KR20040066409A - Stent for percutaneous coronary intervention coated with drugs for the prevention of vascular restenosis - Google Patents

Stent for percutaneous coronary intervention coated with drugs for the prevention of vascular restenosis Download PDF

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Publication number
KR20040066409A
KR20040066409A KR1020030003465A KR20030003465A KR20040066409A KR 20040066409 A KR20040066409 A KR 20040066409A KR 1020030003465 A KR1020030003465 A KR 1020030003465A KR 20030003465 A KR20030003465 A KR 20030003465A KR 20040066409 A KR20040066409 A KR 20040066409A
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South Korea
Prior art keywords
stent
ring
coronary intervention
percutaneous coronary
struts
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KR1020030003465A
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Korean (ko)
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KR100495875B1 (en
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박정의
Original Assignee
사회복지법인삼성생명공익재단(삼성서울병원)
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Priority to KR20030003465A priority Critical patent/KR100495875B1/en
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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 sheet material 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 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
    • A61F2/86Stents 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
    • 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 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 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 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
    • 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 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
    • 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
    • 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
    • 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
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91575Adjacent bands being connected to each other connected peak to trough
    • 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
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0002Two-dimensional shapes, e.g. cross-sections
    • A61F2230/0028Shapes in the form of latin or greek characters
    • A61F2230/0054V-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
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0067Means for introducing or releasing pharmaceutical products into the body
    • A61F2250/0068Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir

Abstract

PURPOSE: A stent for percutaneous coronary intervention is provided to stably contain a large amount of the drugs for preventing vascular restenosis to release continuously into the blood for a long time. CONSTITUTION: The stent for percutaneous coronary intervention comprises a first ring structure(10) which is formed in a circumferential loop by connecting plural struts(11) in a zigzag-pattern and includes a round end(12) and a small well(12a) for loading the drugs in the joining part of the struts(11); a second ring structure(20) which is formed in a circumferential loop by connecting plural struts(21) in a zigzag-pattern; and a bridge(30) which connects the first ring structure(10) with the second ring structure(20) and includes a bending link(31) in the middle portion. The groove formed in the strut(11) and the small well are loaded with the drugs for preventing vascular restenosis.

Description

BACKGROUND OF THE INVENTION 1. Field of the Invention [0001] The present invention relates to a stent for percutaneous coronary intervention (PCI)

The present invention relates to a stent for percutaneous coronary intervention (PCI), and in particular, to prevent restenosis of blood vessels due to barotrauma after percutaneous coronary intervention When a stent is provided in a blood vessel by forming a large number of fine holes or grooves on the surface of the stent and applying a drug for preventing restenosis, the restenosis preventing agent stored in the hole or groove is gradually released over a period of several weeks to several months, The present invention relates to a stent for percutaneous coronary intervention (PCI) coated with an anti-angiostatic agent that effectively prevents stenosis.

Percutaneous coronary intervention (PCI) is a procedure in which a guidewire and a balloon catheter are inserted into the artery through the wrist or leg arteries when a cardiovascular disease is caused by myocardial infarction, angina pectoris, or coronary artery stenosis. And then inflated the balloon to widen the clogged portion of the coronary artery, which is widely accepted as the most effective treatment for cardiovascular disease. Currently, percutaneous coronary intervention is performed more than one million per year in the United States, more than 100,000 per year in Japan, and more than 15,000 per year in Korea.

Percutaneous coronary intervention may be accomplished by simply widening the arterial wall by using a balloon catheter. However, about 70% of the patients undergoing the procedure have inserted a thin metal mesh made of stainless steel into the vessel wall to expand the vessel wall In a state of being supported.

A schematic procedure of the percutaneous coronary intervention using the stent will be described with reference to Figs. 1A to 1D.

In order to insert the stent into the coronary artery, the artery narrowed by the arteriosclerosis (plaque) protruded into the blood vessel wall must first be widened. This operation is the same as the general coronary artery intervention. In other words, by inserting the balloon catheter to the position of the stenosis lesion, and inflating the balloon, the narrowed artery can be widened by the atherosclerotic plaque. In some cases, the use of a directional coronary atherectomy to remove atherosclerotic plaque, or a severe atherosclerotic plaque in atherosclerotic plaque, removes the atherosclerotic plaque using a rotating atherectomy to facilitate stenting Respectively. Next, the balloon catheter 2 equipped with the optimal stent 1 that meets all conditions such as the length of the stenotic lesion and the diameter of the blood vessel is selected and pushed to reach the position of the stenotic lesion L (see Fig. 1A) . When the balloon 2a of the balloon catheter 2 is inflated after reaching the precise position of the stenotic lesion, the stent 1 loaded on the balloon 2a is also plastically deformed to become inflated (see FIG. The balloon 2a is retracted and the balloon catheter 2 is removed so that only the stent 1 is left in the arterial blood vessel and the blood vessel CA of the affected part is held in the expanded state to prevent the blood vessel from becoming narrow Reference). However, since the stent itself can not be denied to the human body, the tissue cell of the blood vessel wall (CA), which is pressed by the stent (1) and pressurized by the stent (1) It undergoes barotrauma and causes rapid cell proliferation. If such proliferated cells are over-coated on the stent, restenosis (L '), in which the vessel walls are clogged, can occur (see FIG. 1d). Restenosis occurs more frequently with longer stent length, smaller stent diameter, and occurs in about 17-25% of stent insertion cases. Restenosis occurs mainly within 1 to 3 months after stenting and rarely occurs after 6 months.

If restenosis occurs, the effect of percutaneous coronary intervention is reduced. Accordingly, various methods for treating such restenosis have been developed and practiced, including reinsertion of a balloon catheter into the affected area to spray a restenosis-preventing drug (for example, heparin sulfate-containing drug) Cobalt 60, iridium 192, etc.) is attached to a catheter or a guide wire to treat the affected part by radioactivity. In recent years, it has been reported that the use of percutaneous coronary intervention with a stent coated with anti-restenosis medication has significantly reduced the restenosis rate after the procedure.

In recent clinical trials using stents coated with anticancer agents such as Rapamycin or Paclitaxel to prevent post-operative restenosis, about 5% to 6% of patients undergoing interventional stenting The incidence of restenosis of the proximal end (P) is about 4% and the distal end (D) of the distal end (D) ) Had a restenosis rate of about 2 ~ 3%. The reason that the incidence of restenosis of the proximal portion (P) is relatively high is because the restenosis prevention drug applied to the stent is washed down to the distal portion (D) by the blood flow, and the concentration of the proximal drug becomes relatively low .

In addition, restenosis of the coronary artery was found to be the most frequent recurrence within 1 to 3 months after percutaneous coronary intervention, and rarely occurs after 6 months. In order to prevent restenosis, percutaneous coronary intervention should be performed for at least 5 to 6 months after the procedure. In addition, There is a need to inject medicines.

Therefore, in future coronary intervention, it is expected that many stents coated with anti-restenosis drugs will be used. Although stents coated with anti-restenosis drugs are currently used, the stents introduced so far have not been specially designed for the coating of anti-restenosis drugs. Instead of simply coating the stent with a polymer material, Coating. Thus, there is a need to improve the design of the stent so that the stent contains a sufficient amount of anti-restenosis drug and slowly releases the drug over a prolonged period of time.

If the patient is treated with a stent coated with a more effective anti-restenotic drug, the risk of restenosis may be reduced, resulting in less physical and psychological pain due to the occurrence of restenosis in the future, .

In order to solve the problem that the stent used in the conventional percutaneous coronary intervention does not effectively prevent the risk of restenosis of the coronary artery, the present invention provides a method for stably restricting the restenosis of the coronary artery for a long period of time The present invention provides a stent for percutaneous coronary intervention capable of sustained release.

In addition, the present invention improves the design of the stent so that the coating of the restenosis preventive drug is effectively performed, allows the stent to smoothly enter the curved vessel lesion, and improves the supporting power, The present invention also provides a stent for percutaneous coronary intervention that can lower the stent diameter.

FIGS. 1A to 1D are schematic cross-sectional views of a blood vessel showing a procedure and restenosis of a percutaneous coronary intervention using a conventional stent. FIG.

FIG. 2 shows a closed form of the expanded state of the stent for percutaneous coronary intervention according to the first embodiment of the present invention, FIG. 3 shows an open form of the stent of FIG. 2, And Fig. 4 shows the constricted state of the stent of Fig.

FIG. 5 is a detailed perspective view of a first ring structure 10 that is a portion of the stent of FIGS. 2-4.

6A and 6B are perspective views of the strut 11 cut along the line VI-VI in FIG.

7A and 7B are perspective views of the rounded end 12 cut along the line VII-VII in FIG.

FIG. 8A shows the expanded state of the stent according to the second embodiment of the present invention, and FIG. 8B shows the contracted state of the stent of FIG. 8A.

Description of the Related Art [0002]

1: stent 2: balloon catheter

2a: balloon 3: guide wire (guidewire)

CA: arterial blood vessel L: stricture lesion

L ': restenosis lesion 10: first ring structure

20: second ring structure 11,21: strut,

11a: drug loading groove 12: round end

12a: drug loading hole 13: medical polymer material layer

14: Vascular restenosis prevention agent 30: Bridge

31: serpentine link

To achieve the first object, the present invention provides a stent for percutaneous coronary intervention (PCI) provided with a plurality of fine struts formed by scratching a surface of a plurality of struts constituting the stent, , And an anti-vascular restenosis preventing agent (14) is applied to the entire surface of the strut including the pit.

In order to achieve the second object, a stent for percutaneous coronary intervention according to the present invention is provided with a plurality of struts 11 arranged in a zigzag fashion and formed in a loop in a circumferential direction, (10) having a round end (12) having a diameter larger than the thickness of the strut (11) is formed at a portion where the first strut (11) meets; And a second ring structure (20) in which a plurality of struts (21) arranged in a staggered arrangement are formed in a ring in a circumferential direction; Are formed alternately in a repeated pattern along the longitudinal direction of the stent, and one end of the first ring structure (10) and one end of the second ring structure (20) are connected to each other and a bending link And a bridge (30).

Hereinafter, a stent for percutaneous coronary intervention (PCI) coated with a drug for preventing vascular restenosis according to the present invention will be described in detail with reference to the accompanying drawings.

FIGS. 2 to 7B relate to a first embodiment of the stent according to the present invention, wherein FIG. 2 shows the stent 1 in an expanded state in a closed form, In an open form.

Referring to FIGS. 2 and 3, the stent 1 is formed such that the patterns of the first ring structure 10 and the second ring structure 10 as a whole are repeated aberration along the longitudinal direction of the stent. The first ring structure 10 is formed by a plurality of struts 11 connected in a zigzag fashion to form a loop in a circumferential direction of the stent 1. The round end 12 formed at the point where the struts 11 meet is formed with a drug charging hole 12a penetrating toward the center axis of the stent 1. [ On the surface of the strut 11, a medicine loading groove 11a is formed in the longitudinal direction thereof (see Figs. 6A and 6B).

The second ring structure 20 is formed by forming a plurality of struts 21 connected in a staggered manner forming a mountain 22 and a valley 23 to form a ring which is rounded in the circumferential direction of the stent 1 7A and 7B).

A number of bridges 30 connecting a point of the strut 11 of the first ring structure 10 and the peak 22 of the second ring structure 20 are formed. The first ring structure 10 and the second ring structure 20 are connected to each other by the bridge 30 to form one net as a whole. An N-shaped serpentine link 31 is provided at an intermediate portion of the bridge 30 so as to provide a sufficient margin even when the stent is inflated in a contracted state and when the stent is bent and installed in accordance with a bent blood vessel .

Fig. 4 shows a state before the expansion of the stent 1 of Figs. 2 and 3, that is, a state where the stent 1 is still manufactured and used. The stent for percutaneous coronary intervention may be a tube made of stainless steel (for example, '316L') through a photomask-and-etch-on-a-tube or precision laser processing, And then carving out the other portions. When the shape of the stent is completed, the whole is coated with the medical polymer material to improve the biocompatibility, and then the vascular restenosis preventing agent necessary on the medical polymer material layer is coated.

Recently, anti-restenosis drugs (for example, rapamycin or paclitaxel) have been mainly used for patients with restenosis, and these agents have been used for the treatment of coronary artery injury after coronary intervention Administration to the wall of the blood vessel inhibits the proliferation cycle of vascular cells and prevents restenosis. In addition, inflammation inhibitors (for example, dexamethasone) and gene therapy agents are used as anti-restenosis drugs, and estrogen-based medicines, which are a kind of female hormones, are also used. In addition, agents that inactivate metalloproteinase enzymes involved in the production of collagenous fibers during cell proliferation have been used. Since the stent for percutaneous coronary intervention according to the present invention contains as much as possible any type of vascular restenosis preventing agent as much as possible and can improve the structure of the conventional stent so that it can be released gradually over a long period of time, As well as all the anti-restenosis drugs to be developed in the future can be coated and used.

5 is a detailed perspective view of the strut 11 and the rounded end 12 of the first ring structure 10 of FIG. The strut 11 is in the shape of a rod having a generally square cross section except for the groove 11a formed therein and has a concave groove 11a with a predetermined depth and width on the surface of the portion to be in contact with the blood vessel wall It is broken. The thickness (a) and width (b) of the strut 11 are preferably 0.006 inch (0.16 mm), assuming the vessel diameter of the coronary artery is 3 mm, The drug loading groove 11a is formed to be long by a depth corresponding to 3 (i.e., 0.002 inch). Such concave drug loading grooves 11a are formed at the same time when a tube of stainless steel is cut by precision laser machining to form a stent.

In addition, a rounded end 12 having a diameter larger than the thickness of the strut 11 is formed at a connecting portion where the two struts 11 are connected in a zigzag shape. A medial charging hole 12a is formed through the center of the rounded end 12 toward the center axis of the stent 1. The drug charging hole 12a is also formed together with the drug charging groove 11a when the stent is manufactured by precision laser processing.

Unlike the first ring structure 10, the second ring structure 20 has a groove on its surface for the purpose of maintaining the radial strength of the stent and allowing the stent to be inserted and adapted to the curved blood vessel. It is preferable that it is formed only by a simple zigzag strut without forming it. However, if the strength of the stent is sufficient and it is necessary to contain more drug, the second ring structure 20 also has the same structure as the strut 11 of the first ring structure 10, It is also possible to manufacture a drug filling groove.

6A and 6B are cross-sectional views of the strut 11 cut along the line VI-VI in FIG. 6A shows a state in which the medical polymer material 13 is coated on stainless steel which is a raw material of the stent 1. FIG. 6B shows a state in which the restenosis prevention agent 14 is applied FIG. The drug loading grooves 11a formed in the strut 11 of the stent 1 are so fine as to have a width of 0.004 inches or less so that even if the restenosis prevention agent is thinly applied to the entire stent, It is covered.

Figs. 7A and 7B are cross-sectional views taken along the line VII-VII in Fig. 3, in which the rounded end 12 is cut. 7A shows a state in which the medical polymer material 13 is coated on the stainless steel which is a raw material of the stent 1. FIG. 7B shows a state in which the restenosis prevention agent 14 is applied FIG. Since the medicament charging hole 12a formed at the center of the rounded end 12 is very fine enough to have a diameter of 0.01 inches or less so that when the restenosis prevention agent 14 is applied to the stent 1, So that it is completely covered.

The stent according to the first embodiment of the present invention prevents the struts constituting the first ring structure 10 and the second ring structure 20 from being evenly distributed with respect to the area of the entire ring portion so as not to cause stress concentration in one portion of the vessel wall It was designed.

FIGS. 8A and 8B show a second embodiment of a stent for percutaneous coronary intervention (PCI) coated with anti-vascular restenosis agent according to the present invention, wherein FIG. 8A shows an expanded state, and FIG. 8B shows a state before And before it is used yet). In Figs. 8A and 8B, the same reference numerals as those in the first embodiment shown in Fig. 2 are used.

The difference compared to the first embodiment shown in FIG. 2 and below is in the formation position of the bridge 30 connecting the first ring structure 10 and the second ring structure 20. That is, the bridge 30 of FIGS. 8A and 8B has one end connected to the valley 23 portion of the second ring structure 20 and the other end connected to the rounded end 11 of the first ring structure 10 2) and the bridge of the first embodiment (see Figs. 2 and 3).

The stent according to the second embodiment of the present invention prevents the struts constituting the first ring structure 10 and the second ring structure 20 from being evenly distributed with respect to the area of the entire ring portion so as not to cause stress concentration on a portion of the blood vessel wall It was designed.

The stents shown in the first and second embodiments may be manufactured in various sizes according to the size, shape, and size of the lesion of the blood vessel at the position to be performed. That is, the stent is manufactured in various sizes such as 2.5 mm, 3.0 mm, 3.5 mm, and 4.0 mm, and the stent is manufactured in various sizes such as 8 mm, 15 mm, 18 mm, 22 mm, and 27 mm.

The stents shown in the first and second embodiments are all arranged so that the rounded end 12 of the first ring structure 10 is located at the outermost position because the restenosis due to the pressure injury at the end of the stent The drug loading hole 12a of the rounded end 12 is disposed at the outermost part of the stent in consideration of the most frequent occurrence, so that a strong restenosis inhibiting effect can be obtained. Since the incidence of restenosis at the proximal portion P is higher than that at the distal portion D, the drug loading hole 12a and the drug loading groove 11a located at the proximal portion P are formed to be somewhat larger, It is desirable that the anti-constriction drug be stored.

In addition, in the drawings attached hereto, when one round end 12 of one first ring structure 10 and two struts 11 attached thereto are defined as one cell C, one ring 6 cells were formed in the structure (see Figs. 2, 3 and 8A). However, the specific fabrication density of the first ring structure and the second ring structure may vary depending on the situation. That is, the number of cells constituting the first ring structure may be five, or may be seven or eight. However, considering the current technology of the stent and the diameter of the arterial blood vessel, the stent having a diameter of less than 3.0 mm preferably forms six cells in one ring structure, and the stent having a diameter of more than 3.0 mm It is preferable that eight cells are formed in one ring structure.

The stent for percutaneous coronary intervention, coated with the anti-angiostatic agent according to the first and second embodiments of the present invention, is not only coated with the anti-angiostatic agent as a whole but also formed into a very fine There is an important feature that a large amount of anti-angiostatic agent can be stored in the drug loading groove 11a and the drug loading hole 12a.

The incidence of restenosis after percutaneous coronary intervention was the highest immediately after the procedure and decreased with time. Therefore, in order for the stent coated with the anti-angiostatic agent to have a desired effect, it is necessary that the tissue cells of the angiostatic wall immediately after the procedure are inhibited from rapidly multiplying by the repair response A sufficient amount of anti-vascular restenosis agent should be administered. Secondly, since there is a risk of restenosis due to pressure injury until an elapse of several weeks or months after the procedure, it is preferable to continuously release the agent for preventing vascular restenosis.

Since the stent (1) according to the present invention is coated with an anti-angiostatic agent on the entire surface of the stent, it is possible to effectively restrain stenosis by administering a large amount of drug to the blood vessel wall immediately after the procedure, The medicines stored in the medicament charging hole 11a and the medicament charging hole 12a are gradually released, so that the medicinal effect can be continuously expected for a long period of several weeks to several months after the procedure.

The stent for percutaneous coronary intervention (PCI) coated with the anti-angiostatic agent according to the present invention not only can achieve a strong restenosis suppression effect immediately after the procedure, but also can achieve a restricting effect of restenosis over a long period of time, It protects the patient from the risk of restenosis and helps to cure cardiovascular disease. It can avoid rehabilitation due to restenosis or separate treatment for injecting medicine, which can reduce the patient's pain and the burden of medical expenses .

In addition, the stent for percutaneous coronary intervention, coated with the anti-angiostatic agent according to the present invention, is designed to optimize the distribution of the strut evenly over the entire area of the affected part, thereby preventing stress concentration on any part of the vessel wall, The effect of minimizing the risk of restenosis due to injury can be obtained.

Claims (13)

  1. In the stent 1 used for percutaneous coronary intervention,
    Characterized in that a plurality of fine pits are formed by scratching the surface of a plurality of struts constituting the stent 1 and an anti-vascular restenosis preventing agent is applied to the entire surface of the struts including the pits A stent for percutaneous coronary intervention with coated anti-angiostatic agents.
  2. The stent according to claim 1, wherein the stent (1)
    A plurality of struts 11 connected in a zigzag fashion are formed in a circumferential direction in a loop and at a portion where the struts 11 meet a round end having a diameter larger than the thickness of the strut 11, a first ring structure (10) having a first end (12) formed therein; And
    A second ring structure (20) in which a plurality of struts (21) connected in zigzag fashion are formed in a ring in a circumferential direction; Are alternately formed in a repeated pattern along the longitudinal direction of the stent,
    Characterized by a bridge (30) connecting a point of the first ring structure (10) to a point of the second ring structure (20) and having a bending link (31) Stent for percutaneous coronary intervention with coated anti - vascular restenosis drug.
  3. The stent according to claim 2, wherein the rounded end (12) has a medicine charging hole (12a) formed to penetrate toward the central axis of the stent (1) (14). ≪ RTI ID = 0.0 > 15. < / RTI > The stent for percutaneous coronary intervention according to claim 1,
  4. 4. The medical device according to claim 3, wherein the struts (11) of the first ring structure (10) have drug loading slots (11a) formed on the surface thereof with a predetermined depth and width along the longitudinal direction, 11. The stent for percutaneous coronary intervention according to claim 1, wherein the vascular restenosis prevention agent (14) is stored in the interior of the stent (11a).
  5. The method according to claim 4, wherein the drug loading groove (11a) has a depth and width corresponding to 1/2 to 2/3 of the thickness of the struts (11) Stent for percutaneous coronary intervention.
  6. 3. The method according to claim 2, characterized in that the bridge (30) connects a rounded end (12) of the first ring structure (10) and a point of the strut (21) of the second ring structure , A stent for percutaneous coronary interventions coated with anti-angiostatic agents.
  7. A stent for percutaneous coronary intervention according to claim 2, characterized in that the distal and proximal portions of the stent (1) are each closed with a first ring structure (10).
  8. 5. The method of claim 4, wherein the struts (21) of the second ring structure (20) have drug loading grooves formed on the surface thereof with a predetermined depth and width along the longitudinal direction, A stent for percutaneous coronary intervention coated with an anti-angiostatic agent, characterized in that the anti-angiostatic agent (14) is stored.
  9. In a stent for percutaneous coronary intervention,
    A plurality of struts 11 connected in a zigzag fashion are formed in a circumferential direction in a loop and at a portion where the struts 11 meet a round end having a diameter larger than the thickness of the strut 11, a first ring structure (10) having a first end (12) formed therein; And
    A second ring structure (20) in which a plurality of struts (21) arranged in a staggered arrangement are formed in a ring shape in the circumferential direction, are alternately formed in a repeated pattern along the longitudinal direction of the stent,
    Characterized in that it comprises a bridge (30) connecting one point of the first ring structure (10) to one point of the second ring structure (20) and having a bending link (31) Stent for coronary intervention.
  10. 10. The stent of claim 9, wherein the rounded end (12) has a through-hole (12a) formed therethrough toward the central axis of the stent (1), the struts (11) And a groove (11a) formed at a predetermined depth and width along the longitudinal direction in the stent (10).
  11. 11. The stent according to claim 10, wherein the groove (11a) has a depth and a width corresponding to 1/2 to 2/3 of the thickness of the struts (11).
  12. 10. The device according to claim 9, characterized in that the bridge (30) connects a rounded end (12) of the first ring structure (10) and a point of the strut (21) of the second ring structure Stent for percutaneous coronary intervention.
  13. 10. The stent for percutaneous coronary intervention according to claim 9, wherein the distal and proximal portions of the stent (1) are each closed with a first ring structure (10).
KR20030003465A 2003-01-18 2003-01-18 Stent for percutaneous coronary intervention coated with drugs for the prevention of vascular restenosis KR100495875B1 (en)

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PCT/KR2004/000069 WO2004064911A1 (en) 2003-01-18 2004-01-16 Stent for percutaneous coronary intervention, coated with vascular restenosis prevention drug

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