JP5059201B2 - 血管ステント - Google Patents
血管ステント Download PDFInfo
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- JP5059201B2 JP5059201B2 JP2011017582A JP2011017582A JP5059201B2 JP 5059201 B2 JP5059201 B2 JP 5059201B2 JP 2011017582 A JP2011017582 A JP 2011017582A JP 2011017582 A JP2011017582 A JP 2011017582A JP 5059201 B2 JP5059201 B2 JP 5059201B2
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- stent
- monofilament
- vascular stent
- plla
- crystallinity
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- Expired - Fee Related
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- 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
- A61F2/885—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 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
-
- 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
-
- 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
- A61F2/90—Stents 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
-
- 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
- A61F2/90—Stents 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
- A61F2/91—Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/90—Stents 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
- A61F2/91—Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/06—Macromolecular materials obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- 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
- A61F2/90—Stents 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
- A61F2/91—Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents 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 sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
- A61F2002/91533—Stents 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 sheet material 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
- A61F2002/91541—Adjacent bands are arranged out of phase
Landscapes
- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Physics & Mathematics (AREA)
- Optics & Photonics (AREA)
- Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Description
これらの理由から、永久的に残留する金属ステントを体内に植え込むことには問題がある。
(a)力学的性質:構造体として、血管を開存するために十分な力学的性質を一定期間備えていること、
(b)拡縮能力:目的血管部位まで搬送時はステント径を縮小でき、目的血管部位では任意の径まで拡大できる構造であること、
(c)搬送能力:血管内での不慮の移動、折れ曲がり、ねじれ、破損等なく、目的とする冠動脈に正確に植え込めること、
等が挙げられる。
図1に示すような太さを有する各モノフィラメントA,B,Cの作成時の結晶化度と荷重との関係は、図2に示すとおりのものであった。すなわち、太さを0.3mmとするモノフィラメントAにおいて、37℃の生理食塩水に6ヶ月浸漬させたときに破断時の荷重として6N以上の条件を満たす25%の結晶化度を有するものは約15%であった。
血管ステントを構成する構造材料としてのアプローチとしては、弾性率や強度(力学的性質)からのアプローチ、折り曲げ易さと加工性(拡縮能力)からのアプローチ、曲がり易さと柔軟性(搬送能力)からのアプローチを挙げることができる。
ここで、上述したよう長さを10mm〜15mmとなし太さを2mm〜5mmとした大きさの血管ステントに作製するため、筒状に編みあるいはジグザグ状に折り曲げながら円筒状の構造体として加工するためには、用いる線材としてのモノフィラメントが加工途中においてひび割れや破断等を発生させることなく湾曲あるいは折り曲げ可能であることが要求される。この要求を満たすためには、線材の太さによっても異なるが、上述の血管ステントを作製するために用いることが可能な0.08mm〜0.30mmのPLLAモノフィラメントにあっては、確実に湾曲あるいは折り曲げられる限度の破断伸度として15%以上必要であることがステント作製の過程で見いだされた。
図3は、太さをそれぞれ0.30mm、0.17mm、0.08mmとするPLLAモノフィラメントA,B,Cの結晶化度と破断伸度の関係を示すものである。図3からも明らかなように、各太さのモノフィラメントA,B,Cとも、図3からも明らかなように、結晶化度に応じて破断伸度も変化しており、破断伸度として、15%以上の条件を満たすPLLAモノフィラメントは、太さを0.08mmとするとき、結晶化度は60%以下でなければならない。実際に、結晶化度60%以上のPLLAモノフィラメントは、硬くて脆くなっており、折り曲げると簡単に折れてしまい上述したような大きさの血管ステントを作製することができなかった。
一般の高分子ポリマーにおいては、結晶化度が高くなれば血栓が付着し難くなるが、高ければ高いほど良いというわけではない。
先ず最初に、上記モノフィラメントを編んで形成した血管ステントについて説明する。
最後に、PLLAのモノフィラメントを不織不編の状態でステントとした例について説明する。
Claims (2)
- 血管内への植え込みに適する形態保持性及び弾力性を有する筒状構造体として形成された血管ステントであって、
上記筒状構造体は、生体吸収性ポリマーであるポリ(L−ラクチド)を用いて形成されてなり、
上記ポリ(L−ラクチド)は、示差走査熱量分析により測定される結晶化度が15%〜60%であって、重量平均分子量が55000以上であることを特徴とする血管ステント。 - 上記ポリ(L−ラクチド)は、重量平均分子量が70000〜400000であることを特徴とする請求項1記載の血管ステント。
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2011017582A JP5059201B2 (ja) | 2000-03-13 | 2011-01-31 | 血管ステント |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP2000073983 | 2000-03-13 | ||
JP2000073983 | 2000-03-13 | ||
JP2011017582A JP5059201B2 (ja) | 2000-03-13 | 2011-01-31 | 血管ステント |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001566461A Division JP4790960B2 (ja) | 2000-03-13 | 2001-03-13 | 血管ステント用線材及びこれを用いた血管ステント |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2011092767A JP2011092767A (ja) | 2011-05-12 |
JP5059201B2 true JP5059201B2 (ja) | 2012-10-24 |
Family
ID=18592109
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001566461A Expired - Fee Related JP4790960B2 (ja) | 2000-03-13 | 2001-03-13 | 血管ステント用線材及びこれを用いた血管ステント |
JP2011017582A Expired - Fee Related JP5059201B2 (ja) | 2000-03-13 | 2011-01-31 | 血管ステント |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2001566461A Expired - Fee Related JP4790960B2 (ja) | 2000-03-13 | 2001-03-13 | 血管ステント用線材及びこれを用いた血管ステント |
Country Status (12)
Country | Link |
---|---|
US (1) | US7070615B1 (ja) |
EP (2) | EP2298366B1 (ja) |
JP (2) | JP4790960B2 (ja) |
KR (1) | KR100788336B1 (ja) |
CN (1) | CN1261084C (ja) |
AT (1) | ATE516826T1 (ja) |
AU (1) | AU780196B2 (ja) |
CA (1) | CA2373961C (ja) |
DK (1) | DK2298366T3 (ja) |
ES (2) | ES2392798T3 (ja) |
PT (1) | PT2298366E (ja) |
WO (1) | WO2001067990A1 (ja) |
Families Citing this family (49)
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US5514378A (en) * | 1993-02-01 | 1996-05-07 | Massachusetts Institute Of Technology | Biocompatible polymer membranes and methods of preparation of three dimensional membrane structures |
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2001
- 2001-03-13 PT PT10192696T patent/PT2298366E/pt unknown
- 2001-03-13 CN CNB01800797XA patent/CN1261084C/zh not_active Expired - Fee Related
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- 2001-03-13 EP EP20100192696 patent/EP2298366B1/en not_active Expired - Lifetime
- 2001-03-13 AT AT01912330T patent/ATE516826T1/de not_active IP Right Cessation
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EP1184008A4 (en) | 2008-08-06 |
US7070615B1 (en) | 2006-07-04 |
EP1184008B1 (en) | 2011-07-20 |
CA2373961A1 (en) | 2001-09-20 |
PT2298366E (pt) | 2012-11-20 |
JP4790960B2 (ja) | 2011-10-12 |
ES2392798T3 (es) | 2012-12-13 |
EP1184008B9 (en) | 2012-09-19 |
ES2367628T3 (es) | 2011-11-07 |
WO2001067990A1 (fr) | 2001-09-20 |
JP2011092767A (ja) | 2011-05-12 |
KR100788336B1 (ko) | 2007-12-27 |
ATE516826T1 (de) | 2011-08-15 |
DK2298366T3 (da) | 2012-11-26 |
CN1366456A (zh) | 2002-08-28 |
AU4112301A (en) | 2001-09-24 |
AU780196B2 (en) | 2005-03-10 |
EP1184008A1 (en) | 2002-03-06 |
CN1261084C (zh) | 2006-06-28 |
CA2373961C (en) | 2009-06-02 |
EP2298366A1 (en) | 2011-03-23 |
KR20020013878A (ko) | 2002-02-21 |
EP2298366B1 (en) | 2012-08-22 |
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