに、ステントのワイヤが面性の壁に接触して
いるところでは、ステントのすべてが内皮細胞により覆
われた。6iJ旧111後でも、分岐につなげられたワ
イヤサイズには成長が見られなかった。加えて、血f6
ム(1′の腐食は見られず、ステントには凝血は全く見
られなかった。
皮1+すを通して拡張Of能な内面性ステン]・は、ジ
グサクハターンに形成Sれたメンテン1/ヌ鋼ワイヤか
ら様々なCkWと長さで製造ijl能である。それらは
皮膚を通]7て動脈及び静脈に配置され、ニチノールコ
・イルを使用する場合のように氷水あるいは熱いII水
を必要としない(参考文献2.3)。
グサクハターンに形成Sれたメンテン1/ヌ鋼ワイヤか
ら様々なCkWと長さで製造ijl能である。それらは
皮膚を通]7て動脈及び静脈に配置され、ニチノールコ
・イルを使用する場合のように氷水あるいは熱いII水
を必要としない(参考文献2.3)。
ステン!・の拡張力は、ワイヤサイズ、ワイヤの折り畳
みの数、ステントの長さを操作することにより制御ll
l’T能である。拡張力はより大きなサイズのワイヤ
により増加可能であるが、そうすると押しつぶしたステ
ントを配置するためにより大きなさやを使用する必要が
ある。ワイヤの折り畳み回数を増加させ、ステントの長
きを減少させることも、拡張力を増加させる。それ故、
スレンレス鋼の血管ステントは長さ、直径及び拡張力に
関してはオーダーメイドが可能である。
みの数、ステントの長さを操作することにより制御ll
l’T能である。拡張力はより大きなサイズのワイヤ
により増加可能であるが、そうすると押しつぶしたステ
ントを配置するためにより大きなさやを使用する必要が
ある。ワイヤの折り畳み回数を増加させ、ステントの長
きを減少させることも、拡張力を増加させる。それ故、
スレンレス鋼の血管ステントは長さ、直径及び拡張力に
関してはオーダーメイドが可能である。
状況によっては複数のステントを使用することも可能で
ある。対象となる血管がステントの長さよりも長い場合
は、複数のステントをその端で少し重なり合う状態で順
次に配置することが可能である。加えて、1つのステン
トでは拡張力が不足する場合は、特定の場所で拡張力を
増加させるために1つを他の内部に配置することかり能
である。
ある。対象となる血管がステントの長さよりも長い場合
は、複数のステントをその端で少し重なり合う状態で順
次に配置することが可能である。加えて、1つのステン
トでは拡張力が不足する場合は、特定の場所で拡張力を
増加させるために1つを他の内部に配置することかり能
である。
血管の内部に配置した後、ステントは徐々に血管の内部
壁に接触し、その接触した部分において内皮の増殖によ
りワイヤが取巻かれた。このことは、血管システムが配
置された場所についてその他の研究において記述された
ことに類似している(参考文献2.3.4)。放射線学
的研究は、ステントを配置した1週間後までに移動を防
ぐために十分な内皮増殖が生じるが、この最初の週の間
に、確実にそうHえるわけではないか、移動のOf能P
1かある。配置の後1か月後、静脈のステントはおよそ
80%が内皮細胞により包まれ、一方、動脈のステント
は30%のみが包まれた。この差異はおそらく、動脈内
のfAeれと圧力が静脈より大きいためであろう。3か
月までに、血管の壁に接触しているステントワイヤはす
べて完全に内皮細胞に包み込まれた。この血管壁への包
み込みはプロトロンビン性を減少させるが(参考文献3
)、6か月後でも露出したステントワイヤの上に凝血を
発見できなかった。ワイヤの部分が血管の壁に接触して
いないところ、例えば、ステントが分岐をつなぐところ
では、細胞の成長は認められなかった。この観察は、内
血管のステンレス鋼ワイヤの使用に関する以前の報告書
に対応している(参考文献4)。それ故、ステントは分
岐点において閉塞や血管の狭窄を生じることなく他の血
管をつなぐことがnf能である。このことは他の形式の
内血管ステントについては報告されていない(参考文献
2.3)。このようにして、このステ〉ルス鋼ステント
は、これに適合する血管システムのとこにおいても配置
が可能である。6か月後でも、ステントを配置された面
省に狭窄は生じていない。これは、ステントワイヤにフ
ィブリンが堆積するために4週間以内に管腔の狭窄が生
じることを示したニチノール内血管ステントとは異なっ
ている(参考文献l、2.3)。ステンi・か除去され
た時点で凝血の形成は認められなかった。これは以前の
報告の結果に類似している(参考文献2,3)。血管の
腐食は見られなかった。
壁に接触し、その接触した部分において内皮の増殖によ
りワイヤが取巻かれた。このことは、血管システムが配
置された場所についてその他の研究において記述された
ことに類似している(参考文献2.3.4)。放射線学
的研究は、ステントを配置した1週間後までに移動を防
ぐために十分な内皮増殖が生じるが、この最初の週の間
に、確実にそうHえるわけではないか、移動のOf能P
1かある。配置の後1か月後、静脈のステントはおよそ
80%が内皮細胞により包まれ、一方、動脈のステント
は30%のみが包まれた。この差異はおそらく、動脈内
のfAeれと圧力が静脈より大きいためであろう。3か
月までに、血管の壁に接触しているステントワイヤはす
べて完全に内皮細胞に包み込まれた。この血管壁への包
み込みはプロトロンビン性を減少させるが(参考文献3
)、6か月後でも露出したステントワイヤの上に凝血を
発見できなかった。ワイヤの部分が血管の壁に接触して
いないところ、例えば、ステントが分岐をつなぐところ
では、細胞の成長は認められなかった。この観察は、内
血管のステンレス鋼ワイヤの使用に関する以前の報告書
に対応している(参考文献4)。それ故、ステントは分
岐点において閉塞や血管の狭窄を生じることなく他の血
管をつなぐことがnf能である。このことは他の形式の
内血管ステントについては報告されていない(参考文献
2.3)。このようにして、このステ〉ルス鋼ステント
は、これに適合する血管システムのとこにおいても配置
が可能である。6か月後でも、ステントを配置された面
省に狭窄は生じていない。これは、ステントワイヤにフ
ィブリンが堆積するために4週間以内に管腔の狭窄が生
じることを示したニチノール内血管ステントとは異なっ
ている(参考文献l、2.3)。ステンi・か除去され
た時点で凝血の形成は認められなかった。これは以前の
報告の結果に類似している(参考文献2,3)。血管の
腐食は見られなかった。
これはおそらく、血管が正常で、拡張可能なため、血管
の壁を抗するステンi・と力を減少させることができた
ためであろう。
の壁を抗するステンi・と力を減少させることができた
ためであろう。
この評価の結果から示されることは、これらのステント
は様々な医学的応用が発見されるべきである、というこ
とである。これらには、隣接する腫瘍により圧迫された
血管内の流れを再確0すること(大静脈症候群)、皮膚
を通しての膨張開放の後の血管の開放性の保持、及び不
完全な、長い不規則な血管の狭窄の修正、をも含み得る
。加えて、これらのステンI・は例えば、呼吸、胆汁、
泌球系の外部からのf5q ;I’l、腫瘍により弱体
化した構造を強化するためにも使用可能であり、尿管、
尿16 あるいはIIIの拡張された部分の膨張によ
る開放、動脈切開、動脈瘤、慟性の傷痕の局限化、を保
)Nすることにも使用可能である。
は様々な医学的応用が発見されるべきである、というこ
とである。これらには、隣接する腫瘍により圧迫された
血管内の流れを再確0すること(大静脈症候群)、皮膚
を通しての膨張開放の後の血管の開放性の保持、及び不
完全な、長い不規則な血管の狭窄の修正、をも含み得る
。加えて、これらのステンI・は例えば、呼吸、胆汁、
泌球系の外部からのf5q ;I’l、腫瘍により弱体
化した構造を強化するためにも使用可能であり、尿管、
尿16 あるいはIIIの拡張された部分の膨張によ
る開放、動脈切開、動脈瘤、慟性の傷痕の局限化、を保
)Nすることにも使用可能である。
第1図は1本発明の好ましい実施例の側面図である。
第2図は、第1図の構造の端の立面図である。
第3図I才、腫瘍が血管のサイズを派、ルさせているこ
とを・トす血管の断面図である。 第4図は、本発明のステントを挿入する方法の1段階奢
、Rす第3図に類似の断面図である。 第5図と第6図は、第4図に描かれた方法の継続する段
階を示す一連の断面図である。 第7図は、軟発明の他の実施例と調和した曲管内に置か
れた3つのステントを示す第6図に類似の断面図である
。 第8図は、本発明の方法の他の実施例に調和した重なり
合う様式で曲管内に置かれた4つのステントを示す第6
図と第7図に類似の断面図である。 第9図は、本発明の方法に使用されたさやの側面図であ
る。 第10図は、本発明の方法の一部としてさやの中に置か
れたスノテ/1・を示すさやの基部の断面図である。 9・・・ステント、lO・・・ワイヤ、11・・・スリ
ーブ、12・・・直線部分、13・・・曲がり、15・
・・管状カートリッジ、16・・・凹部、17・・・ア
ダプタ、20・・・さや、21・・・端の平らな推進器
。 ■ つD ・− ぐ D
とを・トす血管の断面図である。 第4図は、本発明のステントを挿入する方法の1段階奢
、Rす第3図に類似の断面図である。 第5図と第6図は、第4図に描かれた方法の継続する段
階を示す一連の断面図である。 第7図は、軟発明の他の実施例と調和した曲管内に置か
れた3つのステントを示す第6図に類似の断面図である
。 第8図は、本発明の方法の他の実施例に調和した重なり
合う様式で曲管内に置かれた4つのステントを示す第6
図と第7図に類似の断面図である。 第9図は、本発明の方法に使用されたさやの側面図であ
る。 第10図は、本発明の方法の一部としてさやの中に置か
れたスノテ/1・を示すさやの基部の断面図である。 9・・・ステント、lO・・・ワイヤ、11・・・スリ
ーブ、12・・・直線部分、13・・・曲がり、15・
・・管状カートリッジ、16・・・凹部、17・・・ア
ダプタ、20・・・さや、21・・・端の平らな推進器
。 ■ つD ・− ぐ D
Claims (10)
- (1)曲がりによって結合され閉じて連続した直線部分
を含む閉じたジグザグ構造に形成されたワイヤを備えて
成るステントにおいて、通路に挿入するために前記直線
部分が相互に密接に隣接して隣り合うように配置された
小さな第一形状へと前記ステントが弾力的に圧縮され、
前記直線部分が通路の壁に抗して通路を開放したまま保
持するように押しつけている第二形状へと弾力的に拡張
可能であることを特徴とするステント。 - (2)前記ステントをその内部に有する管状カートリッ
ジを追加的に備えて成り、前記ステントが弾力的に前記
小さな第一形状へと圧縮されることを特徴とする特許請
求の範囲第1項に記載の装置。 - (3)貫通する管腔を有するさやを追加的に備えて成り
、前記さやが前記管腔と同軸に配置されたアダプタ凹部
を有し、前記アダプタ凹部が前記管腔に比較して大きな
サイズを有し、閉じた端を有する可撓性部材が前記さや
の内部に適合するに十分に小さい外径を有するが、なお
前記さやの外へ前記ステントを押し出すに十分な大きさ
を有することを特徴とする特許請求の範囲第1項に記載
の装置。 - (4)前記ステンレス鋼ワイヤが外径0.018インチ
(0.045cm)であることを特徴とする特許請求の
範囲第1項に記載の装置。 - (5)前記ステントがその第二形状において長さ5.5
cm、直径4cmであることを特徴とする特許請求の範
囲第4項に記載のステント。 - (6)前記ステントがその第二形状において長さ3cm
、直径2.5cmであることを特徴とする特許請求の範
囲第4項に記載のステント。 - (7)前記曲がりが比較的鋭く、その半径が0.2cm
以下であることを特徴とする特許請求の範囲第4項に記
載のステント。 - (8)ステントを挿入する方法において、 閉じたジグザグ構造に形成されたワイヤを含むステント
を、ジグザグ構造が平行して密接に隣接する、応力によ
り曲がりによって結合された直線部分を含む第一形状に
圧縮し、 前記圧縮されたワイヤステントをさやの中へ移動させ、 圧縮されたワイヤを内部に有するさやの末端を通路の中
に配置し、 ステントをその場所に保持したまま通路からさやを除去
し、それによりステントの応力が通路を開いて開放した
まま保持するように通路の中でステントを拡張する方法
。 - (9)前記圧縮、移動、配置及び除去の段階により1つ
以上のステントが通路に配置され、前記1つ以上のステ
ントが重なり合うことを特徴とする特許請求の範囲第8
項に記載の方法。 - (10)前記圧縮、移動、配置及び除去の段階により1
つ以上のステントが通路に配置され、前記1つ以上のス
テントが通路の長さ方向に間隔を置いて配置されること
を特徴とする特許請求の範囲第8項に記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US06/656,261 US4580568A (en) | 1984-10-01 | 1984-10-01 | Percutaneous endovascular stent and method for insertion thereof |
US656261 | 1991-02-15 |
Publications (2)
Publication Number | Publication Date |
---|---|
JPS6187540A true JPS6187540A (ja) | 1986-05-02 |
JPH0432662B2 JPH0432662B2 (ja) | 1992-05-29 |
Family
ID=24632304
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP60219016A Granted JPS6187540A (ja) | 1984-10-01 | 1985-10-01 | 血管ステント |
Country Status (8)
Country | Link |
---|---|
US (1) | US4580568A (ja) |
EP (1) | EP0177330B1 (ja) |
JP (1) | JPS6187540A (ja) |
AT (1) | ATE64538T1 (ja) |
AU (1) | AU581464B2 (ja) |
CA (1) | CA1245527A (ja) |
DE (1) | DE3583276D1 (ja) |
DK (1) | DK166529B1 (ja) |
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JPS63230158A (ja) * | 1987-03-13 | 1988-09-26 | クック・インコーポレーテッド | 血管内ステント |
JPH0644910B2 (ja) * | 1987-03-13 | 1994-06-15 | クック・インコーポレーテッド | 血管内ステント |
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JPH023740U (ja) * | 1988-06-22 | 1990-01-11 | ||
JPH054806Y2 (ja) * | 1988-06-22 | 1993-02-08 | ||
JPH02172456A (ja) * | 1988-12-26 | 1990-07-04 | Kato Hatsujo Kaisha Ltd | 管状器官の治療器 |
JPH0556109U (ja) * | 1991-12-27 | 1993-07-27 | 泉工医科工業株式会社 | 気管の内径確保用器具及びその挿入用器具 |
JP2691074B2 (ja) * | 1992-01-15 | 1997-12-17 | クック・インコーポレーテッド | 螺旋型ステント |
US8287587B2 (en) | 2006-12-28 | 2012-10-16 | Terumo Kabushiki Kaisha | Self-expandable stent |
Also Published As
Publication number | Publication date |
---|---|
CA1245527A (en) | 1988-11-29 |
US4580568A (en) | 1986-04-08 |
AU4811385A (en) | 1986-04-10 |
ATE64538T1 (de) | 1991-07-15 |
DK445885D0 (da) | 1985-10-01 |
DE3583276D1 (de) | 1991-07-25 |
DK445885A (da) | 1986-04-02 |
DK166529B1 (da) | 1993-06-07 |
AU581464B2 (en) | 1989-02-23 |
JPH0432662B2 (ja) | 1992-05-29 |
EP0177330B1 (en) | 1991-06-19 |
EP0177330A2 (en) | 1986-04-09 |
EP0177330A3 (en) | 1986-09-24 |
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