WO2017130747A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2017130747A1
WO2017130747A1 PCT/JP2017/001088 JP2017001088W WO2017130747A1 WO 2017130747 A1 WO2017130747 A1 WO 2017130747A1 JP 2017001088 W JP2017001088 W JP 2017001088W WO 2017130747 A1 WO2017130747 A1 WO 2017130747A1
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WO
WIPO (PCT)
Prior art keywords
connection part
connection
stent
holding
axial direction
Prior art date
Application number
PCT/JP2017/001088
Other languages
French (fr)
Japanese (ja)
Inventor
智範 本間
孝之 鬼頭
隆 熊澤
Original Assignee
テルモ株式会社
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Publication of WO2017130747A1 publication Critical patent/WO2017130747A1/en

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2/89—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements comprising two or more adjacent rings flexibly connected by separate members

Definitions

  • the present invention relates to a stent.
  • a stent is placed in an expanded state in a stenosis site or an occlusion site generated in a biological lumen such as a blood vessel to maintain the patency state of the biological lumen, and has a strength for maintaining the expanded state. Desired.
  • the stent is also required to have flexibility to follow the shape of the body lumen, and various attempts have been made to improve the flexibility.
  • struts are connected with a bridge made of a biodegradable material (bioabsorbable polymer), placed in a living body lumen, and after a predetermined period has passed, A stent is disclosed that is configured to exhibit a desired flexibility by releasing the connection.
  • a biodegradable material bioabsorbable polymer
  • connection force between the struts it is possible to reinforce the connection force between the struts by adding a shape or the like to the struts and providing a mechanical connection structure without depending on only the bridge made of the biodegradable material.
  • a shape or the like it is possible to reinforce the connection force between the struts by adding a shape or the like to the struts and providing a mechanical connection structure without depending on only the bridge made of the biodegradable material.
  • sufficient studies have not been made on the strut connection structure suitable for improving the connection force.
  • the present invention provides a stent configured to maintain a good connection between struts over a desired period of time by a mechanical connection structure provided in the strut and a biodegradable material. Objective.
  • the stent of the present invention has a linear strut that forms a cylindrical outer periphery in which a gap is formed, and a plurality of link portions that connect the struts with the gap. At least one of the link parts is provided integrally with each of the adjacent one of the struts and the other struts, and one connection part and the other connection part arranged in a state of facing each other. And a biodegradable material that interposes the one connection part and the other connection part to connect the one connection part and the other connection part. Both the one connection part and the other connection part are arranged at a position overlapping an imaginary line parallel to the circumferential direction of the cylindrical shape.
  • Each of the one connection part and the other connection part has a holding part for holding the biodegradable material formed in the protruding part so as to penetrate or be recessed in the thickness direction from the surface of the strut.
  • the holding portion and the other connecting portion of the one connecting portion are both arranged at a position overlapping an imaginary line parallel to the axial direction of the cylindrical shape, and the holding portion and the one connecting portion of the other connecting portion are arranged.
  • the connecting portion is arranged at a position overlapping a virtual line parallel to the cylindrical axial direction.
  • the link portion that connects the struts has a pair of connection portions as a mechanical connection structure in addition to the biodegradable material.
  • One connection part of the pair of connection parts is arranged so that the position where the holding part is formed overlaps the virtual line parallel to the axial direction together with the other connection part.
  • the lengths of the portions nested in each other can be made relatively long. For this reason, even if force is applied to the stent inadvertently, the mechanical connection at the link portion can be maintained well. As a result, the stent can be placed in the living body lumen, and the connection between the struts can be maintained well until a predetermined period of time passes and the biodegradable material is decomposed.
  • FIG. 3 is a development view in which a part of the outer periphery of the stent according to the embodiment is developed by cutting linearly along the axial direction.
  • (A) is an enlarged view of the link portion of the stent of the embodiment, and (B) is an enlarged cross-sectional view taken along line 3B-3B of (A). It is a figure with which it uses for description of arrangement
  • FIGS. 1 and 2 are schematic views showing the structure of the stent 100 of the embodiment.
  • 3 and 4 are schematic views showing the structure of the link portion 120 of the stent 100 of the embodiment.
  • the biodegradable material 121 (see FIG. 3A) is omitted.
  • the stent 100 of the embodiment will be described with reference to FIGS.
  • the stent 100 of the embodiment has struts 110 and 111 which are linear components.
  • the struts 110 and 111 form a cylindrical outer periphery in which a gap is formed.
  • axial direction D1 the axial direction of the cylindrical shape formed by the struts 110 and 111
  • circumferential direction D2 the circumferential direction of the cylindrical shape
  • the struts 110 are located at both ends in the axial direction D1 and extend in the circumferential direction D2 while being folded in a wave shape to form an endless annular shape.
  • the strut 111 extends spirally around the axial direction D1 while being folded back in a wave shape between the strut 110 at one end and the strut 110 at the other end.
  • the material forming the struts 110 and 111 is, for example, a non-biodegradable material that does not degrade in vivo.
  • Such materials include, for example, stainless steel, cobalt-based alloys such as cobalt-chromium alloy (eg, CoCrWNi alloy), elastic metals such as platinum-chromium alloy (eg, PtFeCrNi alloy), and superelastic alloys such as nickel-titanium alloy. Etc.
  • the stent 100 of the embodiment has a plurality of link portions 120 and 130.
  • the link portion 120 connects them with a gap between the vertices of adjacent struts 111 folded in a wave shape and the vertices of the struts 111 folded back in a wave shape.
  • the link part 130 connects them with a gap between the vertices of the adjacent struts 110 that are folded back and the vertices of the struts 111 that are folded back.
  • the link portions 120 are arranged at a predetermined interval in a direction S2 that intersects a separation direction S1 between adjacent struts 111 with a gap.
  • the link parts 130 are arranged at a predetermined interval in the circumferential direction D2.
  • the link part 120 includes a first connection part 112, a second connection part 113, and a biodegradable material 121.
  • the first connection part 112 and the second connection part 113 are provided integrally with each of the adjacent struts 111 and struts 111 and are arranged in a state of facing each other, and are connected by a biodegradable material 121. .
  • the first connection part 112 is formed by partially protruding one of the two struts 111 adjacent to the first connection part 112, and the second connection part 113 is a part of the other strut 111. Projectingly.
  • the first connection portion 112 protrudes toward the second connection portion 113 and has a rounded curved shape, and a protrusion 112a.
  • the biodegradable material 121 by penetrating in the thickness direction D3 from the surface of the strut 111 and the accommodating portion 112b having a concave shape corresponding to the outer shape of the protruding portion 113a of the second connecting portion 113.
  • Holding part 112c The holding part 112c is provided on the protruding part 112a.
  • the second connecting portion 113 protrudes toward the first connecting portion 112 and has a rounded curved shape 113a.
  • the second connecting portion 113 is connected to the protruding portion 113a, and the outer shape of the protruding portion 112a of the first connecting portion 112.
  • the housing portion 113b has a concave shape corresponding to the shape, and the holding portion 113c that is formed to be recessed from the surface of the strut 111 in the thickness direction D3 and holds the biodegradable material 121.
  • the holding portion 113c is provided on the protruding portion 113a.
  • each of the protrusions 112a and 113a is from a cylindrical radial direction (direction indicated by an arrow R in FIG. 1; hereinafter referred to as “radial direction R”). When viewed, it has an arcuate outer shape.
  • the concave shape of the accommodating part 112b is formed larger than the external shape of the protrusion part 113a.
  • the protruding portion 113a is accommodated with a gap in the concave shape of the accommodating portion 112b.
  • the concave shape of the accommodating portion 113b is formed larger than the outer shape of the protruding portion 112a.
  • the protruding portion 112a is accommodated in a nested manner with a gap in the concave shape of the accommodating portion 113b.
  • the protruding portion 113a is accommodated in a nested manner with a gap in the concave shape of the accommodating portion 112b.
  • the protruding portion 112a may partially contact the housing portion 113b. Further, the protruding portion 113a may partially contact the housing portion 112b.
  • each holding portion 112c, 113c is configured by a through hole that penetrates the strut 111 in the thickness direction D3.
  • each holding part 112c, 113c does not need to be a through-hole as long as the biodegradable material 121 can be held, and may have a shape that is recessed to some extent at least in the thickness direction D3 of the strut 111.
  • each holding portion 112c, 113c has a circular outer shape when viewed from the radial direction R.
  • the holding portions 112c and 113c are arranged so that the centers P1 and P2 of the holding portions 112c and 113c are aligned with the centers of the arcuate outer shapes of the protruding portions 112a and 113a when viewed from the radial direction R.
  • maintenance part 112c, 113c is not limited to circular, For example, an ellipse may be sufficient.
  • the first connection part 112 and the second connection part 113 are both arranged at a position overlapping the virtual line Y1 parallel to the circumferential direction D2. That is, the first connection part 112 and the second connection part 113 are both arranged so as to intersect with one virtual line Y1 drawn in parallel to the circumferential direction D2.
  • the length along the axial direction D1 of the portion overlapping the imaginary line drawn in parallel with the circumferential direction D2 at an arbitrary position in the axial direction D1 is L1.
  • the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged at positions overlapping the virtual line X1 parallel to the axial direction D1. That is, the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged so as to intersect with one virtual line X1 drawn in parallel with the axial direction D1.
  • the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L12.
  • the holding part 112c of the second connection part 113 and the first connection part 112 are both arranged at a position overlapping the virtual line X2 parallel to the axial direction D1. That is, the second connecting portion 113 and the holding portion 112c of the first connecting portion 112 are both arranged so as to intersect with one imaginary line X2 drawn parallel to the axial direction D1.
  • the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L13.
  • the center P1 of the holding part 112c of the first connection part 112 and the second connection part 113 are both arranged at a position overlapping the virtual line X2 parallel to the axial direction D1. That is, the center P1 of the holding part 112c of the first connection part 112 and the second connection part 113 are both arranged so as to intersect with one virtual line X2 drawn parallel to the axial direction D1.
  • the center P2 of the holding portion 113c of the second connection portion 113 and the first connection portion 112 are both arranged at positions overlapping the virtual line X1 parallel to the axial direction D1. That is, the center P2 of the holding portion 113c of the second connection portion 113 and the first connection portion 112 are both arranged so as to intersect with one virtual line X1 drawn in parallel with the axial direction D1.
  • first connection part 112 and the second connection part 113 have a relationship with the direction T of the tensile force F acting on the link part 120 when the stent 100 is expanded (hereinafter referred to as “tensile direction T”).
  • tensile direction T the direction T of the tensile force F acting on the link part 120 when the stent 100 is expanded.
  • the first connecting portion 112 and the second connecting portion 113 are configured so that the virtual line K1 connecting the centers P1 and P2 of the holding portions 112c and 113c has the holding portions 112c and 113c with respect to the pulling direction T. Both are arranged so as to incline toward a direction a1 (hereinafter referred to as “overlapping direction a1”) overlapping with one imaginary line parallel to the axial direction D1. That is, the first connection part 112 and the second connection part 113 are arranged so that the angle between the virtual line K1 and the virtual lines X1 and X2 parallel to the axial direction D1 is small.
  • the tensile direction T differs depending on the arrangement of the link portion, the stent structure such as the strut shape, the shape when the stent is expanded, and the like, and can be specified by analysis or experiment.
  • the number of folded portions 111a of the struts 111 provided between one link portion 120 and another adjacent link portion 120 is the first range A1.
  • the number is four.
  • the tension direction T can be generally specified as being inclined toward the first range A1 with respect to the axial direction D1 of the stent 100.
  • the biodegradable material 121 has a first connection portion until the stent 100 is decomposed after a predetermined period of time after the stent 100 is placed in the living body lumen. 112 and the 2nd connection part 113 are connected.
  • the biodegradable material 121 is integrated into the surfaces of the first connection portion 112 and the second connection portion 113, the gap between the first connection portion 112 and the second connection portion 113, and the holding portions 112c and 113c. It is formed to be continuous. In addition to providing the biodegradable material 121 so as to cover the surfaces of the first connection portion 112 and the second connection portion 113, the gap between the first connection portion 112 and the second connection portion 113 and the holding portions 112c, By filling the biodegradable material 121 in 113c, the 1st connection part 112 and the 2nd connection part 113 can be connected more favorably.
  • the biodegradable material 121 is not particularly limited as long as it is a material that can be decomposed in vivo.
  • examples of such a material include polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polycaprolactone, and lactic acid.
  • -Biodegradable synthetic polymer materials such as caprolactone copolymer, glycolic acid-caprolactone copolymer, poly- ⁇ -glutamic acid, biodegradable natural polymer materials such as collagen, biodegradability such as magnesium and zinc A metal material is mentioned.
  • the stent 100 including the link portion 120 includes a covering 122 containing a drug on the surface thereof.
  • the covering 122 is preferably formed on the outer surface of the stent 100 on the side facing the inner peripheral surface of the living body lumen, but is not limited thereto.
  • the covering 122 includes a drug capable of suppressing the growth of the neointimal and a drug carrier for supporting the drug.
  • the covering body 122 may be comprised only with the chemical
  • the drug contained in the covering 122 is at least one selected from the group consisting of sirolimus, everolimus, zotarolimus, paclitaxel, and the like. Although it does not specifically limit as a constituent material of a chemical
  • the link part 130 is formed integrally with the strut 110 and the strut 111.
  • the link portion 130 is formed of a non-biodegradable material that does not decompose in the same living body as the struts 110 and 111, and does not have the biodegradable material 121.
  • the stent 100 is delivered to a stenosis site or an occlusion site generated in a living body lumen such as a blood vessel, a bile duct, a trachea, an esophagus, or a urethra using a medical device for stent delivery such as a balloon catheter.
  • a medical device for stent delivery such as a balloon catheter.
  • the first connection part 112 and the holding part 113c are both arranged at a position overlapping the virtual line X1 parallel to the axial direction D1
  • the second connection Each of the portion 113 and the holding portion 112c is disposed at a position overlapping the virtual line X2 parallel to the axial direction D1.
  • the length along the peripheral direction D2 of the part which has overlapped with the virtual line parallel to axial direction D1 in the arbitrary positions of peripheral direction D2 is comparatively long, Even if force is applied to the stent 100 inadvertently during delivery, the mechanical connection of the link portion 120 can be maintained well.
  • the delivered stent 100 is expanded at a stenosis site or an occlusion site of a living body lumen.
  • the virtual line K1 connecting the centers P1 and P2 of the holding portions 112c and 113c is directed toward the overlapping direction a1 with respect to the pulling direction T. Inclined.
  • the tensile force F acting on each of the connection portions 112 and 113 is changed into a component f 1 in the direction along the imaginary line K1 and a component f 2 in the direction orthogonal to the imaginary line K1. if it decomposes representation component f 2 acts in the overlapping direction a1.
  • connection portions 112 and 113 when the stent 100 is expanded, a tensile force F acts on each of the connection portions 112 and 113 in a direction overlapping with one imaginary line X1 and X2 parallel to the axial direction D1. For this reason, it is possible to suitably prevent the connection portions 112 and 113 from being disconnected together with the expansion of the stent 100. As a result, the connection of the link part 120 can be maintained well even after the stent 100 is placed.
  • FIG. 5 is a diagram showing a link portion 220 of a comparative example.
  • the biodegradable material 121 (see FIG. 3A) is omitted as in FIG.
  • the first connecting part 112 and the holding part 113c are not arranged at a position overlapping the virtual line X3 parallel to the axial direction D1. That is, the first connecting portion 112 and the holding portion 113c do not intersect at all with one imaginary line X3 drawn parallel to the axial direction D1.
  • the second connection part 113 and the holding part 112c are not arranged at a position overlapping the virtual line X4 parallel to the axial direction D1. That is, neither the second connection portion 113 nor the holding portion 112c intersects at all with one imaginary line X4 drawn parallel to the axial direction D1.
  • the first connection part 112 and the second connection part 113 are virtual lines parallel to the axial direction D1 at an arbitrary position in the circumferential direction D2 in the first connection part 112 and the second connection part 113.
  • the link part 220 of the comparative example is a virtual parallel to the axial direction D1 at an arbitrary position in the circumferential direction D2 in the first connection part 112 and the second connection part 113.
  • the length along the circumferential direction D2 of the portion overlapping the line is short by the length L12 (L13), and the mechanical connection is weak accordingly.
  • a virtual line K2 connecting the centers P1 and P2 of the holding parts 112c and 113c is a direction a2 opposite to the overlapping direction a1 with respect to the pulling direction T (hereinafter referred to as “overlapping release direction”). a2 ”).
  • overlapping release direction a2
  • the tensile force F acting on each of the connection portions 112 and 113 is divided into a component f 1 in the direction along the imaginary line K2 and a component f 2 in the direction orthogonal to the imaginary line K2. if decomposed and expressed in, component f 2 acts overlap releasing direction a2.
  • each connection portion 112 and 113 is subjected to a tensile force F in a direction to release the overlap with one virtual line X1 and X2 parallel to the axial direction D1.
  • the link part 220 of a comparative example is easily disconnected between the struts 111.
  • the biodegradable material 121 does not progress so much in the acute phase when the day after placement is short and there is a possibility of re-treatment, and as described above, the first connection portion 112 is not developed. And the connection of the link part 120 is maintained well by the second connection part 113. For this reason, the stent 100 has high strength and more reliably maintains a greatly expanded state immediately after indwelling.
  • a catheter for IVUS intravascular ultrasonography
  • Devices such as an OFDI (optical coherence tomography) catheter or a post-dilatation balloon catheter can be easily passed inside the stent 100.
  • the stent 100 maintains high strength, the risk that the stent 100 deforms (deforms) in the axial direction D1 is suppressed even if the above-described devices and the like are inadvertently contacted when passing inside. .
  • the biodegradable material 121 is decomposed to some extent, and the connection of the link part 120 is weakened.
  • the stent 100 is more flexible and easily deforms following the shape of the living body lumen.
  • the link part 120 After entering the chronic phase after the advance of endothelialization, the link part 120 is disconnected by the decomposition of the biodegradable material 121. Therefore, the stent 100 has particularly high flexibility and flexibly follows the shape of the living body lumen. As a result, the stent 100 can maintain the patency state while supporting the living body lumen in a minimally invasive manner over a long period of time.
  • the link part 120 is provided integrally with each of the adjacent struts 111 and the other struts 111, and is arranged in a state of facing each other.
  • 1 connection part 112 and 2nd connection part 113, and biodegradable material 121 which intervenes in 1st connection part 112 and 2nd connection part 113, and connects 1st connection part 112 and 2nd connection part 113 .
  • the first connection part 112 and the second connection part 113 are both arranged at a position overlapping the virtual line Y1 parallel to the circumferential direction D2.
  • Each of the first connection portion 112 and the second connection portion 113 has holding portions 112c and 113c that are formed so as to penetrate or be recessed in the thickness direction D3 from the surface of the strut 111 and hold the biodegradable material 121.
  • the holding part 112c and the second connection part 113 of the first connection part 112 are both arranged at a position overlapping the virtual line X2 parallel to the axial direction D1.
  • the holding part 113c and the first connection part 112 of the second connection part 113 are both arranged at a position overlapping the virtual line X1 parallel to the axial direction D1.
  • the link part 120 that connects the struts 111 includes the first connection part 112 and the second connection part 113 as a mechanical connection structure in addition to the biodegradable material 121.
  • each connection part 112,113 is arrange
  • the link part 120 can maintain a good mechanical connection. Therefore, the stent 100 can be placed in the living body lumen, and the connection between the struts 111 can be maintained well until the biodegradable material 121 is decomposed after a predetermined period.
  • each connection part 112 and 113 is arrange
  • connection parts 112 and 113 the length of the part which overlaps with the virtual line parallel to the axial direction D1 in the arbitrary positions of the circumferential direction D2 can be made still longer. As a result, the mechanical connection of the link part 120 can be further strengthened.
  • first connecting portion 112 and the second connecting portion 113 are tensile members that act on the link portion 120 when the virtual line K1 connecting the centers P1 and P2 of the holding portions 112c and 113c of each of the first connecting portion 112 and 113c expands the stent 100.
  • the holding portions 112c and 113c are disposed so as to incline toward a direction a1 overlapping with virtual lines X1 and X2 parallel to the axial direction D1.
  • a tensile force F acts on the connecting portions 112 and 113 in a direction overlapping the virtual lines X1 and X2 parallel to the axial direction D1. Therefore, it is possible to suitably prevent the connection between the connection portions 112 and 113 from being expanded by the expansion of the stent 100.
  • each connecting portion 112, 113 is projected to the other connecting portion side and is connected to the projecting portions 112a, 113a having a rounded curved shape and the projecting portions 112a, 113a, and the projecting portions 112a, 113a.
  • Storage portions 112b and 113b having a concave shape corresponding to the outer shape of the holding portions 112c and 113c are provided on the protruding portions 112a and 113a. For this reason, the protrusion part of one connection part can be accommodated in the accommodation part of the other connection part in a nested manner, and the state where the connection parts 112 and 113 are connected to each other can be favorably maintained. Further, the protrusions 112a and 113a can be well connected to each other via the biodegradable material 121.
  • the holding portions 112c and 113c are arranged with their centers P1 and P2 aligned with the centers of the outer shapes of the protruding portions 112a and 113a. Therefore, the protrusions 112a and 113a can be more reliably connected to each other via the biodegradable material 121.
  • the strut 111 extends spirally around the axial direction D1. For this reason, in the stent 100 provided with the spiral strut 111, the connection of the link part 120 can be maintained favorably.
  • the stent 100 is provided with the covering 122, and since the drug capable of suppressing the growth of the neointimal is gradually eluted from the covering 122, restenosis of the lesion site can be suppressed.
  • FIG. 6 is a diagram illustrating a link unit 320 according to a modification.
  • symbol is attached
  • the biodegradable material 121 is omitted.
  • the center of the holding portion 112c when viewed from the radial direction R is shifted from the center P3 of the arcuate outer shape of the protruding portion 112a, and the center of the holding portion 113c protrudes. It differs from the link part 120 of embodiment mentioned above in the point which has shifted
  • the link part 320 of a modification is explained in full detail.
  • the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged at positions overlapping with virtual lines parallel to the axial direction D1. That is, the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged so as to intersect with one virtual line X5 drawn in parallel with the axial direction D1.
  • the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L32.
  • the holding part 112c of the second connection part 113 and the first connection part 112 are both arranged at a position overlapping the virtual line X6 parallel to the axial direction D1. That is, the second connecting portion 113 and the holding portion 112c of the first connecting portion 112 are both arranged so as to intersect with one imaginary line X6 drawn parallel to the axial direction D1.
  • the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L33.
  • first connecting portion 112 and the second connecting portion 113 are overlapped with each other in the overlapping direction a1 with respect to the pulling direction T when the virtual line K3 connecting the centers P3 and P4 of the protruding portions 112a and 113a expands the stent 100. It is arrange
  • the type of the link part is not limited to the above embodiment as long as at least one link part includes the first connection part, the second connection part, and the biodegradable material.
  • the link part 130 may be configured by the first connection part 112, the second connection part 113, and the biodegradable material 121 similarly to the link part 120.
  • the arrangement of the link portions is not limited to the above embodiment, and can be changed as appropriate.
  • the form of the strut is not limited to the above-described embodiment and modifications.
  • the stent of the present invention does not include, for example, a strut extending spirally around the axial direction D1 like the strut 111 of the above embodiment, and the shaft is folded back in a wave shape like the strut 110 of the above embodiment. You may be comprised by the strut which extends in the circumferential direction D2 around the direction D1, and forms an endless annular shape.
  • the external shapes of the protruding portion, the accommodating portion, and the holding portion are not limited to the above-described embodiment and modification examples.
  • the outer shapes of the protruding portion, the accommodating portion, and the holding portion can be formed in an arbitrary polygonal shape.
  • the center of the protruding portion and the holding portion can be the center of gravity of the outer shape of each portion viewed from the radial direction of the cylindrical shape. .
  • the two points connecting the virtual lines in the protruding portion or the holding portion are the center or the center of gravity according to the shape of the protruding portion or the holding portion
  • the present invention is not limited to this.
  • the two points that connect the imaginary line are set at positions that contribute to maintaining the connection relationship between a pair of connection parts facing each other when a tensile force F acts on the link part when expanding the stent.
  • the imaginary line connecting the points is set to be inclined in the overlapping direction a1 with respect to the pulling direction T. Therefore, as long as the above setting is satisfied, two points connecting the imaginary lines can be appropriately set according to the shape of the protruding portion or the holding portion. For example, when the tensile force F is applied, it is conceivable to set a portion where physical force is concentrated in the protruding portion or the holding portion as a point connecting virtual lines.
  • the struts 110 and 111 of the above embodiment are formed of a non-biodegradable material, the present invention is not limited to this form.
  • the strut may be formed of a biodegradable material that decomposes slower than the biodegradable material included in the link portion.
  • the present invention includes a form without the covering 122 and a form in which the biodegradable material 121 contains a drug capable of suppressing the growth of the neointimal.
  • the drug is gradually eluted with the degradation of the biodegradable material 121, and restenosis of the lesion site is suppressed.
  • 100 stents 110 struts (struts located at both axial ends), 111 struts (struts extending in a spiral around the axial direction), 112 1st connection part, 113 second connection part, 112a, 113a protrusion, 112b, 113b accommodating portion, 112c, 113c holding part, 120, 220, 320 link part, 130 link section, 121 biodegradable materials, 122 covering, X1, X2, X3, X4, X5, X6 Virtual lines parallel to the axial direction, Y1 Virtual line parallel to the circumferential direction, K1, K2, K3 Virtual lines connecting the centers of the protrusions, T tensile direction, D1 axial direction, D2 circumferential direction, D3 thickness direction, P1, P2 center of holding part, R radial direction.

Abstract

[Problem] To provide a stent that can adequately maintain connections between struts throughout a prescribed period due to a biodegradable material and a mechanical connection structure that is provided to the struts. [Solution] A link section of a cylindrically shaped stent (100) includes a first connection section (112) and a second connection section (113) that are integrally provided to neighboring struts (111) and are positioned facing one another, and a biodegradable material (121) that is between the first connection section and the second connection section and connects the first connection section and the second connection section. The first connection section and the second connection section are both positioned in locations that overlap an imaginary line (Y1), said imaginary line being parallel to the circumferential direction (D2) of the cylindrical shape. The first connection section and the second connection section each have, in a protruding section thereof, a holding section (112c), (113c) that holds the biodegradable material and is formed by piercing or depressing the surface of the strut in the thickness direction (D3). The first connection section and the holding section of the second connection section are both positioned in locations that overlap an imaginary line (X1), said imaginary line being parallel to the axial direction (D1) of the cylindrical shape, and the second connection section and the holding section of the first connection section are both positioned in locations that overlap an imaginary line (X2), said imaginary line being parallel to the axial direction (D1) of the cylindrical shape.

Description

ステントStent
　本発明は、ステントに関する。 The present invention relates to a stent.
　ステントは、血管等の生体管腔内に生じた狭窄部位または閉塞部位に拡張した状態で留置されて生体管腔の開存状態を維持するものであり、拡張した状態を保持するための強度が求められる。その一方で、ステントには生体管腔の形状に追従する柔軟性も求められ、柔軟性を向上させるための様々な試みがなされている。 A stent is placed in an expanded state in a stenosis site or an occlusion site generated in a biological lumen such as a blood vessel to maintain the patency state of the biological lumen, and has a strength for maintaining the expanded state. Desired. On the other hand, the stent is also required to have flexibility to follow the shape of the body lumen, and various attempts have been made to improve the flexibility.
　例えば、下記特許文献１には、生分解性材料（生体吸収性ポリマー）で構成されたブリッジでストラット同士を接続し、生体管腔内に留置した後、所定の期間が経過した後にストラット同士の接続を解除することにより所望の柔軟性を発揮し得るように構成されたステントが開示されている。 For example, in Patent Document 1 below, struts are connected with a bridge made of a biodegradable material (bioabsorbable polymer), placed in a living body lumen, and after a predetermined period has passed, A stent is disclosed that is configured to exhibit a desired flexibility by releasing the connection.
国際公開第２００７／０１３１０２号International Publication No. 2007/013102
　しかしながら、生分解性材料で構成されたブリッジのみを利用してストラット同士を接続した場合、ステントに不用意に力が付加されると、ストラット同士の接続が解除されてしまい、ステントの機械特性が意図せずに変化してしまうことが起こり得る。例えば、ステントを生体管腔内にデリバリーする際や、バルーンにクリンプしたステントを生体管腔内で拡張する際や、留置後にステントの内腔を通じて各種の医療器具を導入して処置を行う際などには、ブリッジによる接続が解除されてしまう可能性が高くなる。 However, when struts are connected using only a bridge made of a biodegradable material, if a force is applied to the stent inadvertently, the connection between the struts is released, and the mechanical properties of the stent are reduced. It can happen that it changes unintentionally. For example, when delivering a stent into a living body lumen, when expanding a stent crimped to a balloon within the living body lumen, or when performing treatment by introducing various medical instruments through the lumen of the stent after placement There is a high possibility that the connection by the bridge is canceled.
　また、例えば、生分解性材料で構成されたブリッジのみに依らずに、ストラットに形状等を付加して機械的な接続構造を設けることにより、ストラット間の接続力を補強することは可能であると考えられるが、これまでは接続力を向上させるのに適したストラットの接続構造については十分な検討がなされていなかった。 In addition, for example, it is possible to reinforce the connection force between the struts by adding a shape or the like to the struts and providing a mechanical connection structure without depending on only the bridge made of the biodegradable material. However, until now, sufficient studies have not been made on the strut connection structure suitable for improving the connection force.
　そこで、本発明は、ストラットに設けられた機械的な接続構造と生分解性材料とによりストラット同士の接続を所望の期間に亘って良好に維持し得るように構成されたステントを提供することを目的とする。 Therefore, the present invention provides a stent configured to maintain a good connection between struts over a desired period of time by a mechanical connection structure provided in the strut and a biodegradable material. Objective.
　上記目的を達成するための本発明のステントは、隙間が形成された円筒形状の外周を形作る線状のストラットと、前記隙間で前記ストラット同士を接続する複数のリンク部と、を有する。前記リンク部の少なくも一つは、隣り合う一の前記ストラットと他の前記ストラットのそれぞれに一体的に設けられており、互いに対向した状態で配置される一の接続部および他の接続部と、前記一の接続部および前記他の接続部に介在して前記一の接続部および前記他の接続部を接続する生分解性材料と、を含む。前記一の接続部および前記他の接続部は、共に前記円筒形状の周方向に平行な仮想線と重なる位置に配置されている。前記一の接続部および前記他の接続部のそれぞれは、前記ストラットの表面から厚み方向に貫通あるいは窪んで形成されて前記生分解性材料を保持する保持部を前記突出部に有する。前記一の接続部の前記保持部および前記他の接続部は、共に前記円筒形状の軸方向に平行な仮想線と重なる位置に配置されており、前記他の接続部の前記保持部および前記一の接続部は、前記円筒形状の軸方向に平行な仮想線と重なる位置に配置されている。 To achieve the above object, the stent of the present invention has a linear strut that forms a cylindrical outer periphery in which a gap is formed, and a plurality of link portions that connect the struts with the gap. At least one of the link parts is provided integrally with each of the adjacent one of the struts and the other struts, and one connection part and the other connection part arranged in a state of facing each other. And a biodegradable material that interposes the one connection part and the other connection part to connect the one connection part and the other connection part. Both the one connection part and the other connection part are arranged at a position overlapping an imaginary line parallel to the circumferential direction of the cylindrical shape. Each of the one connection part and the other connection part has a holding part for holding the biodegradable material formed in the protruding part so as to penetrate or be recessed in the thickness direction from the surface of the strut. The holding portion and the other connecting portion of the one connecting portion are both arranged at a position overlapping an imaginary line parallel to the axial direction of the cylindrical shape, and the holding portion and the one connecting portion of the other connecting portion are arranged. The connecting portion is arranged at a position overlapping a virtual line parallel to the cylindrical axial direction.
　上記構成を有するステントによれば、ストラット同士を接続するリンク部は、生分解性材料に加え、機械的な接続構造として一対の接続部を有している。一対の接続部のうち一方の接続部は、保持部が形成されている位置が他方の接続部と共に軸方向に平行な仮想線と重なるように配置されているため、周方向において接続部同士の互いに入れ子になっている部分の長さを比較的長くすることができる。このため、仮に、ステントに不用意に力が加わったとしても、リンク部における機械的な接続を良好に維持することができる。その結果、ステントを生体管腔内に留置し、所定の期間が経過して生分解性材料が分解されるまでの間、ストラット同士の接続を良好に維持することができる。 According to the stent having the above-described configuration, the link portion that connects the struts has a pair of connection portions as a mechanical connection structure in addition to the biodegradable material. One connection part of the pair of connection parts is arranged so that the position where the holding part is formed overlaps the virtual line parallel to the axial direction together with the other connection part. The lengths of the portions nested in each other can be made relatively long. For this reason, even if force is applied to the stent inadvertently, the mechanical connection at the link portion can be maintained well. As a result, the stent can be placed in the living body lumen, and the connection between the struts can be maintained well until a predetermined period of time passes and the biodegradable material is decomposed.
実施形態のステントの斜視図である。It is a perspective view of the stent of an embodiment. 実施形態のステントの外周の一部を軸方向に沿って直線状に切断して展開した展開図である。FIG. 3 is a development view in which a part of the outer periphery of the stent according to the embodiment is developed by cutting linearly along the axial direction. （Ａ）は実施形態のステントのリンク部の拡大図であり、（Ｂ）は、（Ａ）の３Ｂ－３Ｂ線に沿う拡大断面図である。(A) is an enlarged view of the link portion of the stent of the embodiment, and (B) is an enlarged cross-sectional view taken along line 3B-3B of (A). 実施形態のリンク部における接続部の配置の説明に供する図である。It is a figure with which it uses for description of arrangement | positioning of the connection part in the link part of embodiment. 比較例のリンク部の拡大図である。It is an enlarged view of the link part of a comparative example. 変形例のリンク部の拡大図である。It is an enlarged view of the link part of a modification.
　以下、添付した図面を参照しながら、本発明の実施形態を説明する。なお、図面の寸法比率は、説明の都合上誇張されており、実際の比率と異なる。 Hereinafter, embodiments of the present invention will be described with reference to the accompanying drawings. In addition, the dimension ratio of drawing is exaggerated on account of description, and differs from an actual ratio.
　図１および図２は、実施形態のステント１００の構造を示す概略図である。図３および図４は、実施形態のステント１００のリンク部１２０の構造を示す概略図である。なお、図４では、生分解性材料１２１（図３（Ａ）参照）を省略して示している。以下、図１～図４を参照して、実施形態のステント１００について説明する。 1 and 2 are schematic views showing the structure of the stent 100 of the embodiment. 3 and 4 are schematic views showing the structure of the link portion 120 of the stent 100 of the embodiment. In FIG. 4, the biodegradable material 121 (see FIG. 3A) is omitted. Hereinafter, the stent 100 of the embodiment will be described with reference to FIGS.
　図１に示すように、実施形態のステント１００は、線状の構成要素であるストラット１１０、１１１を有する。ストラット１１０、１１１は、隙間が形成された円筒形状の外周を形作っている。 As shown in FIG. 1, the stent 100 of the embodiment has struts 110 and 111 which are linear components. The struts 110 and 111 form a cylindrical outer periphery in which a gap is formed.
　なお、明細書中、ストラット１１０、１１１によって形作られた円筒形状の軸方向は、単に「軸方向Ｄ１」と記載し（図１参照）、円筒形状の周方向は、単に「周方向Ｄ２」と記載する（図３（Ａ）参照）。 In the specification, the axial direction of the cylindrical shape formed by the struts 110 and 111 is simply referred to as “axial direction D1” (see FIG. 1), and the circumferential direction of the cylindrical shape is simply referred to as “circumferential direction D2”. It is described (see FIG. 3A).
　ストラット１１０は、軸方向Ｄ１の両端に位置し、波状に折り返されつつ周方向Ｄ２に延在して無端の環状形状を形作っている。 The struts 110 are located at both ends in the axial direction D1 and extend in the circumferential direction D2 while being folded in a wave shape to form an endless annular shape.
　ストラット１１１は、一端のストラット１１０と他端のストラット１１０との間において、波状に折り返されつつ軸方向Ｄ１のまわりに螺旋状に延在している。 The strut 111 extends spirally around the axial direction D1 while being folded back in a wave shape between the strut 110 at one end and the strut 110 at the other end.
　ストラット１１０、１１１を形成する材料は、例えば、生体内で分解しない非生分解性の材料である。そのような材料としては、例えば、ステンレス鋼、コバルト－クロム合金（例えばＣｏＣｒＷＮｉ合金）等のコバルト系合金、プラチナ－クロム合金（例えばＰｔＦｅＣｒＮｉ合金）等の弾性金属、ニッケル－チタン合金等の超弾性合金等が挙げられる。 The material forming the struts 110 and 111 is, for example, a non-biodegradable material that does not degrade in vivo. Such materials include, for example, stainless steel, cobalt-based alloys such as cobalt-chromium alloy (eg, CoCrWNi alloy), elastic metals such as platinum-chromium alloy (eg, PtFeCrNi alloy), and superelastic alloys such as nickel-titanium alloy. Etc.
　図２に示すように、実施形態のステント１００は、複数のリンク部１２０、１３０を有する。 As shown in FIG. 2, the stent 100 of the embodiment has a plurality of link portions 120 and 130.
　リンク部１２０は、隣り合うストラット１１１の波状に折り返された頂点とストラット１１１の波状に折り返された頂点との間の隙間でそれらを接続している。リンク部１３０は、隣り合うストラット１１０の波状に折り返された頂点とストラット１１１の波状に折り返された頂点との間の隙間でそれらを接続している。 The link portion 120 connects them with a gap between the vertices of adjacent struts 111 folded in a wave shape and the vertices of the struts 111 folded back in a wave shape. The link part 130 connects them with a gap between the vertices of the adjacent struts 110 that are folded back and the vertices of the struts 111 that are folded back.
　リンク部１２０は、隙間を空けて隣り合うストラット１１１同士の離間方向Ｓ１に対して交差する方向Ｓ２において、所定の間隔で配置されている。リンク部１３０は、周方向Ｄ２において、所定の間隔で配置されている。 The link portions 120 are arranged at a predetermined interval in a direction S2 that intersects a separation direction S1 between adjacent struts 111 with a gap. The link parts 130 are arranged at a predetermined interval in the circumferential direction D2.
　図３（Ａ）に示すように、リンク部１２０は、第１接続部１１２および第２接続部１１３、ならびに生分解性材料１２１を含む。 As shown in FIG. 3A, the link part 120 includes a first connection part 112, a second connection part 113, and a biodegradable material 121.
　第１接続部１１２および第２接続部１１３は、隣り合うストラット１１１とストラット１１１のそれぞれに一体的に設けられるとともに、互いに対向した状態で配置されており、生分解性材料１２１によって接続されている。 The first connection part 112 and the second connection part 113 are provided integrally with each of the adjacent struts 111 and struts 111 and are arranged in a state of facing each other, and are connected by a biodegradable material 121. .
　第１接続部１１２は、隣接する２つのストラット１１１のうち、一方のストラット１１１の一部が部分的に突出して形成されており、第２接続部１１３は、他方のストラット１１１の一部が部分的に突出して形成されている。 The first connection part 112 is formed by partially protruding one of the two struts 111 adjacent to the first connection part 112, and the second connection part 113 is a part of the other strut 111. Projectingly.
　図３（Ａ）、（Ｂ）に示すように、第１接続部１１２は、第２接続部１１３側に向けて突出し、かつ、丸みを帯びた湾曲形状を有する突出部１１２ａと、突出部１１２ａに連なり、第２接続部１１３の突出部１１３ａの外形形状に応じた凹形状を有する収容部１１２ｂと、ストラット１１１の表面から厚み方向Ｄ３に貫通して形成されて生分解性材料１２１を保持する保持部１１２ｃと、を有する。保持部１１２ｃは、突出部１１２ａに設けられている。第２接続部１１３は、第１接続部１１２側に向けて突出し、かつ、丸みを帯びた湾曲形状を有する突出部１１３ａと、突出部１１３ａに連なり、第１接続部１１２の突出部１１２ａの外形形状に応じた凹形状を有する収容部１１３ｂと、ストラット１１１の表面から厚み方向Ｄ３に貫通して窪んで形成されて生分解性材料１２１を保持する保持部１１３ｃと、を有する。保持部１１３ｃは、突出部１１３ａに設けられている。 As shown in FIGS. 3A and 3B, the first connection portion 112 protrudes toward the second connection portion 113 and has a rounded curved shape, and a protrusion 112a. And holding the biodegradable material 121 by penetrating in the thickness direction D3 from the surface of the strut 111 and the accommodating portion 112b having a concave shape corresponding to the outer shape of the protruding portion 113a of the second connecting portion 113. Holding part 112c. The holding part 112c is provided on the protruding part 112a. The second connecting portion 113 protrudes toward the first connecting portion 112 and has a rounded curved shape 113a. The second connecting portion 113 is connected to the protruding portion 113a, and the outer shape of the protruding portion 112a of the first connecting portion 112. The housing portion 113b has a concave shape corresponding to the shape, and the holding portion 113c that is formed to be recessed from the surface of the strut 111 in the thickness direction D3 and holds the biodegradable material 121. The holding portion 113c is provided on the protruding portion 113a.
　図３（Ａ）に示すように、本実施形態では、各突出部１１２ａ、１１３ａは、円筒形状の径方向（図１の矢印Ｒで示す方向。以下、「径方向Ｒ」と記載する）から見たときに、円弧状の外形形状を備えている。 As shown in FIG. 3A, in this embodiment, each of the protrusions 112a and 113a is from a cylindrical radial direction (direction indicated by an arrow R in FIG. 1; hereinafter referred to as “radial direction R”). When viewed, it has an arcuate outer shape.
　収容部１１２ｂの凹形状は、突出部１１３ａの外形形状よりも大きく形成されている。突出部１１３ａは、収容部１１２ｂの凹形状内に隙間を設けて収容される。収容部１１３ｂの凹形状は、突出部１１２ａの外形形状よりも大きく形成されている。突出部１１２ａは、収容部１１３ｂの凹形状内に隙間を設けて入れ子状に収容される。突出部１１３ａは、収容部１１２ｂの凹形状内に隙間を設けて入れ子状に収容される。なお、突出部１１２ａは、収容部１１３ｂに部分的に接触してもよい。また、突出部１１３ａは、収容部１１２ｂに部分的に接触してもよい。 The concave shape of the accommodating part 112b is formed larger than the external shape of the protrusion part 113a. The protruding portion 113a is accommodated with a gap in the concave shape of the accommodating portion 112b. The concave shape of the accommodating portion 113b is formed larger than the outer shape of the protruding portion 112a. The protruding portion 112a is accommodated in a nested manner with a gap in the concave shape of the accommodating portion 113b. The protruding portion 113a is accommodated in a nested manner with a gap in the concave shape of the accommodating portion 112b. Note that the protruding portion 112a may partially contact the housing portion 113b. Further, the protruding portion 113a may partially contact the housing portion 112b.
　図３（Ｂ）に示すように、本実施形態では、各保持部１１２ｃ、１１３ｃは、ストラット１１１を厚み方向Ｄ３に貫通する貫通穴によって構成されている。ただし、各保持部１１２ｃ、１１３ｃは、生分解性材料１２１を保持可能であれば、貫通穴である必要はなく、少なくともストラット１１１の厚み方向Ｄ３にある程度窪んだ形状であればよい。 As shown in FIG. 3 (B), in the present embodiment, each holding portion 112c, 113c is configured by a through hole that penetrates the strut 111 in the thickness direction D3. However, each holding part 112c, 113c does not need to be a through-hole as long as the biodegradable material 121 can be held, and may have a shape that is recessed to some extent at least in the thickness direction D3 of the strut 111.
　図３（Ａ）に示すように、各保持部１１２ｃ、１１３ｃは、径方向Ｒから見たときに、円形の外形形状を備えている。各保持部１１２ｃ、１１３ｃは、径方向Ｒから見たときの各突出部１１２ａ、１１３ａの円弧状の外形形状の中心に、各保持部１１２ｃ、１１３ｃの中心Ｐ１、Ｐ２を位置合わせするように配置されている。なお、各保持部１１２ｃ、１１３ｃの外形形状は円形に限定されず、例えば楕円形でも良い。 As shown in FIG. 3A, each holding portion 112c, 113c has a circular outer shape when viewed from the radial direction R. The holding portions 112c and 113c are arranged so that the centers P1 and P2 of the holding portions 112c and 113c are aligned with the centers of the arcuate outer shapes of the protruding portions 112a and 113a when viewed from the radial direction R. Has been. In addition, the external shape of each holding | maintenance part 112c, 113c is not limited to circular, For example, an ellipse may be sufficient.
　図４に示すように、第１接続部１１２および第２接続部１１３は、共に周方向Ｄ２に平行な仮想線Ｙ１と重なる位置に配置されている。すなわち、第１接続部１１２および第２接続部１１３は、いずれも周方向Ｄ２に平行に引いた１本の仮想線Ｙ１と交差するように配置されている。第１接続部１１２および第２接続部１１３において、軸方向Ｄ１の任意の位置に周方向Ｄ２に平行に引いた仮想線と重なっている部分の軸方向Ｄ１に沿う長さは、Ｌ１である。 As shown in FIG. 4, the first connection part 112 and the second connection part 113 are both arranged at a position overlapping the virtual line Y1 parallel to the circumferential direction D2. That is, the first connection part 112 and the second connection part 113 are both arranged so as to intersect with one virtual line Y1 drawn in parallel to the circumferential direction D2. In the first connecting portion 112 and the second connecting portion 113, the length along the axial direction D1 of the portion overlapping the imaginary line drawn in parallel with the circumferential direction D2 at an arbitrary position in the axial direction D1 is L1.
　また、第１接続部１１２および第２接続部１１３の保持部１１３ｃは、共に軸方向Ｄ１に平行な仮想線Ｘ１と重なる位置に配置されている。すなわち、第１接続部１１２および第２接続部１１３の保持部１１３ｃは、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ１と交差するように配置されている。第１接続部１１２および保持部１１３ｃにおいて、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行に引いた仮想線と重なっている部分の周方向Ｄ２に沿う長さは、Ｌ１２である。同様に、第２接続部１１３および第１接続部１１２の保持部１１２ｃは、共に軸方向Ｄ１に平行な仮想線Ｘ２と重なる位置に配置されている。すなわち、第２接続部１１３および第１接続部１１２の保持部１１２ｃは、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ２と交差するように配置されている。第２接続部１１３および保持部１１２ｃにおいて、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行に引いた仮想線と重なっている部分の周方向Ｄ２に沿う長さは、Ｌ１３である。 Further, the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged at positions overlapping the virtual line X1 parallel to the axial direction D1. That is, the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged so as to intersect with one virtual line X1 drawn in parallel with the axial direction D1. In the first connecting portion 112 and the holding portion 113c, the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L12. Similarly, the holding part 112c of the second connection part 113 and the first connection part 112 are both arranged at a position overlapping the virtual line X2 parallel to the axial direction D1. That is, the second connecting portion 113 and the holding portion 112c of the first connecting portion 112 are both arranged so as to intersect with one imaginary line X2 drawn parallel to the axial direction D1. In the second connection portion 113 and the holding portion 112c, the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L13.
　したがって、径方向Ｒから見たときの突出部１１３ａ（または突出部１１２ａ）の周縁と保持部１１３ｃ（または保持部１１２ｃ）の周縁との間の部分の距離をΔＬとすれば、第１接続部１１２および第２接続部１１３において、軸方向Ｄ１に平行な仮想線と重なっている部分の周方向Ｄ２に沿う長さは、ΔＬ＋Ｌ１２（＝ΔＬ＋Ｌ１３）である。 Accordingly, when the distance between the peripheral edge of the protrusion 113a (or the protrusion 112a) and the peripheral edge of the holding part 113c (or the holding part 112c) when viewed from the radial direction R is ΔL, the first connection part In 112 and the second connecting portion 113, the length along the circumferential direction D2 of the portion overlapping the virtual line parallel to the axial direction D1 is ΔL + L12 (= ΔL + L13).
　さらに、第１接続部１１２の保持部１１２ｃの中心Ｐ１および第２接続部１１３は、共に軸方向Ｄ１に平行な仮想線Ｘ２と重なる位置に配置されている。すなわち、第１接続部１１２の保持部１１２ｃの中心Ｐ１および第２接続部１１３は、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ２と交差するように配置されている。同様に、第２接続部１１３の保持部１１３ｃの中心Ｐ２および第１接続部１１２は、共に軸方向Ｄ１に平行な仮想線Ｘ１と重なる位置に配置されている。すなわち、第２接続部１１３の保持部１１３ｃの中心Ｐ２および第１接続部１１２は、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ１と交差するように配置されている。 Furthermore, the center P1 of the holding part 112c of the first connection part 112 and the second connection part 113 are both arranged at a position overlapping the virtual line X2 parallel to the axial direction D1. That is, the center P1 of the holding part 112c of the first connection part 112 and the second connection part 113 are both arranged so as to intersect with one virtual line X2 drawn parallel to the axial direction D1. Similarly, the center P2 of the holding portion 113c of the second connection portion 113 and the first connection portion 112 are both arranged at positions overlapping the virtual line X1 parallel to the axial direction D1. That is, the center P2 of the holding portion 113c of the second connection portion 113 and the first connection portion 112 are both arranged so as to intersect with one virtual line X1 drawn in parallel with the axial direction D1.
　さらに、第１接続部１１２および第２接続部１１３は、ステント１００を拡張させる際にリンク部１２０に作用する引張力Ｆの方向Ｔ（以下、「引張方向Ｔ」と記載する）との関係を考慮して配置することができる。本実施形態においては、第１接続部１１２および第２接続部１１３は、保持部１１２ｃ、１１３ｃの中心Ｐ１、Ｐ２同士を繋ぐ仮想線Ｋ１が、引張方向Ｔに対して、保持部１１２ｃ、１１３ｃが共に軸方向Ｄ１に平行な１本の仮想線と重なる方向ａ１（以下、「重なり方向ａ１」と記載する）に向けて傾斜するように、配置されている。すなわち、第１接続部１１２および第２接続部１１３は、仮想線Ｋ１と軸方向Ｄ１に平行な仮想線Ｘ１、Ｘ２との角度が小さくなるように配置されている。 Furthermore, the first connection part 112 and the second connection part 113 have a relationship with the direction T of the tensile force F acting on the link part 120 when the stent 100 is expanded (hereinafter referred to as “tensile direction T”). Can be arranged in consideration. In the present embodiment, the first connecting portion 112 and the second connecting portion 113 are configured so that the virtual line K1 connecting the centers P1 and P2 of the holding portions 112c and 113c has the holding portions 112c and 113c with respect to the pulling direction T. Both are arranged so as to incline toward a direction a1 (hereinafter referred to as “overlapping direction a1”) overlapping with one imaginary line parallel to the axial direction D1. That is, the first connection part 112 and the second connection part 113 are arranged so that the angle between the virtual line K1 and the virtual lines X1 and X2 parallel to the axial direction D1 is small.
　なお、引張方向Ｔは、リンク部の配置やストラット形状等のステント構造、ステントの拡張時の形状等によって異なり、解析や実験等によって特定することができる。例えば、本実施形態では、図２に示すように、１つのリンク部１２０を中心として、隣接する他のリンク部１２０との間に設けられるストラット１１１の折り返し部１１１ａの数は、第１範囲Ａ１では２つであるのに対し、第２範囲Ａ２では４つである。このため、ステント１００の拡張に伴いストラット１１１が伸びたとき、折り返し部１１１ａの数が少なく比較的伸びにくい第１範囲Ａ１におけるストラット１１１の方が、第２範囲Ａ２におけるストラット１１１よりもリンク部１２０を引っ張る力が強い。したがって、ステント構造に基づけば、本実施形態では、引張方向Ｔは、ステント１００の軸方向Ｄ１に対して第１範囲Ａ１側に傾くと概ね特定できる。 The tensile direction T differs depending on the arrangement of the link portion, the stent structure such as the strut shape, the shape when the stent is expanded, and the like, and can be specified by analysis or experiment. For example, in the present embodiment, as shown in FIG. 2, the number of folded portions 111a of the struts 111 provided between one link portion 120 and another adjacent link portion 120 is the first range A1. In the second range A2, the number is four. For this reason, when the struts 111 are expanded with the expansion of the stent 100, the struts 111 in the first range A1 in which the number of the folded portions 111a is small and relatively difficult to expand are more than the struts 111 in the second range A2. Strong pulling force. Therefore, based on the stent structure, in this embodiment, the tension direction T can be generally specified as being inclined toward the first range A1 with respect to the axial direction D1 of the stent 100.
　図３（Ａ）、（Ｂ）に示すように、生分解性材料１２１は、ステント１００が生体管腔内において留置された後、所定時間経過して分解されるまでの間、第１接続部１１２と第２接続部１１３とを繋ぎ止める。 As shown in FIGS. 3 (A) and 3 (B), the biodegradable material 121 has a first connection portion until the stent 100 is decomposed after a predetermined period of time after the stent 100 is placed in the living body lumen. 112 and the 2nd connection part 113 are connected.
　生分解性材料１２１は、第１接続部１１２および第２接続部１１３の表面と、第１接続部１１２と第２接続部１１３との間の隙間と、各保持部１１２ｃ、１１３ｃ内とに一体的に連なるように形成されている。第１接続部１１２および第２接続部１１３の表面を覆うように生分解性材料１２１を設けるだけでなく、第１接続部１１２と第２接続部１１３との間の隙間および各保持部１１２ｃ、１１３ｃ内に生分解性材料１２１を充填することにより、第１接続部１１２および第２接続部１１３をより良好に繋ぎ止めることができる。 The biodegradable material 121 is integrated into the surfaces of the first connection portion 112 and the second connection portion 113, the gap between the first connection portion 112 and the second connection portion 113, and the holding portions 112c and 113c. It is formed to be continuous. In addition to providing the biodegradable material 121 so as to cover the surfaces of the first connection portion 112 and the second connection portion 113, the gap between the first connection portion 112 and the second connection portion 113 and the holding portions 112c, By filling the biodegradable material 121 in 113c, the 1st connection part 112 and the 2nd connection part 113 can be connected more favorably.
　生分解性材料１２１は、生体内で分解される材料である限り特に限定されず、そのような材料としては、例えば、ポリ乳酸、ポリグリコール酸、乳酸－グリコール酸共重合体、ポリカプロラクトン、乳酸－カプロラクトン共重合体、グリコール酸－カプロラクトン共重合体、ポリ－γ－グルタミン酸等の生分解性合成高分子材料、あるいは、コラーゲン等の生分解性天然高分子材料、マグネシウム、亜鉛等の生分解性金属材料が挙げられる。 The biodegradable material 121 is not particularly limited as long as it is a material that can be decomposed in vivo. Examples of such a material include polylactic acid, polyglycolic acid, lactic acid-glycolic acid copolymer, polycaprolactone, and lactic acid. -Biodegradable synthetic polymer materials such as caprolactone copolymer, glycolic acid-caprolactone copolymer, poly-γ-glutamic acid, biodegradable natural polymer materials such as collagen, biodegradability such as magnesium and zinc A metal material is mentioned.
　リンク部１２０を含むステント１００は、その表面に、薬剤を含む被覆体１２２を備える。被覆体１２２は、ステント１００の表面のうち、好ましくは、生体管腔の内周面と対向する側の外表面に形成されるが、これに限定されない。 The stent 100 including the link portion 120 includes a covering 122 containing a drug on the surface thereof. The covering 122 is preferably formed on the outer surface of the stent 100 on the side facing the inner peripheral surface of the living body lumen, but is not limited thereto.
　被覆体１２２は、新生内膜の増殖を抑制可能な薬剤と、薬剤を担持するための薬剤担持体と、を含んでいる。なお、被覆体１２２は、薬剤のみによって構成されていてもよい。被覆体１２２に含まれる薬剤は、例えば、シロリムス、エベロリムス、ゾタロリムス、パクリタキセル等からなる群より選択される少なくとも１種である。薬剤担持体の構成材料としては、特に限定されないが、生分解性材料が好ましく、生分解性材料１２１と同様の材料を適用できる。 The covering 122 includes a drug capable of suppressing the growth of the neointimal and a drug carrier for supporting the drug. In addition, the covering body 122 may be comprised only with the chemical | medical agent. The drug contained in the covering 122 is at least one selected from the group consisting of sirolimus, everolimus, zotarolimus, paclitaxel, and the like. Although it does not specifically limit as a constituent material of a chemical | medical agent carrier, A biodegradable material is preferable and the material similar to the biodegradable material 121 is applicable.
　リンク部１３０は、ストラット１１０およびストラット１１１と一体的に形成されている。リンク部１３０は、ストラット１１０、１１１と同じ生体内で分解しない非生分解性の材料で形成されており、生分解性材料１２１を有していない。 The link part 130 is formed integrally with the strut 110 and the strut 111. The link portion 130 is formed of a non-biodegradable material that does not decompose in the same living body as the struts 110 and 111, and does not have the biodegradable material 121.
　次に本実施形態のステント１００の作用効果について述べる。 Next, the effect of the stent 100 of this embodiment will be described.
　ステント１００は、例えば、血管、胆管、気管、食道、または尿道等の生体管腔内に生じた狭窄部位または閉塞部位に、バルーンカテーテル等のステントデリバリー用の医療器具を用いてデリバリーされる。本実施形態のリンク部１２０では、図４に示すように、第１接続部１１２および保持部１１３ｃは、いずれも軸方向Ｄ１に平行な仮想線Ｘ１と重なる位置に配置されており、第２接続部１１３および保持部１１２ｃは、いずれも軸方向Ｄ１に平行な仮想線Ｘ２と重なる位置に配置されている。このため、第１接続部１１２および第２接続部１１３において、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行な仮想線と重なっている部分の周方向Ｄ２に沿う長さが比較的長く、デリバリーの際に、仮に、ステント１００に不用意に力が加わったとしても、リンク部１２０の機械的な接続を良好に維持することができる。 The stent 100 is delivered to a stenosis site or an occlusion site generated in a living body lumen such as a blood vessel, a bile duct, a trachea, an esophagus, or a urethra using a medical device for stent delivery such as a balloon catheter. In the link part 120 of the present embodiment, as shown in FIG. 4, the first connection part 112 and the holding part 113c are both arranged at a position overlapping the virtual line X1 parallel to the axial direction D1, and the second connection Each of the portion 113 and the holding portion 112c is disposed at a position overlapping the virtual line X2 parallel to the axial direction D1. For this reason, in the 1st connection part 112 and the 2nd connection part 113, the length along the peripheral direction D2 of the part which has overlapped with the virtual line parallel to axial direction D1 in the arbitrary positions of peripheral direction D2 is comparatively long, Even if force is applied to the stent 100 inadvertently during delivery, the mechanical connection of the link portion 120 can be maintained well.
　また、デリバリーされたステント１００は、生体管腔の狭窄部位または閉塞部位において拡張される。この際、図４に示すように、本実施形態のリンク部１２０では、保持部１１２ｃ、１１３ｃの中心Ｐ１、Ｐ２同士を繋ぐ仮想線Ｋ１が、引張方向Ｔに対して、重なり方向ａ１に向けて傾斜している。このため、ステント１００を拡張させた際に各接続部１１２、１１３に作用する引張力Ｆを、仮想線Ｋ１に沿う方向の成分ｆ１と、仮想線Ｋ１に直交する方向の成分ｆ２とに分解して表現すれば、成分ｆ２は、重なり方向ａ１に作用する。すなわち、ステント１００を拡張させると、各接続部１１２、１１３には、軸方向Ｄ１に平行な１本の仮想線Ｘ１、Ｘ２と重なる方向に引張力Ｆが作用する。このため、ステント１００の拡張に伴って、接続部１１２、１１３同士の接続が解除されるのを好適に防止することができる。その結果、ステント１００の留置後においてもリンク部１２０の接続を良好に維持することができる。 In addition, the delivered stent 100 is expanded at a stenosis site or an occlusion site of a living body lumen. At this time, as shown in FIG. 4, in the link portion 120 of the present embodiment, the virtual line K1 connecting the centers P1 and P2 of the holding portions 112c and 113c is directed toward the overlapping direction a1 with respect to the pulling direction T. Inclined. For this reason, when the stent 100 is expanded, the tensile force F acting on each of the connection portions 112 and 113 is changed into a component f 1 in the direction along the imaginary line K1 and a component f 2 in the direction orthogonal to the imaginary line K1. if it decomposes representation component f 2 acts in the overlapping direction a1. That is, when the stent 100 is expanded, a tensile force F acts on each of the connection portions 112 and 113 in a direction overlapping with one imaginary line X1 and X2 parallel to the axial direction D1. For this reason, it is possible to suitably prevent the connection portions 112 and 113 from being disconnected together with the expansion of the stent 100. As a result, the connection of the link part 120 can be maintained well even after the stent 100 is placed.
　図５は、比較例のリンク部２２０を示す図である。なお、図５では、図４と同様に、生分解性材料１２１（図３（Ａ）参照）を省略して示している。 FIG. 5 is a diagram showing a link portion 220 of a comparative example. In FIG. 5, the biodegradable material 121 (see FIG. 3A) is omitted as in FIG.
　比較例のリンク部２２０では、第１接続部１１２および保持部１１３ｃは、軸方向Ｄ１に平行な仮想線Ｘ３と重なる位置に配置されていない。すなわち、第１接続部１１２および保持部１１３ｃは、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ３と全く交差することがない。また、比較例のリンク部２２０では、第２接続部１１３および保持部１１２ｃは、軸方向Ｄ１に平行な仮想線Ｘ４と重なる位置に配置されていない。すなわち、第２接続部１１３および保持部１１２ｃは、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ４と全く交差することがない。比較例のリンク部２２０では、第１接続部１１２と第２接続部１１３は、第１接続部１１２および第２接続部１１３において、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行な仮想線と互いに重なっている部分の周方向Ｄ２沿う長さがΔＬとなるように配置された状態で、生分解性材料１２１によって繋ぎ合わされている。このため、比較例のリンク部２２０は、本実施形態のリンク部１２０と比較すると、第１接続部１１２および第２接続部１１３において、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行な仮想線と重なっている部分の周方向Ｄ２に沿う長さが、長さＬ１２（Ｌ１３）だけ短く、その分、機械的な接続が弱い。 In the link part 220 of the comparative example, the first connecting part 112 and the holding part 113c are not arranged at a position overlapping the virtual line X3 parallel to the axial direction D1. That is, the first connecting portion 112 and the holding portion 113c do not intersect at all with one imaginary line X3 drawn parallel to the axial direction D1. Further, in the link part 220 of the comparative example, the second connection part 113 and the holding part 112c are not arranged at a position overlapping the virtual line X4 parallel to the axial direction D1. That is, neither the second connection portion 113 nor the holding portion 112c intersects at all with one imaginary line X4 drawn parallel to the axial direction D1. In the link part 220 of the comparative example, the first connection part 112 and the second connection part 113 are virtual lines parallel to the axial direction D1 at an arbitrary position in the circumferential direction D2 in the first connection part 112 and the second connection part 113. Are connected by the biodegradable material 121 in such a state that the length along the circumferential direction D2 of the overlapping portions is ΔL. For this reason, compared with the link part 120 of this embodiment, the link part 220 of the comparative example is a virtual parallel to the axial direction D1 at an arbitrary position in the circumferential direction D2 in the first connection part 112 and the second connection part 113. The length along the circumferential direction D2 of the portion overlapping the line is short by the length L12 (L13), and the mechanical connection is weak accordingly.
　さらに、比較例のリンク部２２０では、保持部１１２ｃ、１１３ｃの中心Ｐ１、Ｐ２同士を繋ぐ仮想線Ｋ２が、引張方向Ｔに対して、重なり方向ａ１と反対の方向ａ２（以下、「重なり解除方向ａ２」と記載する）に向けて傾斜している。このため、ステント１００を拡張させた際に、各接続部１１２、１１３に作用する引張力Ｆを、仮想線Ｋ２に沿う方向の成分ｆ１と、仮想線Ｋ２に直交する方向の成分ｆ２とに分解して表現すれば、成分ｆ２は、重なり解除方向ａ２に作用する。すなわち、ステント１００を拡張させると、各接続部１１２、１１３は、軸方向Ｄ１に平行な１本の仮想線Ｘ１、Ｘ２との重なりを解除する方向に引張力Ｆが作用する。このため、比較例のリンク部２２０は、本実施形態のリンク部１２０と比較すると、ステント１００を拡張させた際にストラット１１１同士の接続が外れ易い。 Further, in the link part 220 of the comparative example, a virtual line K2 connecting the centers P1 and P2 of the holding parts 112c and 113c is a direction a2 opposite to the overlapping direction a1 with respect to the pulling direction T (hereinafter referred to as “overlapping release direction”). a2 ”). For this reason, when the stent 100 is expanded, the tensile force F acting on each of the connection portions 112 and 113 is divided into a component f 1 in the direction along the imaginary line K2 and a component f 2 in the direction orthogonal to the imaginary line K2. if decomposed and expressed in, component f 2 acts overlap releasing direction a2. That is, when the stent 100 is expanded, each connection portion 112 and 113 is subjected to a tensile force F in a direction to release the overlap with one virtual line X1 and X2 parallel to the axial direction D1. For this reason, compared with the link part 120 of this embodiment, when the stent 100 is expanded, the link part 220 of a comparative example is easily disconnected between the struts 111.
　本実施形態のステント１００は、留置から日が浅く再治療の可能性のある急性期では、生分解性材料１２１の分解はあまり進行しておらず、また、前述したように第１接続部１１２および第２接続部１１３によってリンク部１２０の接続が良好に保たれている。このため、ステント１００は、強度が高く、留置直後の大きく拡張した状態をより確実に維持するので、例えば、留置状態等の確認に適用されるＩＶＵＳ（血管内超音波検査法）用のカテーテルもしくはＯＦＤＩ（光干渉断層診断）用のカテーテル、または後拡張用のバルーンカテーテル等のデバイスを、ステント１００の内側に通し易い。 In the stent 100 of the present embodiment, the biodegradable material 121 does not progress so much in the acute phase when the day after placement is short and there is a possibility of re-treatment, and as described above, the first connection portion 112 is not developed. And the connection of the link part 120 is maintained well by the second connection part 113. For this reason, the stent 100 has high strength and more reliably maintains a greatly expanded state immediately after indwelling. For example, a catheter for IVUS (intravascular ultrasonography) applied to confirmation of an indwelling state or the like Devices such as an OFDI (optical coherence tomography) catheter or a post-dilatation balloon catheter can be easily passed inside the stent 100.
　また、ステント１００は高い強度を保つため、例示した上記の各デバイス等が内側を通る際に意図せず接触したとしても、軸方向Ｄ１にステント１００が変形（デフォメーション）するリスクが抑制される。 In addition, since the stent 100 maintains high strength, the risk that the stent 100 deforms (deforms) in the axial direction D1 is suppressed even if the above-described devices and the like are inadvertently contacted when passing inside. .
　急性期後、内皮化が進行する時期にあっては、生分解性材料１２１がある程度分解され、リンク部１２０の接続が弱まる。 After the acute period, when the endothelialization progresses, the biodegradable material 121 is decomposed to some extent, and the connection of the link part 120 is weakened.
　その結果、ステント１００は、柔軟性が増し、生体管腔の形状に追従して変形し易い。 As a result, the stent 100 is more flexible and easily deforms following the shape of the living body lumen.
　内皮化が進んだ後、慢性期に入ると、リンク部１２０は、生分解性材料１２１の分解によって接続を解除する。このため、ステント１００は、特に高い柔軟性を有し、生体管腔の形状に柔軟に追従する。その結果、ステント１００は、長期にわたって低侵襲に生体管腔を支持しつつ開存状態を維持することができる。 After entering the chronic phase after the advance of endothelialization, the link part 120 is disconnected by the decomposition of the biodegradable material 121. Therefore, the stent 100 has particularly high flexibility and flexibly follows the shape of the living body lumen. As a result, the stent 100 can maintain the patency state while supporting the living body lumen in a minimally invasive manner over a long period of time.
　以上のように、本実施形態のステント１００では、リンク部１２０は、隣り合う一のストラット１１１と他のストラット１１１のそれぞれに一体的に設けられており、互いに対向した状態で配置されている第１接続部１１２および第２接続部１１３と、第１接続部１１２および第２接続部１１３に介在して第１接続部１１２および第２接続部１１３を接続する生分解性材料１２１と、を含む。第１接続部１１２および第２接続部１１３は、共に周方向Ｄ２に平行な仮想線Ｙ１と重なる位置に配置されている。第１接続部１１２および第２接続部１１３のそれぞれは、ストラット１１１の表面から厚み方向Ｄ３に貫通あるいは窪んで形成されて生分解性材料１２１を保持する保持部１１２ｃ、１１３ｃを有する。第１接続部１１２の保持部１１２ｃおよび第２接続部１１３は、共に軸方向Ｄ１に平行な仮想線Ｘ２と重なる位置に配置されている。第２接続部１１３の保持部１１３ｃおよび第１接続部１１２は、共に軸方向Ｄ１に平行な仮想線Ｘ１と重なる位置に配置されている。 As described above, in the stent 100 of the present embodiment, the link part 120 is provided integrally with each of the adjacent struts 111 and the other struts 111, and is arranged in a state of facing each other. 1 connection part 112 and 2nd connection part 113, and biodegradable material 121 which intervenes in 1st connection part 112 and 2nd connection part 113, and connects 1st connection part 112 and 2nd connection part 113 . The first connection part 112 and the second connection part 113 are both arranged at a position overlapping the virtual line Y1 parallel to the circumferential direction D2. Each of the first connection portion 112 and the second connection portion 113 has holding portions 112c and 113c that are formed so as to penetrate or be recessed in the thickness direction D3 from the surface of the strut 111 and hold the biodegradable material 121. The holding part 112c and the second connection part 113 of the first connection part 112 are both arranged at a position overlapping the virtual line X2 parallel to the axial direction D1. The holding part 113c and the first connection part 112 of the second connection part 113 are both arranged at a position overlapping the virtual line X1 parallel to the axial direction D1.
　上記構成を有するステント１００によれば、ストラット１１１同士を接続するリンク部１２０は、生分解性材料１２１に加え、機械的な接続構造として第１接続部１１２および第２接続部１１３を有している。各接続部１１２、１１３は、保持部１１２ｃ、１１３ｃが形成されている位置が他方の接続部と共に軸方向Ｄ１に平行な仮想線Ｘ１、Ｘ２と重なるように配置されているため、接続部１１２、１１３において、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行な仮想線と重なっている部分の長さを比較的長くすることができる。その結果、ステント１００に不用意に力が加わったとしても、リンク部１２０は、機械的な接続を良好に維持することができる。したがって、ステント１００を生体管腔内に留置し、所定の期間が経過して生分解性材料１２１が分解されるまでの間、ストラット１１１同士の接続を良好に維持することができる。 According to the stent 100 having the above configuration, the link part 120 that connects the struts 111 includes the first connection part 112 and the second connection part 113 as a mechanical connection structure in addition to the biodegradable material 121. Yes. Since each connection part 112,113 is arrange | positioned so that the position in which the holding | maintenance part 112c, 113c is formed may overlap with the virtual line X1, X2 parallel to the axial direction D1 with the other connection part, the connection part 112, In 113, the length of a portion overlapping an imaginary line parallel to the axial direction D1 at an arbitrary position in the circumferential direction D2 can be made relatively long. As a result, even if force is applied to the stent 100 inadvertently, the link part 120 can maintain a good mechanical connection. Therefore, the stent 100 can be placed in the living body lumen, and the connection between the struts 111 can be maintained well until the biodegradable material 121 is decomposed after a predetermined period.
　また、径方向Ｒから見たときの第１接続部１１２の保持部１１２ｃの中心Ｐ１および第２接続部１１３は、共に軸方向Ｄ１に平行な仮想線Ｘ２と重なる位置に配置されており、第２接続部１１３の保持部１１３ｃの中心Ｐ２および第１接続部１１２は、共に軸方向Ｄ１に平行な仮想線Ｘ１と重なる位置に配置されている。すなわち、各接続部１１２、１１３は、保持部の中心Ｐ１、Ｐ２が、他方の接続部と共に軸方向Ｄ１に平行な仮想線Ｘ１、Ｘ２と重なるように配置されている。このため、接続部１１２、１１３において、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行な仮想線と重なっている部分の長さを、より一層長くすることができる。その結果、リンク部１２０の機械的な接続をより一層強固にすることができる。 Further, when viewed from the radial direction R, the center P1 of the holding portion 112c of the first connection portion 112 and the second connection portion 113 are both arranged at positions overlapping the virtual line X2 parallel to the axial direction D1, The center P2 of the holding part 113c of the two connection part 113 and the first connection part 112 are both arranged at a position overlapping the virtual line X1 parallel to the axial direction D1. That is, each connection part 112 and 113 is arrange | positioned so that the centers P1 and P2 of a holding | maintenance part may overlap with the virtual lines X1 and X2 parallel to the axial direction D1 with the other connection part. For this reason, in the connection parts 112 and 113, the length of the part which overlaps with the virtual line parallel to the axial direction D1 in the arbitrary positions of the circumferential direction D2 can be made still longer. As a result, the mechanical connection of the link part 120 can be further strengthened.
　また、第１接続部１１２と第２接続部１１３は、それぞれが有する保持部１１２ｃ、１１３ｃの中心Ｐ１、Ｐ２同士を繋ぐ仮想線Ｋ１が、ステント１００を拡張させる際にリンク部１２０に作用する引張力Ｆの方向Ｔに対して、保持部１１２ｃ、１１３ｃが軸方向Ｄ１に平行な仮想線Ｘ１、Ｘ２と重なる方向ａ１に向けて傾斜するように配置されている。このため、ステント１００を拡張させると、各接続部１１２、１１３には、軸方向Ｄ１に平行な仮想線Ｘ１、Ｘ２と重なる方向に引張力Ｆが作用する。したがって、ステント１００の拡張によって、接続部１１２、１１３同士の接続が解除されるのを好適に防止することができる。 In addition, the first connecting portion 112 and the second connecting portion 113 are tensile members that act on the link portion 120 when the virtual line K1 connecting the centers P1 and P2 of the holding portions 112c and 113c of each of the first connecting portion 112 and 113c expands the stent 100. With respect to the direction T of the force F, the holding portions 112c and 113c are disposed so as to incline toward a direction a1 overlapping with virtual lines X1 and X2 parallel to the axial direction D1. For this reason, when the stent 100 is expanded, a tensile force F acts on the connecting portions 112 and 113 in a direction overlapping the virtual lines X1 and X2 parallel to the axial direction D1. Therefore, it is possible to suitably prevent the connection between the connection portions 112 and 113 from being expanded by the expansion of the stent 100.
　また、各接続部１１２、１１３は、他方の接続部側に向けて突出し、かつ、丸みを帯びた湾曲形状を有する突出部１１２ａ、１１３ａと、突出部１１２ａ、１１３ａに連なり、突出部１１２ａ、１１３ａの外形形状に応じた凹形状を有する収容部１１２ｂ、１１３ｂと、を有し、保持部１１２ｃ、１１３ｃが突出部１１２ａ、１１３ａに設けられている。このため、一方の接続部の突出部を他方の接続部の収容部に入れ子状に収容することができ、接続部１１２、１１３同士が接続された状態を良好に維持することができる。また、突出部１１２ａ、１１３ａ同士を、生分解性材料１２１を介して良好に繋ぎ止めることができる。 In addition, each connecting portion 112, 113 is projected to the other connecting portion side and is connected to the projecting portions 112a, 113a having a rounded curved shape and the projecting portions 112a, 113a, and the projecting portions 112a, 113a. Storage portions 112b and 113b having a concave shape corresponding to the outer shape of the holding portions 112c and 113c are provided on the protruding portions 112a and 113a. For this reason, the protrusion part of one connection part can be accommodated in the accommodation part of the other connection part in a nested manner, and the state where the connection parts 112 and 113 are connected to each other can be favorably maintained. Further, the protrusions 112a and 113a can be well connected to each other via the biodegradable material 121.
　また、保持部１１２ｃ、１１３ｃは、突出部１１２ａ、１１３ａの外形形状の中心に、その中心Ｐ１、Ｐ２が位置合わせして配置されている。したがって、突出部１１２ａ、１１３ａ同士を、生分解性材料１２１を介してより良好に繋ぎ止めることができる。 Further, the holding portions 112c and 113c are arranged with their centers P1 and P2 aligned with the centers of the outer shapes of the protruding portions 112a and 113a. Therefore, the protrusions 112a and 113a can be more reliably connected to each other via the biodegradable material 121.
　また、ストラット１１１は、軸方向Ｄ１の周りに螺旋状に延在している。このため、螺旋状のストラット１１１を備えるステント１００において、リンク部１２０の接続を良好に維持することができる。 Further, the strut 111 extends spirally around the axial direction D1. For this reason, in the stent 100 provided with the spiral strut 111, the connection of the link part 120 can be maintained favorably.
　また、ステント１００には被覆体１２２が備えられており、新生内膜の増殖を抑制可能な薬剤が被覆体１２２から徐々に溶出するため、病変部位の再狭窄を抑制できる。 In addition, the stent 100 is provided with the covering 122, and since the drug capable of suppressing the growth of the neointimal is gradually eluted from the covering 122, restenosis of the lesion site can be suppressed.
　（変形例）
　図６は、変形例のリンク部３２０を示す図である。なお、前述した実施形態と同様の構成については、同一の符号を付し、その説明を省略する。また、図６では、図４と同様に、生分解性材料１２１（図３（Ａ）参照）を省略して示している。 (Modification)
FIG. 6 is a diagram illustrating a link unit 320 according to a modification. In addition, about the structure similar to embodiment mentioned above, the same code | symbol is attached | subjected and the description is abbreviate | omitted. Further, in FIG. 6, as in FIG. 4, the biodegradable material 121 (see FIG. 3A) is omitted.
　変形例のリンク部３２０は、径方向Ｒから見たときの保持部１１２ｃの中心が、突出部１１２ａの円弧状の外形形状の中心Ｐ３からずれており、また、保持部１１３ｃの中心が、突出部１１３ａの円弧状の外形形状の中心Ｐ４からずれている点において、前述した実施形態のリンク部１２０と相違する。以下、変形例のリンク部３２０について詳述する。 In the link portion 320 of the modified example, the center of the holding portion 112c when viewed from the radial direction R is shifted from the center P3 of the arcuate outer shape of the protruding portion 112a, and the center of the holding portion 113c protrudes. It differs from the link part 120 of embodiment mentioned above in the point which has shifted | deviated from the center P4 of the circular-arc-shaped external shape of the part 113a. Hereinafter, the link part 320 of a modification is explained in full detail.
　第１接続部１１２および第２接続部１１３の保持部１１３ｃは、共に軸方向Ｄ１に平行な仮想線と重なる位置に配置されている。すなわち、第１接続部１１２および第２接続部１１３の保持部１１３ｃは、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ５と交差するように配置されている。第１接続部１１２および保持部１１３ｃにおいて、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行に引いた仮想線と重なっている部分の周方向Ｄ２に沿う長さは、Ｌ３２である。同様に、第２接続部１１３および第１接続部１１２の保持部１１２ｃは、共に軸方向Ｄ１に平行な仮想線Ｘ６と重なる位置に配置されている。すなわち、第２接続部１１３および第１接続部１１２の保持部１１２ｃは、いずれも軸方向Ｄ１に平行に引いた１本の仮想線Ｘ６と交差するように配置されている。第２接続部１１３および保持部１１２ｃにおいて、周方向Ｄ２の任意の位置に軸方向Ｄ１に平行に引いた仮想線と重なっている部分の周方向Ｄ２に沿う長さは、Ｌ３３である。 The holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged at positions overlapping with virtual lines parallel to the axial direction D1. That is, the holding portions 113c of the first connection portion 112 and the second connection portion 113 are both arranged so as to intersect with one virtual line X5 drawn in parallel with the axial direction D1. In the first connecting portion 112 and the holding portion 113c, the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L32. Similarly, the holding part 112c of the second connection part 113 and the first connection part 112 are both arranged at a position overlapping the virtual line X6 parallel to the axial direction D1. That is, the second connecting portion 113 and the holding portion 112c of the first connecting portion 112 are both arranged so as to intersect with one imaginary line X6 drawn parallel to the axial direction D1. In the second connection portion 113 and the holding portion 112c, the length along the circumferential direction D2 of the portion overlapping the imaginary line drawn in parallel with the axial direction D1 at an arbitrary position in the circumferential direction D2 is L33.
　また、第１接続部１１２と第２接続部１１３は、突出部１１２ａ、１１３ａの中心Ｐ３、Ｐ４同士を繋ぐ仮想線Ｋ３が、ステント１００を拡張させる際に、引張方向Ｔに対して重なり方向ａ１に向けて傾斜するように配置されている。 In addition, the first connecting portion 112 and the second connecting portion 113 are overlapped with each other in the overlapping direction a1 with respect to the pulling direction T when the virtual line K3 connecting the centers P3 and P4 of the protruding portions 112a and 113a expands the stent 100. It is arrange | positioned so that it may incline toward.
　このため、ステント１００を拡張させた際に各接続部１１２、１１３に作用する引張力Ｆを、仮想線Ｋ３に沿う方向の成分ｆ１と、仮想線Ｋ３に直交する方向の成分ｆ２とに分解して表現すれば、成分ｆ２は、重なり方向ａ１に作用する。したがって、ステント１００を拡張させると、各接続部１１２、１１３には、軸方向Ｄ１に平行な仮想線と重なる方向に引張力Ｆが作用する。 For this reason, when the stent 100 is expanded, the tensile force F acting on each of the connecting portions 112 and 113 is changed into a component f 1 in the direction along the imaginary line K3 and a component f 2 in the direction orthogonal to the imaginary line K3. if it decomposes representation component f 2 acts in the overlapping direction a1. Therefore, when the stent 100 is expanded, a tensile force F acts on each of the connection portions 112 and 113 in a direction overlapping with a virtual line parallel to the axial direction D1.
　このように、各保持部１１２ｃ、１１３ｃの中心が各突出部１１２ａ、１１３ａの中心Ｐ３、Ｐ４と一致していない場合であっても、各突出部１１２ａ、１１３ａの中心Ｐ３、Ｐ４同士を繋ぐ仮想線Ｋ３が、引張方向Ｔに対して重なり方向ａ１に向けて傾斜していれば、ステント１００の拡張によって、接続部１１２、１１３同士の接続が解除されるのを好適に防止することができる。 As described above, even when the centers of the holding portions 112c and 113c do not coincide with the centers P3 and P4 of the protruding portions 112a and 113a, a virtual connecting the centers P3 and P4 of the protruding portions 112a and 113a. If the line K <b> 3 is inclined toward the overlapping direction a <b> 1 with respect to the pulling direction T, it is possible to suitably prevent the connection portions 112 and 113 from being disconnected due to the expansion of the stent 100.
　本発明は、上述した実施形態および変形例に限定されるものではなく、特許請求の範囲内で種々改変できる。 The present invention is not limited to the above-described embodiments and modifications, and various modifications can be made within the scope of the claims.
　例えば、リンク部の種類は、少なくとも１つのリンク部が第１接続部、第２接続部および生分解性材料を備えていればよく、上記実施形態に限定されない。例えば、上記実施形態において、リンク部１３０は、リンク部１２０と同様に第１接続部１１２、第２接続部１１３および生分解性材料１２１によって構成されていてもよい。 For example, the type of the link part is not limited to the above embodiment as long as at least one link part includes the first connection part, the second connection part, and the biodegradable material. For example, in the above-described embodiment, the link part 130 may be configured by the first connection part 112, the second connection part 113, and the biodegradable material 121 similarly to the link part 120.
　また、リンク部の配置も上記実施形態に限定されず、適宜変更することが可能である。 Also, the arrangement of the link portions is not limited to the above embodiment, and can be changed as appropriate.
　また、ストラットの形態も上記実施形態および変形例に限定されない。本発明のステントは、例えば、上記実施形態のストラット１１１のような軸方向Ｄ１のまわりに螺旋状に延在するストラットを含まず、上記実施形態のストラット１１０のような、波状に折り返されつつ軸方向Ｄ１のまわりで周方向Ｄ２に延在して無端の環状形状を形作るストラットにより構成されていてもよい。 Also, the form of the strut is not limited to the above-described embodiment and modifications. The stent of the present invention does not include, for example, a strut extending spirally around the axial direction D1 like the strut 111 of the above embodiment, and the shaft is folded back in a wave shape like the strut 110 of the above embodiment. You may be comprised by the strut which extends in the circumferential direction D2 around the direction D1, and forms an endless annular shape.
　また、突出部、収容部および保持部の外形形状は、上記実施形態および変形例に限定されない。例えば、突出部、収容部および保持部の外形形状は、任意の多角形状に形成することができる。なお、突出部および保持部の外形形状が、円形状、楕円形状等ではない場合、突出部および保持部の中心は、円筒形状の径方向から見た各部の外形形状の重心とすることができる。 Further, the external shapes of the protruding portion, the accommodating portion, and the holding portion are not limited to the above-described embodiment and modification examples. For example, the outer shapes of the protruding portion, the accommodating portion, and the holding portion can be formed in an arbitrary polygonal shape. When the outer shape of the protruding portion and the holding portion is not circular, elliptical, or the like, the center of the protruding portion and the holding portion can be the center of gravity of the outer shape of each portion viewed from the radial direction of the cylindrical shape. .
　さらに、突出部または保持部における仮想線を結ぶ２点は、突出部または保持部の形状に応じて中心または重心としたが、本発明はこれに限定されない。仮想線を結ぶ２点は、ステントを拡張させる際にリンク部に引張力Ｆが作用した際に、互いに対向する一対の接続部同士の接続関係の保持に寄与する位置に設定すると共に、該２点を結んだ仮想線が引張方向Ｔに対して重なり方向ａ１へ傾斜するように設定することが好ましい。そのため、前記設定を満たす限りにおいて、突出部または保持部の形状に応じて、仮想線を結ぶ２点は適宜設定することができる。例えば、引張力Ｆが作用した際に、突出部または保持部において、物理的な力が集中する箇所を、仮想線を結ぶ点として設定することが考えられる。 Furthermore, although the two points connecting the virtual lines in the protruding portion or the holding portion are the center or the center of gravity according to the shape of the protruding portion or the holding portion, the present invention is not limited to this. The two points that connect the imaginary line are set at positions that contribute to maintaining the connection relationship between a pair of connection parts facing each other when a tensile force F acts on the link part when expanding the stent. It is preferable that the imaginary line connecting the points is set to be inclined in the overlapping direction a1 with respect to the pulling direction T. Therefore, as long as the above setting is satisfied, two points connecting the imaginary lines can be appropriately set according to the shape of the protruding portion or the holding portion. For example, when the tensile force F is applied, it is conceivable to set a portion where physical force is concentrated in the protruding portion or the holding portion as a point connecting virtual lines.
　上記実施形態のストラット１１０、１１１は、非生分解性材料によって形成されているが、本発明はこの形態に限定されない。ストラットは、リンク部に含まれる生分解性材料よりも分解が遅い生分解性材料によって形成されていてもよい。 Although the struts 110 and 111 of the above embodiment are formed of a non-biodegradable material, the present invention is not limited to this form. The strut may be formed of a biodegradable material that decomposes slower than the biodegradable material included in the link portion.
　また、本発明は、被覆体１２２のない形態、および、生分解性材料１２１に新生内膜の増殖を抑制可能な薬剤が含まれている形態を含む。後者の形態では、生分解性材料１２１の分解とともに薬剤が徐々に溶出し、病変部位の再狭窄が抑制される。 In addition, the present invention includes a form without the covering 122 and a form in which the biodegradable material 121 contains a drug capable of suppressing the growth of the neointimal. In the latter form, the drug is gradually eluted with the degradation of the biodegradable material 121, and restenosis of the lesion site is suppressed.
　本出願は、２０１６年１月２６日に出願された日本国特許出願第２０１６－０１２７７５号に基づいており、その開示内容は、参照により全体として引用されている。 This application is based on Japanese Patent Application No. 2016-012775 filed on January 26, 2016, the disclosure of which is incorporated by reference in its entirety.
１００　　ステント、
１１０　　ストラット（軸方向両端に位置するストラット）、
１１１　　ストラット（軸方向のまわりに螺旋状に延在するストラット）、
１１２　　第１接続部、
１１３　　第２接続部、
１１２ａ、１１３ａ　　突出部、
１１２ｂ、１１３ｂ　　収容部、
１１２ｃ、１１３ｃ　　保持部、
１２０、２２０、３２０　　リンク部、
１３０　　リンク部、
１２１　　生分解性材料、
１２２　　被覆体、
Ｘ１、Ｘ２、Ｘ３、Ｘ４、Ｘ５、Ｘ６　軸方向に平行な仮想線、
Ｙ１　　　周方向に平行な仮想線、
Ｋ１、Ｋ２、Ｋ３　　突出部の中心同士を繋ぐ仮想線、
Ｔ　　引張方向、
Ｄ１　　軸方向、
Ｄ２　　周方向、
Ｄ３　　厚み方向、
Ｐ１、Ｐ２　　保持部の中心、
Ｒ　　径方向。 100 stents,
110 struts (struts located at both axial ends),
111 struts (struts extending in a spiral around the axial direction),
112 1st connection part,
113 second connection part,
112a, 113a protrusion,
112b, 113b accommodating portion,
112c, 113c holding part,
120, 220, 320 link part,
130 link section,
121 biodegradable materials,
122 covering,
X1, X2, X3, X4, X5, X6 Virtual lines parallel to the axial direction,
Y1 Virtual line parallel to the circumferential direction,
K1, K2, K3 Virtual lines connecting the centers of the protrusions,
T tensile direction,
D1 axial direction,
D2 circumferential direction,
D3 thickness direction,
P1, P2 center of holding part,
R radial direction.

Claims (7)

  1. 　隙間が形成された円筒形状の外周を形作る線状のストラットと、前記隙間で前記ストラット同士を接続する複数のリンク部と、を有するステントであって、
    　前記リンク部の少なくも一つは、
    　隣り合う一の前記ストラットと他の前記ストラットのそれぞれに一体的に設けられており、互いに対向した状態で配置されている一の接続部および他の接続部と、前記一の接続部および前記他の接続部に介在して前記一の接続部および前記他の接続部を接続する生分解性材料と、を含み、
    　前記一の接続部および前記他の接続部は、共に前記円筒形状の周方向に平行な仮想線と重なる位置に配置され、
    　前記一の接続部および前記他の接続部のそれぞれは、前記ストラットの表面から厚み方向に貫通あるいは窪んで形成されて前記生分解性材料を保持する保持部を有し、
    　前記一の接続部の前記保持部および前記他の接続部は、共に前記円筒形状の軸方向に平行な仮想線と重なる位置に配置されており、
    　前記他の接続部の前記保持部および前記一の接続部は、共に前記円筒形状の軸方向に平行な仮想線と重なる位置に配置されている、ステント。     A stent having a linear strut that forms a cylindrical outer periphery in which a gap is formed, and a plurality of link portions that connect the struts in the gap,
    At least one of the link parts is
    One connecting portion and another connecting portion that are integrally provided in each of the adjacent one of the struts and the other struts and are arranged in a state of facing each other, the one connecting portion and the other A biodegradable material that connects the one connection part and the other connection part interposed in the connection part of
    The one connection part and the other connection part are both arranged at a position overlapping a virtual line parallel to the circumferential direction of the cylindrical shape,
    Each of the one connection part and the other connection part has a holding part that is formed through or recessed in the thickness direction from the surface of the strut and holds the biodegradable material,
    The holding part and the other connection part of the one connection part are both arranged at a position overlapping an imaginary line parallel to the axial direction of the cylindrical shape,
    The stent, wherein the holding part and the one connection part of the other connection part are both arranged at a position overlapping an imaginary line parallel to the cylindrical axial direction.
  2. 　前記円筒形状の径方向から見たときの前記一の接続部の保持部の中心および前記他の接続部は、共に前記円筒形状の軸方向に平行な仮想線と重なる位置に配置されており、
    　前記円筒形状の径方向から見たときの前記他の接続部の保持部の中心および前記一の接続部は、共に前記円筒形状の軸方向に平行な仮想線と重なる位置に配置されている、請求項１に記載のステント。     The center of the holding part of the one connection part when viewed from the radial direction of the cylindrical shape and the other connection part are both arranged at a position overlapping an imaginary line parallel to the axial direction of the cylindrical shape,
    The center of the holding part of the other connecting part and the one connecting part when viewed from the radial direction of the cylindrical shape and the one connecting part are both arranged at positions overlapping with a virtual line parallel to the axial direction of the cylindrical shape. The stent according to claim 1.
  3. 　前記一の接続部と前記他の接続部は、それぞれが有する前記保持部の中心同士を繋ぐ仮想線が、当該ステントを拡張させる際に前記リンク部に作用する引張力の方向に対して、前記保持部が前記円筒形状の軸方向に平行な仮想線と重なる方向に向けて傾斜するように配置されている、請求項２に記載のステント。 The one connection part and the other connection part are each provided with respect to the direction of the tensile force acting on the link part when an imaginary line connecting the centers of the holding parts of each of the connection parts expands the stent. The stent according to claim 2, wherein the holding portion is disposed so as to be inclined in a direction overlapping a virtual line parallel to the cylindrical axial direction.
  4. 　前記一の接続部と前記他の接続部のそれぞれは、
    　他方の前記接続部側に向けて突出し、かつ、丸みを帯びた湾曲形状を有する突出部と、前記突出部に連なり、前記突出部の外形形状に応じた凹形状を有する収容部と、を有し、前記保持部が前記突出部に設けられている請求項１～３のいずれか１項に記載のステント。     Each of the one connection part and the other connection part is
    A projecting portion that protrudes toward the other connecting portion and has a rounded curved shape, and a housing portion that is connected to the projecting portion and has a concave shape corresponding to the outer shape of the projecting portion. The stent according to any one of claims 1 to 3, wherein the holding portion is provided on the protruding portion.
  5. 　前記保持部は、前記突出部の外形形状の中心に、その中心が位置合わせして配置された請求項４に記載のステント。 The stent according to claim 4, wherein the holding portion is arranged with its center aligned with the center of the outer shape of the protruding portion.
  6. 　前記ストラットの少なくとも一部は、前記円筒形状の軸方向の周りに螺旋状に延在している、請求項１～５のいずれか１項に記載のステント。 The stent according to any one of claims 1 to 5, wherein at least a part of the strut extends spirally around the axial direction of the cylindrical shape.
  7. 　前記ステントは、新生内膜の増殖を抑制可能な薬剤を含む被覆体を、その表面に備える、請求項１～６のいずれか１項に記載のステント。 The stent according to any one of claims 1 to 6, wherein the stent is provided with a covering containing a drug capable of suppressing the growth of neointimal on the surface thereof.
PCT/JP2017/001088 2016-01-26 2017-01-13 Stent WO2017130747A1 (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009082244A (en) * 2007-09-27 2009-04-23 Terumo Corp In-vivo indwelling stent, and living organ dilator
US20120102708A1 (en) * 2005-02-25 2012-05-03 Abbott Laboratories Vascular Enterprises Limited Modular vascular prosthesis and methods of use
WO2015045101A1 (en) * 2013-09-27 2015-04-02 テルモ株式会社 Stent

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120102708A1 (en) * 2005-02-25 2012-05-03 Abbott Laboratories Vascular Enterprises Limited Modular vascular prosthesis and methods of use
JP2009082244A (en) * 2007-09-27 2009-04-23 Terumo Corp In-vivo indwelling stent, and living organ dilator
WO2015045101A1 (en) * 2013-09-27 2015-04-02 テルモ株式会社 Stent

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