JPH0432662B2 - - Google Patents
Info
- Publication number
- JPH0432662B2 JPH0432662B2 JP60219016A JP21901685A JPH0432662B2 JP H0432662 B2 JPH0432662 B2 JP H0432662B2 JP 60219016 A JP60219016 A JP 60219016A JP 21901685 A JP21901685 A JP 21901685A JP H0432662 B2 JPH0432662 B2 JP H0432662B2
- Authority
- JP
- Japan
- Prior art keywords
- stent
- sheath
- shape
- passageway
- lumen
- 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
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)
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通過する通路を開いたま
ま保持するための装置が提供されることが好まし
い。そのような状況は例えば動脈硬化症並びに腫
瘍などとして知られている血管を通過する血液の
流れを制限しあるいは停止させるような病気に関
連して生じる。チヤールズ・トツター博士その他
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
して配置されたコイルバネの末端動脈の管の接
合」ドツターその他、調査、放射線学、1969、
４〕329−332参照（参考文献１）。最近２つの研
究所が形状記憶合金、ニチノールにより製造され
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。ドツターその他の「管腔を通過する拡
張可能なニチノールコイルステント接合」、放射
線学、1983年４月、147：259−260（参考文献２）、
クラツグ・Ａその他の「外科手術によらない動脈
の内部プロテーゼの挿入」放射線学1983年４月；
147：261−263（参考文献３）参照。このようなス
テントは氷水あるいは加熱さ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
ステントワイヤの上にフイブリンが堆積するため
に管腔の狭窄を生じる。
張しあるいは管腔部分を通過する通路を開いたま
ま保持するための装置が提供されることが好まし
い。そのような状況は例えば動脈硬化症並びに腫
瘍などとして知られている血管を通過する血液の
流れを制限しあるいは停止させるような病気に関
連して生じる。チヤールズ・トツター博士その他
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
して配置されたコイルバネの末端動脈の管の接
合」ドツターその他、調査、放射線学、1969、
４〕329−332参照（参考文献１）。最近２つの研
究所が形状記憶合金、ニチノールにより製造され
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。ドツターその他の「管腔を通過する拡
張可能なニチノールコイルステント接合」、放射
線学、1983年４月、147：259−260（参考文献２）、
クラツグ・Ａその他の「外科手術によらない動脈
の内部プロテーゼの挿入」放射線学1983年４月；
147：261−263（参考文献３）参照。このようなス
テントは氷水あるいは加熱さ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
ステントワイヤの上にフイブリンが堆積するため
に管腔の狭窄を生じる。
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4124587号、第3868956号、第
4425908号、ソ連特許第978821号。以下の刊行物
も含む。Ｃ・ギアンツルコその他「新ベナ、サバ
フイルタ：実験動物の評価」放射線学、1980年12
月、137：835−837（参考文献４）、Ｍ・シモンそ
の他Ｔ形状記憶合金を使用したベナ・サバフイル
タ」診断放射線学、125：89−９、1977年10月
（参考文献５）。更にその他の刊行物は、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、152：659−663である。
国特許である。第4124587号、第3868956号、第
4425908号、ソ連特許第978821号。以下の刊行物
も含む。Ｃ・ギアンツルコその他「新ベナ、サバ
フイルタ：実験動物の評価」放射線学、1980年12
月、137：835−837（参考文献４）、Ｍ・シモンそ
の他Ｔ形状記憶合金を使用したベナ・サバフイル
タ」診断放射線学、125：89−９、1977年10月
（参考文献５）。更にその他の刊行物は、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、152：659−663である。
本発明の詳細な説明
本発明の目的は、配置及び使用が容易で、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。
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。
本発明は、多数の直線部分が互に屈曲部により
接続されてジグザグ構造の閉ループに形成された
ワイヤから成り、弾性的に圧縮された時、上記直
線部分が互に並列的に密接する第１の形状を成し
て通路に挿入可能となり、前記屈曲部が弾性復帰
力を有し、該屈曲部の弾性復帰力を解放した時、
弾性的に拡開して第２の形状となし、前記通路の
壁を押して該通路を開放状態に維持することがで
きるステントを提供する。
接続されてジグザグ構造の閉ループに形成された
ワイヤから成り、弾性的に圧縮された時、上記直
線部分が互に並列的に密接する第１の形状を成し
て通路に挿入可能となり、前記屈曲部が弾性復帰
力を有し、該屈曲部の弾性復帰力を解放した時、
弾性的に拡開して第２の形状となし、前記通路の
壁を押して該通路を開放状態に維持することがで
きるステントを提供する。
図面を参照しつつ、本発明の実施例を説明す
る。ジグザグの構造の閉ループに形成されたステ
ンレス鋼のワイヤ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、連続構造の閉ループを作り出すために
ワイヤの端を溶接あるいはさや１１による締めつ
けにより閉じられている。第４図を見ると、直線
部分１２が相互に密接に隣接して配置されたステ
ントが弾力的に圧縮された第一形状を示してい
る。
る。ジグザグの構造の閉ループに形成されたステ
ンレス鋼のワイヤ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、連続構造の閉ループを作り出すために
ワイヤの端を溶接あるいはさや１１による締めつ
けにより閉じられている。第４図を見ると、直線
部分１２が相互に密接に隣接して配置されたステ
ントが弾力的に圧縮された第一形状を示してい
る。
ステントと直線部分１２は比較的鋭い屈曲部１
３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、屈曲部１３
は曲率半径は0.2cm以下である。本発明のこの特
定の実施例は、ステンレス鋼の外径が0.018イン
チ（0.46mm）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
形状へと拡張可能であり、ここでは、直線部分１
２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。
３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、屈曲部１３
は曲率半径は0.2cm以下である。本発明のこの特
定の実施例は、ステンレス鋼の外径が0.018イン
チ（0.46mm）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
形状へと拡張可能であり、ここでは、直線部分１
２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。
本発明の方法を実行するために、ステントは第
１０図に描かれた第一形状に圧縮され、管状カー
トリツジ１５内に配置される（第１０図）。カー
トリツジ１５はさや２０のアダプタ１７にある凹
部１６へ挿入される。それからステントは端の平
らな推進器２１の助けによりさや２０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、端の平らな可撓性のあ
る金属棒が好ましい。第４図に示されているよう
に、ステント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
必要がある場合は、ステントが追加能であり、上
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つて血管内に
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。
１０図に描かれた第一形状に圧縮され、管状カー
トリツジ１５内に配置される（第１０図）。カー
トリツジ１５はさや２０のアダプタ１７にある凹
部１６へ挿入される。それからステントは端の平
らな推進器２１の助けによりさや２０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、端の平らな可撓性のあ
る金属棒が好ましい。第４図に示されているよう
に、ステント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
必要がある場合は、ステントが追加能であり、上
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つて血管内に
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2.5
cm）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インチ即ち0.46mm）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、プロトロンビン
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（体重18−
27Kg）が使用された。これらの犬はi.v.ナトリウ
ムペントバルビタール（ネムブタル；30mg／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、テーパチツプを有する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、対象となつている場所への前
進を蛍光透視法によりモニタした。ステントは圧
縮され、８フレンチさやのアダプタの内部に適合
する８フレンチカートリツ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ツ
ジはさやアダプタの内部に配置され、ステントは
８フレンチポリエレン管によりさやを通つて前進
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き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されるためである。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
に配置される（表）。配置の後に続いて、配置
直後と１週間後とに血管撮影が行われ、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
された。犬は研究の最後に深いネムブタルの麻酔
をかけられ安楽死させられ、完全な死体解剖が実
行された。
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2.5
cm）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インチ即ち0.46mm）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、プロトロンビン
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（体重18−
27Kg）が使用された。これらの犬はi.v.ナトリウ
ムペントバルビタール（ネムブタル；30mg／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、テーパチツプを有する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、対象となつている場所への前
進を蛍光透視法によりモニタした。ステントは圧
縮され、８フレンチさやのアダプタの内部に適合
する８フレンチカートリツ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ツ
ジはさやアダプタの内部に配置され、ステントは
８フレンチポリエレン管によりさやを通つて前進
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き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されるためである。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
に配置される（表）。配置の後に続いて、配置
直後と１週間後とに血管撮影が行われ、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
された。犬は研究の最後に深いネムブタルの麻酔
をかけられ安楽死させられ、完全な死体解剖が実
行された。
表：５匹の犬への血管ステントの配置の要約
犬 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（AA）に配置された。
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、右の心房のレベルで１つは内部に他は
大静脈（SVC）に配置された。
大静脈（SVC）に配置された。
１つ、両方の腎臓の動脈をつなぐ小さい静脈
（IVC）に配置された。
（IVC）に配置された。
ステントサイズ3.0cm、使用個数３個。
血管配置……１つ、SVCの上８cmの右頚部
に配置された。
に配置された。
２つ、１つは内部に、他はSVCの上８cmの
左頚部に配置された。
左頚部に配置された。
犬 ステントサイズ5.5cm、 期間
355 使用個数、３個 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。
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IVCに配置された。
をつなぐIVC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つは右心房の上2.3cmのレベルに
配置された。
に、そして１つは右心房の上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。
臓の動脈をつなぐAAに配置された。
１つ、両方の腎臓の静脈をつなぐIVCに配置
された。
された。
犬 ステントサイズ5.5cm、 期間
505 使用個数、５個 ５か月
血管配置……４つ、順次にダイヤフラム（Ｔ
１１）から始まりＬ５で終るAAに配置され
た。
１１）から始まりＬ５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ある最後の長
いステントの内部に配置された。
いステントの内部に配置された。
２つ、順次に肝臓と腎臓の静脈の間にある
IVCの内部に配置された。
IVCの内部に配置された。
血管ステントを配置することには何の困難も生
じなかつた。それらは使用が容易で、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、ステン
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。
じなかつた。それらは使用が容易で、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、ステン
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、流れ
の障害、管腔の狭窄、あるいは閉塞は見られなか
つた。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か月後にも狭窄を示す証拠は発見
されなかつた。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つた。頭蓋の小さい静
脈に配置された長いステント（5.5cm）１つのみ
がおよそ２cm、配置後の最初の１週間に移動した
が、それ以上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つた。
の障害、管腔の狭窄、あるいは閉塞は見られなか
つた。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か月後にも狭窄を示す証拠は発見
されなかつた。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つた。頭蓋の小さい静
脈に配置された長いステント（5.5cm）１つのみ
がおよそ２cm、配置後の最初の１週間に移動した
が、それ以上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つた。
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が始
まつたばかり（30％）であつた。12週間までに、
ステントのワイヤが血管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。６週間後でも、分岐につなげられたワイヤ
部分には成長が見られなかつた。加えて、血管壁
の腐食は見られず、ステントには凝血は全く見ら
れなかつた。
に接触した部分の周囲で内皮の増殖がが発生して
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が始
まつたばかり（30％）であつた。12週間までに、
ステントのワイヤが血管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。６週間後でも、分岐につなげられたワイヤ
部分には成長が見られなかつた。加えて、血管壁
の腐食は見られず、ステントには凝血は全く見ら
れなかつた。
皮膚を通して拡張可能な内血管ステントは、ジ
グザグパターンに形成されたステンレス鋼ワイヤ
から様々な直径と長さで製造可能である。それら
は皮膚を通し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
熱い塩水を必要としない（参考文献２、３）。ス
テントの拡張力は、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
制御可能である。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、ステントの長さを減少させることも、
拡張力を増加させる。それ故、ステンレス鋼の血
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。
グザグパターンに形成されたステンレス鋼ワイヤ
から様々な直径と長さで製造可能である。それら
は皮膚を通し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
熱い塩水を必要としない（参考文献２、３）。ス
テントの拡張力は、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
制御可能である。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、ステントの長さを減少させることも、
拡張力を増加させる。それ故、ステンレス鋼の血
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。
状況によつ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が可能であ
る。
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が可能であ
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、確実にそう言えるわけではないが、移動の可
能性がある。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、動脈内の流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
見できなかつた。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つ
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
ぐことが可能である。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、このステンレス鋼
ステントは、これに適合する血管システムのどこ
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血管に狭窄は生じていない。
これは、ステントワイヤにフイブリンが堆積する
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つている
（参考文献１、２、３）。ステントが除去された時
点で凝血の形成は認められなかつた。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つた。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
るステントと力を減少させることができたためで
あろう。
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、確実にそう言えるわけではないが、移動の可
能性がある。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、動脈内の流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
見できなかつた。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つ
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
ぐことが可能である。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、このステンレス鋼
ステントは、これに適合する血管システムのどこ
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血管に狭窄は生じていない。
これは、ステントワイヤにフイブリンが堆積する
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つている
（参考文献１、２、３）。ステントが除去された時
点で凝血の形成は認められなかつた。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つた。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
るステント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立する
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、これらのステントは例えば、呼吸、胆汁、泌
尿系の外部からの圧迫、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
道、あるいは腸の拡張された部分の膨張による開
放、動脈切開、動脈瘤、慢性の傷痕の局限化、を
保持することにも使用可能である。
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立する
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、これらのステントは例えば、呼吸、胆汁、泌
尿系の外部からの圧迫、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
道、あるいは腸の拡張された部分の膨張による開
放、動脈切開、動脈瘤、慢性の傷痕の局限化、を
保持することにも使用可能である。
第１図は、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図は、腫瘍が血管のサイズを減少させて
いることを示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段階を示す
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
一速の断面図である。第７図は、本発明の他の実
施例と調和した血管内に置かれた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
様式で血管内に置かれた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
に置かれたスンテントを示すさやの基部の断面図
である。 ９……ステント、１０……ワイヤ、１１……ス
リーブ、１２……直線部分、１３……屈曲部、１
５……管状カートリツジ、１６……凹部、１７…
…アダプタ、２０……さや、２１……端の平らな
推進器。
ある。第２図は、第１図の構造の端の立面図であ
る。第３図は、腫瘍が血管のサイズを減少させて
いることを示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段階を示す
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
一速の断面図である。第７図は、本発明の他の実
施例と調和した血管内に置かれた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
様式で血管内に置かれた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
に置かれたスンテントを示すさやの基部の断面図
である。 ９……ステント、１０……ワイヤ、１１……ス
リーブ、１２……直線部分、１３……屈曲部、１
５……管状カートリツジ、１６……凹部、１７…
…アダプタ、２０……さや、２１……端の平らな
推進器。
Claims (1)
- 【特許請求の範囲】 １ 多数の直線部分が互に屈曲部により接続され
てジグザグ構造の閉ループに形成されたワイヤか
ら成り、弾性的に圧縮された時、上記直線部分が
互に並列的に密接する第１の形状を成して通路に
挿入可能となり、前記屈曲部が弾性復帰力を有
し、該屈曲部の弾性復帰力を解放した時、弾性的
に拡開して第２の形状となし、前記通路の壁を押
して該通路を開放状態に維持することができるス
テント。 ２ 前記第１の形状に圧縮されて管状カートリツ
ジに挿入される特許請求の範囲第１項のステン
ト。 ３ 貫通する管腔および該管腔と共軸で該管腔よ
り直径の大きなアダプタ凹部を該管腔の一端に有
するさやの該凹部に、前記第１の形状のステント
を内蔵する前記管状カートリツジを挿入し、閉じ
た端を有する可撓性部材を前記管状カートリツジ
に挿入して前記管腔を貫通させることにより前記
管状カートリツジから前記さやを貫通して押出さ
れる特許請求の範囲第２項のステント。 ４ 前記ワイヤが外形0.018インチ（0.46mm）の
ステンレス鋼ワイヤ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 前記第二形状において長さ5.5cm、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 前記屈曲部が比較的鋭く、その曲率半径が
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。
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 | 1984-10-01 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JPS6187540A JPS6187540A (ja) | 1986-05-02 |
| JPH0432662B2 true 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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- 1985-09-30 AU AU48113/85A patent/AU581464B2/en not_active Expired
- 1985-10-01 AT AT85307008T patent/ATE64538T1/de not_active IP Right Cessation
- 1985-10-01 EP EP85307008A patent/EP0177330B1/en not_active Expired - Lifetime
- 1985-10-01 JP JP60219016A patent/JPS6187540A/ja active Granted
- 1985-10-01 DK DK445885A patent/DK166529B1/da not_active IP Right Cessation
- 1985-10-01 DE DE8585307008T patent/DE3583276D1/de not_active Expired - Lifetime
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| EP1051953A2 (en) | 1994-06-17 | 2000-11-15 | Terumo Kabushiki Kaisha | Indwelling stent and the method for manufacturing the same |
| JP4889151B2 (ja) * | 1998-09-08 | 2012-03-07 | 株式会社 京都医療設計 | 脈管用ステント |
| WO2008081870A1 (ja) | 2006-12-28 | 2008-07-10 | Terumo Kabushiki Kaisha | 自己拡張型ステント |
Also Published As
| Publication number | Publication date |
|---|---|
| EP0177330B1 (en) | 1991-06-19 |
| DK166529B1 (da) | 1993-06-07 |
| DE3583276D1 (de) | 1991-07-25 |
| EP0177330A2 (en) | 1986-04-09 |
| AU581464B2 (en) | 1989-02-23 |
| US4580568A (en) | 1986-04-08 |
| DK445885A (da) | 1986-04-02 |
| JPS6187540A (ja) | 1986-05-02 |
| EP0177330A3 (en) | 1986-09-24 |
| CA1245527A (en) | 1988-11-29 |
| DK445885D0 (da) | 1985-10-01 |
| ATE64538T1 (de) | 1991-07-15 |
| AU4811385A (en) | 1986-04-10 |
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