WO2011122444A1 - ステントデリバリーシステム - Google Patents
ステントデリバリーシステム Download PDFInfo
- Publication number
- WO2011122444A1 WO2011122444A1 PCT/JP2011/057209 JP2011057209W WO2011122444A1 WO 2011122444 A1 WO2011122444 A1 WO 2011122444A1 JP 2011057209 W JP2011057209 W JP 2011057209W WO 2011122444 A1 WO2011122444 A1 WO 2011122444A1
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- WIPO (PCT)
- Prior art keywords
- stent
- tube body
- delivery system
- proximal end
- housing
- Prior art date
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents 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
- A61F2/91—Stents 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
- A61F2/915—Stents 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/9517—Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2/962—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
- A61F2/966—Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9505—Instruments specially adapted for placement or removal of stents or stent-grafts having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/95—Instruments specially adapted for placement or removal of stents or stent-grafts
- A61F2002/9534—Instruments specially adapted for placement or removal of stents or stent-grafts for repositioning of stents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0028—Shapes in the form of latin or greek characters
- A61F2230/005—Rosette-shaped, e.g. star-shaped
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers 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 stent delivery system used for improving a stenosis or occlusion occurring in a lumen in a living body such as a blood vessel, a bile duct, a trachea, an esophagus, or a urethra.
- a stent delivery system includes a stent for improving a stenosis or an occlusion.
- Stents are used to expand the stenosis or occlusion site and place it to secure the lumen to treat various diseases caused by stenosis or occlusion of blood vessels or other in-vivo lumens.
- it is a tubular medical device.
- a blood vessel will be described as an example, but the present invention is not limited to this.
- a metal wire or a cylindrical shape obtained by processing a metal tube is generally used.
- a stent is attached to a catheter or the like in a thin state, inserted into a living body, expanded in some way at a target site (stenosis or occlusion site), and tightly fixed to the inner wall of the lumen to maintain the lumen shape.
- Stents are differentiated between self-expandable and balloon-expandable stents by function and placement method.
- the balloon-expandable stent does not have an expansion function, and after the stent mounted on the balloon is inserted into the target site, the balloon is expanded, and the stent is expanded (plastically deformed) by the expansion force of the balloon.
- a self-expanding stent is a stent that has an expansion function, and is inserted into a living body in a thin and contracted state, and then returns to its original expanded state when released at a target site.
- the lumen shape is maintained by closely adhering to and fixing.
- the purpose of current stent placement is to restore a stenotic or occluded blood vessel for some reason to its original patency, mainly to prevent and reduce restenosis that occurs after procedures such as PTCA. Most are things.
- drug-eluting stents loaded with drugs such as immunosuppressants and anticancer drugs have been used, and their effects are generally known.
- Patent Document 1 Japanese Patent Publication No. 11-505441, WO96 / 26689
- Patent Document 2 Japanese Translation of PCT International Publication No. 2007-504897, WO2005 / 032614 is a system for delivering and deploying a medical device (stent) in a patient's body, and includes a region to which the medical device is attached.
- a delivery catheter comprising an inner catheter member and an outer constraining member coaxially fitted over the inner catheter member and the medical device, wherein the outer constraining member is adapted to move axially relative to the inner catheter member.
- Merare delivery system is disclosed in which the inner catheter member medical device is exposed remain stationary.
- Patent Document 1 In a stent delivery system using a self-expandable stent as in Patent Document 1, the positioning during placement is difficult compared to a balloon-expandable stent due to the self-expandability of the stent, and the jumping phenomenon in which the stent jumps out of the stent delivery system When this phenomenon occurs, the stent is placed at a position shifted from the planned placement position. Also, during the stent placement procedure, the placement position may need to be readjusted after the stent has been ejected to some extent. However, in Patent Document 1, it is difficult to re-stent the stent into the stent delivery system. In the thing of patent document 2, the operativity of the outer side restraint member for releasing a stent is a favorable thing. However, even the one in Patent Document 2 is difficult to re-stent the stent into the stent delivery system.
- an object of the present invention is a stent delivery system using a self-expanding stent, in which the release operation of the stent is good, and even after the stent is exposed to some extent from the stent housing tube body, It is an object of the present invention to provide a stent delivery system that can be stored again in the stent storage tube body and that can be easily stored in the stent storage tube body.
- a stent delivery system main body capable of releasing the stent by moving to the proximal end side with respect to the tube body, and a proximal end portion of the stent delivery system main body for moving the stent storage tube body
- a stent delivery system including an operation unit including a moving mechanism, wherein the inner tube body includes the gasket.
- a distal end tube having a drained lumen; and a proximal end tube connected to the proximal end of the distal end tube and penetrating through the inside of the stent storage tube.
- a shaft-shaped rack member fixed to the proximal end of the stent storage tube body, and an operating gear for engaging the gear of the rack member and moving the rack member within the housing.
- the stent delivery comprising: a rotating roller; and a connector fixed to a proximal end portion of the proximal end side tube protruding from a proximal end of the stent storage tube body fixed to the rack member and held by the housing.
- the system releasably holds the stent and partially exposes the stent from the stent housing tube body.
- the rack is provided with a stent holding function for allowing the stent to be re-stored in the stent storage tube by the advancement of the stent storage tube, and the rotation roller in the predetermined direction rotates.
- a stent delivery system in which the rack member is moved in the opposite direction to the connector in the housing by rotating in a direction opposite to the direction, and the stent can be re-stored in the stent storage tube.
- the stent delivery system of the present invention includes a stent delivery system main body including a stent, an inner tube body, and a stent storage tube body in which the stent is stored in a distal end portion, and a stent storage provided at a proximal end portion of the stent delivery system main body.
- an operation unit including a moving mechanism for moving the tube body.
- the inner tube body includes a distal tube having a guide wire lumen and a proximal tube connected to the proximal side of the distal tube.
- the operation portion is a housing, a shaft-shaped rack member fixed in the proximal end of the stent storage tube body, and an operation for moving the rack member in the housing by meshing with the gear of the rack member.
- a rotating roller for operation having a gear; and a connector fixed to a proximal end portion of a proximal tube protruding from a proximal end of a stent housing tube body fixed to a rack member and held by a housing.
- the stent delivery system holds the stent in a releasable manner so that the stent can be re-stored in the stent storage tube body by advancement of the stent storage tube body after partial exposure of the stent from the stent storage tube body.
- the stent can be released from the stent storage tube body by moving the rack member in the connector direction by the rotation of the operation rotary roller in the predetermined direction, and the stent storage tube of the stent.
- the rack member After partial exposure from the body, the rack member is moved in the opposite direction to the connector in the housing by rotating the operation rotary roller in the direction opposite to the predetermined direction, so that the stent can be re-stored in the stent storage tube. Is possible.
- the shaft-shaped rack member moves in the connector direction in the housing by the rotation of the operation rotating roller in the predetermined direction, so that the stent can be released from the stent storage tube body.
- the stent release operation is easy.
- the shaft-like rack member is moved in the opposite direction to the connector in the housing by rotating the operation rotating roller in the direction opposite to the predetermined direction, and the stent is moved. Since the stent can be re-stored in the storage tube, the stent can be stored again in the stent storage tube even after the stent is exposed to some extent from the stent storage tube, and the stent is rearranged. In addition, since the operation of storing the stent in the stent storage tube body only rotates the roller, the operation is easy.
- the proximal tube has a lumen whose distal end is open in the stent housing tube and communicates to the proximal end, and the liquid from the connector into the stent delivery system using the lumen in the proximal tube. Priming work in the distal end portion of the stent storage tube body is facilitated, and further, a liquid (for example, a medicine) can be discharged from the distal end of the stent storage tube body.
- a liquid for example, a medicine
- FIG. 1 is a partially omitted external view of a stent delivery system according to an embodiment of the present invention.
- FIG. 2 is an enlarged view of the distal end portion of the stent delivery system shown in FIG.
- FIG. 3 is an enlarged longitudinal sectional view of the distal end portion of the stent delivery system shown in FIG.
- FIG. 4 is a partially omitted enlarged external view of the inner tube body (including the stent) of the stent delivery system shown in FIG.
- FIG. 5 is an explanatory diagram for explaining the vicinity of the distal end portion of the stent delivery system shown in FIG. 1.
- 6 is a partially omitted enlarged cross-sectional view of the distal end portion of the stent delivery system shown in FIG. FIG.
- FIG. 7 is an explanatory diagram for explaining an internal structure in the vicinity of an intermediate portion of the stent delivery system shown in FIG.
- FIG. 8 is a front view of an example of an in-vivo stent used in the stent delivery system of the present invention.
- FIG. 9 is a development view of the in-dwelling stent of FIG.
- FIG. 10 is an enlarged view of a proximal end side coupling portion of the in-vivo stent in FIG. 11 is a cross-sectional view taken along line AA in FIG.
- FIG. 12 is an explanatory diagram for explaining the internal structure of the operation unit of the stent delivery system of the present invention.
- FIG. 13 is an enlarged front view of the operation unit of the stent delivery system of the present invention.
- FIG. 14 is a plan view of an operation unit of the stent delivery system shown in FIG.
- FIG. 15 is an explanatory diagram for explaining the internal structure of the operation unit of the stent delivery system of the present invention.
- FIG. 16 is an explanatory diagram for explaining the internal structure of the operation unit of the stent delivery system of the present invention.
- FIG. 17 is an explanatory diagram for explaining the internal structure of the operation unit of the stent delivery system of the present invention.
- FIG. 18 is an explanatory diagram for explaining the operation of the stent delivery system of the present invention.
- FIG. 19 is an explanatory diagram for explaining the operation of the stent delivery system of the present invention.
- FIG. 20 is an explanatory diagram for explaining the operation of the stent delivery system of the present invention.
- FIG. 20 is an explanatory diagram for explaining the operation of the stent delivery system of the present invention.
- FIG. 21 is an explanatory diagram for explaining the operation of the stent delivery system of the present invention.
- FIG. 22 is an explanatory diagram for explaining the operation of the stent delivery system of the present invention.
- FIG. 23 is an enlarged longitudinal sectional view of a distal end portion of a stent delivery system according to another embodiment of the present invention.
- FIG. 24 is a developed view of another example of the in-vivo stent used in the stent delivery system of the present invention.
- FIG. 25 is an explanatory diagram for explaining a stent delivery system using the in-vivo stent of FIG.
- a stent delivery system (in other words, a living organ lesion improvement instrument) 1 of the present invention has a large number of side wall openings, is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into a living body, and is placed in the living body.
- a stent 10 that can sometimes be expanded outwardly and restored to its pre-compression shape, an inner tube body 3 having a guide wire lumen 61, and a stent housing tube body (stent housing member) 5 that houses the stent 10 in its distal end.
- the stent 10 is disposed so as to cover the distal end portion of the inner tube body 3, and the stent storage tube body 5 is moved proximally with respect to the inner tube body 3, so that the stent 10 can be released.
- a stent delivery system main body 2 and a proximal end of the stent delivery system main body 2 are moved to move the stent storage tube body 5 And an operation unit 6 provided with a moving mechanism for causing.
- the inner tube body 3 includes a distal end side tube 31 having a guide wire lumen 61 and a proximal end side tube 34 connected to the proximal end side of the distal end side tube 31.
- the operation unit 6 includes a housing 40, a shaft-shaped rack member 43 that is housed in the housing 40, and is fixed to the proximal end of the stent housing tube body 5 (specifically, the proximal tube 22), An operation rotary roller 50 having an operation gear 54 for meshing with the gear 66 of the rack member 43 and moving the rack member 43 within the housing 40, and the stent housing tube body 5 (specifically, the rack member 43 is fixed). , And a connector 46 fixed to the base end portion of the base end side tube 34 projecting from the base end and projecting from the base end, and held by the housing 40.
- the stent delivery system 1 holds the stent 10 in a releasable manner, and after the stent 10 is partially exposed from the stent storage tube body 5, the stent storage tube body 5 is advanced to advance the stent into the stent storage tube body 5.
- Stent holding functions 35 and 36 for enabling 10 re-storing are provided. Further, the rotation of the operation rotary roller 50 in a predetermined direction causes the shaft-shaped rack member 43 to move toward the connector 46 in the housing 40, and the stent 10 can be released from the stent housing tube body 5.
- the shaft-like rack member 43 is connected to the connector 46 in the housing 40 by rotating the operation rotary roller 50 in the direction opposite to the predetermined direction.
- the stent 10 moves in the opposite direction, and the stent 10 can be re-stored in the stent storage tube body 5.
- the proximal end side tube 34 of the inner side tube body 3 has the lumen
- the proximal end side tube 34 is connected to the proximal end side of the distal end side tube 31 by a connecting member.
- the stent delivery system 1 according to this embodiment can inject liquid into the stent delivery system from the connector 46 using the lumen 38 in the proximal tube 34.
- the stent delivery system 1 of the present invention includes a stent delivery system main body 2 and an operation unit 6 provided at a proximal end portion of the stent delivery system main body 2.
- the stent delivery system 1 of the illustrated embodiment has a large number of side wall openings, is formed in a substantially cylindrical shape, is compressed in the central axis direction when inserted into the living body, and is expanded and compressed outward when placed in the living body.
- the stent delivery system 1 of the illustrated embodiment includes a stent 10 that can be expanded outwardly during in vivo placement and restored to a shape before compression, a stent housing tube body 5 that houses the stent 10 in the distal end portion, An inner tube body 3 for slidably inserting the inside of the stent housing tube body 5 and for releasing the stent 10 from the distal end of the stent housing tube body 5 is provided.
- the stent 10 includes a distal end portion facing the distal end side of the stent housing tube body 5 and a proximal end portion facing the proximal end side, and further has substantially no bending free end facing at least the proximal end side except for the proximal end portion.
- the exposed portion can be re-accommodated in the stent accommodating tube body 5 by moving the stent accommodating tube body 5 to the distal end side after exposing the distal end side portion from the stent accommodating tube body 5.
- the stent delivery system 1 has a guide wire lumen 61 having one end opened at the distal end of the stent delivery system and the other end opened proximally from the stent housing portion of the stent housing tube body 5.
- the stent delivery system main body 2 includes a stent 10, a stent storage tube body 5 in which the stent 10 is stored in the distal end portion, and an inner tube body 3 that is slidably inserted inside the stent storage tube body 5.
- the stent housing tube body 5 includes a distal tube 21 and a proximal tube 22 fixed to the proximal end of the distal tube 21.
- the distal tube 21 is a tubular body, and the distal end and the proximal end are open. The distal end opening functions as a discharge port of the stent 10 when the stent 10 is placed at a target site in the lumen.
- the stent 10 is released from the distal end opening, thereby releasing the stress load and expanding and restoring the shape before compression.
- the distal end portion of the distal tube 21 is a stent housing part that houses the stent 10 therein. Further, the distal tube 21 includes a side hole 23 provided on the proximal end side from the stent accommodation site. The side hole 23 is for leading the guide wire to the outside. Further, it is preferable to provide a contrast marker 28 at the distal end of the distal tube 21. As shown in FIG. 6, the stent 10 is housed in the distal tube 21 so that the position of the distal end thereof substantially coincides with the position of the distal end of the contrast marker 28.
- the shape of the contrast marker 28 is preferably a cylindrical member formed of a contrast material. Further, as a material for forming a contrast marker, one (single) or two selected from the group of elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, and hafnium. The above (alloys) can be suitably used.
- the proximal tube 22 is a tube body having a pipe line penetrating from the distal end to the proximal end, the distal end is fixed to the proximal end of the distal tube 21 described above, and the proximal end portion is in the operation unit 6 described later.
- the outer diameter of the distal tube 21 is preferably 0.5 to 4.0 mm, particularly preferably 0.8 to 2.0 mm.
- the inner diameter of the distal tube 21 is preferably 0.2 to 1.8 mm.
- the length of the distal tube 21 is preferably 50 to 500 mm, particularly preferably 100 to 300 mm.
- the outer diameter of the proximal tube 22 is preferably 0.3 to 4.0 mm, particularly preferably 0.5 to 1.0 mm.
- the inner diameter of the proximal end tube 22 is preferably 0.1 to 1.0 mm.
- the length of the proximal tube 22 is preferably 500 to 4000 mm, and particularly preferably 800 to 2000 mm.
- the distal end tube 21 and the proximal end tube 22 in consideration of physical properties (flexibility, hardness, strength, slipperiness, kink resistance, stretchability) required for the tube, for example, stainless steel, super elastic metal Fluorine polymers such as polyethylene, polypropylene, nylon, polyethylene terephthalate, PTFE and ETFE, and thermoplastic elastomers are preferred.
- the thermoplastic elastomer is appropriately selected from nylon (for example, polyamide elastomer), urethane (for example, polyurethane elastomer), polyester (for example, polyethylene terephthalate elastomer), and olefin (for example, polyethylene elastomer, polypropylene elastomer). Is done.
- the distal tube 21 is preferably more flexible than the proximal tube 22. By doing in this way, operativity becomes favorable. Furthermore, it is preferable that the outer surface (the distal end tube 21 and the proximal end tube 22) of the stent housing tube body 5 is subjected to a treatment for exhibiting lubricity.
- Examples of such treatment include poly (2-hydroxyethyl methacrylate), polyhydroxyethyl acrylate, hydroxypropyl cellulose, methyl vinyl ether maleic anhydride copolymer, polyethylene glycol, polyacrylamide, polyvinyl pyrrolidone, dimethylacrylamide-glycidyl methacrylate.
- Examples thereof include a method of coating or fixing a hydrophilic polymer such as a copolymer.
- a hydrophilic polymer such as a copolymer.
- the inner tube body 3 has a distal end portion protruding from the distal end of the stent housing tube body 5, a proximal tube 34, and a proximal end of the distal tube 31. And a connector 46 fixed to the proximal end of the proximal end tube 34.
- the inner tube body 3 includes a proximal end opening of a guide wire lumen that opens at a side portion proximal to the stent housing portion of the stent housing tube body 5, and the stent housing tube body 5 A side hole provided on the base end side from the stent housing part is provided, and a guide wire can be inserted through the side hole and the base end side opening. As shown in FIG.
- the distal end side tube 31 protrudes from the distal end of the stent housing tube body 5 (the distal end tube 21).
- the distal tube 31 is provided with a stopper 32 that prevents the stent housing tube body 5 from moving in the distal direction.
- the base end portion of the distal end side tube 31 is curved, enters the side hole 23 of the distal end tube 21, and is detachably engaged.
- the outer diameter of the distal tube 31 is preferably 0.2 mm to 2.0 mm.
- tip part of the front end side stopper 32 is diameter-reduced toward the front end side, as shown in FIG.
- the outer diameter of the maximum diameter portion of the stopper 32 is preferably 0.5 to 4.0 mm. Moreover, it is preferable that the base end part of the stopper 32 is also diameter-reduced toward the base end side, as shown in FIG.
- the distal tube 31 has a guide wire lumen 61 extending from the distal end to the proximal end, and the position of the proximal opening 39 is 10 to 400 mm proximal to the distal end of the distal tube 31. In particular, it is preferably 50 to 350 mm located on the base end side. Further, the position of the proximal end opening 39 is preferably about 50 to 250 mm from the proximal end of the stent 10 to be arranged (in other words, the proximal end of the stent storage site).
- the stent delivery system 1 of this invention hold
- the inner tube body 3 is positioned in the proximal end portion of the stent 10 and is provided at a distal end side position provided at a position not entering the side wall opening of the stent 10.
- a contact portion 36, and a proximal end contact portion 35 provided at a position behind the proximal end of the stent 10 and in the vicinity of the distal end contact portion 36 and capable of contacting the proximal end of the stent 10.
- a proximal-side inward projecting portion 17a that can abut on the distal-side abutting portion 36 of the inner tube body 3, and the stent 10 has a proximal-side inward projecting portion 17a that is It is disposed so as to be positioned between the distal end side contact portion 36 and the proximal end side contact portion 35. Accordingly, after the stent 10 is partially exposed from the stent storage tube body 5, the stent 10 can be re-stored in the stent storage tube body 5 again by the advancement of the stent storage tube body 5.
- the stent 10 used in this embodiment is a so-called self-expanding stent that has a large number of openings on the side surface and can be expanded outwardly to be restored to its pre-compression shape when placed in vivo.
- the stent 10 further includes a distal end portion facing the distal end side of the stent housing tube body 5 and a proximal end portion facing the proximal end side, and further has a bending free end facing at least the proximal end side except for the proximal end portion.
- the stent storage tube body 5 can be re-stored in the stent storage tube body 5 by moving the stent storage tube body 5 to the distal end side after the distal end portion is exposed from the stent storage tube body 5.
- the end portion of each linear component may be one that does not have a free end by being combined with another linear component.
- the stent used may be as shown in FIGS.
- FIG. 8 is a front view of an example of an in-vivo stent used in the stent delivery system of the present invention.
- FIG. 9 is a development view of the in-dwelling stent of FIG.
- the stent 10 extends in a predetermined long axis direction while connecting the adjacent wavy struts 13 and 14 that are axially extended from one end side to the other end side of the stent and arranged in the circumferential direction of the stent.
- One or more connecting struts 15 are provided, and the ends of the wavy struts 13, 14 are coupled to the ends of the adjacent wavy struts.
- the stent 10 includes a large number of openings formed between the struts.
- the stent 10 shown in FIGS. 8 and 9 includes a plurality of first wavy struts 13 extending in the axial direction from one end side to the other end side of the stent 10 and arranged in the circumferential direction of the stent, and the first wavy struts 13.
- a plurality of second wavy struts 14 that extend in the axial direction from one end side to the other end side of the stent and are arranged in the circumferential direction of the stent, and the first wavy struts 13 and the second wavy struts 14 that are adjacent to each other.
- One or a plurality of connecting struts 15 that are connected and extend in a predetermined major axis direction are provided.
- the apex of the second wavy strut 14 is shifted by a predetermined length in the axial direction of the stent with respect to the apex of the first wavy strut 13 that is close to the circumferential direction of the stent 10 and curves in the same direction. . Further, the end portions 13a and 13b of the first wavy strut 13 are coupled to the end portions 14a and 14b of the adjacent second wavy struts.
- the stent 10 of this embodiment is a so-called self-expanding stent that is formed in a substantially cylindrical shape, is compressed in the direction of the central axis when inserted into a living body, and expands outward when placed in the living body to restore the shape before compression. ing.
- the first wavy strut 13 extends in the axial direction substantially parallel to the central axis of the stent.
- a plurality of first wavy struts 13 are arranged in the circumferential direction of the stent.
- the number of the first wavy struts 13 is preferably 3 or more, and particularly 3 to 8 is preferable.
- the plurality of first wavy struts 13 are preferably arranged so as to be substantially equiangular with respect to the central axis of the stent.
- the second wavy strut 14 also extends in the axial direction substantially parallel to the central axis of the stent.
- a plurality of second wavy struts 14 are arranged in the circumferential direction of the stent, and each second wavy strut 14 is arranged between each first wavy strut.
- the number of the second wavy struts 14 is preferably 3 or more, and particularly 3 to 8 is preferable. Furthermore, it is preferable that the plurality of second wavy struts 14 are arranged so as to be substantially equiangular with respect to the central axis of the stent.
- the number of second wavy struts 14 is preferably the same as the number of first wavy struts 13.
- the stent 10 includes one or a plurality of connection struts 15 that connect the adjacent first wavy struts 13 and second wavy struts 14 and extend in a predetermined major axis direction.
- the connection strut 15 has one end near the inflection point of one wavy strut, and the other end in a region slightly beyond the apex of the adjacent wavy strut. And extending in the axial direction and curved in the same direction as the apex of the other wavy strut. As shown in FIG.
- connection strut 15 includes a curved first connection strut 15 a having a vertex toward the one side in the circumferential direction of the stent 10 and a curve having a vertex toward the other side in the circumferential direction of the stent 10.
- Second connecting strut 15b The connecting strut 15 is curved in an arc shape and has substantially the same radius as the arc of the curved portion of the first wavy strut 13 or the second wavy strut 14 that is close to the circumferential direction of the stent 10.
- the stent 10 of this Example is provided with the connection parts 16 and 18 which couple
- one end 13a of the first wavy strut 13 of the stent 10 is adjacent to one second wavy strut 14 (specifically, the second wavy adjacent and located on the other side in the circumferential direction).
- the one end side 14a of the strut 14) is connected to the connecting portion 16.
- the other end 13b of the first wavy strut 13 is adjacent to one of the adjacent second wavy struts 14 (specifically, the second wavy strut 14 that is close and located on one side in the circumferential direction).
- the end side end portion 14b and the connecting portion 18 are connected. That is, the combination of the first wavy strut 13 and the second wavy strut 14 to be coupled is different (shifted one by one) in the coupling portion 16 on the one end side and the coupling portion 18 on the other end side.
- the stent 10 is provided with the base end side inward protrusion part 17a which can contact
- the stent 10 is disposed so that the proximal-side inward protruding portion 17 a is located between the distal-side contact portion 36 and the proximal-side contact portion 35 of the inner tube body 3.
- the proximal-side inward protruding portion 17 a is preferably formed by a contrast marker (radiopaque marker) 17 attached to the proximal end portion (bonding portion) 16 of the stent 10. Further, as shown in FIG.
- the proximal-side inward protruding portion 17 a of the stent 10 is not in contact with the outer surface of the distal-side tube 31 of the inner tube body 3.
- the protrusion height of the base end side inward protrusion is preferably 0.05 to 0.2 mm.
- the difference in height between the proximal-side inward protruding portion of the stent and the other portion that is not the protruding portion is preferably 0.01 to 0.1 mm.
- the stent 10 of this embodiment may have a distal end side inward protruding portion 19 a at the distal end portion of the stent 10. It is preferable that the distal side inward protruding portion 19a is formed by a contrast marker 19 attached to the distal end portion (joint portion) 18 of the stent.
- a contrast marker 17 is attached to the joint 16.
- the coupling portion 16 has an opening, and includes two frame portions 16a and 16b extending in parallel with a predetermined distance apart in the direction of the proximal end (end portion of the coupling portion) of the stent.
- the contrast marker 17 encapsulates substantially the entire two frame portions 16a and 16b.
- the proximal-end-side inward protruding portion 17a of the stent 10 is constituted by the inner surface side portion of the stent of the contrast marker 17. Furthermore, in the stent of this embodiment, as shown in FIGS.
- the proximal-side inward protruding portion 17 a of the stent 10 is wound around the opening of the proximal end portion (joining portion) 16 of the stent 10. It is formed in the inner surface side part of the stent of a cylindrical member. Furthermore, in the stent of this embodiment, the sheet-like member has an inner overlapping portion 17b that protrudes toward the inner surface side of the stent 10, and forms a portion that protrudes larger than the other portions. It is preferable that the contrast marker 17 forming the proximal end inward protruding portion has a predetermined thickness (wire diameter).
- the contrast marker 17 accommodates two frame portions forming the base end portion (joining portion) 16 inside, and the central portion is recessed and partly overlaps. Thus, it is fixed to the two frame portions.
- a base end part (joining part) of a stent you may not have an independent opening as shown to FIG. 10 and FIG.
- the base end of the strut end portion 14a is continuous with the end portion of the frame portion 16a
- the base end of the strut end portion 13a is continuous with the frame portion 16b
- the opening is open at the end portion. It may communicate with the space between the two struts.
- the proximal end portion (joint portion) of the stent may not have the above-described opening at all.
- the coupling portion is a slightly curved plate-like portion having a predetermined area, and a contrast marker is attached so as to cover the front and back surfaces thereof.
- the proximal end part of the stent is provided with the latching
- FIG. 10 it is preferable to provide two locking portions 16c so as to face each other. By providing such a locking portion, the contrast marker 17 is pushed to the proximal end side of the stent by the distal-side contact portion 36 of the inner tube body 3 when the stent 10 is re-stored in the stent storage tube body 5. At this time, the movement and detachment of the contrast marker 17 with respect to the stent can be prevented.
- the proximal end portion 16 of the stent is in a state protruding from the contrast marker 17 to the proximal end. For this reason, when releasing the stent, the proximal end contact portion 35 of the inner tube body 3 comes into contact with the proximal end of the proximal end portion 16 of the stent 10, and the proximal end contact of the inner tube body 3. Since the portion 35 does not contact the contrast marker 17, the contrast marker 17 does not move or leave the stent.
- the above-described sheet-like member is preferably used as the contrast marker. However, a wire-like member may be wound around the proximal end portion (joint portion) of the stent.
- the contrast marker it is preferable to have an inner overlapping portion that protrudes toward the inner surface side of the stent.
- a material for forming the above-described contrast marker one (single) or two selected from the group of elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, and hafnium The above (alloys) can be suitably used.
- the contrast marker can be fixed by welding, soldering, adhesion, welding, or diffusion.
- a super elastic metal is suitable.
- a superelastic alloy is preferably used.
- the superelastic alloy here is generally called a shape memory alloy, and exhibits superelasticity at least at a living body temperature (around 37 ° C.).
- a superelastic alloy such as (Si, Sn, Al, Ga), Ni-Al alloy of 36 to 38 atomic% Al is preferably used.
- Particularly preferred is the Ti—Ni alloy described above.
- the buckling strength (yield stress during loading) of the superelastic alloy used is 5 to 200 kg / mm 2 (22 ° C.), more preferably 8 to 150 kg / mm 2.
- Restoring stress (yield stress during unloading) ) Is 3 to 180 kg / mm 2 (22 ° C.), more preferably 5 to 130 kg / mm 2 .
- Superelasticity here means that even if it is deformed (bending, pulling, compressing) to a region where normal metal is plastically deformed at the operating temperature, it will recover to its almost uncompressed shape without the need for heating after the deformation is released. It means to do.
- the stent preferably has a compressed diameter of 0.5 to 1.8 mm, particularly 0.6 to 1.4 mm.
- the length of the stent when not compressed is preferably 5 to 200 mm, and particularly preferably 8.0 to 100.0 mm.
- the diameter of the stent when not compressed is preferably 1.5 to 6.0 mm, particularly preferably 2.0 to 5.0 mm.
- the thickness of the stent is preferably 0.05 to 0.15 mm, and particularly preferably 0.05 to 0.40 mm.
- the width of the wavy strut is preferably from 0.01 to 1.00 mm, particularly preferably from 0.05 to 0.2 mm.
- the surface of the wavy strut is preferably processed smoothly, and smoothing by electropolishing is more preferable.
- the radial strength of the stent is preferably 0.1 to 30.0 N / cm, and particularly preferably 0.5 to 5.0 N / cm.
- the inner tube body 3 is located in the proximal end portion of the stent 10 and does not enter the side wall opening of the stent 10.
- the abutting portion 36 includes a proximal-side abutting portion 35 that is provided at a position behind the proximal end of the stent 10 and close to the distal-side abutting portion 36 and that can abut on the proximal end of the stent 10.
- the distal end side contact portion 36 is a distal end side protruding portion that protrudes from the outer surface of the distal end side tube 31.
- proximal end abutting portion 35 is a proximal end protruding portion that protrudes from the outer surface of the distal end side tube 31, similarly to the distal end side abutting portion 36.
- the proximal-side inward protruding portion 17 a of the stent 10 described above can be brought into contact with the distal-side contact portion 36 of the inner tube body 3. As shown in FIG. 6, the proximal-side inward protruding portion 17 a of the stent 10 is located between the distal-side contact portion 36 and the proximal-side contact portion 35 of the inner tube body 3.
- the stent delivery system 1 of this Example has the front end side contact part 36 in the position which becomes a predetermined distance base end side from the front-end
- the distal end side contact portion 36 is disposed in the proximal end portion of the stent 10 and at a position slightly closer to the distal end side than the proximal end of the stent 10.
- a proximal end contact portion 35 is provided at a position slightly proximal to the distal end side contact portion 36.
- the proximal end contact portion 35 is disposed in the vicinity of the proximal end of the stent 10 and behind it (the proximal end side).
- the proximal-side inward protruding portion 17 a of the stent 10 is located between the distal-side contact portion 36 and the proximal-side contact portion 35 of the inner tube body 3. For this reason, the distance between the distal end side contact portion 36 and the proximal end side contact portion 35 is slightly longer than the axial length of the proximal end side inward protruding portion 17a of the stent 10.
- the distance between the distal end side contact portion 36 and the proximal end side contact portion 35 is preferably 0.02 to 1.0 mm longer than the axial length of the proximal end side inward protruding portion 17a of the stent 10, In particular, it is preferably 0.05 to 0.3 mm long.
- the distal end side contact portion 36 does not enter the side wall opening of the stent 10.
- the front end side contact portion 36 is an annular projecting portion provided continuously over the outer periphery of the front end side tube 31.
- the annular protrusion is formed, for example, by attaching a cylindrical member to the outer periphery of the distal end side tube. By making such an annular protrusion, the abutment with the proximal-end-side inward protrusion 17a of the stent 10 is ensured.
- the front end side contact portion 36 is not substantially in contact with the inner surface of the stent 10. By doing so, the distal end side contact portion 36 does not become an obstacle when the stent is released.
- the distal end side contact portion 36 has a height capable of contacting the proximal end side inward protruding portion 17 a of the stent 10.
- the height of the distal end side contact portion 36 is preferably 0.06 to 0.11 mm, and particularly preferably 0.08 to 0.11 mm.
- the axial length of the distal end side contact portion 36 is preferably 0.1 to 3.0 mm, and particularly preferably 0.3 to 2.0 mm.
- the front end side contact part 36 is a cyclic
- the base end side contact part 35 is a cyclic
- the annular protrusion is formed, for example, by attaching a cylindrical member to the outer periphery of the distal end side tube.
- the base end side contact part 35 does not contact the inner surface of the stent storage tube body 5. By doing so, the proximal-side contact portion 35 does not become an obstacle to the operation when the stent is released.
- the proximal end contact portion 35 has a height capable of contacting the proximal end of the stent 10.
- the height of the base end side contact portion 35 is preferably 0.08 to 0.18 mm, and particularly preferably 0.1 to 0.16 mm. Further, the axial length of the base end side contact portion 35 is preferably 0.1 to 3.0 mm, and particularly preferably 0.3 to 2.0 mm. Further, the distance between the outer surface of the proximal end contact portion 35 and the inner surface of the stent housing tube body 5 is preferably 0.01 to 0.04 mm. Further, the base end side contact portion 35 is higher than the tip end side contact portion 36, and the difference in height between them is preferably 0.02 to 0.1 mm. Furthermore, it is preferable that the distal end side contact portion 36 and the proximal end side contact portion 35 are formed of a contrast material.
- the above-described contrast marker forming material can be preferably used.
- it is preferably formed by attaching a cylindrical member made of a contrast material.
- the distal end side contact portion 36 and the proximal end side contact portion 35 are made of contrast material and have different axial lengths. By doing in this way, both can be easily identified. Either may be longer, but the difference between the two is preferably 0.3 to 1.0 mm.
- the inner tube body 3 (specifically, the distal end side tube 31) communicates with the guide wire lumen on the proximal side from the stent storage site of the stent storage tube body 5.
- An opening 39 is provided.
- the distal tube 31 may be provided with a reinforcing layer 31 a at least on the proximal side of the proximal end of the stent.
- the reinforcing layer 31 a is preferably provided over the entire distal end side tube 31. Note that the reinforcing layer 31 a may not be provided at the most distal end portion of the distal end side tube 31.
- the reinforcing layer 31a is preferably a mesh-like reinforcing layer.
- the mesh-like reinforcing layer is preferably formed by blade lines.
- the blade wire can be formed of, for example, a metal wire such as stainless steel, elastic metal, superelastic alloy, or shape memory alloy having a wire diameter of 0.01 to 0.2 mm, preferably 0.03 to 0.1 mm.
- wire with synthetic fibers, such as a polyamide fiber, a polyester fiber, a polypropylene fiber.
- the inner tube body 3 connects the distal end side tube 31, the proximal end side tube 34, and the proximal end portion of the distal end side tube 31 and the distal end portion of the proximal end side tube 34.
- a wire-like member 33 and a connector 46 fixed to the proximal end of the proximal end side tube 34 are provided.
- the proximal end side tube 34 of the inner tube body opens at the distal end within the stent storage tube body 5 (specifically, within the distal end portion of the proximal end tube 22 of the stent storage tube body 5), and the proximal end within the connector 46.
- a tube having an internal lumen penetrating through As shown in FIG.
- the inner tube body 3 includes a connecting member that connects the distal end side tube 31 and the proximal end side tube 34.
- the connecting member is composed of a wire-like member 33 and a heat shrinkable tube 81.
- the proximal end portion of the wire-like member 33 enters the distal end portion of the proximal end side tube 34 and is fixed.
- the distal end portion of the wire-like member 33 is fixed to the side surface of the distal end side tube 31 by a heat shrinkable tube 81.
- the wire-like member 33 has a small diameter portion on the distal end side of the portion fixed to the distal end side tube 31.
- the length of the inner tube body 3 is preferably 400 to 2500 mm, and particularly preferably 400 to 2200 mm.
- the outer diameter of the base end side tube 34 is preferably 0.3 to 3.0 mm, and particularly preferably 0.5 to 1.0 mm.
- the inner diameter of the proximal end side tube 34 is preferably 0.1 to 2.5 mm, and particularly preferably 0.2 to 2.0 mm.
- the length of the distal end side tube 31 is preferably 10 to 400 mm, particularly preferably 50 to 350 mm, and the outer diameter is preferably 0.2 to 2.0 mm, and particularly preferably 0.4 to 1.7 mm.
- the inner diameter of the lumen 61 is preferably 0.1 to 1.8 mm, and particularly preferably 0.3 to 1.0 mm.
- the inner tube body As a forming material of the inner tube body (the distal end side tube 31 and the proximal end side tube 34), a material having hardness and a certain degree of flexibility is preferable.
- a material having hardness and a certain degree of flexibility is preferable.
- stainless steel, super elastic metal, polyethylene, polypropylene, nylon Fluorine polymers such as polyethylene terephthalate and ETFE, PEEK (polyether ether ketone), polyimide and the like can be preferably used.
- the outer surface of the inner tube body 3 may be coated with a material having biocompatibility, particularly antithrombotic properties.
- antithrombogenic material for example, polyhydroxyethyl methacrylate, a copolymer of hydroxyethyl methacrylate and styrene (for example, HEMA-St-HEMA block copolymer) and the like can be preferably used. Furthermore, it is preferable that the outer surface of the part which may protrude from the stent storage tube body 5 among the inner tube bodies 3 has lubricity.
- a hydrophilic polymer such as, for example, may be coated or fixed. Further, the above may be coated or fixed on the entire outer surface of the inner tube body 3. Furthermore, in order to improve the slidability with the guide wire, the inner tube body 3 may be coated with or fixed to the inner surface of the inner tube body 3.
- the proximal tube 34 penetrates through the stent housing tube and protrudes from the proximal opening of the stent housing tube 5 (proximal tube 22).
- a connector 46 is fixed to the proximal end portion of the proximal end side tube 34.
- a liquid injection tool can be connected to the connector 46, and the liquid injected by the connected liquid injection tool passes through the lumen 38 in the proximal tube 34.
- the stent delivery system (stent storage tube body) flows out and flows out in the distal end side portion of the stent delivery system (stent storage tube body), and the stent delivery system (stent storage tube body) can be flushed. ).
- the stent 10 included in the stent delivery system 1 of the present invention is partially exposed from the stent storage tube body 5, the stent 10 can be stored in the stent storage tube body 5 again by the advancement of the stent storage tube body 5.
- the stent holding function is not limited to the above-described configuration, and may be, for example, as shown in FIG.
- the inner tube body 3 is provided on an outer surface at a position that is at least in the proximal end portion of the stent, and includes an elastic member 85 that presses the stent 10 toward the stent housing tube body 5. It is sandwiched between the elastic member 85 and the stent storage tube body 5 and is slidable with respect to the stent storage tube body 5. Further, the stent 10 is substantially non-slidable with respect to the elastic member 85.
- the elastic member 85 is fixed to the outer surface of the inner tube body 3 (specifically, the distal end side tube 31). And the elastic member 85 is a wire coil which has the elastic part 85b which presses the fixing
- the fixing portion 85a is formed by winding a wire constituting a wire coil around the distal end side tube 31, and the elastic portion 85b has a wire forming the fixing portion 85a from the distal end side tube 31 as shown in FIG. It is comprised by expanding and diameter-separating.
- the elastic portion 85b has a size that can press the stent 10 housed in the stent housing tube body 5 and has spring elasticity.
- At least the elastic portion 85b of the elastic member 85 made of a wire coil is slightly inclined toward the base end side as shown in FIG.
- at least the elastic portion 85b of the elastic member 85 made of a wire coil may be slightly inclined toward the distal end side.
- the elastic member 85 presses a part of the inner periphery of the stent 10 as shown in FIG.
- a plurality of elastic members 85 are provided.
- a plurality of elastic members 85 are provided in the proximal end portion of the stent 10.
- the arrangement intervals of the elastic members 85 are substantially equal.
- the operation unit 6 includes a moving mechanism for moving the stent storage tube body 5.
- the operation unit 6 includes a housing 40 and a shaft-shaped rack member that is housed in the housing 40 and is fixed to the proximal end of the stent housing tube body 5 (specifically, the proximal tube 22).
- an operation rotation roller 50 having an operation gear 54 for meshing with the gear 66 of the rack member 43 and moving the rack member 43 within the housing 40, and the stent storage tube body 5 (specifically, fixed to the rack member 43) Specifically, it includes a connector 46 that passes through the proximal tube 22) and is fixed to the proximal end of the proximal tube 34 that protrudes from the proximal end of the stent housing tube body 5.
- the operation unit 6 of this embodiment includes a moving mechanism for moving the shaft-shaped rack member 43 backward and forward, whereby the stent storage tube body 5 fixed to the rack member 43 is moved with respect to the inner tube body 3. Thus, it is possible to retract (expose the stent) and advance (stent storage).
- the operation unit 6 includes a housing 40 as shown in FIGS.
- the housing 40 includes a first housing 41 and a second housing 42.
- the housing 40 has a shape in which the proximal end side and the central portion are bent and rounded, so that the housing 40 is easily grasped and the roller is easily operated in the grasped state.
- the housing 40 includes an opening 72 for partially protruding the operation rotary roller 50 from the storage portion, a bearing portion 56 for storing one end 52 of the rotation shaft of the roller 50, and a roller A bearing portion 68 that houses the other end 53 of the 50 rotation shafts is provided.
- a cylindrical connector 46 is fixed to the proximal end portion of the proximal end side tube 34 of the inner tube body 3, and the housing 40 includes housing portions 58 and 69 of the connector 46.
- a shaft-shaped rack member 43 is fixed to the proximal end portion of the proximal end tube 22 of the stent housing tube body 5, and the housing 40 accommodates the rack member 43 so as to be movable in the axial direction. Parts 70 and 71 are provided.
- a distal end member 48 is fixed to the distal end portion of the housing 40 so as to slidably fit the proximal end tube 22 of the stent housing tube body 5. In the distal end member 48, a passage 67 through which the proximal end tube 22 slidably passes is provided.
- the rack member 43 is composed of a first rack member 44 and a second rack member 45, and sandwiching the proximal end portion of the proximal tube 22 of the stent housing tube body 5 between the two, A proximal end portion of the proximal end tube 22 is fixed.
- the rack member 43 has a shaft shape longer than the stent 10 by a predetermined length, and a gear 66 is formed on a roller side surface (a surface facing the lower side of the housing). The gear 66 is provided on the entire gear forming surface of the rack member 43. As shown in FIGS.
- the operation rotating roller 50 includes one end 52 of a rotating shaft provided on one side surface, the other end 53 of the rotating shaft provided on the other side surface, and a gear of the rack member 43. 66 and an operating gear 54 for moving the rack member 43 in the housing 40.
- the operating gear 54 has a smaller diameter than the rotating roller, and the outer diameter of the operating gear 54 is preferably 10 to 60 mm.
- the roller 50 includes a gear-like portion 55 provided to enable intermittent rotation of the roller. The operation rotating roller 50 is partially exposed from the opening 72 of the housing 40, and this portion becomes an operation portion.
- the operation unit 6 includes a lock lever 47.
- the lock lever 47 includes a lock lever main body 62, a lock bar 63 protruding from the lock lever main body 62, and a mounting portion 64 to the housing. I have.
- the first housing 41 engages with a lock bar storage port 59 that slidably stores the lock bar 63, and a mounting portion 64 that is slidable and engages with a distal end portion of the mounting portion 64.
- a mounting opening 60 for holding the lock lever 47 is provided.
- the mounting opening 60 is provided with a rib 65 for holding the position of the lock lever 47 in the locked state and the unlocked position.
- the lock bar 63 contacts the base end surface of the rack member 43, and the rear of the rack member 43 ( The movement in the connector member 46 direction and the stent release direction) is prevented.
- the lock lever mounting portion 64 is formed on the inner surface of the mounting port 60 by pressing down the lock lever 47 (pressing in a direction away from the opening 72 of the housing 40).
- the operation unit 6 of this embodiment abuts against the end of the rack member when the operation rotary roller 50 rotates, and the rack member moves more than a predetermined amount (in other words, the rotation of the roller, the stent storage tube body 5).
- a movement restricting portion (rotation restricting portion) for restricting movement with respect to the inner tube body 3 is provided. Specifically, as shown in FIG. 16 showing a state in which the first housing 41 is removed from the operation unit 40, the tip 43a of the rack member 43 can come into contact with the inner surface of the tip of the housing 40 (second housing). Thus, the rack member 43 cannot advance further.
- the operation portion 6 of this embodiment abuts against the front end 43a of the rack member 43 when the operation rotation roller 50 rotates in a direction opposite to a predetermined direction (advancing direction of the stent storage tube body 5 and a stent storage direction). Further, a movement restricting portion (rotation restricting portion) for restricting further movement of the rack member (rotation of the roller) is provided. Similarly, as shown in FIGS. 16 and 19, the base end 43 b of the rack member 43 can come into contact with the base end inner surface 42 a of the housing 40 (second housing). No further retreat is possible.
- the operation rotating roller 50 rotates in a predetermined direction (the retracting direction of the stent housing tube body 5 and the stent releasing direction), it contacts the base end 43b of the rack member 43. It has a movement restricting portion (rotation restricting portion) that restricts the movement (roller rotation) of the rack member as described above (predetermined or more).
- rotation restricting portion that restricts the movement (roller rotation) of the rack member as described above (predetermined or more).
- Such an idling generation mechanism can be formed, for example, by a clearance in a bearing portion 56 that houses one end 52 of the rotating shaft of the operation rotating roller 50 and a bearing portion 68 that houses the other end 53 of the rotating shaft of the roller 50. it can. And it is preferable that said safety setting value shall be lower than the fracture strength of a stent storage tube body.
- the operation unit 6 of this embodiment is provided with a roller intermittent rotation mechanism that holds the operation rotation roller 50, applies rotation resistance, and enables intermittent rotation of the roller.
- the roller intermittent rotation mechanism is constituted by a gear-like portion 55 provided on the operation rotary roller 50 and an elastically deformable pin 49 whose tip portion enters a recess of the gear-like portion 55.
- the elastically deformable pin 49 includes a main body portion extending in the direction of the gear-shaped portion 55 and a base portion provided at the base end portion of the main body portion, and the base portion is fixed to the pin fixing portion 74 of the second housing 42. ing.
- the gear-shaped portion 55 is formed on a surface different from the surface on which the operating gear 54 of the roller 50 is formed.
- the deformable pin 49 presses the roller 50 in the direction of the opening 72, so that inadvertent rotation is restricted.
- the pin 49 is deformed to allow the roller to rotate, and when the tip of the pin 49 enters the recess of the gear-shaped portion 55, the roller is held. (Stepwise) rotation is possible.
- the pin 49 generates a sound when restoring after deformation when the roller rotates. In this way, the operator can recognize the rotation.
- the pin 49 generates a recognizable rotation sound depending on the rotation direction of the roller. By doing in this way, it is possible to confirm in which direction the sound rotates, in other words, whether the stent housing tube body 5 is advanced or retracted.
- the stent delivery system 1 in which the guide wire 82 is inserted into the distal tube 31 is inserted into the blood vessel to be treated, and the stent reaches the target site.
- the entire stent 10 is stored in the stent storage tube body 5.
- the lock lever 47 is pushed and the lock
- the stent storage tube body 5 moves rearward with respect to the inner tube body 3, and as shown in FIG. 10 is gradually exposed and expanded from its tip side.
- the proximal end of the stent 10 abuts on the proximal end abutting portion 35 of the inner tube body 3 (the distal end side tube 31). Since the movement toward the proximal end side is restricted, the stent 10 can be exposed.
- the stent 10 exposed from the stent housing tube body 5 expands by a self-expanding force and tries to restore the form before compression.
- the stent storage tube body 5 is moved in the distal direction as shown in FIG. 22 by rotating the roller in a direction opposite to the predetermined direction (arrow direction).
- the stent is moved and part or all of the stent is re-stored in the stent storage tube body 5 (the distal end side tube 31).
- the proximal-side inward protruding portion 17a of the stent 10 abuts on the distal-side abutting portion 36 of the inner tube body 3 (the distal-side tube 31), so that the movement of the stent 10 toward the distal end side is performed. Due to the restriction, the stent 10 can be stored.
- the stent storage tube body 5 is moved to the proximal end side by rotating the roller again in a predetermined direction (arrow direction). It is exposed from the tip opening of the tube body 5. Then, by rotating the roller in a predetermined direction (arrow direction) until the proximal end of the stent is exposed, the stent is completely released from the stent housing tube body and detached from the inner tube body 3. Further, in the stent delivery system 1 of the present invention, a liquid injection tool (not shown) can be connected to the connector 46, and liquid injection into the stent delivery system 1 is performed by the connected liquid injection tool. Is possible.
- the liquid injected from the connector 46 passes through the lumen 38 in the proximal end side tube 34 and flows out in the distal end side portion of the stent delivery system (stent accommodating tube body), and the stent delivery system (stent accommodating tube).
- the inside of the body) can be flushed, and further, it can be discharged from the tip of the stent delivery system (stent housing tube body).
- the stent used in the present invention may be as shown in FIG. Similar to the stent 10 described above, the stent 170 is a so-called self-expanding stent that has a large number of openings on its side surface and can be expanded outwardly and restored to its original shape when compressed in vivo. Furthermore, the stent 170 includes a distal end portion facing the distal end side of the stent housing tube body (stent housing member) 5 and a proximal end portion facing the proximal end side, and further, the stent 170 can be bent at least toward the proximal end side except for the proximal end portion.
- the exposed distal end portion is moved to the stent housing tube body 5. It can be stored again.
- the stent 170 is an in-vivo indwelling stent formed in a substantially cylindrical shape.
- the stent 170 includes a plurality of connecting struts that connect the wavy struts 173 and 174 that extend in the axial direction from one end side to the other end side of the stent 170 and are arranged in the circumferential direction of the stent, and the adjacent wavy struts 173 and 174. 175.
- Adjacent wavy struts 173 and 174 include a plurality of adjacent portions and spaced apart portions, and a connection strut 175 connects adjacent portions of the adjacent wavy struts 173 and 174, and the axial front end side of the stent is disposed at the center portion.
- a bent portion 185 is provided.
- the plurality of wavy struts 173 and 174 include a plurality of first wavy struts 173 having a plurality of upper points 173a and a plurality of lower points 173b, a plurality of upper points 174a and a plurality of lower points 174b. And a plurality of second wavy struts 174 located between the first wavy struts.
- Each adjacent first wavy strut 173 and second wavy strut 174 forms a proximity portion by having the lower or upper point of the other wavy strut close to the upper or lower point of one wavy strut substantially facing each other. Yes.
- connection strut 175 connects the upper point 173a or the lower point 173b of the first wavy strut 173 constituting the proximity portion and the lower point 174b or the upper point 174a of the second wavy strut. Further, each adjacent first wavy strut 173 and second wavy strut 174 forms a separation portion by the upper point or lower point of the other wavy strut adjacent to the lower point or upper point of one wavy strut substantially facing each other. is doing.
- the stent 170 is formed in a substantially cylindrical shape, and is a so-called self-expanding stent that is compressed in the central axis direction when inserted into a living body and expands outwardly when it is placed in the living body to restore the shape before compression.
- the first wavy strut 173 extends in the axial direction substantially parallel to the central axis of the stent.
- a plurality of first wavy struts 173 are arranged in the circumferential direction of the stent.
- the number of first wavy struts 173 is preferably 2 or more, and particularly 3 to 8 is preferable.
- the plurality of first wavy struts 173 are preferably arranged so as to be substantially equiangular with respect to the central axis of the stent.
- the first wavy strut 173 has substantially the same waveform for a predetermined length except for both sides.
- the first wavy strut 173 has substantially the same waveform, that is, waves having the same wavelength and the same amplitude, except for the vicinity of both ends.
- the wavelength varies depending on the outer diameter of the stent, but is preferably 0.5 to 8.0 mm, particularly 2.0 to 4.0 mm is preferable, and the amplitude is preferably 0.1 to 10.0 mm, and particularly preferably 0.3 to 3.0 mm.
- the second wavy strut 174 also extends in the axial direction substantially parallel to the central axis of the stent.
- a plurality of second wavy struts 174 are arranged in the circumferential direction of the stent, and each second wavy strut 174 is arranged between each first wavy strut.
- the number of the second wavy struts 174 is preferably 2 or more, and particularly 3 to 8 is preferable.
- the plurality of second wavy struts 174 are preferably arranged so as to be substantially equiangular with respect to the central axis of the stent.
- the number of second wavy struts 174 is the same as the number of first wavy struts.
- the second wavy strut 174 has substantially the same waveform for a predetermined length except for both sides. That is, the second wavy strut 174 has substantially the same waveform, that is, waves having the same wavelength and the same amplitude, except for the vicinity of both ends.
- the wavelength varies depending on the outer diameter of the stent, but is preferably 0.5 to 8.0 mm, particularly 2.0 to 4.0 mm is preferable, and the amplitude is preferably 0.1 to 10.0 mm, and particularly preferably 0.3 to 3.0 mm.
- the first wavy strut 173 and the second wavy strut 174 have substantially the same waveform.
- the first wavy strut 173 and the second wavy strut 174 have substantially the same wavelength and substantially the same amplitude, and the second wavy strut 174 is relative to the first wavy strut 173.
- About half wavelength is shifted in the axial direction of the stent. Therefore, as shown in FIG.
- the adjacent first wavy strut 173 and second wavy strut 174 are the upper point 173 a or lower point 173 b of the first wavy strut 173 and the lower point 174 b or upper side of the second wavy strut 174.
- the point 174a substantially faces each other to form a proximity part and a separation part.
- the adjacent first wavy strut 173 and second wavy strut 174 are such that their upper points and lower points do not face each other. It has alternately.
- each of the wavy struts 173 and 174 has the same length except for both ends.
- each strut approaches parallel to the axial direction, and since the length is the same, the diameter is reduced without stretching in the axial direction.
- the wavy struts 173 and 174 are arranged so as to be equiangular with respect to the central axis of the stent except for both ends. For this reason, when the stent is compressed in the central axis direction, the gaps between the struts are uniformly reduced, so that the struts contract well without overlapping.
- the axial length of the connecting strut 175 varies depending on the outer diameter of the stent, but is preferably 0.1 to 3.0 mm, and particularly preferably 0.5 to 2.0 mm. Further, the connecting strut 175 is symmetric with respect to the central axis of the stent 170 and the apex of the bent portion 185.
- connection strut 175 In the stent 170, almost all of the plurality of adjacent portions of the adjacent first wavy strut 173 and second wavy strut 174 are connected by the connecting strut 175.
- the bent portion 185 of the connection strut 175 is located in the vicinity of the separation portion formed between the waved struts 173 and 174. Further, the bent portion 185 of the connecting strut 175 is a free end facing the distal end direction of the stent 170.
- a plurality of connection struts 175 are provided in series in the axial direction of the stent.
- a plurality of connection struts 175 are provided in the circumferential direction of the stent.
- the stent 170 of this embodiment includes a bent portion 172 formed by combining the distal ends of the first wavy strut 173 and the second wavy strut 174 at the distal end portion of the stent, the first wavy strut 173 and the branching portion.
- 161 a distal end portion of the linear portion 163 connected via the 161, a second wavy strut 174, and a bent portion 176 formed by joining the distal end portions of the linear portion 164 connected via the branch portion 162, are provided alternately.
- a radiopaque marker 177 is attached to the bent portion 176. Further, the bent portion 176 having the radiopaque marker 177 is located on the distal end side of the stent with respect to the bent portion 172.
- the stent 170 includes a bent portion 179 formed by joining the proximal ends of the first wavy strut 173 and the second wavy strut 174 at the proximal end portion of the stent, the first wavy strut 173 and the branching portion 181.
- a bent portion 178 formed by joining a proximal end portion of the linear portion 183 connected via the second wavy strut 174 and a proximal end portion of the linear portion 184 connected via the branching portion 182 to each other. It is to prepare alternately in the direction.
- the stent 170 forms a proximal end portion facing the proximal end side of the stent housing tube body by the bent portion 178 and the bent portion 179.
- a radiopaque marker 177 is attached to the bent portion 178.
- a radiopaque marker 177 forms a proximal side inward protruding portion 177a to be described later.
- the bent portion 178 having the radiopaque marker 177 is located on the proximal end side of the stent with respect to the bent portion 179. And this stent 170 does not have the free end which faces the base end direction of a stent except for the bending parts 178 and 179.
- the stent storage tube body (stent storage member).
- the linear portions 183 and 184 constituting the bent portion 178 in the proximal end portion are longer in the axial direction than the linear portions 163 and 164 constituting the bent portion 176 in the distal end portion. It has become.
- the stent 170 is inserted into the living body from the distal end side (the bent portion 176 side) and is left in place.
- the radiopaque marker 177 encapsulates almost the whole or a part of the two frame parts constituting the bent part.
- the radiopaque marker 177 has a thin rectangular parallelepiped shape, and is housed in the two frame portions and is fixed to the two frame portions by recessing the central portion.
- a material for forming the radiopaque marker for example, one kind selected from the group of elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, and hafnium (single substance) Alternatively, two or more kinds (alloys) can be suitably used.
- the length of the marker is preferably from 0.1 to 4.0 mm, particularly preferably from 0.3 to 1.0 mm.
- the marker thickness is preferably from 0.01 to 0.30 mm, particularly preferably from 0.03 to 0.10 mm.
- FIG. 25 is an explanatory diagram for explaining a stent delivery system using the in-vivo stent of FIG.
- the stent 170 includes a proximal-side inward protruding portion 177 a formed by a radiopaque marker 177.
- the bent portion 178 is disposed so as to be positioned between the distal-side contact portion 36 and the proximal-side contact portion 35 of the inner tube body 3.
- the bent portion 179 provided between the adjacent bent portions 178 is disposed so as to be located on the distal end side with respect to the distal end side contact portion 36.
- the radiopaque markers 177 adjacent to each other are prevented from coming into contact with each other or overlapping, and the stent 170 contracts well.
- the stent delivery system of the present invention is as follows. (1) a stent having a large number of side wall openings, formed in a substantially cylindrical shape, compressed in the direction of the central axis when inserted into the living body, and expanded outwardly when placed in the living body to be restored to the shape before compression; An inner tube body having a guide wire lumen; and a stent housing tube body in which the stent is housed in a distal end portion; and the stent is disposed so as to cover the distal end portion of the inner tube body, and the stent housing tube body.
- the stent delivery system main body capable of releasing the stent and the proximal end portion of the stent delivery system main body are provided, and the stent storage tube body is moved.
- a stent delivery system including an operation unit including a moving mechanism for causing
- the inner tube body includes a distal tube having the guide wire lumen, and a proximal tube that is connected to the proximal side of the distal tube and penetrates the stent storage tube body
- the operation portion includes a housing, a shaft-shaped rack member fixed to the proximal end of the stent storage tube body, which is accommodated in the housing, and meshes with a gear of the rack member, and the rack member is accommodated in the housing.
- a rotating roller for operation having an operating gear for moving and a proximal end portion of the proximal end side tube protruding from a proximal end of the stent housing tube body fixed to the rack member, and mounted on the housing With a held connector,
- the stent delivery system holds the stent releasably and re-stors the stent in the stent housing tube by advancement of the stent housing tube body after partial exposure of the stent from the stent housing tube body.
- the rack member can be connected to the connector in the housing by rotating the rotating roller for operation in a direction opposite to the predetermined direction after the stent is partially exposed from the stent housing tube body.
- the stent is moved in the opposite direction, and the step into the stent storage tube is performed.
- the stent delivery system is a possible capital of the re-accommodated.
- the stent delivery system according to (1) wherein the proximal end side tube has a lumen having a distal end opening in the stent storage tube body and communicating to the proximal end.
- the stent delivery system according to (2) wherein the stent delivery system is capable of injecting liquid into the stent delivery system using the lumen in the proximal tube from the connector.
- the stent includes a distal end portion facing the distal end side of the stent storage tube body and a proximal end portion facing the proximal end side, and does not have a bending free end facing the proximal end side except for the proximal end portion.
- the stent delivery system as described.
- the operation unit includes a lock mechanism that releasably locks the rack member.
- the operation unit includes a movement regulating unit that abuts against an end of the rack member and regulates the movement of the rack member at a predetermined level or more when the operation rotating roller rotates in the predetermined direction.
- the operation portion includes a movement restricting portion that abuts against an end portion of the rack member and restricts movement of the rack more than a predetermined amount when the operation rotating roller rotates in a direction opposite to the predetermined direction.
- the stent delivery system according to any one of (1) to (6) above. (8) Any of the above (1) to (7), wherein the operation unit includes a roller intermittent rotation mechanism that applies rotation resistance to the operation rotation roller and enables intermittent rotation of the roller.
- the stent delivery system is provided with the stent-holding function as a function of holding the distal end provided in the proximal end portion of the stent of the inner tube body and not entering the side wall opening of the stent.
- a proximal end abutting portion provided at a position behind the proximal end of the stent and in the vicinity of the distal end side abutting portion of the inner tube body and capable of contacting the proximal end of the stent.
- the stent includes a proximal-side inward protruding portion capable of contacting the distal-side abutting portion, and the proximal-side inward protruding portion is The stent delivery system according to (9), wherein the stent delivery system is configured so as to be positioned between the distal end side contact portion and the proximal end side contact portion of the inner tube body.
- the stent delivery system includes, as the stent holding function, an elastic member that is provided at a position at least in the proximal end portion of the stent of the inner tube body and presses the stent toward the stent housing tube body.
- the stent according to any one of (1) to (8), wherein the stent is sandwiched between the elastic member and the stent storage tube body and is slidable with respect to the stent storage tube body. Stent delivery system.
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Abstract
Description
以下血管を例に説明するが、これに限定されるものではない。
ステントは、体外から生体内に挿入する際には、その直径が小さく、目的の狭窄もしくは閉塞部位で拡張させて直径を大きくし、かつその管腔をそのままで保持する物である。
ステントとしては、金属線材、あるいは金属管を加工した円筒状のものが一般的である。ステントは、カテーテルなどに細くした状態で装着され、生体内に挿入され、目的部位(狭窄あるいは閉塞部位)で何らかの方法で拡張させ、その管腔内壁に密着、固定することで管腔形状を維持する。ステントは、機能および留置方法によって、自己拡張型ステントとバルーン拡張型ステントに区別される。バルーン拡張型ステントはステント自体に拡張機能はなく、バルーンの上にマウントしたステントを目的部位に挿入した後、バルーンを拡張させ、バルーンの拡張力によりステントを拡張(塑性変形)させ目的管腔の内面に密着させて固定する。このタイプのステントでは、上記のようなステントの拡張作業が必要になる。一方、自己拡張型ステントはステント自体に拡張機能を持たせたものであり、細く縮めた状態として生体内に挿入し、目的部位で開放することで自ら元の拡張された状態に戻り管腔内壁に密着、固定して管腔形状を維持する。
現在のステント留置の目的は、何らかの原因で狭窄あるいは閉塞した血管を元の開存状態に戻すことであり、主にはPTCA等の手技を施した後に起こる再狭窄の予防、その低減化を図るものがほとんどである。近年においては、より再狭窄の確率を抑制するために、免疫抑制剤や制癌剤等の薬剤を搭載した薬剤溶出ステントも使用されており、その効果が一般的に知られている。
また、特許文献2(特表2007-504897号公報、WO2005/032614)には、患者の体内に医療器具(ステント)を送達して配備するシステムであって、医療器具が取り付けられる領域を備えた内側カテーテル部材と、内側カテーテル部材及び医療器具上に同軸状に嵌められた外側拘束部材を含む送達カテーテルを有し、外側拘束部材は、内側カテーテル部材に対して軸方向に運動できるようになっており、格納機構に連結されている回転式サムホイールを備えた操作ハンドルを有し、内側カテーテル部材は、操作ハンドルに取り付けられた近位端部を有し、外側拘束部材は、格納機構に取り付けられた近位端部を有し、サムホイールの回転により、格納機構の直線運動が引き起こされて外側拘束部材シースが近位側へ引っ込められ、内側カテーテル部材が静止状態のままで医療器具が露出される送達システムが開示されている。
特許文献2のものでは、ステントを放出するための外側拘束部材の操作性が良好なものとなっている。しかし、特許文献2のものでもステントのステントデリバリーシステム内への再収納は困難である。
多数の側壁開口を有し、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元可能なステントと、ガイドワイヤルーメンを有する内側チューブ体と、前記ステントを先端部内に収納したステント収納チューブ体とを備え、かつ前記ステントが前記内側チューブ体の先端部を覆うように配置され、かつ前記ステント収納チューブ体を前記内側チューブ体に対して基端側に移動させることにより、前記ステントを放出可能であるステントデリバリーシステム本体と、該ステントデリバリーシステム本体の基端部に設けられ、前記ステント収納チューブ体を移動させるための移動機構を備える操作部とを備えるステントデリバリーシステムであって、前記内側チューブ体は、前記ガイドワイヤルーメンを有する先端側チューブと、該先端側チューブの基端側に連結された、前記ステント収納チューブ体内を貫通する基端側チューブとを備え、前記操作部は、ハウジングと、前記ハウジング内に収納された、前記ステント収納チューブ体の基端に固定されたシャフト状のラック部材と、前記ラック部材の歯車と噛み合い前記ラック部材を前記ハウジング内にて移動させるための作動歯車を有する操作用回転ローラと、前記ラック部材に固定された前記ステント収納チューブ体の基端より突出する前記基端側チューブの基端部に固定され、かつ前記ハウジングに保持されたコネクタとを備え、前記ステントデリバリーシステムは、前記ステントを解除可能に保持し、前記ステントの前記ステント収納チューブ体からの部分的露出後に前記ステント収納チューブ体の前進により、前記ステント収納チューブ体内への前記ステントの再収納を可能とするためのステント保持機能を備え、さらに、前記操作用回転ローラの所定方向への回転による前記ラック部材の前記コネクタ方向への移動により、前記ステントの前記ステント収納チューブ体からの放出を可能とし、かつ、前記ステントの前記ステント収納チューブ体からの部分的露出後に、前記操作用回転ローラを前記所定方向と逆方向に回転させることにより、前記ラック部材を前記ハウジング内にて前記コネクタと反対方向に移動させ、前記ステント収納チューブ体内への前記ステントの再収納が可能であるステントデリバリーシステム。
本発明のステントデリバリーシステムでは、操作用回転ローラの所定方向への回転により、シャフト状のラック部材がハウジング内にてコネクタ方向に移動し、ステントのステント収納チューブ体からの放出が可能であるので、ステントの放出操作が容易である。さらに、ステントのステント収納チューブ体からの部分的露出後に、操作用回転ローラを所定方向と逆方向に回転させることにより、シャフト状のラック部材がハウジング内にてコネクタと反対方向に移動し、ステント収納チューブ体内へのステントの再収納が可能であるので、ステントをある程度ステント収納チューブ体より露出させた後であっても、再度ステント収納チューブ体内に収納することができ、ステントの再配置を行うことができ、かつ、ステントのステント収納チューブ体への収納作業もローラを回転させるのみであるので、操作が容易である。
また、基端側チューブは、先端部がステント収納チューブ体内にて開口し、基端まで連通するルーメンを有し、コネクタより、基端側チューブ内のルーメンを用いてステントデリバリーシステム内への液体の注入が可能なものであれば、ステント収納チューブ体の先端部内のプライミング作業が容易となり、さらに、ステント収納チューブ体の先端より液体(例えば、薬剤)の吐出も可能となる。
本発明のステントデリバリーシステム(言い換えれば、生体器官病変部改善用器具)1は、多数の側壁開口を有し、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元可能なステント10と、ガイドワイヤルーメン61を有する内側チューブ体3と、ステント10を先端部内に収納したステント収納チューブ体(ステント収納部材)5とを備え、かつステント10が内側チューブ体3の先端部を覆うように配置され、かつステント収納チューブ体5を内側チューブ体3に対して基端側に移動させることにより、ステント10を放出可能であるステントデリバリーシステム本体2と、ステントデリバリーシステム本体2の基端部に設けられ、ステント収納チューブ体5を移動させるための移動機構を備える操作部6とを備える。
そして、内側チューブ体3は、ガイドワイヤルーメン61を有する先端側チューブ31と、先端側チューブ31の基端側に連結された基端側チューブ34とを備える。
そして、操作部6は、ハウジング40と、ハウジング40内に収納された、ステント収納チューブ体5(具体的には、基端チューブ22)の基端に固定されたシャフト状のラック部材43と、ラック部材43の歯車66と噛み合いラック部材43をハウジング40内にて移動させるための作動歯車54を有する操作用回転ローラ50と、ラック部材43に固定されたステント収納チューブ体5(具体的には、基端チューブ22)を貫通し、かつ基端より突出する基端側チューブ34の基端部に固定され、かつハウジング40に保持されたコネクタ46とを備える。
そして、ステントデリバリーシステム1は、ステント10を解除可能に保持し、ステント10のステント収納チューブ体5からの部分的露出後に、ステント収納チューブ体5の前進により、ステント収納チューブ体5内へのステント10の再収納を可能とするためのステント保持機能35,36を備える。さらに、操作用回転ローラ50の所定方向への回転により、シャフト状のラック部材43が、ハウジング40内にてコネクタ46方向に移動し、ステント10のステント収納チューブ体5からの放出が可能であり、かつ、ステント10のステント収納チューブ体5からの部分的露出後に、操作用回転ローラ50を所定方向と逆方向に回転させることにより、シャフト状のラック部材43がハウジング40内にてコネクタ46と反対方向に移動し、ステント収納チューブ体5内へのステント10の再収納が可能となっている。
そして、この実施例のステントデリバリーシステム1では、内側チューブ体3の基端側チューブ34は、先端部がステント収納チューブ体内にて開口し、基端まで連通するルーメン38を有する。なお、基端側チューブ34は、先端側チューブ31の基端側と連結部材により連結されている。また、この実施例のステントデリバリーシステム1は、コネクタ46より、基端側チューブ34内のルーメン38を用いて、ステントデリバリーシステム内への液体の注入が可能となっている。
そして、図示する実施例のステントデリバリーシステム1は、多数の側壁開口を有し、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元可能なステント10と、ガイドワイヤルーメン61を有する内側チューブ体3と、ステント10を先端部内に収納したステント収納チューブ体5とを備え、かつステント10が内側チューブ体3の先端部を被包するように配置されている。
また、図示する実施例のステントデリバリーシステム1は、生体内留置時には外方に拡張して圧縮前の形状に復元可能なステント10と、ステント10を先端部内に収納したステント収納チューブ体5と、ステント収納チューブ体5の内側を摺動可能に挿通し、ステント10をステント収納チューブ体5の先端より放出するための内側チューブ体3とを備える。ステント10は、ステント収納チューブ体5の先端側を向く先端部と基端側を向く基端部を備え、さらに、基端部を除き少なくとも基端側を向く屈曲自由端を実質的に持たず、ステント収納チューブ体5から先端側部分の露出後にステント収納チューブ体5を先端側に移動させることにより、露出部分をステント収納チューブ体5に再収納可能なものとなっている。ステントデリバリーシステム1は、ステントデリバリーシステムの先端にて一端が開口し、他端がステント収納チューブ体5のステント収納部位より基端側にて開口するガイドワイヤルーメン61を有する。
ステント収納チューブ体5は、図1ないし図7に示すように、先端チューブ21と、先端チューブ21の基端に固定された基端チューブ22とを備える。
先端チューブ21は、管状体であり、先端および基端は開口している。先端開口は、ステント10を管腔の目的部位に留置する際、ステント10の放出口として機能する。ステント10は、この先端開口より放出されることにより応力負荷が解除されて拡張し圧縮前の形状に復元する。先端チューブ21の先端部は、ステント10を内部に収納するステント収納部位となっている。また、先端チューブ21は、ステント収納部位より基端側に設けられた側孔23を備えている。側孔23は、ガイドワイヤを外部に導出するためのものである。
また、先端チューブ21の先端部には、造影マーカー28を設けることが好ましい。図6に示すように、ステント10は、その先端の位置が、造影マーカー28の先端の位置とほぼ一致するように、先端チューブ21内に収納されている。造影マーカー28の形状としては、造影材料により形成された筒状部材であることが好ましい。また、造影マーカーの形成材料としては、イリジウム、プラチナ、金、レニウム、タングステン、パラジウム、ロジウム、タンタル、銀、ルテニウム、及びハフニウムからなる元素の群から選択された一種のもの(単体)もしくは二種以上のもの(合金)が好適に使用できる。
また、基端チューブ22は、先端から基端まで貫通した管路を有するチューブ体であり、先端が上述した先端チューブ21の基端に固定され、基端部は、後述する操作部6内に収納されたラック部材43に固定されている。
先端チューブ21の外径としては、0.5~4.0mmが好ましく、特に、0.8~2.0mmが好ましい。また、先端チューブ21の内径としては、0.2~1.8mmが好ましい。先端チューブ21の長さは、50~500mmが好ましく、特に、100~300mmが好ましい。
基端チューブ22の外径としては、0.3~4.0mmが好ましく、特に、0.5~1.0mmが好ましい。また、基端チューブ22の内径としては、0.1~1.0mmが好ましい。基端チューブ22の長さは、500~4000mmが好ましく、特に、800~2000mmが好ましい。
そして、先端チューブ21は、基端チューブ22より柔軟であることが好ましい。このようにすることにより、操作性が良好となる。
さらに、ステント収納チューブ体5の外面(先端チューブ21および基端チューブ22)には、潤滑性を呈するようにするための処理を施すことが好ましい。このような処理としては、例えば、ポリ(2-ヒドロキシエチルメタクリレート)、ポリヒドロキシエチルアクリレート、ヒドロキシプロピルセルロース、メチルビニルエーテル無水マレイン酸共重合体、ポリエチレングリコール、ポリアクリルアミド、ポリビニルピロリドン、ジメチルアクリルアミド-グリシジルメタクリレート共重合体等の親水性ポリマーをコーティング、または固定する方法などが挙げられる。また、先端チューブ21の内面に、ステント10及び内側チューブ体3との摺動性を良好なものにするため、上述のものをコーティング、または固定してもよい。
そして、この実施例では、内側チューブ体3は、ステント収納チューブ体5のステント収納部位より基端側の側部にて開口するガイドワイヤルーメンの基端側開口を備え、ステント収納チューブ体5は、ステント収納部位より基端側に設けられた側孔を備え、側孔および基端側開口より、ガイドワイヤを挿通可能なものとなっている。
先端側チューブ31は、図5に示すように、その先端は、ステント収納チューブ体5(先端チューブ21)の先端より突出している。また、先端側チューブ31には、ステント収納チューブ体5の先端方向への移動を阻止するストッパー32が設けられている。先端側チューブ31の基端部は、図7に示すように、湾曲し、先端チューブ21の側孔23に侵入し、離脱可能に係合している。先端側チューブ31の外径は、0.2mm~2.0mmであることが好ましい。また、先端側ストッパー32の先端部は、図5に示すように、先端側に向かって縮径していることが好ましい。ストッパー32の最大径部の外径は、0.5~4.0mmであることが好ましい。また、ストッパー32の基端部も図5に示すように、基端側に向かって縮径していることが好ましい。また、先端側チューブ31は、先端より基端まで伸びるガイドワイヤルーメン61を有しており、その基端開口39の位置は、先端側チューブ31の先端より、10~400mm基端側に位置することが好ましく、特に、50~350mm基端側に位置することが好ましい。また、基端開口39の位置は、配置されるステント10の基端(言い換えれば、ステント収納部位の基端)より、50~250mm程度基端側であることが好ましい。
この実施例のステントデリバリーシステム1では、ステント保持機能として、内側チューブ体3は、ステント10の基端部内に位置し、かつ、ステント10の側壁開口内に進入しない位置に設けられた先端側当接部36と、ステント10の基端後方かつ先端側当接部36と近接する位置に設けられ、かつステント10の基端に当接可能な基端側当接部35とを備え、ステント10は、内側チューブ体3の先端側当接部36に当接可能な基端側内方突出部17aを備え、さらに、ステント10は、基端側内方突出部17aが、内側チューブ体3の先端側当接部36と基端側当接部35間に位置するように配置されている。これにより、ステント10のステント収納チューブ体5からの部分的露出後に、ステント収納チューブ体5の前進により、再度ステント収納チューブ体5内へのステント10の再収納が可能となっている。
使用するステントとしては、各線状構成要素の端部が他の線状構成要素と結合することにより、自由端を持たないものとなっているものであってもよい。また、使用するステントとしては、図8および図9に示すようなものであってもよい。図8は、本発明のステントデリバリーシステムに使用される生体内留置用ステントの一例の正面図である。図9は、図8の生体内留置用ステントの展開図である。
このステント10は、ステントの一端側から他端側まで軸方向に延びかつステントの周方向に複数配列された波状ストラット13,14と、各隣り合う波状ストラットを接続するとともに所定長軸方向に延びる1つもしくは複数の接続ストラット15とを備え、さらに、波状ストラット13,14の端部は、近接する波状ストラットの端部と結合されている。また、ステント10は、各ストラット間に形成された多数の開口を備えている。
この実施例のステント10は、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元するいわゆる自己拡張型ステントとなっている。
第2波状ストラット14もステントの中心軸にほぼ平行に軸方向に延びるものとなっている。そして、第2波状ストラット14は、ステントの周方向に複数本配列されており、各第2波状ストラット14は、各第1波状ストラット間に配列されている。第2波状ストラット14の数としては、3本以上であることが好ましく、特に、3~8本が好適である。さらに、複数本の第2波状ストラット14は、ステントの中心軸に対してほぼ等角度となるように配置されていることが好ましい。また、第2波状ストラット14の数は、第1波状ストラット13の数と同じとなっていることが好ましい。
そして、このステント10は、各隣り合う第1波状ストラット13と第2波状ストラット14とを接続するとともに所定長軸方向に延びる1つもしくは複数の接続ストラット15を備えている。特に、この実施例のステント10では、接続ストラット15は、一方の波状ストラットの変曲点付近に一端を有し、隣接する他方の波状ストラットの頂点付近からこの頂点を若干越えた領域に他端を有し、軸方向に延びかつ他方の波状ストラットの頂点と同じ方向に湾曲している。そして、図9に示すように、接続ストラット15は、ステント10の周方向の一方側に向かう頂点を有する湾曲した第1の接続ストラット15aとステント10の周方向の他方側に向かう頂点を有する湾曲した第2の接続ストラット15bとからなる。また、接続ストラット15は、円弧状に湾曲するとともに、ステント10の周方向に近接する第1波状ストラット13または第2波状ストラット14の湾曲部の円弧とほぼ同じ半径を有するものとなっている。
さらに、この実施例のステント10は、図6に示すように、ステント10の先端部に、先端側内方突出部19aを有するものであってもよい。先端側内方突出部19aは、ステントの先端部(結合部)18に装着された造影マーカー19により形成されていることが好ましい。なお、ステントの先端側内方突出部は、ステントの先端部(結合部)に形成された肉厚部により構成してもよい。
基端側内方突出部を形成する造影マーカー17としては、所定の厚さ(線径)を有するものであることが好ましい。そして、図10および図11に示すものでは、造影マーカー17は、基端部(結合部)16を形成する2本のフレーム部を内部に収納し、かつ中央部が窪むとともに、一部が重なり合うことにより、2本のフレーム部に固定されている。
なお、ステントの基端部(結合部)としては、図10および図11に示すような独立した開口を持たないものであってもよい。例えば、ストラットの端部14aの基端が、フレーム部16aの端部と連続し、ストラットの端部13aの基端が、フレーム部16bと連続し、開口がその端部において開放しており、2本のストラット間の空間と連通しているものであってもよい。
さらに、ステントの基端部(結合部)としては、上述した開口を一切を持たないものであってもよい。このタイプのステントでは、結合部は、所定面積を有する若干湾曲した板状部となっており、その表裏面を覆うように、造影マーカーが取り付けられるものとなる。
なお、上述したすべての実施例において、造影マーカーとしては、上記のシート状部材を用いることが好ましいが、ワイヤ状部材をステントの基端部(結合部)に巻き付けたものであってもよい。さらに、この場合においても、ステントの内面側に突出する内側重合部を持たせることが好ましい。上述した造影マーカーの形成材料としては、イリジウム、プラチナ、金、レニウム、タングステン、パラジウム、ロジウム、タンタル、銀、ルテニウム、及びハフニウムからなる元素の群から選択された一種のもの(単体)もしくは二種以上のもの(合金)が好適に使用できる。
そして、造影マーカーの固定は、溶接、はんだ、接着、溶着、拡散のいずれかにて行うことができる。
そして、ステントは、圧縮時の直径が、0.5~1.8mmが好適であり、特に、0.6~1.4mmが好ましい。また、ステントの非圧縮時の長さは、5~200mmが好適であり、特に、8.0~100.0mmが好ましい。また、ステントの非圧縮時の直径は、1.5~6.0mmが好適であり、特に、2.0~5.0mmが好ましい。さらに、ステントの肉厚としては、0.05~0.15mmが好適であり、特に、0.05~0.40mmが好ましい。波状ストラットの幅は、0.01~1.00mmが好適であり、0.05~0.2mmが特に好ましい。波状ストラットの表面は滑らかに加工されていることが好ましく、電解研磨による平滑化がより好ましい。また、ステントの半径方向強度は、0.1~30.0N/cmが好ましく、0.5~5.0N/cmであることが特に好ましい。
そして、上述したステント10の基端側内方突出部17aは、内側チューブ体3の先端側当接部36に当接可能となっている。そして、図6に示すように、ステント10の基端側内方突出部17aは、内側チューブ体3の先端側当接部36と基端側当接部35間に位置している。
そして、この実施例のステントデリバリーシステム1は、図5および図6に示すように、先端側チューブ31の先端より所定距離基端側となる位置に、先端側当接部36を有する。先端側当接部36は、ステント10の基端部内であり、ステント10の基端より若干先端側となる位置に配置されている。そして、この先端側当接部36より若干基端側となる位置に、基端側当接部35が設けられている。基端側当接部35は、ステント10の基端付近かつその後方(基端側)に配置されている。ステント10の基端側内方突出部17aは、内側チューブ体3の先端側当接部36と基端側当接部35間に位置している。このため、先端側当接部36と基端側当接部35間の距離は、ステント10の基端側内方突出部17aの軸方向長より、若干長いものとなっている。先端側当接部36と基端側当接部35間の距離は、ステント10の基端側内方突出部17aの軸方向長より、0.02~1.0mm長いものであることが好ましく、特に、0.05~0.3mm長いことが好ましい。
なお、先端側当接部36は、先端側チューブ31の外周にわたって連続して設けられた環状突出部であることが好ましいが、環状に配置された連続しない複数のリブにより構成してもよい。
さらに、先端側当接部36および基端側当接部35は、造影材料にて形成されていることが好ましい。造影材料としては、上述した造影マーカーの形成材料が好適に使用できる。特に、造影材料からなる筒状部材を取り付けることにより形成することが好ましい。さらに、先端側当接部36および基端側当接部35は、造影材料にて形成されるとともに、両者の軸方向長さが異なるものとなっていることが好ましい。このようにすることにより、両者の識別が容易となる。どちらが長いものであってもよいが、両者の差異は、0.3~1.0mmであることが好ましい。
また、先端側チューブ31は、図7に示すように、少なくともステントの基端より基端側となる部分に補強層31aを備えるものとしてもよい。補強層31aは、先端側チューブ31の全体にわたり設けられていることが好ましい。なお、補強層31aは、先端側チューブ31の最先端部分には設けないものとしてもよい。補強層31aは、網目状の補強層であることが好ましい。網目状の補強層は、ブレード線で形成することが好ましい。ブレード線は、例えば、線径0.01~0.2mm、好ましくは0.03~0.1mmのステンレス、弾性金属、超弾性合金、形状記憶合金等の金属線で形成することができる。また、ポリアミド繊維、ポリエステル繊維、ポリプロピレン繊維等の合成繊維でブレード線を形成してもよい。
内側チューブ体の基端側チューブ34は、先端がステント収納チューブ体5内(具体的には、ステント収納チューブ体5の基端チューブ22の先端部内)にて開口し、基端がコネクタ46内にて開口した貫通する内部ルーメンを有するチューブである。
そして、図7に示すように、内側チューブ体3は、先端側チューブ31と基端側チューブ34とを連結する連結部材を備えている。この実施例では、連結部材は、ワイヤ状部材33と熱収縮チューブ81により構成されている。ワイヤ状部材33の基端部は、基端側チューブ34の先端部内に進入し、固定されている。また、ワイヤ状部材33の先端部は、熱収縮チューブ81により、先端側チューブ31の側面に固定されている。さらに、この実施例では、ワイヤ状部材33は、先端側チューブ31に固定された部分の先端側が小径部となっている。
内側チューブ体3の長さは、400~2500mmが好ましく、特に、400~2200mmが好ましい。また、基端側チューブ34の外径としては、0.3~3.0mmが好ましく、特に、0.5~1.0mmが好ましい。また、基端側チューブ34の内径としては、0.1~2.5mmが好ましく、特に、0.2~2.0mmが好ましい。先端側チューブ31の長さは、10~400mmが好ましく、特に、50~350mmが好ましく、外径は、0.2~2.0mmが好ましく、特に、0.4~1.7mmが好ましい。また、ルーメン61の内径としては、0.1~1.8mmが好ましく、特に、0.3~1.0mmが好ましい。
さらに、内側チューブ体3のうち、ステント収納チューブ体5より突出する可能性のある部分の外面は、潤滑性を有していることが好ましい。このために、例えば、ポリ(2-ヒドロキシエチルメタクリレート)、ポリヒドロキシエチルアクリレート、ヒドロキシプロピルセルロース、メチルビニルエーテル無水マレイン酸共重合体、ポリエチレングリコール、ポリアクリルアミド、ポリビニルピロリドン、ジメチルアクリルアミド-グリシジルメタクリレート共重合体等の親水性ポリマーをコーティング、または固定してもよい。また、内側チューブ体3の外面全体に上記のものをコーティング、または固定してもよい。さらに、ガイドワイヤとの摺動性を向上させるために、内側チューブ体3の内面にも上記のものをコーティング、または固定してもよい。
そして、このステントデリバリーシステム1では、コネクタ46に液体注入具を接続することが可能となっており、接続された液体注入具により、注入された液体は、基端側チューブ34内のルーメン38を通過し、ステントデリバリーシステム(ステント収納チューブ体)の先端側部分内にて流出し、ステントデリバリーシステム(ステント収納チューブ体)内をフラッシュすることができ、さらには、ステントデリバリーシステム(ステント収納チューブ体)の先端より吐出させることも可能である。
この実施例のものでは、内側チューブ体3は、少なくともステントの基端部内となる位置の外面に設けられ、ステント10をステント収納チューブ体5方向に押圧する弾性部材85を備え、ステント10は、弾性部材85とステント収納チューブ体5とにより挟持され、かつステント収納チューブ体5に対して摺動可能となっている。また、ステント10は、弾性部材85に対して実質的に摺動不能となっている。
そして、弾性部材85は、複数設けられている。特に、図23に示すステントデリバリーシステム1では、弾性部材85は、ステント10の基端部内に複数設けられている。また、弾性部材85の配置間隔は、ほぼ等間隔となっている。なお、ステントの基端側に向かうに従って、距離が近くなるように複数の弾性部材を配置してもよい。
操作部6は、ステント収納チューブ体5を移動させるための移動機構を備えている。この実施例では、操作部6は、ハウジング40と、ハウジング40内に収納された、ステント収納チューブ体5(具体的には、基端チューブ22)の基端に固定されたシャフト状のラック部材43と、ラック部材43の歯車66と噛み合いラック部材43をハウジング40内にて移動させるための作動歯車54を有する操作用回転ローラ50と、ラック部材43に固定されたステント収納チューブ体5(具体的には、基端チューブ22)を貫通し、かつステント収納チューブ体5の基端より突出する基端側チューブ34の基端部に固定されたコネクタ46とを備える。
この実施例の操作部6は、シャフト状のラック部材43を後退および前進させる移動機構を備えており、これにより、ラック部材43に固定されているステント収納チューブ体5を内側チューブ体3に対して、後退(ステントの露出)および前進(ステントの収納)させることを可能としている。
ハウジング40は、図12ないし図19に示すように、操作用回転ローラ50を収納部より部分的に突出させるための開口部72、ローラ50の回転軸の一端52を収納する軸受部56、ローラ50の回転軸の他端53を収納する軸受部68を備えている。
そして、図12ないし19に示すように、内側チューブ体3の基端側チューブ34の基端部には、筒状コネクタ46が固定されており、ハウジング40は、コネクタ46の収納部58,69を有する。また、ステント収納チューブ体5の基端チューブ22の基端部には、シャフト状のラック部材43が固定されており、ハウジング40は、ラック部材43を軸方向に移動可能に収納するラック部材収納部70,71を備えている。また、ハウジング40の先端部には、ステント収納チューブ体5の基端チューブ22を摺動可能に被嵌する先端部材48が固定されている。先端部材48内には、基端チューブ22が摺動可能に貫通する通路67を備えている。
操作用回転ローラ50は、図12ないし19に示すように、一方の側面に設けられた回転軸の一端52と、他方の側面に設けられた回転軸の他端53と、ラック部材43の歯車66と噛み合いラック部材43をハウジング40内にて移動させるための作動歯車54を備えている。作動歯車54は、回転ローラより小径のものとなっており、作動歯車54の外径としては、10~60mmが好適である。また、ローラ50は、間欠的なローラの回転を可能とするために設けられた歯車状部分55を備えている。操作用回転ローラ50は、ハウジング40の開口部72より、部分的に露出しており、この部分が操作部となる。
なお、ステント収納チューブ体5の移動時に、過剰な力によりステント収納チューブ体が変形・破損しないよう、安全設定値以上の力が負荷されたときに、回転ローラの作動歯車とラック部材の歯車との噛み合いが解除され空転するものとしてもよい。このような空転発生機構は、例えば、操作用回転ローラ50の回転軸の一端52を収納する軸受部56、ローラ50の回転軸の他端53を収納する軸受部68におけるクリアランスによって形成することができる。そして、上記の安全設定値は、ステント収納チューブ体の破壊強度より低いものとすることが好ましい。
先端側チューブ31内にガイドワイヤ82を挿通したステントデリバリーシステム1を治療対象血管に挿入し、目的部位にステントを到達させる。この状態では、ステント10の全体が、ステント収納チューブ体5に収納された状態となっている。そして、図18に示すように、ロックレバー47を押し、ラック部材43のロックを解除する。そして、図19に示すように、ローラを所定方向(矢印方向)に回転させることにより、ステント収納チューブ体5は、内側チューブ体3に対して後方に移動し、図20に示すように、ステント10は、その先端側より徐々に露出するとともに拡張する。この実施例のステントデリバリーシステムでは、図21に示すように、ステント10の基端が、内側チューブ体3(先端側チューブ31)の基端側当接部35に当接することにより、ステント10の基端側への移動が規制されるため、ステント10の露出が可能である。ステント収納チューブ体5より露出したステント10は、自己拡張力により拡張し、圧縮前の形態に復元しようとする。そして、ステント10の配置位置の再調整が必要な場合には、ローラを所定方向(矢印方向)と逆方向に回転させることにより、図22に示すように、ステント収納チューブ体5は先端方向に移動し、ステントの一部もしくは全部がステント収納チューブ体5(先端側チューブ31)内に再収納される。この実施例では、ステント10の基端側内方突出部17aが、内側チューブ体3(先端側チューブ31)の先端側当接部36に当接することにより、ステント10の先端側への移動が規制されるため、ステント10の収納が可能である。
このステント170は、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元するいわゆる自己拡張型ステントとなっている。
そして、このステント170では、第1波状ストラット173は、両側部を除きほぼ同じ波形が所定長継続するものとなっている。つまり、第1波状ストラット173は、両端部付近を除き、ほぼ同じ波形、つまり、同じ波長および同じ振幅の波が連続するものとなっている。第1波状ストラット173が、ほぼ全体に同じ波形を有する場合には、その波長は、ステントの外径によっても相違するが、0.5~8.0mmが好適であり、特に、2.0~4.0mmが好適であり、振幅は、0.1~10.0mmが好適であり、特に、0.3~3.0mmが好適である。
そして、このステント170では、第2波状ストラット174は、両側部を除きほぼ同じ波形が所定長継続するものとなっている。つまり、第2波状ストラット174は、両端部付近を除き、ほぼ同じ波形、つまり、同じ波長および同じ振幅の波が連続するものとなっている。第2波状ストラット174が、ほぼ全体に同じ波形を有する場合には、その波長は、ステントの外径によっても相違するが、0.5~8.0mmが好適であり、特に、2.0~4.0mmが好適であり、振幅は、0.1~10.0mmが好適であり、特に、0.3~3.0mmが好適である。
このため、図24に示すように、隣り合う第1波状ストラット173と第2波状ストラット174は、第1波状ストラット173の上点173aもしくは下点173bと第2波状ストラット174の下点174bもしくは上点174aとがほぼ向かい合うことにより、近接部および離間部を形成している。つまり、このステント170では、隣り合う第1波状ストラット173と第2波状ストラット174は、それぞれの上点同士、下点同士が向かい合わないものとなっているため、近接部と離間部を軸方向に交互に有するものとなっている。
また、この実施例のステントでは、各波状ストラット173、174は、両端部を除いて全て同じ長さとなっている。このため、ステントを中心軸方向に圧縮させたとき、各ストラットが軸方向に対して平行に近づくとともに、長さが同じであるため、軸方向に突っ張ることなく良好に縮径する。また、この実施例のステントでは、各波状ストラット173、174は、両端を除いてステントの中心軸に対して等角度となるように配置されている。このため、ステントを中心軸方向に圧縮させた時に、ストラット間の隙間が均等に小さくなっていくので、ストラット同士が重なることなく良好に収縮する。
そして、この実施例のステント170は、ステントの先端部において、第1波状ストラット173および第2波状ストラット174の先端部が結合して形成された屈曲部172と、第1波状ストラット173と分岐部161を介して接続する線状部163の先端部と第2波状ストラット174と分岐部162を介して接続する線状部164の先端部が結合して形成された屈曲部176とを、周方向に交互に備えるものとなっている。そして、屈曲部176には、放射線不透過性マーカー177が取り付けられている。また、放射線不透過性マーカー177を有する屈曲部176は、屈曲部172よりステントの先端側に位置している。
図25に示すように、ステント170は、放射線不透過性マーカー177により形成された基端側内方突出部177aを備えている。そして、基端側内方突出部177a、すなわち屈曲部178のみが、内側チューブ体3の先端側当接部36と基端側当接部35間に位置するように配置されている。また、隣り合う屈曲部178間に設けられた屈曲部179は先端側当接部36より先端側に位置するように配置されている。このような構成にすることにより、ステント170を中心軸方向に圧縮させた際に、隣り合う放射線不透過性マーカー177同士が接触すること、あるいは重なり合うことが防止され、良好に収縮する。また、ステントの基端側内方突出部177aの先端側当接部36と基端側当接部35間への配置も容易である。
(1) 多数の側壁開口を有し、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元可能なステントと、ガイドワイヤルーメンを有する内側チューブ体と、前記ステントを先端部内に収納したステント収納チューブ体とを備え、かつ前記ステントが前記内側チューブ体の先端部を覆うように配置され、かつ前記ステント収納チューブ体を前記内側チューブ体に対して基端側に移動させることにより、前記ステントを放出可能であるステントデリバリーシステム本体と、該ステントデリバリーシステム本体の基端部に設けられ、前記ステント収納チューブ体を移動させるための移動機構を備える操作部とを備えるステントデリバリーシステムであって、
前記内側チューブ体は、前記ガイドワイヤルーメンを有する先端側チューブと、該先端側チューブの基端側に連結された、前記ステント収納チューブ体内を貫通する基端側チューブとを備え、
前記操作部は、ハウジングと、前記ハウジング内に収納された、前記ステント収納チューブ体の基端に固定されたシャフト状のラック部材と、前記ラック部材の歯車と噛み合い前記ラック部材を前記ハウジング内にて移動させるための作動歯車を有する操作用回転ローラと、前記ラック部材に固定された前記ステント収納チューブ体の基端より突出する前記基端側チューブの基端部に固定され、かつ前記ハウジングに保持されたコネクタとを備え、
前記ステントデリバリーシステムは、前記ステントを解除可能に保持し、前記ステントの前記ステント収納チューブ体からの部分的露出後に前記ステント収納チューブ体の前進により、前記ステント収納チューブ体内への前記ステントの再収納を可能とするためのステント保持機能を備え、さらに、前記操作用回転ローラの所定方向への回転による前記ラック部材の前記コネクタ方向への移動により、前記ステントの前記ステント収納チューブ体からの放出を可能とし、かつ、前記ステントの前記ステント収納チューブ体からの部分的露出後に、前記操作用回転ローラを前記所定方向と逆方向に回転させることにより、前記ラック部材を前記ハウジング内にて前記コネクタと反対方向に移動させ、前記ステント収納チューブ体内への前記ステントの再収納が可能であるステントデリバリーシステム。
(2) 前記基端側チューブは、先端部が前記ステント収納チューブ体内にて開口し、基端まで連通するルーメンを有している上記(1)に記載のステントデリバリーシステム。
(3) 前記ステントデリバリーシステムは、前記コネクタより前記基端側チューブ内の前記ルーメンを用いて前記ステントデリバリーシステム内への液体の注入が可能である上記(2)に記載のステントデリバリーシステム。
(4) 前記ステントは、前記ステント収納チューブ体の先端側を向く先端部と基端側を向く基端部を備え、基端部を除き基端側を向く屈曲自由端を持たず、前記ステント収納チューブ体からの先端側部分の露出後に前記ステント収納チューブ体を移動させることにより、露出部分を前記ステント収納チューブ体内に再収納可能なものである上記(1)ないし(3)のいずれかに記載のステントデリバリーシステム。
(5) 前記操作部は、前記ラック部材を解除可能にロックするロック機構を備えている上記(1)ないし(4)のいずれかに記載のステントデリバリーシステム。
(6) 前記操作部は、前記操作用回転ローラの前記所定方向への回転時に、前記ラック部材の端部と当接し、所定以上の前記ラック部材の移動を規制する移動規制部を備えている上記(1)ないし(5)のいずれかに記載のステントデリバリーシステム。
(7) 前記操作部は、前記操作用回転ローラの前記所定方向と逆方向への回転時に、前記ラック部材の端部と当接し、所定以上の前記ラックの移動を規制する移動規制部を備えている上記(1)ないし(6)のいずれかに記載のステントデリバリーシステム。
(8) 前記操作部は、前記操作用回転ローラに回転抵抗を付与するとともに、間欠的なローラの回転を可能とするローラ間欠的回転機構を備えている上記(1)ないし(7)のいずれかに記載のステントデリバリーシステム。
(9) 前記ステントデリバリーシステムは前記ステント保持機能として、前記内側チューブ体の前記ステントの基端部内に位置し、かつ、前記ステントの前記側壁開口内に進入しない位置に設けられた先端側当接部と、前記内側チューブ体の前記ステントの基端後方かつ前記先端側当接部と近接する位置に設けられ、かつ前記ステントの基端に当接可能な基端側当接部とを備えている上記(1)ないし(8)のいずれかに記載のステントデリバリーシステム。
(10) 前記ステントデリバリーシステムの前記ステント保持機能として、前記ステントは、前記先端側当接部に当接可能な基端側内方突出部を備え、かつ、前記基端側内方突出部が、前記内側チューブ体の前記先端側当接部と前記基端側当接部間に位置するように配置することにより構成されている上記(9)に記載のステントデリバリーシステム。
(11) 前記ステントデリバリーシステムは前記ステント保持機能として、前記内側チューブ体の少なくとも前記ステントの基端部内となる位置に設けられ、前記ステントを前記ステント収納チューブ体方向に押圧する弾性部材を備え、かつ、前記ステントは、前記弾性部材と前記ステント収納チューブ体とにより挟持され、かつ前記ステント収納チューブ体に対して摺動可能となっている上記(1)ないし(8)のいずれかに記載のステントデリバリーシステム。
Claims (11)
- 多数の側壁開口を有し、略円筒形状に形成され、生体内挿入時には中心軸方向に圧縮され、生体内留置時には外方に拡張して圧縮前の形状に復元可能なステントと、ガイドワイヤルーメンを有する内側チューブ体と、前記ステントを先端部内に収納したステント収納チューブ体とを備え、かつ前記ステントが前記内側チューブ体の先端部を覆うように配置され、かつ前記ステント収納チューブ体を前記内側チューブ体に対して基端側に移動させることにより、前記ステントを放出可能であるステントデリバリーシステム本体と、該ステントデリバリーシステム本体の基端部に設けられ、前記ステント収納チューブ体を移動させるための移動機構を備える操作部とを備えるステントデリバリーシステムであって、
前記内側チューブ体は、前記ガイドワイヤルーメンを有する先端側チューブと、該先端側チューブの基端側に連結された、前記ステント収納チューブ体内を貫通する基端側チューブとを備え、
前記操作部は、ハウジングと、前記ハウジング内に収納された、前記ステント収納チューブ体の基端に固定されたシャフト状のラック部材と、前記ラック部材の歯車と噛み合い前記ラック部材を前記ハウジング内にて移動させるための作動歯車を有する操作用回転ローラと、前記ラック部材に固定された前記ステント収納チューブ体の基端より突出する前記基端側チューブの基端部に固定され、かつ前記ハウジングに保持されたコネクタとを備え、
前記ステントデリバリーシステムは、前記ステントを解除可能に保持し、前記ステントの前記ステント収納チューブ体からの部分的露出後に前記ステント収納チューブ体の前進により、前記ステント収納チューブ体内への前記ステントの再収納を可能とするためのステント保持機能を備え、さらに、前記操作用回転ローラの所定方向への回転による前記ラック部材の前記コネクタ方向への移動により、前記ステントの前記ステント収納チューブ体からの放出を可能とし、かつ、前記ステントの前記ステント収納チューブ体からの部分的露出後に、前記操作用回転ローラを前記所定方向と逆方向に回転させることにより、前記ラック部材を前記ハウジング内にて前記コネクタと反対方向に移動させ、前記ステント収納チューブ体内への前記ステントの再収納が可能であることを特徴とするステントデリバリーシステム。 - 前記基端側チューブは、先端部が前記ステント収納チューブ体内にて開口し、基端まで連通するルーメンを有している請求項1に記載のステントデリバリーシステム。
- 前記ステントデリバリーシステムは、前記コネクタより前記基端側チューブ内の前記ルーメンを用いて前記ステントデリバリーシステム内への液体の注入が可能である請求項2に記載のステントデリバリーシステム。
- 前記ステントは、前記ステント収納チューブ体の先端側を向く先端部と基端側を向く基端部を備え、基端部を除き基端側を向く屈曲自由端を持たず、前記ステント収納チューブ体からの先端側部分の露出後に前記ステント収納チューブ体を移動させることにより、露出部分を前記ステント収納チューブ体内に再収納可能なものである請求項1ないし3のいずれかに記載のステントデリバリーシステム。
- 前記操作部は、前記ラック部材を解除可能にロックするロック機構を備えている請求項1ないし4のいずれかに記載のステントデリバリーシステム。
- 前記操作部は、前記操作用回転ローラの前記所定方向への回転時に、前記ラック部材の端部と当接し、所定以上の前記ラック部材の移動を規制する移動規制部を備えている請求項1ないし5のいずれかに記載のステントデリバリーシステム。
- 前記操作部は、前記操作用回転ローラの前記所定方向と逆方向への回転時に、前記ラック部材の端部と当接し、所定以上の前記ラックの移動を規制する移動規制部を備えている請求項1ないし6のいずれかに記載のステントデリバリーシステム。
- 前記操作部は、前記操作用回転ローラに回転抵抗を付与するとともに、間欠的なローラの回転を可能とするローラ間欠的回転機構を備えている請求項1ないし7のいずれかに記載のステントデリバリーシステム。
- 前記ステントデリバリーシステムは前記ステント保持機能として、前記内側チューブ体の前記ステントの基端部内に位置し、かつ、前記ステントの前記側壁開口内に進入しない位置に設けられた先端側当接部と、前記内側チューブ体の前記ステントの基端後方かつ前記先端側当接部と近接する位置に設けられ、かつ前記ステントの基端に当接可能な基端側当接部とを備えている請求項1ないし8のいずれかに記載のステントデリバリーシステム。
- 前記ステントデリバリーシステムの前記ステント保持機能として、前記ステントは、前記先端側当接部に当接可能な基端側内方突出部を備え、かつ、前記基端側内方突出部が、前記内側チューブ体の前記先端側当接部と前記基端側当接部間に位置するように配置することにより構成されている請求項9に記載のステントデリバリーシステム。
- 前記ステントデリバリーシステムは前記ステント保持機能として、前記内側チューブ体の少なくとも前記ステントの基端部内となる位置に設けられ、前記ステントを前記ステント収納チューブ体方向に押圧する弾性部材を備え、かつ、前記ステントは、前記弾性部材と前記ステント収納チューブ体とにより挟持され、かつ前記ステント収納チューブ体に対して摺動可能となっている請求項1ないし8のいずれかに記載のステントデリバリーシステム。
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Also Published As
Publication number | Publication date |
---|---|
CN102821719A (zh) | 2012-12-12 |
JPWO2011122444A1 (ja) | 2013-07-08 |
EP2545887A1 (en) | 2013-01-16 |
EP2545887A4 (en) | 2013-11-13 |
EP2545887B1 (en) | 2016-08-10 |
CN102821719B (zh) | 2015-01-07 |
US20120330401A1 (en) | 2012-12-27 |
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