KR100548781B1 - A cylindrical stent - Google Patents

A cylindrical stent Download PDF

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KR100548781B1
KR100548781B1 KR1020030021913A KR20030021913A KR100548781B1 KR 100548781 B1 KR100548781 B1 KR 100548781B1 KR 1020030021913 A KR1020030021913 A KR 1020030021913A KR 20030021913 A KR20030021913 A KR 20030021913A KR 100548781 B1 KR100548781 B1 KR 100548781B1
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turns
turn
stent
cylindrical
lumen
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KR1020030021913A
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KR20040087492A (en
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강성권
김은상
이세철
김종규
권정수
이정철
조금희
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주식회사 에스앤지바이오텍
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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
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/04Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06Blood vessels
    • A61F2/07Stent-grafts
    • 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
    • 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 sheet material 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 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
    • 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
    • A61F2/94Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS 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
    • A61L31/00Materials 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
    • A61L31/02Inorganic materials
    • A61L31/022Metals or alloys
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/3011Cross-sections or two-dimensional shapes
    • A61F2002/30112Rounded shapes, e.g. with rounded corners
    • A61F2002/30136Rounded shapes, e.g. with rounded corners undulated or wavy, e.g. serpentine-shaped or zigzag-shaped
    • 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
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108Shapes
    • A61F2002/30199Three-dimensional shapes
    • A61F2002/30224Three-dimensional shapes cylindrical
    • 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
    • A61F2002/821Ostial stents
    • 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
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2210/0014Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof using shape memory or superelastic materials, e.g. nitinol
    • 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
    • A61F2250/0004Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
    • A61F2250/0012Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting elasticity, flexibility, spring rate or mechanical tension

Abstract

본 발명은 와이어로 이루어져 있으며 길이방향의 축을 가지는 원통형 스텐트에 관한 것으로서, [ⅰ] 와이어가 원주면을 따라 직선부(1a)들로 연결되는 다수의 피크부(1c)와 밸리부(1b)를 가지면서 지그재그로 일회전 하면서 형성하는 기준턴(1)들이 원통 길이방향을 따라 기준턴의 높이(h)와 동일한 간격으로 서로 교차점 없이 배열되어 있는 복수개의 기준턴과, [ⅱ] 상기 기준턴의 좌·우 경사방향으로 배열되면서 겹쳐지는 기준턴의 직선부(1a)들을 코일 상으로 감아 상기 복수개의 기준턴들을 메쉬형태로 서로 연결하고 있는 연결턴(2)들이 좌·우 경사방향으로 기준턴 직선부 간의 거리(d)와 동일한 간격으로 배치 되어있는 복수개의 연결턴으로 구성되는 것을 특징으로 한다. 본 발명은 기준턴(1)들을 연결하는 연결턴(2)을 구비하여 유연성이 우수함과 동시에, 상기 연결턴(2)이 기준턴(1)을 감고있어 팽창성도 우수하다. 그 결과 내강의 변형곡선과 밀착이 잘 되고, 굴곡시에도 원통형상을 그대로 유지하여 혈관 등의 흐름을 양호하게 하고, 고정용 와이어 형성도 최소화 할 수 있다.The present invention relates to a cylindrical stent composed of a wire and having a longitudinal axis, wherein a plurality of peaks 1c and valleys 1b are connected to the linear portions 1a along the circumferential surface. The reference turns (1) having a one-turn in a zigzag and having a plurality of reference turns are arranged without crossing points at intervals equal to the height (h) of the reference turn along the cylindrical longitudinal direction, and [ii] The connecting turns 2 connecting the plurality of reference turns to each other in a mesh form by winding the linear portions 1a of the reference turns overlapping while being arranged in the left and right inclined directions are turned in the reference turn in the left and right inclination directions. It is characterized by consisting of a plurality of connecting turns arranged at the same interval as the distance (d) between the straight portion. The present invention is provided with a connection turn (2) for connecting the reference turns (1) and excellent flexibility, the connection turn (2) is wound around the reference turn (1) is also excellent in expandability. As a result, the lumen is in close contact with the deformation curve of the lumen, and even when bending, it is possible to maintain the cylindrical shape as it is, to improve the flow of blood vessels, etc., and to minimize the formation of fixing wire.

스텐트, 의료용구, 원통형, 코일상, 기준턴, 연결턴, 간격, 탄력성Stent, Medical Device, Cylindrical, On Coil, Reference Turn, Connecting Turn, Spacing, Elasticity

Description

원통형 스텐트 {A cylindrical stent} Cylindrical stent {A cylindrical stent}             

도 1은 본 발명 스텐트의 사시 개략도1 is a perspective schematic view of the stent of the present invention

도 2는 본 발명 스텐트의 단위셀을 나타내는 확대도Figure 2 is an enlarged view showing a unit cell of the stent of the present invention

도 3은 본 발명 스텐트의 기준턴을 나타내는 확대도Figure 3 is an enlarged view showing the reference turn of the stent of the present invention

도 4 - 도 6은 본 발명 스텐트를 제조하는 방법을 설명하기 위한 도면4 to 6 are views for explaining a method of manufacturing the stent of the present invention

도 7 및 도 8은 종래 스텐트에 있어서 기준턴들의 연결상태를 나타내는 도면7 and 8 are views showing the connection state of the reference turns in the conventional stent

※ 도면중 주요부분에 대한 부호 설명※ Explanation of main parts in drawings

1 : 기준턴 2 : 연결턴1: reference turn 2: connection turn

1a : 기준턴의 직선부 1b : 기준턴의 밸리부1a: straight portion of the reference turn 1b: valley portion of the reference turn

1c : 기준턴의 피크부 d : 기준턴의 직선부간 거리 1c: peak portion of the reference turn d: distance between the straight portions of the reference turn

h : 기준턴의 높이 H : 기준턴 간의 간격h: Height of reference turn H: Spacing between reference turns

10 : 스텐트 제작용 지그 11 : 제 1 기준핀 12 : 제 2 기준핀10: jig for manufacturing stent 11: 1st reference pin 12: 2nd reference pin

본 발명은 내강용 의료용구에 관한 것으로서, 구체적으로는 혈관 또는 식도 등의 내강이 협착된 경우 이를 확장해 주는 자기팽창형 의료용구(이하 "스텐트" 라고 한다)에 관한 것이다. 보다 구체적으로 본 발명은 최소한의 크기로 축소될 수 있을 뿐만아니라 팽창성이 우수하고, 내강의 굽어진 모양대로 잘 휘면서 유연성도 아주 우수한 스텐트에 관한 것이다.The present invention relates to a luminal medical device, and more particularly, to a self-expansion type medical device (hereinafter referred to as a "stent") that expands when the lumen of blood vessels or esophagus is constricted. More specifically, the present invention relates to a stent that is not only able to be reduced to a minimum size but also has excellent expandability and excellent flexibility while bending in a curved shape of the lumen.

일반적으로 인체내에 발생되는 질병에 의해 인체내의 내강들은 협착되어 기능이 저하되거나 심한 경우 아무런 기능을 할 수 없는 상태가 될 수 있다. 예컨대, 내강이 협착된 경우로는 식도암으로 식도가 협착을 일으키거나, 동맥경화증에 의해 원활한 혈액순환이 이루어지지 않을 때, 또는 간으로부터 나오는 담즙이 흐를 수 있는 트랙이 협착된 경우가 있다.In general, due to diseases occurring in the human body, the lumens in the human body may become narrowed and may be in a state in which no function may occur in severe cases. For example, when the lumen is narrowed, esophageal cancer may cause narrowing of the esophagus, when atherosclerosis does not allow a smooth blood circulation, or when a track through which bile from the liver flows may be narrowed.

이와 같이 내강이 협착된 상태에서는 음식물이나 혈액 또는 담즙 등이 원활히 흐를 수 없기 때문에 협착된 내강을 확장시켜 통로를 유지시켜 주어야 하는데, 이 경우에 협착된 통로를 확장하여 유지시켜 주기위한 방법으로 예컨대, 스텐트(Stent)가 내강에 삽입된다.As the lumen is confined as described above, food, blood, or bile cannot flow smoothly. Therefore, the constricted lumen should be expanded to maintain the passage. In this case, for example, as a method for extending and maintaining the constricted passage, A stent is inserted into the lumen.

이러한 스텐트는 대체적으로 전체적인 형상이 원통형 구조체를 이루고, 자체가 탄성력을 가지고 있어 외력을 가하여 수축시킬 수 있고 이 외력을 제거하면 자체 팽창하는 방식이 널리 사용되고 있다.Such stents generally have a cylindrical structure in overall shape, and have an elastic force so that the stent can be contracted by applying an external force, and when the external force is removed, the self-expanding method is widely used.

상기한 자체 팽창형 스텐트는 여러가지 특성 즉, 내강을 팽창시켜 주기 위한 팽창성과, 내강의 굽어진 부위에서 내강의 굽어진 모양을 그대로 유지하면서 유연하게 적응할 수 있는 유연성과, 일정한 직경으로 축소되기 위한 축소성 등을 보유 해야 스텐트로서의 기능을 제대로 발휘할 수 있게 되는 것이다.The self-expandable stent has various characteristics, that is, expandability to expand the lumen, flexibility to adapt flexibly while maintaining the curved shape of the lumen at the bent portion of the lumen, and shrinkage to be reduced to a constant diameter. If you have sex, you will be able to function properly as a stent.

상기한 스텐트의 특성중 팽창성이 부족하면 내강의 최초 삽입된 위치로부터 쉽게 이동하게 되고, 유연성이 부족하면 스텐트가 내강의 굽어진 부위에서 팽창할 때 내강의 굽어진 부위에서 적응성이 떨어지게 되며, 축소성이 부족하면 스텐트를 삽입하기 위한 삽입장치의 크기가 커지게 되는 것이다.If the stent lacks the expandability of the characteristics of the stent, it is easy to move from the initial insertion position of the lumen, if the lack of flexibility, when the stent expands in the bent portion of the lumen, it is inadequate in the bent portion of the lumen, shrinkage If this is insufficient, the size of the inserting device for inserting the stent will increase.

따라서 상기한 기능을 갖는 스텐트가 다수 개발되어 왔으며, 이러한 스텐트는 크게 나선형 스텐트와 지그재그형 스탠트로 나눌 수 있다.Therefore, a number of stents having the above functions have been developed, and these stents can be largely divided into spiral stents and zigzag stents.

상기한 나선형 스텐트중 대표적인 것으로는, 단위 길이를 갖는 필라멘트를 원통형 벽면을 따라 나선상으로 감아주고 다시 지그재그 형태로 양끝단을 왕복함과 아울러 서로 교차하여 메쉬를 만들어 전체적으로 원통형상을 갖게 된다. 이러한 나선형 스텐트는 작은 직경으로 축소될 수 있어 유연성이 우수한 반면 이 유연성으로 인하여 팽창성이 크게 떨어지게 되는 단점이 있다.Representative of the spiral stents, the filament having a unit length spirally wound along the cylindrical wall surface and reciprocating both ends in a zigzag form again and intersecting with each other to form a mesh to have an overall cylindrical shape. Such a spiral stent can be reduced to a small diameter, so that the flexibility is excellent while the flexibility is greatly reduced in expandability.

한편, 대한민국 공개특허 제 1998-67399호 등에서는, 필라멘트를 다수의 직선부와 다수의 밴딩 포인트에 의하여 이 직선부를 연결하는 피크부 및 밸리부를 이루도록 지그재그로 다수의 턴을 행하며, 상기한 어느 일턴의 밸리부는 이 일턴과 이웃하는 턴의 대응하는 피크부를 도 7 및 도 8과 같이 서로 꼬아서 연결하여 이루어진 스텐트를 제시하고 있다.On the other hand, the Republic of Korea Patent Publication No. 1998-67399 and the like, a plurality of turns in a zigzag to form a peak portion and a valley portion connecting the filament by a plurality of straight portions and a plurality of bending points, and the one-turn of The valley portion presents a stent formed by twisting the corresponding peak portions of the one turn and the neighboring turns with each other as shown in FIGS. 7 and 8.

그러나, 상기 종래의 스텐트는 좁아진 내강을 확장시키는 팽창성이 우수한 반면 유연성이 떨어질 뿐만아니라 작은 크기로 축소하기 곤란하며, 내강의 굽어진 부위에서 굽어진 모양을 그대로 유지하지 못하게 되는 단점이 있다.However, the conventional stent is excellent in expandability to expand the narrowed lumen, but also inferior in flexibility, it is difficult to shrink to a small size, there is a disadvantage that does not maintain the bent shape in the bent portion of the lumen.

본 발명은 상기한 문제점을 해결하기 위하여 제안된 것으로서, 본 발명의 목적은 기준턴들을 감싸면서 서로 연결하는 연결턴을 구비하여 최소한의 크기로 축소될 수 있고, 팽창성과 유연성이 우수하여 내강이 굽어진 부위에서 혈액 등의 흐름이 원활하도록 원통형상을 잘 유지하고 내강의 굽어진 모양대로 휘면서 내강 내벽과 잘 밀착되는 원통상 스텐트를 제공하기 위한 것이다.
The present invention has been proposed to solve the above problems, an object of the present invention is to reduce the size to a minimum size having a connecting turn to connect to each other while wrapping the reference turns, excellent in expandability and flexibility bending the lumen It is to provide a cylindrical stent that maintains the cylindrical shape well to smooth the flow of blood, etc. in the jin site and be in close contact with the inner wall of the lumen while bending in the bent shape of the lumen.

이와 같은 과제를 달성하기 위한 본 발명의 원통상 스텐트는, [ⅰ] 와이어가 원주면을 따라 직선부(1a)들로 연결되는 다수의 피크부(1c)와 밸리부(1b)를 가지면서 지그재그로 일회전 하면서 형성하는 기준턴(1)들이 원통 길이방향을 따라 서로 교차점 없이 배열되어 있는 복수개의 기준턴과 [ⅱ] 상기 기준턴의 좌·우 경사방향으로 배열되면서 겹쳐지는 기준턴의 직선부(1a)들을 코일 상으로 감아 상기 복수개의 기준턴들을 메쉬형태로 서로 연결하고 있는 복수개의 연결턴으로 구성되며 길이방향의 축을 가지는 원통형 스텐트에 있어서, 상기 기준턴들의 배열 간격이 기준턴의 높이(h)와 동일하고, 상기 연결턴들의 배열 간격이 기준턴의 직선부 간의 거리(d)와 동일한 것을 특징으로 한다.Cylindrical stent of the present invention for achieving such a problem, the [Zig] zigzag while the wire has a plurality of peaks (1c) and valleys (1b) connected to the straight portion (1a) along the circumferential surface [00] A linear portion of the reference turns overlapping while being arranged in the left and right inclination directions of the plurality of reference turns and the reference turns (1) which are formed while rotating one by one in the longitudinal direction of the cylinder without crossing each other. In the cylindrical stent having a plurality of connecting turns that connect the plurality of reference turns to each other in a mesh form by winding (1a) onto a coil and having a longitudinal axis, an arrangement interval of the reference turns is the height of the reference turn ( Same as h), and the arrangement interval of the connection turns is equal to the distance d between the straight portions of the reference turn.

이하, 첨부한 도면 등을 통하여 본 발명을 상세하게 설명한다.Hereinafter, the present invention will be described in detail with reference to the accompanying drawings.

본 발명의 원통상 스텐트는 도 1의 사시개략도와 같이 단위길이를 갖는 와이 어가 원주면을 따라 다수의 밴딩 포인트를 가지면서 지그재그로 일회전하면서 형성하는 다수개의 기준턴(1)을 포함한다.Cylindrical stent of the present invention includes a plurality of reference turns (1) formed by rotating one wire in a zigzag while having a plurality of bending points along the circumferential surface of the wire having a unit length as shown in the perspective schematic of FIG.

상기 기준턴은 도 3과 같이 다수개의 피크부(1c)와 밸리부(1b)를 갖고, 상기 피크부(1c)와 밸리부(1b)들은 좌·우로 경사진 직선부(1a)들에 의해 연결된 구조를 갖는다. 상기 기준턴(1)들은 원통 길이방향을 따라 기준턴의 높이(h)와 동일한 간격으로 서로 교차점 없이 배열된다.The reference turn has a plurality of peak portions 1c and valley portions 1b as shown in FIG. 3, and the peak portions 1c and valley portions 1b are formed by straight portions 1a inclined left and right. It has a connected structure. The reference turns 1 are arranged without intersections at intervals equal to the height h of the reference turns along the cylindrical longitudinal direction.

한편, 본 발명의 원통상 스텐트는 도 1의 사시개략도와 같이 상기 기준턴의 좌·우 경사 방향으로 배열(기준턴의 직선부를 따라 배열)되면서 이와 겹쳐지는 기준턴의 직선부(1a)들을 코일상으로 감아 상기 복수개의 기준턴들을 서로 연결하고 있는 다수개의 연결턴(2)을 포함한다. 상기 연결턴(2)들은 기준턴 직선부(1a) 간의 거리(d)와 동일한 간격으로 배열된다.On the other hand, the cylindrical stent of the present invention is arranged in the direction of the left and right inclination of the reference turn as shown in the perspective schematic view of Figure 1 (arranged along the straight portion of the reference turn) while overlapping the straight portion (1a) of the reference turn It comprises a plurality of connecting turns (2) which are wound around the routine to connect the plurality of reference turns to each other. The connection turns 2 are arranged at the same interval as the distance d between the reference turn straight portions 1a.

이상에서 설명한 기준턴(1)과 연결턴(2)들에 의해 본 발명의 원통상 스텐트는 도 2와 같은 단위셀을 형성한다.The cylindrical stent of the present invention forms the unit cell as shown in FIG. 2 by the reference turns 1 and the connection turns 2 described above.

상기 도 2의 단위셀에는 서로 교차되지 않은 상태로 배열된 기준턴(1)들을 코일상으로 감으면서 메쉬상으로 연결하는 연결턴(2)이 있어서, 스텐트의 유연성을 크게 향상시키게 된다. 이로 인해 스텐트를 적은 크기로 축소할 수 있으며, 내강의 굴곡부분에서도 스텐트가 원형을 그대로 유지할 수 있어서 혈액 등의 흐름을 양호하게 한다.In the unit cell of FIG. 2, the connection turns 2 connecting the reference turns 1 arranged in a non-crossed state in a coil shape are connected to a mesh, thereby greatly improving the flexibility of the stent. Because of this, the stent can be reduced to a smaller size, and even in the bent portion of the lumen, the stent can maintain the original shape, thereby improving the flow of blood and the like.

또한, 본 발명은 연결턴(2)들이 이와 겹쳐지는 기준턴의 직선부(1a)들을 코일상으로 감고 있어서 팽창성도 우수하다. 연결턴(2)이 기준턴의 직선부(1a)를 감는 회수는 2-10회인 것이 바람직 하다. 기준턴(1) 및 연결턴(2)을 이루고 있는 와이어는 형상기억 합금인 니타놀인 것이 바람직 하다.In addition, the present invention is excellent in expandability because the connecting turns (2) are wound on the coil of the straight portion (1a) of the reference turn overlapping this. It is preferable that the number of times that the connecting turn 2 winds the straight portion 1a of the reference turn is 2-10 times. The wire constituting the reference turn 1 and the connection turn 2 is preferably nitanol, which is a shape memory alloy.

본 발명의 원통상 스텐트를 제조하는 방법 일례를 살펴보면 다음과 같다.Looking at one example of a method for producing a cylindrical stent of the present invention.

먼저, 도 4와 같이 스텐트 제작용 지그(10)의 제 1 기준핀(11)과 제 2 기준핀(12)을 따라 와이어를 지그재그로 일회전하여 하나의 기준턴(1)을 형성하고, 상기와 같이 형성된 기준턴으로부터 지그(10)의 아래방향으로 기준턴 높이(h)와 동일한 간격(H) 만큼 떨어진 위치에 상기와 동일한 방법으로 또하나의 기준턴(1)을 형성하는 작업을 반복하여 원통길이 방향을 따라 서로 교차점 없이 배열 되어있는 복수개의 기준턴들을 형성한다.First, as shown in FIG. 4, one reference turn 1 is formed by zigzag a wire along the first reference pin 11 and the second reference pin 12 of the stent fabrication jig 10. Repeating the operation of forming another reference turn (1) in the same manner as described above at a position spaced apart from the reference turn formed as shown in the jig 10 by a distance (H) equal to the reference turn height (h) A plurality of reference turns are formed along the length of the cylinder and arranged without intersections.

다음으로는, 도 5 및 도 6과 같이 기준턴의 직선부(1a)들을 좌·우 경사방향으로 연결하는 연결턴(2)을 형성한다. 이때, 연결턴(2) 간의 간격은 기준턴 직선부간 거리(d)와 동일하도록 조정하며, 연결턴(2)과 겹쳐지는 기준턴의 직선부(1a)는 연결턴(2)으로 감아준다.Next, as shown in Figs. 5 and 6 to form a connecting turn 2 for connecting the straight portion (1a) of the reference turn in the left and right inclined direction. At this time, the interval between the connection turns (2) is adjusted to be equal to the distance (d) between the reference turn linear portion, and the straight portion (1a) of the reference turn overlapping the connection turn (2) is wound by the connection turn (2).

상기한 연결턴(2)의 형성이 완료되면 와이어가 지그(10)의 제 1 기준핀(11)으로 위치하게 되며, 이때 와이어를 매듭하면 스텐트의 세선 작업이 완료 된다.When the formation of the connecting turn 2 is completed, the wire is positioned as the first reference pin 11 of the jig 10. In this case, when the wire is knotted, the thin wire work of the stent is completed.

본 발명은 상기의 연결턴(2)의 매듭이 스텐트를 내강에 고정시키는 고정용 와이어 역할을 수행하기 때문에, 별도로 고정용 와이어를 제작, 부착하는 것을 최소화 할 수 있는 장점이 있다.In the present invention, since the knot of the connecting turn 2 serves as a fixing wire for fixing the stent to the lumen, there is an advantage of minimizing the production and attachment of the fixing wire separately.

다음으로는, 세선작업이 완료된 스텐트를 스텐트 제작용 지그(10)와 함께 400℃-600℃로 세팅된 가열오븐에서 10-20분 동안 가열한 후 상온에서 30분-4시간 서냉하고, 스텐트를 지그(10)로 부터 분리하고, 마무리 작업을 하면 스텐트의 제조가 완료 된다.Next, the thin stent is completed, the stent is heated for 10-20 minutes in a heating oven set at 400 ° C.-600 ° C. together with the jig 10 for stent fabrication, and then slowly cooled at room temperature for 30 minutes-4 hours, and the stent is Separating from the jig 10, and finishing work is completed the manufacture of the stent.

본 발명에서는 스텐트 제조를 위한 가열 및 서냉 조건을 특별하게 한정하는 것은 아니다.In the present invention, the heating and slow cooling conditions for producing the stent are not particularly limited.

본 발명의 원통상 스텐트는 단위셀 내에 기준턴(1)을 감싸면서 이들을 메쉬상으로 연결시키는 연결턴(2)을 갖고 있어서 유연성과 팽창성이 매우 우수하다. 그 결과 최소한의 크기로 축소될 수 있고, 내강의 굽어진 부위에서 원형상을 그대로 유지할 수 있고, 내강의 굽어진 부위와의 밀착성이 우수하다. 또한, 본 발명은 별도의 고정용 와이어 개수를 최소화 할 수 있다.Cylindrical stent of the present invention has a connection turn (2) for connecting them in a mesh shape while wrapping the reference turn (1) in the unit cell is very excellent in flexibility and expandability. As a result, it can be reduced to a minimum size, the circular shape can be maintained at the bent portion of the lumen, and the adhesion to the bent portion of the lumen is excellent. In addition, the present invention can minimize the number of separate fixing wires.

Claims (3)

[ⅰ] 와이어가 원주면을 따라 직선부(1a)들로 연결되는 다수의 피크부(1c)와 밸리부(1b)를 가지면서 지그재그로 일회전 하면서 형성하는 기준턴(1)들이 원통 길이방향을 따라 서로 교차점 없이 배열되어 있는 복수개의 기준턴과 [ⅱ] 상기 기준턴의 좌·우 경사방향으로 배열되면서 겹쳐지는 기준턴의 직선부(1a)들을 코일 상으로 감아 상기 복수개의 기준턴들을 메쉬형태로 서로 연결하고 있는 복수개의 연결턴으로 구성되며 길이방향의 축을 가지는 원통형 스텐트에 있어서, 상기 기준턴들의 배열 간격이 기준턴의 높이(h)와 동일하고, 상기 연결턴들의 배열 간격이 기준턴의 직선부 간의 거리(d)와 동일한 것을 특징으로 하는 원통형 스텐트.[Ⅰ] The reference turns 1, which are formed while the wire is rotated zigzag and have a plurality of peak portions 1c and valley portions 1b connected to the straight portions 1a along the circumferential surface thereof, are formed in the cylindrical longitudinal direction. A plurality of reference turns arranged without a cross point along each other and [ii] the plurality of reference turns mesh by winding the linear portions 1a of the reference turns overlapped while being arranged in the left and right inclined directions of the reference turns onto a coil. In a cylindrical stent having a plurality of connecting turns connected to each other in a form and having a longitudinal axis, an arrangement interval of the reference turns is equal to a height h of the reference turns, and an arrangement interval of the connection turns is a reference turn. Cylindrical stent, characterized in that the same as the distance (d) between the straight portions of. 1항에 있어서, 와이어가 형상기억 합금인 니타놀로 이루어져 있는 것을 특징으로 하는 원통형 스텐트.The cylindrical stent of claim 1, wherein the wire is made of nitanol, which is a shape memory alloy. 1항에 있어서, 연결턴(2)이 이와 겹쳐지는 기준턴의 직선부(1a)들을 2-10회 감싸고 있는 것을 특징으로 하는 원통형 스텐트.2. The cylindrical stent according to claim 1, wherein the connecting turn (2) surrounds the straight portions (1a) of the reference turn overlapping with each other two to ten times.
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KR100958578B1 (en) * 2008-07-16 2010-05-18 주식회사 에스앤지바이오텍 Stent used in blood vessel
JP7391866B2 (en) * 2018-03-29 2023-12-05 サハジャナンド メディカル テクノロジーズ リミテッド stent

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