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
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Application number
PCT/JP2017/001088
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English (en)
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/fr

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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

L'invention fournit un stent qui permet de maintenir de manière satisfaisante et pendant la durée souhaitée une connexion réciproque d'entretoise à l'aide d'un mécanisme de connexion mécanique et d'un matériau biodégradable agencés sur les entretoises. Une partie anneau du stent (100) de forme cylindrique contient : une première ainsi qu'une seconde partie connexion (112, 113) qui sont agencées d'un seul tenant sur chacune des entretoises (111) adjacentes, et qui sont disposées dans un état d'opposition mutuelle ; et le matériau biodégradable (121) connectant la première et la seconde partie connexion en s'intercalant entre elles. La première et la seconde partie connexion sont toutes deux disposées en une position de superposition à une ligne virtuelle (Y1) parallèle à une direction périphérique (D2) de forme cylindrique. La première et la seconde partie connexion possèdent au niveau d'une partie saillie des parties support (112c, 113c) qui sont formées de manière à traverser ou à creuser dans une direction épaisseur (D3) à partir de la surface des entretoises, et qui supportent le matériau biodégradable. La partie support de la première partie connexion et la seconde partie connexion sont toutes deux disposées en une position de superposition à une ligne virtuelle (X2) parallèle à une direction axiale (D1) de forme cylindrique. La partie support de la seconde partie connexion et la première partie connexion sont toutes deux disposées en une position de superposition à une ligne virtuelle (X1) parallèle à la direction axiale (D1) de forme cylindrique.
PCT/JP2017/001088 2016-01-26 2017-01-13 Stent WO2017130747A1 (fr)

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JP2016-012775 2016-01-26

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2009082244A (ja) * 2007-09-27 2009-04-23 Terumo Corp 生体内留置用ステントおよび生体器官拡張器具
US20120102708A1 (en) * 2005-02-25 2012-05-03 Abbott Laboratories Vascular Enterprises Limited Modular vascular prosthesis and methods of use
WO2015045101A1 (fr) * 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 (ja) * 2007-09-27 2009-04-23 Terumo Corp 生体内留置用ステントおよび生体器官拡張器具
WO2015045101A1 (fr) * 2013-09-27 2015-04-02 テルモ株式会社 Stent

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