JP2002537072A - Composite superelastic / shape memory alloy and malleable alloy stents - Google Patents

Composite superelastic / shape memory alloy and malleable alloy stents

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Publication number
JP2002537072A
JP2002537072A JP2000600710A JP2000600710A JP2002537072A JP 2002537072 A JP2002537072 A JP 2002537072A JP 2000600710 A JP2000600710 A JP 2000600710A JP 2000600710 A JP2000600710 A JP 2000600710A JP 2002537072 A JP2002537072 A JP 2002537072A
Authority
JP
Japan
Prior art keywords
copper
zinc
stent
nickel
titanium
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.)
Pending
Application number
JP2000600710A
Other languages
Japanese (ja)
Inventor
ウィリアム、ジェイ．ボイル
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Abbott Cardiovascular Systems Inc
Original Assignee
Advanced Cardiocasvular Systems Inc
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Filing date
Publication date
Application filed by Advanced Cardiocasvular Systems Inc filed Critical Advanced Cardiocasvular Systems Inc
Publication of JP2002537072A publication Critical patent/JP2002537072A/en
Pending legal-status Critical Current

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Classifications

    • 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
    • A61L31/12—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
    • A61L31/121—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix
    • A61L31/124—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having an inorganic matrix of other specific inorganic materials not covered by A61L31/122 or A61L31/123
    • 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
    • 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
    • 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
    • A61F2002/9155—Adjacent bands being connected to each other
    • A61F2002/91575—Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
    • 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
    • A61F2230/0004—Rounded shapes, e.g. with rounded corners
    • A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
    • 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
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014—Special 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
    • A61F2250/0048—Special 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

Abstract

(57)【要約】 生体適合性のある展性金属の１以上の層と、超弾性または形状記憶合金の１以上の層と、から形成された管状部材内の開口によって規定された複合のステント構造。当該層は、共に、共引き込みされるか、圧縮適合されている。 (57) Abstract: A composite stent defined by an opening in a tubular member formed from one or more layers of a biocompatible malleable metal and one or more layers of a superelastic or shape memory alloy. Construction. The layers are co-drawn or compression-fit together.

Description

【発明の詳細な説明】DETAILED DESCRIPTION OF THE INVENTION

【０００１】 本発明は、一般にステントと呼ばれて、血管等の患者の体内の内腔内に移植さ
れてその開通性を維持するようになっている、拡張可能な体内人工物装置に関し
ている。特に、本発明は、超弾性または形状記憶合金及び生体適合性のある展性
合金の個別の層を備えた複合構造から形成された金属ステントに関している。The present invention relates to an expandable endoprosthesis device, commonly referred to as a stent, which is implanted in a lumen of a patient's body, such as a blood vessel, to maintain its patency. In particular, the invention relates to metal stents formed from composite structures with separate layers of superelastic or shape memory alloys and a biocompatible malleable alloy.

【０００２】 ステントは、血管または他の解剖内腔の断面の開放状態を保持すると共に時々
それを拡張するよう機能する、全体に円筒形状の装置である。ステントは特に、
内部の流路を塞ぐ可能性のある切開された動脈の内層を支持して押さえておくた
めの使用、あるいは、血管形成施術を受けた血管の部分の開通性を維持するため
の使用、に好適である。[0002] A stent is a generally cylindrical device that functions to keep the cross section of a blood vessel or other anatomical lumen open and sometimes expand it. Stents in particular
Suitable for use to support and hold the lining of an incised artery that may block the internal flow path, or to maintain patency of the portion of the blood vessel that has undergone angioplasty It is.

【０００３】 種々の装置が、ステントとしての使用のために、従来技術において知られてお
り、コイル状のワイヤ、スロット付きの管、バルーンカテーテル上で腔内に置か
れた後で拡張される種々のパターンに隣接接続された円筒状要素、熱的に拡張可
能な金属から製造されたらせん巻きコイルバネ、圧縮状態で挿入されて腔内の目
標位置にて例えばその上に存在するさやによって提供される圧縮力の撤回によっ
て拡張することが許容される自己拡張ステント、を含む。従来のステントを用い
て遭遇する困難の一つは、曲がりくねった人体の脈管構造の経路を容易に移動可
能なように長手方向に柔軟であって、容易かつ均一に拡張され得て、一旦ステン
トが配置され拡張された後で人体内腔自身によってあるいは人体内腔への外部力
によって作用される圧縮力のための永久変形に抵抗する、ステント構造を提供す
ることである。永久変形への抵抗は、例えば、患者の頸動脈内に配置されたステ
ントの場合に、特に望まれ得る。そこでは、ステントが、患者の頭及び首の運動
によって、あるいは、睡眠時に患者に使用される枕やアームや他のヘッドレスト
によって、あるいは、患者の首や頭への強風によって、発生される付加力を受け
る。[0003] Various devices are known in the art for use as stents, and are deployed after being placed in a lumen on a coiled wire, slotted tube, balloon catheter. Cylindrical element connected adjacent to the pattern of a spiral wound coil spring made of thermally expandable metal, provided in a compressed state at a target location in the cavity, e.g. by a sheath present thereon. A self-expanding stent that is allowed to expand upon withdrawal of the compressive force. One of the difficulties encountered with conventional stents is that they are longitudinally flexible so that they can be easily moved through the path of the tortuous vasculature, and can be easily and uniformly expanded, and once stented. Is to provide a stent structure that resists permanent deformation due to compressive forces applied by the body lumen itself or by external forces into the body lumen after it has been deployed and expanded. Resistance to permanent deformation may be particularly desirable, for example, in the case of a stent placed in the carotid artery of a patient. There, stents are used to provide additional force generated by movement of the patient's head and neck, or by pillows, arms and other headrests used on the patient during sleep, or by strong winds on the patient's neck and head. Receive.

【０００４】 多数の従来技術のステントが、種々の望ましい物理特性のために選択された異
なる材料を有する構造を採用することによって、それらに課された種々の要求を
満たすという問題に取り組むことを試みている。例えば、バナスらに与えられた
米国特許第５７４９８８０号は、その壁表面を貫通して半径方向拡張を許容する
開口とステントの内側及び外側壁表面を覆うポリテトラフルオロエチレン（ｅＰ
ＴＦＥ）の周方向隣接層とを有する管状ステント構造を備えたステント移植（st
ent-graft ）を開示している。ｅＰＴＦＥカバーは、管状ステントに焼結されて
、管状ステントの壁表面の周囲及びそれを通って結合している。ステントの拡張
時、ｅＰＴＦＥカバーは、同様に拡張して、体内組織または流体にステントを曝
すことを防止している。従って、当該ステントの目標は、その機械的特性を向上
するというよりもむしろ、ステントの生体適合性を向上することである。[0004] A number of prior art stents attempt to address the problem of meeting the varying requirements imposed on them by employing structures having different materials selected for various desired physical properties. ing. For example, U.S. Pat. No. 5,749,880 to Banas et al. Discloses polytetrafluoroethylene (eP) that covers the inner and outer wall surfaces of a stent with openings that allow radial expansion through the wall surface.
A stent-graft (stF) with a tubular stent structure having a circumferentially adjacent layer of TFE)
ent-graft). The ePTFE cover is sintered into the tubular stent and bonded around and through the wall surface of the tubular stent. Upon expansion of the stent, the ePTFE cover also expands to prevent exposure of the stent to body tissue or fluid. Thus, the goal of the stent is to improve the biocompatibility of the stent, rather than improve its mechanical properties.

【０００５】 ヘスらに与えられた米国特許５７２５５７０号は、露出された外側面を有する
金属外側層と当該外側層とは異なる材料で構成された内側コアとからなるフィラ
メントから編まれた管状の人工器官を開示している。外側層は、ニッケル−チタ
ン（ニチノール）またはステンレススチールのような超弾性合金から選択され、
コアは、タンタルのような高密度の放射線不透過性金属である。そのようなフィ
ラメントから形成されたステントは、実質的に、固体ニチノールフィラメントの
弾性特性と高い放射線不透過性とを示すと言われている。しかしながら、このよ
うなフィラメントは、増大された構造強度をフィラメントに与えないし、所望の
破砕抵抗よりも低い等の編まれたワイヤステントに関する問題を緩和しない。さ
らに、フィラメントは、ステントの編みまたは配置の間、同様に使用の間、にそ
れが曲げられる際に、広い範囲の張力及び圧縮力を受ける。これらの力は、内側
コアと外側層とで異なる程度で受けられ、コアと外側層との異なる金属によって
示される異なる応答のために、潜在的な故障の原因となり得る。[0005] US Pat. No. 5,725,570 to Hess et al. Discloses a tubular artificial woven from filaments consisting of a metal outer layer having an exposed outer surface and an inner core composed of a different material than the outer layer. Discloses an organ. The outer layer is selected from a superelastic alloy such as nickel-titanium (Nitinol) or stainless steel,
The core is a dense radiopaque metal such as tantalum. Stents formed from such filaments are said to exhibit substantially the elastic properties and high radiopacity of solid nitinol filaments. However, such filaments do not impart increased structural strength to the filament and do not alleviate problems with braided wire stents, such as being less than the desired crush resistance. In addition, the filament is subjected to a wide range of tension and compression forces as it is bent during braiding or placement of the stent, as well as during use. These forces are experienced to different degrees at the inner core and outer layers and can cause potential failure due to the different responses exhibited by the different metals at the core and outer layers.

【０００６】 装置の別のタイプは、例えば、フォガーティらに与えられた米国特許５７６９
８８２号に開示されており、人工物体の外側表面と人体内腔の内側壁との間に液
密シールを提供するための上方シール層を有する本質的に管状の人工物体本体を
備えている。この管状本体は、例えば形状記憶、薬剤送付、生体被吸収可能性及
び放射線不透過性等の異なる特性を当該管状本体に与えるべく、２以上の異なる
材料、例えば有機ポリマーと金属要素、で構成されるように記載されている。当
該明細書は、そのような異なる材料が種々の態様、例えば異なる編み込まれたら
せん及び編みひも、で合体され得て、タンタル、ニチノール、ポリエステル及び
ＰＴＦＥを含むことを開示している。また、このタイプの装置は、編まれた構造
に限定されているように見え、個々のフィラメントが単一の均質材料で構成され
ている構造に向けられている。さらに、このタイプの装置は、増大された構造強
度の目標に取り組んでいるようには見えない。[0006] Another type of device is disclosed, for example, in US Pat.
No. 882, which comprises an essentially tubular prosthesis body having an upper sealing layer to provide a fluid-tight seal between the outer surface of the prosthesis and the inner wall of the body lumen. The tubular body is composed of two or more different materials, such as an organic polymer and a metal element, to provide the tubular body with different properties, such as, for example, shape memory, drug delivery, bioabsorbability and radiopacity. It is described as follows. The specification discloses that such different materials can be combined in various aspects, such as different braided helices and braids, including tantalum, nitinol, polyester and PTFE. Also, devices of this type appear to be limited to knitted structures and are directed to structures where the individual filaments are composed of a single homogeneous material. Moreover, this type of device does not appear to address the goal of increased structural strength.

【０００７】 以上の見地から、脈管内の配置及び使用の間に生じ得る永久変形に抵抗する実
質的な弾性を示しながら増大された構造強度を提供するステントの必要性が残っ
ていることが明らかである。[0007] From the above, it is apparent that there remains a need for a stent that provides increased structural strength while exhibiting substantial elasticity to resist permanent deformation that may occur during endovascular placement and use. It is.

【０００８】 本発明は、超弾性または形状記憶合金材料の１以上の層と、それと共引き込み
（ｃｏ−ｄｒａｗｎ）または圧縮適合された生体適合性のある展性材料の１以上
の層と、を備えた金属管から製造された管状のステント構造を提供することによ
って、前述の必要性に取り組む。このステントは、種々のパターンを管の壁に形
成して、半径方向に拡張可能な相互接続された要素を生成することによって製造
される。このパターンは、種々の方法、例えばレーザ切断、機械的研削、化学エ
ッチング、これらの方法の組み合わせ等、によって形成され得る。[0008] The present invention provides for one or more layers of a superelastic or shape memory alloy material and one or more layers of a biocompatible malleable material that is co-drawn or compression-fitted therewith. The foregoing needs are addressed by providing a tubular stent structure made from provided metal tubing. The stent is manufactured by forming various patterns in the wall of the tube to create a radially expandable interconnected element. This pattern can be formed by various methods, such as laser cutting, mechanical grinding, chemical etching, combinations of these methods, and the like.

【０００９】 使用時において、当該ステントは、患者の脈管構造内に導入されて、よく知ら
れたバルーン血管形成技術を用いる目標位置に配置される。一旦拡張されると、
当該ステントは、展性材料の層のために、構造強度と破砕抵抗とを示し、血管壁
を支持すると共に血管の開通性を維持する。当該ステントは、付加的に、圧縮力
を受ける時はいつでも所定の拡張サイズ及び形状にバネ的に戻り続ける超弾性材
料の層のために、永久変形への高められた抵抗を示す。In use, the stent is introduced into a patient's vasculature and placed at a target location using well-known balloon angioplasty techniques. Once expanded,
Due to the layer of malleable material, the stent exhibits structural strength and crush resistance, supports the vessel wall and maintains the patency of the vessel. The stent additionally exhibits increased resistance to permanent deformation due to the layer of superelastic material that continues to spring back to a predetermined expanded size and shape whenever subjected to a compressive force.

【００１０】 本発明の方法に従って形成されるステントは、拡張された時に半径方向強度と
永久変形への優れた抵抗とを提示する軸方向に柔軟な構造を提供する。当該ステ
ントは、公知の方法及び材料を用いて経済的に製造され、ステント及びステント
状の装置の長期間の安全に対する重要な改良を備える。[0010] Stents formed in accordance with the methods of the present invention provide an axially flexible structure that, when expanded, exhibits radial strength and excellent resistance to permanent deformation. The stents are economically manufactured using known methods and materials and provide significant improvements to the long-term safety of stents and stent-like devices.

【００１１】 図１は、本発明によるステントを製造するための管を示す断面図である。FIG. 1 is a sectional view showing a tube for manufacturing a stent according to the present invention.

【００１２】 図２は、本発明によって製造されたステントパターンの平らな断面を示す平面
図である。FIG. 2 is a plan view showing a flat cross section of a stent pattern manufactured according to the present invention.

【００１３】 図３は、本発明によって製造された別の実施の形態のステントパターンの平ら
な断面を示す平面図である。FIG. 3 is a plan view showing a flat cross-section of another embodiment of a stent pattern made according to the present invention.

【００１４】 本発明によるステントを製造するための管の好適な実施の形態が示されている
図１を参照すると、円筒管１０が共引き込みされた外側層３０と内側層３２とか
ら構成されている。図１に示された円筒状管１０の実施の形態は、内側層３２の
内側露出面３４によって規定され管１０を通って軸方向に延びる内側内腔４０を
有する円筒状形態に引き込まれている。Referring to FIG. 1, which shows a preferred embodiment of a tube for manufacturing a stent according to the present invention, a cylindrical tube 10 is comprised of a co-retracted outer layer 30 and an inner layer 32. I have. The embodiment of the cylindrical tube 10 shown in FIG. 1 is drawn into a cylindrical configuration having an inner lumen 40 defined by the inner exposed surface 34 of the inner layer 32 and extending axially through the tube 10. .

【００１５】 内側層３２は、種々の方法によって、外側層３０内に配置され得る。好適な方
法は、内側層と外側層とを共引き込みすることを伴い、結果的に、内側層と外側
層との間に緊密な連続界面３６をもたらす。共引き込み処理の詳細は、例えば、
ＡＳＭインターナショナルによる１９８８年著作権の金属ハンドブック９版のボ リューム１４：形成と鍛造 、に見出され得る。別の方法は、例えば内側層を支持
のための所定の形状の適合マンドレルの上に配置して、外側層を内側層の上方に
スライドして、２つの層からなる組立体に当該２つの層がマンドレル上で押し縮
められてマンドレルの形状を帯びるのに十分な圧縮力を与える、等の内側層の上
への外側層の圧縮適合を含む。それに続いて、２つの層によってかように形成さ
れた管状本体は、マンドレルから取り外され得て、開示の他の所に記載されたよ
うに更に処理され得る。The inner layer 32 may be disposed within the outer layer 30 by various methods. The preferred method involves co-pulling the inner and outer layers, resulting in a tight continuous interface 36 between the inner and outer layers. Details of the co-pull-in process are, for example,
Volume of metal Handbook 9 edition of the 1988 copyright by ASM International volume 14: forming and forging, it can be found in. Another method is to place the inner layer over a conforming mandrel of a predetermined shape for support and slide the outer layer over the inner layer to form the two layer assembly into a two layer assembly. Include a compression fit of the outer layer over the inner layer, such as being compressed over the mandrel to provide sufficient compressive force to assume the shape of the mandrel. Subsequently, the tubular body thus formed by the two layers can be removed from the mandrel and further processed as described elsewhere in the disclosure.

【００１６】 更に図１を参照して、外側層３０は、好適には、血管壁の開通性を維持すべく
拡張された時に十分な強度を示す展性金属材料から形成されている。外側層の好
適な材料は、ステンレススチールである。それは、その生体適合性及び構造強度
のために脈管内の応用に十分に適している。外側層を形成する際に採用され得る
他の材料は、コバルト、プラチナ、イリジウム、金、マグネシウム、チタン、タ
ンタル、及び、プラチナ−イリジウム合金、を含む。Still referring to FIG. 1, the outer layer 30 is preferably formed from a malleable metallic material that exhibits sufficient strength when expanded to maintain the patency of the vessel wall. A preferred material for the outer layer is stainless steel. It is well suited for intravascular applications due to its biocompatibility and structural strength. Other materials that may be employed in forming the outer layer include cobalt, platinum, iridium, gold, magnesium, titanium, tantalum, and platinum-iridium alloys.

【００１７】 内側層３２は、変形力を受ける時にはいつでもその元のサイズ及び形状にバネ
的に戻る弾性金属材料から形成されている。従って、内側層は、バネスチールか
ら、あるいは、超弾性または形状記憶特性を示す合金から、製造され得る。その
ような合金から製造される物品は、それらの元の形状から熱的に不安定な異なる
形態へと変形され得て、熱の適用によって元の形態に戻る。ある種の形状記憶合
金は、当業者によく知られた超弾性のニッケル−チタン合金（ＮｉＴｉ）（ニチ
ノール）または銅−亜鉛−アルミニウム合金（ＣｕＺｎＡｌ）を含み、製造物品
への応力の適用によって変形され得て、当該応力の除去時に応力誘引マルテンサ
イト（ＳＩＭ）と一般に呼ばれる現象で元の形状に戻る。これによれば、物品を
交互に冷却及び加熱する必要が無くなる。合金がオーステナイトからマルテンサ
イトに最初に変換し始める温度とマルテンサイトが発生し得る最大温度との間の
温度で応力を与えられるＳＩＭ形状記憶合金は、限界応力まで弾性的に変形して
、その後ＳＩＭの形成によって変形し続ける。変形応力が除去されて、合金がオ
ーステナイトに戻り始める温度を上回る温度である時、合金はその元の形状に戻
ろうとする。合金が安定なオーステナイト相に戻り始める温度は、合金の組成に
従って変化する。内側層３２を作るために選択されるＳＩＭ形状記憶合金が約３
６．７℃（９８°Ｆ）の典型的な人体温度でオーステナイトに戻る合金であるこ
とが、本発明の実践にとって明らかに好適である。内側層３２を形成するために
好適な他の材料は、銅−スズ、銅−亜鉛、銅−亜鉛−スズ、銅−亜鉛−キセノン
、銅−アルミニウム−ニッケル、銅−金−亜鉛、金−カドミウム、金−銅−亜鉛
、鉄ベリリウム（Ｆｅ３ Ｂｅ）、鉄プラチナ（Ｆｅ３ Ｐｔ）、インジウム−
タリウム、鉄−マンガン、鉄−ニッケル−チタン−コバルト、ニッケル−チタン
−バナジウム、及び、銀−カドミウム、を含む。超弾性及び形状記憶合金の例は
、ハリソンらに与えられた米国特許第４０３５００７号、メルトンらに与えられ
た米国特許第４１４４０５７号、クインに与えられた米国特許第４５０５７６７
号、ヤマウチに与えられた米国特許第４８９４１００号、アブジュドムらに与え
られた米国特許第５１１４５０４号、及び、ゴルドバーグに与えられた米国特許
第５６４１３６４号、に見出される。The inner layer 32 is formed from a resilient metallic material that resiliently returns to its original size and shape whenever subjected to a deforming force. Thus, the inner layer may be manufactured from spring steel or from an alloy exhibiting superelastic or shape memory properties. Articles made from such alloys can be deformed from their original shape to a different form that is thermally unstable, and return to their original form upon the application of heat. Certain shape memory alloys include superelastic nickel-titanium alloys (NiTi) (Nitinol) or copper-zinc-aluminum alloys (CuZnAl), well known to those skilled in the art, and are deformed by the application of stress to a manufactured article. When the stress is removed, the shape returns to its original shape by a phenomenon generally called stress-induced martensite (SIM). This eliminates the need to alternately cool and heat the article. SIM shape memory alloys that are stressed at a temperature between the temperature at which the alloy first begins to convert from austenite to martensite and the maximum temperature at which martensite can occur, will elastically deform to a critical stress and then SIM Continue to deform due to the formation of When the deformation stress is removed and the temperature is above the temperature at which the alloy begins to return to austenite, the alloy attempts to return to its original shape. The temperature at which the alloy begins to return to the stable austenite phase varies according to the composition of the alloy. The SIM shape memory alloy selected to make the inner layer 32 is about 3
An alloy that returns to austenite at a typical human body temperature of 6.7 ° C. (98 ° F.) is clearly suitable for the practice of the present invention. Other materials suitable for forming the inner layer 32 include copper-tin, copper-zinc, copper-zinc-tin, copper-zinc-xenon, copper-aluminum-nickel, copper-gold-zinc, gold-cadmium. gold - copper - zinc, iron beryllium (Fe 3 Be), iron Platinum (Fe 3 Pt), indium -
Thallium, iron-manganese, iron-nickel-titanium-cobalt, nickel-titanium-vanadium, and silver-cadmium. Examples of superelastic and shape memory alloys are U.S. Pat. No. 4,035,007 to Harrison et al., U.S. Pat. No. 4,144,057 to Melton et al., And U.S. Pat. No. 4,505,767 to Quinn.
No. 4,894,100 to Yamauchi, U.S. Pat. No. 5,114,504 to Abjudom et al., And U.S. Pat. No. 5,641,364 to Goldberg.

【００１８】 図２を参照して、内側層３２と外側層３０とが本体１０を形成すべく共に結合
されている時、最終的なステントは、外側層及び内側層を貫通するパターンを切
断して、相互接続部材５２によって隣接要素に接続された半径方向に拡張可能な
要素５０を形成することによって、製造される。非常に多くのパターンが、本体
１０内に切り込まれ得て、拡張可能なステントを形成する。図３は、そのような
パターンの別の実施の形態を示している。共有のラウらに与えられた米国特許第
５５１４１５４号、ラムに与えられた米国特許第５５６９２９５号、オースらに
与えられた米国特許第５５９１１９７号、ラウらに与えられた米国特許第５６０
３７２１号、ラムに与えられた米国特許第５６４９９５２号、ラウらに与えられ
た米国特許第５７２８１５８号、及び、ラウらに与えられた米国特許第５７３５
８９３号、がそのような半径方向に拡張可能なステントパターンを開示している
。Referring to FIG. 2, when inner layer 32 and outer layer 30 are joined together to form body 10, the final stent cuts the pattern through the outer and inner layers. It is manufactured by forming a radially expandable element 50 connected to an adjacent element by an interconnecting member 52. Numerous patterns can be cut into body 10 to form an expandable stent. FIG. 3 shows another embodiment of such a pattern. U.S. Patent No. 5,514,154 to Lau et al., U.S. Patent No. 5,569,295 to Ram, U.S. Patent No. 5,591,197 to Oath et al., U.S. Patent No. 560 to Lau et al.
No. 3,721, U.S. Pat. No. 5,649,952 to Ram, U.S. Pat. No. 5,728,158 to Lau et al., And U.S. Pat.
No. 893 discloses such a radially expandable stent pattern.

【００１９】 図２及び図３を参照して、拡張可能な要素５０及び６０は、好適には、例えば
前記の特許や共有のサウンダースに与えられた米国特許第５７５９１９２号に記
載された処理等のレーザ切断処理によって本体１０から形成される。別の好適な
方法は、例えば前記のラウらに与えられた米国特許第５７３５８９３号に記載さ
れた処理等によって、管１０を化学的にエッチングすることを含んでいる。With reference to FIGS. 2 and 3, expandable elements 50 and 60 are preferably constructed of a process, such as the process described in US Pat. No. 5,759,192, issued to the aforementioned patents and commonly owned Sounders. It is formed from the main body 10 by a laser cutting process. Another suitable method involves chemically etching the tube 10, such as by the process described in US Pat. No. 5,735,893 to Lau et al., Supra.

【００２０】 永久変形への優れた抵抗を提示しながら人体の内腔の開通性を維持するために
、本発明が新しい改良されたステントを提供することが、以上から明らかである
。本発明は、ここでは、脈管内のステントとしての使用について図示され説明さ
れたが、ここで開示されたステント構造が他のタイプの拡張可能な脈管内装置、
例えば移植片（grafts）やフィルタ等、を製造するために使用され得ることは、
当業者にとって明らかである。付加的に、本発明の範囲は、展性金属と弾性合金
との各一層のみのステントに限定されないで、ステント及び他の装置を形成すべ
く、そのような展性金属と弾性合金との多層から構成された管状構造の使用を含
んでいる。本発明は、層を共に適合及び／または結合するための開示された方法
のみに限定されない。開示された方法は、多くの実践可能な可能性の単なる例で
ある。更なる修正及び改良が、本発明の範囲から離れないで、なされ得る。従っ
て、本発明が限定されることは、添付の請求の範囲を除いて、意図されていない
。From the foregoing, it is apparent that the present invention provides a new and improved stent for maintaining the patency of a body lumen while exhibiting excellent resistance to permanent deformation. Although the invention has been illustrated and described herein for use as an intravascular stent, the stent structures disclosed herein may be used in other types of expandable intravascular devices,
What can be used to produce, for example, grafts, filters, etc.
It will be clear to those skilled in the art. Additionally, the scope of the present invention is not limited to a single-layer stent of a malleable metal and an elastic alloy, but rather a multilayer of such malleable metal and an elastic alloy to form stents and other devices. And the use of tubular structures composed of The invention is not limited to only the disclosed methods for fitting and / or bonding layers together. The disclosed method is merely an example of many possible possibilities. Further modifications and improvements can be made without departing from the scope of the invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.

【図面の簡単な説明】[Brief description of the drawings]

【図１】 本発明によるステントを製造するための管を示す断面図。FIG. 1 is a sectional view showing a tube for manufacturing a stent according to the present invention.

【図２】 本発明によって製造されたステントパターンの平らな断面を示す平面図。FIG. 2 is a plan view showing a flat cross section of a stent pattern manufactured according to the present invention.

【図３】 本発明によって製造された別の実施の形態のステントパターンの平らな断面を
示す平面図。FIG. 3 is a plan view showing a flat cross-section of another embodiment of a stent pattern made according to the present invention.

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Claims (17)

【特許請求の範囲】[Claims] 【請求項１】 生体適合性のある展性金属から形成され、管状の半径方向拡張可能な本体を規
定する外側層と、 超弾性金属から形成され、外側層内に配置され、管状の本体を通る長手方向内
腔を規定する内側層と、 を備えた人体内腔内で移植及び拡張するためのステント。1. An outer layer formed of a biocompatible malleable metal and defining a tubular radially expandable body; and an outer layer formed of a superelastic metal and disposed within the outer layer to form the tubular body. An inner layer defining a longitudinal lumen therethrough; and a stent for implantation and expansion within a body lumen. 【請求項２】 展性金属は、ステンレススチール、コバルト、プラチナ、イリジウム、金、マ
グネシウム、チタン、タンタル、及び、プラチナ−イリジウム合金、からなる群
から選択される ことを特徴とする請求項１に記載のステント。2. The malleable metal according to claim 1, wherein the malleable metal is selected from the group consisting of stainless steel, cobalt, platinum, iridium, gold, magnesium, titanium, tantalum, and a platinum-iridium alloy. The stent according to any of the preceding claims. 【請求項３】 超弾性金属は、銅−スズ、銅−亜鉛、銅−亜鉛−アルミニウム、銅−亜鉛−ス
ズ、銅−亜鉛−キセノン、銅−アルミニウム−ニッケル、銅−金−亜鉛、金−カ
ドミウム、金−銅−亜鉛、鉄ベリリウム（Ｆｅ３ Ｂｅ）、鉄プラチナ（Ｆｅ３ Ｐｔ）、インジウム−タリウム、鉄−マンガン、鉄−ニッケル−チタン−コバ
ルト、ニッケル−チタン、ニッケル−チタン−バナジウム、及び、銀−カドミウ
ム、からなる合金の群から選択される ことを特徴とする請求項１に記載のステント。3. The superelastic metal is copper-tin, copper-zinc, copper-zinc-aluminum, copper-zinc-tin, copper-zinc-xenon, copper-aluminum-nickel, copper-gold-zinc, gold- Cadmium, gold-copper-zinc, iron beryllium (Fe 3 Be), iron platinum (Fe 3 Pt), an alloy selected from the group consisting of indium-thallium, iron-manganese, iron-nickel-titanium-cobalt, nickel-titanium, nickel-titanium-vanadium, and silver-cadmium. Item 2. The stent according to Item 1. 【請求項４】 外側層と内側層とは、管状本体を規定する一体の管を形成すべく、共引き込み
されている ことを特徴とする請求項１に記載のステント。4. The stent according to claim 1, wherein the outer layer and the inner layer are co-retracted to form an integral tube defining a tubular body. 【請求項５】 内側層と外側層とは、管状本体を形成すべく、共引き込みされている ことを特徴とする請求項１に記載のステント。5. The stent of claim 1, wherein the inner and outer layers are co-drawn to form a tubular body. 【請求項６】 内側層は、管状本体を形成すべく、外側層に結合されている ことを特徴とする請求項１に記載のステント。6. The stent of claim 1, wherein the inner layer is joined to the outer layer to form a tubular body. 【請求項７】 外側層は、管状本体を形成すべく、内側層上に圧縮されて締まりばめを形成し
ている ことを特徴とする請求項１に記載のステント。7. The stent of claim 1, wherein the outer layer is compressed over the inner layer to form an interference fit to form a tubular body. 【請求項８】 管状本体内になされるレーザ切断によって規定された複数の拡張可能要素を更
に備える ことを特徴とする請求項１に記載のステント。8. The stent of claim 1, further comprising a plurality of expandable elements defined by a laser cut made in the tubular body. 【請求項９】 生体適合性のある展性金属から形成され、外側面と内側面とを有し、管状の半
径方向拡張可能な本体を規定する、少なくとも１つの層と、 超弾性金属から形成され、少なくとも１つの展性金属層の面の一つに結合され
た、少なくとも１つの層と、 を備えた人体内腔内で移植するためのステント。9. At least one layer formed of a biocompatible malleable metal, having an outer surface and an inner surface, defining a tubular, radially expandable body, formed from a superelastic metal. And at least one layer bonded to one of the faces of the at least one malleable metal layer. 【請求項１０】 展性金属は、ステンレススチール、コバルト、プラチナ、イリジウム、金、マ
グネシウム、チタン、タンタル、及び、プラチナ−イリジウム合金、からなる群
から選択される ことを特徴とする請求項９に記載のステント。10. The malleable metal according to claim 9, wherein the malleable metal is selected from the group consisting of stainless steel, cobalt, platinum, iridium, gold, magnesium, titanium, tantalum, and a platinum-iridium alloy. The stent according to any of the preceding claims. 【請求項１１】 超弾性金蔵は、銅−スズ、銅−亜鉛、銅−亜鉛−アルミニウム、銅−亜鉛−ス
ズ、銅−亜鉛−キセノン、銅−アルミニウム−ニッケル、銅−金−亜鉛、金−カ
ドミウム、金−銅−亜鉛、鉄ベリリウム（Ｆｅ３ Ｂｅ）、鉄プラチナ（Ｆｅ３ Ｐｔ）、インジウム−タリウム、鉄−マンガン、鉄−ニッケル−チタン−コバ
ルト、ニッケル−チタン、ニッケル−チタン−バナジウム、及び、銀−カドミウ
ム、からなる合金の群から選択される ことを特徴とする請求項９に記載のステント。11. The superelastic metallurgy includes copper-tin, copper-zinc, copper-zinc-aluminum, copper-zinc-tin, copper-zinc-xenon, copper-aluminum-nickel, copper-gold-zinc, gold- Cadmium, gold-copper-zinc, iron beryllium (Fe 3 Be), iron platinum (Fe 3 Pt), an alloy selected from the group consisting of indium-thallium, iron-manganese, iron-nickel-titanium-cobalt, nickel-titanium, nickel-titanium-vanadium, and silver-cadmium. Item 10. The stent according to item 9, 【請求項１２】 管状本体内に形成される開口によって規定された複数の拡張可能要素を更に備
える ことを特徴とする請求項９に記載のステント。12. The stent of claim 9, further comprising a plurality of expandable elements defined by openings formed in the tubular body. 【請求項１３】 第１の生体適合性のある展性金属と第２の超弾性金属とから形成された交互の
層であって、互いの内部に配置され、それを通って延びる長手方向内腔を有する
管状の半径方向拡張可能な本体を規定する交互の層 を備えた人体内腔内で移植するためのステント。13. An alternating layer formed from a first biocompatible malleable metal and a second superelastic metal, wherein the layers are disposed within each other and extend longitudinally therethrough. A stent for implantation in a human body lumen having alternating layers defining a tubular, radially expandable body having a lumen. 【請求項１４】 展性金属は、ステンレススチール、コバルト、プラチナ、イリジウム、金、マ
グネシウム、チタン、タンタル、及び、プラチナ−イリジウム合金、からなる群
から選択される ことを特徴とする請求項１３に記載のステント。14. The malleable metal according to claim 13, wherein the malleable metal is selected from the group consisting of stainless steel, cobalt, platinum, iridium, gold, magnesium, titanium, tantalum, and a platinum-iridium alloy. The stent according to any of the preceding claims. 【請求項１５】 超弾性金属は、銅−スズ、銅−亜鉛、銅−亜鉛−アルミニウム、銅−亜鉛−ス
ズ、銅−亜鉛−キセノン、銅−アルミニウム−ニッケル、銅−金−亜鉛、金−カ
ドミウム、金−銅−亜鉛、鉄ベリリウム（Ｆｅ３ Ｂｅ）、鉄プラチナ（Ｆｅ３ Ｐｔ）、インジウム−タリウム、鉄−マンガン、鉄−ニッケル−チタン−コバ
ルト、ニッケル−チタン、ニッケル−チタン−バナジウム、及び、銀−カドミウ
ム、からなる合金の群から選択される ことを特徴とする請求項１３に記載のステント。15. The superelastic metal may be copper-tin, copper-zinc, copper-zinc-aluminum, copper-zinc-tin, copper-zinc-xenon, copper-aluminum-nickel, copper-gold-zinc, gold- Cadmium, gold-copper-zinc, iron beryllium (Fe 3 Be), iron platinum (Fe 3 Pt), an alloy selected from the group consisting of indium-thallium, iron-manganese, iron-nickel-titanium-cobalt, nickel-titanium, nickel-titanium-vanadium, and silver-cadmium. Item 14. The stent according to item 13. 【請求項１６】 交互の層は、拡張可能な本体を規定する一体の管として、共引き込みされてい
る ことを特徴とする請求項１３に記載のステント。16. The stent of claim 13, wherein the alternating layers are co-retracted as a unitary tube defining an expandable body. 【請求項１７】 交互の層は、管状本体を形成すべく、共に圧縮されて締まりばめを形成してい
る ことを特徴とする請求項１３に記載のステント。17. The stent according to claim 13, wherein the alternating layers are compressed together to form an interference fit to form a tubular body.
JP2000600710A 1999-02-26 2000-02-25 Composite superelastic / shape memory alloy and malleable alloy stents Pending JP2002537072A (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007319516A (en) * 2006-06-02 2007-12-13 Norikata Taguma Gastrostomy tube using shape memory alloy and its use method

Families Citing this family (23)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6890350B1 (en) 1999-07-28 2005-05-10 Scimed Life Systems, Inc. Combination self-expandable, balloon-expandable endoluminal device
ATE432673T1 (en) * 2000-10-31 2009-06-15 Boston Scient Ltd ENDOLUMINAL DEVICE WITH SUPERELASTIC AND PLASTIC DEFORMABLE SECTIONS
EP1212986A1 (en) 2000-12-08 2002-06-12 SORIN BIOMEDICA CARDIO S.p.A. An angioplasty stent and manufacturing method thereof
DE10301850B4 (en) * 2003-01-16 2017-05-04 Dendron Gmbh stent
US7789979B2 (en) 2003-05-02 2010-09-07 Gore Enterprise Holdings, Inc. Shape memory alloy articles with improved fatigue performance and methods therefor
EP1771132B1 (en) 2004-02-03 2019-03-27 V-Wave Ltd. Device and method for controlling in-vivo pressure
WO2007083288A2 (en) 2006-01-23 2007-07-26 Atria Medical Inc. Heart anchor device
US7955383B2 (en) 2006-04-25 2011-06-07 Medtronics Vascular, Inc. Laminated implantable medical device having a metallic coating
US8062378B2 (en) 2007-03-26 2011-11-22 Mx Orthopedics Corp. Proximal self-locking long bone prosthesis
JP5295104B2 (en) 2007-05-09 2013-09-18 独立行政法人科学技術振興機構 Guidewire and stent
US20210161637A1 (en) 2009-05-04 2021-06-03 V-Wave Ltd. Shunt for redistributing atrial blood volume
CN102499800B (en) * 2011-11-17 2014-07-16 苏州大学 Blood vessel stent and preparation method thereof
CN105555204B (en) 2013-05-21 2018-07-10 V-波有限责任公司 For delivering the equipment for the device for reducing left atrial pressure
US10835394B2 (en) 2016-05-31 2020-11-17 V-Wave, Ltd. Systems and methods for making encapsulated hourglass shaped stents
US20170340460A1 (en) 2016-05-31 2017-11-30 V-Wave Ltd. Systems and methods for making encapsulated hourglass shaped stents
US11291807B2 (en) 2017-03-03 2022-04-05 V-Wave Ltd. Asymmetric shunt for redistributing atrial blood volume
US11458287B2 (en) 2018-01-20 2022-10-04 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
EP3740163A1 (en) 2018-01-20 2020-11-25 V-Wave Ltd. Devices and methods for providing passage between heart chambers
US10898698B1 (en) * 2020-05-04 2021-01-26 V-Wave Ltd. Devices with dimensions that can be reduced and increased in vivo, and methods of making and using the same
CN108543109B (en) * 2018-03-13 2020-09-18 淮阴工学院 Low-abrasion dual-antibacterial titanium-based nanocomposite bone implant and forming method thereof
US11612385B2 (en) 2019-04-03 2023-03-28 V-Wave Ltd. Systems and methods for delivering implantable devices across an atrial septum
US11865282B2 (en) 2019-05-20 2024-01-09 V-Wave Ltd. Systems and methods for creating an interatrial shunt
WO2023199267A1 (en) 2022-04-14 2023-10-19 V-Wave Ltd. Interatrial shunt with expanded neck region

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2380683C (en) * 1991-10-28 2006-08-08 Advanced Cardiovascular Systems, Inc. Expandable stents and method for making same
US5733326A (en) * 1996-05-28 1998-03-31 Cordis Corporation Composite material endoprosthesis
US6174329B1 (en) * 1996-08-22 2001-01-16 Advanced Cardiovascular Systems, Inc. Protective coating for a stent with intermediate radiopaque coating
US6264687B1 (en) * 1998-04-20 2001-07-24 Cordis Corporation Multi-laminate stent having superelastic articulated sections

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2007319516A (en) * 2006-06-02 2007-12-13 Norikata Taguma Gastrostomy tube using shape memory alloy and its use method

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