JPH01145076A - 血管内で放射状に膨脹可能なステント及びその移植装置 - Google Patents
血管内で放射状に膨脹可能なステント及びその移植装置Info
- Publication number
- JPH01145076A JPH01145076A JP63262677A JP26267788A JPH01145076A JP H01145076 A JPH01145076 A JP H01145076A JP 63262677 A JP63262677 A JP 63262677A JP 26267788 A JP26267788 A JP 26267788A JP H01145076 A JPH01145076 A JP H01145076A
- Authority
- JP
- Japan
- Prior art keywords
- stent
- balloon
- wire
- blood vessel
- band
- 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
- 238000000034 method Methods 0.000 title claims abstract description 27
- 210000004204 blood vessel Anatomy 0.000 title claims description 17
- 238000002054 transplantation Methods 0.000 title 1
- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 claims abstract description 6
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 claims abstract description 6
- 239000010931 gold Substances 0.000 claims abstract description 6
- 229910052737 gold Inorganic materials 0.000 claims abstract description 6
- 239000010936 titanium Substances 0.000 claims abstract description 6
- 229910052719 titanium Inorganic materials 0.000 claims abstract description 6
- 239000010935 stainless steel Substances 0.000 claims abstract description 4
- 229910001220 stainless steel Inorganic materials 0.000 claims abstract description 4
- 239000000463 material Substances 0.000 claims abstract description 3
- 238000004804 winding Methods 0.000 claims abstract 7
- 238000002513 implantation Methods 0.000 claims description 11
- 229910000881 Cu alloy Inorganic materials 0.000 claims description 4
- 238000002399 angioplasty Methods 0.000 description 12
- 229910052751 metal Inorganic materials 0.000 description 5
- 239000002184 metal Substances 0.000 description 5
- 208000027418 Wounds and injury Diseases 0.000 description 4
- 208000037803 restenosis Diseases 0.000 description 4
- 208000007536 Thrombosis Diseases 0.000 description 3
- 230000006870 function Effects 0.000 description 3
- 238000003780 insertion Methods 0.000 description 3
- 230000037431 insertion Effects 0.000 description 3
- 229920000728 polyester Polymers 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- 230000002792 vascular Effects 0.000 description 3
- RYGMFSIKBFXOCR-UHFFFAOYSA-N Copper Chemical compound [Cu] RYGMFSIKBFXOCR-UHFFFAOYSA-N 0.000 description 2
- 241001465754 Metazoa Species 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000017531 blood circulation Effects 0.000 description 2
- 238000010276 construction Methods 0.000 description 2
- 238000002224 dissection Methods 0.000 description 2
- 238000002474 experimental method Methods 0.000 description 2
- 230000035876 healing Effects 0.000 description 2
- 238000010561 standard procedure Methods 0.000 description 2
- 206010002329 Aneurysm Diseases 0.000 description 1
- 208000002251 Dissecting Aneurysm Diseases 0.000 description 1
- 241000282887 Suidae Species 0.000 description 1
- 239000004809 Teflon Substances 0.000 description 1
- 229920006362 Teflon® Polymers 0.000 description 1
- 230000033115 angiogenesis Effects 0.000 description 1
- 206010002895 aortic dissection Diseases 0.000 description 1
- 210000001367 artery Anatomy 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 210000000988 bone and bone Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 239000013505 freshwater Substances 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 210000000936 intestine Anatomy 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 235000015277 pork Nutrition 0.000 description 1
- 230000002028 premature Effects 0.000 description 1
- 230000000717 retained effect Effects 0.000 description 1
- 229920000260 silastic Polymers 0.000 description 1
- 238000009751 slip forming Methods 0.000 description 1
- 230000035899 viability Effects 0.000 description 1
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
- A61F2/82—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
- A61F2/88—Stents 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
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B21—MECHANICAL METAL-WORKING WITHOUT ESSENTIALLY REMOVING MATERIAL; PUNCHING METAL
- B21F—WORKING OR PROCESSING OF METAL WIRE
- B21F45/00—Wire-working in the manufacture of other particular articles
- B21F45/008—Wire-working in the manufacture of other particular articles of medical instruments, e.g. stents, corneal rings
-
- 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
- A61F2/958—Inflatable balloons for placing stents or stent-grafts
-
- 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
- A61F2002/825—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having longitudinal struts
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00017—Iron- or Fe-based alloys, e.g. stainless steel
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00023—Titanium or titanium-based alloys, e.g. Ti-Ni alloys
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00077—Copper or Cu-based alloys
-
- 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
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00011—Metals or alloys
- A61F2310/00035—Other metals or alloys
- A61F2310/00155—Gold or Au-based alloys
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】
発明の分野
本発明は、人間及び動物において血管の開存性(pat
ency)を維持する血管内の移植に関する。本発明は
、基本的に円筒形状のデバイスを形成する先端の開いた
ワイヤを具え、軟質のスプリング型金属でつくられ、米
国特許第4.195゜637号及び米国特許第4.44
02.307号に記載されたような典型的な気球(ba
llo。
ency)を維持する血管内の移植に関する。本発明は
、基本的に円筒形状のデバイスを形成する先端の開いた
ワイヤを具え、軟質のスプリング型金属でつくられ、米
国特許第4.195゜637号及び米国特許第4.44
02.307号に記載されたような典型的な気球(ba
llo。
n)形カテーテルの膨脹可能な素子に適合される。
ワイヤ形成デバイスは、永久的な人工器管ステントとし
て作用させようとするものであり、管腔に移植される。
て作用させようとするものであり、管腔に移植される。
特に、本発明は、経皮的に導入された後放射状に私服さ
れ、管腔に移動され、所望の位置に配置される血管内の
ステントの能力を具えることを特徴とする。
れ、管腔に移動され、所望の位置に配置される血管内の
ステントの能力を具えることを特徴とする。
更に、本発明は移植方法に関するものであり、それによ
り永久的な人工器管ステントは、血管形成移植処置(a
ngioplasty procedure)が実行
されると同時に移植される。本発明は、特に、心臓学の
分野のステントの管腔移植に有用である。
り永久的な人工器管ステントは、血管形成移植処置(a
ngioplasty procedure)が実行
されると同時に移植される。本発明は、特に、心臓学の
分野のステントの管腔移植に有用である。
発明の背景
米国特許第4.649.992号において、部分的にふ
くらんだ気球(balloon)と、カテーテルシャフ
ト上の気球のすぐ後の接合部との間に保持される基本的
に圧縮スプリングであるカテーテルと組合せたデバイス
が説明されている。
くらんだ気球(balloon)と、カテーテルシャフ
ト上の気球のすぐ後の接合部との間に保持される基本的
に圧縮スプリングであるカテーテルと組合せたデバイス
が説明されている。
ステントは、所望の位置にこの方法でスプリング補綴を
輸送するためであり、次に、有効な血管形成手順の後で
前記膨脹した気球を全体的に退避させることによって前
記スプリング補綴を解放し、かくして、前記スプリング
補綴が直線的に膨脹することを可能にし、気球(バルー
ン)カテーテルが取出される間適当な位置に留る。この
方法は、全く簡単であり、その簡単さは、極めて魅力的
であるが、しかし、幾つかの欠点を有している。先づ第
1に、スプリングは、固定された直径を有しており、所
々で全く曲りくねっているので、おそらく幾分血液の乱
流を発生することができ、血栓症は、ある場合の結果に
おいて可能となる。他の特許即ち、米国特許第4,55
3,545号は、比較的複雑な機械的回転デバイス及び
同軸ケーブルが、必要な手段を達成するのに使用され、
移植する点において移植ステントの直径を大きな寸法に
変更する、異なる方法を教示している。更に、他の特許
即ち米国特許筒3,868,956号は、温度応動金属
デバイスが、適用され、外部加熱源を使用して移植後、
膨脹される方法を説明している。前述したデバイスのす
べては、血液凝固及び可能な血栓症、手順の相当な複雑
さを含む種々の量の欠点を与える。この時点の血管形成
手順において、多くの場合、再発狭窄症がその後間もな
く起り、2次的処置又は外科的側管(bypass)手
術を必要とする。ここに記述したような移植人工層管は
、かような追加の手順を排除し、血管の開通性を無限に
維持するであろう。
輸送するためであり、次に、有効な血管形成手順の後で
前記膨脹した気球を全体的に退避させることによって前
記スプリング補綴を解放し、かくして、前記スプリング
補綴が直線的に膨脹することを可能にし、気球(バルー
ン)カテーテルが取出される間適当な位置に留る。この
方法は、全く簡単であり、その簡単さは、極めて魅力的
であるが、しかし、幾つかの欠点を有している。先づ第
1に、スプリングは、固定された直径を有しており、所
々で全く曲りくねっているので、おそらく幾分血液の乱
流を発生することができ、血栓症は、ある場合の結果に
おいて可能となる。他の特許即ち、米国特許第4,55
3,545号は、比較的複雑な機械的回転デバイス及び
同軸ケーブルが、必要な手段を達成するのに使用され、
移植する点において移植ステントの直径を大きな寸法に
変更する、異なる方法を教示している。更に、他の特許
即ち米国特許筒3,868,956号は、温度応動金属
デバイスが、適用され、外部加熱源を使用して移植後、
膨脹される方法を説明している。前述したデバイスのす
べては、血液凝固及び可能な血栓症、手順の相当な複雑
さを含む種々の量の欠点を与える。この時点の血管形成
手順において、多くの場合、再発狭窄症がその後間もな
く起り、2次的処置又は外科的側管(bypass)手
術を必要とする。ここに記述したような移植人工層管は
、かような追加の手順を排除し、血管の開通性を無限に
維持するであろう。
使用されるサイズに依存して、本発明によるステントは
、他の応用においても有効である。即ち、動脈瘤の治癒
、人工的脈管又は脈管の内張りの支持、解剖の初期治癒
及び通過の遅い脈管の虚脱を防ぐ支持、等の応用である
。他の多くの同様な応用が、基本的な前提及び概念から
逸脱することなく本発明により満足されるであろう。
、他の応用においても有効である。即ち、動脈瘤の治癒
、人工的脈管又は脈管の内張りの支持、解剖の初期治癒
及び通過の遅い脈管の虚脱を防ぐ支持、等の応用である
。他の多くの同様な応用が、基本的な前提及び概念から
逸脱することなく本発明により満足されるであろう。
このステント及びその使用方法は、特に、本質的な血管
形成と、再発狭窄を防止するように設計され意図された
永久的な人工層管の同時移植を結合させる単一の手順を
可能にし、更に、それより起る複雑さは、患者に対する
危険要素と損傷とを減少する。
形成と、再発狭窄を防止するように設計され意図された
永久的な人工層管の同時移植を結合させる単一の手順を
可能にし、更に、それより起る複雑さは、患者に対する
危険要素と損傷とを減少する。
他の参照刊行物
1、小さな脈管用の自己膨脂金属ステント放射線医学(
Radiology)162.P469〜472 2、小さな脈管用の柔軟なバルーン膨脂可能なステント
放射線医学(Radiology )jan、87゜ 3、管腔の血管形成移植後閉塞及び再発狭窄症を防止す
る血管内ステント N、E、J、of M 1987 3月19日4、
米国特許筒4.580,568号 経皮的な血管内(endovascular)ステント 5、米国特許筒4,503.569号 管腔に配置される豚腸可能な移植人工層管6、米国特許
筒4.649.992号 可能直径先端及びスプリング人工層管を有するカテーテ
ル配置、Wiktor 19877、米国特許筒4,
681.110号 カテーテル配置及び血管ライナー、Wiktor 1
987 前記引例のすべては、本発明においてここに説明した1
つと同様な応用に対する異なる型及び設計のステントを
提供するか又は導入する種々の方法を説明し教示してい
る。
Radiology)162.P469〜472 2、小さな脈管用の柔軟なバルーン膨脂可能なステント
放射線医学(Radiology )jan、87゜ 3、管腔の血管形成移植後閉塞及び再発狭窄症を防止す
る血管内ステント N、E、J、of M 1987 3月19日4、
米国特許筒4.580,568号 経皮的な血管内(endovascular)ステント 5、米国特許筒4,503.569号 管腔に配置される豚腸可能な移植人工層管6、米国特許
筒4.649.992号 可能直径先端及びスプリング人工層管を有するカテーテ
ル配置、Wiktor 19877、米国特許筒4,
681.110号 カテーテル配置及び血管ライナー、Wiktor 1
987 前記引例のすべては、本発明においてここに説明した1
つと同様な応用に対する異なる型及び設計のステントを
提供するか又は導入する種々の方法を説明し教示してい
る。
発明の要約
前記の特許、特に米国特許筒4. 649. 992号
に説明した先の本発明に設置されると同様な他のデバイ
ス以上の本発明の改良点は、極めて低い側面と小さな前
部面積、従って経皮的な挿入の目的に極めて重要性を考
慮して維持するのが本発明デバイスの能力である。かく
して、本発明のステントは、USCI Cat #
006128のような標準的な#8F誘導カテーテル即
ちそれは標準的な手順及び方法を使用している、を介し
て挿入され移動されることができる。ひとたび位置が選
定されると、ステントは、最初に導入されたより大きな
直径に放射状に膨脹され得る。2番:1の比は、o、o
osインチのワイヤ直径と0゜075インチの最初のス
テント直径により容易に達成できる。膨脹した大きな直
径は、血管内側に適合し、内壁と密接な接触を維持する
。本発明のステントは、ワイヤ用に使用される比較的容
易に変形し得る金属の低記憶レベルを特徴とする。
に説明した先の本発明に設置されると同様な他のデバイ
ス以上の本発明の改良点は、極めて低い側面と小さな前
部面積、従って経皮的な挿入の目的に極めて重要性を考
慮して維持するのが本発明デバイスの能力である。かく
して、本発明のステントは、USCI Cat #
006128のような標準的な#8F誘導カテーテル即
ちそれは標準的な手順及び方法を使用している、を介し
て挿入され移動されることができる。ひとたび位置が選
定されると、ステントは、最初に導入されたより大きな
直径に放射状に膨脹され得る。2番:1の比は、o、o
osインチのワイヤ直径と0゜075インチの最初のス
テント直径により容易に達成できる。膨脹した大きな直
径は、血管内側に適合し、内壁と密接な接触を維持する
。本発明のステントは、ワイヤ用に使用される比較的容
易に変形し得る金属の低記憶レベルを特徴とする。
発明の概要
血管のステントとして使用されるデバイスは、銅合金、
チタニウム又は金のような低記憶(l。
チタニウム又は金のような低記憶(l。
w−memory)金属でつくられる円筒状の制限なし
のワイヤ成分を具え、そこに移植された後血管内から放
射状の支持を与える。冠状動脈のステントは、初期の挿
人後大きな直径に放射状に膨脹される能力と、前記ステ
ントを大きな直径に膨脹させる手段と、かような冠状動
脈のステントを管腔に移動させ、配置し、移植する方法
と、前記ステントを永久的な人工層管として作用させ、
豚骨の開通性を保証すること、とを特徴とする。また、
同時に血管形−成移植及びステント移植手順の方法をも
提供する。
のワイヤ成分を具え、そこに移植された後血管内から放
射状の支持を与える。冠状動脈のステントは、初期の挿
人後大きな直径に放射状に膨脹される能力と、前記ステ
ントを大きな直径に膨脹させる手段と、かような冠状動
脈のステントを管腔に移動させ、配置し、移植する方法
と、前記ステントを永久的な人工層管として作用させ、
豚骨の開通性を保証すること、とを特徴とする。また、
同時に血管形−成移植及びステント移植手順の方法をも
提供する。
発明の詳細な説明
第1図に示すようなステントlの構成は、次の通りであ
る。即ち、ワイヤ2は、最初2次元ジグザグ形3、基本
的には平らな膨張可能なバンド(band)3aをつく
る形に予備成形される。ジグザグ形(パターン)は、反
対方向の曲り(bend)の形及び結びに関して変化し
得るが、簡単な記述のために、典型的な正弦波形式は、
このバンド(b a n d)構造を説明するのに選ば
れる。
る。即ち、ワイヤ2は、最初2次元ジグザグ形3、基本
的には平らな膨張可能なバンド(band)3aをつく
る形に予備成形される。ジグザグ形(パターン)は、反
対方向の曲り(bend)の形及び結びに関して変化し
得るが、簡単な記述のために、典型的な正弦波形式は、
このバンド(b a n d)構造を説明するのに選ば
れる。
ステント1をつくり、第1図に示すような最初の構成を
想定し、また、第5図に示すような連続的に放射状に膨
脹した状態を考えるために、予備成形したバンド3aの
長さは、第1図に示したような簡単な螺旋スプリングを
巻回すると同様な方法で適当な心棒4上に巻かれる。心
棒4のまわりに平らにワイヤバンド3aを形成するため
に取られる注意は、バンド3aの早すぎる直線膨張を防
ぐために殆んど又は全く張力をなくすことである。
想定し、また、第5図に示すような連続的に放射状に膨
脹した状態を考えるために、予備成形したバンド3aの
長さは、第1図に示したような簡単な螺旋スプリングを
巻回すると同様な方法で適当な心棒4上に巻かれる。心
棒4のまわりに平らにワイヤバンド3aを形成するため
に取られる注意は、バンド3aの早すぎる直線膨張を防
ぐために殆んど又は全く張力をなくすことである。
ひとたびジグザグバンドが円筒形状に巻かれると、心棒
から除去され、第2図の如く典型的に血管形成手順に使
用されるふくらました気球(バルーン)5のような適当
な可変直径デバイス上に置かれる。適当な総形バイト(
forming tool)(図示せず)が、バルー
ン上にステントを固く締めるのに使用され、バルーン上
のステントを締めつける手動操作がまた受は入れられる
。
から除去され、第2図の如く典型的に血管形成手順に使
用されるふくらました気球(バルーン)5のような適当
な可変直径デバイス上に置かれる。適当な総形バイト(
forming tool)(図示せず)が、バルー
ン上にステントを固く締めるのに使用され、バルーン上
のステントを締めつける手動操作がまた受は入れられる
。
ステントの制御された放射状の膨脹は、ふくらんだバル
ーンにより発生される力によって達成される。膨脹した
バルーンにより作用される時に、本発明のステントは、
先の開いた円筒形に連続的に形成されたジグザグ状の予
備成形ワイヤバンド3aが設計により放射状に膨脹し得
るようになっている。
ーンにより発生される力によって達成される。膨脹した
バルーンにより作用される時に、本発明のステントは、
先の開いた円筒形に連続的に形成されたジグザグ状の予
備成形ワイヤバンド3aが設計により放射状に膨脹し得
るようになっている。
事実上、放射状の膨張は、予備成形ワイヤバンド3aの
正弦波状パターンに印加される制御変形及び張力により
達成される。ワイヤ形成ステントの製造に使用される低
記憶(メモリ)金属は、放射状に膨脹したステントが膨
張状態にとどまりその主たる意図及び機能を実行する。
正弦波状パターンに印加される制御変形及び張力により
達成される。ワイヤ形成ステントの製造に使用される低
記憶(メモリ)金属は、放射状に膨脹したステントが膨
張状態にとどまりその主たる意図及び機能を実行する。
先に述べた参照刊行物1〜7上の本発明の利点は、血管
内に冠状動脈内のステントに対する優れた組合せにより
固有の膨脹後の放射状の剛性及び直線的柔軟性である。
内に冠状動脈内のステントに対する優れた組合せにより
固有の膨脹後の放射状の剛性及び直線的柔軟性である。
冠状動脈に適用する場合、最優先の要素は、極めて低い
側面と非常に小さい前部面積を考慮しているので、標準
8F誘導カテーテルを介して最初に管腔導入及び移動さ
せるのに極めて本質的なものとなる。
側面と非常に小さい前部面積を考慮しているので、標準
8F誘導カテーテルを介して最初に管腔導入及び移動さ
せるのに極めて本質的なものとなる。
本発明の主たる目的は、予備成形された柔軟性ワイヤス
テントを具え、容易に放射状の膨脹を可能にし、血管内
によく固着され放射状に膨脹した形状を連続して維持さ
せることである。
テントを具え、容易に放射状の膨脹を可能にし、血管内
によく固着され放射状に膨脹した形状を連続して維持さ
せることである。
更に、本発明の他の目的は、その適用の簡単さであり、
特に血管形成に関し、1つの手順が2つの異なる機能を
達成させることである。バルーンとの組合せにおいて、
それは、プラク(plaqus)を圧縮し、かくして、
血管形成を特徴とする内腔をつくり出し、新しくつくら
れた管腔内に永久式な人工層管を配置して移植し、可能
な再閉鎖及び再発狭窄症を防止し、かくして血液の自由
な流れを無限に可能にする。両機能は、単一のカテーテ
ルの挿入と同時に実行される。
特に血管形成に関し、1つの手順が2つの異なる機能を
達成させることである。バルーンとの組合せにおいて、
それは、プラク(plaqus)を圧縮し、かくして、
血管形成を特徴とする内腔をつくり出し、新しくつくら
れた管腔内に永久式な人工層管を配置して移植し、可能
な再閉鎖及び再発狭窄症を防止し、かくして血液の自由
な流れを無限に可能にする。両機能は、単一のカテーテ
ルの挿入と同時に実行される。
好ましい実施例の説明
本発明によりよく明確に理解するために、第1図〜第6
図が参照される。本発明の好ましい実施例は、血管形成
の適用に図示、説明される。しかし、ここに特に述べな
い他の応用が可能であり、本発明の範囲の限定は意図し
ないか、又は本発明の基本原理から逸脱しないことを意
味しない。
図が参照される。本発明の好ましい実施例は、血管形成
の適用に図示、説明される。しかし、ここに特に述べな
い他の応用が可能であり、本発明の範囲の限定は意図し
ないか、又は本発明の基本原理から逸脱しないことを意
味しない。
第1図は、以後単にステントと呼ばれる人工層管ステン
トlの構成の詳細を示し、それは、基本的に中空の先の
細い円筒形をしている。ステントlは、基本的には、適
当な心棒4上に典型的に巻回されるコイル状に予備成形
されたワイヤの管状形である。ワイヤは、スティンレス
スチール、チタニウムF63−83グレードl又は高金
位に19−22のような引張された低記憶レベル材料で
つくられる。適当にポリエステル又はテフロンで被覆さ
れた銅合金が典型的に使用され得る。チタニウム及び金
は、生物学的に両立し得る不活性のものであり、特殊の
処理を必要としない。
トlの構成の詳細を示し、それは、基本的に中空の先の
細い円筒形をしている。ステントlは、基本的には、適
当な心棒4上に典型的に巻回されるコイル状に予備成形
されたワイヤの管状形である。ワイヤは、スティンレス
スチール、チタニウムF63−83グレードl又は高金
位に19−22のような引張された低記憶レベル材料で
つくられる。適当にポリエステル又はテフロンで被覆さ
れた銅合金が典型的に使用され得る。チタニウム及び金
は、生物学的に両立し得る不活性のものであり、特殊の
処理を必要としない。
第2図において、ステント1がバルーン5の長さに関し
中心に配置され位置され、平らな予備成形されたワイヤ
バンド3aのターン(turn)が等間隔に離れている
ので、ステント1が第5図。
中心に配置され位置され、平らな予備成形されたワイヤ
バンド3aのターン(turn)が等間隔に離れている
ので、ステント1が第5図。
第6図に図示の如く膨脹した時、ステント1は血管8の
内面の−様な支持を与え、外部負荷に耐えることができ
る。第3図において、バルーン及びステント集合体5a
がカテーテルを血管8の内部に如何に誘導させ部分的閉
塞部IOに向って前進させるかを示している。第4図に
おいて、バルーン及びステント集合体5aは血管8内の
内部閉塞部10に配置され、バルーン5はふくらんだま
まである。ひとたび積極的に閉塞部10内に置かれると
、バルーン5は標準的な血管形成手順及び技術を使用し
て膨脹される。バルーン5が膨脹すると、第5図に図示
されるステント1の状態になる。
内面の−様な支持を与え、外部負荷に耐えることができ
る。第3図において、バルーン及びステント集合体5a
がカテーテルを血管8の内部に如何に誘導させ部分的閉
塞部IOに向って前進させるかを示している。第4図に
おいて、バルーン及びステント集合体5aは血管8内の
内部閉塞部10に配置され、バルーン5はふくらんだま
まである。ひとたび積極的に閉塞部10内に置かれると
、バルーン5は標準的な血管形成手順及び技術を使用し
て膨脹される。バルーン5が膨脹すると、第5図に図示
されるステント1の状態になる。
ステントlは、前記プラク7を保持し、可能な閉塞を防
止する。血管形成手順が完了すると、バルーン5はふく
らまされ、血管8内に固定的に移植されたステント1を
そのままにしてバルーンを取り出す、前述した如く、閉
塞した血管8は、今や完全に再疎通し、開通性は復元さ
れた。第6図は、圧縮したプラグ7に固定的に移植され
埋込まれたステントlを示し、いかなる突出部も、乱れ
た血液流及び潜在的な血栓症の形成を導通させるから、
適当な支持と共にあらゆる突出部に平滑な内腔空所を与
え、極めて望ましい特徴及び状態となる。
止する。血管形成手順が完了すると、バルーン5はふく
らまされ、血管8内に固定的に移植されたステント1を
そのままにしてバルーンを取り出す、前述した如く、閉
塞した血管8は、今や完全に再疎通し、開通性は復元さ
れた。第6図は、圧縮したプラグ7に固定的に移植され
埋込まれたステントlを示し、いかなる突出部も、乱れ
た血液流及び潜在的な血栓症の形成を導通させるから、
適当な支持と共にあらゆる突出部に平滑な内腔空所を与
え、極めて望ましい特徴及び状態となる。
この新規な原理にもとづくステント構成の生存能力をテ
ストするため、0.008インチ直径のポリエステル被
覆の銅ワイヤは第1図に図示のジグザグ形3に前もって
形成されバンド3aを形成する。このバンドは、端部を
固く結んだループ状2aに曲げられた管状形に連続的に
巻回され、固く結んだループはワイヤ2の鋭い端部がバ
ルーン5に孔をあけるのを防ぐ。管状ステントは、前記
バルーン上にしっかりと合致することによりつくられた
3、5mmPTCA20/3.5Tバルーン上に置かれ
る。バルーン及びステント集合体は、約3mmの内径の
シラスチックな薄い壁の管内に8F誘導カテーテルを介
して導かれ、バルーンは、淡水を使用して標準的な10
cc注射器によりふくらまされる。ステントの膨脹は、
ビデオにより観察され記録される。典型的にMeado
x 3urgimed A/SカタログNo、70
0720の10mm直径及びMedi、Techバルー
ンの12mm直径の大きなバルーンを使用して同様な性
質の幾つかの連続的なテストが、0.014インチ直径
のポエリエステル被覆銅ワイヤによりつくられたステン
トによって使用された。前記すべてのテストは、殆んど
完全な膨脹及びベンチ型(bench type)移
植を示した。更に、多数のステントが縦並びに使用し得
ることを実験により示された。事実、典型的なバルーン
及びステント集合体は、前に移植しγ膨脹したステント
を介して正しく導かれ、前に移植したステントの前方の
下流に移植し得る。実生活の立場に顕著な利点がある。
ストするため、0.008インチ直径のポリエステル被
覆の銅ワイヤは第1図に図示のジグザグ形3に前もって
形成されバンド3aを形成する。このバンドは、端部を
固く結んだループ状2aに曲げられた管状形に連続的に
巻回され、固く結んだループはワイヤ2の鋭い端部がバ
ルーン5に孔をあけるのを防ぐ。管状ステントは、前記
バルーン上にしっかりと合致することによりつくられた
3、5mmPTCA20/3.5Tバルーン上に置かれ
る。バルーン及びステント集合体は、約3mmの内径の
シラスチックな薄い壁の管内に8F誘導カテーテルを介
して導かれ、バルーンは、淡水を使用して標準的な10
cc注射器によりふくらまされる。ステントの膨脹は、
ビデオにより観察され記録される。典型的にMeado
x 3urgimed A/SカタログNo、70
0720の10mm直径及びMedi、Techバルー
ンの12mm直径の大きなバルーンを使用して同様な性
質の幾つかの連続的なテストが、0.014インチ直径
のポエリエステル被覆銅ワイヤによりつくられたステン
トによって使用された。前記すべてのテストは、殆んど
完全な膨脹及びベンチ型(bench type)移
植を示した。更に、多数のステントが縦並びに使用し得
ることを実験により示された。事実、典型的なバルーン
及びステント集合体は、前に移植しγ膨脹したステント
を介して正しく導かれ、前に移植したステントの前方の
下流に移植し得る。実生活の立場に顕著な利点がある。
動物についてテストした実験室は、現在、初期の結果が
極めて励まされる期待を轟いた。冠状動脈内ステントと
大動脈内ステントの両者は、この時点で実験され、完全
なプロトコルが準備されている。
極めて励まされる期待を轟いた。冠状動脈内ステントと
大動脈内ステントの両者は、この時点で実験され、完全
なプロトコルが準備されている。
5個のステントが最近豚の小さな動脈に移植され、3.
5mmまで膨脹したステントが数理間100%の開通性
を連続して維持し、この時点でこれを継続している。
5mmまで膨脹したステントが数理間100%の開通性
を連続して維持し、この時点でこれを継続している。
別個の実験において、前につくられた大動脈解剖は、前
記解剖内で10mm直径のステントを膨脹することによ
り血流をストップした。
記解剖内で10mm直径のステントを膨脹することによ
り血流をストップした。
第1図は、心棒の上に巻回された本発明による好ましい
実施例のステントの側方正面図である。 第2図は、収縮されたバルーン上に合致したステント人
工層管の全面図を示す側方正面図である。 第3図は、血管内の部分的閉塞部に近づくバルーン及び
ステント集合体を示す。 第4図は、部分的に閉塞した血管の内側のバルーン及び
ステント集合体を示す第3図と同様である。 第5図は、第4図と同様に、永久的な人工層管ステント
の同時配置と移植に結合される血管形成手順の好ましい
方法を説明する膨脂したバルーン及び放射状に拡張した
ステントである。 第6図は、バルーンを除去した後、移植された人工層管
ステント及び圧縮、保持されたプラグ(plaque)
を示す第5図と同様な図面である。 図において、 1はステント 2はワイヤ 2aはループ 3はジグザグ形(パターン) 3aはバンド 4は心棒 5はバルーン 5aはバルーン及びステント集会所 7はプラク 8は血管 9はカテーテル 10は閉塞部 特許出願人 メトトロニック・インコーポレーテッド代
理人 弁理士 玉 蟲 久五部 FIG、 I FIG、2 FIG、4
実施例のステントの側方正面図である。 第2図は、収縮されたバルーン上に合致したステント人
工層管の全面図を示す側方正面図である。 第3図は、血管内の部分的閉塞部に近づくバルーン及び
ステント集合体を示す。 第4図は、部分的に閉塞した血管の内側のバルーン及び
ステント集合体を示す第3図と同様である。 第5図は、第4図と同様に、永久的な人工層管ステント
の同時配置と移植に結合される血管形成手順の好ましい
方法を説明する膨脂したバルーン及び放射状に拡張した
ステントである。 第6図は、バルーンを除去した後、移植された人工層管
ステント及び圧縮、保持されたプラグ(plaque)
を示す第5図と同様な図面である。 図において、 1はステント 2はワイヤ 2aはループ 3はジグザグ形(パターン) 3aはバンド 4は心棒 5はバルーン 5aはバルーン及びステント集会所 7はプラク 8は血管 9はカテーテル 10は閉塞部 特許出願人 メトトロニック・インコーポレーテッド代
理人 弁理士 玉 蟲 久五部 FIG、 I FIG、2 FIG、4
Claims (1)
- 【特許請求の範囲】 1、中空円筒形状のワイヤ構成の巻線、予備成形された
ジグザグ型パターンの連続的ワイヤ構成の平らなバンド
を含む巻線、ステントの長さ方向に連続した螺旋状に巻
かれた平らなバンド、ジグザグ型の予備成形されたワイ
ヤバンドの両端を締めくくつた完全ループ、を具え、体
の血管内に移植する放射状に膨脹可能なステント。 2、ジグザグ型パターンは、軸方向に関し縦方向に方向
づけられる前記特許請求の範囲第1項記載のステント。 3、ワイヤ形は、銅合金、ステンレススチール、チタニ
ウム又は高金位の金の低記憶レベル特性を有する材料で
つくられる前記特許請求の範囲第1項記載のステント。 4、ワイヤ形は銅合金でつくられる前記特許請求の範囲
第4項記載のステント。 5、ワイヤ形は外科用程度のステンレススチールでつく
られる前記特許請求の範囲第1項記載のステント。 6、ワイヤ形は生物学的に適合するチタニウムでつくら
れる前記特許請求の範囲第1項記載のステント。 7、ワイヤ形は純度が少なくとも18Kを有する金でつ
くられる前記特許請求の範囲第1項記載のステント。 8、膨脹していないステントは、0.075インチ以下
の外径を有する前記特許請求の範囲第1項記載のステン
ト。 9、ステントは近似的に原の直径の3倍に放射状に膨脹
し得る前記特許請求の範囲第8項記載のステント。 10、巻線を膨脹させるためワイヤ巻線内の手段組合さ
れる前記特許請求の範囲第1項記載のステント。 11、前記膨脹手段は巻線内で縦方向に延びている膨脹
可能なバルーンである前記特許請求の範囲第10項記載
のステント。 12、予備成形されたワイヤ巻線がバルーンを固定的に
把握するようにしつかりと合致したサイズである前記特
許請求の範囲第11項記載のステント。 13、円筒形であり、放射状に膨脹可能で膨脹後その形
状を保持する能力を有する巻回ワイヤのステントを提供
するステップ、 バルーンが膨脹され、ステント及びバルーンを体の血管
内に挿入し、次いでそれらが治療されるべき血管部分に
到達するまで血管に沿つて導かれるステント内のバルー
ンを提供するステップ、血管の内表面に向つてステント
を膨脹させるようにバルーンを膨脹させるステップ、 膨脹したステントを適当な場所に残すようにバルーンを
収縮させ除去するステップ、 を具える体の血管を治療する方法。 14、体の脈管が少なくとも部分的に閉塞した血管であ
り、ステント及びバルーンが血管内に挿入され、それら
が閉塞して点まで移動され、バルーンの膨脹が閉塞を開
口すると同時にステントを拡張するように作用する、前
記特許請求の範囲第13項記載の方法。 15、第1の膨脹したステントを介してその内部に第2
のステント及びバルーンを挿入し、バルーンを膨脹し、
第1のステントから縦方向のオフセット点に第2ステン
トを挿入するステップを具える前記特許請求の範囲第1
3項記載の方法。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US109,686 | 1987-10-19 | ||
US07/109,686 US4886062A (en) | 1987-10-19 | 1987-10-19 | Intravascular radially expandable stent and method of implant |
Publications (2)
Publication Number | Publication Date |
---|---|
JPH01145076A true JPH01145076A (ja) | 1989-06-07 |
JPH0724688B2 JPH0724688B2 (ja) | 1995-03-22 |
Family
ID=22328991
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP63262677A Expired - Lifetime JPH0724688B2 (ja) | 1987-10-19 | 1988-10-18 | 血管内で放射状に膨脹可能なステント及びその移植装置 |
Country Status (7)
Country | Link |
---|---|
US (1) | US4886062A (ja) |
EP (1) | EP0312852B1 (ja) |
JP (1) | JPH0724688B2 (ja) |
AU (1) | AU614095B2 (ja) |
CA (1) | CA1292598C (ja) |
DE (1) | DE3864369D1 (ja) |
ES (1) | ES2023995B3 (ja) |
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Also Published As
Publication number | Publication date |
---|---|
EP0312852A1 (en) | 1989-04-26 |
AU614095B2 (en) | 1991-08-22 |
ES2023995B3 (es) | 1992-02-16 |
DE3864369D1 (de) | 1991-09-26 |
AU2378488A (en) | 1989-04-20 |
CA1292598C (en) | 1991-12-03 |
JPH0724688B2 (ja) | 1995-03-22 |
EP0312852B1 (en) | 1991-08-21 |
US4886062A (en) | 1989-12-12 |
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