WO2014171183A1 - Medical tubular body - Google Patents

Medical tubular body Download PDF

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Publication number
WO2014171183A1
WO2014171183A1 PCT/JP2014/054562 JP2014054562W WO2014171183A1 WO 2014171183 A1 WO2014171183 A1 WO 2014171183A1 JP 2014054562 W JP2014054562 W JP 2014054562W WO 2014171183 A1 WO2014171183 A1 WO 2014171183A1
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WO
WIPO (PCT)
Prior art keywords
tubular body
marker
medical
diameter
markers
Prior art date
Application number
PCT/JP2014/054562
Other languages
French (fr)
Japanese (ja)
Inventor
雄起 向井
Original Assignee
株式会社カネカ
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社カネカ filed Critical 株式会社カネカ
Publication of WO2014171183A1 publication Critical patent/WO2014171183A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/88Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
    • 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
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • A61F2/91Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
    • A61F2/915Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
    • A61F2002/9155Adjacent bands being connected to each other
    • A61F2002/91558Adjacent bands being connected to each other connected peak to peak
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2230/00Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2230/0063Three-dimensional shapes
    • A61F2230/0069Three-dimensional shapes cylindrical
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006Additional features; Implant or prostheses properties not otherwise provided for modular
    • A61F2250/0063Nested prosthetic parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

  • the present invention relates to a medical tubular body that can be expanded in diameter, and is used, for example, to treat a lesion where a blood vessel or other in-vivo lumen is narrowed or occluded. More specifically, the present invention relates to a medical tubular body typified by a stent placed in a lesioned part of a living body lumen, or a medical tubular body used for removing a thrombus generated in a lesioned part.
  • a medical tubular body typified by a stent is generally a medical instrument for treating various diseases caused by stenosis or occlusion of a blood vessel or other living body lumen.
  • the medical tubular body includes a lesion that is expanded from the inside, such as a stenosis or occlusion, and is placed in the lesion to maintain the inner diameter of the lumen, or a thrombus that has developed in or around the lesion. Examples include those that are removed from the entangled body and restored to the luminal inner diameter at the lesion.
  • the medical tubular body is used in the body, but once the medical tubular body is inserted into the body, its position cannot be visually confirmed. Therefore, usually, a marker including a radiopaque material is provided at a predetermined position of the medical tubular body, and the treatment is performed while confirming the exact position of the marker under fluoroscopy.
  • the marker visibility is required to be improved in terms of accurate transport to the lesion (delivery) and alignment of the exact extended range (working range) in the expanded state.
  • FIG. 14 of Patent Document 1 describes an intravascular medical instrument (medical tubular body) that can be inserted into a small-diameter delivery system by making the marker shape longer in the axial direction and shorter in the radial direction. ing.
  • Patent Document 2 describes a medical tubular body in which markers having a predetermined distance are arranged around the end of the tubular body for the purpose of facilitating the determination of the direction of the medical tubular body. Yes.
  • the present invention has excellent visibility under fluoroscopy, insertion into a catheter, and slidability within a catheter, and can suppress contact between a marker and a tubular body or adjacent markers in a reduced diameter state.
  • An object of the present invention is to provide a medical tubular body that can be reduced in diameter.
  • the present inventor has made various studies on the shape and arrangement of the markers in order to solve the above problems. As the medical tubular body is reduced in diameter, each marker formed at the end of the tubular body gathers toward the central axis of the tubular body. In the present study, the present inventor did not make the marker small because the markers gathered in one place do not contact with each other in this way, but utilized the axial dimension of the tubular body to place the marker in a different place. The present invention was completed by thinking that it could not be escaped.
  • the medical tubular body of the present invention that has solved the above-described problem has a tubular body that can be expanded in diameter, and at least two markers formed at at least one end of the tubular body.
  • the markers have different axial positions when the tubular body is reduced in diameter.
  • the two markers have different axial positions, they do not contact each other.
  • the tubular body includes a plurality of struts having different lengths, and the marker is formed at an end of each strut. If struts having different lengths are used, markers can be easily formed at different positions in the axial direction of the tubular body.
  • tubular body has a mesh structure and the mesh units are arranged in a spiral shape
  • the tubular body has a mesh structure and the mesh units are arranged in a spiral shape
  • the two markers do not contact each other when the tubular body is reduced in diameter.
  • housing In the medical tubular body, when the diameter of the tubular body is reduced, it is desirable that members (hereinafter referred to as “housing”) that are non-deformable portions included in the tubular body do not contact each other. .
  • the marker is formed inside the tubular body.
  • the gap inside the tubular body is effectively used and the marker is stored in the gap. Therefore, even if the markers do not contact each other or the marker and the tubular body, or even if they contact each other, the degree of contact is reduced as compared with the conventional case. As a result, the diameter of the tubular body when contracted can be made smaller than before.
  • the marker is formed on a flat portion on the inner surface of the tubular body.
  • the inner surface of the tubular body is a flat surface, it is easy to increase the contact area between the inner surface of the tubular body and the marker, so that the tubular body and the marker can be more firmly fixed.
  • the marker is preferably welded to the inner surface of the tubular body. It is possible to provide a medical tubular body with reduced risk of marker dropping.
  • the marker is preferably sized to be accommodated in an inner space when the tubular body is reduced in diameter.
  • a gap is formed between one end of the marker and the tubular body when the diameter of the tubular body is reduced. Since the tubular body does not necessarily have a reduced diameter as designed, it may be advantageous to reduce the diameter of the tubular body by leaving some gaps.
  • the marker can preferably be implemented such that the axial length of the tubular body is longer than the radial length of the tubular body. Even when the marker is arranged using the inner space of the tubular body, the inner space of the tubular body is naturally limited, so that the marker volume can be increased by forming it longer in the axial direction of the tubular body.
  • the marker housing has an opening, and the marker is embedded in the opening.
  • the markers are spaced apart from each other more than the length of the marker housing in the axial direction of the tubular body.
  • the marker is preferably columnar.
  • the end of the tubular body has a shape obtained by obliquely cutting a cylinder.
  • the two markers formed at the end of the medical tubular body are different in the axial direction of the tubular body, the two markers do not contact each other even when the tubular body contracts. Therefore, it is possible to reduce the diameter of the medical tubular body smaller than before while maintaining the volume per marker.
  • FIG. 1 is a development view of the medical tubular body according to the first embodiment of the present invention.
  • FIG. 2 is an enlarged view of an end of the medical tubular body according to the first embodiment of the present invention.
  • FIG. 3 is an end perspective view of the medical tubular body (when the diameter is reduced) according to the first embodiment of the present invention.
  • FIG. 4 is a development view of the medical tubular body according to the second embodiment of the present invention.
  • FIG. 5 is a development view of the medical tubular body according to the third embodiment of the present invention.
  • FIG. 6A is an end perspective view of the medical tubular body according to the third embodiment (during diameter expansion)
  • FIG. 6B is a medical tubular body according to the third embodiment (expanded diameter).
  • FIG. 7A is an end perspective view of the medical tubular body according to the third embodiment (when the diameter is reduced), and FIG. 7B is a medical tubular body according to the third embodiment (the diameter is reduced). It is the figure which looked at time from the axial direction.
  • FIG. 8 is a development view of the medical tubular body according to the fourth embodiment of the present invention.
  • FIG. 9A is an end perspective view of the medical tubular body according to the fourth embodiment (when the diameter is expanded), and FIG. 9B is a medical tubular body according to the fourth embodiment (the diameter is expanded). It is the figure which looked at time from the axial direction.
  • FIG. 10A is an end perspective view of the medical tubular body according to the fourth embodiment (when the diameter is reduced), and FIG. 10B is a medical tubular body according to the fourth embodiment (the diameter is reduced). It is the figure which looked at time from the axial direction.
  • the medical tubular body of the present invention has a tubular body that can be expanded, and at least two markers formed on at least one end of the tubular body, and the two markers are contractions of the tubular body.
  • the positions in the axial direction at the time of diameter are different from each other.
  • the two markers have different axial positions, and the markers do not come into contact with each other even when the diameter of the tubular body is reduced, so that the diameter of the medical tubular body can be further reduced.
  • the positional relationship in the axial direction of the marker may change depending on the expansion / contraction of the tubular body.
  • the fact that the axial positions of the two markers are different from each other is based on the structure of the tubular body when the diameter is reduced.
  • “Different positions in the axial direction of the tubular body” means that “positions separated by at least one marker length in the axial direction of the tubular body so that the markers do not contact each other”. Can understand. In the present specification, a configuration in which a marker is removed from a medical tubular body is referred to as a “tubular body”.
  • the medical tubular body is used in a living body lumen. For example, it is placed in a lesioned part of a living body lumen to maintain or expand the diameter of the living body lumen.
  • a peripheral protection device such as a peripheral protection filter, a thrombectomy device for removing a thrombus formed in a lumen in a living body, and the like.
  • the medical tubular body is used by being attached to a catheter (delivery system: delivery device) or the like having a portion where the medical tubular body is placed for delivery (delivery) to a lesioned part.
  • the medical tubular body is (i) a balloon that mounts (mounts) a medical tubular body on the outer surface of the balloon and transports it to the lesioned area, and expands the medical tubular body with the balloon at the lesioned area. It can be classified into an expandable type and (ii) a self-expandable type that expands itself by removing the member that suppresses expansion at the lesioned part by transporting to the lesioned part with a catheter having a member that suppresses expansion.
  • the medical tubular body is reduced in a direction perpendicular to the longitudinal axis of the tubular body (that is, the radial direction of the tubular body) in a state where the medical tubular body is installed in a delivery system composed of a balloon, a catheter, or the like, and the longitudinal axis direction.
  • the diameter is reduced to a cylindrical shape that is longer than the expanded state.
  • the diameter of the reduced diameter state can be reduced as compared with the balloon expansion type.
  • Tubular body A tubular body is a structure which can be expanded in diameter, for example comprised by mesh structures, such as a mesh.
  • being able to expand the diameter means that the tube can be expanded in a direction perpendicular to the major axis (radial direction) of the tubular body, and can be contracted (reduced diameter) from the expanded state.
  • the tubular body is formed, for example, from a pattern of interconnected structural elements that expand and contract in the circumferential and axial directions.
  • the tubular body in the present invention can be applied in any pattern and is therefore not limited to any particular stent shape or structural element pattern.
  • a marker including a radiopaque material is provided at a predetermined position of the medical tubular body so that the medical tubular body can be observed under X-ray fluoroscopy.
  • the marker does not need to completely block X-rays, and may have an X-ray transmittance that can detect the presence of the marker under fluoroscopy.
  • FIG. 1 is a development view of the medical tubular body according to the first embodiment of the present invention.
  • the medical tubular body 100 has a distal end 101 and a proximal end 102, and has a metal mesh portion 111 between the distal end 101 and the proximal end 102.
  • the metal mesh portion 111 is configured by a combination of continuous cells 112.
  • the metal mesh portion 111 is bent into a tubular shape with the longitudinal direction as the central axis, and the two long sides of the metal mesh portion 111 are joined to form a tubular body.
  • the medical tubular body 100 has a marker housing 161 at the distal end 101 or the proximal end 102, a marker 121 fixed to the marker housing 161, and other markers 122 to 124. is doing.
  • the marker housing 161 will be described later with reference to FIG.
  • FIG. 2 is an enlarged view of the vicinity of the marker 121 of the medical tubular body 100 according to the first embodiment of the present invention.
  • a marker housing 161 having an opening at the distal end 101 is provided, and a marker 121 is embedded in the opening.
  • the material of the marker housing 161 is preferably the same material as that of the metal mesh portion 111 in terms of strength and corrosion resistance, and preferably has an integral structure with the metal mesh portion 111.
  • FIG. 3 is a perspective view of the end portion (distal end 101) of the medical tubular body (when the diameter is reduced) 100 according to the first embodiment of the present invention. Due to the reduced diameter of the medical tubular body 100, the markers 122 to 124 are very close to the vicinity of the axis of the medical tubular body 100. However, since the markers 121 to 124 in the present embodiment have different axial positions when the tubular body is reduced in diameter, the markers 121 to 124 are in contact with each other even when the tubular body is reduced in diameter. The diameter of the medical tubular body 100 can be made smaller than before.
  • the form of fixing the markers 121 to 124 is not particularly limited. However, as shown in FIGS. 1 to 3, when the marker housing 161 is larger than the marker 121, the marker in the axial direction of the tubular body is used. It is desirable that the markers 121 to 124 be separated from each other by a length longer than the length of the housing 161.
  • the material used for the metal mesh portion 111 is not particularly limited as long as it is a material that can withstand a strong load at the time of deformation or indwelling, such as expansion or contraction, but is stainless steel for medical use.
  • 316L stainless steel, tantalum, Co—Cr (cobalt chromium) alloy, Ni—Ti (nickel-titanium) alloy and the like can be preferably used.
  • a nickel-titanium alloy can be preferably used because it has shape memory characteristics and elastic characteristics and is excellent in workability.
  • an alloy containing about 50% by mass to about 60% by mass of nickel can be preferably used.
  • the metal mesh portion 111 may include a biodegradable material such as a biodegradable polymer or metal.
  • the biodegradable material may be a composite of at least two biodegradable polymers and / or metals.
  • a laser processing method, an electric discharge processing method, a mechanical cutting method, an etching method, or the like can be suitably used.
  • a method of cutting a tubular material into a pattern of the cells 112 by a laser processing method and forming a mesh shape can be preferably used.
  • the material constituting the marker 121 is not particularly limited as long as it is a material having higher radiopacity than the constituent material of the medical tubular body 100.
  • a metal material is preferable from the viewpoint of workability such as an influence on a living body or a difficulty in deformation when attached to the marker housing 161.
  • platinum, palladium, and tantalum are preferable because they have excellent biological compatibility with the human body.
  • tantalum is preferable because it has a small difference in electrochemical potential and is difficult to corrode.
  • the size of the tubular body is not particularly limited, but in Embodiment 1, the outer diameter of the tubular body is, for example, about 0.36 to 0.46 mm when the diameter is reduced, and is about 4.0 to 4.5 mm when the diameter is expanded, for example. .
  • the marker has a thickness of about 0.05 to 0.10 mm and an outer diameter of about 0.1 to 0.3 mm, for example.
  • FIG. 4 is a development view of the medical tubular body according to the second embodiment of the present invention.
  • the medical tubular body 100 has a distal end 101 and a proximal end 102, and has a metal mesh portion 111 between the distal end 101 and the proximal end 102.
  • the metal mesh portion 111 is configured by a combination of cells 112 that are continuous in the spiral direction.
  • the medical tubular body 100 according to the second embodiment of the present invention basically has the same configuration as that of the medical tubular body 100 according to the first embodiment of the present invention. The same reference numerals are given and description thereof is omitted.
  • the medical tubular body 100 according to the second embodiment of the present invention is different from the medical tubular body 100 according to the first embodiment in that the length of the support columns 151 to 154 is different in the first embodiment.
  • the positions of the markers 121 to 124 in the body axial direction are different, in the second embodiment, as shown in FIG. 4, the cells 112 are made continuous in the spiral direction to form the metal mesh portion 111.
  • the positions of the markers 121 to 124 in the axial direction of the tubular body are different.
  • the struts 151 to 154 are formed very long, the strut may be deformed in the living body lumen.
  • the end of the tubular body is configured obliquely (that is, shaped like the tip of an injection needle) due to the configuration of the metal mesh portion 111 itself, so that the long support as in the first embodiment This is advantageous in that the rigidity of the end of the tubular body is maintained.
  • the markers 121 to 124 are aligned in a straight line with a certain angle with respect to the axial direction of the medical tubular body 100.
  • 1 and 4 are developed views, but the markers 121 to 124 can be seen in a straight line even when the metal mesh portion 111 is bent to form a tubular shape and the medical tubular body 100 is observed from the side. This is because the end of the tubular body has a shape obtained by obliquely cutting the cylinder (that is, a shape like the tip of an injection needle). As the diameter of the tubular body shrinks, the angle between the straight line in which the markers 121 to 124 are arranged and the axial direction of the tubular body becomes smaller.
  • the straight line in which the markers 121 to 124 are arranged becomes substantially parallel to the axis of the tubular body.
  • the expansion and contraction of the tubular body can be performed from the angle formed by the straight line in which the markers 121 to 124 are arranged and the axis of the tubular body. You can know the degree.
  • FIG. 5 is a development view of the medical tubular body according to the third embodiment of the present invention.
  • the medical tubular body 100 has a distal end 101 and a proximal end 102, and has a metal mesh portion 111 between the distal end 101 and the proximal end 102. Since the medical tubular body 100 according to the third embodiment of the present invention has the same configuration as the medical tubular body 100 according to the second embodiment of the present invention, the same reference numerals are given to the same configurations. The description is omitted.
  • the medical tubular body 100 according to the third embodiment of the present invention is different from the medical tubular body 100 according to the second embodiment in that the marker 121 and the like are embedded in the marker housing 161 in the second embodiment. However, in the third embodiment, the marker 121 and the like are formed on the marker housing 131 and on the inner surface of the tubular body.
  • the method for attaching each of the markers 121 to 124 to the marker housing is not particularly limited as long as it is a method that does not drop off during the transportation of the medical tubular body 100 or the indwelling operation in the lesioned part.
  • the method for example, welding, brazing, caulking, and the like can be mentioned. This is because, in the case of welding, a material different from a marker material such as a marker housing or a solder is not used. On the other hand, in the case of brazing, a material different from the marker housing or the marker material is used, and in the case of caulking, it is difficult to obtain the smoothness of the outer surface in the radial direction of the marker housing.
  • the inner surface of the marker housing is preferably flat, and is preferably oval, square, or rectangular because a linear length corresponding to the diameter of the welding spot is required.
  • the diameter of the welding spot is preferably 80% or less of the short side of the fixed surface of the marker, more preferably 70% or less, and still more preferably 60%, from the viewpoint of not adversely affecting the fluoroscopic image.
  • the diameter of the welding spot is preferably 20% or more of the short side of the fixed surface of the marker, more preferably 30% or more, and even more preferably 40% or more.
  • the diameter of the welding spot is preferably about 40 ⁇ m to 100 ⁇ m, more preferably about 50 ⁇ m to 90 ⁇ m.
  • FIG. 6A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the third embodiment (when the diameter is expanded), and FIG. 6B is a view of the distal end 101 viewed from the axial direction.
  • FIG. 7A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the third embodiment (when the diameter is reduced), and FIG. 7B is a view of the distal end 101 seen from the axial direction. It is a figure.
  • the markers 121 to 124 are formed at different positions in the axial direction of the tubular body as in the first and second embodiments, the markers 121 to 124 when the diameter of the tubular body is reduced. Are accommodated in the internal space of the tubular body without interfering with each other.
  • the marker of the medical tubular body 100 according to the present embodiment is formed inside the tubular body capable of expanding the diameter. ⁇ 124 fit in the void inside the tubular body. Therefore, even if a marker and a tubular body do not contact each other or contact, the degree of contact is reduced more than before.
  • the markers 121 to 124 have some gaps on the side opposite to the side fixed to the marker housings 131 to 134, and the diameter of the markers 121 to 124 is reduced. It may not be perfectly aligned with the axial direction of the tubular body. Of course, it is ideal that the markers 121 to 124 are perfectly aligned in that a marker having a large volume can be arranged by making the best use of the voids in the tubular body. However, since the tubular body does not necessarily have a reduced diameter as designed, leaving some clearance may be advantageous for reducing the diameter of the tubular body. Therefore, it is also a preferable aspect to employ a configuration in which the markers 121 to 124 are not arranged in a straight line when the diameter of the tubular body is reduced.
  • FIG. 8 is a development view of the medical tubular body according to the fourth embodiment of the present invention.
  • FIG. 9A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the fourth embodiment (when expanded in diameter), and FIG. 9B shows the distal end 101 viewed from the axial direction.
  • FIG. 10A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the fourth embodiment (when the diameter is reduced), and FIG. 10B is a view of the distal end 101 seen from the axial direction. It is a figure.
  • the medical tubular body 100 according to the fourth embodiment of the present invention has substantially the same configuration as the medical tubular body 100 according to the third embodiment of the present invention.
  • 124 is formed in a columnar shape, but the fourth embodiment is different in that the markers 121 to 124 are formed in a prismatic shape. If the markers 121 to 124 are prismatic shapes, the contact surface with the marker housings 131 to 134 is large, which is advantageous in terms of fixing strength.
  • the medical tubular body of the present invention can be suitably used for various medical tubular bodies such as drug-coated stents and biodegradable stents in addition to those exemplified.

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Abstract

The purpose of the present invention is to provide a medical tubular body which has excellent visibility under X-ray fluoroscopy, excellent insertability into a catheter, and excellent slidability inside of the catheter, which can contract to become even smaller, and which, in a contracted state, suppresses contact between markers and the tubular body, or between adjacent markers. This medical tubular body is manufactured provided with an expandable tubular body and at least two markers (121, 122) formed on at least one end of the tubular body, wherein the two markers (121, 122) have mutually different positions in the axial direction when the tubular body is contracted.

Description

医療用管状体Medical tubular body
 本発明は、拡径可能な医療用管状体に関するものであり、例えば、血管その他の生体内管腔が狭窄あるいは閉塞した病変部を治療するために用いられるものである。さらに詳しくは、生体内管腔の病変部に留置するステントに代表される医療用管状体、あるいは病変部に発生した血栓などを除去するために用いられる医療用管状体に関するものである。 The present invention relates to a medical tubular body that can be expanded in diameter, and is used, for example, to treat a lesion where a blood vessel or other in-vivo lumen is narrowed or occluded. More specifically, the present invention relates to a medical tubular body typified by a stent placed in a lesioned part of a living body lumen, or a medical tubular body used for removing a thrombus generated in a lesioned part.
 ステントに代表される医療用管状体は、一般に、血管その他の生体内管腔が狭窄あるいは閉塞することにより生じる様々な疾患を治療するための医療器具である。医療用管状体には、狭窄または閉塞部位等の病変部を内側から拡張し、その管腔内径を維持するために病変部に留置するもの、あるいは、病変部またはその周囲に発生した血栓などを絡め取り体外へ除去し、その病変部における管腔内径を回復させるもの等が挙げられる。 A medical tubular body typified by a stent is generally a medical instrument for treating various diseases caused by stenosis or occlusion of a blood vessel or other living body lumen. The medical tubular body includes a lesion that is expanded from the inside, such as a stenosis or occlusion, and is placed in the lesion to maintain the inner diameter of the lumen, or a thrombus that has developed in or around the lesion. Examples include those that are removed from the entangled body and restored to the luminal inner diameter at the lesion.
 医療用管状体は体内で用いるものであるが、医療用管状体をひとたび体内に入れると、その位置を目視で確認することはできない。そのため、通常はX線不透過材料を含むマーカーを医療用管状体の所定位置に設け、このマーカーの正確な位置をX線透視下で確認しながら施術を進めていく。 The medical tubular body is used in the body, but once the medical tubular body is inserted into the body, its position cannot be visually confirmed. Therefore, usually, a marker including a radiopaque material is provided at a predetermined position of the medical tubular body, and the treatment is performed while confirming the exact position of the marker under fluoroscopy.
 マーカーの視認性は、病変部への正確な搬送(デリバリー)や拡張状態での正確な拡張範囲(ワーキングレンジ)の位置合わせの点で向上が求められている。 The marker visibility is required to be improved in terms of accurate transport to the lesion (delivery) and alignment of the exact extended range (working range) in the expanded state.
 例えば、特許文献1の図14には、マーカーの形状を軸方向に長く、半径方向に短くすることにより小径のデリバリーシステム内への挿入が可能な管内医用器具(医療用管状体)が記載されている。 For example, FIG. 14 of Patent Document 1 describes an intravascular medical instrument (medical tubular body) that can be inserted into a small-diameter delivery system by making the marker shape longer in the axial direction and shorter in the radial direction. ing.
 また、特許文献2には、医療用管状体の方向決定を容易にする目的で、管状体端部の周囲に予め決められた距離を隔てたマーカーが配置された医療用管状体が記載されている。 Patent Document 2 describes a medical tubular body in which markers having a predetermined distance are arranged around the end of the tubular body for the purpose of facilitating the determination of the direction of the medical tubular body. Yes.
特開2003-334256号公報JP 2003-334256 A 特表2003-527925号公報Special table 2003-527925 gazette
 しかしながら、特許文献1や特許文献2の医療用管状体では、マーカーの視認性の更なる向上や、カテーテル内への挿入性、カテーテル内での摺動性などの性能を向上させるには、それぞれの構成上の特徴に応じた限界がある。マーカーの視認性を向上させるためにマーカーを単純に大型化したりマーカー数を増やしたりする方法は、カテーテル内への管状体の挿入や、カテーテル内での管状体の摺動に対して障害となる。管状体を縮径するときにマーカーが管状体の一部をなす支柱であるストラット、または隣接するマーカーと接触してしまい、縮径時でも管状体の外径を十分に小さくできないからである。 However, in the medical tubular body of Patent Document 1 and Patent Document 2, in order to further improve the marker visibility, insertability into the catheter, slidability within the catheter, There is a limit according to the characteristics of the configuration. The method of simply increasing the size of the marker or increasing the number of markers in order to improve the visibility of the marker is an obstacle to insertion of the tubular body into the catheter and sliding of the tubular body within the catheter. . This is because when the diameter of the tubular body is reduced, the marker comes into contact with a strut, which is a column that forms a part of the tubular body, or an adjacent marker, and the outer diameter of the tubular body cannot be sufficiently reduced even when the diameter is reduced.
 本発明は、X線透視下での視認性、カテーテル内への挿入性、カテーテル内での摺動性に優れ、縮径状態でマーカーと管状体または隣接するマーカーどうしの接触を抑制でき、一層小さく縮径することのできる医療用管状体を提供することを目的とする。 The present invention has excellent visibility under fluoroscopy, insertion into a catheter, and slidability within a catheter, and can suppress contact between a marker and a tubular body or adjacent markers in a reduced diameter state. An object of the present invention is to provide a medical tubular body that can be reduced in diameter.
 本発明者は、上記課題を解決するためにマーカーの形状や配置について様々な検討を行なった。医療用管状体が縮径するにしたがって、管状体の端部に形成された各マーカーは、管状体の中心軸に向かって集まってくる。本発明者は検討の中で、このように一箇所に集まってくるマーカーどうしが接触しないためにマーカーを小さく作製するのではなく、管状体の軸方向の次元を利用してマーカーを異なる場所に逃がすことができないものかと考え、本発明を完成するに至った。 The present inventor has made various studies on the shape and arrangement of the markers in order to solve the above problems. As the medical tubular body is reduced in diameter, each marker formed at the end of the tubular body gathers toward the central axis of the tubular body. In the present study, the present inventor did not make the marker small because the markers gathered in one place do not contact with each other in this way, but utilized the axial dimension of the tubular body to place the marker in a different place. The present invention was completed by thinking that it could not be escaped.
 すなわち上記課題を解決し得た本発明の医療用管状体は、拡径可能な管状体と、前記管状体の少なくとも一方の端部に形成された少なくとも2つのマーカーとを有し、当該2つのマーカーは、前記管状体の縮径時における軸方向の位置が互いに異なるものである。このように、2つのマーカーは軸方向の位置が互いに異なるために、互いに接触し合わない。 That is, the medical tubular body of the present invention that has solved the above-described problem has a tubular body that can be expanded in diameter, and at least two markers formed at at least one end of the tubular body. The markers have different axial positions when the tubular body is reduced in diameter. Thus, since the two markers have different axial positions, they do not contact each other.
 上記医療用管状体において、前記管状体は長さの異なる複数の支柱を含んでおり、各支柱の端部に前記マーカーが形成されていることが好ましい。異なる長さの支柱を用いれば、管状体の軸方向の異なる位置に容易にマーカーを形成することができる。 In the medical tubular body, it is preferable that the tubular body includes a plurality of struts having different lengths, and the marker is formed at an end of each strut. If struts having different lengths are used, markers can be easily formed at different positions in the axial direction of the tubular body.
 上記医療用管状体において、前記管状体が網目構造を有しており、かつ前記網目の単位が螺旋状に並べられている態様も好ましく実施できる。 In the above-described medical tubular body, an embodiment in which the tubular body has a mesh structure and the mesh units are arranged in a spiral shape can be preferably implemented.
 上記医療用管状体において、前記管状体の縮径時に、前記2つのマーカーどうしが互いに接触しないことが望ましい。 In the medical tubular body, it is desirable that the two markers do not contact each other when the tubular body is reduced in diameter.
 上記医療用管状体において、前記管状体の縮径時に、前記管状体に含まれる非変形部であって前記マーカーを固定する部材(以下、「ハウジング」と記載)どうしが互いに接触しないことが望ましい。 In the medical tubular body, when the diameter of the tubular body is reduced, it is desirable that members (hereinafter referred to as “housing”) that are non-deformable portions included in the tubular body do not contact each other. .
 上記医療用管状体において、前記マーカーは、前記管状体の内側に形成されていることが望ましい。このような構成により、管状体の径が収縮しても、管状体の内側の空隙が有効利用されてマーカーが空隙内に納まっていく。そのため、マーカーどうし、あるいは、マーカーと管状体とが互いに接触することがなくなるか、接触したとしても接触の程度は従来よりも軽減される。その結果、管状体の収縮時の径を従来よりも小さくすることができる。 In the medical tubular body, it is preferable that the marker is formed inside the tubular body. With such a configuration, even if the diameter of the tubular body contracts, the gap inside the tubular body is effectively used and the marker is stored in the gap. Therefore, even if the markers do not contact each other or the marker and the tubular body, or even if they contact each other, the degree of contact is reduced as compared with the conventional case. As a result, the diameter of the tubular body when contracted can be made smaller than before.
 上記医療用管状体において、前記マーカーは、前記管状体の内側面の平面部に形成されていることが好ましい。管状体の内側面を平面とした場合には、管状体の内側面とマーカーとの接触面積を増やしやすいため、管状体とマーカーとをより強固に固定することができる。 In the medical tubular body, it is preferable that the marker is formed on a flat portion on the inner surface of the tubular body. When the inner surface of the tubular body is a flat surface, it is easy to increase the contact area between the inner surface of the tubular body and the marker, so that the tubular body and the marker can be more firmly fixed.
 上記医療用管状体において、前記マーカーは、前記管状体の内側面に溶接されていることが好ましい。マーカーの脱落リスクを低減した医療用管状体を提供することができる。 In the medical tubular body, the marker is preferably welded to the inner surface of the tubular body. It is possible to provide a medical tubular body with reduced risk of marker dropping.
 上記医療用管状体において、前記マーカーは、前記管状体の縮径時の内側空隙に収容される大きさであることが好ましい。 In the medical tubular body, the marker is preferably sized to be accommodated in an inner space when the tubular body is reduced in diameter.
 上記医療用管状体において、前記管状体の縮径時には、前記マーカーの一方端は前記管状体との間に空隙を形成していることが好ましい。管状体は設計通りに縮径するとは限らないため、多少の空隙を残しておくことは、管状体の小径化にとって有利に働く場合がある。 In the medical tubular body, it is preferable that a gap is formed between one end of the marker and the tubular body when the diameter of the tubular body is reduced. Since the tubular body does not necessarily have a reduced diameter as designed, it may be advantageous to reduce the diameter of the tubular body by leaving some gaps.
 上記医療用管状体において、前記マーカーは、前記管状体の径方向の長さよりも、前記管状体の軸方向の長さのほうが長く形成されている態様を好ましく実施できる。管状体の内側空隙を利用してマーカーを配した場合でも、管状体の内側空隙にも当然ながら限度があるため、管状体の軸方向に長く形成することによりマーカー容積を増大させることができる。 In the above-described medical tubular body, the marker can preferably be implemented such that the axial length of the tubular body is longer than the radial length of the tubular body. Even when the marker is arranged using the inner space of the tubular body, the inner space of the tubular body is naturally limited, so that the marker volume can be increased by forming it longer in the axial direction of the tubular body.
 上記医療用管状体において、前記マーカーハウジングは、開口部を有し、開口内にマーカーが埋設されていることが好ましい。 In the medical tubular body, it is preferable that the marker housing has an opening, and the marker is embedded in the opening.
 上記医療用管状体において、前記管状体の軸方向における前記マーカーハウジングの長さ以上に、前記マーカーどうしが離間していることが好ましい。 In the medical tubular body, it is preferable that the markers are spaced apart from each other more than the length of the marker housing in the axial direction of the tubular body.
 上記医療用管状体において、前記マーカーは、柱状であることが好ましい。 In the medical tubular body, the marker is preferably columnar.
 上記医療用管状体において、前記管状体の端部が、円筒を斜めに切った形状をなしていることが好ましい。 In the medical tubular body, it is preferable that the end of the tubular body has a shape obtained by obliquely cutting a cylinder.
 本発明では、医療用管状体の端部に形成された2つのマーカーの位置が、管状体の軸方向において異なるために、管状体の収縮時においても2つのマーカーが互いに接触することがない。そのため、マーカーひとつ当たりの容積を維持しつつも、医療用管状体を従来よりも小さく縮径することができる。 In the present invention, since the positions of the two markers formed at the end of the medical tubular body are different in the axial direction of the tubular body, the two markers do not contact each other even when the tubular body contracts. Therefore, it is possible to reduce the diameter of the medical tubular body smaller than before while maintaining the volume per marker.
図1は、本発明の実施の形態1にかかる医療用管状体の展開図である。FIG. 1 is a development view of the medical tubular body according to the first embodiment of the present invention. 図2は、本発明の実施の形態1にかかる医療用管状体の端部拡大図である。FIG. 2 is an enlarged view of an end of the medical tubular body according to the first embodiment of the present invention. 図3は、本発明の実施の形態1にかかる医療用管状体(縮径時)の端部斜視図である。FIG. 3 is an end perspective view of the medical tubular body (when the diameter is reduced) according to the first embodiment of the present invention. 図4は、本発明の実施の形態2にかかる医療用管状体の展開図である。FIG. 4 is a development view of the medical tubular body according to the second embodiment of the present invention. 図5は、本発明の実施の形態3にかかる医療用管状体の展開図である。FIG. 5 is a development view of the medical tubular body according to the third embodiment of the present invention. 図6(a)は、実施の形態3にかかる医療用管状体(拡径時)の端部斜視図であり、図6(b)は、実施の形態3にかかる医療用管状体(拡径時)を軸方向から見た図である。FIG. 6A is an end perspective view of the medical tubular body according to the third embodiment (during diameter expansion), and FIG. 6B is a medical tubular body according to the third embodiment (expanded diameter). It is the figure which looked at time from the axial direction. 図7(a)は、実施の形態3にかかる医療用管状体(縮径時)の端部斜視図であり、図7(b)は、実施の形態3にかかる医療用管状体(縮径時)を軸方向から見た図である。FIG. 7A is an end perspective view of the medical tubular body according to the third embodiment (when the diameter is reduced), and FIG. 7B is a medical tubular body according to the third embodiment (the diameter is reduced). It is the figure which looked at time from the axial direction. 図8は、本発明の実施の形態4にかかる医療用管状体の展開図である。FIG. 8 is a development view of the medical tubular body according to the fourth embodiment of the present invention. 図9(a)は、実施の形態4にかかる医療用管状体(拡径時)の端部斜視図であり、図9(b)は、実施の形態4にかかる医療用管状体(拡径時)を軸方向から見た図である。FIG. 9A is an end perspective view of the medical tubular body according to the fourth embodiment (when the diameter is expanded), and FIG. 9B is a medical tubular body according to the fourth embodiment (the diameter is expanded). It is the figure which looked at time from the axial direction. 図10(a)は、実施の形態4にかかる医療用管状体(縮径時)の端部斜視図であり、図10(b)は、実施の形態4にかかる医療用管状体(縮径時)を軸方向から見た図である。FIG. 10A is an end perspective view of the medical tubular body according to the fourth embodiment (when the diameter is reduced), and FIG. 10B is a medical tubular body according to the fourth embodiment (the diameter is reduced). It is the figure which looked at time from the axial direction.
 本発明の医療用管状体は、拡径可能な管状体と、前記管状体の少なくとも一方の端部に形成された少なくとも2つのマーカーとを有し、当該2つのマーカーは、前記管状体の縮径時における軸方向の位置が互いに異なるものである。このように、2つのマーカーは軸方向の位置が互いに異なり、管状体の縮径時でもマーカーどうしが互いに接触し合わないため、医療用管状体の径を一層小さくすることができる。なおマーカーの軸方向の位置関係は、管状体の拡縮によって変化する場合があり、本発明において2つのマーカーの軸方向の位置が互いに異なるというのは、あくまでも管状体の縮径時の構造を基準とするものであり、拡径時の軸方向の位置を基準とするものではない。
 「管状体の軸方向の異なる位置」は、「マーカーどうしが接触しないために、管状体の軸方向において少なくとも一つのマーカーの長さ以上に離間した位置」を意味することは、当業者において容易に理解することができる。なお、本明細書においては、医療用管状体からマーカーを除いた構成を「管状体」と呼ぶこととする。
The medical tubular body of the present invention has a tubular body that can be expanded, and at least two markers formed on at least one end of the tubular body, and the two markers are contractions of the tubular body. The positions in the axial direction at the time of diameter are different from each other. In this way, the two markers have different axial positions, and the markers do not come into contact with each other even when the diameter of the tubular body is reduced, so that the diameter of the medical tubular body can be further reduced. The positional relationship in the axial direction of the marker may change depending on the expansion / contraction of the tubular body. In the present invention, the fact that the axial positions of the two markers are different from each other is based on the structure of the tubular body when the diameter is reduced. It is not intended to be based on the axial position at the time of diameter expansion.
“Different positions in the axial direction of the tubular body” means that “positions separated by at least one marker length in the axial direction of the tubular body so that the markers do not contact each other”. Can understand. In the present specification, a configuration in which a marker is removed from a medical tubular body is referred to as a “tubular body”.
(1)医療用管状体の用途
 医療用管状体は、生体内管腔内で用いられるものであり、例えば生体内管腔の病変部に留置して生体内管腔の径を維持ないし拡張するためのステントや、生体内管腔に形成された血栓を除去するための血栓回収デバイス、あるいは末梢保護フィルターなどの末梢保護デバイス等が挙げられる。
(1) Use of medical tubular body The medical tubular body is used in a living body lumen. For example, it is placed in a lesioned part of a living body lumen to maintain or expand the diameter of the living body lumen. And a peripheral protection device such as a peripheral protection filter, a thrombectomy device for removing a thrombus formed in a lumen in a living body, and the like.
(2)医療用管状体の分類
 医療用管状体には、例えば、(i)1本の線状の金属もしくは高分子材料からなるコイル状のタイプ、(ii)金属チューブをレーザーなどで切り抜き加工したタイプ、(iii)線状の部位を溶接し組み立てたタイプ、(iv)複数の線状金属を織って作ったタイプ等がある。
(2) Classification of medical tubular bodies For medical tubular bodies, for example, (i) a coiled type made of a single linear metal or polymer material, and (ii) a metal tube cut out with a laser or the like (Iii) a type in which linear portions are welded and assembled, and (iv) a type in which a plurality of linear metals are woven.
 医療用管状体は、病変部まで搬送(デリバリー)するために医療用管状体を設置する部位を有するカテーテル(デリバリーシステム:搬送装置)等に取り付けて用いられている。医療用管状体は、拡張機構の観点から、(i)バルーン外表面上に医療用管状体を装着(マウント)して病変部まで搬送し、病変部でバルーンによって医療用管状体を拡張するバルーン拡張型と、(ii)拡張を抑制する部材を有するカテーテルで病変部に搬送し、病変部で拡張を抑制する部材を取り外すことにより自ら拡張する自己拡張型とに分類することができる。 The medical tubular body is used by being attached to a catheter (delivery system: delivery device) or the like having a portion where the medical tubular body is placed for delivery (delivery) to a lesioned part. From the viewpoint of an expansion mechanism, the medical tubular body is (i) a balloon that mounts (mounts) a medical tubular body on the outer surface of the balloon and transports it to the lesioned area, and expands the medical tubular body with the balloon at the lesioned area. It can be classified into an expandable type and (ii) a self-expandable type that expands itself by removing the member that suppresses expansion at the lesioned part by transporting to the lesioned part with a catheter having a member that suppresses expansion.
 医療用管状体は、バルーンやカテーテル等からなるデリバリーシステム内に設置された状態においては、管状体の長手方向軸に直交する方向(すなわち、管状体の半径方向)には縮小し、長手軸方向には伸びることにより、拡張状態よりも細長い円筒状の形態である縮径状態となる。自己拡張型では内部にバルーンを設けなくても良いことから、バルーン拡張型に比べて縮径状態の径を小さくすることができる。 The medical tubular body is reduced in a direction perpendicular to the longitudinal axis of the tubular body (that is, the radial direction of the tubular body) in a state where the medical tubular body is installed in a delivery system composed of a balloon, a catheter, or the like, and the longitudinal axis direction. In other words, by extending, the diameter is reduced to a cylindrical shape that is longer than the expanded state. In the self-expanding type, since it is not necessary to provide a balloon inside, the diameter of the reduced diameter state can be reduced as compared with the balloon expansion type.
(3)管状体
 管状体は、例えばメッシュなどの網目構造で構成されている拡径可能な構造体である。本発明において拡径可能とは、管状体の長軸に垂直な方向(径方向)に伸張することができ、径が伸張された状態からは逆に収縮(縮径)することもできることを意味する。管状体は、例えば周方向および軸方向に伸縮する、相互に連結している構造要素のパターンから形成される。本発明において管状体は、任意のパターンに適用可能であり、したがって、いかなる特定のステントの形状あるいは構造要素のパターンにも限定されない。
(3) Tubular body A tubular body is a structure which can be expanded in diameter, for example comprised by mesh structures, such as a mesh. In the present invention, being able to expand the diameter means that the tube can be expanded in a direction perpendicular to the major axis (radial direction) of the tubular body, and can be contracted (reduced diameter) from the expanded state. To do. The tubular body is formed, for example, from a pattern of interconnected structural elements that expand and contract in the circumferential and axial directions. The tubular body in the present invention can be applied in any pattern and is therefore not limited to any particular stent shape or structural element pattern.
(4)マーカー
 医療用管状体をひとたび体内に入れると、その位置を目視で確認することはできない。そのため、X線透視下において医療用管状体を観察できるよう、X線不透過材料を含むマーカーが医療用管状体の所定位置に設けられる。マーカーは、X線を完全に遮断するものでなくてもよく、X線透視下においてマーカーの存在が検知できる程度のX線透過率を有していればよい。
(4) Marker Once the medical tubular body is placed in the body, its position cannot be confirmed visually. Therefore, a marker including a radiopaque material is provided at a predetermined position of the medical tubular body so that the medical tubular body can be observed under X-ray fluoroscopy. The marker does not need to completely block X-rays, and may have an X-ray transmittance that can detect the presence of the marker under fluoroscopy.
 本願は、2013年4月16日に出願された日本国特許出願第2013-86134号に基づく優先権の利益を主張するものである。上記日本国特許出願第2013-86134号の明細書の全内容が、本願に参考のため援用される。 This application claims the benefit of priority based on Japanese Patent Application No. 2013-86134 filed on April 16, 2013. The entire contents of the above Japanese Patent Application No. 2013-86134 are incorporated herein by reference.
(実施の形態1)
 以下、本発明の実施の形態1にかかる医療用管状体について、図面を用いて説明する。図1は、本発明の実施の形態1にかかる医療用管状体の展開図である。医療用管状体100は、遠位端101、近位端102を有し、遠位端101と近位端102の間には金属メッシュ部111を有している。金属メッシュ部111は、連続したセル112の組み合わせにより構成されている。金属メッシュ部111は、長手方向を中心軸として管状に曲げられ、金属メッシュ部111の2つの長辺どうしが接合されることにより管状体として構成される。
(Embodiment 1)
Hereinafter, the medical tubular body according to the first embodiment of the present invention will be described with reference to the drawings. FIG. 1 is a development view of the medical tubular body according to the first embodiment of the present invention. The medical tubular body 100 has a distal end 101 and a proximal end 102, and has a metal mesh portion 111 between the distal end 101 and the proximal end 102. The metal mesh portion 111 is configured by a combination of continuous cells 112. The metal mesh portion 111 is bent into a tubular shape with the longitudinal direction as the central axis, and the two long sides of the metal mesh portion 111 are joined to form a tubular body.
 本発明の実施の形態1にかかる医療用管状体100は、遠位端101あるいは近位端102のマーカーハウジング161と、マーカーハウジング161に固定されたマーカー121、およびその他のマーカー122~124を有している。マーカーハウジング161については、後に図2を用いて説明する。 The medical tubular body 100 according to the first embodiment of the present invention has a marker housing 161 at the distal end 101 or the proximal end 102, a marker 121 fixed to the marker housing 161, and other markers 122 to 124. is doing. The marker housing 161 will be described later with reference to FIG.
 図2は、本発明の実施の形態1にかかる医療用管状体100のマーカー121付近の拡大図である。図2において、遠位端101に開口部を有するマーカーハウジング161が設けられており、開口内にマーカー121が埋設されている。マーカーハウジング161の材料には、強度や耐腐食性の点で金属メッシュ部111と同一の材料を用い、金属メッシュ部111と一体構造を形成していることが好ましい。 FIG. 2 is an enlarged view of the vicinity of the marker 121 of the medical tubular body 100 according to the first embodiment of the present invention. In FIG. 2, a marker housing 161 having an opening at the distal end 101 is provided, and a marker 121 is embedded in the opening. The material of the marker housing 161 is preferably the same material as that of the metal mesh portion 111 in terms of strength and corrosion resistance, and preferably has an integral structure with the metal mesh portion 111.
 図3は、本発明の実施の形態1にかかる医療用管状体(縮径時)100の端部(遠位端101)の斜視図である。医療用管状体100の縮径によりマーカー122~124は医療用管状体100の軸付近に非常に近接してくる。しかし、本実施の形態におけるマーカー121~124は、管状体の縮径時における軸方向の位置が互いに異なるものであるため、管状体の縮径時においてもマーカー121~124どうしが互いに接触しあうことはなく、医療用管状体100の径を従来よりも小さくすることができる。なお、マーカー121~124の固定の形態は特に限定されないが、図1~3に示すように、マーカー121よりもマーカーハウジング161の方が大きいものである場合には、管状体の軸方向におけるマーカーハウジング161の長さ以上に、マーカー121~124どうしを離間させることが望ましい。 FIG. 3 is a perspective view of the end portion (distal end 101) of the medical tubular body (when the diameter is reduced) 100 according to the first embodiment of the present invention. Due to the reduced diameter of the medical tubular body 100, the markers 122 to 124 are very close to the vicinity of the axis of the medical tubular body 100. However, since the markers 121 to 124 in the present embodiment have different axial positions when the tubular body is reduced in diameter, the markers 121 to 124 are in contact with each other even when the tubular body is reduced in diameter. The diameter of the medical tubular body 100 can be made smaller than before. The form of fixing the markers 121 to 124 is not particularly limited. However, as shown in FIGS. 1 to 3, when the marker housing 161 is larger than the marker 121, the marker in the axial direction of the tubular body is used. It is desirable that the markers 121 to 124 be separated from each other by a length longer than the length of the housing 161.
 金属メッシュ部111に使用される材料としては、拡径、縮径などの変形時や留置時の強度的な負荷に耐えうる材料であれば特に限定されるものではないが、医療用ステンレスである316Lステンレス、タンタル、Co-Cr(コバルトクロム)合金、Ni-Ti(ニッケル-チタン)合金等を好ましく用いることができる。特に、形状記憶特性や弾性特性を有し、加工性にも優れる点でニッケル-チタン合金が好ましく用いることができる。また、ニッケル-チタン合金の中でも、特に約50質量%~約60質量%のニッケルを含む合金を好ましく用いることができる。 The material used for the metal mesh portion 111 is not particularly limited as long as it is a material that can withstand a strong load at the time of deformation or indwelling, such as expansion or contraction, but is stainless steel for medical use. 316L stainless steel, tantalum, Co—Cr (cobalt chromium) alloy, Ni—Ti (nickel-titanium) alloy and the like can be preferably used. In particular, a nickel-titanium alloy can be preferably used because it has shape memory characteristics and elastic characteristics and is excellent in workability. Of the nickel-titanium alloys, an alloy containing about 50% by mass to about 60% by mass of nickel can be preferably used.
 金属メッシュ部111は、生分解性のポリマーまたは金属などの生分解性材料を含んでよい。あるいは、生分解性材料は、少なくとも2種類の生分解性のポリマーおよび/または金属の複合物であってもよい。 The metal mesh portion 111 may include a biodegradable material such as a biodegradable polymer or metal. Alternatively, the biodegradable material may be a composite of at least two biodegradable polymers and / or metals.
 金属メッシュ部111の作製方法としては、レーザー加工法、放電加工法、機械的な切削加工方法、エッチング方法などを好適に用いることができる。本発明においては、特に、チューブ状の材料をレーザー加工法によりセル112のパターンに切り抜き、メッシュ形状を成形する方法を好ましく用いることができる。 As a method for producing the metal mesh portion 111, a laser processing method, an electric discharge processing method, a mechanical cutting method, an etching method, or the like can be suitably used. In the present invention, in particular, a method of cutting a tubular material into a pattern of the cells 112 by a laser processing method and forming a mesh shape can be preferably used.
 マーカー121を構成する材料としては、医療用管状体100の構成材料よりも高いX線不透過性を有する材料であれば特に限定されない。生体への影響、または、マーカーハウジング161への取り付け時に変形しにくい等加工性の点で、金属材料であることが好ましい。特に人体に対して良好な生物学的適合性に優れている点で、白金、パラジウム、タンタルであることが好ましい。特に、マーカーハウジング161の材料としてニッケル-チタン合金が用いられている場合は、電気化学的電位の差が小さく、腐食しにくい点でタンタルであることが好ましい。 The material constituting the marker 121 is not particularly limited as long as it is a material having higher radiopacity than the constituent material of the medical tubular body 100. A metal material is preferable from the viewpoint of workability such as an influence on a living body or a difficulty in deformation when attached to the marker housing 161. In particular, platinum, palladium, and tantalum are preferable because they have excellent biological compatibility with the human body. In particular, when a nickel-titanium alloy is used as the material of the marker housing 161, tantalum is preferable because it has a small difference in electrochemical potential and is difficult to corrode.
 管状体の大きさは特に限定されないが、実施の形態1において、管状体の外径は、縮径時に例えば0.36~0.46mm、拡径時に例えば4.0~4.5mm程度である。また、マーカーは、例えば厚さ0.05~0.10mm、外径0.1~0.3mm程度である。 The size of the tubular body is not particularly limited, but in Embodiment 1, the outer diameter of the tubular body is, for example, about 0.36 to 0.46 mm when the diameter is reduced, and is about 4.0 to 4.5 mm when the diameter is expanded, for example. . The marker has a thickness of about 0.05 to 0.10 mm and an outer diameter of about 0.1 to 0.3 mm, for example.
(実施の形態2)
 以下、本発明の実施の形態2にかかる医療用管状体について、図面を用いて説明する。図4は、本発明の実施の形態2にかかる医療用管状体の展開図である。医療用管状体100は、遠位端101、近位端102を有し、遠位端101と近位端102の間には金属メッシュ部111を有している。金属メッシュ部111は、螺旋方向に連続したセル112の組み合わせにより構成されている。本発明の実施の形態2にかかる医療用管状体100は、基本的には、本発明の実施の形態1にかかる医療用管状体100と同様の構成を有しているため、同じ構成には同じ符号を付してその説明を省略する。
(Embodiment 2)
Hereinafter, the medical tubular body according to the second embodiment of the present invention will be described with reference to the drawings. FIG. 4 is a development view of the medical tubular body according to the second embodiment of the present invention. The medical tubular body 100 has a distal end 101 and a proximal end 102, and has a metal mesh portion 111 between the distal end 101 and the proximal end 102. The metal mesh portion 111 is configured by a combination of cells 112 that are continuous in the spiral direction. The medical tubular body 100 according to the second embodiment of the present invention basically has the same configuration as that of the medical tubular body 100 according to the first embodiment of the present invention. The same reference numerals are given and description thereof is omitted.
 本発明の実施の形態2にかかる医療用管状体100が実施の形態1にかかる医療用管状体100と異なる点は、実施の形態1では支柱151~154の長さをそれぞれ異ならせることにより管状体の軸方向におけるマーカー121~124の位置を異ならせているのに対して、実施の形態2では図4に示したようにセル112を螺旋方向に連続させて金属メッシュ部111を構成することにより、管状体の軸方向におけるマーカー121~124の位置を異ならせている点にある。実施の形態1の方法では、支柱151~154を非常に長く形成する場合に支柱が生体内管腔内で変形してしまう可能性もある。しかし本実施の形態では、金属メッシュ部111自体の構成により管状体の端部を斜めに構成(すなわち、注射針の先端のような形状)しているため、実施の形態1のような長い支柱を用いる必要がなく管状体の端部の剛性が保たれる点で有利である。 The medical tubular body 100 according to the second embodiment of the present invention is different from the medical tubular body 100 according to the first embodiment in that the length of the support columns 151 to 154 is different in the first embodiment. Whereas the positions of the markers 121 to 124 in the body axial direction are different, in the second embodiment, as shown in FIG. 4, the cells 112 are made continuous in the spiral direction to form the metal mesh portion 111. Thus, the positions of the markers 121 to 124 in the axial direction of the tubular body are different. In the method of the first embodiment, when the struts 151 to 154 are formed very long, the strut may be deformed in the living body lumen. However, in the present embodiment, the end of the tubular body is configured obliquely (that is, shaped like the tip of an injection needle) due to the configuration of the metal mesh portion 111 itself, so that the long support as in the first embodiment This is advantageous in that the rigidity of the end of the tubular body is maintained.
 実施の形態1,2では、マーカー121~124は、医療用管状体100の軸方向に対して一定の角度をもって一直線上に並んでいる。図1,4は展開図であるが、金属メッシュ部111を曲げて管状に形成して医療用管状体100を横から観察してもマーカー121~124は一直線上に並んで見える。これは、管状体の端部が、円筒を斜めに切った形状(すなわち、注射針の先端のような形状)をなしているためである。管状体の径が収縮していくにつれて、マーカー121~124が並ぶ直線と管状体の軸方向とのなす角が小さくなっていく。管状体の収縮が完了すると図3に示されるように、マーカー121~124が並ぶ直線は管状体の軸にほぼ平行になる。このようなマーカーの動きを利用すれば、マーカー121~124が並ぶ直線と管状体の軸とがなす角度から、例えば、拡径状態、半拡径状態、縮径状態など、管状体の伸縮の度合いを知ることができる。 In the first and second embodiments, the markers 121 to 124 are aligned in a straight line with a certain angle with respect to the axial direction of the medical tubular body 100. 1 and 4 are developed views, but the markers 121 to 124 can be seen in a straight line even when the metal mesh portion 111 is bent to form a tubular shape and the medical tubular body 100 is observed from the side. This is because the end of the tubular body has a shape obtained by obliquely cutting the cylinder (that is, a shape like the tip of an injection needle). As the diameter of the tubular body shrinks, the angle between the straight line in which the markers 121 to 124 are arranged and the axial direction of the tubular body becomes smaller. When the contraction of the tubular body is completed, as shown in FIG. 3, the straight line in which the markers 121 to 124 are arranged becomes substantially parallel to the axis of the tubular body. By utilizing such movement of the marker, the expansion and contraction of the tubular body can be performed from the angle formed by the straight line in which the markers 121 to 124 are arranged and the axis of the tubular body. You can know the degree.
(実施の形態3)
 以下、本発明の実施の形態3にかかる医療用管状体について、図面を用いて説明する。図5は、本発明の実施の形態3にかかる医療用管状体の展開図である。医療用管状体100は、遠位端101、近位端102を有し、遠位端101と近位端102の間には金属メッシュ部111を有している。本発明の実施の形態3にかかる医療用管状体100は、本発明の実施の形態2にかかる医療用管状体100と同様の構成を有しているため、同じ構成には同じ符号を付してその説明を省略する。
(Embodiment 3)
Hereinafter, the medical tubular body according to the third embodiment of the present invention will be described with reference to the drawings. FIG. 5 is a development view of the medical tubular body according to the third embodiment of the present invention. The medical tubular body 100 has a distal end 101 and a proximal end 102, and has a metal mesh portion 111 between the distal end 101 and the proximal end 102. Since the medical tubular body 100 according to the third embodiment of the present invention has the same configuration as the medical tubular body 100 according to the second embodiment of the present invention, the same reference numerals are given to the same configurations. The description is omitted.
 本発明の実施の形態3にかかる医療用管状体100が実施の形態2にかかる医療用管状体100と異なる点は、実施の形態2ではマーカー121等はマーカーハウジング161に埋め込まれている構造であるが、実施の形態3ではマーカー121等はマーカーハウジング131上であって管状体の内側面に形成されている点である。 The medical tubular body 100 according to the third embodiment of the present invention is different from the medical tubular body 100 according to the second embodiment in that the marker 121 and the like are embedded in the marker housing 161 in the second embodiment. However, in the third embodiment, the marker 121 and the like are formed on the marker housing 131 and on the inner surface of the tubular body.
 マーカー121~124をそれぞれマーカーハウジングに取り付ける方法としては、医療用管状体100の搬送時や、病変部における留置操作時に脱落することがない方法であれば特に限定されない。その方法としては、例えば、溶接、ロウ付けやカシメ等が挙げられるが、中でも溶接によって取り付けられていることが好ましい。溶接の場合はマーカーハウジングやロウなどのマーカー材とは異なる材料を用いないからである。一方、ロウ付けの場合はマーカーハウジングやマーカー材と異なる材料を用いることになり、カシメの場合はマーカーハウジングの半径方向外側面の平滑性が得られ難くなる。マーカーを溶接により取り付ける場合、マーカーハウジングの内側面は平坦であることが望ましく、また溶接スポットの直径分の直線長さが必要である点から、長円形や正方形、長方形であることが好ましい。 The method for attaching each of the markers 121 to 124 to the marker housing is not particularly limited as long as it is a method that does not drop off during the transportation of the medical tubular body 100 or the indwelling operation in the lesioned part. As the method, for example, welding, brazing, caulking, and the like can be mentioned. This is because, in the case of welding, a material different from a marker material such as a marker housing or a solder is not used. On the other hand, in the case of brazing, a material different from the marker housing or the marker material is used, and in the case of caulking, it is difficult to obtain the smoothness of the outer surface in the radial direction of the marker housing. When the marker is attached by welding, the inner surface of the marker housing is preferably flat, and is preferably oval, square, or rectangular because a linear length corresponding to the diameter of the welding spot is required.
 溶接スポットの直径は、X線透視像に悪影響を及ぼさない観点から、マーカーの固定面の短辺の80%以下の長さであることが好ましく、より好ましくは70%以下、さらに好ましくは60%以下とする。一方、マーカーの取り付け強度を保つ観点から、溶接スポットの直径は、マーカーの固定面の短辺の20%以上の長さであることが好ましく、より好ましくは30%以上、さらに好ましくは40%以上とする。溶接スポットの直径は、具体的には、好ましくは40μm~100μm程度、より好ましくは50μm~90μm程度である。 The diameter of the welding spot is preferably 80% or less of the short side of the fixed surface of the marker, more preferably 70% or less, and still more preferably 60%, from the viewpoint of not adversely affecting the fluoroscopic image. The following. On the other hand, from the viewpoint of maintaining the attachment strength of the marker, the diameter of the welding spot is preferably 20% or more of the short side of the fixed surface of the marker, more preferably 30% or more, and even more preferably 40% or more. And Specifically, the diameter of the welding spot is preferably about 40 μm to 100 μm, more preferably about 50 μm to 90 μm.
 図6(a)は、実施の形態3にかかる医療用管状体(拡径時)の遠位端101付近の斜視図であり、(b)は、その遠位端101を軸方向から見た図である。また図7(a)は、実施の形態3にかかる医療用管状体(縮径時)の遠位端101付近の斜視図であり、(b)は、その遠位端101を軸方向から見た図である。図6,7からわかるように、実施の形態1,2と同様にマーカー121~124が管状体の軸方向の異なる位置にそれぞれ形成されているために、管状体の縮径時にマーカー121~124が互いに干渉し合わずに管状体の内部空隙に納められる。 FIG. 6A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the third embodiment (when the diameter is expanded), and FIG. 6B is a view of the distal end 101 viewed from the axial direction. FIG. 7A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the third embodiment (when the diameter is reduced), and FIG. 7B is a view of the distal end 101 seen from the axial direction. It is a figure. As can be seen from FIGS. 6 and 7, since the markers 121 to 124 are formed at different positions in the axial direction of the tubular body as in the first and second embodiments, the markers 121 to 124 when the diameter of the tubular body is reduced. Are accommodated in the internal space of the tubular body without interfering with each other.
 さらに、図7から分かるように、本実施の形態にかかる医療用管状体100のマーカーは拡径可能な管状体の内側に形成されているため、管状体の径を収縮させても、マーカー121~124が管状体内部の空隙に納まる。そのため、マーカーと管状体とが互いに接触することがなくなるか、接触したとしても接触の程度は従来よりも軽減される。 Furthermore, as can be seen from FIG. 7, the marker of the medical tubular body 100 according to the present embodiment is formed inside the tubular body capable of expanding the diameter. ˜124 fit in the void inside the tubular body. Therefore, even if a marker and a tubular body do not contact each other or contact, the degree of contact is reduced more than before.
 なお、図7(b)にはやや極端に表示しているが、マーカー121~124は、マーカーハウジング131~134に固定されている側とは反対側に多少の空隙を残しており、縮径時の管状体の軸方向に完全に一直線に並んでいなくてもよい。もちろんマーカー121~124が完全に一直線に並んでいることは、管状体内の空隙を最大限利用して容積の大きいマーカーを配置できる点では理想的である。しかしながら管状体は必ずしも設計通りに縮径するとは限らないため、多少のクリアランスを残しておくことは、管状体の小径化にとって有利に働く場合がある。したがって、管状体の縮径時にマーカー121~124が一直線状に並んでいない構成を採用することも一つの好ましい態様である。 7B, the markers 121 to 124 have some gaps on the side opposite to the side fixed to the marker housings 131 to 134, and the diameter of the markers 121 to 124 is reduced. It may not be perfectly aligned with the axial direction of the tubular body. Of course, it is ideal that the markers 121 to 124 are perfectly aligned in that a marker having a large volume can be arranged by making the best use of the voids in the tubular body. However, since the tubular body does not necessarily have a reduced diameter as designed, leaving some clearance may be advantageous for reducing the diameter of the tubular body. Therefore, it is also a preferable aspect to employ a configuration in which the markers 121 to 124 are not arranged in a straight line when the diameter of the tubular body is reduced.
(実施の形態4)
 以下、本発明の実施の形態4にかかる医療用管状体について、図面を用いて説明する。図8は、本発明の実施の形態4にかかる医療用管状体の展開図である。図9(a)は、実施の形態4にかかる医療用管状体(拡径時)の遠位端101付近の斜視図であり、(b)は、その遠位端101を軸方向から見た図である。また図10(a)は、実施の形態4にかかる医療用管状体(縮径時)の遠位端101付近の斜視図であり、(b)は、その遠位端101を軸方向から見た図である。
(Embodiment 4)
Hereinafter, the medical tubular body according to the fourth embodiment of the present invention will be described with reference to the drawings. FIG. 8 is a development view of the medical tubular body according to the fourth embodiment of the present invention. FIG. 9A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the fourth embodiment (when expanded in diameter), and FIG. 9B shows the distal end 101 viewed from the axial direction. FIG. FIG. 10A is a perspective view of the vicinity of the distal end 101 of the medical tubular body according to the fourth embodiment (when the diameter is reduced), and FIG. 10B is a view of the distal end 101 seen from the axial direction. It is a figure.
 本発明の実施の形態4にかかる医療用管状体100は、本発明の実施の形態3にかかる医療用管状体100とほぼ同様の構成を有しているが、実施の形態3ではマーカー121~124が円柱状に形成されているのに対して、実施の形態4ではマーカー121~124が角柱状に形成されている点で異なるものである。マーカー121~124が角柱状であれば、マーカーハウジング131~134との接触面が大きいため固定強度の観点で有利である。 The medical tubular body 100 according to the fourth embodiment of the present invention has substantially the same configuration as the medical tubular body 100 according to the third embodiment of the present invention. 124 is formed in a columnar shape, but the fourth embodiment is different in that the markers 121 to 124 are formed in a prismatic shape. If the markers 121 to 124 are prismatic shapes, the contact surface with the marker housings 131 to 134 is large, which is advantageous in terms of fixing strength.
 以上、本発明の実施の形態にかかる医療用管状体について具体例を用いて説明したが、本発明は上記実施の形態によって制限を受けるものではなく、前記および後記の趣旨に適合し得る範囲で変更を加えて実施することももちろん可能であり、それらはいずれも本発明の技術的範囲に包含される。 As mentioned above, although the medical tubular body concerning embodiment of this invention was demonstrated using the specific example, this invention is not restrict | limited by the said embodiment, In the range which can adapt to the meaning of the said and the postscript. Of course, it is possible to carry out with modifications, and they are all included in the technical scope of the present invention.
 本発明の医療用管状体は、例示したものの他、薬剤コーティングステント、生分解性ステント等の様々な医療用管状体に好適に用いることができる。 The medical tubular body of the present invention can be suitably used for various medical tubular bodies such as drug-coated stents and biodegradable stents in addition to those exemplified.
 100 医療用管状体
 101 遠位端
 102 近位端
 111 金属メッシュ部
 112 セル
 121,122,123,124 マーカー
 131,132,133,134 マーカーハウジング
 141 マーカーハウジングの内側面
 151,152,153,154 支柱
 161 マーカーハウジング
DESCRIPTION OF SYMBOLS 100 Medical tubular body 101 Distal end 102 Proximal end 111 Metal mesh part 112 Cell 121,122,123,124 Marker 131,132,133,134 Marker housing 141 Inner side surface of marker housing 151,152,153,154 161 Marker housing

Claims (15)

  1.  拡径可能な管状体と、前記管状体の少なくとも一方の端部に形成された少なくとも2つのマーカーとを有し、当該2つのマーカーは、前記管状体の縮径時における軸方向の位置が互いに異なることを特徴とする医療用管状体。 The tubular body has a diameter-expandable tubular body and at least two markers formed on at least one end of the tubular body, and the two markers have an axial position when the diameter of the tubular body is reduced. A medical tubular body characterized by being different.
  2.  前記管状体は長さの異なる複数の支柱を含んでおり、各支柱の端部に前記マーカーが形成されている請求項1に記載の医療用管状体。 The medical tubular body according to claim 1, wherein the tubular body includes a plurality of struts having different lengths, and the marker is formed at an end of each strut.
  3.  前記管状体は網目構造を有しており、かつ前記網目の単位が螺旋状に並べられている請求項1または2に記載の医療用管状体。 The medical tubular body according to claim 1 or 2, wherein the tubular body has a mesh structure, and the mesh units are arranged in a spiral shape.
  4.  前記管状体の縮径時に、前記2つのマーカーどうしが互いに接触しない請求項1~3のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 3, wherein the two markers do not contact each other when the diameter of the tubular body is reduced.
  5.  前記管状体の縮径時に、前記管状体の一部を構成する非変形部であって前記マーカーを固定する部材(以下、「ハウジング」と記載)どうしが互いに接触しない請求項1~4のいずれかに記載の医療用管状体。 The member according to any one of claims 1 to 4, wherein members (hereinafter referred to as "housings") that are non-deformable portions constituting a part of the tubular body and do not contact each other when the diameter of the tubular body is reduced. A medical tubular body according to claim 1.
  6.  前記マーカーは、前記管状体の内側に形成されている請求項1~5のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 5, wherein the marker is formed inside the tubular body.
  7.  前記マーカーは、前記管状体の内側面の平面部に形成されている請求項1~6のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 6, wherein the marker is formed on a flat portion of an inner surface of the tubular body.
  8.  前記マーカーは、前記管状体の内側面に溶接されている請求項1~7のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 7, wherein the marker is welded to an inner surface of the tubular body.
  9.  前記マーカーは、前記管状体の縮径時の内側空隙に収容される大きさである請求項1~8のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 8, wherein the marker is sized to be accommodated in an inner space when the diameter of the tubular body is reduced.
  10.  前記管状体の縮径時において、前記マーカーの一方端は前記管状体との間に空隙を形成している請求項6~9のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 6 to 9, wherein a gap is formed between one end of the marker and the tubular body when the tubular body is reduced in diameter.
  11.  前記マーカーは、前記管状体の径方向の長さよりも、前記管状体の軸方向の長さのほうが長い請求項1~10のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 10, wherein the marker is longer in the axial length of the tubular body than in the radial direction of the tubular body.
  12.  前記マーカーハウジングは、開口部を有し、開口内にマーカーが埋設されている請求項1~11のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 11, wherein the marker housing has an opening, and the marker is embedded in the opening.
  13.  前記管状体の軸方向における前記マーカーハウジングの長さ以上に、前記マーカーどうしが離間している請求項1~12のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 12, wherein the markers are spaced apart from each other beyond the length of the marker housing in the axial direction of the tubular body.
  14.  前記マーカーは、柱状である請求項1~13のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 13, wherein the marker is columnar.
  15.  前記管状体の端部が、円筒を斜めに切った形状をなしている請求項1~14のいずれかに記載の医療用管状体。 The medical tubular body according to any one of claims 1 to 14, wherein an end of the tubular body has a shape obtained by obliquely cutting a cylinder.
PCT/JP2014/054562 2013-04-16 2014-02-25 Medical tubular body WO2014171183A1 (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016140716A (en) * 2015-02-05 2016-08-08 オリンパス株式会社 Medical electrostimulation electrodes
US20220061985A1 (en) * 2020-08-25 2022-03-03 Medtronic, Inc. Devices and methods for multi-alignment of implantable medical devices
US11969343B2 (en) 2020-12-07 2024-04-30 Medtronic, Inc. Transcatheter heart valve prosthesis systems and methods for rotational alignment

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002272855A (en) * 2001-03-14 2002-09-24 Piolax Medical Device:Kk Stent
US20040254627A1 (en) * 2003-04-04 2004-12-16 Thompson Paul J. Stent with end adapted for flaring
JP2008511423A (en) * 2004-09-01 2008-04-17 アンギオメット ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コムパニー メディツィンテヒニク コマンデイトゲゼルシャフト Stent and stent manufacturing method
US20090306760A1 (en) * 2008-06-06 2009-12-10 Bay Street Medical Prosthesis and delivery system
WO2011093941A2 (en) * 2010-01-29 2011-08-04 Dc Devices, Inc. Devices and systems for treating heart failure
WO2011122444A1 (en) * 2010-03-30 2011-10-06 テルモ株式会社 Stent delivery system
WO2012031748A2 (en) * 2010-09-08 2012-03-15 Phenox Gmbh Implant for influencing the blood flow in arteriovenous defects

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2002272855A (en) * 2001-03-14 2002-09-24 Piolax Medical Device:Kk Stent
US20040254627A1 (en) * 2003-04-04 2004-12-16 Thompson Paul J. Stent with end adapted for flaring
JP2008511423A (en) * 2004-09-01 2008-04-17 アンギオメット ゲゼルシャフト ミット ベシュレンクテル ハフツング ウント コムパニー メディツィンテヒニク コマンデイトゲゼルシャフト Stent and stent manufacturing method
US20090306760A1 (en) * 2008-06-06 2009-12-10 Bay Street Medical Prosthesis and delivery system
WO2011093941A2 (en) * 2010-01-29 2011-08-04 Dc Devices, Inc. Devices and systems for treating heart failure
WO2011122444A1 (en) * 2010-03-30 2011-10-06 テルモ株式会社 Stent delivery system
WO2012031748A2 (en) * 2010-09-08 2012-03-15 Phenox Gmbh Implant for influencing the blood flow in arteriovenous defects

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2016140716A (en) * 2015-02-05 2016-08-08 オリンパス株式会社 Medical electrostimulation electrodes
US20220061985A1 (en) * 2020-08-25 2022-03-03 Medtronic, Inc. Devices and methods for multi-alignment of implantable medical devices
US11969343B2 (en) 2020-12-07 2024-04-30 Medtronic, Inc. Transcatheter heart valve prosthesis systems and methods for rotational alignment

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