WO2015060424A1 - 医療用ステント - Google Patents
医療用ステント Download PDFInfo
- Publication number
- WO2015060424A1 WO2015060424A1 PCT/JP2014/078351 JP2014078351W WO2015060424A1 WO 2015060424 A1 WO2015060424 A1 WO 2015060424A1 JP 2014078351 W JP2014078351 W JP 2014078351W WO 2015060424 A1 WO2015060424 A1 WO 2015060424A1
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- WIPO (PCT)
- Prior art keywords
- flap
- stent
- internal space
- diameter
- thread
- Prior art date
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Classifications
-
- 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
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
-
- 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
- A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2002/041—Bile ducts
-
- 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
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
- A61F2002/8483—Barbs
-
- 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
- A61F2/848—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs
- A61F2002/8486—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents having means for fixation to the vessel wall, e.g. barbs provided on at least one of the ends
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
Definitions
- the present invention relates to a medical stent used by being inserted into a body cavity.
- a stent is placed in order to expand the stenosis part and maintain the patency state with respect to the stenosis part formed in the bile duct.
- a stent delivery system used in this case, the one described in Patent Document 1 is known.
- a long insertion portion having flexibility extends from an operation portion operated by an operator, and a stent is detachably attached to a distal end of the insertion portion.
- the insertion part has a pusher catheter.
- a guide sheath (insertion member) is inserted into the lumen of the pusher catheter so as to be movable back and forth.
- the distal end portion of the pusher catheter is provided with an abutting surface with which the proximal end surface of the stent can abut and a stent accommodating portion that accommodates at least a part of the stent.
- the stent accommodating portion is configured such that the pusher catheter is expanded radially outward and the lumen diameter is larger than the stent diameter.
- the stent is provided with a flap at each end in the axial direction of a cylindrical stent body.
- the inner diameter of the stent body can be inserted through the guide sheath, but the inner diameter of the distal end portion is slightly reduced. For this reason, the stent can be lightly engaged with the guide sheath by friction.
- the flap on the distal end side of the stent is formed so as to open toward the proximal end side in a natural state.
- the proximal end side flap is formed so as to open toward the distal end side in a natural state.
- an endoscope is inserted through a natural opening such as a patient's mouth to the vicinity of the duodenal papilla.
- the insertion portion of the stent delivery system is inserted into the working channel of the endoscope, and the stent housing portion is projected from the distal end of the endoscope.
- the guide sheath and the insertion portion are inserted in order from the nipple, and the stent housing portion is guided to the narrowed portion formed in the bile duct.
- the guide sheath is removed from the stent.
- the insertion portion is retracted, the stent housing portion is lowered and the stent is exposed.
- the flap pressed against the stent housing part opens, and the narrowed part of the bile duct is positioned between the distal end side and proximal end side flaps. The movement of the stent is suppressed by the flap.
- the stent delivery system described in Patent Literature 1 when a stent is attached to the stent accommodation portion, the stent accommodation portion is attached so as to cover the outer peripheral surface on the proximal end side of the stent. For this reason, the outer diameter of the stent delivery system as a whole when the stent is placed becomes thick, and the introduction into a bile duct or the like is deteriorated.
- a pusher catheter generally used to place a stent is tubular, and the pusher catheter provided with the abutment surface and the stent accommodating portion described in Patent Document 1 is a special surgical tool.
- the present invention has been made in view of the above circumstances, and when the stent is introduced into the body, it is possible to maintain the closed state of the flap portion without requiring a special surgical tool covering the outer peripheral surface of the stent.
- the aim is to provide a possible stent.
- the medical stent has an internal space extending along the longitudinal axis, and a side opening formed on the side surface so as to communicate with the internal space.
- a long shaft member that is movable along the longitudinal axis, an extension portion that extends radially outward from a side surface of the long shaft member so as to be engaged with tissue, and the extension portion.
- a fixed portion fixed to the long shaft member, and the extending portion extends along the longitudinal axis of the long shaft member and an open state extending radially from the side surface of the long shaft member.
- a flap portion that can be deformed into a closed state, and a flap diameter-expansion prevention that allows the flap portion to be held in the internal space by the insertion member while at least a portion passes through the side opening when the flap portion is in the closed state A part.
- the flap diameter-expanding preventing portion is configured by forming a thread-like member in an annular shape, and the side opening is formed on the long-axis member.
- the flap diameter-enhancing prevention part may be locked to the insertion member by being formed on the side of the flap part with respect to the longitudinal axis and inserting the insertion member through the annular flap diameter-enhancing prevention part.
- the flap diameter increasing prevention portion is disposed outside the internal space of the long shaft member. Good.
- the flap diameter-expansion preventing portion is formed by forming a thread-like member in an annular shape, and the side opening is formed by the long shaft member.
- the insertion member does not move to the side opening side of the thread-like member that is formed on the opposite side of the flap with respect to the longitudinal axis and that passes through the side opening and is arranged along the circumferential direction on the inner surface of the internal space.
- the flap diameter-preventing portion is a thread-like member, and a force that deforms the flap portion from the open state to the closed state is applied to the flap portion.
- a pressed portion that is pressed by the thread-like member so as to act may be provided in the flap portion.
- the extension portion of the flap portion is provided with a locking portion so that the position of the pressed portion in the flap portion does not shift. It may be.
- the locking portion is a through hole formed in the pressed portion so as to extend in a thickness direction of the flap portion, and the through hole The thread-like member may be inserted through the cable.
- the locking portion is formed through one end of the flap portion in the width direction of the pressed portion so as to penetrate in the thickness direction of the flap portion.
- the thread-like member may be arranged in the groove part.
- the long shaft member is tubular
- the flap portion is a part of a side surface of the long shaft member
- the side opening is the The opening formed in the side surface of the said long-axis member may be sufficient by cutting and raising the side surface of a long-axis member.
- the flap diameter increasing prevention portion is formed in a band shape, and passes through the side opening and is disposed in the inner space.
- the flap expansion preventing portion may be held by the insertion member by a frictional force acting between the insertion member and the insertion member.
- the flap diameter-preventing portion is connected to the first end portion connected to the extension portion of the flap portion and the first end portion. At least a part of the second end portion of the flap diameter-enhancing prevention portion has the side opening so that the flap portion maintains the closed state when the flap portion is in the closed state. The second end may be locked to the insertion member while passing.
- FIG. 6 is a cross-sectional view taken along a cutting line A1-A1 in FIG.
- FIG. 12 is a cross-sectional view taken along section line A2-A2 in FIG. It is sectional drawing of the principal part of the stent in the modification of embodiment of this invention.
- FIG. 15 is a cross-sectional view taken along line A3-A3 in FIG. It is a top view of the principal part of the stent in the modification of embodiment of this invention.
- FIG. 17 is a cross-sectional view taken along section line A4-A4 in FIG. It is a side view of the principal part of the state which made the guide sheath penetrate the stent of 2nd Embodiment of this invention.
- FIG. 19 is a cross-sectional view taken along a cutting line A6-A6 in FIG. It is a side view of the principal part of the state which pulled out the guide sheath from the stent of 2nd Embodiment of this invention.
- FIG. 21 is a cross-sectional view taken along line A7-A7 in FIG. It is a side view of the principal part of the state which made the guide sheath penetrate the stent of 3rd Embodiment of this invention.
- FIG. 23 is a cross-sectional view taken along a cutting line A8-A8 in FIG. It is a side view of the principal part of the state which pulled out the guide sheath from the stent of 3rd Embodiment of this invention.
- FIG. 25 is a cross-sectional view taken along section line A9-A9 in FIG.
- the stent 1 of this embodiment includes an internal space 11 extending along a longitudinal axis (central axis) C, and a side surface formed on the side surface so as to communicate with the internal space 11.
- a main body (long-axis member) 10 having an opening 12, a flap portion 30 formed in a plate shape, and a flap diameter increasing prevention portion 40 in which one end portion (first end) 41 is connected to an extension portion 31 of the flap portion 30.
- the flap portion 30 includes an extending portion 31 that extends radially outward from the side surface of the main body 10 so as to be locked to the tissue, and a fixing portion 32 that is connected to the extending portion 31 and is fixed to the main body 10. .
- the main body 10 is formed in a tubular shape.
- a distal end opening 14 formed in the distal end surface 21 of the main body 10 and a proximal end opening 15 formed in the proximal end surface 22 of the main body 10 communicate with the internal space 11.
- the internal space 11, the distal end opening 14, and the proximal end opening 15 constitute a pipe line of the main body 10.
- a second side surface opening 16 communicating with the internal space 11 is provided on the side surface of the distal end portion of the main body 10.
- the side surface of the distal end portion of the main body 10 is formed so as to reduce the diameter toward the distal end side.
- the main body 10 is formed of a resin material having elasticity, flexibility, and biocompatibility such as urethane and polyethylene.
- the extension portion 31 extends from the fixed portion 32 to the distal end side, and the flap portion 30 extends radially outward from the side surface of the main body 10 and opens. That is, the flap part 30 is formed so as to be in an open state in a natural state.
- the natural state said here means the state which external force other than the gravity and the load by the flap diameter-expansion prevention part 40 does not act on the flap part 30.
- a through-hole (locking portion) 33 extending in the thickness direction of the flap portion 30 is formed in the extending portion 31 of the flap portion 30.
- a step portion 34 is formed in the flap portion 30 by making the width on the extending portion 31 side narrower than the width on the fixed portion 32 side. The length in the width direction of the flap portion 30 in the step portion 34 is larger than the outer diameter of the thread-like member 43 described later.
- one flap portion 30 is provided on the base end side of the main body 10.
- the flap portion 30 and the side opening 12 are formed by cutting up the side surface of the main body 10. That is, the side surface of the main body 10 is cut to form a tongue-shaped portion (not shown), and the above-described stepped portion 34 is formed on the tongue-shaped portion.
- the flap 30 is formed by applying a known heat treatment to the tongue, for example, so that the tongue is naturally bent outwardly in the radial direction. For this reason, the side opening 12 is formed on the side of the flap 30 with respect to the longitudinal axis C.
- the flap portion 30 When the flap portion 30 is pressed from the outside in the radial direction toward the longitudinal axis C, the flap portion 30 is elastically deformed (moved) to the longitudinal axis C side and becomes a closed state extending along the longitudinal axis C.
- the flap portion 30 is accommodated in the opening 12.
- the flap part 30 is deformable between an open state and a closed state.
- one flap portion 50 is provided on the distal end side of the main body 10.
- the flap portion 50 is formed in a plate shape, and includes an extending portion 51 that extends radially outward from a side surface of the main body 10 and a fixing portion 52 that is connected to the extending portion 51 and is fixed to the main body 10.
- the fixing portion 52 of the flap portion 50 is fixed to the side surface of the main body 10 on the distal end side with respect to the second side surface opening 16. While the extended portion 51 extends from the fixed portion 52 to the proximal end side in the natural state, the flap portion 50 extends radially outward from the side surface of the main body 10 and opens. That is, the flap part 50 is formed so as to be open in a natural state.
- the flap portion 50 and the second side opening 16 are formed by cutting the side surface of the main body 10 in the same manner as the flap portion 30 and the side opening 12.
- the flap portion 50 is pressed from the radially outer side toward the longitudinal axis C of the main body 10
- the flap portion 50 is elastically deformed to the longitudinal axis C side
- the flap portion 50 is formed in the second side surface opening 16. Be contained.
- the flap portions 30 and 50 are made of the same material as that of the main body 10.
- the flap diameter-expansion preventing portion 40 is configured by forming a thread-like member 43 in an annular shape. More specifically, the flap diameter-expanding preventing portion 40 bends the thread-like member 43 to form a folded portion at one end portion 41, and connects the ends of the thread-like member 43 on both sides with respect to the one end portion 41 to form a knot 44. It is composed of things.
- the thread member 43 can be formed of a resin having flexibility and biocompatibility, such as nylon, polypropylene, polydioxanone.
- One end portion 41 of the thread-like member 43 is inserted into the through hole 33 of the flap portion 30, and the other end portion (second end portion) 42 of the thread-like member 43 is disposed closer to the extending portion 31 side than the step portion 34 side of the flap portion 30.
- the flap diameter increasing prevention portion 40 is attached to the flap portion 30 by forming a knot 44 in a state where one thread-like member 43 is inserted through the through-hole 33.
- the flap diameter-preventing portion 40 when the flap portion 30 is in the open state, the entire flap diameter-preventing portion 40 is disposed outside the internal space 11 of the main body 10. As shown in FIGS. 5 and 6, the flap diameter increasing prevention portion 40 has a side opening at the other end portion 42 connected to the one end portion 41 when the flap portion 30 is deformed to the longitudinal axis C side and is closed. 12 is passed to the internal space 11 side.
- the extension portion 31 of the flap portion 30 is covered by a threaded member 43 so that a force that deforms the flap portion 30 from the open state to the closed state acts on the flap portion 30.
- a pressing portion 38 is provided.
- the aforementioned through-hole 33 is formed in the pressed portion 38 of the flap portion 30, and is configured so that the displacement of the pressed portion 38 in the flap portion 30 does not occur when the thread-like member 43 is inserted into the through-hole 33. Has been.
- the end portion of the grip portion 60 is attached to the base end portion of the main body 10.
- the gripping part 60 can be formed of the same material as the thread-like member 43.
- a marker having radiopacity may be embedded at positions corresponding to the extending portion 31 of the flap portion 30 and the extending portion 51 of the flap portion 50 of the main body 10.
- a user such as an operator inserts a side-viewing type endoscope into a patient's body cavity through a natural opening such as a patient's mouth, and the insertion portion E1 of the endoscope E as shown in FIG.
- the tip is advanced through the duodenum P1 to the vicinity of the duodenal papilla P2.
- the user inserts the guide wire E10 into the channel E2 from the forceps opening (not shown) of the endoscope E, and appropriately operates the raising base (not shown), and the tip of the guide wire E10 is opened to the tip of the channel E2. Project toward the duodenal papilla P2. Then, the distal end of the guide wire E10 is inserted into the hepatic duct P4 from the duodenal papilla P2 through the bile duct P3.
- the inner diameter of the hepatic duct P4 is smaller than the inner diameter of the bile duct P3.
- a guide sheath (insertion member) E20 is externally fitted to the guide wire E10. With the positions of the insertion portion E1 and the guide wire E10 maintained, the guide sheath E20 is pushed in (moved toward the distal end side). When the distal end of the guide sheath E20 comes into contact with the connection portion P5 between the hepatic duct P4 and the bile duct P3, the guide sheath E20 cannot be pushed further.
- the user confirms the shape of the narrowed portion P6 of the bile duct P3 under fluoroscopy, and from the extended portion 31 of the flap portion 30 to the extended portion 51 of the flap portion 50 when the flap portions 30 and 50 are opened.
- a stent 1 is selected whose length is substantially the same as or longer than the length of the constriction P6 along the bile duct P3.
- the stent 1 is fitted onto the guide sheath E20 from the distal end side. That is, the guide sheath E20 is inserted into the internal space 11 of the main body 10 of the stent 1.
- the guide sheath E20 is movable along the longitudinal axis C in the internal space 11 of the main body 10.
- the user presses the flap portion 30 from the outside in the radial direction toward the longitudinal axis C of the main body 10 with his / her hand or the like, thereby extending the flap portion 30 as shown in FIGS. 5 and 6.
- the portion 31 is elastically deformed toward the longitudinal axis C, and the flap portion 30 is accommodated in the side opening 12.
- the guide sheath E20 inserted into the internal space 11 of the main body 10 can be inserted into the annular thread-like member 43 disposed in the internal space 11.
- the fact that the guide sheath E20 can be inserted into the annular thread-shaped member 43 means that the length of the portion of the thread-shaped member 43 disposed in the inner space 11 is equal to or longer than the outer circumference of the guide sheath E20.
- the guide sheath E20 is inserted into the internal space 11 of the main body 10 and further into the annular flap expansion preventing portion 40. As shown in FIG. 5, the guide sheath E20 is inserted into the flap diameter-preventing portion 40 because the guide sheath E20 inserted into the internal space 11 of the main body 10 is within the reference range R in the direction along the longitudinal axis C. When it is arranged.
- the reference range R mentioned here refers to the stent 1 from the position Q1 where the guide sheath E20 is disposed with respect to the stent 1 so that the distal end of the guide sheath E20 coincides with the flap diameter preventing portion 40.
- the guide sheath E20 is in a range up to the position Q2, that is, the state where the guide sheath E20 is arranged so that the proximal end of the guide sheath E20 coincides with the flap diameter-preventing portion 40.
- the guide sheath E20 When the guide sheath E20 is disposed within the reference range R with respect to the stent 1, the guide sheath E20 is inserted into the annular flap diameter preventing portion 40 so that the other end portion 42 of the flap diameter preventing portion 40 is inserted. It is locked (held) on the longitudinal axis C side, and the extension part 31 of the flap part 30 is held in a state of being elastically deformed on the longitudinal axis C side. At this time, the flap part 30 is accommodated in the side surface opening 12, and the closed state of the flap part 30 is maintained.
- the flap diameter-expanding preventing portion 40 and the guide sheath E20 are locked. Canceled.
- the extension part 31 of the flap part 30 moves and opens in the direction away from the longitudinal axis C by its own elastic force.
- the distal end surface of the pusher catheter E30 is brought into contact with the proximal end surface 22 of the stent 1, and the pusher catheter E30 is fitted onto the guide sheath E20.
- This pusher catheter E30 is generally tubular, and the outer diameter thereof is selected to be approximately equal to the outer diameter of the main body 10 of the stent 1.
- the pusher catheter E30 is pushed into the insertion portion E1 and the guide sheath E20, and the stent 1 is moved to the distal end side in the channel E2.
- the guide sheath E20 does not move to the proximal end side relative to the position Q1 with respect to the stent 1, and the guide sheath E20 is arranged in the reference range R. For this reason, the guide sheath E20 is locked to the flap diameter-expanding preventing portion 40, and the closed state of the flap portion 30 in which the flap portion 30 is accommodated in the side surface opening 12 is maintained.
- the flap portion 50 on the distal end side is formed to open radially outward while extending to the proximal end side, so that it is pressed against the inner wall of the bile duct P3.
- the flap portion 50 is deformed to the longitudinal axis C side.
- a special surgical tool that covers the outer peripheral surface of the stent 1 is not required, and the flap portion 50 is deformed to the longitudinal axis C side along the inner wall of the bile duct P3. Since it is in the closed state, the entire stent 1 can be easily introduced into the bile duct P3.
- the flap part 50 of the stent 1 When the flap 50 of the stent 1 reaches the stenosis part P6, the flap part 50 is pressed against the inner wall of the stenosis part P6 and further deformed to the longitudinal axis C side, and is accommodated in the second side opening 16 to be closed.
- the user introduces the stent 1 while confirming the positions of the flap portions 30 and 50 with the above-described markers or the like under fluoroscopy, and the stent 1 is placed at a position where the flap portion 50 exceeds the constriction P6 as shown in FIG. Place.
- the pressure by the inner wall of the narrowed portion P6 is released, and the flap portion 50 is opened and locked to the back side of the narrowed portion P6.
- the proximal end portion of the grasping portion 60 protrudes from the duodenal papilla P2 into the lumen of the duodenum P1.
- the guide wire E10 is pulled back to the proximal end side as shown in FIG. 8, and is taken out from the forceps opening.
- the guide sheath E20 is pulled back to the proximal end side. Since the distal end surface of the pusher catheter E30 is in contact with the proximal end surface 22 of the stent 1, the stent 1 does not move to the proximal end side.
- the guide sheath E20 is disposed outside the reference range R when the guide sheath E20 moves to the proximal end side with respect to the stent 1 with respect to the position Q1.
- the engagement between the flap diameter-preventing portion 40 and the guide sheath E20 is released, and the flap portion 30 is opened. Whether or not the flap portion 30 is completely open depends on the state of the inner wall of the bile duct P3 around the flap portion 30.
- the flap part 30 When the flap part 30 is in the open state, the flap diameter-preventing part 40 is drawn out of the internal space 11 through the side opening 12. Since the stent 1 in which the length from the extension part 31 of the flap part 30 to the extension part 51 of the flap part 50 is set as described above is selected, the flap part 30 is also locked on the near side of the narrowed part P6. To do.
- the user pulls back the guide sheath E20 and the pusher catheter E30 to the proximal end side and removes them from the forceps opening of the endoscope E.
- the insertion portion E1 of the endoscope E is taken out from the body cavity of the patient, and an appropriate procedure is performed to complete the procedure for placing the stent 1.
- bile generated in the liver flows through the duct of the main body 10 of the stent 1 at a portion corresponding to the stenosis P6 in the bile duct P3 and is supplied to the lumen of the duodenum P1.
- the procedure is as follows. As described above, the distal end of the insertion portion E1 of the endoscope E is advanced to the vicinity of the duodenal papilla P2 through the duodenum P1. A grasping forceps (not shown) or the like is inserted into the channel E2 through the forceps opening. The proximal end portion of the gripping portion 60 is gripped by the gripping forceps, the gripping forceps are pulled back with respect to the insertion portion E1, and the stent 1 is pulled out from the bile duct P3. The insertion part E1 is taken out from the body cavity of the patient together with the grasping forceps.
- the guide sheath E20 inserted through the internal space 11 of the main body 10 is disposed in the reference range R in the direction along the longitudinal axis C
- the guide is guided to the flap diameter-expanding preventing portion 40.
- the closed state in which the sheath E20 is locked and the extended portion 31 of the flap portion 30 is deformed to the longitudinal axis C side is maintained.
- the closed state of the flap portion 30 is maintained, so that the guide sheath E20 and the stent 1 can be maintained within the reference range R while the closed state of the flap portion 30 is maintained.
- the position in the direction along the longitudinal axis C can be adjusted.
- the guide sheath E20 When the stent 1 is disposed at a desired position, the guide sheath E20 is pulled back to the proximal end while the stent 1 is held so as not to move proximally by the pusher catheter E30.
- the guide sheath E20 When the guide sheath E20 is disposed outside the reference range R with respect to the stent 1, the engagement between the flap diameter-preventing portion 40 and the guide sheath E20 is released, the flap portion 30 is closed, and the front side of the narrowed portion P6. Lock to.
- the closed state of the flap part 30 can be maintained, so that the flap part 30 is locked to the duodenal papilla P2 and the inner wall of the bile duct P3 when the stent 1 is introduced. Can be suppressed. As a result, the introduction property when the stent 1 is introduced into the bile duct P3 can be enhanced. In addition, since a special surgical tool that covers the outer peripheral surface of the stent 1 is not required, a compact configuration as a whole can be achieved.
- the stent 1 can be placed using a general tubular pusher catheter E30, the placement of the stent 1 can be performed easily. Since the flap diameter preventing portion 40 is configured by forming the thread-like member 43 in an annular shape, the flap diameter preventing portion 40 can be easily configured, and the manufacturing cost of the stent 1 can be reduced.
- the flap diameter-preventing portion 40 When the flap portion 30 is in the open state, the flap diameter-preventing portion 40 is disposed outside the internal space 11 of the main body 10. For this reason, when bile flows in the internal space 11 of the stent 1, it can prevent that the flap diameter-expansion prevention part 40 obstructs the flow of bile.
- the through-hole 33 is formed in the extension part 31 of the flap part 30, the position of the pressed part 38 of the flap part 30 pressed by the thread-like member 43 when the flap part 30 is deformed from the open state to the closed state. Deviation can be prevented.
- the thread-like member 43 is inserted into the through hole 33 of the flap portion 30, so that the flap diameter preventing portion 40 can be prevented from coming off from the flap portion 30 and the flap diameter preventing portion 40 can be securely attached to the flap portion 30. it can.
- the flap portion 30 and the side opening 12 are formed by cutting and raising the side surface of the main body 10, the flap portion 30 and the side opening 12 can be easily formed from the tubular main body 10 at a time.
- the thread-like member 43 is disposed closer to the extending portion 31 than the step portion 34 side of the flap portion 30. Therefore, when the flap part 30 deform
- the stent 1 of the present embodiment can be variously deformed as described below.
- the stent 1A shown in FIG. 9 since the bile can flow into the internal space 11 when the stent 1A is indwelled, the other end of the flap diameter-increasing prevention portion 40 when the flap portion 30 is open.
- the part 42 may be disposed in the internal space 11 of the main body 10. By configuring in this way, bile can flow into the internal space 11 when the stent 1A is indwelled.
- the introduction property can be improved without requiring a special surgical tool when introduced.
- grooves (locking portions) 35 and 36 are formed in the pressed portion 38 of the flap portion 30 instead of the through holes 33 and the step portions 34, and the grooves 35 and 36 are formed in the grooves 35 and 36.
- the groove portions 35 and 36 are formed so as to penetrate in the thickness direction of the flap portion 30 on the side surfaces at the respective ends in the width direction of the flap portion 30.
- the size of the groove portions 35 and 36 when viewed in the thickness direction shown in FIG. 10 is formed to be substantially equal to the cross section orthogonal to the longitudinal direction of the thread-like member 43.
- One end portion 41 of the flap diameter-preventing portion 40 is disposed on a surface 30 a of the flap portion 30 opposite to the internal space 11 of the main body 10.
- the thread-like member 43 may be fixed to the groove parts 35 and 36 by press-fitting the thread-like member 43 into the groove parts 35 and 36.
- the stent 1 ⁇ / b> B configured as described above, it is possible to reliably prevent the thread-like member 43 and the pressed portion 38 from moving toward the distal end side or the proximal end side with respect to the flap portion 30. Since it is not necessary to form the knot 44 after the thread-like member 43 is inserted into the through-hole 33 of the flap portion 30, the knot 44 can be formed on the thread-like member 43 in advance and attached to the flap portion 30. The knot 44 can be easily formed.
- the width of the gap S formed between the flap portion 30 and the main body 10 and on the width direction side of the flap portion 30 is preferably sufficiently smaller than the outer diameter of the thread-like member 43.
- the width S of the gap S is made larger than the outer diameter of the thread-like member 43, and one end portion 41 of the flap diameter-expanding prevention portion 40 disposed on the surface 30 a of the flap portion 30 is formed.
- a position Q3 indicated by a two-dot chain line in FIG. 12 indicates a position when the flap portion 30 is in the closed state accommodated in the side opening 12.
- the through hole 33, the step portion 34, and the groove portions 35 and 36 as described above are not formed in the flap portion 30.
- the width of the gap S is preferably larger than the outer diameter of the thread-like member 43 so that the main body 10 does not interfere with the thread-like member 43 when the flap portion 30 is deformed into an open state or a closed state.
- the flap diameter-increasing prevention portion 40 can be attached to the flap portion 30 without forming the through hole 33 or the like in the flap portion 30.
- one end portion 41 of the flap diameter-preventing portion 40 disposed on the surface 30 b on the inner space 11 side of the main body 10 in the flap portion 30 is connected to the flap portion 30 by the fixing portion 71. It may be fixed.
- the entire flap diameter-preventing portion 40 is disposed closer to the internal space 11 than the flap portion 30.
- step portions 34 are formed on both sides in the width direction of the flap portion 30, and one end portion 41 of the flap diameter-increasing prevention portion 40 disposed on the surface 30 a of the flap portion 30 is formed.
- FIG. 14 and 15 show a closed state of the flap portion 30 in which the flap portion 30 is accommodated in the side opening 12, and in FIG. 15, the shape of the flap portion 30 in the open state is indicated by a two-dot chain line.
- the side surface 12a which forms the edge part of the front end side of the side surface opening 12 in the main body 10 is inclined so as to approach the longitudinal axis C toward the base end side.
- a side surface 30c forming an edge portion on the distal end side of the flap portion 30 when accommodated in the side surface opening 12 is inclined so as to approach the longitudinal axis C toward the proximal end side. That is, when the flap portion 30 is accommodated in the side surface opening 12, the side surface 12 a of the main body 10 and the side surface 30 c of the flap portion 30 face each other. At this time, the distance between the side surface 12 a and the side surface 30 c is smaller than the outer diameter of the thread-like member 43.
- the blade 30 is separated from the main body 10 by inserting a blade obliquely with respect to the longitudinal axis C as indicated by an arrow B in FIG. 15.
- the side surfaces 12a and 30c become opposing surfaces formed obliquely with respect to the longitudinal axis C, and the radial direction in which the flap part 30 shown in FIG.
- the side surface 12a and the side surface 30c overlap.
- the thread-like member 43 on each side with respect to the one end portion 41 is disposed on the extending portion 31 side with respect to the step portion 34 side of the flap portion 30.
- the side surfaces 12 a and 30 c overlap each other when viewed in the radial direction when the flap portion 30 is accommodated in the side surface opening 12, so that the thread-like member 43 is attached to the flap portion 30. It can prevent falling off from the tip side.
- one end portion 41 of the thread-like member 43 may be disposed on the surface 30a of the flap portion 30. 16 and 17 show a closed state in which the flap portion 30 is accommodated in the side opening 12, and in FIG. 17, the shape of the flap portion 30 in the open state is indicated by a two-dot chain line.
- the width of the gap S is slightly smaller than the outer diameter of the thread-like member 43.
- the stent 2 of this embodiment has a side opening 76 and a communication opening 77 in the main body 10 instead of the side opening 12 formed in the main body 10 of the stent 1 of the first embodiment. Is formed.
- the side opening 76 is formed on the side opposite to the flap portion 30 with respect to the longitudinal axis C.
- the communication opening 77 is formed at a position facing the flap portion 30 of the main body 10 and communicates with the internal space 11.
- the thread-like member 43 of the flap diameter-preventing portion 40 is longer than that in the first embodiment.
- the thread-like member 43 inserted through the through-hole 33 of the flap portion 30 is wound around the outer peripheral surface of the main body 10 in a state where the guide sheath E20 is not inserted.
- the present stent 2 configured as described above is used as follows in the procedure.
- the flap portion 30 is deformed to the longitudinal axis C side to be in a closed state.
- the other end portion 42 of the thread-like member 43 that is wound around the outer peripheral surface of the main body 10 is disposed on the inner space 11 side through the side opening 76.
- the thread-like member 43 is disposed on the inner surface of the internal space 11 along the circumferential direction.
- the guide sheath E20 is inserted into the internal space 11 of the main body 10 of the stent 2.
- the guide sheath E20 By arranging the guide sheath E20 on the side opening 76 side of the thread-like member 43 arranged along the circumferential direction on the inner surface of the internal space 11, the guide sheath E20 causes the other end portion 42 of the thread-like member 43 to face the side opening 76. Lock (hold) to prevent movement. Since the thread-like member 43 arranged in the internal space 11 is configured so as not to move to the side opening 76 side, the flap diameter-preventing portion 40 is locked to the guide sheath E20, and the flap portion 30 is kept closed.
- the guide sheath E20 is pulled back to the proximal end side with respect to the stent 2. As shown in FIGS. 20 and 21, the engagement between the flap diameter-preventing portion 40 and the guide sheath E20 is released, and the flap portion 30 is opened by its own elastic force.
- the thread-like member 43 disposed in the internal space 11 passes through the side opening 76 and is drawn out of the main body 10.
- the guide sheath E20 maintains the closed state of the flap portion 30 for introduction. Can be increased.
- the thread-like member 43 is disposed outside the internal space 11. For this reason, when bile flows through the internal space 11, the flap diameter-preventing portion 40 can be prevented from obstructing the flow of bile, and the stent 2 can be prevented from being clogged.
- the stent 3 of this embodiment includes a flap diameter-preventing portion 80 instead of the flap diameter-preventing portion 40 of the stent 1 of the first embodiment.
- the through hole 33 and the stepped portion 34 are not formed in the flap portion 30.
- the flap diameter-preventing portion 80 is formed in a band shape and is provided with a pair.
- the flap diameter-preventing portion 80 can be formed of the same material as the flap portion 30.
- the pair of flap diameter preventing portions 80 are arranged side by side with the longitudinal axis C in the width direction of the flap portion 30.
- One end portion 81 of each flap diameter increasing prevention portion 80 is connected to the surface 30b on the inner space 11 side in the flap portion 30 with a known adhesive or the like.
- the distance in the width direction of the pair of flap diameter preventing portions 80 is smaller than the outer diameter of the guide sheath E20, and the overall length in the width direction of the pair of flap diameter preventing portions 80 is the width direction of the side opening 12. Less than length.
- the present stent 3 configured as described above is used as follows in the procedure.
- the flap portion 30 is deformed to the longitudinal axis C side to be in a closed state.
- the other end portion 82 of each flap diameter increasing prevention portion 80 passes through the side surface opening 12 and is disposed in the internal space 11.
- the guide sheath E20 is inserted into the internal space 11 of the main body 10 of the stent 3.
- the other end portions 82 of the flap diameter preventing portions 80 are opened so as to be separated from each other, and the flap diameter preventing portion 80, the guide sheath E20, A frictional force acts between the two.
- each flap diameter preventing portion 80 cannot move to the side opening 12 side with respect to the guide sheath E20, and each flap diameter preventing portion 80 is locked to the guide sheath E20, and the flap portion 30 is closed. Is maintained.
- the guide sheath E20 is pulled back to the proximal end side with respect to the stent 3.
- the flap diameter preventing portion 80 and the guide sheath E20 are unlocked, and the flap portion 30 is opened by its own elastic force.
- Each flap diameter-preventing portion 80 disposed in the internal space 11 passes through the side opening 12 and moves to the outside of the main body 10.
- a special surgical tool is not required when introduced into the bile duct P3, and the introduction property is maintained by maintaining the closed state of the flap portion 30 with the guide sheath E20. Can be increased.
- a frictional force is also applied between the flap diameter preventing portion 80 and the main body 10. It may be.
- the flap portion 30 is accommodated in the side opening 12 when the guide sheath E20 is locked to the flap diameter preventing portion 40.
- the extension portion 31 of the flap portion 30 only needs to be configured to move to the longitudinal axis C side.
- One flap portion 30 is provided on the proximal end side of the main body 10, and one flap portion 50 is provided on the distal end side of the main body 10.
- the number of the flap portions 30 and 50 provided in the main body 10 is not limited and may be two or more.
- the linear member is assumed to be a guide sheath E20. However, the linear member is the guide wire E10, and the flap diameter-expanding preventing portion 40 may be locked or released by the guide wire E10.
- the flap portion 30 is formed by cutting and raising the side surface of the main body 10.
- the main body is formed in a tubular shape, and a side opening is formed on the side surface of the base end of the main body.
- the stent may be formed by fixing the fixing portion of the flap portion formed separately from the main body to the main body by bonding or heat welding.
- the flap portion 50 may not be provided in the main body 10. This is because the main body 10 can be locked to the narrowed portion with an adhesive or the like on the back side of the narrowed portion. Further, the grip 60 may not be provided on the stent.
- the thread-like member may be formed of a material such as Dexon (registered trademark, manufactured by Covidien) that is decomposed and absorbed by body fluid or the like.
- Dexon registered trademark, manufactured by Covidien
- body fluid or the like By preventing the bile from flowing through the internal space 11 even if a part of the filamentous member is disposed in the internal space 11 at the time of detention by absorbing the filamentous member in a certain period after the detention. Can do.
- the stent 1 is placed in the bile duct P3 has been described. However, the stent 1 may be used by being placed in the pancreatic duct.
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Abstract
Description
本願は、2013年10月25日に、米国に仮出願された米国特許出願第61/895,541号に基づき優先権を主張し、その内容をここに援用する。
この場合に用いられるステントデリバリシステムとして、特許文献1に記載されたものが知られている。
ステントデリバリシステムは、術者が操作する操作部から可撓性を有する長尺の挿入部が延びており、挿入部の先端にステントが取外し可能に装着されている。
挿入部は、プッシャーカテーテルを有する。プッシャーカテーテルのルーメンには、ガイドシース(挿入部材)が進退自在に挿入されている。プッシャーカテーテルの先端部分には、ステントの基端面が当接可能な突き当て面と、ステントの少なくとも一部を収容するステント収容部とが設けられている。ステント収容部は、プッシャーカテーテルを径方向外側に膨らませ、ルーメン径をステント径よりも大きくした構成である。
ステントの先端側のフラップは、自然状態で基端側に向かって開くように形成されている。基端側のフラップは、自然状態で先端側に向かって開くように形成されている。ステント収容部にステントが収容されたときは、ステント収容部の内壁に押圧されてそれぞれのフラップが折りたたまれるように閉じる。
このように構成されたステントデリバリシステムを用いてステントを留置する手技の手順を以下に示す。
ガイドシースをステントから除去する。挿入部を後退させると、ステント収容部が下がってステントが露出する。ステント収容部に押さえ付けられていたフラップが開き、先端側と基端側のフラップ間に胆管の狭窄部が位置する。フラップによってステントの移動が抑制される。
ステントを留置するのに一般的に用いられるプッシャーカテーテルは管状のものであり、特許文献1に記載された突き当て面およびステント収容部が設けられたプッシャーカテーテルは特別な術具である。
本発明は、上記事情に鑑みてなされたものであって、ステントを体内に導入する際、ステントの外周面を覆う特別な術具を必要とせずに、フラップ部の閉状態を維持することが可能なステントの提供を目的とする。
本発明の第2の態様によれば、上記第1の態様において、前記フラップ拡径防止部は、糸状部材が環状に形成されることで構成され、前記側面開口は、前記長軸部材の前記長手軸に対する前記フラップ部側に形成され、前記環状の前記フラップ拡径防止部に前記挿入部材が挿通されることで、前記フラップ拡径防止部が前記挿入部材に係止されていてもよい。
本発明の第3の態様によれば、上記第1の態様において、前記フラップ部が前記開状態において、前記フラップ拡径防止部は前記長軸部材の前記内部空間の外部に配されていてもよい。
本発明の第5の態様によれば、上記第1の態様において、前記フラップ拡径防止部は糸状部材であり、前記フラップ部を前記開状態から前記閉状態に変形させる力が前記フラップ部に作用するように前記糸状部材によって押圧される被押圧部が前記フラップ部に設けられていてもよい。
本発明の第6の態様によれば、上記第5の態様において、前記フラップ部における前記被押圧部の位置ずれが起きないように、前記フラップ部の前記延部には係止部が設けられていてもよい。
本発明の第7の態様によれば、上記第6の態様において、前記係止部は、前記被押圧部に前記フラップ部の厚さ方向に延びて形成された貫通孔であり、前記貫通孔に前記糸状部材が挿通されていてもよい。
本発明の第8の態様によれば、上記第6の態様において、前記係止部は、前記被押圧部における前記フラップ部の幅方向の一端に前記フラップ部の厚さ方向に貫通して形成された溝部であり、前記溝部に前記糸状部材が配されていてもよい。
本発明の第9の態様によれば、上記第1の態様において、前記長軸部材は管状であり、前記フラップ部 は、前記長軸部材の側面の一部であり、前記側面開口は、前記長軸部材の側面を切り起こすことで前記長軸部材の側面に形成された開口であってもよい。
本発明の第10の態様によれば、上記第1の態様において、前記フラップ拡径防止部は帯状に形成され、前記側面開口を通過して前記内部空間に配された前記フラップ拡径防止部と前記挿入部材との間に作用する摩擦力により、前記フラップ拡径防止部が前記挿入部材に保持されていてもよい。
上記各態様によれば、ステントを体内に導入する際、ステントの外周面を覆う特別な術具を必要とせずに、フラップ部の閉状態を維持することが可能となる。
(第1実施形態)
以下、本発明に係る医療用ステント(以下、「ステント」とも略称する。)の第1実施形態を、図1から図17を参照しながら説明する。なお、以下の全ての図面においては、図面を見やすくするため、各構成要素の厚さや寸法の比率は適宜異ならせている。
本体10は、管状に形成されている。本体10の先端面21に形成された先端開口14、および本体10の基端面22に形成された基端開口15は、内部空間11と連通している。前述の内部空間11と、先端開口14と、基端開口15とによって本体10の管路が構成されている。
本体10は、ウレタンやポリエチレンなどの弾性、柔軟性および生体適合性を有する樹脂材料で形成されている。
このように、フラップ部30は開状態と閉状態との間で変形可能である。
フラップ部50は、板状に形成され、本体10の側面から径方向外方に延びた延部51と、延部51と連なって本体10に固定された固定部52とを有している。フラップ部50の固定部52は、第二の側面開口16よりも先端側の本体10の側面に固定されている。自然状態で延部51が固定部52から基端側に延びつつ、フラップ部50が本体10の側面から径方向外方に延びて開く。すなわち、フラップ部50は、自然状態で開状態となるように形成されている。
フラップ部50および第二の側面開口16は、フラップ部30および側面開口12と同様に本体10の側面に切り込みを入れることで形成されている。フラップ部50が径方向外方から本体10の長手軸Cに向けて押付けられたときに、フラップ部50が弾性的に長手軸C側に変形して第二の側面開口16にフラップ部50が収容される。
フラップ拡径防止部40は、図2および図3に示すように、糸状部材43を環状に形成することで構成されている。より具体的には、フラップ拡径防止部40は、糸状部材43を曲げて一端部41に折返し部を形成し、一端部41に対する両側の糸状部材43の端部を結んで結び目44を形成することなどで構成されている。糸状部材43は、ナイロン、ポリプロピレン、ポリジオキサノンなどの柔軟性および生体適合性を有する樹脂で形成することができる。
本体10の長手軸Cに沿う方向において、本体10のフラップ部30の延部31、フラップ部50の延部51に対応する位置に、X線不透過性を有するマーカーを埋設させてもよい。
まず、術者などの使用者は、患者の口などの自然開口から側視タイプの内視鏡を患者の体腔内に挿入し、図4に示すように、内視鏡Eの挿入部E1の先端を、十二指腸P1を通して十二指腸乳頭P2付近まで進める。
使用者は、X線透視下において胆管P3の狭窄部P6の形状を確認して、各フラップ部30、50が開いたときの、フラップ部30の延部31からフラップ部50の延部51までの長さが、胆管P3に沿った狭窄部P6の長さとほぼ同一、あるいは、それ以上であるステント1を選択する。
このとき、使用者は、自身の手などでフラップ部30を径方向外方から本体10の長手軸Cに向けて押付けることなどにより、図5および図6に示すようにフラップ部30の延部31を弾性的に長手軸C側に変形させ、側面開口12にフラップ部30を収容しておく。すると、フラップ拡径防止部40の他端部42が側面開口12を通過し、内部空間11内に配される。このとき、内部空間11内に配された環状の糸状部材43に、本体10の内部空間11に挿入されたガイドシースE20が挿通可能となる。環状の糸状部材43にガイドシースE20が挿通可能となるとは、糸状部材43のうち内部空間11内に配された部分の長さがガイドシースE20の外周の長さ以上になることを意味する。
この状態ではフラップ拡径防止部40にガイドシースE20が挿通することができず、フラップ拡径防止部40にガイドシースE20を係止させることはできない。
挿入部E1およびガイドシースE20に対してプッシャーカテーテルE30を押込み、チャンネルE2内でステント1を先端側に移動させる。このとき、ステント1に対してガイドシースE20が位置Q1よりも基端側に移動することはなくガイドシースE20は基準範囲R内に配されている。このため、フラップ拡径防止部40にガイドシースE20が係止し、側面開口12にフラップ部30が収容されたフラップ部30の閉状態が保持される。
ステント1のフラップ50が狭窄部P6に達すると、フラップ部50は狭窄部P6の内壁に押圧されてさらに長手軸C側に変形し、第二の側面開口16に収容されて閉状態となる。
フラップ部30が完全に開状態となるか否かは、フラップ部30の周囲の胆管P3の内壁の状態に依存する。
ステント1の留置中には、肝臓で生成された胆汁は、胆管P3における狭窄部P6に対応する部分ではステント1の本体10の管路内を流れ、十二指腸P1の内腔に供給される。
このように、ステント1を胆管P3内に導入するときに、フラップ部30の閉状態を維持することができるため、ステント1の導入時にフラップ部30が十二指腸乳頭P2や胆管P3の内壁に係止されるのを抑えることができる。この結果、ステント1を胆管P3内に導入するときの導入性を高めることができる。
また、ステント1の外周面を覆う特別な術具を必要としないため、全体としてコンパクトな構成を図ることができる。
フラップ拡径防止部40は糸状部材43を環状に形成して構成されているため、フラップ拡径防止部40を容易に構成することができ、ステント1の製造コストを低減させことができる。
糸状部材43がフラップ部30の貫通孔33に挿通されることで、フラップ部30からフラップ拡径防止部40が外れるのを防止しフラップ部30にフラップ拡径防止部40を確実に取付けることができる。
糸状部材43がフラップ部30の段部34側よりも延部31側に配置されている。したがって、フラップ部30が開状態や閉状態に変形するときに、糸状部材43が本体10に接触してフラップ部30が変形しにくくなるのを抑制することができる。
例えば、図9に示すステント1Aのように、ステント1Aを留置したときに内部空間11に胆汁を流すことができるため、フラップ部30が開状態のときに、フラップ拡径防止部40の他端部42が本体10の内部空間11に配されてもよい。このように構成することによって、ステント1Aを留置したときに内部空間11に胆汁を流すことができる。
このように構成されたステント1Aによれば、導入するときに、特別な術具を必要とすることなく、導入性を良くすることができる。
このように構成されたステント1Bによれば、フラップ部30に対して糸状部材43および被押圧部38が先端側や基端側に移動するのを確実に防止することができる。糸状部材43をフラップ部30の貫通孔33に挿通した後で結び目44を形成する必要が無く、予め糸状部材43に結び目44を形成してからフラップ部30に取付けることができるため、糸状部材43に結び目44を容易に形成することができる。
本変形例では、フラップ部30のそれぞれの端に溝部35、36を形成したが、フラップ部30には少なくとも溝部35が形成されていればよい。溝部35内のみに糸状部材43を配することでも、上記と同様の効果を奏することができるからである。
この変形例では、フラップ部30に前述のような貫通孔33、段部34、および溝部35、36は形成されない。フラップ部30が開状態や閉状態に変形するときに本体10が糸状部材43に干渉しないように、隙間Sの幅は糸状部材43の外径よりも大きくすることが好ましい。
図14および図15に示すステント1Dのように、フラップ部30の幅方向の両側に段部34を形成し、フラップ部30の面30aに配されたフラップ拡径防止部40の一端部41を固定部71によりフラップ部30に固定してもよい。なお、図14および図15においては側面開口12にフラップ部30が収容されたフラップ部30の閉状態を示し、図15において開状態におけるフラップ部30の形状を二点鎖線で示している。
一端部41に対するそれぞれの側の糸状部材43は、フラップ部30の段部34側よりも延部31側に配置されている。
図16および図17に示すステント1Eのように、フラップ部30の面30aに糸状部材43の一端部41を配してもよい。なお、図16および図17においては側面開口12にフラップ部30が収容された閉状態を示し、図17において開状態におけるフラップ部30の形状を二点鎖線で示している。
隙間Sの幅は糸状部材43の外径よりもわずかに小さく、隙間Sに糸状部材43を挿通したときに、フラップ部30および本体10と糸状部材43との間に作用する摩擦力により、フラップ部30および本体10に対して糸状部材43が先端側や基端側に移動できない。
次に、本発明の第2実施形態について図18から図21を参照しながら説明するが、前記実施形態と同一の部位には同一の符号を付してその説明は省略し、異なる点についてのみ説明する。
本実施形態では、フラップ拡径防止部40の糸状部材43は第1実施形態よりも長い。フラップ部30の貫通孔33に挿通された糸状部材43は、ガイドシースE20が挿通されていない状態において、本体10の外周面に沿って這わすように掛け回されている。
フラップ部30を長手軸C側に変形させて閉状態にする。本体10の外周面に沿って掛け回された糸状部材43の他端部42を、側面開口76を通過して内部空間11側に配置させる。糸状部材43を内部空間11の内面に周方向に沿って配置する。
内部空間11に配された糸状部材43が側面開口76側に移動できないように構成されているため、フラップ拡径防止部40がガイドシースE20に係止され、フラップ部30の閉状態が維持される。
ガイドシースE20を引き抜いてフラップ部30が開状態となったときに糸状部材43が内部空間11の外部に配される。このため、内部空間11を胆汁が流れるときに、フラップ拡径防止部40が胆汁の流れを妨げるのを防止し、ステント2を詰まりづらくすることができる。
次に、本発明の第3実施形態について図22から図25を参照しながら説明するが、前記実施形態と同一の部位には同一の符号を付してその説明は省略し、異なる点についてのみ説明する。
一対のフラップ拡径防止部80の幅方向の距離はガイドシースE20の外径よりも小さく、一対のフラップ拡径防止部80の全体としての幅方向の長さは、側面開口12の幅方向の長さよりも小さい。
フラップ部30を長手軸C側に変形させて閉状態にする。このとき、各フラップ拡径防止部80の他端部82は、側面開口12を通過して内部空間11に配される。
ステント3の本体10の内部空間11にガイドシースE20を挿入させる。一対のフラップ拡径防止部80間にガイドシースE20を挿入させるときに、各フラップ拡径防止部80の他端部82が互いに離間するように開き、フラップ拡径防止部80とガイドシースE20との間に摩擦力が作用する。この摩擦力により、ガイドシースE20に対して各フラップ拡径防止部80が側面開口12側に移動できなくなり、各フラップ拡径防止部80がガイドシースE20に係止され、フラップ部30の閉状態が維持される。
なお、本実施形態では、一対のフラップ拡径防止部80間にガイドシースE20を挿入させたときに、フラップ拡径防止部80と本体10との間にも摩擦力が作用するように構成されていてもよい。
例えば、前記第1実施形態および第2実施形態では、ガイドシースE20をフラップ拡径防止部40に係止させたときに側面開口12にフラップ部30が収容されるとした。しかし、ガイドシースE20をフラップ拡径防止部40に係止させたときに、フラップ部30の延部31が長手軸C側に移動するように構成されていればよい。
線状部材がガイドシースE20であるとした。しかし、線状部材がガイドワイヤE10であり、ガイドワイヤE10によりフラップ拡径防止部40を係止させたりこの係止を解除させたりしてもよい。
本体10にフラップ部50が設けられていなくてもよい。狭窄部の奥側に対しては接着剤などにより本体10を狭窄部に係止することができるからである。また、ステントに把持部60は備えられなくてもよい。
前記実施形態では、ステント1を胆管P3内に留置する場合について説明した。しかし、本ステント1は膵管内に留置して用いてもよい。
また、本発明は前述した説明によって限定されることはなく、添付のクレームの範囲によってのみ限定される。
11 内部空間
12 側面開口
12a 側面
30 フラップ部
33 貫通孔(係止部)
35、36 溝部(係止部)
38 被押圧部
40 フラップ拡径防止部
Claims (11)
- 長手軸に沿って延設された内部空間、および側面に前記内部空間と連通して形成された側面開口を有し、前記内部空間に挿入された挿入部材が前記長手軸に沿って移動自在である長軸部材と、
組織に係止するように前記長軸部材の側面から径方向外方に延びた延部と前記延部と連なって前記長軸部材に固定された固定部とを有し、前記延部が前記長軸部材の前記側面から径方向に延びた開状態と前記長軸部材の前記長手軸に沿って延びた閉状態とに変形可能なフラップ部と、
前記フラップ部が前記閉状態において、少なくとも一部が前記側面開口を通過するとともに前記挿入部材により前記フラップ部を前記内部空間に保持可能なフラップ拡径防止部と、
を備える医療用ステント。 - 前記フラップ拡径防止部は、糸状部材が環状に形成されることで構成され、
前記側面開口は、前記長軸部材の前記長手軸に対する前記フラップ部側に形成され、
前記環状の前記フラップ拡径防止部に前記挿入部材が挿通されることで、前記フラップ拡径防止部が前記挿入部材により前記内部空間に保持される
請求項1に記載の医療用ステント。 - 前記フラップ部が前記開状態において、前記フラップ拡径防止部は前記長軸部材の前記内部空間の外部に配されている
請求項1に記載の医療用ステント。 - 前記フラップ拡径防止部は、糸状部材が環状に形成されることで構成され、
前記側面開口は、前記長軸部材の前記長手軸に対する前記フラップ部とは反対側に形成され、
前記側面開口を通過して前記内部空間の内面に周方向に沿って配された前記糸状部材を前記挿入部材が前記側面開口側に移動しないように保持することで、前記フラップ拡径防止部が前記挿入部材により前記内部空間に保持される
請求項1に記載の医療用ステント。 - 前記フラップ拡径防止部は糸状部材であり、
前記フラップ部を前記開状態から前記閉状態に変形させる力が前記フラップ部に作用するように前記糸状部材によって押圧される被押圧部が前記フラップ部に設けられている
請求項1に記載の医療用ステント。 - 前記フラップ部における前記被押圧部の位置ずれが起きないように、前記フラップ部の前記延部には係止部が設けられている
請求項5に記載の医療用ステント。 - 前記係止部は、前記被押圧部に前記フラップ部の厚さ方向に延びて形成された貫通孔であり、
前記貫通孔に前記糸状部材が挿通されている
請求項6に記載の医療用ステント。 - 前記係止部は、前記被押圧部における前記フラップ部の幅方向の一端に前記フラップ部の厚さ方向に貫通して形成された溝部であり、
前記溝部に前記糸状部材が配されている
請求項6に記載の医療用ステント。 - 前記長軸部材は管状であり、
前記フラップ部は、前記長軸部材の側面の一部であり、
前記側面開口は、前記長軸部材の側面を切り起こすことで前記長軸部材の側面に形成された開口である
請求項1に記載の医療用ステント。 - 前記フラップ拡径防止部は帯状に形成され、
前記側面開口を通過して前記内部空間に配された前記フラップ拡径防止部と前記挿入部材との間に作用する摩擦力により、前記フラップ拡径防止部が前記挿入部材により前記内部空間に保持される
請求項1に記載の医療用ステント。 - 前記フラップ拡径防止部は、前記フラップ部の前記延部に接続された第一端部及び前記第一端部と連なる第二端部を有し、
前記フラップ部が前記閉状態において、前記フラップ部が前記閉状態を維持するように、前記フラップ拡径防止部の前記第二端部の少なくとも一部が前記側面開口を通過するとともに前記第二端部が前記挿入部材に係止されている
請求項1に記載の医療用ステント。
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