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JP4261770B2 - 性質が変化するステント - Google Patents

性質が変化するステント Download PDF

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Publication number
JP4261770B2
JP4261770B2 JP2000534148A JP2000534148A JP4261770B2 JP 4261770 B2 JP4261770 B2 JP 4261770B2 JP 2000534148 A JP2000534148 A JP 2000534148A JP 2000534148 A JP2000534148 A JP 2000534148A JP 4261770 B2 JP4261770 B2 JP 4261770B2
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Japan
Prior art keywords
stent
region
end region
diameter
force
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Expired - Fee Related
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JP2000534148A
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JP2002505149A (ja
Inventor
ピー. キリオン、ダグラス
アール. リニンジャー、ジェームス
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Boston Scientific Limited
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Boston Scientific Limited
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=21875223&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=JP4261770(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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    • 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
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • 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
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • 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
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91525Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other within the whole structure different bands showing different meander characteristics, e.g. frequency or amplitude
    • 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
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/91533Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other characterised by the phase between adjacent bands
    • 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
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheets or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • 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
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
    • 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
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • 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
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0039Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in diameter
    • 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
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0048Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Physics & Mathematics (AREA)
  • Vascular Medicine (AREA)
  • Optics & Photonics (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Prostheses (AREA)
  • Materials For Medical Uses (AREA)

Description

【0001】
(発明の分野)
本発明は一般的に医療器具及びその使用に関する。より詳細には、本発明は動脈などの血管を、特に分岐部領域において流れに対して開放状態に保持するためのステントに関する。
【0002】
(発明の背景)
ステントは、径方向に拡張させることが可能な体内プロテーゼであり、通常は、経皮的に導入された後、経管的に留置して径方向に拡大させることが可能な血管内移植片である。ステントはまた尿道や胆管内にも留置される。ステントは体内の脈管を強化し、脈管系における血管形成術後の再狭窄を防止するうえで使用される。ステントには自己拡張式のものとバルーンに装着される場合のように内部の径方向の力によって拡張される形式のものとがある。
【0003】
ステントは管状の脈管内に挿入するためにほぼ管状をなす要素として形成される。バルーン拡張式のステントでは、バルーンへの装着、位置決定、及びステントを径方向外側に拡張するためにバルーンを膨張させる必要がある。自己拡張式のステントは、拘束がなくなるとバルーンの補助によることなく拡大して固定される。自己拡張式ステントは送達カテーテルから解放されると拡大するように付勢されている。
【0004】
狭窄部を有する血管は、硬化した物質が円筒状の脈管壁に円弧をなして内側に突出するように付着したものと考えることが可能であり、狭窄領域では幾分堅い物質が柔軟な壁に沿って付着している。狭窄によって架橋された領域においては脈管のいかなる拡大に対しても狭窄による抵抗が生じる。狭窄は例えばカルシウム沈着の程度などの組成において異なり、したがって性質においても異なる。
【0005】
全ての狭窄の円弧状の形状のため、ステントの径方向外向きの力に抗する抵抗は脈管の中心軸に沿って変化する。具体的には、狭窄した脈管の抵抗はしばしば中央に向かって最大となり、端部に向かうにしたがって減少し、健康な脈管組織が始まる点において急激に低下する。
【0006】
分岐部領域におけるような特定の場合においては、狭窄は流れに関連した現象と考えられている。これについては血管分岐部におけるアテローム性動脈硬化症についての考察が述べられている「Handbook of Bioengineering」(Richard Shaloh & Shu Chin, Macgraw-Hill Book Company, 1987)(生体工学の手引き)の第21章を参照されたい。
【0007】
左及び右総動脈がこうした血管分岐部としては典型的なものである。これらの動脈は頭部及び頚部における主要な動脈である。これらの総頚動脈は互いに非常に似通っており、頚動脈分岐または頚動脈球において外頚動脈と内頚動脈とに分岐する。総頚動脈(左および右の両方)から内頚動脈にかけての血管内部が大きく先細っているため、狭窄によって頚動脈球および内頚動脈口の領域において、頚動脈へのステント留置における特定の問題が生じる。頚動脈の分岐部すなわち球の領域は、特に両頚動脈の内頚動脈口の領域において、狭窄の頻度が最も高い部位である。頚動脈へのステント留置には、この部位が外部からの圧迫を受ける解剖学的位置であるために自己拡張式のステントが一般に好適である。
【0008】
従来の自己拡張式ステントは、開放状態に保持されるべき狭窄部の長さよりも大きな長さを好適に有する。現在使用されているステントは、ステントの全長に沿ってほぼ一様な径方向外側に向けた力および一様な圧縮力に対する抵抗力を有する。現在使用されているステントでは、血管の形状や抵抗に合わせてこれらの力が変化することはない。狭窄した血管内に開放通路を維持し、かつ圧縮力に抗するうえで充分な力を有する、一定の力を作用させるステントとしての従来技術に基づくステントは、狭窄部の末端側の健康な血管部分においては必要以上の力を有する。このためステントの端部が外側に広がる場合があり、狭窄部以外の組織内に突出して組織を刺激する場合がある。
【0009】
狭窄部の両側に位置する、非対称な形状を有する血管部分において狭窄が発生する場合がある。その一例として、より狭隘な動脈に移行する広い開口部を有する内頚動脈口がある。開口部の領域に留置された従来のステントは、不均一な血管径にほぼ均一な径方向外側に向かう力を作用させる。すなわち、作用する力は小径部において大径部よりも大きくなる。この力が小径の血管領域に好適な大きさに調整されている場合、大径の血管領域においては最適値よりも小さな値となる。逆にこの力が大径の血管領域に好適な大きさに調整されている場合、小径の血管領域においては最適値よりも大きな値となる。
【0010】
反発する狭窄内において血管を開放状態に保つうえで充分な力を与えるが、狭窄のない健康な血管領域に対しては必要な大きさの力のみを与えることが可能なテーパ形成されたステントが待望されているが、これまでのところ提供されてこなかった。また、狭窄部の両側の不均一な血管径を有する血管領域内の狭窄に沿って、必要とされる力(外側に向けた力および圧縮に対する抵抗)のみを与えるテーパ形成されたステントも提供されてこなかった。これは、全長に沿って、径方向の力、セルの大きさ、形状、柔軟性が変化し、全長に沿ってより一定な金属対動脈比(M/A)を与える本発明のテーパ形成されたステントによって提供される。M/Aは、ステントの金属表面の面積の、ステントによって覆われる血管の表面積に対する比である。
【0011】
(発明の概要)
本発明は、その好適な一実施形態において、非拡張状態においては管状または円筒形状を有し、拡張状態すなわち記憶された状態においてはテーパ形成された管状または円筒形状を有する形状記憶金属にて形成された自己拡張式ステントを含む。また、圧縮に対するその抵抗は全長に沿って変化する。更に、ステントを構成するセルの形態は、力の作用、及び、プラークを大きく覆いこれを支持することが求められる部位において閉じており、柔軟性が求められる部位において開いている。更に、金属対動脈比は、拡張状態にあるステントの全長にわたってより一定となっている。こうしたステントの1つとしてニッケル−チタン合金(ニチノール)にて形成されるものがある。他の形状記憶金属を使用することも可能である。一実施形態においては、ステントは、径方向外側に向けた力が中央においてより大きく、両端においてより小さくなるように構成される。別の一実施形態においては、ステントは、径方向外側に向けた力が一端においてより大きく、反対側の端部においてより小さくなるように構成される。こうしたステントは、頚動脈の分岐部やこれに付随する開口部領域などの、狭窄し、狭くなった血管領域に留置するうえで好適である。
【0012】
本発明のステントでは、より大きな径方向の力を要する領域においてより多量の金属を用い、より小さな径方向の力を要する領域においてより少量の金属を用いた連結部において交差する構造的要素をステントにおいて有することにより、全長に沿った径方向の力の変化を実現することが可能である。交差部の金属またはストラット要素の金属の量は、交差領域のサイズまたはストラットのサイズを変更することによって変化させることが可能である。実際には、より多くの、またはより少ない数の連結要素を使用することにより、径方向の力を増大させること以上にステントの全長に沿った柔軟性を変化させる。好適な一実施形態においては、ステント構造はニチノール製の管をレーザによって切り抜くことによって形成され、より大きな径方向外側の力および圧縮抵抗を要する領域においてより大きな幅かつより小さな長さを有するストラットが形成される。
【0013】
さらに本発明のストラットは、拡張状態、すなわちテーパ形状に拡張された状態において、全長にわたってより一定の金属対動脈比を与えるように構成されることを特徴とする。
【0014】
好適な一実施形態において、ステント構造は、管状構造を与えるように整列された複数の蛇状かつ環状のセグメントを有する。これらのセグメントは長手方向に相互に連結される。この実施形態及び他の実施形態においてステントのストラットの寸法を変更することにより、所望の径方向の力を変化させることが可能である。一実施形態においては、より大きな径方向の力を要するステントの領域は、より小さな力を要する領域におけるよりも、より大きな幅とより小さな長さを有するストラットを備える。この目的のためにセグメント間の連結要素の数を変更することも可能である。さらに、ストラットの長さ及び間隔、及び全体のサイズを変更することによってこれを行うことも可能である。別の制御方法は、セルの構成自体によるものである。閉じたセルによって、開いたセルと比較してプラークをより大きく覆いかつ支持することが可能である。一般に、閉じたセルはステントの隣り合うセグメントのセルに連結されるのに対して、開いたセルはそのようには連結されない。これらの因子によっても、柔軟性及び形状一致性といった性質を制御することが可能である。閉じた、または開いたセルの形状を利用して、狭窄部において、より大きな支持をプラークに与え(閉じたセル)、狭窄部の両側においてより小さな支持及び大きな柔軟性を与える(開いたセル)ことが可能である。更に、閉じたセル構造を利用して外頚動脈の起点部や他の任意の血管側枝への開口部に架橋することが可能である。
【0015】
一般的に、本発明のステントには、ステントの全長にわたって所定の規則性にて変化する上記に述べたような径方向の力を与えることが好ましい。すなわち、セルの形態は、狭窄部のプラークにステントが接触する領域において閉じており、健康な血管組織にステントが接触する領域においてより開いている。また、柔軟性及び形状一致性は、非拡張状態及び拡張状態の両方においてステントの全長にわたって所定の規則性にて変化するように構成される。
【0016】
本発明に基づいて製造されるステントにより、先細りする血管における局所的な力の条件により見合った径方向外側を向いた力が与えられる。具体的には、本発明のステントにより、健康な組織の領域において過剰な力を作用させることなく、狭窄においてのみ必要とされるより大きな力が与えられる。本発明のステントにより、先細りする血管の領域の条件により見合った拡張した形状が与えられる。ステントは、好ましくは基端側の大径端部または中間部においてより高い剛性及び強度を有し、末端側の小径部においてより低い強度及び高い柔軟性を有することにより、ステントの末端側の血管の緊張を緩和して捩れを防止する。基端を柔軟性とすることも可能である。
【0017】
さらに、全長に沿って変化する性質を有する本発明のステントは、直径が大きく変化する分岐部にわたって使用することが可能なバルーン拡張式のステントにおいて、末端側のより小さなバルーン及び基端側のより大きなバルーンを膨らませることによって適用することも可能である。
【0018】
本発明は更に、上記に述べたような種類のステントの使用をともなう、血管の分岐領域における狭窄を治療するための方法にも関する。
(発明の詳細な説明)
図1は、大径領域56、小径領域58、及び、これら領域の間のどこか、すなわち、交差線にてハッチングが施された部分において狭窄(図に示されていない)を有する、内頚動脈などの先細る血管52を示したものである。図1の先細る血管は、左総頚動脈57の分岐部における開口部において見られるような形状を示したものであり、ここで血液は左総頚動脈57から左内頚動脈59内に流入する。分岐部はまた左外頚動脈60内に開口する。大径領域56を開放状態に保つうえで充分な力を有する通常のステントは、小径領域58を開放状態に保つうえで必要であるよりも大きな力を有することになる。
【0019】
図2aは、本発明を具体化したステントの、テーパ形成されるとともに拡張されたステント長Lに沿って径方向外側に向かう力Fをプロットしたグラフ66aを示したものである。このステントは端部領域68aにおいて反対側の端部領域70aよりも大きな力を有する。図2aの力曲線を有するテーパ形成されたステントは、血管の大径部56を開放状態に保つうえで充分な力を有するとともに、作用する力が小さいことが求められる、健康組織を有する血管の小径領域においてはより小さな力を作用させるため、図1に示されるような狭窄にわたって配設するうえで好適である。
【0020】
図3は、図2に示されるような力の分布を有する本発明のニチノール製ステントの好適な一実施形態を概略的に示したものである。自己拡張式ステント80は、健康な血管組織に接触するための形状適合可能な末端82と、より硬く、より大きなプラークの支持を与える閉鎖セル基端領域88とを有する。自己拡張式ステント80は、拡張される際には図に示されるようなテーパが付けられた径を有する。例として、0.599cm(0.236インチ)の末端側の径及び0.899cm(0.354インチ)の基端側の径が一般的である。これらの寸法は変更可能である。ステント80は送達カテーテルの末端に配され、着脱可能なシースにてこれを覆って挿通されるべき狭窄にまで進め、シースを外すことにより自己拡張を行うために露出させる。ステント80は記憶されたテーパ形状へと径方向に拡張して狭窄及び血管壁を押す。
【0021】
図4は、中間領域104、端部領域106及び108を有するステント100として実施された、非拡張状態にある図3のニチノール性ステントをより詳細に示したものである。ステント100は図5に示されるように管状であり、ジグザグのパターンをなす複数の蛇状セグメント105,107,109,111及び113にて構成される。各セグメントはステント100の一部を径方向において包囲する。再び図4を参照すると、セグメント113同士が連結要素110によって長手方向に相互に連結されているのに対し、蛇状セグメント105,107,109及び111は図4a及び4bに示されるように直接連結112により相互に連結されている。ステント100を形成するうえで好ましい材料としてニチノールがある。この実施形態では、ステントは、0.015cm(0.006インチ)の壁厚と0.206cm(0.081インチ)の直径を有し、連続した壁を有するニチノール製の管をレーザ加工することにより形成され、図に示されるようなステント構造のみが切り残される。ステントの異なる要素の典型的な寸法を例として図に示した。
【0022】
図6を参照すると、図4のステントが拡張されるとともに先細った状態にて示されている。ニチノールは形状記憶合金であるので、図4に示されるような形状かつサイズに形成し、テーパが付けられたツール上に配して、例として上述した0.599cm(0.236インチ)の末端側の直径と0.899cm(0.354インチ)の基端側の直径のような所望の拡張形状及びサイズに拡張させ、例として500℃の高温に加熱して、記憶されるサイズ及び形状をツール上で与えることが可能である。この後ステントをツールから外し、送達カテーテルに装着するために圧縮することが可能である。
【0023】
図4において上述した寸法を有するニチノール製ステントから始めることにより、拡張状態において、図3に基づいて前述したような所望の性質を有するステントが与えられる。図の寸法はすべてインチにて示されている。無論これが本発明に基づくステントのあくまで一例に過ぎないことは云うまでもない。
【0024】
図7では図1と同様、大径領域56、小径領域58、分岐血管55、及び領域56と58との間、すなわち交差線にてハッチングが施された領域のどこかに存在する狭窄(図に示されていない)を有する先細る血管52が示されている。ここでもやはり図7の先細る血管は左総頚動脈57の分岐部において見られるような形状を示し、ここで血液は左総頚動脈57から左内頚動脈59に流入する。
【0025】
図2bは、本発明を具体化したステントの、テーパ形成されるとともに拡張されたステント長Lに沿って径方向外側に向かう力Fをプロットしたグラフ66bを示したものである。このステントは中間領域67bにおいて端部領域68b及び70bよりも大きな力を有する。図2bの力曲線を有するテーパ形成されたステントは、内頚動脈59の開口部において大径部を開放状態に保つうえで充分な力を有するとともに、大径端部56及び小径端部58の健康な組織にはより小さな力を作用させるため、図7に示されるような狭窄にわたって配設するうえで好適である。
【0026】
このような交差線にてハッチングした領域において使用するためのステントとして、図1〜6に基づいて上述したステントとは異なる、図8及び9に基づいて述べられるような性質を有するものがある。
【0027】
図8の概略図を参照すると、ステント80は中間領域84、端部領域86及び87を有する。ステントの単位長さ当りに作用する径方向の力の大きさは、より短く幅の広いストラットを有する領域においてより大きい。図8に概略的に示されるように、ステント80は中央領域84において端部領域86及び87におけるよりも短くて幅の広いストラットを有する。したがって、ステント80は、中央領域84において端部領域86及び87におけるよりも大きな径方向外側に向かう力と圧縮抵抗を有し、図7の交差線ハッチングされた領域に配するうえで特に有用である。
【0028】
図9は、中間領域104、端部領域106及び108を有するステントとしての、図8の非拡張状態にあるニチノール製ステントの実施形態を平面図にてより詳細に示したものである。ステント100は図10に示されるように管状であり、ジグザグのパターンをなす複数の蛇状セグメント105,107,109,111及び113にて構成される。各セグメントはステント100の一部を径方向において包囲する。セグメント111及び113は複数の連結要素110によって長手方向にそれぞれ相互に連結されるのに対し、蛇状セグメント105,107及び109はすべて、図9a及び9bに詳細に示されるように直接連結112によって連結される。この実施形態もやはり0.015cm(0.006インチ)の壁厚と0.206cm(0.081インチ)の直径を有し、連続した壁を有するニチノール製の管をレーザ加工することにより形成され、図に示されるようなステント構造のみが切り残される。ステントの異なる要素の典型的な寸法を例として図9に示した。
【0029】
図6に示されるテーパ形状に拡張された図4のステントの実施形態と同様、図9のステントにも拡張状態において先細りした記憶形状を与えることが可能である。このステントはこれまでに述べた所望の性質のすべて、特に図2bに基づいて述べた性質を備えるものである。図9の寸法はすべてインチである。
【0030】
本発明は、先細りした解剖学的構造において使用するためのステントであって、先細りした形状に拡張される際に全長に沿って変化する径方向の力を与えるステントを提供するものである。以上、こうしたステントを、使用状態において狭窄した血管領域にわたって配設されるものとして説明の目的で述べた。別の用途として、ステントがなければ狭窄してしまう身体の管路において通路を開放状態に維持することがある。他の目的に使用されるステントも本発明の範囲に含まれることは明らかである。
【0031】
ここでは本発明を説明するために自己拡張式のステントを示したが、いわゆるバルーン拡張式ステントにおいてもやはりここに述べられたような、径方向の力が変化するという特徴を備えることが可能である。しかしバルーン拡張式のステントでは、これらの力は一般にステントを拡張するうえで必要とされるよりも小さく、したがってバルーンを当業者に知られる方法にて使用してステントを完全に拡張する。テーパ形状を得るために直径の異なる2個のバルーンを使用してステントの各端部を拡張することが可能である。これらのバルーン拡張式ステントは、開口部におけるような血管の領域において有利に用いることが可能である。これは、開口部では、狭窄領域においてより剛性かつ重い要素を有するステントが望ましく、ステントの末端部がより高い可撓性を有することが望ましいことによる。例として、バルーン拡張式ステントを、図4または図9に示されるような構成及び寸法にてステンレス鋼から形成することが可能である。したがって、バルーン拡張式のステントも本発明の範囲に包含されることは認識されるべきである。
【0032】
使用に際しては、非拡張形態の自己拡張型のステントを、送達カテーテルに装着し、引き込み可能なシースにて覆う。このカテーテル血管内に導入し、分岐領域にまで進める(開口または分岐部留置)。通常、基端方向に引っ張ることによりシースを引き込んでステントを露出させる。これによりステントは自己拡張して血管壁及び狭窄に接触する。ここに述べられるニチノール型のもののような自己拡張式ステントの場合、ステントは露出されるとテーパが付けられた形態へと拡張し、上記に述べたような所望の性質を示す。自己拡張式のステントを拘束するために一般にシースが用いられる。バルーン拡張式ステントは通常バルーン上にクリンプされ、シースによって覆われない。非自己拡張式のステントの場合、バルーンや他の径方向の力を与える手段はステント内で膨らまされてこれを拡張する。ここに述べられるステントの場合、2個のバルーンを順次使用してこれを行うことが可能である。例として、テーパ形態の小径の端部において小さなバルーンを用いてステントを拡張し、次いでテーパ形態の大径の端部において大きなバルーンを用いてステントを拡張する。ここでカテーテルを抜脱するとステントは血管内に留置される。この方法は、ステントの開口部型または分岐部型のいずれが移植されているかに応じて調整可能である。
【0033】
この出願に含まれる発明の多くの特徴ならびに利点を上記の記載において述べたが、この開示は多くの側面においてあくまで説明的のものであることは認識されるであろう。発明の範囲を超えることなく、特に形状、大きさ、部品の配置、材料といった細部において変更を行うことが可能である。発明の範囲は無論のこと特許請求の範囲を記述する文言において定義されるものである。
【図面の簡単な説明】
【図1】頚動脈ステント留置の方法1を示す模式図。
【図2a】図1に示されるように配置される開口部ステントとしての改良ステントの力と長さの関係を示すグラフ。
【図2b】図7に示されるように配置される分岐部ステントとしての改良ステントの力と長さの関係を示すグラフ。
【図3】図1の方法1において使用されるテーパ形成されたステントの拡張された状態を示す概略断面図。
【図4】例示的寸法を有する、非拡張状態にある図3に概略的に示される種類のステントの細部を示す平面図。
【図4a】図4の一部を詳細に示す図。
【図4b】図4の一部を詳細に示す図。
【図4c】図4の一部を詳細に示す図。
【図4d】図4の一部を詳細に示す図。
【図5】図4のステントを示す端面図。
【図6】拡張状態にある図4のステントを示す図。
【図7】頚動脈ステント留置の方法2を示す模式図。
【図8】拡張状態にある、図7の方法2において使用されるテーパ形成されたステントを示す概略断面図。
【図9】例示的寸法を有する、非拡張状態にある図8に概略的に示される種類のステントの細部を示す平面図。
【図10】図9のステントを示す端面図。

Claims (12)

  1. 非拡張形態と拡張形態とを有し、該拡張形態は、所定の全長と、該全長に沿って変化する直径とを有する、体腔内に設置されるステント(80)であって、
    該ステントは拡張形態において先端ほど小径となるようテーパ状に形成された管状構造を有することと、該構造は径方向外方に向かって、ステントが設置された体腔の部位に対して作用する力と圧縮抵抗とを有することと、前記力は所定の規則性にて前記全長に沿って変化することと、該テーパ状に形成された管状構造は、基端側の部位に対応する最大径の第1の端部領域(86)と、より小径の中間領域(84)と、末端側の部位に対応する最小径の第2の端部領域(87)とを有し、前記力は前記中間領域において前記第1の領域におけるよりも強く、前記第2の端部領域において前記中間領域におけるよりも弱いことを特徴とするステント。
  2. 全長に沿って変化する柔軟性を有し、体腔内の狭窄した部位に対対して接する領域において最も固く、前記第1の端部領域及び第2の端部領域においてより柔軟であることを特徴とする請求項1に記載のステント。
  3. 前記第1の端部領域及び第2の端部領域における、開いたセル構造と比較して、相対的に閉じたセル構造を中間領域において有することを特徴とする請求項1に記載のステント。
  4. 自己拡張式ステントとして構成及び配置される請求項1に記載のステント。
  5. バルーン拡張式ステントとして構成及び配置される請求項1に記載のステント。
  6. 前記ステント構造は自己拡張式とするために形状記憶材料にて形成されることと、該ステント構造は、非拡張形態と、記憶された拡張形態とを有し、該非拡張形態においては拡張形態における平均の径よりも小さい平均の径を有し、拡張形態においては、第1の端部領域から中間領域(84)へ、さらには第2の端部領域へと全長にわたって変化する直径を有し、該拡張形態の直径は、前記第2の端部領域(87)においてより小さく、前記中間領域において前記第2の領域における直径よりも大きく、前記第1の端部領域(86)において前記中間領域または前記第2の端部領域における直径よりも大きいことを特徴とする請求項1に記載のステント。
  7. ニチノールにて形成されることを特徴とする請求項6に記載のステント。
  8. ステントは金属からなる表面を備えることと、第1の端部領域及び第2の端部領域(86,87)における、開いたセル構造と比較して相対的に閉じたセル構造を中間領域(84)において有し、ステントの金属表面の面積の、ステントによって覆われる体腔の表面積に対する比は拡張形態のステントの全長にわたってほぼ一定であることを特徴とする請求項6に記載のステント。
  9. ステントは金属からなる表面を備えることと、最大径の第1の端部領域(86)において、中間領域(84)及び第2の端部領域(86)における、開いたセル構造と比較して相対的に閉じたセル構造を有し、ステントの金属表面の面積の、ステントによって覆われる体腔の表面積に対する比は拡張形態のステントの全長にわたってほぼ一定であることを特徴とする請求項6に記載のステント。
  10. 相互に連結された蛇状かつ環状のセグメント(105)を有することを特徴とする請求項1に記載のステント。
  11. 自己拡張式のステントとして構成及び配置され、前記第2の端部領域における、開いたセル構造と比較して相対的に閉じたセル構造を前記最大径の第1の端部領域において有することを特徴とする請求項1に記載のステント。
  12. 相互に連結された複数のストラット(120)にて構成され、中間領域(84)の該ストラットは、第1の端部領域及び第2の端部領域(86,87)のストラットよりも大きな幅と小さな長さとを有することを特徴とする請求項1に記載のステント。
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US7060091B2 (en) 2006-06-13
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US20030074056A1 (en) 2003-04-17
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EP1598031B1 (en) 2010-06-16
US7780719B2 (en) 2010-08-24
DE69926219T2 (de) 2006-01-12
US20080281397A1 (en) 2008-11-13
WO1999044540A2 (en) 1999-09-10
US5938697A (en) 1999-08-17
US6159238A (en) 2000-12-12
US20010004705A1 (en) 2001-06-21
EP1059894A2 (en) 2000-12-20
US6669723B2 (en) 2003-12-30
ATE299681T1 (de) 2005-08-15
US20040102838A1 (en) 2004-05-27
DE69942512D1 (de) 2010-07-29
DE69926219D1 (de) 2005-08-25
US7402169B2 (en) 2008-07-22
US20060142849A1 (en) 2006-06-29
EP1598031A2 (en) 2005-11-23
EP1059894B1 (en) 2005-07-20
JP2002505149A (ja) 2002-02-19

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