WO2011132634A1 - Stent - Google Patents

Stent Download PDF

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Publication number
WO2011132634A1
WO2011132634A1 PCT/JP2011/059517 JP2011059517W WO2011132634A1 WO 2011132634 A1 WO2011132634 A1 WO 2011132634A1 JP 2011059517 W JP2011059517 W JP 2011059517W WO 2011132634 A1 WO2011132634 A1 WO 2011132634A1
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WO
WIPO (PCT)
Prior art keywords
stent
central axis
cylindrical member
ring
ring member
Prior art date
Application number
PCT/JP2011/059517
Other languages
French (fr)
Japanese (ja)
Inventor
寛治 井上
Original Assignee
Inoue Kanji
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Filing date
Publication date
Application filed by Inoue Kanji filed Critical Inoue Kanji
Publication of WO2011132634A1 publication Critical patent/WO2011132634A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/89Stents 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/826Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents more than one stent being applied sequentially
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2002/828Means for connecting a plurality of stents allowing flexibility of the whole structure

Definitions

  • the present invention relates to a stent which is a medical instrument used by being placed in a luminal organ.
  • Stents are used to expand strictures caused by lesions in digestive organs such as blood vessels, trachea, and bile ducts, and luminal organs such as esophagus, urinary organs, and reproductive organs. High nature.
  • a percutaneous transluminal tube such as inserting and placing a stent in a lesion through a catheter introduced into the body from a blood vessel puncture part of an artery or vein, etc. Treatment has become the main treatment. The same applies to other luminal organs as well as blood vessels.
  • the procedure for introducing a stent into a luminal organ is to reduce the diameter of a generally cylindrical stent, insert it into the catheter, transport it to the target affected area, and then release the stent from the catheter to expand the diameter.
  • a general procedure is to dilate the stenosis of the luminal organ.
  • Stents are roughly classified into two types: a type that uses a balloon catheter to expand a reduced diameter stent, and a self-expanding type based on the structure of the stent itself.
  • a type that uses a balloon catheter to expand a reduced diameter stent and a self-expanding type based on the structure of the stent itself.
  • the present invention belongs to the self-expanding type, various types of stents have been proposed and used so far.
  • a typical stent hereinafter referred to as a “stent” for only a self-expanding stent
  • a zigzag metal wire is formed in an annular shape, and a plurality of the annular members are connected.
  • a plurality of arc-shaped parts in which metal wires are formed in a zigzag shape, such as those configured to be cylindrical as a whole, or those formed by knitting metal wires in a mesh shape, etc. are connected to each other by a member made of a bioabsorbable material to form a cylindrical shape as a whole (Patent Document 1), and metal wires are arranged circumferentially and interlocked in a spiral with adjacent metal wires
  • Patent Document 2 A cylindrical structure in which a large number of rhombus cells are formed by connecting and braiding
  • an annular body in which both ends of a metal wire bent in a zigzag are connected in series.
  • Patent Document 3 a configuration in which metal wires are formed in a zigzag shape to form a spiral and each part is connected with a thread so as to form a cylindrical shape as a whole
  • Patent Document 4 Various configurations of stents have been proposed. These conventional stents have the common feature that any cylindrical frame portion is made of a metal member.
  • the conventional metal stent as described above is minimally invasive and has a small burden on the patient, but the following problems have been pointed out. That is, the first problem is that almost the entire stent (at least the frame portion) is made of a metal material, and there is inevitably a limit in the flexibility in the longitudinal direction (cylindrical central axis direction). That is. For example, a blood vessel has a large number of curved portions and bent portions in a living body, and stenosis due to a lesion or the like is often observed at such a site.
  • metal stent when a metal stent is introduced into a curved part or a bent part of a luminal organ, the metal stent may break if it exceeds the limit of the bending performance.
  • the second problem with metal stents is that they are not highly durable.
  • the metal stent When a metal stent is introduced into a luminal organ that repeats bending motion or a luminal organ that is repeatedly subjected to external compression, the metal stent itself eventually wears or breaks due to metal fatigue, and the luminal organ It causes further stenosis and damage to the luminal organs.
  • rupture of a metal stent can cause major bleeding, which can cause serious injury and life risk for the patient.
  • the metal self-expanding stent has a drawback that the expansion force is insufficient, and a sufficient expansion force cannot be obtained in a hard stenosis. If the metal framework is stiff to increase this expansion force, the flexibility of the stent will be reduced and the bending performance will be reduced. The tendency of the stent to be easily broken by repeated bending and stretching movements of the hollow organ becomes strong.
  • both ends of metal stents are hard metal stumps (some stents have rounded ends, but in any case Because the end is a hard metal), there is a risk of damaging the luminal organ even if the stent itself does not wear or break.
  • peripheral vascular stents used for diseases from the aortic bifurcation to downstream arteries are indicated for the iliac arterial region. It cannot be used for blood vessels downstream from the arterial region, particularly lower limb blood vessels below the ridge.
  • the placed metal stent is not only in the vertical direction but also in the horizontal direction due to contraction from surrounding muscles and the shape and movement of the blood vessel itself.
  • an external force in the direction of the cylindrical cross-sectional diameter
  • metal stents are inherently caused by the fact that the skeleton itself is made of metal, and the expansion and contraction properties in the direction of the diameter of the cylindrical cross section, particularly the expandability, are low. There is a problem that it is inferior to the following ability. Furthermore, even if a metal stent is a structure in which metal wires are connected or knitted, or a structure in which a plurality of annular members formed in a zigzag by laser cutting a metal tube are connected, the mesh becomes large. As a result, the thickened neointima infiltrates from the mesh and sticks out into the lumen of the stent, causing restenosis.
  • a commercially available metal stent has a particularly large angle in an actual medical field because of various problems including the danger described above, even if it has high bending performance. It is not applicable to bending or stretching luminal organs, thin luminal organs that are compressed by muscle contraction, or fragile inner wall luminal organs that are easily damaged by stump stumps. The development of applicable stents is strongly desired for patients such as patients who have lesions, their families, and medical workers.
  • the present invention solves such problems in conventional metal stents, and is flexible, tough, excellent in flexibility, easy to manufacture, and lumens for which conventional stents have been used so far.
  • the main object is to provide an excellent self-expanding stent that can be applied to fragile lumen organs on the inner wall.
  • the stent according to the present invention is a self-expanding stent that is inserted and indwelled in a luminal organ, has flexibility and elasticity, has a mesh shape through which bodily fluids can pass inside and outside, and has a central axis. It is composed mainly of a cylindrical member whose arbitrary cross section perpendicular to each other forms a substantially circular shape, and a plurality of ring members that are spaced apart from each other with their centers substantially coincident with the central axis of the cylindrical member.
  • the cylindrical member is formed so that both ends in the central axis direction are opened, and the vertical and horizontal linear portions constituting the mesh shape are three-dimensionally intersected at substantially the same angle with respect to the central axis,
  • a plurality of ring members are disposed at least inward from both ends in the central axis direction of the cylindrical member, and an elastic restoring force that can be bent in both the radial direction and the central axis direction of the cylindrical member is provided. Consists of a flexible annular member having a cylinder It is characterized in that attached to the member.
  • the stent of the present invention can be applied to digestive organs such as blood vessels, trachea and bile ducts of animals including humans, human body such as esophagus, urinary organs, and reproductive organs, or almost any luminal organ of animals.
  • the femur that can be applied to luminal organs that have been developed, and that is subjected to strong compression due to contraction of blood vessels and muscles that flex and stretch in a large angle range such as hip joints and knees, where conventional stents could not be applied. It can also be used by inserting and placing it in the blood vessels of the part.
  • the stent of the present invention is flexible and elastic in itself (in other words, has a tension), and is a mesh-like cylinder (that is, a mesh shape through which blood or the like can pass) through which body fluid can pass in and out.
  • a cylindrical member having a shape is intermittently supported by a plurality of flexible and elastic ring members.
  • the cylindrical member does not necessarily have a cylindrical shape as long as both ends in the central axis direction are open. If the arbitrary cross section perpendicular to the central axis is substantially circular, the thickness may be different in each part. I do not care.
  • ring members it is necessary to arrange a plurality of ring members at least inward from the end in the central axis direction of the cylindrical member, and the ring members are provided at the end in the same central axis (both ends or one end). It is optional.
  • one part or all part ring member can also be attached to the inner surface side of a cylindrical member, and can also be attached to an outer surface side.
  • the ring member has one linear material formed in a substantially circular shape, one linear material wound in a plurality of turns into a substantially circular shape, and one linear material formed in a substantially circular shape
  • Flexible, elastic such as a bundle of a plurality of tubes, a cylindrical shape whose length in the long axis direction is very short compared to its diameter, and a conventional stent (eg, a Z-stent) that has a very short length in the long axis direction
  • a conventional stent eg, a Z-stent
  • the material and structure are not particularly limited, and it is also possible to employ a plurality of ring members having different configurations. .
  • the mesh-shaped cylindrical member is a tubular member in which the vertical and horizontal linear portions constituting the mesh are not substantially parallel to the central axis of the cylindrical member or do not intersect three-dimensionally at a substantially right angle. The three-dimensional crossing is made at a substantially equal angle to the central axis.
  • warps and wefts made of natural or synthetic resin fibers or metal fibers (which can be applied to either monofilaments or multifilaments) are knitted in a mesh shape, such as Adopting an appropriate configuration such as a mesh formed by welding or adhering warp and weft to each other, or a mesh formed by forming a large number of holes aligned in a synthetic resin sheet or cylindrical body be able to.
  • the warp and weft yarns correspond to the vertical and horizontal linear portions constituting the mesh
  • the cylindrical member is formed into a mesh by forming a large number of holes in the sheet or tubular body.
  • the linear part around the hole connecting each hole corresponds.
  • the shape of the mesh formed by the vertical and horizontal linear portions of the cylindrical member is not limited to a specific shape. Note that a biocompatible material should be selected as the material used for the tubular member.
  • the stent of the present invention has a basic structure in which the mesh-shaped cylindrical member as described above is intermittently supported by a plurality of ring members, it maintains the flexibility in the central axis direction while maintaining the flexibility in the circumferential direction. It will be equipped with expansion power.
  • the expansion force in the circumferential direction can be made stronger by increasing the expansion force in the circumferential direction of the ring member, and the flexibility of the entire stent in the central axis direction can be maintained.
  • the stent according to the present invention does not buckle or wrinkle the tubular member even when the stent is reduced in diameter or expanded using the flexibility and elastic restoring force of each ring member.
  • the degree is extremely small, and the mesh composed of vertical and horizontal linear portions expands and contracts while maintaining a basic shape such as a rhombus.
  • the cylindrical member itself in a reduced diameter state or the cylindrical member and the ring member hardly interfere with each other, and a stent having a reduced diameter using a catheter or the like is delivered to a stenosis portion of a luminal organ.
  • it can be easily introduced into the affected area by spreading at the stenosis, and it can be introduced into a luminal organ such as a thin blood vessel or a narrow stenosis. It can easily follow the movement.
  • the stent bends flexibly in both the central axis direction and the radial direction of the cylindrical shape, and can easily and flexibly follow its movement while in close contact with the inserted and indwelling luminal organ. it can.
  • This differs from conventional metal stents in that the stent is subjected to external forces such as the movement of the luminal organ itself, such as the pulsation and bending of blood vessels, and compression from the muscles outside the luminal organ.
  • both the tubular member and the ring member can continue to function without being damaged or ruptured. For this reason, the stent has a very low possibility of damaging the luminal organ. It can be said that it is a good stent.
  • the stent of the present invention is introduced into a narrowed portion of a blood vessel that bends at a large angle such as a knee, the mesh structure of the cylindrical member supported by the elasticity of each ring member is maintained, and the entire stent is maintained. Since it bends following the blood vessel while maintaining the cylindrical shape, it can be continuously used for a long time without causing a positional shift.
  • the overall shape of the stent of the present invention is defined by a simple structural member in which a plurality of ring members whose centers coincide with the central axis are attached to a mesh-like cylindrical member, so that the structure is simplified. Therefore, even a stent having a relatively small diameter can be easily produced.
  • the stent of the present invention can be applied to a luminal organ to which various conventional stents have been applied while maintaining high safety and durability. It can also be applied to the blood vessels of the knee that repeatedly bend and stretch in a large angle range that could not be applied with a stent made of stent.
  • the stent of the present invention employs a structure in which a cylindrical member that can easily form a mesh size (mesh) is in close contact with a luminal organ.
  • the stent of the present invention has an advantage that intimal proliferation of the affected area hardly infiltrates into the stent, particularly when the mesh of the cylindrical member is set finely.
  • the mesh of the cylindrical member is fine, the intima of the luminal organ is appropriately grown on the inner surface side of the stent and the stent is easily integrated with the body tissue, so that the thrombus is difficult to adhere.
  • the stent of the present invention is suitable for insertion and placement in a hollow organ, which was difficult to apply with conventional stents, and therefore, treatment by percutaneous transluminal surgery has been greatly advanced. It can be said that it can be made to.
  • the ring member in the stent of the present invention, a configuration in which the ring member is attached to the inner surface side of the cylindrical member or a configuration in which the ring member is attached to the outer surface side is possible.
  • the ring member When attached to the side, the ring member does not contact the inner wall of the luminal organ, but only the flexible cylindrical member contacts, so the stimulation applied to the inner wall of the luminal organ over the entire stent is extremely small. Therefore, it can contribute to the progression of intimal proliferation and the prevention of the accompanying restenosis.
  • a plurality of ring members arranged inward from the opening portions at both ends are arranged along the central axis of the tubular member, and the ring is formed at the opening portions at both ends of the tubular member.
  • the central axis of the stent Only the cylindrical member comes into contact with the luminal organ at both ends in the direction, and the compression and stimulation applied to the inner wall of the luminal organ at that site can be reduced to prevent the progression of intimal proliferation and the accompanying restenosis There is an advantage.
  • the tubular member is sufficiently tensioned, sufficient shape retention is ensured even with a stent having no ring member at the opening at both ends, and the tube member is compressed before insertion into a luminal organ. Easier to fold when diameter is improved.
  • the shape retention of the entire stent can be improved.
  • the side on which the ring member is provided is upstream of the flow of body fluid such as blood flow.
  • the inner ring member of the cylindrical member may be arranged on either the inner surface side or the outer surface side of the cylindrical member, but even when the ring member is provided on at least one of both end openings, You may arrange
  • a flexible metal wire material having a bendable elastic restoring force can be applied as a ring member.
  • strength and durability are ensured while ensuring flexibility of the stent. Can be improved.
  • the ring member may be formed by bundling a plurality of annular metal wires.
  • a ring member having such a configuration for example, a structure in which one metal wire is formed into a ring member by annularly wrapping multiple metal rings, or a plurality of annular rings formed from metal wires are formed and bundled together.
  • Such a metal ring member can increase the elastic restoring force while ensuring flexibility and is difficult to break and has high durability. It is possible to improve safety.
  • the elastic restoring force and durability of each ring member can be easily adjusted by adjusting the number of multiple windings of the metal wire or the number of rings to be bundled.
  • a stent is expanded at a position where it is inserted into a further narrow stenosis through a luminal organ such as a thin blood vessel.
  • a luminal organ such as a thin blood vessel.
  • the essential condition for the stent is to make the diameter at the time of diameter reduction as small as possible.
  • the present invention adopts the basic configuration as described above, so that the compactness at the time of the diameter reduction of the stent, particularly the diameter can be made as small as possible.
  • each ring member is greatly deformed as a result of being folded into a compact corrugated shape (a shape in which two tops and two bottoms of the corrugation are alternately formed) facing one end and the other end in the central axis direction of the cylindrical member, this ring
  • the cylindrical member is not interfered with the deformation of the member, and only four points in the circumferential direction of the cylindrical member fixing the ring members approach in the central axis direction. Rarely occurs. Therefore, it becomes possible to efficiently insert a stent having a reduced diameter into a very thin catheter or the like and transport it to a stenosis of a luminal organ.
  • each ring member has the elastic restoring force as described above, the ring member bent into the corrugated shape is restored to the original annular shape when released from the catheter or the like.
  • it is not limited to the case where each ring member is fixed to the cylindrical member at four locations in the circumferential direction.
  • fixing each ring member to the cylindrical member at four locations is extremely useful because both the small diameter of the stent when the diameter is reduced and the simplicity of fixing the ring member to the cylindrical member are compatible. is there.
  • the elastic restoring force of each ring member can be made substantially constant, but the elastic restoring force can be made different for each ring member, for example, in the direction of the central axis of the cylindrical member
  • the elastic restoring force of the ring member disposed in the vicinity of the center portion may be set larger than the elastic restoring force of the ring member disposed in the vicinity of the end portion in the same central axis direction. It is usual to place a stent so that the central portion in the central axis direction is located in a portion where the degree of stenosis is strong in a hollow organ.
  • the elastic restoring force of the ring member near the central portion in the central axis direction of the stent can be larger, the stenosis of the luminal organ can be continuously and effectively spread by the stent having a large expansion force. It becomes possible.
  • the interval between adjacent ring members can be substantially constant, but the interval between adjacent ring members can be arbitrarily set, for example, a cylindrical member.
  • the interval between the plurality of ring members arranged near the central portion in the central axis direction may be set to be narrower than the interval between the plurality of ring members arranged near the end portion in the central axis direction. In this case, for the same reason as described above, it is possible to continuously and effectively spread the narrowing of the luminal organ by the stent by narrowing the interval between the ring members in the central axial direction vicinity of the stent. Is possible.
  • the diameter of each ring member can be made substantially constant, but the diameter can also be made different for each ring member, for example, in the vicinity of one end in the central axis direction of the tubular member
  • the diameter of the ring member disposed in the center may be set larger than the diameter of the ring member disposed in the vicinity of the other end in the same central axis direction.
  • the shape of the stent can accurately correspond to the shape of the placement site of the luminal organ.
  • the stent can be used in such a mode that the end portion having the larger diameter is disposed in the main flow portion of the artery and the end portion having the smaller diameter is disposed in the branch of the artery.
  • the cylindrical member is made of a synthetic resin
  • a metal material as a skeleton that is, a metal caused by repeated bending or bending in a luminal organ.
  • the problem of tearing due to fatigue does not occur, and a safer and more durable stent can be realized.
  • the cylindrical member made of synthetic resin is supported by a plurality of ring members, it is structurally stable and can continue to function in the luminal organ for a long time.
  • a stent using a cylindrical member made of a synthetic resin can reduce irritation to a luminal organ, and can prevent intimal proliferation and accompanying restenosis.
  • a drug can be applied to a cylindrical member or used as a drug-eluting stent.
  • a cylindrical member made of a synthetic resin is employed, the elution drug can be applied. It is easy to select a suitable synthetic resin material.
  • the stent of the present invention has a network structure that is flexible, elastic, excellent in flexibility, durable against bending, and has a cylindrical shape with a circular cross section, and is positioned inward from both ends of the central axial direction opening of the cylindrical member. It has a basic configuration in which a plurality of elastic ring members are arranged, and further, the vertical and horizontal linear portions constituting the mesh of the cylindrical member are three-dimensionally crossed at substantially equal angles with respect to the central axis of the cylindrical shape. It is composed. Because of such a structure, the stent of the present invention easily follows the movement of the luminal organ, and is easily maintained in a cylindrical shape even when bent at a large angle, is not easily broken, has high durability, and has a strong expansion force.
  • a strong stenosis can also be expanded. Also, it functions in the structure that the stimulation to the luminal organ applied by insertion and placement is small, there is little infiltration of intimal proliferation into the stent, and moderate intimal proliferation on the inner surface side of the stent is easy.
  • the above also has various excellent advantages. Therefore, the present invention is not only suitable for application to a luminal organ to which a conventional stent has been applied, but also to a luminal organ that bends and stretches in a large angle range that cannot be applied to a conventional stent. Therefore, it is possible to provide an extremely excellent stent that has an unprecedented safety, durability, and wide application range.
  • the schematic diagram which shows schematic structure of the stent which concerns on 1st Embodiment of this invention.
  • the perspective view which shows the stent of the embodiment.
  • the schematic diagram which shows an example of the bent state of the stent of the embodiment.
  • the schematic diagram which expands and shows a part of stent of the embodiment.
  • the schematic diagram which shows the state between the expansion state and diameter-reduction state of the stent of the embodiment.
  • the schematic diagram which shows the state which diameter-reduced the stent of the embodiment.
  • the schematic diagram which shows the other example of the state between the expansion state of the stent of the embodiment, and a diameter-reduced state.
  • FIG. The schematic diagram which shows the state immediately after releasing the diameter of the stent of the same embodiment, conveying it to the stenosis part of a blood vessel, and discharging
  • FIG. The schematic diagram which shows the state which expanded the stent of the embodiment in the constriction part of the blood vessel.
  • the schematic diagram which shows the state which expanded the stent of the embodiment in the narrowed part of the curved blood vessel.
  • the schematic diagram which shows schematic structure of the stent of 4th Embodiment of this invention The schematic diagram which shows schematic structure of the stent of 5th Embodiment of this invention.
  • a stent 1 includes a lesion part of a luminal organ, particularly a stenosis part of a lower limb artery due to arteriosclerosis, a trachea or esophagus due to cancer, a stenosis part such as a duodenum, a biliary tract, and other blood vessels.
  • a stent 1 that is inserted and placed in a blood vessel will be described as an example.
  • the basic configuration is the same as that of the stent 1 described below, except that the size and the number of ring members are different.
  • the stent 1 of the present embodiment is a schematic diagram of the stent 1 in which the cylindrical portion 2 schematically representing the cylindrical shape in FIG. 1 and the ring member 31 viewed from an oblique direction are combined, and FIG. FIG. 3 is a perspective view showing the appearance of the stent, and FIG. 3 is a schematic diagram showing a state in which the stent 1 is bent, and a mesh-like cylindrical member 2 having a large number of aligned meshes forming a cylindrical shape, and the cylindrical shape
  • a plurality of ring members 31, 31... That are intermittently disposed inward from both end openings in the central axis direction of the member 2 are provided as a basic configuration.
  • the plurality of ring members 31 are arranged at regular intervals on the inner surface side of the cylindrical member, but depending on the type of the luminal organ to be applied, the position of the affected part, etc. It is also possible to vary the separation interval of the ring member 31 as appropriate.
  • each part of this stent 1 is explained in full detail.
  • the cylindrical member 2 is formed in a mesh shape (mesh shape) with a plurality of flexible warp yarns 21 and weft yarns 22 respectively, and is equivalent to the diameter of the applied luminal organ (blood vessel in this embodiment). It is a member having a cylindrical shape with a slightly thicker diameter (in this embodiment, a diameter of about 6 mm).
  • the warp yarn 21 and the weft yarn 22 forming the network structure correspond to the vertical and horizontal linear portions of the cylindrical member 2 in the present invention.
  • a thread having a thickness of about 150 ⁇ m can be used for the warp 21 and the weft 22, and the thickness of the thread is preferably about 50 to 300 ⁇ m.
  • the material of the yarn is natural fiber, synthetic resin fiber, metal fiber, composite fiber, etc.
  • polyester polyethylene, polypropylene, polytetrafluoroethylene, nylon and the like can be exemplified as materials that are particularly suitable for the synthetic resin fibers as the warp yarn 21 and the weft yarn 22. In this embodiment, polyester is used. Yes.
  • the properties of the drug such as an antithrombotic agent, an intimal thickening preventive agent, and an anticancer agent are compatible with application to the warp yarn 21 and the weft yarn 22.
  • appropriate materials for the warp yarn 21 and the weft yarn 22 may be selected.
  • the size of the mesh composed of the plurality of warp yarns 21 and weft yarns 22 can also be set as appropriate.
  • the size is preferably in the range of 200 to 800 ⁇ m per side. In this embodiment, for example, an extremely fine mesh having a rhombus with a side of about 600 ⁇ m is used.
  • a plurality of warp yarns 21 and weft yarns 22 constituting the cylindrical member 2 are shown by a one-dot chain line in FIG.
  • the cylindrical member 2 is disposed so as to form a three-dimensional intersection with the central axis m at an equal angle ⁇ with respect to the cylindrical central axis m.
  • the cylindrical member 2 is configured so that the warp yarn 21 and the weft yarn 22 intersect three-dimensionally at an angle of about 45 ° with respect to the central axis. Can do.
  • the plurality of warp yarns 21 and weft yarns 22 form a curved circumferential surface of the mesh-like cylindrical member 2 on a curved line, but if the neighborhood of each mesh is viewed locally,
  • the warp yarn 21 and the weft yarn 22 can be regarded as straight lines. Accordingly, one diagonal of one mesh forming a rhombus composed of two warp yarns 21 and 21 and two weft yarns 22 and 22 is substantially parallel to the central axis m, and the other diagonal is substantially perpendicular to the central axis m. A three-dimensional intersection will occur.
  • the cylindrical member 2 composed of the warp yarn 21 and the weft yarn 22 has a tensioned structure having both flexibility and elasticity.
  • the opening both ends 2a of the cylindrical member 2 are heat-welded so that the warp 21 and the weft 22 do not fall apart, the end 2a may be processed by sewing or the like. .
  • the plurality of ring members 31 are all circular ring-shaped members made of the same material and the same configuration.
  • an appropriate linear material having appropriate strength, tension and flexibility and having biocompatibility can be selected from metals, synthetic resins, composite materials, etc.
  • Nitinol wire which is a nickel titanium alloy is used.
  • each of the ring members 31 and 32 is formed into a cylindrical shape by winding a nitinol wire a plurality of times (for example, 3 to 7 times) and fixing both ends thereof by adhesion or caulking to enhance elasticity and durability.
  • the member 2 is formed in a circular shape having substantially the same diameter.
  • a single ring may be applied, or a ring manufactured in advance in a circular shape may be used as the ring members 31 and 32 of the present embodiment.
  • a ring-shaped member obtained by bending a linear material in a zigzag manner or a cylindrical member that is extremely short in the long axis direction can be used as the ring member.
  • the plurality of ring members 31 as described above are arranged and attached at substantially equal intervals on the inner surface side of the tubular member 2.
  • each ring member 31 is disposed at each predetermined position inside the tubular member 2, and is rotated every 90 degrees around the central axis m.
  • a ring member is attached to only one of the warp yarn 21 or the weft yarn 22 although the yarn 23 is tied and fixed to the intersecting portion of the warp yarn 21 and the weft yarn 22 constituting the mesh of the cylindrical member 2 at four locations (see FIG. 4). 31 may be attached.
  • the fixing points at the four points with respect to each ring member 31 are substantially matched on four straight lines parallel to the central axis of the cylindrical member 2 common to all the ring members 31.
  • the fixing method of each ring member 31 to the cylindrical member 2 is not limited to fixing with a thread, but can be performed with a biocompatible adhesive, and the fixing location is limited to four locations or the entire circumference. is not.
  • the stent 1 configured in this manner is in a state in which the central axis m of the tubular member 2 and the center of each ring member 31 are substantially aligned, as shown in each drawing. Therefore, the stent 1 as a whole has flexibility and elasticity both in the direction of the central axis m and in the radial direction (the radial direction of the tubular member 2 and the radial direction of the ring members 31 and 32 corresponding thereto). As shown in FIG. 2, when the stent 1 is bent in the direction of the central axis m, it can be bent while maintaining the cylindrical shape.
  • the rhomboid meshes are expanded and contracted in both diagonal directions by the warp yarn 21 and the weft yarn 22 which are maintained in a state of three-dimensionally intersecting with the central axis m of the cylindrical member 2 so that the cylindrical member 2 is centered. It bends and stretches flexibly in the direction of the axis m, so that the tubular member 2 does not buckle in the middle or a crease is formed on the tubular member 2, or buckling and crease are extremely unlikely to occur. Further, since such a cylindrical member 2 is used, the stent 1 can be expanded and contracted to a certain extent in the direction of the central axis m of the cylindrical member 2, and contracts in the diametrical direction when expanded and bulky when contracted.
  • FIG. 3 shows the bent state of the stent 1, but the case where the stent 1 is bent at an angle larger than that shown in the figure (for example, a U-turn of about 180 ° or more). Even so, the stent 1 can maintain a cylindrical shape.
  • the stent 1 of the present embodiment is introduced into a blood vessel percutaneously via a transluminal tube and placed to expand a stenosis, the stent 1 is not shown in advance before inserting the stent 1 into the blood vessel.
  • the stent 1 is provided through a preload system in which the stent 1 is mounted on an appropriate delivery device and then released to expand the stent 1 or through a delivery device (catheter or sheath, etc.) that has been inserted to a target position in the blood vessel in advance. It is possible to adopt an afterload system that transports, discharges, and detains.
  • the delivery / release method to the target site uses a method of pushing the rear end side of the stent 1 or pulling the distal end side (providing a suspension device at the distal end of a thin catheter).
  • the balloon catheter is finally used as needed and expansion operation with respect to the stent 1 may be added.
  • the diameter of the stent 1 is reduced by, for example, inserting the stent 1 from the large diameter portion of the funnel-shaped device connected to the end of the tubular device such as a catheter toward the small diameter portion, and the elasticity of the ring member 31 and the cylindrical member.
  • the stent 1 is automatically generated by the elasticity of 2, but the diameter of the stent 1 can be reduced by using an instrument such as a finger or tweezers. Further, by temporarily attaching a thread to the distal end portion of the stent 1, pulling the thread and introducing the thread into a sheath or a catheter through a funnel-like device, it is possible to reduce the diameter of the stent 1 as a result. is there.
  • the diameter reduction of the stent 1 is realized by bending each ring member 31 into an aligned waveform and the tubular member 2 extending in the central axis m direction and contracting in the radial direction.
  • FIG. 5 shows a schematic diagram of the stent 1 in the process of the expanded state and the reduced diameter state
  • FIG. 6 shows the stent 1 in the reduced state.
  • the wave form of each ring member 31 that is bent is alternately two along the circumference of the ring member 31 for each 90 ° angle phase around the center axis m of the wave. Each shape is formed.
  • a portion facing the one opening end 2a side of the cylindrical member 2 is referred to as a corrugated top portion 31a, 31c, and a portion facing the other opening end 2a side is referred to as a corrugated bottom portion 31b, 31d.
  • the top portions 31 a and 31 c and the bottom portions 31 b and 31 d of these corrugations are formed at substantially intermediate positions of the four threads 23 that attach the ring members 31 to the tubular member 2. That is, all the ring members 31 are bent, and the corrugated top portion 31a, bottom portion 31b, top portion 31c, and bottom portion 31d respectively connect the central axis m of the cylindrical member 2 (that is, the circular center of each ring member 31).
  • the line is aligned in parallel with the line segment.
  • the waveform of the bent ring member 31 is not aligned.
  • the tubular member 2 extends in the direction of the central axis m following the wavy deformation of the ring member 31 and contracts in the radial direction.
  • the fixing point of the ring member 31 by the yarn 23 of the warp yarn 21 and the weft yarn 22 approaches the central axis m, and as a result, the mesh of the cylindrical member 2
  • the rhombus shape extends in a diagonal direction parallel to the central axis m and contracts in the other diagonal direction. Therefore, in the present embodiment, when the diameter of the stent 1 is reduced, the ring members 31 and 32 have the top part 31a and the top part 31c, the bottom part 31b and the bottom part 31d, and the top part with the central axis m of the cylindrical member 2 interposed therebetween.
  • FIG. 7 shows the top portions 31a and 31c and the bottom portions 31b and 31d of a part of the plurality of ring members 31 as shown in FIG.
  • the bent state may be bent toward the opposite side in the direction of the central axis m. The same applies to other embodiments described below.
  • FIG. 8 shows a state immediately after the diameter-reduced stent 1 is released from the catheter (not shown) in the vicinity of the narrowed portion Aa of the blood vessel A. After the release, the expanded stent 1 is placed in the blood vessel A.
  • FIG. 9 schematically shows the state in which the constricted portion Aa is pushed and expanded. That is, in the case of placement of the stent 1 in the case where the stenosis Aa develops in the linear portion of the blood vessel A, the tubular member 2 is expanded into a cylindrical shape by the elastic ring members 31 and the inner wall of the blood vessel A The stenosis Aa can be appropriately expanded by coming into contact with A1.
  • each ring member 31 and the cylindrical member 2 are elastic even when subjected to the pulsation of the blood vessel A itself, expansion and contraction associated therewith, or compression from the muscle outside the blood vessel A.
  • the elasticity of 31 and 32 is transmitted also to the cylindrical member 2, and the stent 1 is bent in the radial direction as a whole or expanded and contracted in the direction of the central axis m by the expansion and contraction based on the elastic network structure of the cylindrical member 2. The state of following the movement of the blood vessel A and contacting the inner wall A1 is maintained.
  • the cylindrical member 2 is expanded while maintaining the rhomboid mesh structure while the warp yarn 21 and the weft yarn 22 constituting the mesh structure are three-dimensionally intersecting at a substantially equal angle with respect to the central axis m of the stent 1. Therefore, even if the blood vessel A itself is subjected to pulsation, expansion and contraction, and external pressure, the mesh structure does not collapse.
  • the mesh-shaped cylindrical member 2 in which the warp yarn 21 and the weft yarn 22 are three-dimensionally intersected with the central axis m of the stent 1 at a substantially equal angle has a structure in which a plurality of ring members 31 are intermittently supported from the inner surface side.
  • the vessel A is placed in the linear stenosis Aa. In the same manner as described above, it is possible to push the stenosis Ab in contact with the inner wall A1 while curving corresponding to the curved shape.
  • the mesh of the cylindrical member 2 is slightly narrowed on the inner side of the curved shape of the stent 1 and slightly expanded on the outer side to form a distorted rhombus shape. It stably abuts against the inner wall A1 of the blood vessel A with almost no wrinkles.
  • the blood vessel A may be bent at a larger angle than the state shown in FIG. Since it has expandability in the circumferential direction while maintaining the curvature of m, it is possible to follow the curvature of the blood vessel A while maintaining the cylindrical shape while increasing the degree of curvature.
  • the mesh of the cylindrical member 2 is formed as a very fine rhombus having a side of about 600 ⁇ m square. Furthermore, since the stimulation given to the inner wall A1 of the blood vessel A is minimized, the intimal proliferation of the inner wall A1 will remain at an appropriate proliferation even when reaching the inner surface side of the cylindrical member 2, Formation of a thrombus is suppressed. Therefore, the stent 1 of the present embodiment can be used by being placed in the stenosis portions Aa and Ab in the blood vessel A over a long period of time.
  • the both ends 2a in the central axis m direction of the stent 1 are only the mesh-shaped tubular member 2, so that the inner wall A1 of the blood vessel A Can reduce the pressure applied.
  • the stent 1 does not have any metal parts that may come into contact with the inner wall A1 of the blood vessel A, the stimulation applied to the inner wall A1 of the blood vessel A can be extremely small. Therefore, if the stent 1 is used, the possibility of restenosis accompanying the proliferation of the intima from the inner wall A1 of the blood vessel A can be made extremely low.
  • the stent 1 of the present embodiment is excellent in durability and affinity to a living body (inner wall A1 of the blood vessel A), and also safe in that it does not break even if bent at a large angle. Is.
  • the stent 1 of the present embodiment has a simple structure as described above, if the cylindrical member 2 and each ring member 31 are formed in a small diameter, the thin stent 1 can be easily configured. . Because of these various features, the stent 1 of the present embodiment is suitable for blood vessels in the iliac artery region, which has been the subject of application of conventional stents for diseases from the aortic branch to the downstream artery, and other applications. In addition to providing many advantages by using it placed in a blood vessel, it can be applied to blood vessels below the siliceous part that could not be applied with conventional stents, especially knees that bend repeatedly at a large angle.
  • the stent of the present invention is not limited to the configuration of the stent 1 of the above-described embodiment.
  • the stent 100 shown as the second embodiment in FIG. 11 has the same cylindrical member 2 as that applied to the stent 1 of the first embodiment and a larger diameter than the ring member 31 applied to the first embodiment.
  • the ring member 32 is applied. That is, a plurality of ring members 32 are provided on the inner surface side of the mesh-like cylindrical member 2 made up of a plurality of warp yarns 21 and weft yarns 22 inwardly of the openings at both ends in the central axis m direction, as in the first embodiment. Are fixed at four locations. Therefore, when compared with the stent 1, in the stent 100, the mesh of the cylindrical member 2 is a rhombus that is shortened in the central axis m direction and extended in the circumferential direction.
  • the stent 100 having such a configuration can be reduced in diameter in the same manner as the stent 1. That is, as shown in FIG. 12, when the ring member 32 is bent into a wave shape, the middle portion of the four fixed portions by the thread 23 to the tubular member 2 has a wave-like top portion 32a and a bottom portion 32b in order in the circumferential direction. The top portion 32c and the bottom portion 32d are further reduced in flexure, so that the diameter of the stent 1 is as thin and compact as the stent 1 shown in FIG. The difference becomes larger.
  • the stent of the present invention may be as shown in FIG. 13 as the third embodiment. That is, the stent 200 shown in the figure is different from the cylindrical member 2 same as the stent 1 of the first embodiment, the ring member 31 used in the first embodiment, and the ring member 32 used in the second embodiment.
  • a plurality of ring members each having a diameter are used. That is, a ring member 31 having a smaller diameter is attached to the inner surface side near the one opening end 2a in the central axis m direction of the cylindrical member 2, and a larger diameter ring is attached to the inner surface side near the other opening end 2a.
  • a member 32 is attached.
  • the rhombic shape of the mesh of the cylindrical member 2 is contracted in the direction parallel to the central axis m in the region where the ring member 32 is disposed, and in the circumferential direction, rather than the region where the ring member 31 is disposed.
  • the stent 200 can be reduced in diameter in the same manner as the stent 1 of the first embodiment and the stent 100 of the second embodiment.
  • Such a stent 200 having different diameters at both ends 2a in the direction of the central axis m is suitable for placement in, for example, a branch portion of a blood vessel, and the larger diameter side of the stent 200 is placed on the main flow side where the blood vessel is thick.
  • the small diameter side of the stent 200 may be disposed on the side where the branch is thin.
  • the stent 200 of the present embodiment may be disposed at a location where the blood vessel is gradually narrowed according to the direction of blood flow.
  • the ring members 31 and 32 having two types of diameters are applied.
  • ring members having three or more types of diameters may be used.
  • a configuration in which a large-diameter member is applied to a ring member attached to a portion near the central portion in the central axis m direction of the cylindrical member can be exemplified.
  • the stent of the present invention can be appropriately made different from the ring members 31 instead of being arranged at substantially equal intervals as in the stent 1 of the first embodiment.
  • the stent 300 shown as the fourth embodiment in FIG. 14 uses the same tubular member 2 and ring member 31 as the stent 1 of the first embodiment, but is arranged at the center in the direction of the central axis m.
  • the interval between the ring members 31 is narrower than the interval between the ring members 31 arranged near the opening end 2a. That is, in the case of such a stent 300, it becomes possible to strongly and continuously push the stenosis by disposing more ring members 31 in the central portion where the degree of stenosis is large as described above.
  • the stent of this invention can be set as the structure which has arrange
  • a stent 400 shown as a fifth embodiment in FIG. 15 includes a ring member 33 at one open end 2a in the central axis m direction in addition to the same cylindrical member 2 and a plurality of ring members 31 as in the first embodiment.
  • the stent 500 shown as the sixth embodiment in FIG. 16 has a configuration in which the ring member 34 is also attached to the other open end 2a in addition to the configuration of the stent 400.
  • the ring members 33 and 34 attached to the open end 2a of the tubular member 2 are each ring member 31 attached closer to the inner side in the central axis m direction than the open end 2a of the tubular member 2.
  • the ring members 33 and 34 may be attached to the outer surface side of the tubular member 2, or The opening end 2a of the shaped member 2 may be folded inward or outward to form a bag shape, and the ring members 33 and 34 may be fixed inside the bag shape.
  • the ring members 33 and 34 when the ring members 33 and 34 are fixed to the cylindrical member 2, the ring members 33 and 34 can be fixed to the cylindrical member 2 at four points similarly to the ring member 31, but at the open end 2 a of the cylindrical member 2, A thread may be wound around the circumference and sewn.
  • the stent 400 When the stent 400 is placed in the blood vessel so that the open end 2a on the side where the ring member 33 is provided is on the upstream side of the blood vessel, the other open end 2a without the ring member is in a so-called blowing state. Even so, since the cylindrical member 2 itself is also tensioned, it can be placed in a stable state in the blood vessel, and the function as a stent can be sufficiently exhibited. Further, regarding the stent 500, the ring members 33 and 34 are provided at both ends 2a of the opening, thereby realizing more stable placement in the blood vessel.
  • the stent of the present invention does not set the elastic restoring force of each ring member as the same, for example, the elastic restoring force of the ring member arranged at the central portion in the central axis direction of the cylindrical member. Can be set larger than the elastic restoring force and diameter of the ring member disposed at a position close to the opening end.
  • the elastic restoring force of each ring member as described above, there is an advantage that a site where the degree of stenosis of the blood vessel is large can be more strongly and continuously pushed.
  • the stent of the present invention can appropriately set the shape of the tubular member and the diameter and width of the ring member in accordance with the shape of the luminal organ applied other than the blood vessel and the shape of the part.
  • the configurations of the above-described embodiments can be appropriately combined.
  • each part such as the constituent material of the cylindrical member and the ring member, the number and configuration of the ring members, the size of the entire stent, and whether the ring member is fixed to the inner surface side or the outer surface side of the cylindrical member
  • the present invention is not limited to the above embodiment, and various modifications can be made without departing from the spirit of the present invention.
  • the stent of the present invention is useful as a stent having a simple structure with high flexibility, safety, durability, and longitudinal and lateral elasticity. Not only the stenosis part of animal luminal organs, but also the stenosis part of the blood vessel downstream from the iliac artery area where conventional stents cannot be applied, and blood vessels that flex and stretch at large angles such as knees, etc. Applicable to luminal organs.

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Abstract

Disclosed is a stent which is mainly configured from a tubular member which forms a meshed tube having flexibility and elasticity, and a plurality of ring members which are arranged separated from one another in positions further inward than both end sections in the central axial direction of the tubular member. The tubular member is configured so that the vertical and horizontal linear sections which form the mesh of said tubular member are formed so as to all three-dimensionally intersect at a substantially equal angle in the central axial direction, and so that the flexible ring members which have a folding and bending restoring elastic force are attached further inward than both end opening sections in the central axial direction of the tubular member. Thus, the disclosed self-expanding stent can be applied to hollow organs such as those with weak inner walls or blood vessels which curve a great deal, to which conventional stents could not be applied due to problems such as durability, and the hardness of the end sections.

Description

ステントStent
 本発明は、管腔臓器内に留置して用いられる医療器具であるステントに関するものである。 The present invention relates to a stent which is a medical instrument used by being placed in a luminal organ.
 ステントは、血管、気管、胆管等の消化器官、食道、泌尿器官、生殖器官等の管腔臓器に病変により生じた狭窄部の拡張に用いられているが、特に血管領域での必要性・需要性が高い。最近では、従来の外科的手術に代わって、より低侵襲な治療法として、動脈や静脈の血管穿刺部より体内に導入したカテーテルを通じてステントを病変部に挿入・留置するなどの経皮的経管的処置が主要な治療法となってきている。このことは、血管に限らず他の管腔臓器についても同様である。ステントを管腔臓器に導入する手技は、概ね円筒形状をなすステントを一旦縮径してカテーテルに挿入して目的の患部部位に搬送し、そこでカテーテルからステントを放出して拡径させることで、管腔臓器の狭窄部位を拡張する、という手順が一般的である。 Stents are used to expand strictures caused by lesions in digestive organs such as blood vessels, trachea, and bile ducts, and luminal organs such as esophagus, urinary organs, and reproductive organs. High nature. Recently, as a less invasive treatment instead of conventional surgery, a percutaneous transluminal tube, such as inserting and placing a stent in a lesion through a catheter introduced into the body from a blood vessel puncture part of an artery or vein, etc. Treatment has become the main treatment. The same applies to other luminal organs as well as blood vessels. The procedure for introducing a stent into a luminal organ is to reduce the diameter of a generally cylindrical stent, insert it into the catheter, transport it to the target affected area, and then release the stent from the catheter to expand the diameter. A general procedure is to dilate the stenosis of the luminal organ.
 ステントには、縮径したステントを拡張するためにバルーンカテーテルを利用するタイプと、ステント自体の構造に基づく自己拡張タイプの2種類に大別される。本発明は自己拡張タイプに属するものであるが、この種のステントとしては、これまで、種々の構造のものが提案され使用されてきている。代表的なステント(以下、自己拡張タイプのステントのみを対象として「ステント」と呼ぶものとする)としては、ジグザグの金属製線条体を環状に形成し、その環状体を複数連結することで全体として筒状となるように構成したものや、金属製のワイヤを網目状に編みこんで円筒形状に構成したもの等であるが、それ以外に、金属線をジグザグに形成した複数の弧状部分を生体吸収性材料からなる部材で接続することで全体として筒状となるように構成したもの(特許文献1)、金属ワイヤを円周状に配置するとともに隣接する金属ワイヤと螺旋状にインターロック接続して編み込むことで菱形のセルが多数形成された円筒形状に構成したもの(特許文献2)、ジグザグに折り曲げた金属ワイヤの両端部を接続した環状体を直列的に並べて接続した構成のもの(特許文献3)、金属製ワイヤをジグザグに形成して螺旋状とするとともに全体として円筒形状となるように糸で各部を接続した構成のもの(特許文献4)など、多種多様な構成のステントが提案されている。これら従来のステントは、何れの円筒形状の骨組み部分が金属部材から構成されているという共通点を有している。 Stents are roughly classified into two types: a type that uses a balloon catheter to expand a reduced diameter stent, and a self-expanding type based on the structure of the stent itself. Although the present invention belongs to the self-expanding type, various types of stents have been proposed and used so far. As a typical stent (hereinafter referred to as a “stent” for only a self-expanding stent), a zigzag metal wire is formed in an annular shape, and a plurality of the annular members are connected. A plurality of arc-shaped parts in which metal wires are formed in a zigzag shape, such as those configured to be cylindrical as a whole, or those formed by knitting metal wires in a mesh shape, etc. Are connected to each other by a member made of a bioabsorbable material to form a cylindrical shape as a whole (Patent Document 1), and metal wires are arranged circumferentially and interlocked in a spiral with adjacent metal wires A cylindrical structure in which a large number of rhombus cells are formed by connecting and braiding (Patent Document 2), and an annular body in which both ends of a metal wire bent in a zigzag are connected in series. Various configurations such as a continuous configuration (Patent Document 3), a configuration in which metal wires are formed in a zigzag shape to form a spiral and each part is connected with a thread so as to form a cylindrical shape as a whole (Patent Document 4). Various configurations of stents have been proposed. These conventional stents have the common feature that any cylindrical frame portion is made of a metal member.
特表2009-522022Special table 2009-522202 特表平09-512460Special table 09-512460 特開2002-291904JP 2002-291904 A 特開平09-164209JP 09-164209 A
 ところで、上述のような従来の金属製ステントは、低侵襲で患者に与える負担が小さいものではあるが、次のような問題が指摘されている。すなわち、第1の問題点は、ステントの略全体(少なくとも骨組み部分)が金属材料で構成されているため、必然的に縦方向(円筒形状の中心軸方向)への屈曲性に限界があるということである。例えば血管には生体内に湾曲部や屈曲部が多数存在しており、病変等による狭窄部はこのような部位での発生が多く認められる。そのため、金属製ステントを管腔臓器の湾曲部や屈曲部に導入した場合、屈曲性能の限界を超えると破断してしまう虞がある。金属製ステントにおける第2の問題点は、耐久性が高くないということである。屈曲運動が繰り返されるような管腔臓器や、外部から繰り返し圧迫を受ける管腔臓器に金属製ステントを導入すると、やがては金属製ステント自体が摩耗したり金属疲労により破断が生じ、管腔臓器のさらなる狭窄の原因や、管腔臓器の損傷の原因となる。特に血管への適用を考えると、金属製ステントの破断は大出血の原因となり、患者に重大な障害や生命の危険をも与えかねないことにもなる。また、金属製自己拡張型のステントは、拡張力が不足し、硬い狭窄部では十分な拡張力が得られないという欠点もある。この拡張力を増すために金属の骨組みを堅いものとすると、ステントの柔軟性が減少するとともに屈曲性能の低下が生じるため、管腔臓器の屈曲部に十分対応できるものとならず、さらに留置された管腔臓器の繰り返しての屈伸運動でステントが容易に破壊される傾向が強くなる。 Incidentally, the conventional metal stent as described above is minimally invasive and has a small burden on the patient, but the following problems have been pointed out. That is, the first problem is that almost the entire stent (at least the frame portion) is made of a metal material, and there is inevitably a limit in the flexibility in the longitudinal direction (cylindrical central axis direction). That is. For example, a blood vessel has a large number of curved portions and bent portions in a living body, and stenosis due to a lesion or the like is often observed at such a site. Therefore, when a metal stent is introduced into a curved part or a bent part of a luminal organ, the metal stent may break if it exceeds the limit of the bending performance. The second problem with metal stents is that they are not highly durable. When a metal stent is introduced into a luminal organ that repeats bending motion or a luminal organ that is repeatedly subjected to external compression, the metal stent itself eventually wears or breaks due to metal fatigue, and the luminal organ It causes further stenosis and damage to the luminal organs. Considering the application to blood vessels in particular, rupture of a metal stent can cause major bleeding, which can cause serious injury and life risk for the patient. In addition, the metal self-expanding stent has a drawback that the expansion force is insufficient, and a sufficient expansion force cannot be obtained in a hard stenosis. If the metal framework is stiff to increase this expansion force, the flexibility of the stent will be reduced and the bending performance will be reduced. The tendency of the stent to be easily broken by repeated bending and stretching movements of the hollow organ becomes strong.
 金属製ステントにおける第3の問題点は、金属製ステントの両端(中心軸方向の両端)が、硬質な金属の断端(ステントによっては両端を丸めているものも存在するが、いずれにしても端部は硬質な金属である)であるため、ステント自体には摩耗や破断が生じなくても、管腔臓器を損傷してしまう虞がある、ということである。 The third problem with metal stents is that both ends of metal stents (both ends in the central axis direction) are hard metal stumps (some stents have rounded ends, but in any case Because the end is a hard metal), there is a risk of damaging the luminal organ even if the stent itself does not wear or break.
 このような3つの大きな問題点が存在するため、金属製ステントを例えば膝等の大きな角度で屈曲する血管に適用することを考慮した場合、血管に追従するように屈曲させると縦方向(円筒形状の中心軸方向)に折れて破断したり摩耗する可能性があり、新たな狭窄の原因となったり、血管壁等の損傷により大出血や死亡という致命的な問題を招来する原因となる。このことから、現在市販されている金属製ステントのうち大動脈分岐部から下流動脈の疾患に用いられる末梢血管用ステントは、腸骨動脈領域が適応とされており、事実、医療現場においても腸骨動脈領域よりも下流域、特にソケイ部以下の下肢の血管には用いることができない。また、現時点で市販の金属製ステントを下肢の血管に用いた場合は、その周囲の筋肉からの収縮や、血管自体の形状や動きによって、留置された金属製ステントが縦方向のみならず横方向(円筒形状の断面直径方向)にも外力を受ける結果、摩耗したり破断する可能性があり、必ずしも安全であるとは言い難いのが実情である。 Because of these three major problems, when considering applying a metal stent to a blood vessel that bends at a large angle, such as a knee, for example, if it is bent so as to follow the blood vessel, the longitudinal direction (cylindrical shape) It may break in the direction of the central axis) and break or wear, causing new stenosis or causing fatal problems such as major bleeding or death due to damage to the blood vessel wall or the like. Therefore, among the metal stents currently available on the market, peripheral vascular stents used for diseases from the aortic bifurcation to downstream arteries are indicated for the iliac arterial region. It cannot be used for blood vessels downstream from the arterial region, particularly lower limb blood vessels below the ridge. In addition, when a commercially available metal stent is used for a lower limb blood vessel at present, the placed metal stent is not only in the vertical direction but also in the horizontal direction due to contraction from surrounding muscles and the shape and movement of the blood vessel itself. As a result of receiving an external force (in the direction of the cylindrical cross-sectional diameter), there is a possibility of wearing or breaking, and it is not always safe to say.
 その他にも、金属製ステントは、その骨組み自体が金属であるという本来的な原因により、円筒形状の断面直径方向への拡縮性、特に拡張性が低いため、特に繰り返し連続的に拡縮する血管への追従性に劣るという問題がある。さらに、金属製ステントは、金属線を連結したり編み込んだものであっても、金属チューブをレーザーカットしてジグザグに形成した環状部材を複数連結した構成のものであっても、網目が大きくなってしまい、肥厚した新生内膜が網目から浸潤して、ステントの内腔に張りだし、再狭窄を発生するという問題もある。 In addition, metal stents are inherently caused by the fact that the skeleton itself is made of metal, and the expansion and contraction properties in the direction of the diameter of the cylindrical cross section, particularly the expandability, are low. There is a problem that it is inferior to the following ability. Furthermore, even if a metal stent is a structure in which metal wires are connected or knitted, or a structure in which a plurality of annular members formed in a zigzag by laser cutting a metal tube are connected, the mesh becomes large. As a result, the thickened neointima infiltrates from the mesh and sticks out into the lumen of the stent, causing restenosis.
 以上の通り、市販されている金属製ステントは、たとえその屈曲性能を謳ったものであっても、上述のような危険性を含む諸問題のために、実際の医療現場では、特に大きい角度で屈伸する管腔臓器や筋肉の収縮により圧迫される細い管腔臓器、またステントの断端により容易に損傷を受ける脆弱な内壁の管腔臓器には適用不可であって、このような管腔臓器に病変を持つ患者やその家族、医療従事者等の関係者には、適用可能なステントの開発が強く望まれている。 As described above, a commercially available metal stent has a particularly large angle in an actual medical field because of various problems including the danger described above, even if it has high bending performance. It is not applicable to bending or stretching luminal organs, thin luminal organs that are compressed by muscle contraction, or fragile inner wall luminal organs that are easily damaged by stump stumps. The development of applicable stents is strongly desired for patients such as patients who have lesions, their families, and medical workers.
 本発明は、このような従来の金属製ステントにおける諸問題を解決し、柔軟且つ強靱で屈曲性にも優れ、しかも簡易に製造することができ、これまで従来のステントが利用されてきた管腔臓器への適用は勿論のこと、特にこれまで実際の経皮的経管的ステント導入の手術現場では使用することができなかった屈曲運動を伴う又は外側からの圧迫により変形する管腔臓器や、内壁の脆弱な管腔臓器への適用をも可能とする優れた自己拡張型のステントを提供することを主たる目的とするものである。 The present invention solves such problems in conventional metal stents, and is flexible, tough, excellent in flexibility, easy to manufacture, and lumens for which conventional stents have been used so far. Of course, it can be applied to organs, especially luminal organs with bending movements that could not be used in the actual percutaneous transluminal stenting operation or deformed by external compression, The main object is to provide an excellent self-expanding stent that can be applied to fragile lumen organs on the inner wall.
 本発明に係るステントは、管腔臓器内に挿入・留置される自己拡張型のステントであって、柔軟性且つ弾力性を有し、体液が内外に通過可能な網目状をなし、中心軸と直交する任意の断面が略円形状をなす筒状部材と、筒状部材の中心軸に中心を略一致させて相互に離間して配置される複数のリング部材とを主体として構成したものであり、さらに筒状部材を、中心軸方向両端部を開口させるとともに、網目状を構成する縦横の各線形部が、何れもその中心軸に対して常に略等しい角度で立体交差するように形成し、複数のリング部材を、少なくとも前記筒状部材の中心軸方向両端部よりも内寄りの位置に配置し、且つ径方向及び前記筒状部材の中心軸方向の何れにも折り曲げ自在な弾性復元力を有する柔軟な環状の部材により構成し、筒状部材に取り付けたことを特徴とするものである。 The stent according to the present invention is a self-expanding stent that is inserted and indwelled in a luminal organ, has flexibility and elasticity, has a mesh shape through which bodily fluids can pass inside and outside, and has a central axis. It is composed mainly of a cylindrical member whose arbitrary cross section perpendicular to each other forms a substantially circular shape, and a plurality of ring members that are spaced apart from each other with their centers substantially coincident with the central axis of the cylindrical member. Further, the cylindrical member is formed so that both ends in the central axis direction are opened, and the vertical and horizontal linear portions constituting the mesh shape are three-dimensionally intersected at substantially the same angle with respect to the central axis, A plurality of ring members are disposed at least inward from both ends in the central axis direction of the cylindrical member, and an elastic restoring force that can be bent in both the radial direction and the central axis direction of the cylindrical member is provided. Consists of a flexible annular member having a cylinder It is characterized in that attached to the member.
 本発明のステントは、人間を含む動物の血管、気管、胆管等の消化器官、食道、泌尿器官、生殖器官等の人体又は動物の凡そあらゆる管腔臓器に適用可能であり、従来のステントが適用されてきた管腔臓器に対して適用可能であるうえに、特に従来のステントが適用できなかった股関節や膝等の大きな角度範囲で屈伸する血管及び筋肉の収縮のために強い圧迫を受ける大腿部の血管にも挿入・留置して使用することができる。 The stent of the present invention can be applied to digestive organs such as blood vessels, trachea and bile ducts of animals including humans, human body such as esophagus, urinary organs, and reproductive organs, or almost any luminal organ of animals. The femur that can be applied to luminal organs that have been developed, and that is subjected to strong compression due to contraction of blood vessels and muscles that flex and stretch in a large angle range such as hip joints and knees, where conventional stents could not be applied. It can also be used by inserting and placing it in the blood vessels of the part.
 すなわち、本発明のステントは、それ自体で柔軟性且つ弾力性を有し(換言すれば張りがある)、体液が内外に通過可能な網目状(すなわち血液等が通過可能なメッシュ状の)筒形状をなす筒状部材を、柔軟で弾力性のある複数のリング部材により間欠的に支持させている構造を有するものである。ただし、筒状部材は中心軸方向両端部が開口していれば必ずしも円筒形状である必要はなく、中心軸と直交する任意の断面が略円形状であれば各部で太さが異なっていても構わない。また、リング部材は、少なくとも筒状部材の中心軸方向端部から内寄りの位置に複数配置している必要があり、同中心軸方向端部(両端部又は一方の端部)にリング部材を設けることは任意である。また、一部又は全部のリング部材を、筒状部材の内面側に取り付けることも外面側に取り付けることもできる。ここで、リング部材には、1本の線形材料を略円形に形成したもの、1本の線形材料を複数回巻回して略円形にしたもの、1本の線形材料を略円形に形成したものを複数個束ねたもの、長軸方向の寸法が直径に比してごく短い筒状のもの、従来のステント(例えばZステント等)のうち長軸方向の寸法がごく短いものなど、柔軟で弾力性を有し環状とみなせる形状のものであって生体適合性があれば、材質や構造は特に限定されるものではなく、複数のリング部材にそれぞれ異なる構成のものを採用することも可能である。 That is, the stent of the present invention is flexible and elastic in itself (in other words, has a tension), and is a mesh-like cylinder (that is, a mesh shape through which blood or the like can pass) through which body fluid can pass in and out. A cylindrical member having a shape is intermittently supported by a plurality of flexible and elastic ring members. However, the cylindrical member does not necessarily have a cylindrical shape as long as both ends in the central axis direction are open. If the arbitrary cross section perpendicular to the central axis is substantially circular, the thickness may be different in each part. I do not care. In addition, it is necessary to arrange a plurality of ring members at least inward from the end in the central axis direction of the cylindrical member, and the ring members are provided at the end in the same central axis (both ends or one end). It is optional. Moreover, one part or all part ring member can also be attached to the inner surface side of a cylindrical member, and can also be attached to an outer surface side. Here, the ring member has one linear material formed in a substantially circular shape, one linear material wound in a plurality of turns into a substantially circular shape, and one linear material formed in a substantially circular shape Flexible, elastic, such as a bundle of a plurality of tubes, a cylindrical shape whose length in the long axis direction is very short compared to its diameter, and a conventional stent (eg, a Z-stent) that has a very short length in the long axis direction As long as it has a shape that can be regarded as an annular shape and has biocompatibility, the material and structure are not particularly limited, and it is also possible to employ a plurality of ring members having different configurations. .
 さらに、メッシュ状の筒状部材は、その網目を構成する縦横の線形部が、筒状部材の中心軸に対して略平行となることも略直角に立体交差することもなく、共に筒状部材の中心軸に略等角度で立体交差するように構成したものである。このような構成の筒状部材には、天然又は合成樹脂繊維又は金属繊維からなる縦糸及び横糸(これらはモノフィラメントでもマルチフィラメントの何れでも適用可能である)を網目状に編み込んだもの、このような縦糸及び横糸を相互に溶着又は接着して網目状に形成したもの、合成樹脂製シートや筒状体に整列した穴を多数形成して網目状としたものなど、適宜の構成のものを採用することができる。網目を構成する縦横の線形部には、縦糸及び横糸を用いた筒状部材の場合はこれら縦糸及び横糸が該当し、シートや筒状体に穴を多数形成して網目状とした筒状部材の場合は各穴を繋ぐ穴の周囲の線状の部分が該当する。筒状部材の縦横の線形部により形成される網目の形状は、特定の形状に限定されるものではない。なお、筒状部材に用いられる素材には、生体適合性のある素材が選択されるべきである。 Further, the mesh-shaped cylindrical member is a tubular member in which the vertical and horizontal linear portions constituting the mesh are not substantially parallel to the central axis of the cylindrical member or do not intersect three-dimensionally at a substantially right angle. The three-dimensional crossing is made at a substantially equal angle to the central axis. In the cylindrical member having such a structure, warps and wefts made of natural or synthetic resin fibers or metal fibers (which can be applied to either monofilaments or multifilaments) are knitted in a mesh shape, such as Adopting an appropriate configuration such as a mesh formed by welding or adhering warp and weft to each other, or a mesh formed by forming a large number of holes aligned in a synthetic resin sheet or cylindrical body be able to. In the case of a cylindrical member using warp and weft, the warp and weft yarns correspond to the vertical and horizontal linear portions constituting the mesh, and the cylindrical member is formed into a mesh by forming a large number of holes in the sheet or tubular body. In the case of, the linear part around the hole connecting each hole corresponds. The shape of the mesh formed by the vertical and horizontal linear portions of the cylindrical member is not limited to a specific shape. Note that a biocompatible material should be selected as the material used for the tubular member.
 本発明のステントは、上述のような網目状の筒状部材を複数のリング部材で間欠的に支持するという基本構造を有しているため、中心軸方向の柔軟性を維持しつつ周方向の拡張力を備えたものとなる。この周方向の拡張力は、リング部材の周方向の拡張力を強くすることによって一層強いものとすることができ、しかもステント全体としての中心軸方向への柔軟性は保つことができる。そのうえ、本発明のステントは、各リング部材の柔軟性及び弾性復元力を利用してステントを縮径又は拡開した場合でも、筒状部材は座屈したり皺ができることなく、若しくは座屈や皺が生じてもその程度は極めて小さく、縦横の線形部から構成される網目が菱形等の基本形状を維持したまま伸縮する。そのため、縮径した状態の筒状部材自体や筒状部材とリング部材とがほとんど干渉し合わず、カテーテル等を利用して極めてコンパクトに縮径させたステントを管腔臓器の狭窄部まで搬送し、狭窄部で拡開させるという患部への導入操作も容易に行うことができるうえに、特に細い血管等の管腔臓器や細い狭窄部への導入も可能となり、また導入後の管腔臓器の動きにも容易に追従できるものとなる。すなわち、本ステントは、筒形状の中心軸方向と径方向との両方に柔軟に曲がるものとなり、挿入・留置された管腔臓器に密着した状態でその動きにも容易且つ柔軟に追従することができる。このことは、従来の金属製ステントとは異なり、本ステントが、例えば血管の拍動や屈伸のような管腔臓器自体の動きや、管腔臓器の外側の筋肉等からの圧迫という外力を受けても、筒状部材とリング部材の何れもが破損したり断裂することなく機能し続けることができることを意味しており、そのために本ステントは管腔臓器に損傷を与える可能性が極めて小さい安全なステントであるといえる。例えば、本発明のステントを膝等の大きい角度で曲がる血管の狭窄部に導入した場合であっても、各リング部材の弾性により支持された筒状部材の網目構造が維持されてステント全体としての筒形状を維持したまま血管に追従して曲がるため、位置ずれを生じることなく継続して長期間使用し続けることができる。また、本発明のステントの全体形状は、メッシュ状の筒状部材にその中心軸に中心を一致させた複数のリング部材を取り付けたという簡易な構造部材により規定されることから、構造の単純化を図ることができるため、比較的細い径のステントであっても容易に作成することができる。したがって、本発明のステントであれば、高い安全性と耐久性を維持しつつ、従来の各種ステントが適用されてきた管腔臓器への適用が可能であるのはいうまでもなく、従来の金属製ステントでは適用できなかった大きい角度範囲で繰り返し屈伸する膝の血管等への適用も可能である。 Since the stent of the present invention has a basic structure in which the mesh-shaped cylindrical member as described above is intermittently supported by a plurality of ring members, it maintains the flexibility in the central axis direction while maintaining the flexibility in the circumferential direction. It will be equipped with expansion power. The expansion force in the circumferential direction can be made stronger by increasing the expansion force in the circumferential direction of the ring member, and the flexibility of the entire stent in the central axis direction can be maintained. In addition, the stent according to the present invention does not buckle or wrinkle the tubular member even when the stent is reduced in diameter or expanded using the flexibility and elastic restoring force of each ring member. Even if this occurs, the degree is extremely small, and the mesh composed of vertical and horizontal linear portions expands and contracts while maintaining a basic shape such as a rhombus. For this reason, the cylindrical member itself in a reduced diameter state or the cylindrical member and the ring member hardly interfere with each other, and a stent having a reduced diameter using a catheter or the like is delivered to a stenosis portion of a luminal organ. In addition, it can be easily introduced into the affected area by spreading at the stenosis, and it can be introduced into a luminal organ such as a thin blood vessel or a narrow stenosis. It can easily follow the movement. In other words, the stent bends flexibly in both the central axis direction and the radial direction of the cylindrical shape, and can easily and flexibly follow its movement while in close contact with the inserted and indwelling luminal organ. it can. This differs from conventional metal stents in that the stent is subjected to external forces such as the movement of the luminal organ itself, such as the pulsation and bending of blood vessels, and compression from the muscles outside the luminal organ. However, this means that both the tubular member and the ring member can continue to function without being damaged or ruptured. For this reason, the stent has a very low possibility of damaging the luminal organ. It can be said that it is a good stent. For example, even when the stent of the present invention is introduced into a narrowed portion of a blood vessel that bends at a large angle such as a knee, the mesh structure of the cylindrical member supported by the elasticity of each ring member is maintained, and the entire stent is maintained. Since it bends following the blood vessel while maintaining the cylindrical shape, it can be continuously used for a long time without causing a positional shift. The overall shape of the stent of the present invention is defined by a simple structural member in which a plurality of ring members whose centers coincide with the central axis are attached to a mesh-like cylindrical member, so that the structure is simplified. Therefore, even a stent having a relatively small diameter can be easily produced. Therefore, it goes without saying that the stent of the present invention can be applied to a luminal organ to which various conventional stents have been applied while maintaining high safety and durability. It can also be applied to the blood vessels of the knee that repeatedly bend and stretch in a large angle range that could not be applied with a stent made of stent.
 また、本発明のステントは、網目(メッシュ)の大きさを選択的に形成し易い筒状部材を管腔臓器に密着させる構造を採用している。このため本発明のステントは、特に筒状部材の網目を細かく設定すれば、患部の内膜増殖がステント内に浸潤しにくいという利点を有することとなる。さらに、本発明のステントにおいて筒状部材の網目が細かい場合、ステントの内面側に管腔臓器の内膜が適度に増殖してステントが体組織と一体化しやすいために血栓が付着しにくくなる。このように、本発明のステントは、従来のステントでは適用が困難であった管腔臓器への挿入・留置にも適したものであるため、経皮的経管的手術による治療を大幅に前進させることができるものであるといえる。 In addition, the stent of the present invention employs a structure in which a cylindrical member that can easily form a mesh size (mesh) is in close contact with a luminal organ. For this reason, the stent of the present invention has an advantage that intimal proliferation of the affected area hardly infiltrates into the stent, particularly when the mesh of the cylindrical member is set finely. Further, in the stent of the present invention, when the mesh of the cylindrical member is fine, the intima of the luminal organ is appropriately grown on the inner surface side of the stent and the stent is easily integrated with the body tissue, so that the thrombus is difficult to adhere. As described above, the stent of the present invention is suitable for insertion and placement in a hollow organ, which was difficult to apply with conventional stents, and therefore, treatment by percutaneous transluminal surgery has been greatly advanced. It can be said that it can be made to.
 また、上述したように、本発明のステントでは、リング部材を筒状部材の内面側に取り付けた構成も外面側に取り付けた構成も可能であるが、特に全てのリング部材を筒状部材の内面側に取り付けた場合には、管腔臓器の内壁にはリング部材は接触せず、柔軟な筒状部材のみが接触することから、ステント全体に亘って管腔臓器の内壁に与える刺激が極めて小さいものとなるため、内膜増殖の進行やそれに伴う再狭窄の発生防止にも寄与し得るものとなる。 Further, as described above, in the stent of the present invention, a configuration in which the ring member is attached to the inner surface side of the cylindrical member or a configuration in which the ring member is attached to the outer surface side is possible. When attached to the side, the ring member does not contact the inner wall of the luminal organ, but only the flexible cylindrical member contacts, so the stimulation applied to the inner wall of the luminal organ over the entire stent is extremely small. Therefore, it can contribute to the progression of intimal proliferation and the prevention of the accompanying restenosis.
 さらに前述の通り、本発明のステントには、筒状部材の中心軸に沿って両端開口部から内寄りに配置される複数のリング部材を配置して、筒状部材の両端開口部にはリング部材を設けない構成を採用することが可能であるが、筒状部材の両端開口部の一方又は両方にリング部材を設けることは任意に行うことができる。筒状部材の内寄り(ここで、『筒状部材の内寄り』とは、「中心軸方向両端開口部を除く」という主旨である)のみにリング部材を有するステントの場合、ステントの中心軸方向両端部においては筒状部材のみが管腔臓器と接することとなり、その部位での管腔臓器の内壁に与える圧迫や刺激を低減させて、内膜増殖の進行やそれに伴う再狭窄も防止できるという利点がある。また、筒状部材の張りが十分である場合には、その両端開口部にはリング部材を有しないステントであっても十分な保形性が確保され、また管腔臓器への挿入前の縮径時の折り畳みやすさが向上する。一方、リング部材を筒状部材の内寄りに加えて一端部又は両端部にも設けた場合には、ステント全体の保形性を高めることができる。特に、筒状部材の内寄りのリング部材以外に両端開口部のうち一方のみにリング部材を設ける場合には、そのリング部材を設けた側が血流等の体液の流れの上流側となるように本ステントを配置することで、管腔臓器の内壁に対する安定性を高めておき、リング部材を設けていない側の端部は体液流による吹き流し状態としても本発明のステントとしての機能を十分に発揮することができる。本発明では、筒状部材の内寄りのリング部材は筒状部材の内面側又は外面側の何れに配置されてもよいが、両端開口部の少なくとも一方にリング部材が設けられる場合にも、そのリング部材が留置される管腔臓器の内壁に接触しないように配置してもよいし、筒状部材の外面側に露出させて管腔臓器の内壁と接触するように配置してもよい。筒状部材の開口端部に配置されるリング部材を管腔臓器の内壁に接触させない状態で筒状部材に取り付ける場合には、例えば筒状部材の端部を内側又は外側に折り返してリング部材を巻き込むように取り付ける構成を採用し、管腔臓器の内壁には筒状部材だけが接触するようにして内壁への刺激を最低限とすることができる。リング部材を管腔臓器の内壁に接触するように筒状部材に取り付ける場合には、例えば筒状部材の端部においてリング部材を部分的に固定する構成を採用することができるが、この場合でも従来のステントと比較すれば管腔臓器の内壁への刺激を極力低減することが可能である。 Further, as described above, in the stent of the present invention, a plurality of ring members arranged inward from the opening portions at both ends are arranged along the central axis of the tubular member, and the ring is formed at the opening portions at both ends of the tubular member. Although it is possible to employ a configuration in which a member is not provided, it is possible to arbitrarily provide a ring member in one or both of the both end openings of the cylindrical member. In the case of a stent having a ring member only on the inward side of the cylindrical member (here, “inward side of the cylindrical member” means “excluding openings at both ends in the central axis direction”), the central axis of the stent Only the cylindrical member comes into contact with the luminal organ at both ends in the direction, and the compression and stimulation applied to the inner wall of the luminal organ at that site can be reduced to prevent the progression of intimal proliferation and the accompanying restenosis There is an advantage. In addition, when the tubular member is sufficiently tensioned, sufficient shape retention is ensured even with a stent having no ring member at the opening at both ends, and the tube member is compressed before insertion into a luminal organ. Easier to fold when diameter is improved. On the other hand, when the ring member is provided at one end or both ends in addition to the inside of the tubular member, the shape retention of the entire stent can be improved. In particular, in the case where a ring member is provided only in one of the openings at both ends other than the inner ring member of the cylindrical member, the side on which the ring member is provided is upstream of the flow of body fluid such as blood flow. By placing this stent, the stability of the inner wall of the luminal organ is enhanced, and the end on the side where the ring member is not provided sufficiently functions as the stent of the present invention even when it is blown by a body fluid flow. can do. In the present invention, the inner ring member of the cylindrical member may be arranged on either the inner surface side or the outer surface side of the cylindrical member, but even when the ring member is provided on at least one of both end openings, You may arrange | position so that a ring member may not contact the inner wall of the hollow organ indwelled, and you may arrange | position so that it may expose to the outer surface side of a cylindrical member and may contact the inner wall of a hollow organ. When attaching the ring member arranged at the open end of the tubular member to the tubular member without contacting the inner wall of the luminal organ, for example, the end of the tubular member is folded back inward or outward to By adopting a configuration of attaching so as to be involved, it is possible to minimize irritation to the inner wall by contacting only the tubular member with the inner wall of the luminal organ. When the ring member is attached to the cylindrical member so as to contact the inner wall of the luminal organ, for example, a configuration in which the ring member is partially fixed at the end of the cylindrical member can be adopted. Compared with a conventional stent, it is possible to reduce the stimulation to the inner wall of the luminal organ as much as possible.
 ここで、本発明のステントには、リング部材として、折り曲げ自在な弾性復元力を有する柔軟な金属製線材を適用することができ、この場合、ステントの柔軟性を確保しつつ、強度と耐久性を向上させることが可能となる。 Here, in the stent of the present invention, as a ring member, a flexible metal wire material having a bendable elastic restoring force can be applied. In this case, strength and durability are ensured while ensuring flexibility of the stent. Can be improved.
 この場合、リング部材は、環状とした金属製線材を複数重に束ねて形成した構成を採用することができる。このような構成のリング部材としては、例えば1本の金属製線材を環状に多重巻きとして1つのリング部材とした構成や、金属製線材から形成される環状のリングを複数形成してそれらを束ねて1つのリング部材とした構成を例示することができ、このような金属製リング部材であれば、柔軟性を確保しつつ、弾性復元力を増強することができるとともに、折れにくく耐久性の高いものとすることができ、安全性も向上することが可能となる。また、金属製線材の多重巻きの巻数、又は束ねるリングの数を調整することで、各リング部材の弾性復元力や耐久性を容易に調整することができる。 In this case, the ring member may be formed by bundling a plurality of annular metal wires. As a ring member having such a configuration, for example, a structure in which one metal wire is formed into a ring member by annularly wrapping multiple metal rings, or a plurality of annular rings formed from metal wires are formed and bundled together. Such a metal ring member can increase the elastic restoring force while ensuring flexibility and is difficult to break and has high durability. It is possible to improve safety. Moreover, the elastic restoring force and durability of each ring member can be easily adjusted by adjusting the number of multiple windings of the metal wire or the number of rings to be bundled.
 一般にステントは、細い血管等の管腔臓器を経てさらに細い狭窄部に挿入した位置で拡開されるのであるが、そのためには、細いカテーテル又はシースを介してステントを搬送する必要があることから、ステントに必須の条件は、縮径時の径をできる限り小さくすることである。特に、従来のステントでは適用できなかった管腔臓器への適用を可能とするためには、縮径時の径を小さくすることは極めて重要な点である。そこで本発明は、上述したような基本構成を採用することで、ステントの縮径時におけるコンパクトさ、特に径を極力小さくすることができるようにしたものであるが、特にリング部材は、周方向に略等間隔で離間させて4箇所で筒状部材に固定することが有用となる。すなわち、ステントの縮径時には、筒状部材を中心軸方向に引き延ばしながらシース等の細い管状部材に挿入すると、リング部材の4箇所の筒状部材への固定箇所の中間部の4点が交互に筒状部材の中心軸方向一端部及び他端部を向くコンパクトな波形(波形の頂部2つと底部2つが交互に形成された形状)に折り畳まれる結果、各リング部材は大きく変形するものの、このリング部材の変形には筒状部材は干渉されることがなく、各リング部材を固定している筒状部材の周方向各4点が中心軸方向に接近するだけで、筒状部材自体には皺はほとんど生じることがない。したがって、効率よくコンパクトに縮径させたステントを極めて細いカテーテル等に挿入して管腔臓器の狭窄部まで搬送することが可能となる。リング部材には、上述したような弾性復元力があるため、波形に折り曲げられたリング部材は、カテーテル等から放出された際には元の環状に復元する。なお、このようなコンパクトな縮径は、本発明のステントの基本構造に基づいてなし得るものであるため、各リング部材を筒状部材に周方向4箇所で固定した場合に限られるものではないが、各リング部材を筒状部材に4箇所で固定することは、縮径時のステントの径の小ささと、リング部材の筒状部材への固定の簡便性が両立するため、極めて有用である。 Generally, a stent is expanded at a position where it is inserted into a further narrow stenosis through a luminal organ such as a thin blood vessel. For this purpose, it is necessary to transport the stent via a thin catheter or sheath. The essential condition for the stent is to make the diameter at the time of diameter reduction as small as possible. In particular, in order to enable application to a luminal organ that could not be applied with a conventional stent, it is extremely important to reduce the diameter when the diameter is reduced. Therefore, the present invention adopts the basic configuration as described above, so that the compactness at the time of the diameter reduction of the stent, particularly the diameter can be made as small as possible. It is useful to fix them to the cylindrical member at four locations separated by approximately equal intervals. That is, when the diameter of the stent is reduced, if the tubular member is inserted into a thin tubular member such as a sheath while being stretched in the central axis direction, the four points at the intermediate portion of the four fixed portions of the ring member to the tubular member are alternately arranged. Although each ring member is greatly deformed as a result of being folded into a compact corrugated shape (a shape in which two tops and two bottoms of the corrugation are alternately formed) facing one end and the other end in the central axis direction of the cylindrical member, this ring The cylindrical member is not interfered with the deformation of the member, and only four points in the circumferential direction of the cylindrical member fixing the ring members approach in the central axis direction. Rarely occurs. Therefore, it becomes possible to efficiently insert a stent having a reduced diameter into a very thin catheter or the like and transport it to a stenosis of a luminal organ. Since the ring member has the elastic restoring force as described above, the ring member bent into the corrugated shape is restored to the original annular shape when released from the catheter or the like. In addition, since such a compact diameter reduction can be made based on the basic structure of the stent of the present invention, it is not limited to the case where each ring member is fixed to the cylindrical member at four locations in the circumferential direction. However, fixing each ring member to the cylindrical member at four locations is extremely useful because both the small diameter of the stent when the diameter is reduced and the simplicity of fixing the ring member to the cylindrical member are compatible. is there.
 また、本発明のステントでは、各リング部材の弾性復元力を全て略一定にすることもできるが、リング部材ごとに弾性復元力を異ならせることも可能であり、例えば筒状部材の中心軸方向中央部近傍に配置されるリング部材の弾性復元力を、同中心軸方向端部近傍に配置されるリング部材の弾性復元力よりも大きく設定してもよい。管腔臓器において狭窄の程度が強い部分に中心軸方向中央部が位置するようにステントを留置するのが通例である。そのため、ステントの中心軸方向中央部近傍におけるリング部材の弾性復元力をより大きく設定しておくことで、この拡張力の大きいステントによって管腔臓器の狭窄を持続的且つ効果的に押し広げることが可能となる。 In the stent of the present invention, the elastic restoring force of each ring member can be made substantially constant, but the elastic restoring force can be made different for each ring member, for example, in the direction of the central axis of the cylindrical member The elastic restoring force of the ring member disposed in the vicinity of the center portion may be set larger than the elastic restoring force of the ring member disposed in the vicinity of the end portion in the same central axis direction. It is usual to place a stent so that the central portion in the central axis direction is located in a portion where the degree of stenosis is strong in a hollow organ. Therefore, by setting the elastic restoring force of the ring member near the central portion in the central axis direction of the stent to be larger, the stenosis of the luminal organ can be continuously and effectively spread by the stent having a large expansion force. It becomes possible.
 さらに、本発明のステントでは、隣接するリング部材同士の間隔を何れも略一定とすることもできるが、隣接するリング部材同士の間隔をそれぞれ任意に設定することも可能であり、例えば筒状部材の中心軸方向中央部近傍に配置される複数のリング部材の間隔を、同中心軸方向端部近傍に配置される複数のリング部材の間隔よりも狭く設定してもよい。この場合、前述と同様の理由により、ステントの中心軸方向中央部近傍におけるリング部材同士の間隔を狭めておくことで、ステントによる管腔臓器の狭窄の押し広げを持続的且つ効果的に行うことが可能となる。 Furthermore, in the stent of the present invention, the interval between adjacent ring members can be substantially constant, but the interval between adjacent ring members can be arbitrarily set, for example, a cylindrical member. The interval between the plurality of ring members arranged near the central portion in the central axis direction may be set to be narrower than the interval between the plurality of ring members arranged near the end portion in the central axis direction. In this case, for the same reason as described above, it is possible to continuously and effectively spread the narrowing of the luminal organ by the stent by narrowing the interval between the ring members in the central axial direction vicinity of the stent. Is possible.
 さらにまた、本発明のステントでは、各リング部材の直径を全て略一定にすることもできるが、リング部材ごとに直径を異ならせることも可能であり、例えば筒状部材の中心軸方向一端部近傍に配置されるリング部材の直径を、同中心軸方向他端部近傍に配置されるリング部材の直径よりも大きく設定してもよい。この場合、特に適用対象となる管腔臓器が例えば上流側の径が大きく下流側の径が小さい形状である場合、ステントの形状を管腔臓器の留置部位の形状に的確に対応させることができ、例えばステントを径が大きい端部側を動脈の本流部分に配置し径が小さい端部側をその動脈の分枝に配置するというような態様でも使用することができる。 Furthermore, in the stent of the present invention, the diameter of each ring member can be made substantially constant, but the diameter can also be made different for each ring member, for example, in the vicinity of one end in the central axis direction of the tubular member The diameter of the ring member disposed in the center may be set larger than the diameter of the ring member disposed in the vicinity of the other end in the same central axis direction. In this case, particularly when the luminal organ to be applied has a shape with a large upstream diameter and a small downstream diameter, the shape of the stent can accurately correspond to the shape of the placement site of the luminal organ. For example, the stent can be used in such a mode that the end portion having the larger diameter is disposed in the main flow portion of the artery and the end portion having the smaller diameter is disposed in the branch of the artery.
 また、特に筒状部材を、合成樹脂製のものとした場合には、金属素材を骨組みとする従来のステントの問題点、すなわち管腔臓器内で繰り返し撓んだり折れ曲がったりすることに起因する金属疲労による断裂という問題が生じず、より安全で耐久性の高いステントを実現することができる。本発明のステントでは、合成樹脂製の筒状部材は、複数のリング部材によって支持されるため、構造的にも安定しており、長期に亘って管腔臓器内で機能させ続けることができる。また、合成樹脂製の筒状部材を用いたステントであれば、管腔臓器に対する刺激が極めて小さくなり、内膜増殖およびそれに伴う再狭窄を防止できることにもなる。さらに、本発明のステントでは、筒状部材に薬剤を塗布したり、薬剤溶出性ステントとして用いることが可能であり、合成樹脂製の筒状部材を採用する場合には、溶出性薬剤の塗布に適した合成樹脂素材の選択も行いやすい。 In particular, when the cylindrical member is made of a synthetic resin, there is a problem with the conventional stent using a metal material as a skeleton, that is, a metal caused by repeated bending or bending in a luminal organ. The problem of tearing due to fatigue does not occur, and a safer and more durable stent can be realized. In the stent of the present invention, since the cylindrical member made of synthetic resin is supported by a plurality of ring members, it is structurally stable and can continue to function in the luminal organ for a long time. In addition, a stent using a cylindrical member made of a synthetic resin can reduce irritation to a luminal organ, and can prevent intimal proliferation and accompanying restenosis. Furthermore, in the stent of the present invention, a drug can be applied to a cylindrical member or used as a drug-eluting stent. When a cylindrical member made of a synthetic resin is employed, the elution drug can be applied. It is easy to select a suitable synthetic resin material.
 本発明のステントは、柔軟で弾力性があり屈曲性に優れ、屈曲に対する耐久性を有する網目構造をなし、断面円形の筒形状を有する筒状部材の中心軸方向開口両端部から内寄りの位置に弾力性があるリング部材を複数配置した基本構成を有し、さらに筒状部材の網目を構成する縦横の線形部を何れも円筒形状の中心軸に対して略等角度で立体交差するように構成したものである。このような構造であるため、本発明のステントは、管腔臓器の動きに追従しやすく、しかも大きな角度で曲げても筒形状が維持されやすく、折れにくく耐久性が高く、拡張力が強いため、強固な狭窄も拡張できる。また挿入・留置して適用される管腔臓器への刺激が小さく、ステント内への内膜増殖の浸潤が少なく且つステントの内面側への適度な内膜増殖がなされやすい、といった構造上も機能上も優れた諸々の利点を有するものである。したがって、本発明は、従来のステントが適用されてきた管腔臓器への適用に適しているのは勿論のこと、従来のステントでは適用できなかった大きな角度範囲で屈伸する管腔臓器への適用をも可能とし、これまでにない安全で耐久性に優れ、適用範囲が広い極めて優れたステントを提供することができるものである。 The stent of the present invention has a network structure that is flexible, elastic, excellent in flexibility, durable against bending, and has a cylindrical shape with a circular cross section, and is positioned inward from both ends of the central axial direction opening of the cylindrical member. It has a basic configuration in which a plurality of elastic ring members are arranged, and further, the vertical and horizontal linear portions constituting the mesh of the cylindrical member are three-dimensionally crossed at substantially equal angles with respect to the central axis of the cylindrical shape. It is composed. Because of such a structure, the stent of the present invention easily follows the movement of the luminal organ, and is easily maintained in a cylindrical shape even when bent at a large angle, is not easily broken, has high durability, and has a strong expansion force. A strong stenosis can also be expanded. Also, it functions in the structure that the stimulation to the luminal organ applied by insertion and placement is small, there is little infiltration of intimal proliferation into the stent, and moderate intimal proliferation on the inner surface side of the stent is easy. The above also has various excellent advantages. Therefore, the present invention is not only suitable for application to a luminal organ to which a conventional stent has been applied, but also to a luminal organ that bends and stretches in a large angle range that cannot be applied to a conventional stent. Therefore, it is possible to provide an extremely excellent stent that has an unprecedented safety, durability, and wide application range.
本発明の第1実施形態に係るステントの概略構造を示す模式図。The schematic diagram which shows schematic structure of the stent which concerns on 1st Embodiment of this invention. 同実施形態のステントを示す斜視図。The perspective view which shows the stent of the embodiment. 同実施形態のステントの曲がった状態の一例を示す模式図。The schematic diagram which shows an example of the bent state of the stent of the embodiment. 同実施形態のステントの一部を拡大して示す模式図。The schematic diagram which expands and shows a part of stent of the embodiment. 同実施形態のステントの拡開状態と縮径状態との間の状態を示す模式図。The schematic diagram which shows the state between the expansion state and diameter-reduction state of the stent of the embodiment. 同実施形態のステントを縮径した状態を示す模式図。The schematic diagram which shows the state which diameter-reduced the stent of the embodiment. 同実施形態のステントの拡開状態と縮径状態との間の状態他の例を示す模式図。The schematic diagram which shows the other example of the state between the expansion state of the stent of the embodiment, and a diameter-reduced state. 同実施形態のステントを縮径して血管の狭窄部に搬送し、シース等より放出した直後の状態を示す模式図。The schematic diagram which shows the state immediately after releasing the diameter of the stent of the same embodiment, conveying it to the stenosis part of a blood vessel, and discharging | emitting from a sheath etc. FIG. 同実施形態のステントを血管の狭窄部で拡開させた状態を示す模式図。The schematic diagram which shows the state which expanded the stent of the embodiment in the constriction part of the blood vessel. 同実施形態のステントを湾曲した血管の狭窄部で拡開させた状態を示す模式図。The schematic diagram which shows the state which expanded the stent of the embodiment in the narrowed part of the curved blood vessel. 本発明の第2実施形態のステントの概略構造を示す模式図。The schematic diagram which shows schematic structure of the stent of 2nd Embodiment of this invention. 同実施形態のステントの拡開状態と縮径状態との間の状態を示す模式図。The schematic diagram which shows the state between the expansion state and diameter-reduction state of the stent of the embodiment. 本発明の第3実施形態のステントの概略構造を示す模式図。The schematic diagram which shows schematic structure of the stent of 3rd Embodiment of this invention. 本発明の第4実施形態のステントの概略構造を示す模式図。The schematic diagram which shows schematic structure of the stent of 4th Embodiment of this invention. 本発明の第5実施形態のステントの概略構造を示す模式図。The schematic diagram which shows schematic structure of the stent of 5th Embodiment of this invention. 本発明の第6実施形態のステントの概略構造を示す模式図。The schematic diagram which shows schematic structure of the stent of 6th Embodiment of this invention.
 以下、本発明の実施形態を、図面を参照して説明する。
 <第1実施形態> 本実施形態に係るステント1は、管腔臓器の病変部、特に動脈硬化による下肢動脈の狭窄部、癌などによる気管や食道、十二指腸、胆道等の狭窄部、他の血管の狭窄部等に対して経皮的経管的術法により挿入・留置して使用されるものであって、本実施形態では一例として血管に挿入・留置されるステント1について説明するが、他の管腔臓器に適用される場合であっても、径や長手寸法等のサイズやリング部材の個数が異なるのみで基本的な構成は下述するステント1と同等である。
Embodiments of the present invention will be described below with reference to the drawings.
First Embodiment A stent 1 according to this embodiment includes a lesion part of a luminal organ, particularly a stenosis part of a lower limb artery due to arteriosclerosis, a trachea or esophagus due to cancer, a stenosis part such as a duodenum, a biliary tract, and other blood vessels. In this embodiment, a stent 1 that is inserted and placed in a blood vessel will be described as an example. Even when applied to a luminal organ, the basic configuration is the same as that of the stent 1 described below, except that the size and the number of ring members are different.
 本実施形態のステント1は、図1に円筒形状を平面的に模して表した筒状部2と斜め方向から見たリング部材31を組み合わせたステント1の模式図、図2に同ステント1の外観を示す斜視図、図3に同ステント1を湾曲させた状態の模式図を示すように、円筒状をなす多数の整列させた網目を有するメッシュ状の筒状部材2と、この筒状部材2の中心軸方向における両端開口部から内寄りに間欠的に配置される複数のリング部材31,31…とを基本構成として備えている。本実施形態のステント1では、複数のリング部材31は、筒状部材の内面側において一定間隔で配置されているが、適用される管腔臓器の種類や患部の位置等によっては、これら複数のリング部材31の離間間隔を適宜異ならせることも可能である。以下、本ステント1の各部について詳述する。 The stent 1 of the present embodiment is a schematic diagram of the stent 1 in which the cylindrical portion 2 schematically representing the cylindrical shape in FIG. 1 and the ring member 31 viewed from an oblique direction are combined, and FIG. FIG. 3 is a perspective view showing the appearance of the stent, and FIG. 3 is a schematic diagram showing a state in which the stent 1 is bent, and a mesh-like cylindrical member 2 having a large number of aligned meshes forming a cylindrical shape, and the cylindrical shape A plurality of ring members 31, 31... That are intermittently disposed inward from both end openings in the central axis direction of the member 2 are provided as a basic configuration. In the stent 1 of the present embodiment, the plurality of ring members 31 are arranged at regular intervals on the inner surface side of the cylindrical member, but depending on the type of the luminal organ to be applied, the position of the affected part, etc. It is also possible to vary the separation interval of the ring member 31 as appropriate. Hereinafter, each part of this stent 1 is explained in full detail.
 筒状部材2は、柔軟な縦糸21及び横糸22をそれぞれ複数本で網目状(メッシュ状)に形成され、適用される管腔臓器(本実施形態では血管)の径に対応させて、それと同等か若干太い直径(本実施形態では直径約6mm)となるような円筒形状をなす部材である。網目構造を形成する縦糸21と横糸22は、本発明における筒状部材2の縦横の線形部に該当する。縦糸21と横糸22には、一例として約150μmの太さの糸を用いることができるが、糸の太さは50~300μm程度が好適である。糸の素材としては天然繊維、合成樹脂繊維、金属繊維、複合繊維等の素材から、適度な強度と張力及び柔軟性を持ち、屈曲性に優れ、屈曲に対する高い耐久性を有し、生体適合性がある適宜の材料を選択することができる。各縦糸21及び横糸22はこのような糸が1本からなるもの、2本以上の複数本からなるもの、縒り糸等の適宜のものを、用途に応じて適宜用いることができる。縦糸21及び横糸22として合成樹脂繊維のうち具体的に適した素材としては、ポリエステル、ポリエチレン、ポリプロピレン、ポリテトラフロオロエチレン、ナイロン等を例示することができ、本実施形態ではポリエステルを採用している。また、本実施形態のステント1を薬剤溶出性ステントとして利用する場合には、抗血栓剤や内膜肥厚防止薬剤や抗癌剤等の薬剤の特性と、縦糸21や横糸22への塗布との適合性に基づいて、縦糸21及び横糸22の適切な素材を選択すればよい。複数の縦糸21及び横糸22により構成される網目の大きさも適宜に設定することができ、例えば一辺200~800μmの範囲とするのが好適であるが、その範囲のサイズ以上とすることも以下とすることも可能であり、本実施形態では一例として一辺約600μmの菱形という極めて細かい網目となるようにしている。 The cylindrical member 2 is formed in a mesh shape (mesh shape) with a plurality of flexible warp yarns 21 and weft yarns 22 respectively, and is equivalent to the diameter of the applied luminal organ (blood vessel in this embodiment). It is a member having a cylindrical shape with a slightly thicker diameter (in this embodiment, a diameter of about 6 mm). The warp yarn 21 and the weft yarn 22 forming the network structure correspond to the vertical and horizontal linear portions of the cylindrical member 2 in the present invention. For example, a thread having a thickness of about 150 μm can be used for the warp 21 and the weft 22, and the thickness of the thread is preferably about 50 to 300 μm. The material of the yarn is natural fiber, synthetic resin fiber, metal fiber, composite fiber, etc. It has moderate strength, tension and flexibility, excellent flexibility, high durability against bending, and biocompatibility An appropriate material can be selected. As the warp yarn 21 and the weft yarn 22, appropriate ones such as one yarn, two or more plural yarns, and twisted yarn can be appropriately used depending on the application. Polyester, polyethylene, polypropylene, polytetrafluoroethylene, nylon and the like can be exemplified as materials that are particularly suitable for the synthetic resin fibers as the warp yarn 21 and the weft yarn 22. In this embodiment, polyester is used. Yes. Further, when the stent 1 of the present embodiment is used as a drug-eluting stent, the properties of the drug such as an antithrombotic agent, an intimal thickening preventive agent, and an anticancer agent are compatible with application to the warp yarn 21 and the weft yarn 22. Based on the above, appropriate materials for the warp yarn 21 and the weft yarn 22 may be selected. The size of the mesh composed of the plurality of warp yarns 21 and weft yarns 22 can also be set as appropriate. For example, the size is preferably in the range of 200 to 800 μm per side. In this embodiment, for example, an extremely fine mesh having a rhombus with a side of about 600 μm is used.
 ここで、筒状部材2を構成する複数の縦糸21と横糸22は、図4にステント1の一部を拡大して模式的に示すように、相互に編み込むことで同図に一点鎖線で示す筒状部材2の円筒形状の中心軸mに対して何れも等しい角度θをなして中心軸mと立体交差するように配置されている。例えばリング部材31を取り付ける前の筒状部材2単独の状態では、縦糸21及び横糸22は、中心軸に対して約45°の角度で立体交差するように筒状部材2を構成しておくことができる。実際には、複数の縦糸21と横糸22は曲線上をなして網目状の筒状部材2の曲面状の周面を形成しているが、1つずつの網目の近傍を局所的に見れば、縦糸21と横糸22は直線とみなすことができる。したがって、2本の縦糸21,21と2本の横糸22,22によって構成される菱形をなす1つの網目の一方の対角線は中心軸mと略平行となり、他方の対角線は中心軸mと略直角に立体交差することとなる。本実施形態では、縦糸21と横糸22から構成された筒状部材2は、柔軟性と弾力性を併せ持つ張りのある構造となっている。なお、筒状部材2の開口両端部2aは、縦糸21と横糸22がバラバラにならないように熱溶着処理しているが、それ以外にも縫い合わせなどで端部2aの処理を行っても構わない。 Here, a plurality of warp yarns 21 and weft yarns 22 constituting the cylindrical member 2 are shown by a one-dot chain line in FIG. The cylindrical member 2 is disposed so as to form a three-dimensional intersection with the central axis m at an equal angle θ with respect to the cylindrical central axis m. For example, in the state of the cylindrical member 2 alone before the ring member 31 is attached, the cylindrical member 2 is configured so that the warp yarn 21 and the weft yarn 22 intersect three-dimensionally at an angle of about 45 ° with respect to the central axis. Can do. Actually, the plurality of warp yarns 21 and weft yarns 22 form a curved circumferential surface of the mesh-like cylindrical member 2 on a curved line, but if the neighborhood of each mesh is viewed locally, The warp yarn 21 and the weft yarn 22 can be regarded as straight lines. Accordingly, one diagonal of one mesh forming a rhombus composed of two warp yarns 21 and 21 and two weft yarns 22 and 22 is substantially parallel to the central axis m, and the other diagonal is substantially perpendicular to the central axis m. A three-dimensional intersection will occur. In this embodiment, the cylindrical member 2 composed of the warp yarn 21 and the weft yarn 22 has a tensioned structure having both flexibility and elasticity. In addition, although the opening both ends 2a of the cylindrical member 2 are heat-welded so that the warp 21 and the weft 22 do not fall apart, the end 2a may be processed by sewing or the like. .
 複数(本実施形態の各図では8本の例を示している)のリング部材31は、何れも同一素材、同一構成からなる円形リング状の部材である。各リング部材31には、金属、合成樹脂、複合材料等のなかから、適度な強度と張力及び柔軟性を有し、生体適合性がある適宜の線形材料を選択することができ、特に本実施形態ではニッケルチタン合金であるナイチノール線を用いている。さらに、各リング部材31,32は、弾性及び耐久性を強化するために、ナイチノール線を複数回(例えば3~7回)巻回して両端部を接着やカシメ等により固定することにより、筒状部材2と略同一の直径を有する円形に形成している。ただし、線材の弾性や強度によっては、一重のリングを適用してもよいし、予め円形状に製造されたリングを本実施形態のリング部材31,32として利用してもよい。このような円環状に形成した線形材料以外にも、線形材料をジグザグに折り曲げて環状とした部材や、長軸方向にごく短い筒状の部材もリング部材として適用することが可能である。本実施形態のステント1では、前述のような複数のリング部材31を、筒状部材2の内面側において略等間隔で配置して取り付けている。 The plurality of ring members 31 (eight examples are shown in the drawings of this embodiment) are all circular ring-shaped members made of the same material and the same configuration. For each ring member 31, an appropriate linear material having appropriate strength, tension and flexibility and having biocompatibility can be selected from metals, synthetic resins, composite materials, etc. In the form, Nitinol wire which is a nickel titanium alloy is used. Further, each of the ring members 31 and 32 is formed into a cylindrical shape by winding a nitinol wire a plurality of times (for example, 3 to 7 times) and fixing both ends thereof by adhesion or caulking to enhance elasticity and durability. The member 2 is formed in a circular shape having substantially the same diameter. However, depending on the elasticity and strength of the wire, a single ring may be applied, or a ring manufactured in advance in a circular shape may be used as the ring members 31 and 32 of the present embodiment. In addition to such a linear material formed in an annular shape, a ring-shaped member obtained by bending a linear material in a zigzag manner or a cylindrical member that is extremely short in the long axis direction can be used as the ring member. In the stent 1 of the present embodiment, the plurality of ring members 31 as described above are arranged and attached at substantially equal intervals on the inner surface side of the tubular member 2.
 ここで、リング部材31の筒状部材2への取り付けについては、各リング部材31を筒状部材2の内部の各所定位置に配置して、それぞれ中心軸m回りに90度の角度位相ごとに4箇所で筒状部材2の網目を構成する縦糸21及び横糸22の交差部位に糸23で結わえて固定している(図4参照)が、縦糸21又は横糸22の何れか一方のみにリング部材31を取り付けても構わない。本実施形態では、各リング部材31に対する4点での固定箇所は、全てのリング部材31に共通する筒状部材2の中心軸と平行な4つの直線上に略一致させた例を示しているが、必ずしも一致させる必要はない。なお、各リング部材31の筒状部材2への固定方法は、糸による固定に限らず、生体適合性のある接着剤によっても可能であり、固定箇所も4箇所又は全周に限定されるものではない。 Here, with respect to the attachment of the ring member 31 to the tubular member 2, each ring member 31 is disposed at each predetermined position inside the tubular member 2, and is rotated every 90 degrees around the central axis m. A ring member is attached to only one of the warp yarn 21 or the weft yarn 22 although the yarn 23 is tied and fixed to the intersecting portion of the warp yarn 21 and the weft yarn 22 constituting the mesh of the cylindrical member 2 at four locations (see FIG. 4). 31 may be attached. In the present embodiment, an example is shown in which the fixing points at the four points with respect to each ring member 31 are substantially matched on four straight lines parallel to the central axis of the cylindrical member 2 common to all the ring members 31. However, it is not necessary to match. In addition, the fixing method of each ring member 31 to the cylindrical member 2 is not limited to fixing with a thread, but can be performed with a biocompatible adhesive, and the fixing location is limited to four locations or the entire circumference. is not.
 このように構成されたステント1は、各図に示すように、筒状部材2の中心軸mと各リング部材31の中心とを略一致させた状態となる。このため、ステント1は全体として、中心軸m方向にも径方向(筒状部材2の径方向及びそれと一致する各リング部材31,32の直径方向)にも柔軟性と弾力性を有しており、図2に示すように、ステント1を中心軸m方向に曲げた場合、筒形状を維持しながら湾曲させることが可能である。しかも、筒状部材2の中心軸mと略等角度で立体交差した状態が維持される縦糸21と横糸22によって菱形の各網目が両対角線方向にそれぞれ伸縮することで、筒状部材2は中心軸m方向に柔軟に屈伸し、筒状部材2が途中で座屈したり筒状部材2に皺が形成されたりすることがないか、座屈や皺が極めて生じにくい。またこのような筒状部材2を用いていることから、ステント1は、筒状部材2中心軸m方向に一定程度伸縮可能であり、伸長時には直径方向への縮小が生じ、縮径時には嵩張りを小さく抑制することにもなる。なお、前述の通り図3には、ステント1を湾曲させた状態を示したが、同図に示すよりも大きい角度(例えば略180°のUターン又はそれ以上のループ形状)で湾曲させた場合であっても、ステント1は筒形状を維持することができる。 The stent 1 configured in this manner is in a state in which the central axis m of the tubular member 2 and the center of each ring member 31 are substantially aligned, as shown in each drawing. Therefore, the stent 1 as a whole has flexibility and elasticity both in the direction of the central axis m and in the radial direction (the radial direction of the tubular member 2 and the radial direction of the ring members 31 and 32 corresponding thereto). As shown in FIG. 2, when the stent 1 is bent in the direction of the central axis m, it can be bent while maintaining the cylindrical shape. In addition, the rhomboid meshes are expanded and contracted in both diagonal directions by the warp yarn 21 and the weft yarn 22 which are maintained in a state of three-dimensionally intersecting with the central axis m of the cylindrical member 2 so that the cylindrical member 2 is centered. It bends and stretches flexibly in the direction of the axis m, so that the tubular member 2 does not buckle in the middle or a crease is formed on the tubular member 2, or buckling and crease are extremely unlikely to occur. Further, since such a cylindrical member 2 is used, the stent 1 can be expanded and contracted to a certain extent in the direction of the central axis m of the cylindrical member 2, and contracts in the diametrical direction when expanded and bulky when contracted. Will also be suppressed. Note that, as described above, FIG. 3 shows the bent state of the stent 1, but the case where the stent 1 is bent at an angle larger than that shown in the figure (for example, a U-turn of about 180 ° or more). Even so, the stent 1 can maintain a cylindrical shape.
 次に、本実施形態のステント1を経皮的経管的に血管内に導入し、狭窄部を拡張するために留置する場合には、血管内にステント1を挿入する前に、予め図示しない適宜の搬送器具にステント1を装備しておき、放出することでステント1を拡開させるプレロード方式や、予め血管内の目的位置まで挿入しておいた搬送器具(カテーテル又はシース等)を通じてステント1を搬送・放出・留置するアフターロード方式を採用することが可能である。上述した何れの導入方法の場合でも、目的部位への搬送・放出方法は、ステント1の後端側を押すか又は先端側を引っ張る(細いカテーテルの先端に吊り下げ装置を設ける)方法が用いられる。ただし、いずれの方式でステント1を狭窄部に留置した場合であっても、必要に応じて最後にバルーンカテーテルを用い、ステント1に対する拡張操作を加える場合がある。 Next, when the stent 1 of the present embodiment is introduced into a blood vessel percutaneously via a transluminal tube and placed to expand a stenosis, the stent 1 is not shown in advance before inserting the stent 1 into the blood vessel. The stent 1 is provided through a preload system in which the stent 1 is mounted on an appropriate delivery device and then released to expand the stent 1 or through a delivery device (catheter or sheath, etc.) that has been inserted to a target position in the blood vessel in advance. It is possible to adopt an afterload system that transports, discharges, and detains. In any of the introduction methods described above, the delivery / release method to the target site uses a method of pushing the rear end side of the stent 1 or pulling the distal end side (providing a suspension device at the distal end of a thin catheter). . However, even if it is a case where the stent 1 is detained in a stenosis part by any system, the balloon catheter is finally used as needed and expansion operation with respect to the stent 1 may be added.
 ステント1の縮径は、例えばカテーテル等の管状器具の端部に接続したロート状器具の大径部から小径部に向けてステント1を入れていくことで、リング部材31の弾性と筒状部材2の伸縮性によって自動的に生じるが、手指やピンセット等の器具を用いてステント1を縮径することも可能である。また、一時的にステント1の先端部に糸を装着し、この糸を引っ張り、ロート状器具を介してシース又はカテーテル内に導入することで、結果として、ステント1を縮径させることも可能である。具体的に、ステント1の縮径は、各リング部材31が整列した波形となるように撓み、且つ筒状部材2が中心軸m方向に伸び径方向に縮むことによって実現される。図5に拡開状態と縮径状態の過程にあるステント1を、図6に縮径した状態のステント1を、それぞれ模式図として示す。まず、リング部材31について説明すると、各リング部材31が撓んだ波形は、リング部材31の周に沿って波の頂部と底部が中心軸m回りに90°の角度位相ごとに交互に2つずつ形成された形状である。ここでは説明の便宜上、筒状部材2の一方の開口端2a側を向く部位を波形の頂部31a,31cとし、他方の開口端2a側を向く部位を波形の底部31b,31dと呼ぶものとする。これら波形の頂部31a,31cと底部31b,31dは、各リング部材31を筒状部材2に取り付けている4つの糸23の略中間位置に形成される。すなわち、全てのリング部材31は、撓んだ状態で波形の頂部31a、底部31b、頂部31c、底部31dがそれぞれ筒状部材2の中心軸m(すなわち各リング部材31の円形状の中心を結ぶ線分)と平行に整列した状態となる。ただし、各糸23が中心軸mと平行に整列していない場合は、撓んだリング部材31の波形も整列したものとはならない。また、筒状部材2は、リング部材31の波形の撓みに追従して中心軸m方向に伸長し、且つ径方向には収縮する。すなわち、拡開状態にあったリング部材31が波形に撓むことにより、縦糸21と横糸22の糸23によるリング部材31の固定点が中心軸mに相寄る結果、筒状部材2の網目の菱形形状が中心軸mと平行な対角線方向に伸び他方の対角線方向に縮むこととなる。したがって、本実施形態ではステント1を縮径した際には、各リング部材31,32は、それぞれ筒状部材2の中心軸mを挟んで、頂部31aと頂部31c、底部31bと底部31d、頂部32aと頂部32c、底部32bと底部32dが向かい合い接触又は近接するように弾性を持って撓み、各リング部材31の形状変化に柔軟に追従した筒状部材2は菱形の網目構造を維持したまま中心軸m方向に伸長するとともに中心軸m寄りに径を細めて(本実施形態では直径約2mm程度まで)収縮する。なお、図5及び図6ではステント1の縮径時(拡開状態と縮径状態の過程)において、全てのリング部材31が同じ方向に波形をなして撓んだ状態を示しているが、図7にステント1の拡開状態と縮径状態の過程の他の状態例を示すように、複数のリング部材31の一部が波形の頂部31a,31cと底部31b、31dを図5に示した状態とは中心軸m方向に反対側を向けて撓むこととなってもよい。以下に述べる他の実施形態でも同様である。 The diameter of the stent 1 is reduced by, for example, inserting the stent 1 from the large diameter portion of the funnel-shaped device connected to the end of the tubular device such as a catheter toward the small diameter portion, and the elasticity of the ring member 31 and the cylindrical member. The stent 1 is automatically generated by the elasticity of 2, but the diameter of the stent 1 can be reduced by using an instrument such as a finger or tweezers. Further, by temporarily attaching a thread to the distal end portion of the stent 1, pulling the thread and introducing the thread into a sheath or a catheter through a funnel-like device, it is possible to reduce the diameter of the stent 1 as a result. is there. Specifically, the diameter reduction of the stent 1 is realized by bending each ring member 31 into an aligned waveform and the tubular member 2 extending in the central axis m direction and contracting in the radial direction. FIG. 5 shows a schematic diagram of the stent 1 in the process of the expanded state and the reduced diameter state, and FIG. 6 shows the stent 1 in the reduced state. First, the ring member 31 will be described. The wave form of each ring member 31 that is bent is alternately two along the circumference of the ring member 31 for each 90 ° angle phase around the center axis m of the wave. Each shape is formed. Here, for convenience of explanation, a portion facing the one opening end 2a side of the cylindrical member 2 is referred to as a corrugated top portion 31a, 31c, and a portion facing the other opening end 2a side is referred to as a corrugated bottom portion 31b, 31d. . The top portions 31 a and 31 c and the bottom portions 31 b and 31 d of these corrugations are formed at substantially intermediate positions of the four threads 23 that attach the ring members 31 to the tubular member 2. That is, all the ring members 31 are bent, and the corrugated top portion 31a, bottom portion 31b, top portion 31c, and bottom portion 31d respectively connect the central axis m of the cylindrical member 2 (that is, the circular center of each ring member 31). The line is aligned in parallel with the line segment. However, when the yarns 23 are not aligned in parallel with the central axis m, the waveform of the bent ring member 31 is not aligned. Further, the tubular member 2 extends in the direction of the central axis m following the wavy deformation of the ring member 31 and contracts in the radial direction. That is, as a result of the ring member 31 in the expanded state being bent into a wave shape, the fixing point of the ring member 31 by the yarn 23 of the warp yarn 21 and the weft yarn 22 approaches the central axis m, and as a result, the mesh of the cylindrical member 2 The rhombus shape extends in a diagonal direction parallel to the central axis m and contracts in the other diagonal direction. Therefore, in the present embodiment, when the diameter of the stent 1 is reduced, the ring members 31 and 32 have the top part 31a and the top part 31c, the bottom part 31b and the bottom part 31d, and the top part with the central axis m of the cylindrical member 2 interposed therebetween. 32a and the top 32c, the bottom 32b and the bottom 32d are elastically bent so that they face each other or come close to each other, and the cylindrical member 2 that flexibly follows the shape change of each ring member 31 is maintained in the center while maintaining the rhombus network structure. While expanding in the direction of the axis m, the diameter is reduced toward the central axis m (in this embodiment, the diameter is reduced to about 2 mm) and contracted. 5 and 6, when the diameter of the stent 1 is reduced (the process of the expanded state and the reduced diameter state), all the ring members 31 are bent in a waveform in the same direction. FIG. 7 shows the top portions 31a and 31c and the bottom portions 31b and 31d of a part of the plurality of ring members 31 as shown in FIG. The bent state may be bent toward the opposite side in the direction of the central axis m. The same applies to other embodiments described below.
 このように縮径させたステント1を血管Aの狭窄部Aaの近傍でカテーテル(図示省略)から放出した直後の状態を図8に、その放出後、拡開したステント1が血管A内に留置されて狭窄部Aaを押し広げている状態を図9に、それぞれ模式的に示す。すなわち、血管Aの直線状部分に狭窄部Aaが発症している場合のステント1の留置例の場合、弾性のある各リング部材31によって筒状部材2が円筒形状に拡張して血管Aの内壁A1に当接し、狭窄部Aaを適切に拡張することができる。そのため、血管A自体の拍動やそれに伴う伸縮、或いは血管Aの外側の筋肉からの圧迫を受けても、各リング部材31と筒状部材2はいずれも弾性を有しているため、リング部材31,32の弾性が筒状部材2にも伝わり、また筒状部材2の弾性のある網目構造に基づく伸縮によって、ステント1は全体として径方向に撓んだり中心軸m方向に伸縮することで、血管Aの動きに追従して内壁A1に当接した状態を維持する。しかも、筒状部材2は、そのメッシュ構造を構成している縦糸21と横糸22が共にステント1の中心軸mに対して略等角度で立体交差しつつ菱形の網目構造を保ったまま拡開していることから、血管A自体の拍動や伸縮、外部からの圧迫を受けてもそのメッシュ構造が崩れてしまうことはない。 FIG. 8 shows a state immediately after the diameter-reduced stent 1 is released from the catheter (not shown) in the vicinity of the narrowed portion Aa of the blood vessel A. After the release, the expanded stent 1 is placed in the blood vessel A. FIG. 9 schematically shows the state in which the constricted portion Aa is pushed and expanded. That is, in the case of placement of the stent 1 in the case where the stenosis Aa develops in the linear portion of the blood vessel A, the tubular member 2 is expanded into a cylindrical shape by the elastic ring members 31 and the inner wall of the blood vessel A The stenosis Aa can be appropriately expanded by coming into contact with A1. Therefore, each ring member 31 and the cylindrical member 2 are elastic even when subjected to the pulsation of the blood vessel A itself, expansion and contraction associated therewith, or compression from the muscle outside the blood vessel A. The elasticity of 31 and 32 is transmitted also to the cylindrical member 2, and the stent 1 is bent in the radial direction as a whole or expanded and contracted in the direction of the central axis m by the expansion and contraction based on the elastic network structure of the cylindrical member 2. The state of following the movement of the blood vessel A and contacting the inner wall A1 is maintained. In addition, the cylindrical member 2 is expanded while maintaining the rhomboid mesh structure while the warp yarn 21 and the weft yarn 22 constituting the mesh structure are three-dimensionally intersecting at a substantially equal angle with respect to the central axis m of the stent 1. Therefore, even if the blood vessel A itself is subjected to pulsation, expansion and contraction, and external pressure, the mesh structure does not collapse.
 縦糸21と横糸22が共にステント1の中心軸mに略等角度で立体交差させたメッシュ状の筒状部材2を、複数のリング部材31で内面側から間欠的に支持する構造を有している本実施形態のステント1であれば、特に、図10に示すように、血管Aの湾曲部に狭窄部Abが生じている場合でも、血管Aの直線状の狭窄部Aaへの留置の場合と同様に、その湾曲形状に対応して湾曲しつつ内壁A1に当接して狭窄部Abを押し広げることが可能である。この場合、筒状部材2の網目は、ステント1の湾曲形状の内側においてはやや狭まり、外側においてはやや広がってそれぞれ歪んだ菱形形状をなすこととなるが、筒状部材2には座屈や皺がほとんど生じることなく安定的に血管Aの内壁A1に当接する。例えばこの狭窄部Abが膝の血管Aに生じている場合、血管Aの湾曲は同図に示した状態よりも大きな角度で曲がる場合があるが、本実施形態のステント1であれば、中心軸mの湾曲性を保持しつつ周方向への拡張性を有しているため、湾曲の度合いを強めつつ筒形状を維持しながら血管Aの湾曲に追従させることができる。 The mesh-shaped cylindrical member 2 in which the warp yarn 21 and the weft yarn 22 are three-dimensionally intersected with the central axis m of the stent 1 at a substantially equal angle has a structure in which a plurality of ring members 31 are intermittently supported from the inner surface side. In particular, in the case of the stent 1 of the present embodiment, as shown in FIG. 10, even when the stenosis Ab is formed in the curved portion of the blood vessel A, the vessel A is placed in the linear stenosis Aa. In the same manner as described above, it is possible to push the stenosis Ab in contact with the inner wall A1 while curving corresponding to the curved shape. In this case, the mesh of the cylindrical member 2 is slightly narrowed on the inner side of the curved shape of the stent 1 and slightly expanded on the outer side to form a distorted rhombus shape. It stably abuts against the inner wall A1 of the blood vessel A with almost no wrinkles. For example, when the stenosis Ab is generated in the blood vessel A of the knee, the blood vessel A may be bent at a larger angle than the state shown in FIG. Since it has expandability in the circumferential direction while maintaining the curvature of m, it is possible to follow the curvature of the blood vessel A while maintaining the cylindrical shape while increasing the degree of curvature.
 さらに、血管Aの直線部分または湾曲部分の何れの狭窄部Aa,Abに本実施形態のステント1を適用した場合であっても、筒状部材2の網目を一辺約600μm四方というごく細かい菱形としており、さらに血管Aの内壁A1に与える刺激を最小限となるようにしていることから、内壁A1の内膜増殖が筒状部材2の内面側に及んでも適度な増殖で留まることとなり、新たな血栓の生成が抑制される。したがって、本実施形態のステント1は、長期に亘って血管A内の狭窄部Aa,Abに留置して使用することができるものである。 Furthermore, even if the stent 1 of this embodiment is applied to any of the narrowed portions Aa and Ab of the straight portion or the curved portion of the blood vessel A, the mesh of the cylindrical member 2 is formed as a very fine rhombus having a side of about 600 μm square. Furthermore, since the stimulation given to the inner wall A1 of the blood vessel A is minimized, the intimal proliferation of the inner wall A1 will remain at an appropriate proliferation even when reaching the inner surface side of the cylindrical member 2, Formation of a thrombus is suppressed. Therefore, the stent 1 of the present embodiment can be used by being placed in the stenosis portions Aa and Ab in the blood vessel A over a long period of time.
 さらに、筒状部材2の開口両端部2aにリング部材が存在しないことから、ステント1の中心軸m方向両端部2aはメッシュ状の筒状部材2のみとなるため、血管Aの内壁A1に内側から与える圧迫を低減させることができる。また同じ理由から、ステント1には血管Aの内壁A1に接触する可能性のある金属部品が全く存在しないため、血管Aの内壁A1に与える刺激も極めて小さいものとすることができる。したがって、ステント1を利用すれば、血管Aの内壁A1からの内膜の増殖に伴う再狭窄の可能性を極めて低いものとすることが可能である。 Furthermore, since there are no ring members at both ends 2a of the opening of the tubular member 2, the both ends 2a in the central axis m direction of the stent 1 are only the mesh-shaped tubular member 2, so that the inner wall A1 of the blood vessel A Can reduce the pressure applied. For the same reason, since the stent 1 does not have any metal parts that may come into contact with the inner wall A1 of the blood vessel A, the stimulation applied to the inner wall A1 of the blood vessel A can be extremely small. Therefore, if the stent 1 is used, the possibility of restenosis accompanying the proliferation of the intima from the inner wall A1 of the blood vessel A can be made extremely low.
 以上に詳述したように、中心軸m方向及び周方向の何れにも伸縮する網目構造の筒状部材2の内面側に複数のリング部材31を間欠的に取り付けた構造であるため、中心軸mの湾曲を伴うステント全体の湾曲性、中心軸m方向及び径方向への伸縮性、周方向への拡張性を有している。したがって、本実施形態のステント1は、耐久性にも生体(血管Aの内壁A1)への親和性にも優れ、しかも大きな角度で曲げられても破損することがないという安全性にも優れたものである。さらに本実施形態のステント1は、上述のような簡易な構造を有するものであるため、筒状部材2と各リング部材31を小径に形成すれば、細いステント1を容易に構成することができる。このような諸々の特徴から、本実施形態のステント1は、大動脈分枝部から下流動脈の疾患に対して従来のステントの適用対象とされたきた腸骨動脈領域の血管や、他の適用対象であった血管に留置して使用することで多くのメリットが得られるだけでなく、従来のステントでは適用できなかったソケイ部以下の血管への適用が可能となり、特に大きな角度で繰り返し曲がる膝や股関節の血管や筋肉の収縮のために強い圧迫を受ける大腿部の血管への適用も可能である。以上では、ステント1を血管Aの狭窄部Aa,Abを押し広げるための適用例について説明したが、ステント1は血管以外の管腔臓器に適用することも可能である。 As described in detail above, since the ring member 31 is intermittently attached to the inner surface side of the tubular member 2 having a mesh structure that expands and contracts in both the central axis m direction and the circumferential direction, the central axis The entire stent has a bend of m, bends in the central axis m direction and the radial direction, and expands in the circumferential direction. Therefore, the stent 1 of the present embodiment is excellent in durability and affinity to a living body (inner wall A1 of the blood vessel A), and also safe in that it does not break even if bent at a large angle. Is. Furthermore, since the stent 1 of the present embodiment has a simple structure as described above, if the cylindrical member 2 and each ring member 31 are formed in a small diameter, the thin stent 1 can be easily configured. . Because of these various features, the stent 1 of the present embodiment is suitable for blood vessels in the iliac artery region, which has been the subject of application of conventional stents for diseases from the aortic branch to the downstream artery, and other applications. In addition to providing many advantages by using it placed in a blood vessel, it can be applied to blood vessels below the siliceous part that could not be applied with conventional stents, especially knees that bend repeatedly at a large angle. Application to the blood vessels of the hip joint and the blood vessels of the thigh that are subjected to strong compression due to muscle contraction is also possible. In the above, the application example for pushing the stent 1 to expand the narrowed portions Aa and Ab of the blood vessel A has been described, but the stent 1 can also be applied to a luminal organ other than the blood vessel.
 <第2実施形態> なお、本発明のステントは、上述した実施形態のステント1の構成に限定されるものではない。例えば、図11に第2実施形態として示したステント100は、第1実施形態のステント1に適用したものと同一の筒状部材2と、第1実施形態に適用したリング部材31よりも大径のリング部材32を適用したものである。すなわち、それぞれ複数の縦糸21及び横糸22からなる網目状の筒状部材2の内面側に、その中心軸m方向両端開口部よりも内寄りに複数のリング部材32を、第1実施形態と同様にそれぞれ4箇所で固定したものである。したがって、ステント1と比較した場合、ステント100では、筒状部材2の網目は、中心軸m方向には短く縮まり周方向には伸びた形状の菱形となっている。 <Second Embodiment> The stent of the present invention is not limited to the configuration of the stent 1 of the above-described embodiment. For example, the stent 100 shown as the second embodiment in FIG. 11 has the same cylindrical member 2 as that applied to the stent 1 of the first embodiment and a larger diameter than the ring member 31 applied to the first embodiment. The ring member 32 is applied. That is, a plurality of ring members 32 are provided on the inner surface side of the mesh-like cylindrical member 2 made up of a plurality of warp yarns 21 and weft yarns 22 inwardly of the openings at both ends in the central axis m direction, as in the first embodiment. Are fixed at four locations. Therefore, when compared with the stent 1, in the stent 100, the mesh of the cylindrical member 2 is a rhombus that is shortened in the central axis m direction and extended in the circumferential direction.
 このような構成のステント100も、ステント1と同様に縮径することができる。すなわち、図12に示すように、リング部材32を波形に撓ませていくと、筒状部材2への糸23による4箇所の固定部分の中間部が周方向へ順に波形の頂部32a、底部32b、頂部32c、底部32dとなり、さらに撓みを強めることで、図6に示したステント1と同様に細くコンパクトに縮径することとなるが、ステント1と比較すると、拡張時と径縮時の径の差はより大きくなる。 The stent 100 having such a configuration can be reduced in diameter in the same manner as the stent 1. That is, as shown in FIG. 12, when the ring member 32 is bent into a wave shape, the middle portion of the four fixed portions by the thread 23 to the tubular member 2 has a wave-like top portion 32a and a bottom portion 32b in order in the circumferential direction. The top portion 32c and the bottom portion 32d are further reduced in flexure, so that the diameter of the stent 1 is as thin and compact as the stent 1 shown in FIG. The difference becomes larger.
 <第3実施形態> さらに本発明のステントは、図13に第3実施形態として示すようなものであってもよい。すなわち、同図に示したステント200は、第1実施形態のステント1と同一の筒状部材2と、第1実施形態で用いたリング部材31と第2実施形態で用いたリング部材32という異なる直径のリング部材を共に複数個ずつ用いたものである。すなわち、筒状部材2の中心軸m方向の一方の開口端部2aに近い内面側にはより小径のリング部材31を取り付け、他方の開口端部2aに近い内面側にはより大径のリング部材32を取り付けている。このような構成のステント200では、筒状部材2の網目の菱形形状が、リング部材31を配置した部位よりもリング部材32を配置した部位において中心軸mと平行な方向に縮まり且つ周方向には伸びた形状となる。またステント200は、第1実施形態のステント1や第2実施形態のステント100と同様に縮径することができる。 <Third Embodiment> Further, the stent of the present invention may be as shown in FIG. 13 as the third embodiment. That is, the stent 200 shown in the figure is different from the cylindrical member 2 same as the stent 1 of the first embodiment, the ring member 31 used in the first embodiment, and the ring member 32 used in the second embodiment. A plurality of ring members each having a diameter are used. That is, a ring member 31 having a smaller diameter is attached to the inner surface side near the one opening end 2a in the central axis m direction of the cylindrical member 2, and a larger diameter ring is attached to the inner surface side near the other opening end 2a. A member 32 is attached. In the stent 200 having such a configuration, the rhombic shape of the mesh of the cylindrical member 2 is contracted in the direction parallel to the central axis m in the region where the ring member 32 is disposed, and in the circumferential direction, rather than the region where the ring member 31 is disposed. Becomes an elongated shape. The stent 200 can be reduced in diameter in the same manner as the stent 1 of the first embodiment and the stent 100 of the second embodiment.
 このような中心軸m方向の両端部2aで径が異なるステント200は、例えば血管の分枝部分に留置するのに適しており、血管が太い本流側にはステント200の大径側を、血管が細い分枝側にはステント200の小径側を配置するようにすればよい。また、血流の方向に従って血管が漸次細くなっている箇所に本実施形態のステント200を配置してもよい。なお、本実施形態では、2種類の直径のリング部材31,32を適用したが、本実施形態の変形例としては、3種類以上の直径のリング部材を用いることも可能である。その他の変形例としては、筒状部材の中心軸m方向中央部に近い部位に取り付けられるリング部材により大径のものを適用した構成を挙げることができる。このような構成のステントであれば、一般に管腔臓器内において狭窄の度合いが大きい部分に中心軸方向中央部が位置付けられるようにステントを配置するのが適切であるため、血管の狭窄の度合いが大きい部位をより強く持続的に押し広げることができる。 Such a stent 200 having different diameters at both ends 2a in the direction of the central axis m is suitable for placement in, for example, a branch portion of a blood vessel, and the larger diameter side of the stent 200 is placed on the main flow side where the blood vessel is thick. The small diameter side of the stent 200 may be disposed on the side where the branch is thin. Further, the stent 200 of the present embodiment may be disposed at a location where the blood vessel is gradually narrowed according to the direction of blood flow. In the present embodiment, the ring members 31 and 32 having two types of diameters are applied. However, as a modification of the present embodiment, ring members having three or more types of diameters may be used. As another modified example, a configuration in which a large-diameter member is applied to a ring member attached to a portion near the central portion in the central axis m direction of the cylindrical member can be exemplified. In the case of a stent having such a configuration, it is generally appropriate to arrange the stent so that the central portion in the central axis direction is positioned in a portion where the degree of stenosis is large in the luminal organ. A large site can be spread more strongly and continuously.
 <第4実施形態> さらに本発明のステントは、リング部材31同士を第1実施形態のステント1のように略等間隔に配置するのではなく、適宜異ならせたものとすることも可能である。図14に第4実施形態として示したステント300は、第1実施形態のステント1と同一の筒状部材2とリング部材31を用いたものであるが、中心軸m方向中央部に配置されるリング部材31同士の間隔を、開口端部2aの近くに配置されるリング部材31同士の間隔よりも狭めたものである。すなわち、このようなステント300であれば、前述の通り狭窄の度合いが大きい中央部にリング部材31をより多く配置することで、狭窄を強く持続的に押し広げることが可能となる。 <Fourth Embodiment> Further, the stent of the present invention can be appropriately made different from the ring members 31 instead of being arranged at substantially equal intervals as in the stent 1 of the first embodiment. . The stent 300 shown as the fourth embodiment in FIG. 14 uses the same tubular member 2 and ring member 31 as the stent 1 of the first embodiment, but is arranged at the center in the direction of the central axis m. The interval between the ring members 31 is narrower than the interval between the ring members 31 arranged near the opening end 2a. That is, in the case of such a stent 300, it becomes possible to strongly and continuously push the stenosis by disposing more ring members 31 in the central portion where the degree of stenosis is large as described above.
 <第5実施形態、第6実施形態> さらに本発明のステントは、筒状部材の開口両端部2aの一方又は他方にリング部材を配置した構成とすることができる。図15に第5実施形態として示すステント400は、第1実施形態と同一の筒状部材2及び複数のリング部材31に加えて、中心軸m方向の一方の開口端部2aにリング部材33を取り付けたものであり、図16に第6実施形態として示すステント500は、ステント400の構成に加えて他方の開口端部2aにもリング部材34を取り付けた構成のものである。ステント400及びステント500において、筒状部材2の開口端部2aに取り付けられるリング部材33,34は、筒状部材2の開口端部2aよりも中心軸m方向内寄りに取り付けられる各リング部材31と実質的に同一のものを採用することができるが、これらリング部材33,34は、必ずしも筒状部材2の内面側に取り付ける必要はなく、例えば筒状部材2の外面側に取り付けたり、筒状部材2の開口端部2aを内側又は外側に折り返して袋状に形成し、その袋状の内部にリング部材33,34を収容した状態で固定しても構わない。また、リング部材33,34の筒状部材2への固定に際しては、リング部材31と同様に4点で筒状部材2に固定することができるが、筒状部材2の開口端部2aにおいて全周に亘って糸を巻回して縫い付けてもよい。 <5th Embodiment, 6th Embodiment> Furthermore, the stent of this invention can be set as the structure which has arrange | positioned the ring member to one or the other of the opening both ends 2a of a cylindrical member. A stent 400 shown as a fifth embodiment in FIG. 15 includes a ring member 33 at one open end 2a in the central axis m direction in addition to the same cylindrical member 2 and a plurality of ring members 31 as in the first embodiment. The stent 500 shown as the sixth embodiment in FIG. 16 has a configuration in which the ring member 34 is also attached to the other open end 2a in addition to the configuration of the stent 400. In the stent 400 and the stent 500, the ring members 33 and 34 attached to the open end 2a of the tubular member 2 are each ring member 31 attached closer to the inner side in the central axis m direction than the open end 2a of the tubular member 2. However, it is not always necessary to attach the ring members 33 and 34 to the inner surface side of the tubular member 2. For example, the ring members 33 and 34 may be attached to the outer surface side of the tubular member 2, or The opening end 2a of the shaped member 2 may be folded inward or outward to form a bag shape, and the ring members 33 and 34 may be fixed inside the bag shape. Further, when the ring members 33 and 34 are fixed to the cylindrical member 2, the ring members 33 and 34 can be fixed to the cylindrical member 2 at four points similarly to the ring member 31, but at the open end 2 a of the cylindrical member 2, A thread may be wound around the circumference and sewn.
 ステント400については、リング部材33を設けた側の開口端部2aが血管の上流側となるように血管内に留置すれば、他方のリング部材を設けていない開口端部2aがいわゆる吹き流し状態となっても筒状部材2自体にも張りがあることから血管内で十分に安定留置することができ、ステントとしての機能を十分に発揮することができる。また、ステント500については、開口両端部2aにリング部材33,34が設けられていることにより、血管内でのさらに安定した留置が実現される。 When the stent 400 is placed in the blood vessel so that the open end 2a on the side where the ring member 33 is provided is on the upstream side of the blood vessel, the other open end 2a without the ring member is in a so-called blowing state. Even so, since the cylindrical member 2 itself is also tensioned, it can be placed in a stable state in the blood vessel, and the function as a stent can be sufficiently exhibited. Further, regarding the stent 500, the ring members 33 and 34 are provided at both ends 2a of the opening, thereby realizing more stable placement in the blood vessel.
 なお、以上の他にも、本発明のステントは、各リング部材の弾性復元力を同一のものとして設定せず、例えば筒状部材の中心軸方向中央部に配置されるリング部材の弾性復元力を、開口端部に近い位置に配置されるリング部材の弾性復元力や直径よりも大きく設定することも可能である。このようなステントの場合には、前述したとおり血管の狭窄度合いが大きい部位をより強く持続的に押し広げることができるという利点がある。 In addition to the above, the stent of the present invention does not set the elastic restoring force of each ring member as the same, for example, the elastic restoring force of the ring member arranged at the central portion in the central axis direction of the cylindrical member. Can be set larger than the elastic restoring force and diameter of the ring member disposed at a position close to the opening end. In the case of such a stent, as described above, there is an advantage that a site where the degree of stenosis of the blood vessel is large can be more strongly and continuously pushed.
 また、本発明のステントは、血管以外にも適用される管腔臓器やその部位の形状に対応させて、筒状部材の形状や、リング部材の径や幅を適宜に設定することが可能であり、上述した各実施形態の構成を適宜組み合わせたものとすることも可能である。 In addition, the stent of the present invention can appropriately set the shape of the tubular member and the diameter and width of the ring member in accordance with the shape of the luminal organ applied other than the blood vessel and the shape of the part. In addition, the configurations of the above-described embodiments can be appropriately combined.
 その他、筒状部材やリング部材の構成素材、リング部材の個数や構成、ステント全体のサイズ、リング部材を筒状部材の内面側又は外面側の何れに固定するか、など、各部の具体的構成についても上記実施形態に限られるものではなく、本発明の趣旨を逸脱しない範囲で種々変形が可能である。 In addition, the specific configuration of each part, such as the constituent material of the cylindrical member and the ring member, the number and configuration of the ring members, the size of the entire stent, and whether the ring member is fixed to the inner surface side or the outer surface side of the cylindrical member The present invention is not limited to the above embodiment, and various modifications can be made without departing from the spirit of the present invention.
 上述したように、本発明のステントは、安全性、耐久性、縦横への弾性を持った湾曲性が高く簡易な構造のステントとして有用なものであり、従来のステントで適用されてきた人体又は動物の管腔臓器の狭窄部は勿論のこと、従来のステントが適用不可とされてきた腸骨動脈領域よりも下流域の血管の狭窄部や、膝等の繰り返し大きい角度で屈伸する血管等の管腔臓器への適用が可能である。 As described above, the stent of the present invention is useful as a stent having a simple structure with high flexibility, safety, durability, and longitudinal and lateral elasticity. Not only the stenosis part of animal luminal organs, but also the stenosis part of the blood vessel downstream from the iliac artery area where conventional stents cannot be applied, and blood vessels that flex and stretch at large angles such as knees, etc. Applicable to luminal organs.

Claims (10)

  1. 管腔臓器内に挿入され留置されるステントであって、
    柔軟性且つ弾力性を有し、体液が内外に通過可能な網目状をなし、中心軸と直交する任意の断面が略円形状をなす筒状部材と、
    前記筒状部材の中心軸に中心を略一致させて相互に離間して配置される複数のリング部材と、を主体として構成され、
    前記筒状部材は、中心軸方向両端部を開口しており、且つ前記網目状を構成する縦横の各線形部が、何れも当該中心軸に対して常に略等しい角度で立体交差するように形成されたものであって、
    前記複数のリング部材は、少なくとも前記筒状部材の中心軸方向両端部よりも内寄りの位置に配置され、且つ径方向及び前記筒状部材の中心軸方向の何れにも折り曲げ自在な弾性復元力を有する柔軟な環状の部材により構成されて前記筒状部材に取り付けたものであることを特徴とするステント。
    A stent inserted into a hollow organ and placed;
    A cylindrical member having flexibility and elasticity, having a mesh shape through which body fluid can pass in and out, and an arbitrary cross section perpendicular to the central axis being substantially circular,
    A plurality of ring members arranged to be spaced apart from each other with their centers substantially coincident with the central axis of the cylindrical member,
    The cylindrical member is open at both ends in the central axis direction, and the vertical and horizontal linear portions constituting the mesh shape are formed so as to three-dimensionally intersect each other at a substantially equal angle with respect to the central axis. Which has been
    The plurality of ring members are arranged at least inward from both ends of the cylindrical member in the central axis direction, and can be bent in both the radial direction and the central axis direction of the cylindrical member. A stent comprising: a flexible annular member having a structure attached to the tubular member.
  2. 前記リング部材は、前記筒状部材の内面側に取り付けたものである請求項1に記載のステント。 The stent according to claim 1, wherein the ring member is attached to an inner surface side of the cylindrical member.
  3. 前記筒状部材の中心軸方向両端の開口部には、前記リング部材を配置していない請求項1又は2の何れかに記載のステント。 The stent according to any one of claims 1 and 2, wherein the ring member is not disposed in openings at both ends in the central axis direction of the cylindrical member.
  4. 前記リング部材は、折り曲げ自在な弾性復元力を有する柔軟な金属製線材からなるものである請求項1乃至3の何れかに記載のステント。 The stent according to any one of claims 1 to 3, wherein the ring member is made of a flexible metal wire having a bendable elastic restoring force.
  5. 前記リング部材は、環状とした前記金属製線材を複数重に束ねて形成したものである請求項4に記載のステント。 The stent according to claim 4, wherein the ring member is formed by bundling a plurality of the metal wires that are annular.
  6. 前記リング部材は、周方向に略等間隔で離間させて4箇所で前記筒状部材に固定している請求項1乃至5の何れかに記載のステント。 The stent according to any one of claims 1 to 5, wherein the ring members are fixed to the cylindrical member at four locations while being spaced apart at substantially equal intervals in the circumferential direction.
  7. 前記筒状部材の中心軸方向中央部近傍に配置されるリング部材の弾性復元力を、中心軸方向端部近傍に配置されるリング部材の弾性復元力よりも大きく設定している請求項1乃至6の何れかに記載のステント。 The elastic restoring force of the ring member arranged near the central portion in the central axis direction of the tubular member is set larger than the elastic restoring force of the ring member arranged near the central axial direction end portion. The stent according to any one of 6.
  8. 前記筒状部材の中心軸方向中央部近傍に配置される複数のリング部材の間隔を、中心軸方向端部近傍に配置される複数のリング部材の間隔よりも狭く設定している請求項1乃至7の何れかに記載のステント。 The interval between a plurality of ring members arranged near the central portion in the central axis direction of the cylindrical member is set to be narrower than the interval between the plurality of ring members arranged near an end portion in the central axis direction. The stent according to any one of 7.
  9. 前記筒状部材の中心軸方向一端部近傍に配置されるリング部材の直径を、中心軸方向他端部近傍に配置されるリング部材の直径よりも大きく設定している請求項1乃至8の何れかに記載のステント。 The diameter of the ring member disposed near one end in the central axis direction of the cylindrical member is set larger than the diameter of the ring member disposed near the other end in the central axis direction. The stent according to crab.
  10. 前記筒状部材は、合成樹脂を材質として形成したものである請求項1乃至9の何れかに記載のステント。 The stent according to any one of claims 1 to 9, wherein the cylindrical member is made of synthetic resin.
PCT/JP2011/059517 2010-04-19 2011-04-18 Stent WO2011132634A1 (en)

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