WO2014115336A1 - Replacement assist device, guiding catheter assembly, and guiding catheter - Google Patents

Replacement assist device, guiding catheter assembly, and guiding catheter Download PDF

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Publication number
WO2014115336A1
WO2014115336A1 PCT/JP2013/051794 JP2013051794W WO2014115336A1 WO 2014115336 A1 WO2014115336 A1 WO 2014115336A1 JP 2013051794 W JP2013051794 W JP 2013051794W WO 2014115336 A1 WO2014115336 A1 WO 2014115336A1
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WO
WIPO (PCT)
Prior art keywords
insertion device
wire
guiding catheter
cavity
main body
Prior art date
Application number
PCT/JP2013/051794
Other languages
French (fr)
Japanese (ja)
Inventor
岩崎泰造
Original Assignee
テルモ株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/051794 priority Critical patent/WO2014115336A1/en
Publication of WO2014115336A1 publication Critical patent/WO2014115336A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00Catheters; Hollow probes
    • A61M25/01Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0169Exchanging a catheter while keeping the guidewire in place

Definitions

  • the present invention relates to a replacement assisting device, a guiding catheter assembly, and a guiding catheter that are used in combination with an insertion device that is inserted into a living body lumen for diagnosis and treatment.
  • a living body intraluminal intervention technique for delivering a catheter is performed.
  • the previously inserted insertion device may be replaced with an insertion device of a different type or a different size for continuous treatment.
  • PTCA percutaneous coronary angioplasty
  • an ultrasonic diagnostic catheter is guided to a lesion in the coronary artery through the inside of the guiding catheter, and an ultrasonic diagnosis of the lesion and the peripheral portion is performed.
  • the ultrasonic catheter is withdrawn and replaced with a treatment catheter (balloon catheter, stent delivery catheter, etc.) for treating the lesion, and the treatment catheter is delivered to the lesion, so that the desired lesion can be obtained.
  • a treatment catheter balloon catheter, stent delivery catheter, etc.
  • the applicant of the present invention has previously proposed a replacement auxiliary device capable of moving only the insertion device backward while fixing the guide wire as disclosed in Japanese Patent Application Laid-Open No. 2003-230631.
  • This exchange assisting device tubular portion
  • the insertion device is movably disposed inside the tubular portion, and between the outer surface of the tubular portion and the inner surface of the Y-connector.
  • the present invention has been made in view of the above-described circumstances in order to more effectively replace the insertion device.
  • the insertion device When the insertion device is pulled out, the insertion device can be inserted by fixing only the guide wire with a simple configuration. It is an object of the present invention to provide an exchange assist device, a guiding catheter assembly, and a guiding catheter capable of easily exchanging a device, thereby enabling quick and good diagnosis and treatment in a living body lumen. To do.
  • the present invention is constituted by a cylindrical main body part that can be inserted through an insertion device guided along a wire, and assists the exchange from one insertion device to another insertion device.
  • the cylindrical body portion has a hollow portion that extends in the axial direction inside thereof and in which the insertion device and the wire are movable, and has the hollow portion therein, and the insertion device.
  • a stopper portion for restricting only the movement of the wire exposed from the insertion device in a state where the distal end portion thereof is moved from the predetermined position to the proximal end side.
  • the stopper portion of the replacement auxiliary device regulates the movement of the wire exposed from the insertion device when the distal end portion of the insertion device moves from the predetermined position to the proximal side. (Fix the wire). Therefore, it is possible to pull out only the insertion device while leaving the wire. Thereby, by passing the next insertion device through the fixed wire, the insertion device can be easily replaced, and the insertion device can be delivered smoothly. Therefore, by using the replacement assisting device, it is possible to quickly and satisfactorily perform diagnosis and treatment in the living body lumen.
  • the stopper portion has a hole portion through which the insertion device and the wire are inserted, and is twisted to twist and lock the wire inserted through the hole portion by rotating with respect to the cylindrical main body portion. And a twisting operation part that is exposed to the outside of the cylindrical main body part and is operable to rotate the twisting part.
  • the replacement assisting device including the twist portion and the twist operation portion can rotate the twist portion with respect to the cylindrical main body portion by operating the twist operation portion. And since this twist part rotates, the wire penetrated by the hole part will be twisted, and the movement of a wire can be controlled easily.
  • the stopper portion has a surface shape that substantially matches the cross-sectional shape of the cavity portion, and a plate member that locks the wire by operating to close the cavity portion in accordance with a predetermined operation; And a plate member operation portion that is exposed to the outside of the cylindrical main body portion and can be operated to close the cavity by the plate member.
  • the replacement auxiliary device including the plate member and the plate member operation unit operates to close the cavity by the plate member by operating the plate member operation unit. And by the obstruction
  • the stopper portion is displaced in a substantially orthogonal direction of the cavity portion by a pressing operation, and a pressing member that locks the wire between the inner wall constituting the cavity portion and the pressing operation is resisted.
  • the auxiliary exchange device including the pressing member and the elastic member can sandwich the wire between the pressing member and the inner wall constituting the hollow portion by pressing the pressing member, and the movement of the wire can be performed. It can be easily regulated. Moreover, the pressing member can be easily returned to the original position by releasing the pressing operation of the pressing member.
  • the insertion device is a rapid exchange type in which the wire is exposed from an exposed portion provided at an intermediate position of the insertion device, and the distance from the stopper portion to the base end portion of the cylindrical main body portion is It is preferable that it is longer than the distance from the front-end
  • the distance from the stopper portion of the cylindrical main body portion to the base end portion is longer than the distance from the distal end portion of the insertion device to the exposed portion, so that the exposed portion of the insertion device is the base end of the cylindrical main body portion.
  • the distal end part of the insertion device is surely located on the proximal side from the stopper part. In this case, only the movement of the wire can be reliably regulated by the operator confirming the exposed portion (in other words, it is possible to reliably prevent the movement of the insertion device from being erroneously regulated).
  • the present invention provides a guiding catheter capable of delivering an insertion device guided along a wire to a desired position in a living body through the inside, and a tube through which the insertion device can be inserted.
  • a guiding catheter assembly that is configured by connecting together an exchange assist device that is constituted by a cylindrical body portion and that assists in exchanging from one insertion device to another insertion device.
  • the cavity has a cavity that extends in the axial direction and in which the insertion device and the wire can move, and the cavity, and the distal end of the insertion device moves from the predetermined position to the proximal side.
  • a stopper portion for restricting only the movement of the wire exposed from the insertion device.
  • the present invention provides a guiding catheter capable of delivering an insertion device guided along a wire to a desired position in a living body through the inside.
  • a guiding catheter capable of delivering an insertion device guided along a wire to a desired position in a living body through the inside.
  • On the end side it is constituted by a cylindrical main body part through which the insertion device can be inserted, and an exchange auxiliary part for assisting exchange from one insertion device to another insertion device is provided.
  • a hollow portion that extends in the axial direction and in which the insertion device and the wire are movable, and has the hollow portion therein, and the distal end portion of the insertion device is moved from the predetermined position to the proximal side.
  • a stopper for restricting only the movement of the wire exposed from the insertion device.
  • the insertion device when the insertion device is pulled out, the insertion device can be easily replaced by fixing only the guide wire with a simple configuration. Treatment can be performed quickly and satisfactorily.
  • FIG. 2A is an exploded side view of the proximal end portion of the guiding catheter assembly of FIG. 1, and FIG. 2B is a cross-sectional view of FIG. 2A.
  • FIG. 3A is a side view showing a distal end portion of an ultrasonic diagnostic catheter that is an example of an insertion device
  • FIG. 3B is a partial side sectional view showing a distal end portion of a stent delivery catheter that is an example of an insertion device.
  • 4A is a first explanatory diagram for explaining the operation of the replacement assisting device of FIG. 1, and FIG.
  • FIG. 4B is a cross-sectional view taken along the line IVB-IVB of FIG. 4A.
  • 5A is a second explanatory diagram for explaining the operation of the replacement assisting device in FIG. 1
  • FIG. 5B is a cross-sectional view taken along the line VB-VB in FIG. 5A.
  • 6A is a third explanatory diagram for explaining the operation of the replacement assisting device of FIG. 1
  • FIG. 6B is a cross-sectional view taken along the line VIB-VIB of FIG. 6A.
  • 7A is a side sectional view of the stopper portion according to the first modification
  • FIG. 7B is a sectional view taken along the line VIIB-VIIB of FIG. 7A
  • FIG. 7C is a block diagram of the stopper portion according to the first modification.
  • FIG. 7D is a side cross-sectional view during operation, and FIG. 7D is a cross-sectional view taken along the VIID-VIID line of FIG. 7C.
  • 8A is a side sectional view of a stopper portion according to a second modification
  • FIG. 8B is a sectional view taken along line VIIIB-VIIIB of FIG. 8A
  • FIG. 8C is a block diagram of the stopper portion according to the second modification.
  • FIG. 8D is a side sectional view in operation
  • FIG. 8D is a sectional view taken along line VIIID-VIIID in FIG. 8C. It is front sectional drawing of the stopper part which concerns on a 3rd modification.
  • FIG. 10A is a side view showing a replacement auxiliary device according to the second embodiment
  • FIG. 10B is a cross-sectional view of FIG. 10A. It is a side view which shows the whole structure of the guiding catheter assembly which has a guiding catheter which concerns on 3rd Embodiment. It is a side view which shows the whole structure of the guiding catheter which concerns on 4th Embodiment.
  • the exchange assist device 10 As shown in FIG. 1, the exchange assist device 10 according to the first embodiment is connected to a proximal end portion of a guiding catheter 12 that is inserted into a blood vessel (biological lumen). Further, a Y-type connector 14 that is an introduction port of the guiding catheter 12 is connected to the proximal end portion of the exchange assisting device 10. That is, at the time of introduction into the blood vessel, the guiding catheter 12, the exchange assist device 10 and the Y-type connector 14 are used in an assembled state (hereinafter, the set of the guiding catheter 12, the exchange assist device 10 and the Y-type connector 14). The attached state is referred to as a guiding catheter assembly 16).
  • the guiding catheter assembly 16 includes an insertion device 18 (for example, an ultrasonic diagnostic catheter 20, a stent delivery catheter 22: see FIGS. 3A and 3B) and a guide wire 24 for guiding the insertion device 18 in the blood vessel. It functions as a conduit that advances to a predetermined position. For example, in PTCA, the guiding catheter assembly 16 is delivered to the ascending aorta and its tip is delivered near the entrance to the coronary artery. Accordingly, when the guide wire 24 is delivered from the distal end portion into the coronary artery, the insertion device 18 is smoothly introduced into the coronary artery along the guide wire 24.
  • an insertion device 18 for example, an ultrasonic diagnostic catheter 20, a stent delivery catheter 22: see FIGS. 3A and 3B
  • a guide wire 24 for guiding the insertion device 18 in the blood vessel. It functions as a conduit that advances to a predetermined position.
  • the guiding catheter assembly 16 is delivered to the ascending aorta and its tip is delivered near
  • the guiding catheter assembly 16 shown in FIG. 1 is curved at the distal end side (the distal end side of the tube body 26) corresponding to the inside of the ascending aorta (valsalva sinus) so as to be disposed near the entrance of the coronary artery. Is formed.
  • the guiding catheter assembly 16 is not limited to the treatment of coronary arteries, but can diagnose various biological organs (for example, other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity, other organs, etc.) Of course, it can be applied to treatment.
  • the shape on the distal end side of the guiding catheter assembly 16 is preferably formed as appropriate according to the treatment site, and may be, for example, linear or may be provided with a bent portion.
  • the guiding catheter assembly 16 for PTCA will be representatively described in detail.
  • the guiding catheter 12 includes a long tube body 26 to be inserted into a blood vessel, and a hub 28 that is connected to a proximal end portion of the tube body 26 and is operated by an operator outside the living body. Inside the guiding catheter 12 is provided an insertion passage 30 that penetrates the tube body 26 and the hub 28 in the axial direction.
  • the inner diameter of the insertion passage 30 is formed larger than the outer diameter of the insertion device 18 described above, and the insertion device 18 is inserted into the insertion passage 30 so as to be movable forward and backward.
  • the tube body 26 has a delivery port 30a communicating with the insertion passage 30 at the tip, and the tip side near the delivery port 30a is curved as described above.
  • the insertion device 18 that has moved through the internal insertion passage 30 can be sent out from the delivery port 30a.
  • the dimensions of the tube body 26 may be appropriately set according to the treatment site and application. For example, the total length is about 200 to 1000 mm, the outer diameter is about 1.5 to 5.0 mm, and the inner diameter is 1.0 to 4. It is good to set to about 5 mm.
  • the tubular body 26 is formed by appropriately considering physical properties such as pushability to the blood vessel, followability, and kink resistance.
  • the material constituting the tube body 26 is not particularly limited.
  • polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer (EVA), polyvinyl chloride, polyurethane, polyamide, acrylonitrile- Polyester such as butadiene-styrene copolymer (ABS resin), acrylonitrile-styrene copolymer (AS resin), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycarbonate, polyimide, fluororesin, styrene, polyolefin , Polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluorine, chlorinated polyethylene and other thermoplastic elastomers, etc.
  • Copolymers mainly, blends, polymer alloys and the like, may be used in combination of two or more of these (e.g., a laminate of two or more layers).
  • the tube body 26 may be reinforced with a metal wire (blade) or the like.
  • the hub 28 connected to the proximal end side of the tube body 26 is formed to have a larger diameter than the tube body 26 so that the operator can easily grasp it.
  • the surgeon grips the hub 28 and the base side of the tube body 26 and performs a predetermined operation (advancement / retraction operation or rotation operation) to move the tube body 26 relative to the blood vessel.
  • a predetermined operation as shown in FIGS. 1, 2A, and 2B
  • the wing etc. may be formed in the outer peripheral surface of the hub 28 so that the hub 28 may be operated easily.
  • a proximal end connection portion 32 for connection to the replacement auxiliary device 10 is provided at the proximal end portion of the hub 28.
  • the connection mechanism between the hub 28 and the replacement auxiliary device 10 is a luer lock type, and the proximal end connection portion 32 is configured as a luer lock type female connector.
  • the base end connection portion 32 includes a base end opening 30 b communicating with the insertion passage 30 and a male screw portion 36 formed on the outer peripheral surface of the hub 28.
  • the replacement auxiliary device 10 connected to the hub 28 includes a cylindrical main body 40 formed in a cylindrical shape.
  • the cylindrical main body portion 40 is formed to have the same thickness as the hub 28 (or slightly thicker than the hub 28) and has a linear outer shape along the axial direction.
  • a hollow portion 42 is formed through the inside of the cylindrical main body portion 40.
  • the cylindrical main body 40 has a distal end connecting portion 44, a stopper portion 46, a body portion 48, and a proximal end connecting portion 50 in order from the distal end to the proximal end.
  • the cavity portion 42 communicates with the inside of the distal end connection portion 44, the stopper portion 46, the body portion 48, and the proximal end connection portion 50, and is formed to have a relatively large diameter although the inner diameter is slightly different in each part.
  • the insertion device 18 and the guide wire 24 can be movably accommodated.
  • the replacement assisting device 10 is formed as a member interposed between the guiding catheter 12 and the Y-type connector 14 which has been conventionally connected directly. Therefore, the distal end connection portion 44 and the proximal end connection portion 50 of the exchange assisting device 10 are basically formed by imitating a connection mechanism between the guiding catheter 12 and the Y-type connector 14. That is, the shape of the distal end connection portion 44 of the replacement auxiliary device 10 is substantially the same as the shape of the distal end connection portion 60 of the Y-type connector 14, and the shape of the proximal end connection portion 50 of the replacement auxiliary device 10 is the guiding. The shape of the proximal end connection portion 32 of the catheter 12 is substantially the same.
  • the distal end connecting portion 44 is configured as a luer lock type male connector, and the inner cylindrical portion 52 that surrounds the axial center and protrudes in the distal end direction is separated from the outer peripheral surface of the inner cylindrical portion 52 by a predetermined distance. And an outer cylindrical portion 54 that surrounds at the position.
  • the inner cylinder portion 52 has a tip opening 42 a that communicates with the cavity portion 42. The inner cylindrical portion 52 is inserted into the proximal end opening 30b of the guiding catheter 12, thereby realizing communication between the insertion passage 30 and the distal end opening 42a (hollow portion 42).
  • the outer cylindrical portion 54 is formed to have a larger diameter than the outer diameter of the proximal end connecting portion 32 of the hub 28, and a female screw portion 38 is formed on the inner peripheral surface facing the inner cylindrical portion 52.
  • the female screw part 38 connects the guiding catheter 12 and the exchange assisting device 10 by screwing into the male screw part 36 of the proximal end connection part 32. That is, the guiding catheter 12 and the exchange assisting device 10 are integrated so as not to move and rotate relatively by the luer lock method. Therefore, the operator can also operate the guiding catheter 12 by grasping the exchange assisting device 10 during the catheter procedure.
  • the stopper portion 46 connected to the proximal end of the distal end connecting portion 44 has a mechanism for restricting the movement of the guide wire 24, and the inner cavity portion 42 is formed with a larger diameter than the others to accommodate the restricting mechanism. Yes.
  • the configuration of the stopper portion 46 will be described in detail later.
  • the body 48 connected to the base end of the stopper 46 has a sufficient length along a straight line and is configured to be grasped by the operator.
  • the insertion device 18 inserted into the exchange assisting device 10 is linearly guided by a predetermined distance by the body portion 48, so that the mobility at the time of insertion is improved.
  • a wing operation piece (not shown) may be provided on the outer peripheral surface of the body portion 48.
  • the proximal end connection portion 50 connected to the proximal end of the body portion 48 is a portion that is connected to the Y-type connector 14 and is formed in substantially the same shape as the proximal end connection portion 32 of the guiding catheter 12 as described above. Yes. That is, the base end connection part 50 has a base end opening 42 b communicating with the cavity part 42 and a male screw part 56 formed on the outer peripheral surface. Furthermore, the base end connection part 50 has a valve body 35 housed and held in the base end opening 42b. The valve body 35 has a function of preventing blood from flowing out to the proximal end side of the replacement assisting device 10 by closing the proximal end side of the hollow portion 42 of the replacement assisting device 10.
  • a slit 35 a is provided at the center of the valve body 35.
  • the valve body 35 is elastically deformed as the Y-type connector 14 is pushed in, the slit 35a is opened and the inner cylindrical portion 66 of the Y-type connector 14 is inserted into the cavity portion 42.
  • the male screw portion 56 is screwed to the female screw portion 70 of the Y-type connector 14.
  • the distal end connecting portion 44, the stopper portion 46, the body portion 48, and the proximal end connecting portion 50 are integrally formed of a resin material and provided as a single member (exchange assisting device 10).
  • the replacement auxiliary device 10 is preferably made of a resin material that is relatively hard and has transparency (or translucency). If the exchange assisting device 10 is transparent, the operator can easily visually recognize the insertion device 18 and the guide wire 24 inserted into the cavity 42.
  • the material constituting the exchange assisting device 10 is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, polyvinyl chloride, polybutadiene, polyamide, polyester, polycarbonate, and polystyrene. And various resin materials.
  • the Y-type connector 14 is formed shorter than the replacement assisting device 10, and a lumen 58 is provided in the inside thereof along the axial direction.
  • the Y-type connector 14 has a distal end connection portion 60, a first port 62 that is continuous with the proximal end side in the axial direction of the distal end connection portion 60, and a second port 64 that is obliquely connected to the first port 62. 58 penetrates the tip connection part 60 and the first port 62.
  • the tip connection part 60 is formed in substantially the same shape as the tip connection part 44 of the replacement auxiliary device 10 as described above. That is, the distal end connecting portion 60 includes an inner cylindrical portion 66 having a distal end opening 58 a continuous with the inner cavity 58, and an outer cylindrical portion 68 having an internal thread portion 70, and the proximal end connecting portion 50 of the replacement auxiliary device 10 is It is comprised so that it may connect firmly.
  • the first port 62 is a port for inserting the insertion device 18 and the guide wire 24.
  • the lumen 58 in the first port 62 is tapered on the proximal end side, so that the insertion device 18 can be easily inserted.
  • the second port 64 is a port for supplying various supply substances to the insertion passage 30 of the guiding catheter 12, and has an introduction cavity 64a communicating with the lumen 58 inside.
  • the supply substance include physiological saline for priming the guiding catheter 12, and a contrast agent discharged from the delivery port 30a.
  • the guiding catheter assembly 16 is connected to the above guiding catheter 12, the exchange assisting device 10, and the Y-type connector 14, so that the insertion passage 30 of the guiding catheter 12, the cavity 42 of the exchange assisting device 10, and the Y-type connector 14. Lumens 58 communicate with each other.
  • the connection mechanism of the guiding catheter 12, the exchange assisting device 10, and the Y-type connector 14 may be reversed in terms of male-female relationships, and is not limited to the above-described luer lock system, and has various configurations. Of course, it may be applied.
  • the insertion device 18 When the insertion device 18 is introduced from the first port 62 of the Y-type connector 14 and advanced, the insertion device 18 extends along the axial direction of the guiding catheter assembly 16 via the lumen 58, the cavity 42, and the insertion passage 30. And is sent out from the outlet 30a on the distal end side of the tube body 26.
  • examples of the insertion device 18 used for PTCA include an ultrasonic diagnostic catheter 20 shown in FIG. 3A and a stent delivery catheter 22 shown in FIG. 3B.
  • the ultrasonic diagnostic catheter 20 includes a diagnostic unit 72 that performs ultrasonic diagnosis and a guide unit 74 that guides the ultrasonic diagnostic catheter 20 along the guide wire 24 in parallel. That is, the ultrasonic diagnostic catheter 20 is provided so as to be parallel to the axial direction of the diagnostic unit 72 at a position where the guide unit 74 is shifted to the side and the distal side of the diagnostic unit 72, and the guide unit 74 is exposed on the proximal end side. It is configured as a so-called rapid exchange type catheter in which the guide wire 24 is exposed from the point 75.
  • the diagnosis unit 72 includes a diagnostic element 72a that generates an ultrasonic wave toward the blood vessel and detects a reflected wave, a driving shaft 72b that transmits a driving force to the diagnostic element 72a, and a window 72c that transmits the ultrasonic wave of the diagnostic element 72a.
  • the guide part 74 bulges from the side part of the diagnosis part 72 (window 72c) and is provided on the tip side from the diagnosis part 72, and penetrates so that the guide wire lumen 74a is parallel to the axial direction of the diagnosis part 72. Is formed.
  • the diagnostic unit 72 of the ultrasonic diagnostic catheter 20 is guided along the guide wire 24 inserted through the guide wire lumen 74a.
  • the distance L1 of the section in which the guide wire 24 guides the ultrasonic diagnostic catheter 20 (that is, the axial length of the guide portion 74) is preferably set to about 15 to 250 mm, for example.
  • the stent delivery catheter 22 has a shaft 76 that protrudes toward the distal end and into which the guide wire 24 is inserted into an internal guide wire lumen 76 a, a stent 78 and a balloon 80 that are disposed on the outer peripheral surface of the shaft 76, and a base of the balloon 80.
  • a distal end side tube 82 extending a predetermined length on the end side and a proximal end side tube 84 provided on the proximal end side of the distal end side tube 82 are provided.
  • the shaft 76 is attached to bend toward the oblique side near the connecting portion between the distal end side tube 82 and the proximal end side tube 84. That is, the stent delivery catheter 22 is configured as a rapid exchange type catheter in which the guide wire 24 inserted from the distal end portion of the shaft 76 is exposed from the exposed portion 85 (the proximal end side portion of the distal end side tube 82) at a midpoint position. ing.
  • the distance L1 of the section where the guide wire 24 guides the stent delivery catheter 22 (that is, the axial length of the shaft 76) is preferably set to about 50 to 250 mm, for example.
  • the stent 78 is a balloon expandable type, and is delivered to a treatment site in a blood vessel in a contracted state when the stent delivery catheter 22 is delivered. Then, as the balloon 80 is expanded, the balloon 80 is expanded outward in the radial direction (see FIG. 3B), and the blood vessel can be supported. The balloon 80 is expanded by the expansion fluid guided through the lumen 86 in the proximal tube 84 and the distal tube 82.
  • the guiding catheter assembly 16 shown in FIG. 1 is delivered and the delivery port 30a is placed at a predetermined position (near the entrance of the coronary artery). Then, the guide wire 24 is delivered from the delivery port 30a, and the ultrasound diagnostic catheter 20 is guided to the treatment site along the preceding guide wire 24 to perform ultrasound diagnosis. Thereafter, the ultrasonic diagnostic catheter 20 is retracted and pulled out relative to the guiding catheter assembly 16 and replaced with the stent delivery catheter 22. The stent delivery catheter 22 is inserted and delivered into the guiding catheter assembly 16 with the guide wire 24 remaining in the guiding catheter assembly 16 passed through the guide wire lumen 76a.
  • the stent 78 is expanded by being guided along the guide wire 24 to the treatment site, and is placed in the blood vessel (treatment site).
  • a balloon catheter, an atherectomy device, or the like may be used as a therapeutic device in addition to (or before use) the stent delivery catheter 22.
  • the guide wire 24 is inserted into the guide wire 24 in order to smoothly deliver the next stent delivery catheter 22. It is important that the moving catheter assembly 16 does not move. In particular, when the insertion device 18 (ultrasound diagnostic catheter 20) inserted previously is pulled out, the guide wire 24 is often retracted together with the insertion device 18 and pulled out from the Y connector 14. For this reason, the replacement auxiliary device 10 is configured to restrict the movement of the guide wire 24.
  • the replacement assisting device 10 restricts the movement of the guide wire 24 at the stopper portion 46.
  • the stopper portion 46 is provided with a rotating ring member 88 (twisting portion) that is rotatable with respect to the cylindrical main body portion 40 and an operation knob 90 (twisting operation portion) for rotating the rotating ring member 88. Yes.
  • the rotating ring member 88 is formed of a hard material (for example, metal material), and the ring portion 92 disposed in the cavity portion 42 formed inside the cylindrical main body portion 40, and the rotation of the ring portion 92 up and down. It has shaft portions 94a and 94b (see FIGS. 4A and 4B) for pivotal support.
  • a relatively large-diameter hole 96 is formed inside the ring part 92, and the hole 96 can be inserted into the insertion device 18 and the guide wire 24 so as to move forward and backward.
  • the upper and lower shaft portions 94a, 94b are formed so as to protrude from each other so that their axial centers coincide with each other and the ring portion 92 is sandwiched therebetween, and can rotate in the bearing hole 40a (see FIG. 4A) of the cylindrical main body portion 40.
  • the upper shaft portion 94 a penetrates the cylindrical main body portion 40, and an operation knob 90 is mounted outside the cylindrical main body portion 40. Sufficient frictional force is applied to the shaft portions 94 a and 94 b by the cylindrical main body portion 40. Therefore, the ring portion 92 is restrained with a strong resistance to automatically rotate except for the operation of the operation knob 90.
  • the shaft portions 94a, 94b and the bearing hole 40a have a notch (not shown) on one contact surface, and a hook portion (not shown) on which the notch is hooked on the other contact surface is provided at every predetermined angle (for example, 90 °). Also good. Thereby, the rotating ring member 88 can be easily maintained in a predetermined direction.
  • the operation knob 90 can transmit the rotational operation force directly to the ring portion 92 by projecting from the outer peripheral surface of the cylindrical main body portion 40 along the axial direction of the shaft portion 94a. Further, the operation knob 90 is formed to be relatively large so that the operator can easily perform the rotation operation, and the outer peripheral surface thereof is formed with unevenness. Further, the operation knob 90 may be provided with a mark indicating the direction of the rotating ring member 88.
  • the rotation ring member 88 has a transparent auxiliary device 10 so that its direction (rotation state of the ring portion 92) can be visually recognized from the outside. For this reason, by operating the operation knob 90, the hole 96 of the ring portion 92 can be easily aligned with the axial direction of the cavity 42. In this coincidence state, the insertion device 18 and the guide wire 24 can be smoothly inserted into the hole 96.
  • the replacement auxiliary device 10 is formed in the taper surface 48a in which the inner peripheral surface on the base end side (body portion 48) connected to the cavity portion 42 of the stopper portion 46 is narrowed toward the distal end side.
  • the insertion device 18 inserted into the cavity 42 can be more easily guided to the hole 96 of the rotating ring member 88.
  • the distance L2 including the proximal end connecting portion 50 from the distal end of the body portion 48 connected to the stopper portion 46 is the accommodation portion of the guide wire 24 in the rapid exchange type insertion device 18 (that is, the distance L1: FIG. 3A, see FIG. 3B). Therefore, when the exposed portions 75 and 85 on the side surface of the insertion device 18 come out from the proximal end side of the Y-type connector 14, the distal end of the insertion device 18 is necessarily located closer to the proximal end side than the stopper portion 46. In this case, the operator can surely regulate only the movement of the guide wire 24 by confirming the exposed portions 75 and 85 (in other words, reliably preventing the movement of the insertion device 18 by mistake). can do). Therefore, only the insertion device 18 can be quickly and easily pulled out from the guiding catheter assembly 16.
  • the replacement assisting device 10 and the guiding catheter assembly 16 according to the first embodiment are basically configured as described above, and their operational effects will be described below.
  • the device inserted into the guiding catheter assembly 16 is not particularly limited as described above, the device will be collectively referred to as the insertion device 18 in the following description.
  • the exchange assist device 10 is used in a state of being incorporated between the guiding catheter 12 and the Y-type connector 14 (in the state of the guiding catheter assembly 16).
  • the guiding catheter assembly 16 may be provided by being assembled in advance as a package, or each member may be assembled before the procedure.
  • the replacement auxiliary device 10 is in a state where the insertion device 18 can smoothly pass through the cavity 42 when the insertion device 18 is inserted.
  • the hole 96 faces the axial direction of the cavity 42 by adjusting the direction of the rotating ring member 88 in the stopper 46 of the replacement assisting device 10. It is out.
  • the insertion device 18 and the guide wire 24 can easily pass through the hole 96 during advance movement toward the distal end side.
  • the insertion device 18 is smoothly inserted into the hole portion 96 because the insertion device 18 is guided by the tapered surface 48 a formed on the proximal end side of the stopper portion 46 so as to approach the axial center of the cavity portion 42.
  • the insertion device 18 smoothly moves through the insertion passage 30 of the guiding catheter 12 and is guided together with the guide wire 24 to the outlet 30a on the distal end side of the insertion passage 30. Then, after the guide wire 24 is advanced to the treatment site of the coronary artery, the insertion device 18 is guided along the guide wire 24 so that a predetermined treatment can be performed at the treatment site.
  • the insertion device 18 In the replacement of the insertion device 18, the insertion device 18 is moved backward while maintaining the position of the guiding catheter assembly 16 with respect to the blood vessel. At this time, the guide wire 24 that has guided the insertion device 18 is suppressed by the surgeon so that the backward movement is suppressed. In particular, since the rapid exchange type insertion device 18 has a short accommodating portion of the guide wire 24, the insertion position is not greatly affected by the backward movement of the insertion device 18.
  • the distal end portion of the insertion device 18 is easily visually recognized by moving to the transparent replacement auxiliary device 10.
  • the exposed portions 75 and 85 of the guide wire 24 on the side surface of the insertion device 18 are located in the replacement auxiliary device 10.
  • the exposed locations 75 and 85 may be located on the proximal end side with respect to the replacement auxiliary device 10, or may protrude from the proximal end side of the Y-type connector 14.
  • the operator can surely regulate only the movement of the guide wire 24 by checking the exposed portions 75 and 85 ( In other words, erroneous movement of the insertion device 18 can be reliably prevented).
  • the operation knob 90 is rotated in a state where the distal end portion of the insertion device 18 is on the proximal end side (preferably the distal end side of the body portion 48) with respect to the stopper portion 46.
  • the operation knob 90 by rotating the operation knob 90 by 90 ° (or an angle slightly larger than 90 °), as shown in FIGS. 6A and 6B, the rotary ring member 88 is rotated and the hole 96 is hollow. It faces the direction substantially perpendicular to the axial direction of the portion 42.
  • the guide wire 24 that has passed through the hole 96 is twisted by the ring 92 by the rotation of the rotating ring member 88. That is, the guide wire 24 that contacts the distal end side of the ring portion 92 is brought closer to the one surface 92a side, and the guide wire 24 that comes into contact with the proximal end side of the ring portion 92 is brought closer to the opposite surface 92b side. Accordingly, the guide wire 24 comes into contact with the ring portion 92 with a strong frictional force, and movement in the axial direction is restricted (hereinafter referred to as a restricted state).
  • the insertion device 18 is pulled out from the Y-type connector 14 by moving backward in a restricted state. At this time, since the guide wire 24 is not moved by the stopper portion 46, even if the guide device 24 is caught when the insertion device 18 is pulled out, the fixed position of the guide wire 24 is maintained. . Therefore, the insertion device 18 can be pulled out quickly.
  • the guide wire 24 that is fixed is inserted from the distal end side and exposed from the exposed portions 75 and 85, and in this state, is inserted into the first port 62 of the Y-type connector 14. . Then, when the rotary ring member 88 is rotated in the direction opposite to that at the time of restriction at the position where the body part 48 has been advanced, the hole 96 faces the axial direction of the cavity 42 and the restriction state of the guide wire 24 is released. Thereby, the next insertion device 18 is easily inserted into the hole 96 along the guide wire 24.
  • the stopper 46 is configured such that the distal end portion of the insertion device 18 is more proximal than the predetermined position when the insertion device 18 is replaced.
  • the movement of the guide wire 24 exposed from the insertion device 18 can be restricted (the guide wire 24 is fixed). Therefore, only the insertion device 18 can be pulled out while leaving the guide wire 24. Thereby, the insertion device 18 can be easily exchanged by passing the next insertion device 18 through the fixed guide wire 24, and the insertion device 18 can be delivered smoothly. Therefore, by using the replacement assisting device 10 and the guiding catheter assembly 16, intravascular diagnosis and treatment can be performed quickly and satisfactorily.
  • the stopper portion 46 can twist the guide wire 24 that has been passed through the hole portion 96 by rotating the ring portion 92 of the rotating ring member 88 by the operation of the operation knob 90.
  • the movement of the guide wire 24 can be easily regulated.
  • stopper portion 46 that restricts the movement of the guide wire 24 is not limited to the above-described configuration, and can have various configurations. Hereinafter, the stopper portion 46 will be described with some modifications. In the following description, the same components as those of the auxiliary replacement device 10 according to the first embodiment or the components having the same functions are denoted by the same reference numerals, and detailed description thereof is omitted.
  • the stopper portion 46A according to the first modification shown in FIGS. 7A to 7D is formed in a cylindrical shape having a substantially semicircular cross section, and the hollow portion 100 also has a flat bottom wall 102 and a bottom wall.
  • a tunnel wall is formed by a ceiling wall 104 provided in a substantially semicircular shape continuous to 102.
  • a plate member 106 having a planar shape that substantially matches the cross-sectional shape of the cavity 100 is disposed on the bottom wall 102 of the cavity 100. That is, the plate member 106 is formed with a straight edge 106a on the distal end side and a substantially semicircular edge 106b on the proximal end side. Shaft portions 108 a and 108 b projecting in a direction perpendicular to the axial direction of the cavity portion 100 are provided on both side portions on the front end side of the plate member 106.
  • One shaft portion 108a protrudes outward through the cylindrical main body portion 40, and the operation lever 110 (plate member operation portion) is located outside the cylindrical main body portion 40. It is connected.
  • the operation lever 110 extends upward in a state where the flat surface of the plate member 106 is in contact with the bottom wall 102, and an operation knob 112 is attached to the upper portion so that the operator can easily hold it.
  • the operation lever 110 is rotatable about the shaft portions 108a and 108b, and can be operated to tilt the plate member 106 in the cavity portion 100 by being tilted forward from a state of facing upward.
  • the base end side edge 106b is lifted with the front end side edge 106a as a fulcrum. That is, the plate member 106 operates to close the cross section of the cavity 100. Further, the shaft portions 108 a and 108 b are pivotally supported with a large frictional force with respect to the cylindrical main body portion 40, and the lifted state of the base end side of the plate member 106 is maintained as it is even when the hand is released from the operation lever 110. Is done.
  • the stopper portion 46B according to the second modification shown in FIGS. 8A to 8D has a cutout portion 122 in which the cylindrical main body portion 120 is formed in a cylindrical shape and the upper half portion is cut away.
  • the cavity 124 is opened through the notch 122.
  • a rectangular box 126 is attached around the cylindrical main body 120 so as to cover the notch 122.
  • a pressing button 128 (pressing member) disposed on the upper portion of the cylindrical main body 120 and a plurality of (four in the second modification) springs elastically supporting the pressing button 128 are provided inside the box 126.
  • a member 130 is provided inside the box 126.
  • the pressing button 128 is elastically pressed against the upper portion of the box body 126 by four spring members 130 (elastic members).
  • the push button 128 has an operation part 132 projecting upward, a flange part 134 projecting in the left-right direction below the operation part 132 and supported by the spring member 130, and projecting below the flange part 134 to have an arcuate cross section.
  • the closed portion 136 is provided.
  • the operation unit 132 protrudes to such a length that the push button 128 can be pushed downward in a state where the push button 128 is waiting at the top.
  • One surface of the flange portion 134 is supported by the spring member 130, and the other surface is in contact with the upper portion of the box body 126.
  • the closing portion 136 is formed in a circular arc shape that substantially matches the inner wall 124a of the opposed cylindrical main body portion 120, and can close the cavity portion 124 by being displaced downward.
  • one end of the spring member 130 is fixed to the bottom surface inside the box body 126, and the other end contacts the flange portion 134, and gives an elastic force to the pressing button 128.
  • a guide bar 138 for guiding the vertical displacement of the push button 128 is provided inside the spring member 130.
  • the stopper portion 46B configured as described above is configured such that the occlusion portion 136 is cut when the operator presses the push button 128 in a state where the insertion device 18 is retracted and only the guide wire 24 is inserted into the cavity portion 124.
  • the guide wire 24 can be sandwiched between the inner wall 124a and the blocking portion 136 by advancing into the cavity portion 124 through the notch portion 122. Thereby, the movement of the guide wire 24 in the axial direction is restricted.
  • the stopper portion 46B is provided with a mechanism that holds the displacement state of the push button 128 when the push button 128 is displaced downward (for example, a locking portion that holds the flange portion 134 displaced downward). It may be. As described above, the stopper portion 46B according to the second modification can obtain the same effect as the stopper portion 46 according to the first embodiment.
  • the stopper portion 46C according to the third modified example shown in FIG. 9 basically has the same configuration as the stopper portion 46B according to the second modified example, but elastically expands and contracts with the cutout portion 122 of the cylindrical main body portion 120. It differs from the stopper part 46B which concerns on a 2nd modification by the point in which the flexible film
  • the membrane material 140 is elastically deformed by being pressed by the closing portion 136 in accordance with the downward displacement of the pressing button 128 and closes the cavity portion 124.
  • the stopper portion 46 ⁇ / b> C includes the membrane material 140, so that, for example, blood can be prevented from leaking to the box body 126 and the press button 128. Further, the blocking of the membrane material 140 can prevent blood from moving further to the proximal end side.
  • the stopper portion 46 a pair of sandwiching members such as pliers is provided, and the guide wire 24 is sandwiched by a sandwiching operation to restrict the movement thereof. Furthermore, the configuration of the stopper portion 46 is not limited to a mechanical mechanism, and a mechanism driven by power supply can be adopted. In short, the stopper portion 46 can employ various configurations that can restrict the movement of the guide wire 24 at a predetermined timing.
  • the replacement auxiliary device 10A according to the second embodiment is integrally formed (coupled) with the Y-type connector 14 and the cylindrical main body 40 according to the first embodiment as one device. It is different from the auxiliary replacement device 10 according to the first embodiment in that it is configured. That is, the first port 62 is connected to the base end side of the body portion 48 of the replacement auxiliary device 10 ⁇ / b> A (cylindrical main body portion 41), and the second port 64 is connected obliquely to the first port 62. .
  • the lumen of the first port 62 constitutes a part of the cavity 43 of the exchange assisting device 10 ⁇ / b> A, and the cavity 43 is formed so as to penetrate along the axial direction of the cylindrical main body 40.
  • the replacement auxiliary device 10A is set such that the distance including the first port 62 from the front end of the body portion 48 connected to the stopper portion 46 is longer than the accommodating portion of the guide wire 24 in the rapid exchange type insertion device 18.
  • the distance from the distal end to the proximal end of the body portion 48 may be set shorter than the accommodating portion of the guide wire 24 in the insertion device 18.
  • the replacement auxiliary device 10A can obtain the same effects as those of the replacement auxiliary device 10 according to the first embodiment.
  • the auxiliary replacement device 10A since the auxiliary replacement device 10A has the function of the Y-type connector 14, the number of parts can be reduced, and the manufacturing cost can be reduced and the labor required for assembly can be reduced.
  • the stopper portion 46 that restricts the movement of the guide wire 24 can take the configuration of the stopper portions 46A to 46C of the first to third modified examples or other forms as in the first embodiment. .
  • the guiding catheter 12 according to the first embodiment and the cylindrical main body 40 are integrally formed, thereby forming one guiding catheter 12A. It differs from 1st and 2nd embodiment by the point comprised. In other words, the guiding catheter 12A has a function of assisting the exchange of the insertion device 18 in the catheter procedure.
  • the guiding catheter 12A has a configuration in which the hub 28 according to the first embodiment is omitted and the tube body 26 is connected and supported by the replacement auxiliary portion 11a. That is, the stopper portion 46 is directly connected to the proximal end side of the tube body 26.
  • the body portion 48 and the base end connection portion 50 described above are provided on the base end side of the stopper portion 46. In this case, the surgeon can hold the body portion 48 as a hub and operate the tube body 26.
  • the guiding catheter 12 ⁇ / b> A may be provided with a hub for operating the tube body 26 on the distal end side from the stopper portion 46.
  • the distal end connection portion 60 of the Y-type connector 14 can be connected to the proximal end connection portion 50, whereby the guiding catheter 12A can be used as the guiding catheter assembly 16A.
  • the guiding catheter 12A is configured in this manner, the same effects as those of the replacement assisting devices 10 and 10A according to the first and second embodiments can be obtained.
  • the number of parts can be reduced, and the manufacturing cost can be reduced and the labor for assembling can be reduced.
  • the stopper portion 46 that restricts the movement of the guide wire 24 can take the configuration of the stopper portions 46A to 46C of the first to third modified examples or other forms as in the first embodiment. .
  • the guiding catheter 12 according to the first embodiment, the cylindrical main body portion 40 (exchange assisting portion 11b), and the Y-type connector 14 are integrally formed, and one guiding catheter is formed.
  • This is different from the first to third embodiments in that it is configured as 12B. That is, this guiding catheter 12B is obtained by providing the guiding catheter 12A according to the third embodiment with the function of the Y-type connector 14.
  • the distance including the first port 62 from the distal end of the body portion 48 connected to the stopper portion 46 is set to be longer than the accommodating portion of the guide wire 24 in the rapid exchange type insertion device 18.
  • the distance from the distal end to the proximal end of the body portion 48 may be set shorter than the accommodating portion of the guide wire 24 in the insertion device 18.
  • the guiding catheter 12B is configured in this way, the same effects as those of the exchange assisting devices 10 and 10A and the guiding catheter 12A according to the first to third embodiments can be obtained. In this case, since the number of parts is further reduced, the manufacturing cost can be greatly reduced, and the assembling work can be eliminated. It should be noted that the stopper portion 46 that restricts the movement of the guide wire 24 can take the configuration of the stopper portions 46A to 46C of the first to third modified examples or other forms as in the first embodiment. .

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Abstract

This replacement assist device (10) is constituted by a cylindrical body (40) through which an insertion device (18) is insertable while guided along a guide wire (24), and is used to assist replacement of one insertion device by another insertion device. The cylindrical body (40) has a cavity part (42) extending in the axial direction through the interior thereof, through which the insertion device (18) and a guide wire (24) are moveable, and a stopper part (46) having the cavity part (42) in the interior, for exclusively restricting movement of the guide wire (24) exposed from the insertion device (18), when the distal end part of the insertion device (18) has been moved towards the basal end side from a prescribed position.

Description

交換補助デバイス、ガイディングカテーテル組立体及びガイディングカテーテルExchange assist device, guiding catheter assembly and guiding catheter
 本発明は、生体管腔内に挿入して診断や治療等を行う挿入デバイスの使用時に併用される交換補助デバイス、ガイディングカテーテル組立体及びガイディングカテーテルに関する。 The present invention relates to a replacement assisting device, a guiding catheter assembly, and a guiding catheter that are used in combination with an insertion device that is inserted into a living body lumen for diagnosis and treatment.
 血管等の生体管腔内を治療する場合、カテーテル(挿入デバイス)を送達する生体管腔内インターベンション手技が行われる。特に、手技によっては、先行挿入した挿入デバイスから、異なる種類や異なるサイズの挿入デバイスに交換して治療を連続的に施すことがある。例えば、PTCA(経皮的冠動脈形成術)では、ガイディングカテーテルの内部を通して超音波診断カテーテルを冠動脈内の病変部に導き、病変部や周辺部の超音波診断を行う。そして、診断後に超音波カテーテルを引き抜き、病変部を治療する治療用カテーテル(バルーンカテーテルやステントデリバリーカテーテル等)に交換して、該治療用カテーテルを病変部に送達することで、病変部に対し所望の治療を施す。 When treating the inside of a living body lumen such as a blood vessel, a living body intraluminal intervention technique for delivering a catheter (insertion device) is performed. In particular, depending on the procedure, the previously inserted insertion device may be replaced with an insertion device of a different type or a different size for continuous treatment. For example, in PTCA (percutaneous coronary angioplasty), an ultrasonic diagnostic catheter is guided to a lesion in the coronary artery through the inside of the guiding catheter, and an ultrasonic diagnosis of the lesion and the peripheral portion is performed. Then, after the diagnosis, the ultrasonic catheter is withdrawn and replaced with a treatment catheter (balloon catheter, stent delivery catheter, etc.) for treating the lesion, and the treatment catheter is delivered to the lesion, so that the desired lesion can be obtained. Give treatment.
 ところで、挿入デバイスの交換作業においては、挿入デバイスを案内するためのガイドワイヤを動かさずに、先に挿入した挿入デバイスのみを引き抜くことが望ましい。ガイドワイヤが挿入デバイスとともに生体管腔から抜けてしまうと、再挿入に手間がかかり治療時のリスクが増加してしまうからである。 By the way, in the replacement work of the insertion device, it is desirable to pull out only the insertion device inserted first without moving the guide wire for guiding the insertion device. This is because if the guide wire is removed from the body lumen together with the insertion device, re-insertion takes time and the risk at the time of treatment increases.
 そのため、本出願人は、特開2003-230631号公報に開示されているように、ガイドワイヤを固定して挿入デバイスのみ後退移動させることが可能な交換補助デバイスを先に提案した。この交換補助デバイス(管状部)は、ガイディングカテーテル基端部のY型コネクタに接続され、管状部内部に挿入デバイスを移動可能に配置し、且つ管状部の外面とY型コネクタの内面の間にガイドワイヤを通すことで、ガイドワイヤのみを挟むことが可能となっている。これにより、ガイドワイヤのみを固定して、ガイドワイヤと相対的に挿入デバイスを後退移動させることができる。 Therefore, the applicant of the present invention has previously proposed a replacement auxiliary device capable of moving only the insertion device backward while fixing the guide wire as disclosed in Japanese Patent Application Laid-Open No. 2003-230631. This exchange assisting device (tubular portion) is connected to the Y-connector at the proximal end of the guiding catheter, and the insertion device is movably disposed inside the tubular portion, and between the outer surface of the tubular portion and the inner surface of the Y-connector. By passing the guide wire through the guide wire, it is possible to sandwich only the guide wire. As a result, only the guide wire can be fixed and the insertion device can be moved backward relative to the guide wire.
 しかしながら、特開2003-230631号公報に開示されている交換補助デバイスを用いた場合でも、Y型コネクタから挿入デバイスを最終的に取り出すためには、Y型コネクタから交換補助デバイスを離脱させる、すなわち交換補助デバイスによるガイドワイヤの固定を解除する必要がある。そのため、ガイディングカテーテルから挿入デバイスを引き抜く際に、挿入デバイスとともにガイドワイヤも後退してY型コネクタから抜けてしまうおそれがある。 However, even when the replacement auxiliary device disclosed in Japanese Patent Application Laid-Open No. 2003-230431 is used, in order to finally take out the insertion device from the Y-type connector, the replacement auxiliary device is detached from the Y-type connector, that is, It is necessary to release the fixation of the guide wire by the replacement auxiliary device. For this reason, when the insertion device is pulled out from the guiding catheter, the guide wire may be retracted together with the insertion device and come out of the Y-type connector.
 本発明は、上記の実情を鑑み、挿入デバイスの交換をより効果的に実施するためになされたものであり、挿入デバイスを引き抜く際に、簡単な構成によってガイドワイヤのみを固定することで、挿入デバイスを容易に交換することができ、これにより生体管腔内の診断や治療を迅速且つ良好に行うことが可能な交換補助デバイス、ガイディングカテーテル組立体及びガイディングカテーテルを提供することを目的とする。 The present invention has been made in view of the above-described circumstances in order to more effectively replace the insertion device. When the insertion device is pulled out, the insertion device can be inserted by fixing only the guide wire with a simple configuration. It is an object of the present invention to provide an exchange assist device, a guiding catheter assembly, and a guiding catheter capable of easily exchanging a device, thereby enabling quick and good diagnosis and treatment in a living body lumen. To do.
 前記の目的を達成するために、本発明は、ワイヤに沿って案内される挿入デバイスを挿通可能な筒状本体部により構成され、一の挿入デバイスから他の挿入デバイスへの交換を補助するための交換補助デバイスであって、前記筒状本体部は、その内部を軸方向に延在し前記挿入デバイス及び前記ワイヤが移動自在な空洞部と、前記空洞部を内部に有し、前記挿入デバイスの先端部が所定位置より基端側に移動した状態で、前記挿入デバイスから露出されるワイヤの移動のみを規制するストッパ部とを備えることを特徴とする。 In order to achieve the above-mentioned object, the present invention is constituted by a cylindrical main body part that can be inserted through an insertion device guided along a wire, and assists the exchange from one insertion device to another insertion device. The cylindrical body portion has a hollow portion that extends in the axial direction inside thereof and in which the insertion device and the wire are movable, and has the hollow portion therein, and the insertion device. And a stopper portion for restricting only the movement of the wire exposed from the insertion device in a state where the distal end portion thereof is moved from the predetermined position to the proximal end side.
 上記によれば、交換補助デバイスのストッパ部は、挿入デバイスを交換する場合、挿入デバイスの先端部が所定位置より基端側に移動した際に、挿入デバイスから露出されるワイヤの移動を規制する(ワイヤを固定する)ことができる。そのため、ワイヤを残して挿入デバイスのみを引き抜くことが可能となる。これにより、固定されたワイヤに次の挿入デバイスを通すことで、挿入デバイスを容易に交換することができ、この挿入デバイスをスムーズに送達することができる。従って、交換補助デバイスを用いることで、生体管腔内の診断や治療を迅速且つ良好に行うことが可能となる。 According to the above, when replacing the insertion device, the stopper portion of the replacement auxiliary device regulates the movement of the wire exposed from the insertion device when the distal end portion of the insertion device moves from the predetermined position to the proximal side. (Fix the wire). Therefore, it is possible to pull out only the insertion device while leaving the wire. Thereby, by passing the next insertion device through the fixed wire, the insertion device can be easily replaced, and the insertion device can be delivered smoothly. Therefore, by using the replacement assisting device, it is possible to quickly and satisfactorily perform diagnosis and treatment in the living body lumen.
 この場合、前記ストッパ部は、前記挿入デバイス及び前記ワイヤが挿通される穴部を有し、前記筒状本体部に対し回転することで前記穴部を挿通する前記ワイヤを捻って係止する捻り部と、前記筒状本体部の外側に露出され前記捻り部の回転を操作可能な捻り操作部とを備えることが好ましい。 In this case, the stopper portion has a hole portion through which the insertion device and the wire are inserted, and is twisted to twist and lock the wire inserted through the hole portion by rotating with respect to the cylindrical main body portion. And a twisting operation part that is exposed to the outside of the cylindrical main body part and is operable to rotate the twisting part.
 このように、捻り部と、捻り操作部とを備える交換補助デバイスは、捻り操作部を操作することで筒状本体部に対し捻り部を回転させることができる。そして、この捻り部が回転することで、穴部に挿通されていたワイヤが捻られることになり、ワイヤの移動を簡単に規制することができる。 As described above, the replacement assisting device including the twist portion and the twist operation portion can rotate the twist portion with respect to the cylindrical main body portion by operating the twist operation portion. And since this twist part rotates, the wire penetrated by the hole part will be twisted, and the movement of a wire can be controlled easily.
 或いは、前記ストッパ部は、前記空洞部の断面形状に略一致する面形状を有し、所定操作にともない前記空洞部を閉塞するように動作することで前記ワイヤを係止する板部材と、前記筒状本体部の外側に露出され前記板部材による前記空洞部の閉塞を操作可能な板部材操作部とを備えてもよい。 Alternatively, the stopper portion has a surface shape that substantially matches the cross-sectional shape of the cavity portion, and a plate member that locks the wire by operating to close the cavity portion in accordance with a predetermined operation; And a plate member operation portion that is exposed to the outside of the cylindrical main body portion and can be operated to close the cavity by the plate member.
 このように、板部材と、板部材操作部とを備える交換補助デバイスは、板部材操作部を操作することで、板部材により空洞部を閉塞するように動作する。そして、板部材による空洞部の閉塞動作により、空洞部を構成する内壁との間で、ワイヤを挟むことができ、ワイヤの移動を簡単に規制することができる。 As described above, the replacement auxiliary device including the plate member and the plate member operation unit operates to close the cavity by the plate member by operating the plate member operation unit. And by the obstruction | occlusion operation | movement of the cavity part by a board member, a wire can be pinched | interposed between the inner walls which comprise a cavity part, and a movement of a wire can be controlled easily.
 また、前記ストッパ部は、押圧操作により前記空洞部の略直交方向に変位し、前記空洞部を構成する内壁との間で前記ワイヤを係止する押圧部材と、前記押圧操作に抗するように前記押圧部材を弾性的に押し出す弾性部材とを備えてもよい。 Further, the stopper portion is displaced in a substantially orthogonal direction of the cavity portion by a pressing operation, and a pressing member that locks the wire between the inner wall constituting the cavity portion and the pressing operation is resisted. You may provide the elastic member which extrudes the said press member elastically.
 このように、押圧部材と弾性部材を備える交換補助デバイスは、押圧部材を押圧操作することで、押圧部材と空洞部を構成する内壁との間で、ワイヤを挟むことができ、ワイヤの移動を簡単に規制することができる。また、押圧部材の押圧操作を解除することで、押圧部材を簡単に元の位置に復帰させることができる。 As described above, the auxiliary exchange device including the pressing member and the elastic member can sandwich the wire between the pressing member and the inner wall constituting the hollow portion by pressing the pressing member, and the movement of the wire can be performed. It can be easily regulated. Moreover, the pressing member can be easily returned to the original position by releasing the pressing operation of the pressing member.
 さらに、前記挿入デバイスは、該挿入デバイスの途中位置に設けられた露出箇所から前記ワイヤを露出させるラピッドエクスチェンジタイプであり、前記筒状本体部の前記ストッパ部から基端部までの距離は、前記挿入デバイスの先端から前記露出箇所までの距離よりも長いことが好ましい。 Further, the insertion device is a rapid exchange type in which the wire is exposed from an exposed portion provided at an intermediate position of the insertion device, and the distance from the stopper portion to the base end portion of the cylindrical main body portion is It is preferable that it is longer than the distance from the front-end | tip of an insertion device to the said exposure location.
 このように、筒状本体部のストッパ部から基端部までの距離が、挿入デバイスの先端部から露出箇所までの距離よりも長いことで、挿入デバイスの露出箇所が筒状本体部の基端部側から出て外部に導出された際、挿入デバイスの先端部がストッパ部よりも基端側に必ず位置することになる。この場合、術者が露出箇所を確認することによって、ワイヤの移動のみを確実に規制することができる(言い換えれば、誤って挿入デバイスの移動を規制することを確実に防止することができる)。 As described above, the distance from the stopper portion of the cylindrical main body portion to the base end portion is longer than the distance from the distal end portion of the insertion device to the exposed portion, so that the exposed portion of the insertion device is the base end of the cylindrical main body portion. When it comes out from the part side and is led out to the outside, the distal end part of the insertion device is surely located on the proximal side from the stopper part. In this case, only the movement of the wire can be reliably regulated by the operator confirming the exposed portion (in other words, it is possible to reliably prevent the movement of the insertion device from being erroneously regulated).
 また、前記の目的を達成するために、本発明は、ワイヤに沿って案内される挿入デバイスを、内部を通して生体内の所望位置に送達可能なガイディングカテーテルと、前記挿入デバイスを挿通可能な筒状本体部により構成され、一の挿入デバイスから他の挿入デバイスへの交換を補助するための交換補助デバイスとを、互いに接続することにより組み立てられるガイディングカテーテル組立体であって、前記筒状本体部は、その内部を軸方向に延在し前記挿入デバイス及び前記ワイヤが移動自在な空洞部と、前記空洞部を内部に有し、前記挿入デバイスの先端部が所定位置より基端側に移動した状態で、前記挿入デバイスから露出されるワイヤの移動のみを規制するストッパ部とを備えることを特徴とする。 In order to achieve the above object, the present invention provides a guiding catheter capable of delivering an insertion device guided along a wire to a desired position in a living body through the inside, and a tube through which the insertion device can be inserted. A guiding catheter assembly that is configured by connecting together an exchange assist device that is constituted by a cylindrical body portion and that assists in exchanging from one insertion device to another insertion device. The cavity has a cavity that extends in the axial direction and in which the insertion device and the wire can move, and the cavity, and the distal end of the insertion device moves from the predetermined position to the proximal side. And a stopper portion for restricting only the movement of the wire exposed from the insertion device.
 さらに、前記の目的を達成するために、本発明は、ワイヤに沿って案内される挿入デバイスを、内部を通して生体内の所望位置に送達可能なガイディングカテーテルであって、当該ガイディングカテーテルの基端側には、前記挿入デバイスを挿通可能な筒状本体部により構成され、一の挿入デバイスから他の挿入デバイスへの交換を補助するための交換補助部が設けられ、前記交換補助部は、その内部を軸方向に延在し前記挿入デバイス及び前記ワイヤが移動自在な空洞部と、前記空洞部を内部に有し、前記挿入デバイスの先端部が所定位置より基端側に移動した状態で、前記挿入デバイスから露出されるワイヤの移動のみを規制するストッパ部とを備えることを特徴とする。 Furthermore, in order to achieve the above object, the present invention provides a guiding catheter capable of delivering an insertion device guided along a wire to a desired position in a living body through the inside. On the end side, it is constituted by a cylindrical main body part through which the insertion device can be inserted, and an exchange auxiliary part for assisting exchange from one insertion device to another insertion device is provided. A hollow portion that extends in the axial direction and in which the insertion device and the wire are movable, and has the hollow portion therein, and the distal end portion of the insertion device is moved from the predetermined position to the proximal side. And a stopper for restricting only the movement of the wire exposed from the insertion device.
 以上のように本発明によれば、挿入デバイスを引き抜く際に、簡単な構成によってガイドワイヤのみを固定することで、挿入デバイスを容易に交換することができ、これにより生体管腔内の診断や治療を迅速且つ良好に行うことができる。 As described above, according to the present invention, when the insertion device is pulled out, the insertion device can be easily replaced by fixing only the guide wire with a simple configuration. Treatment can be performed quickly and satisfactorily.
第1実施形態に係る交換補助デバイスを有するガイディングカテーテル組立体の全体構成を示す側面図である。It is a side view which shows the whole structure of the guiding catheter assembly which has the exchange assistance device which concerns on 1st Embodiment. 図2Aは、図1のガイディングカテーテル組立体の基端側部分を分解して示す側面図であり、図2Bは、図2Aの断面図である。2A is an exploded side view of the proximal end portion of the guiding catheter assembly of FIG. 1, and FIG. 2B is a cross-sectional view of FIG. 2A. 図3Aは、挿入デバイスの一例である超音波診断カテーテルの先端部を示す側面図であり、図3Bは、挿入デバイスの一例であるステントデリバリーカテーテルの先端部を示す部分側面断面図である。FIG. 3A is a side view showing a distal end portion of an ultrasonic diagnostic catheter that is an example of an insertion device, and FIG. 3B is a partial side sectional view showing a distal end portion of a stent delivery catheter that is an example of an insertion device. 図4Aは、図1の交換補助デバイスの作用を説明するための第1説明図であり、図4Bは、図4AのIVB-IVB線の断面図である。4A is a first explanatory diagram for explaining the operation of the replacement assisting device of FIG. 1, and FIG. 4B is a cross-sectional view taken along the line IVB-IVB of FIG. 4A. 図5Aは、図1の交換補助デバイスの作用を説明するための第2説明図であり、図5Bは、図5AのVB-VB線の断面図である。5A is a second explanatory diagram for explaining the operation of the replacement assisting device in FIG. 1, and FIG. 5B is a cross-sectional view taken along the line VB-VB in FIG. 5A. 図6Aは、図1の交換補助デバイスの作用を説明するための第3説明図であり、図6Bは、図6AのVIB-VIB線の断面図である。6A is a third explanatory diagram for explaining the operation of the replacement assisting device of FIG. 1, and FIG. 6B is a cross-sectional view taken along the line VIB-VIB of FIG. 6A. 図7Aは、第1変形例に係るストッパ部の側面断面図であり、図7Bは、図7AのVIIB-VIIB線の断面図であり、図7Cは、第1変形例に係るストッパ部の閉塞動作時の側面断面図であり、図7Dは、図7CのVIID-VIID線の断面図である。7A is a side sectional view of the stopper portion according to the first modification, FIG. 7B is a sectional view taken along the line VIIB-VIIB of FIG. 7A, and FIG. 7C is a block diagram of the stopper portion according to the first modification. FIG. 7D is a side cross-sectional view during operation, and FIG. 7D is a cross-sectional view taken along the VIID-VIID line of FIG. 7C. 図8Aは、第2変形例に係るストッパ部の側面断面図であり、図8Bは、図8AのVIIIB-VIIIB線の断面図であり、図8Cは、第2変形例に係るストッパ部の閉塞動作時の側面断面図であり、図8Dは、図8CのVIIID-VIIID線の断面図である。8A is a side sectional view of a stopper portion according to a second modification, FIG. 8B is a sectional view taken along line VIIIB-VIIIB of FIG. 8A, and FIG. 8C is a block diagram of the stopper portion according to the second modification. FIG. 8D is a side sectional view in operation, and FIG. 8D is a sectional view taken along line VIIID-VIIID in FIG. 8C. 第3変形例に係るストッパ部の正面断面図である。It is front sectional drawing of the stopper part which concerns on a 3rd modification. 図10Aは、第2実施形態に係る交換補助デバイスを示す側面図であり、図10Bは、図10Aの断面図である。FIG. 10A is a side view showing a replacement auxiliary device according to the second embodiment, and FIG. 10B is a cross-sectional view of FIG. 10A. 第3実施形態に係るガイディングカテーテルを有するガイディングカテーテル組立体の全体構成を示す側面図である。It is a side view which shows the whole structure of the guiding catheter assembly which has a guiding catheter which concerns on 3rd Embodiment. 第4実施形態に係るガイディングカテーテルの全体構成を示す側面図である。It is a side view which shows the whole structure of the guiding catheter which concerns on 4th Embodiment.
 以下、本発明に係る交換補助デバイス、ガイディングカテーテル組立体及びガイディングカテーテルについて好適な実施形態(第1~4実施形態)を挙げ、添付の図面を参照して詳細に説明する。 Hereinafter, preferred embodiments (first to fourth embodiments) of a replacement assisting device, a guiding catheter assembly, and a guiding catheter according to the present invention will be described in detail with reference to the accompanying drawings.
〔第1実施形態〕
 図1に示すように、第1実施形態に係る交換補助デバイス10は、血管(生体管腔)内に挿入されるガイディングカテーテル12の基端部に接続される。また、交換補助デバイス10の基端部には、ガイディングカテーテル12の導入用ポートであるY型コネクタ14が接続される。すなわち、血管内の導入時には、ガイディングカテーテル12、交換補助デバイス10及びY型コネクタ14が組み付けられた状態で使用される(以下、ガイディングカテーテル12、交換補助デバイス10及びY型コネクタ14の組付状態を、ガイディングカテーテル組立体16と称する)。
[First Embodiment]
As shown in FIG. 1, the exchange assist device 10 according to the first embodiment is connected to a proximal end portion of a guiding catheter 12 that is inserted into a blood vessel (biological lumen). Further, a Y-type connector 14 that is an introduction port of the guiding catheter 12 is connected to the proximal end portion of the exchange assisting device 10. That is, at the time of introduction into the blood vessel, the guiding catheter 12, the exchange assist device 10 and the Y-type connector 14 are used in an assembled state (hereinafter, the set of the guiding catheter 12, the exchange assist device 10 and the Y-type connector 14). The attached state is referred to as a guiding catheter assembly 16).
 ガイディングカテーテル組立体16は、挿入デバイス18(例えば、超音波診断カテーテル20、ステントデリバリーカテーテル22:図3A、図3B参照)と、挿入デバイス18を案内するためのガイドワイヤ24とを血管内の所定位置まで進める導管として機能する。例えば、PTCAでは、ガイディングカテーテル組立体16を上行大動脈に送達して、その先端部を冠動脈の入口付近に配置するように送達する。これにより、先端部からガイドワイヤ24を冠動脈内に送出すると、挿入デバイス18がガイドワイヤ24に沿って冠動脈内にスムーズに導入される。 The guiding catheter assembly 16 includes an insertion device 18 (for example, an ultrasonic diagnostic catheter 20, a stent delivery catheter 22: see FIGS. 3A and 3B) and a guide wire 24 for guiding the insertion device 18 in the blood vessel. It functions as a conduit that advances to a predetermined position. For example, in PTCA, the guiding catheter assembly 16 is delivered to the ascending aorta and its tip is delivered near the entrance to the coronary artery. Accordingly, when the guide wire 24 is delivered from the distal end portion into the coronary artery, the insertion device 18 is smoothly introduced into the coronary artery along the guide wire 24.
 図1中に示すガイディングカテーテル組立体16は、冠動脈の入口付近に配置されるように、上行大動脈の内部(バルサルバ洞)に対応して、その先端側(管体26の先端側)が湾曲形成されている。なお、ガイディングカテーテル組立体16は、冠動脈の治療に限定されるものではなく、種々の生体器官(例えば、他の血管、胆管、気管、食道、尿道、鼻腔、その他の臓器等)の診断や治療に適用できることは勿論である。ガイディングカテーテル組立体16の先端側の形状は、治療部位に応じて適宜形成されることが好ましく、例えば直線状であってもよく、屈曲部が設けられてもよい。以下の説明では、PTCA用のガイディングカテーテル組立体16について代表的に詳述していく。 The guiding catheter assembly 16 shown in FIG. 1 is curved at the distal end side (the distal end side of the tube body 26) corresponding to the inside of the ascending aorta (valsalva sinus) so as to be disposed near the entrance of the coronary artery. Is formed. The guiding catheter assembly 16 is not limited to the treatment of coronary arteries, but can diagnose various biological organs (for example, other blood vessels, bile ducts, trachea, esophagus, urethra, nasal cavity, other organs, etc.) Of course, it can be applied to treatment. The shape on the distal end side of the guiding catheter assembly 16 is preferably formed as appropriate according to the treatment site, and may be, for example, linear or may be provided with a bent portion. In the following description, the guiding catheter assembly 16 for PTCA will be representatively described in detail.
 ガイディングカテーテル12は、血管内に挿入される長尺な管体26と、この管体26の基端部に連結され生体外において術者により操作されるハブ28とを有する。ガイディングカテーテル12の内部には、管体26及びハブ28を軸方向に貫通する挿通路30が設けられている。挿通路30の内径は、上述した挿入デバイス18の外径よりも大きく形成されており、この挿通路30には挿入デバイス18が進退移動自在に挿入される。 The guiding catheter 12 includes a long tube body 26 to be inserted into a blood vessel, and a hub 28 that is connected to a proximal end portion of the tube body 26 and is operated by an operator outside the living body. Inside the guiding catheter 12 is provided an insertion passage 30 that penetrates the tube body 26 and the hub 28 in the axial direction. The inner diameter of the insertion passage 30 is formed larger than the outer diameter of the insertion device 18 described above, and the insertion device 18 is inserted into the insertion passage 30 so as to be movable forward and backward.
 管体26は、挿通路30に連通する送出口30aを先端に有するとともに、送出口30a寄りの先端側が上述したように湾曲形成されている。送出口30aからは、内部の挿通路30を介して移動してきた挿入デバイス18が送出可能となっている。管体26の寸法は、治療部位や用途に応じて適宜設定されればよく、例えば、全長が200~1000mm程度、外径が1.5~5.0mm程度、内径が1.0~4.5mm程度に設定するとよい。 The tube body 26 has a delivery port 30a communicating with the insertion passage 30 at the tip, and the tip side near the delivery port 30a is curved as described above. The insertion device 18 that has moved through the internal insertion passage 30 can be sent out from the delivery port 30a. The dimensions of the tube body 26 may be appropriately set according to the treatment site and application. For example, the total length is about 200 to 1000 mm, the outer diameter is about 1.5 to 5.0 mm, and the inner diameter is 1.0 to 4. It is good to set to about 5 mm.
 管体26は、血管に対する押し込み性や追随性、耐キンク性等の物性が適宜考慮されて形成される。管体26を構成する材料は、特に限定されるものではないが、例えば、ポリエチレン、ポリプロピレン、ポリブタジエン、エチレン-酢酸ビニル共重合体(EVA)等のポリオレフィン、ポリ塩化ビニル、ポリウレタン、ポリアミド、アクリロニトリル-ブタジエン-スチレン共重合体(ABS樹脂)、アクリロニトリル-スチレン共重合体(AS樹脂)、ポリエチレンテレフタレート(PET)、ポリブチレンテレフタレート(PBT)等のポリエステル、ポリカーボネート、ポリイミド、フッ素系樹脂、スチレン系、ポリオレフィン系、ポリ塩化ビニル系、ポリウレタン系、ポリエステル系、ポリアミド系、ポリブタジエン系、トランスポリイソプレン系、フッ素系、塩素化ポリエチレン系等の各種熱可塑性エラストマー等、又はこれらを主とする共重合体、ブレンド体、ポリマーアロイ等が挙げられ、これらのうちの2種以上を組み合わせて(例えば2層以上の積層体として)用いることができる。また、管体26は金属線(ブレード)等により補強されていてもよい。 The tubular body 26 is formed by appropriately considering physical properties such as pushability to the blood vessel, followability, and kink resistance. The material constituting the tube body 26 is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, polybutadiene, ethylene-vinyl acetate copolymer (EVA), polyvinyl chloride, polyurethane, polyamide, acrylonitrile- Polyester such as butadiene-styrene copolymer (ABS resin), acrylonitrile-styrene copolymer (AS resin), polyethylene terephthalate (PET), polybutylene terephthalate (PBT), polycarbonate, polyimide, fluororesin, styrene, polyolefin , Polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, trans polyisoprene, fluorine, chlorinated polyethylene and other thermoplastic elastomers, etc. Copolymers mainly, blends, polymer alloys and the like, may be used in combination of two or more of these (e.g., a laminate of two or more layers). The tube body 26 may be reinforced with a metal wire (blade) or the like.
 図1、図2A及び図2Bに示すように、管体26の基端側に連結されるハブ28は、術者が把持し易いように管体26よりも大径に形成される。術者は、このハブ28及び管体26の基部側を把持して所定の操作(進退操作や回動操作)を行うことで、管体26を血管と相対的に動作させる。なお、図示は省略するものの、ハブ28の外周面には、ハブ28を操作し易いようにウイング等が形成されていてもよい。 As shown in FIGS. 1, 2A, and 2B, the hub 28 connected to the proximal end side of the tube body 26 is formed to have a larger diameter than the tube body 26 so that the operator can easily grasp it. The surgeon grips the hub 28 and the base side of the tube body 26 and performs a predetermined operation (advancement / retraction operation or rotation operation) to move the tube body 26 relative to the blood vessel. In addition, although illustration is abbreviate | omitted, the wing etc. may be formed in the outer peripheral surface of the hub 28 so that the hub 28 may be operated easily.
 また、ハブ28の基端部には、交換補助デバイス10に接続するための基端接続部32が設けられている。ハブ28と交換補助デバイス10の接続機構はルアーロック方式であり、基端接続部32はルアーロック方式のメスコネクタとして構成されている。具体的には、基端接続部32は、挿通路30に連通する基端開口30bと、ハブ28の外周面に形成された雄ネジ部36とを有する。 Further, a proximal end connection portion 32 for connection to the replacement auxiliary device 10 is provided at the proximal end portion of the hub 28. The connection mechanism between the hub 28 and the replacement auxiliary device 10 is a luer lock type, and the proximal end connection portion 32 is configured as a luer lock type female connector. Specifically, the base end connection portion 32 includes a base end opening 30 b communicating with the insertion passage 30 and a male screw portion 36 formed on the outer peripheral surface of the hub 28.
 上記のハブ28に接続される交換補助デバイス10は、円筒状に形成された筒状本体部40によって構成されている。筒状本体部40は、ハブ28と同程度の太さに(又はハブ28よりも多少太く)形成され、且つ軸方向に沿って直線状の外形を呈している。この筒状本体部40の内部には空洞部42が貫通形成されている。 The replacement auxiliary device 10 connected to the hub 28 includes a cylindrical main body 40 formed in a cylindrical shape. The cylindrical main body portion 40 is formed to have the same thickness as the hub 28 (or slightly thicker than the hub 28) and has a linear outer shape along the axial direction. A hollow portion 42 is formed through the inside of the cylindrical main body portion 40.
 また、筒状本体部40は、先端から基端に向かって順に、先端接続部44、ストッパ部46、胴体部48及び基端接続部50を有する。空洞部42は、先端接続部44、ストッパ部46、胴体部48及び基端接続部50の内部を連通しており、各部位において内径が若干異なるものの比較的大径に形成されることで、挿入デバイス18及びガイドワイヤ24を移動自在に収容することが可能である。 Moreover, the cylindrical main body 40 has a distal end connecting portion 44, a stopper portion 46, a body portion 48, and a proximal end connecting portion 50 in order from the distal end to the proximal end. The cavity portion 42 communicates with the inside of the distal end connection portion 44, the stopper portion 46, the body portion 48, and the proximal end connection portion 50, and is formed to have a relatively large diameter although the inner diameter is slightly different in each part. The insertion device 18 and the guide wire 24 can be movably accommodated.
 また、交換補助デバイス10は、従来、ガイディングカテーテル12とY型コネクタ14とを直接接続していた構成に対し、その間に介在させる部材として形成されたものである。そのため、交換補助デバイス10の先端接続部44と基端接続部50は、基本的にガイディングカテーテル12とY型コネクタ14の接続機構を模して形成されている。すなわち、交換補助デバイス10の先端接続部44の形状は、Y型コネクタ14の先端接続部60の形状と略同一となっており、交換補助デバイス10の基端接続部50の形状は、ガイディングカテーテル12の基端接続部32の形状と略同一となっている。 Further, the replacement assisting device 10 is formed as a member interposed between the guiding catheter 12 and the Y-type connector 14 which has been conventionally connected directly. Therefore, the distal end connection portion 44 and the proximal end connection portion 50 of the exchange assisting device 10 are basically formed by imitating a connection mechanism between the guiding catheter 12 and the Y-type connector 14. That is, the shape of the distal end connection portion 44 of the replacement auxiliary device 10 is substantially the same as the shape of the distal end connection portion 60 of the Y-type connector 14, and the shape of the proximal end connection portion 50 of the replacement auxiliary device 10 is the guiding. The shape of the proximal end connection portion 32 of the catheter 12 is substantially the same.
 具体的には、先端接続部44は、ルアーロック方式のオスコネクタとして構成されており、軸心寄りを囲い先端方向に突出する内側筒部52と、内側筒部52の外周面を所定間隔離間した位置で囲う外側筒部54とを有する。内側筒部52は、空洞部42と連通する先端開口42aを有する。この内側筒部52が、ガイディングカテーテル12の基端開口30bに挿入されることで、挿通路30と先端開口42a(空洞部42)との連通を実現する。 Specifically, the distal end connecting portion 44 is configured as a luer lock type male connector, and the inner cylindrical portion 52 that surrounds the axial center and protrudes in the distal end direction is separated from the outer peripheral surface of the inner cylindrical portion 52 by a predetermined distance. And an outer cylindrical portion 54 that surrounds at the position. The inner cylinder portion 52 has a tip opening 42 a that communicates with the cavity portion 42. The inner cylindrical portion 52 is inserted into the proximal end opening 30b of the guiding catheter 12, thereby realizing communication between the insertion passage 30 and the distal end opening 42a (hollow portion 42).
 外側筒部54は、ハブ28の基端接続部32の外径よりも大径に形成され、内側筒部52に対向する内周面に雌ネジ部38が形成されている。雌ネジ部38は、基端接続部32の雄ネジ部36にねじ嵌合することで、ガイディングカテーテル12と交換補助デバイス10を連結する。すなわち、ガイディングカテーテル12と交換補助デバイス10は、ルアーロック方式により相対的に移動や回転をしないように一体化される。そのため、術者は、カテーテル手技時に交換補助デバイス10を把持して、ガイディングカテーテル12を操作することもできる。 The outer cylindrical portion 54 is formed to have a larger diameter than the outer diameter of the proximal end connecting portion 32 of the hub 28, and a female screw portion 38 is formed on the inner peripheral surface facing the inner cylindrical portion 52. The female screw part 38 connects the guiding catheter 12 and the exchange assisting device 10 by screwing into the male screw part 36 of the proximal end connection part 32. That is, the guiding catheter 12 and the exchange assisting device 10 are integrated so as not to move and rotate relatively by the luer lock method. Therefore, the operator can also operate the guiding catheter 12 by grasping the exchange assisting device 10 during the catheter procedure.
 先端接続部44の基端に連なるストッパ部46は、ガイドワイヤ24の移動を規制する機構を有し、この規制機構を収容するため内部の空洞部42が他と比べて大径に形成されている。このストッパ部46の構成については後に詳述する。 The stopper portion 46 connected to the proximal end of the distal end connecting portion 44 has a mechanism for restricting the movement of the guide wire 24, and the inner cavity portion 42 is formed with a larger diameter than the others to accommodate the restricting mechanism. Yes. The configuration of the stopper portion 46 will be described in detail later.
 ストッパ部46の基端に連なる胴体部48は、直線状に沿って充分な長さを有し、術者が把持できるように構成されている。交換補助デバイス10に挿入される挿入デバイス18は、胴体部48により一定距離だけ直線的にガイドされることで、挿入時の移動性がよくなる。また、ガイディングカテーテル12(ハブ28)から挿入デバイス18を抜き出す際に、挿入デバイス18が不意に抜け落ちてしまう不都合を回避することもできる。なお、操作性を向上するため、胴体部48の外周面には図示しないウイング(操作片)が設けられてもよい。 The body 48 connected to the base end of the stopper 46 has a sufficient length along a straight line and is configured to be grasped by the operator. The insertion device 18 inserted into the exchange assisting device 10 is linearly guided by a predetermined distance by the body portion 48, so that the mobility at the time of insertion is improved. Moreover, when extracting the insertion device 18 from the guiding catheter 12 (hub 28), the inconvenience of the insertion device 18 falling off unexpectedly can be avoided. In order to improve operability, a wing (operation piece) (not shown) may be provided on the outer peripheral surface of the body portion 48.
 胴体部48の基端に連なる基端接続部50は、Y型コネクタ14との接続をなす部位であり、上述したようにガイディングカテーテル12の基端接続部32と略同じ形状に形成されている。すなわち、基端接続部50は、空洞部42に連通する基端開口42bと、外周面に形成された雄ネジ部56とを有する。さらに、基端接続部50は、基端開口42bに収納保持された弁体35を有する。弁体35は、交換補助デバイス10の空洞部42の基端側を閉塞することで、交換補助デバイス10よりも基端側に血液が流出することを抑止する機能を有している。弁体35中央部にはスリット35aが設けられている。弁体35は、Y型コネクタ14の押し込みにともない弾性変形すると、スリット35aが開口してY型コネクタ14の内側筒部66を空洞部42に挿入させる。また、雄ネジ部56は、Y型コネクタ14の雌ネジ部70にねじ止めされる。 The proximal end connection portion 50 connected to the proximal end of the body portion 48 is a portion that is connected to the Y-type connector 14 and is formed in substantially the same shape as the proximal end connection portion 32 of the guiding catheter 12 as described above. Yes. That is, the base end connection part 50 has a base end opening 42 b communicating with the cavity part 42 and a male screw part 56 formed on the outer peripheral surface. Furthermore, the base end connection part 50 has a valve body 35 housed and held in the base end opening 42b. The valve body 35 has a function of preventing blood from flowing out to the proximal end side of the replacement assisting device 10 by closing the proximal end side of the hollow portion 42 of the replacement assisting device 10. A slit 35 a is provided at the center of the valve body 35. When the valve body 35 is elastically deformed as the Y-type connector 14 is pushed in, the slit 35a is opened and the inner cylindrical portion 66 of the Y-type connector 14 is inserted into the cavity portion 42. The male screw portion 56 is screwed to the female screw portion 70 of the Y-type connector 14.
 以上の先端接続部44、ストッパ部46、胴体部48及び基端接続部50は、樹脂材料により一体成形されて一つの部材(交換補助デバイス10)として提供される。交換補助デバイス10は、比較的硬質であり、且つ透明性(又は半透明性)を有する樹脂材料によって構成されることが好ましい。交換補助デバイス10が透明であれば、空洞部42に挿入されている挿入デバイス18及びガイドワイヤ24を術者が容易に視認することができる。交換補助デバイス10を構成する材料としては、特に限定されるものではないが、例えば、ポリエチレン、ポリプロピレン、エチレン-酢酸ビニル共重合体等のポリオレフィン、ポリ塩化ビニル、ポリブタジエン、ポリアミド、ポリエステル、ポリカーボネート、ポリスチレン等の各種樹脂材料が挙げられる。 The distal end connecting portion 44, the stopper portion 46, the body portion 48, and the proximal end connecting portion 50 are integrally formed of a resin material and provided as a single member (exchange assisting device 10). The replacement auxiliary device 10 is preferably made of a resin material that is relatively hard and has transparency (or translucency). If the exchange assisting device 10 is transparent, the operator can easily visually recognize the insertion device 18 and the guide wire 24 inserted into the cavity 42. The material constituting the exchange assisting device 10 is not particularly limited. For example, polyolefin such as polyethylene, polypropylene, and ethylene-vinyl acetate copolymer, polyvinyl chloride, polybutadiene, polyamide, polyester, polycarbonate, and polystyrene. And various resin materials.
 一方、Y型コネクタ14は、交換補助デバイス10と比較して短尺に形成されており、その内部には軸方向に沿って内腔58が設けられている。Y型コネクタ14は、先端接続部60と、先端接続部60の軸方向基端側に連なる第1ポート62と、第1ポート62に対し斜めに連なる第2ポート64とを有し、内腔58は先端接続部60と第1ポート62を貫通している。 On the other hand, the Y-type connector 14 is formed shorter than the replacement assisting device 10, and a lumen 58 is provided in the inside thereof along the axial direction. The Y-type connector 14 has a distal end connection portion 60, a first port 62 that is continuous with the proximal end side in the axial direction of the distal end connection portion 60, and a second port 64 that is obliquely connected to the first port 62. 58 penetrates the tip connection part 60 and the first port 62.
 先端接続部60は、上述したように、交換補助デバイス10の先端接続部44と略同じ形状に形成されている。すなわち、先端接続部60は、内腔58に連なる先端開口58aを有する内側筒部66と、雌ネジ部70を有する外側筒部68とを備え、交換補助デバイス10の基端接続部50に対し強固に連結するように構成されている。 The tip connection part 60 is formed in substantially the same shape as the tip connection part 44 of the replacement auxiliary device 10 as described above. That is, the distal end connecting portion 60 includes an inner cylindrical portion 66 having a distal end opening 58 a continuous with the inner cavity 58, and an outer cylindrical portion 68 having an internal thread portion 70, and the proximal end connecting portion 50 of the replacement auxiliary device 10 is It is comprised so that it may connect firmly.
 第1ポート62は、挿入デバイス18及びガイドワイヤ24を挿入するためのポートである。第1ポート62内の内腔58は、その基端側がテーパ状に形成されており、挿入デバイス18が挿入し易くなっている。 The first port 62 is a port for inserting the insertion device 18 and the guide wire 24. The lumen 58 in the first port 62 is tapered on the proximal end side, so that the insertion device 18 can be easily inserted.
 第2ポート64は、ガイディングカテーテル12の挿通路30に種々の供給物質を供給するためのポートであり、内腔58に連通する導入腔64aを内部に有する。供給物質としては、例えば、ガイディングカテーテル12をプライミングするための生理食塩水や、送出口30aから吐出する造影剤等が挙げられる。 The second port 64 is a port for supplying various supply substances to the insertion passage 30 of the guiding catheter 12, and has an introduction cavity 64a communicating with the lumen 58 inside. Examples of the supply substance include physiological saline for priming the guiding catheter 12, and a contrast agent discharged from the delivery port 30a.
 ガイディングカテーテル組立体16は、以上のガイディングカテーテル12、交換補助デバイス10、Y型コネクタ14の接続により、ガイディングカテーテル12の挿通路30、交換補助デバイス10の空洞部42、Y型コネクタ14の内腔58が相互に連通し合う。なお、ガイディングカテーテル12、交換補助デバイス10、Y型コネクタ14の接続機構は、雄雌の関係性が逆となっていてもよく、また上述したルアーロック方式に限定されず、種々の構成を適用してよいことは勿論である。 The guiding catheter assembly 16 is connected to the above guiding catheter 12, the exchange assisting device 10, and the Y-type connector 14, so that the insertion passage 30 of the guiding catheter 12, the cavity 42 of the exchange assisting device 10, and the Y-type connector 14. Lumens 58 communicate with each other. In addition, the connection mechanism of the guiding catheter 12, the exchange assisting device 10, and the Y-type connector 14 may be reversed in terms of male-female relationships, and is not limited to the above-described luer lock system, and has various configurations. Of course, it may be applied.
 挿入デバイス18は、Y型コネクタ14の第1ポート62から導入されて進出操作がなされると、内腔58、空洞部42、挿通路30を介してガイディングカテーテル組立体16の軸方向に沿って移動し、管体26先端側の送出口30aから送出される。 When the insertion device 18 is introduced from the first port 62 of the Y-type connector 14 and advanced, the insertion device 18 extends along the axial direction of the guiding catheter assembly 16 via the lumen 58, the cavity 42, and the insertion passage 30. And is sent out from the outlet 30a on the distal end side of the tube body 26.
 ここで、PTCAに用いる挿入デバイス18としては、例えば、図3Aに示す超音波診断カテーテル20、図3Bに示すステントデリバリーカテーテル22が挙げられる。超音波診断カテーテル20は、超音波診断を行う診断部72と、超音波診断カテーテル20をガイドワイヤ24に沿って案内する案内部74とを並列的に備える。すなわち、超音波診断カテーテル20は、案内部74が診断部72の側方且つ先端側にずれる位置で、診断部72の軸方向に平行となるように設けられ、案内部74基端側の露出箇所75からガイドワイヤ24が露出される、いわゆるラピッドエクスチェンジタイプのカテーテルとして構成されている。 Here, examples of the insertion device 18 used for PTCA include an ultrasonic diagnostic catheter 20 shown in FIG. 3A and a stent delivery catheter 22 shown in FIG. 3B. The ultrasonic diagnostic catheter 20 includes a diagnostic unit 72 that performs ultrasonic diagnosis and a guide unit 74 that guides the ultrasonic diagnostic catheter 20 along the guide wire 24 in parallel. That is, the ultrasonic diagnostic catheter 20 is provided so as to be parallel to the axial direction of the diagnostic unit 72 at a position where the guide unit 74 is shifted to the side and the distal side of the diagnostic unit 72, and the guide unit 74 is exposed on the proximal end side. It is configured as a so-called rapid exchange type catheter in which the guide wire 24 is exposed from the point 75.
 診断部72は、血管に向けて超音波を発生し反射波を検出する診断子72aと、診断子72aに駆動力を伝達するドライビングシャフト72bと、診断子72aの超音波を透過する窓72cとを有する。案内部74は、診断部72(窓72c)の側部から膨出して診断部72よりも先端側に設けられており、ガイドワイヤルーメン74aが診断部72の軸方向に平行となるように貫通形成されている。超音波診断カテーテル20の診断部72は、ガイドワイヤルーメン74aに挿通したガイドワイヤ24に沿って案内される。ガイドワイヤ24が超音波診断カテーテル20をガイドする区間(つまり案内部74の軸方向長さ)の距離L1は、例えば、15~250mm程度に設定されることが好ましい。 The diagnosis unit 72 includes a diagnostic element 72a that generates an ultrasonic wave toward the blood vessel and detects a reflected wave, a driving shaft 72b that transmits a driving force to the diagnostic element 72a, and a window 72c that transmits the ultrasonic wave of the diagnostic element 72a. Have The guide part 74 bulges from the side part of the diagnosis part 72 (window 72c) and is provided on the tip side from the diagnosis part 72, and penetrates so that the guide wire lumen 74a is parallel to the axial direction of the diagnosis part 72. Is formed. The diagnostic unit 72 of the ultrasonic diagnostic catheter 20 is guided along the guide wire 24 inserted through the guide wire lumen 74a. The distance L1 of the section in which the guide wire 24 guides the ultrasonic diagnostic catheter 20 (that is, the axial length of the guide portion 74) is preferably set to about 15 to 250 mm, for example.
 一方、ステントデリバリーカテーテル22は、先端側に突出し内部のガイドワイヤルーメン76aにガイドワイヤ24が挿入されるシャフト76と、シャフト76の外周面に配置されるステント78及びバルーン80と、バルーン80の基端側で所定長さ延びる先端側チューブ82と、先端側チューブ82の基端側に設けられた基端側チューブ84とを有する。 On the other hand, the stent delivery catheter 22 has a shaft 76 that protrudes toward the distal end and into which the guide wire 24 is inserted into an internal guide wire lumen 76 a, a stent 78 and a balloon 80 that are disposed on the outer peripheral surface of the shaft 76, and a base of the balloon 80. A distal end side tube 82 extending a predetermined length on the end side and a proximal end side tube 84 provided on the proximal end side of the distal end side tube 82 are provided.
 シャフト76は、先端側チューブ82と基端側チューブ84の連結部付近で斜め側方に向かって湾曲して取り付けられている。すなわち、ステントデリバリーカテーテル22は、シャフト76の先端部から挿入されたガイドワイヤ24が途中位置の露出箇所85(先端側チューブ82の基端側部)から露出されるラピッドエクスチェンジタイプのカテーテルとして構成されている。ガイドワイヤ24がステントデリバリーカテーテル22をガイドする区間(つまりシャフト76の軸方向長さ)の距離L1は、例えば、50~250mm程度に設定されることが好ましい。 The shaft 76 is attached to bend toward the oblique side near the connecting portion between the distal end side tube 82 and the proximal end side tube 84. That is, the stent delivery catheter 22 is configured as a rapid exchange type catheter in which the guide wire 24 inserted from the distal end portion of the shaft 76 is exposed from the exposed portion 85 (the proximal end side portion of the distal end side tube 82) at a midpoint position. ing. The distance L1 of the section where the guide wire 24 guides the stent delivery catheter 22 (that is, the axial length of the shaft 76) is preferably set to about 50 to 250 mm, for example.
 ステント78は、バルーン拡張型であり、ステントデリバリーカテーテル22の送達時には収縮状態で血管内の治療部位に送達される。そして、バルーン80の拡張にともない径方向外側に拡張し(図3B参照)、血管を支持可能な状態となる。バルーン80は、基端側チューブ84及び先端側チューブ82内のルーメン86を介して案内される拡張用流体により拡張する。 The stent 78 is a balloon expandable type, and is delivered to a treatment site in a blood vessel in a contracted state when the stent delivery catheter 22 is delivered. Then, as the balloon 80 is expanded, the balloon 80 is expanded outward in the radial direction (see FIG. 3B), and the blood vessel can be supported. The balloon 80 is expanded by the expansion fluid guided through the lumen 86 in the proximal tube 84 and the distal tube 82.
 カテーテル手技では、図1に示すガイディングカテーテル組立体16を送達して、送出口30aを所定位置(冠動脈の入口付近)に配置する。そして、ガイドワイヤ24を送出口30aから送出し、先行するガイドワイヤ24に沿って超音波診断カテーテル20を治療部位に案内して超音波診断を行う。その後、ガイディングカテーテル組立体16と相対的に超音波診断カテーテル20を後退移動して引き抜き、ステントデリバリーカテーテル22に交換する。ステントデリバリーカテーテル22は、ガイディングカテーテル組立体16内に残るガイドワイヤ24をガイドワイヤルーメン76aに通した状態として、ガイディングカテーテル組立体16内に挿入及び送達される。そして、ガイドワイヤ24に沿って治療部位に案内されることで、ステント78を拡張して血管内(治療部位)に留置する。なお、PTCAでは、ステントデリバリーカテーテル22の他(或いは使用前)に、治療用デバイスとしてバルーンカテーテルやアテレクトミーデバイス等が用いられてもよい。 In the catheter procedure, the guiding catheter assembly 16 shown in FIG. 1 is delivered and the delivery port 30a is placed at a predetermined position (near the entrance of the coronary artery). Then, the guide wire 24 is delivered from the delivery port 30a, and the ultrasound diagnostic catheter 20 is guided to the treatment site along the preceding guide wire 24 to perform ultrasound diagnosis. Thereafter, the ultrasonic diagnostic catheter 20 is retracted and pulled out relative to the guiding catheter assembly 16 and replaced with the stent delivery catheter 22. The stent delivery catheter 22 is inserted and delivered into the guiding catheter assembly 16 with the guide wire 24 remaining in the guiding catheter assembly 16 passed through the guide wire lumen 76a. The stent 78 is expanded by being guided along the guide wire 24 to the treatment site, and is placed in the blood vessel (treatment site). In PTCA, a balloon catheter, an atherectomy device, or the like may be used as a therapeutic device in addition to (or before use) the stent delivery catheter 22.
 以上のカテーテル手技を実施する場合、ガイディングカテーテル組立体16から超音波診断カテーテル20を後退移動して引き抜く際には、次に入れるステントデリバリーカテーテル22をスムーズに送達するため、ガイドワイヤ24をガイディングカテーテル組立体16内で動かない状態とすることが重要となる。特に、先に挿入した挿入デバイス18(超音波診断カテーテル20)を引き抜く際には、ガイドワイヤ24を挿入デバイス18とともに後退させてY型コネクタ14から抜いてしまうことが多い。このため、交換補助デバイス10は、ガイドワイヤ24の移動を規制する構成となっている。 When performing the above catheter procedure, when the ultrasonic diagnostic catheter 20 is retracted from the guiding catheter assembly 16 and pulled out, the guide wire 24 is inserted into the guide wire 24 in order to smoothly deliver the next stent delivery catheter 22. It is important that the moving catheter assembly 16 does not move. In particular, when the insertion device 18 (ultrasound diagnostic catheter 20) inserted previously is pulled out, the guide wire 24 is often retracted together with the insertion device 18 and pulled out from the Y connector 14. For this reason, the replacement auxiliary device 10 is configured to restrict the movement of the guide wire 24.
 具体的には、図2Bに示すように、交換補助デバイス10は、ストッパ部46においてガイドワイヤ24の移動を規制している。ストッパ部46には、筒状本体部40に対し回転自在な回転リング部材88(捻り部)と、この回転リング部材88を回転操作するための操作ツマミ90(捻り操作部)とが設けられている。 Specifically, as shown in FIG. 2B, the replacement assisting device 10 restricts the movement of the guide wire 24 at the stopper portion 46. The stopper portion 46 is provided with a rotating ring member 88 (twisting portion) that is rotatable with respect to the cylindrical main body portion 40 and an operation knob 90 (twisting operation portion) for rotating the rotating ring member 88. Yes.
 回転リング部材88は、硬質な材料(例えば、金属材)によって形成され、筒状本体部40の内部に形成された空洞部42に配置されるリング部92と、リング部92の回転を上下で軸支する軸部94a、94b(図4A、図4B参照)とを有する。リング部92の内側には、比較的大径の穴部96が形成されており、この穴部96は、挿入デバイス18とガイドワイヤ24を進退移動自在に挿入することが可能となっている。 The rotating ring member 88 is formed of a hard material (for example, metal material), and the ring portion 92 disposed in the cavity portion 42 formed inside the cylindrical main body portion 40, and the rotation of the ring portion 92 up and down. It has shaft portions 94a and 94b (see FIGS. 4A and 4B) for pivotal support. A relatively large-diameter hole 96 is formed inside the ring part 92, and the hole 96 can be inserted into the insertion device 18 and the guide wire 24 so as to move forward and backward.
 上下の軸部94a、94bは、互いに軸心が一致しリング部92を間に挟むように突出形成(連設)され、筒状本体部40の軸受孔40a(図4A参照)に回転可能に挿入されている。上側の軸部94aは、筒状本体部40を貫通し、筒状本体部40の外側にて操作ツマミ90が装着されている。軸部94a、94bには、筒状本体部40により充分な摩擦力が付与される。そのため、リング部92は、操作ツマミ90の操作以外で自動的に回転することが強い抵抗力を持って抑止される。なお、軸部94a、94bと軸受孔40aは、一方の接触面に図示しないノッチを有し、他方の接触面にノッチが引っ掛かる図示しない引掛部が所定角度(例えば90°)毎に設けられてもよい。これにより、回転リング部材88を所定の向きに容易に維持することができる。 The upper and lower shaft portions 94a, 94b are formed so as to protrude from each other so that their axial centers coincide with each other and the ring portion 92 is sandwiched therebetween, and can rotate in the bearing hole 40a (see FIG. 4A) of the cylindrical main body portion 40. Has been inserted. The upper shaft portion 94 a penetrates the cylindrical main body portion 40, and an operation knob 90 is mounted outside the cylindrical main body portion 40. Sufficient frictional force is applied to the shaft portions 94 a and 94 b by the cylindrical main body portion 40. Therefore, the ring portion 92 is restrained with a strong resistance to automatically rotate except for the operation of the operation knob 90. The shaft portions 94a, 94b and the bearing hole 40a have a notch (not shown) on one contact surface, and a hook portion (not shown) on which the notch is hooked on the other contact surface is provided at every predetermined angle (for example, 90 °). Also good. Thereby, the rotating ring member 88 can be easily maintained in a predetermined direction.
 操作ツマミ90は、軸部94aの軸方向に沿って筒状本体部40の外周面から突出することで、リング部92に直接的に回転操作力を伝達することが可能である。また、操作ツマミ90は、術者が回転操作しやすいように、比較的大きく形成されるとともに、その外周面には凹凸が形成されている。さらに、操作ツマミ90には、回転リング部材88の向きを示す目印が付けられていてもよい。 The operation knob 90 can transmit the rotational operation force directly to the ring portion 92 by projecting from the outer peripheral surface of the cylindrical main body portion 40 along the axial direction of the shaft portion 94a. Further, the operation knob 90 is formed to be relatively large so that the operator can easily perform the rotation operation, and the outer peripheral surface thereof is formed with unevenness. Further, the operation knob 90 may be provided with a mark indicating the direction of the rotating ring member 88.
 回転リング部材88は、交換補助デバイス10が透明性を有することで、その向き(リング部92の回転状態)が外側から視認可能となっている。このため、操作ツマミ90を操作することで、リング部92の穴部96を空洞部42の軸方向に簡単に一致させることができる。この一致状態では、挿入デバイス18及びガイドワイヤ24が穴部96にスムーズに挿入可能である。 The rotation ring member 88 has a transparent auxiliary device 10 so that its direction (rotation state of the ring portion 92) can be visually recognized from the outside. For this reason, by operating the operation knob 90, the hole 96 of the ring portion 92 can be easily aligned with the axial direction of the cavity 42. In this coincidence state, the insertion device 18 and the guide wire 24 can be smoothly inserted into the hole 96.
 なお、交換補助デバイス10は、ストッパ部46の空洞部42に連なる基端側(胴体部48)の内周面が先端側に向かって狭まるテーパ面48aに形成されていることが好ましい。これにより、空洞部42に挿入された挿入デバイス18を回転リング部材88の穴部96に一層容易に案内することができる。 In addition, it is preferable that the replacement auxiliary device 10 is formed in the taper surface 48a in which the inner peripheral surface on the base end side (body portion 48) connected to the cavity portion 42 of the stopper portion 46 is narrowed toward the distal end side. As a result, the insertion device 18 inserted into the cavity 42 can be more easily guided to the hole 96 of the rotating ring member 88.
 また、交換補助デバイス10は、ストッパ部46に連なる胴体部48先端から基端接続部50を含む距離L2が、ラピッドエクスチェンジタイプの挿入デバイス18におけるガイドワイヤ24の収容部分(すなわち、距離L1:図3A、図3B参照)よりも長く設定されている。従って、挿入デバイス18側面の露出箇所75、85がY型コネクタ14の基端側から抜け出た場合、挿入デバイス18の先端がストッパ部46よりも基端側に必ず位置することになる。この場合、術者が露出箇所75、85を確認することによって、ガイドワイヤ24の移動のみを確実に規制することができる(言い換えれば、誤って挿入デバイス18の移動を規制することを確実に防止することができる)。よって、ガイディングカテーテル組立体16から挿入デバイス18のみを迅速且つ容易に引き抜くことができる。 Further, in the replacement assisting device 10, the distance L2 including the proximal end connecting portion 50 from the distal end of the body portion 48 connected to the stopper portion 46 is the accommodation portion of the guide wire 24 in the rapid exchange type insertion device 18 (that is, the distance L1: FIG. 3A, see FIG. 3B). Therefore, when the exposed portions 75 and 85 on the side surface of the insertion device 18 come out from the proximal end side of the Y-type connector 14, the distal end of the insertion device 18 is necessarily located closer to the proximal end side than the stopper portion 46. In this case, the operator can surely regulate only the movement of the guide wire 24 by confirming the exposed portions 75 and 85 (in other words, reliably preventing the movement of the insertion device 18 by mistake). can do). Therefore, only the insertion device 18 can be quickly and easily pulled out from the guiding catheter assembly 16.
 第1実施形態に係る交換補助デバイス10及びガイディングカテーテル組立体16は、基本的には以上のように構成されるものであり、以下、その作用効果について説明する。なお、上述したようにガイディングカテーテル組立体16に挿入されるデバイスは特に限定されないため、以下の説明では、該デバイスを挿入デバイス18と総称して説明していく。 The replacement assisting device 10 and the guiding catheter assembly 16 according to the first embodiment are basically configured as described above, and their operational effects will be described below. In addition, since the device inserted into the guiding catheter assembly 16 is not particularly limited as described above, the device will be collectively referred to as the insertion device 18 in the following description.
 交換補助デバイス10は、図1に示すように、ガイディングカテーテル12とY型コネクタ14の間に組み込まれた状態(ガイディングカテーテル組立体16の状態)で使用される。なお、ガイディングカテーテル組立体16は、パッケージとして予め組み立てられて提供されてもよく、手技前に各部材が組み立てられてもよい。 As shown in FIG. 1, the exchange assist device 10 is used in a state of being incorporated between the guiding catheter 12 and the Y-type connector 14 (in the state of the guiding catheter assembly 16). The guiding catheter assembly 16 may be provided by being assembled in advance as a package, or each member may be assembled before the procedure.
 交換補助デバイス10は、挿入デバイス18の挿入において、挿入デバイス18が空洞部42内を円滑に通過可能な状態となっている。具体的には、図4A及び図4Bに示すように、交換補助デバイス10のストッパ部46において、回転リング部材88の向きが調整されることで、穴部96が空洞部42の軸方向を臨んでいる。これにより、挿入デバイス18とガイドワイヤ24は、先端側への進出移動時に穴部96を容易に通過することができる。特に、挿入デバイス18は、ストッパ部46の基端側に形成されたテーパ面48aにより、空洞部42の軸心に寄るようにガイドされるため、穴部96にスムーズに挿入される。 The replacement auxiliary device 10 is in a state where the insertion device 18 can smoothly pass through the cavity 42 when the insertion device 18 is inserted. Specifically, as shown in FIGS. 4A and 4B, the hole 96 faces the axial direction of the cavity 42 by adjusting the direction of the rotating ring member 88 in the stopper 46 of the replacement assisting device 10. It is out. As a result, the insertion device 18 and the guide wire 24 can easily pass through the hole 96 during advance movement toward the distal end side. In particular, the insertion device 18 is smoothly inserted into the hole portion 96 because the insertion device 18 is guided by the tapered surface 48 a formed on the proximal end side of the stopper portion 46 so as to approach the axial center of the cavity portion 42.
 挿入デバイス18は、ガイディングカテーテル12の挿通路30を円滑に移動して、ガイドワイヤ24とともに挿通路30先端側の送出口30aに導かれる。そして、ガイドワイヤ24を冠動脈の治療部位まで先行させた後、挿入デバイス18をガイドワイヤ24に沿って案内することで、治療部位にて所定の処置を行うことができる。 The insertion device 18 smoothly moves through the insertion passage 30 of the guiding catheter 12 and is guided together with the guide wire 24 to the outlet 30a on the distal end side of the insertion passage 30. Then, after the guide wire 24 is advanced to the treatment site of the coronary artery, the insertion device 18 is guided along the guide wire 24 so that a predetermined treatment can be performed at the treatment site.
 挿入デバイス18の交換においては、血管に対するガイディングカテーテル組立体16の位置を保った状態で、挿入デバイス18を後退移動させる。この際、挿入デバイス18を案内していたガイドワイヤ24は、術者に押さえられることで後退移動が抑制される。特に、ラピッドエクスチェンジタイプの挿入デバイス18は、ガイドワイヤ24の収容部分が短いため、挿入デバイス18の後退移動の影響を大きく受けずに挿入位置が保持される。 In the replacement of the insertion device 18, the insertion device 18 is moved backward while maintaining the position of the guiding catheter assembly 16 with respect to the blood vessel. At this time, the guide wire 24 that has guided the insertion device 18 is suppressed by the surgeon so that the backward movement is suppressed. In particular, since the rapid exchange type insertion device 18 has a short accommodating portion of the guide wire 24, the insertion position is not greatly affected by the backward movement of the insertion device 18.
 そして、挿入デバイス18の先端部は、透明な交換補助デバイス10に移動することで、容易に視認される。図5A及び図5Bに示すように、挿入デバイス18の先端部がストッパ部46の基端側まで移動した段階では、回転リング部材88の穴部96にガイドワイヤ24のみが残される。また、この状態では、挿入デバイス18側面のガイドワイヤ24の露出箇所75、85が交換補助デバイス10内に位置している。なお、露出箇所75、85は交換補助デバイス10よりも基端側に位置していてもよく、Y型コネクタ14の基端側から抜け出ていても良い。特に露出箇所75、85がY型コネクタ14の基端側から抜け出ている場合、術者が露出箇所75、85を確認することによって、ガイドワイヤ24の移動のみを確実に規制することができる(言い換えれば、誤って挿入デバイス18の移動を規制することを確実に防止することができる)。 Then, the distal end portion of the insertion device 18 is easily visually recognized by moving to the transparent replacement auxiliary device 10. As shown in FIGS. 5A and 5B, at the stage where the distal end portion of the insertion device 18 has moved to the proximal end side of the stopper portion 46, only the guide wire 24 remains in the hole portion 96 of the rotating ring member 88. In this state, the exposed portions 75 and 85 of the guide wire 24 on the side surface of the insertion device 18 are located in the replacement auxiliary device 10. In addition, the exposed locations 75 and 85 may be located on the proximal end side with respect to the replacement auxiliary device 10, or may protrude from the proximal end side of the Y-type connector 14. In particular, when the exposed portions 75 and 85 are pulled out from the proximal end side of the Y-type connector 14, the operator can surely regulate only the movement of the guide wire 24 by checking the exposed portions 75 and 85 ( In other words, erroneous movement of the insertion device 18 can be reliably prevented).
 そして、挿入デバイス18の先端部がストッパ部46よりも基端側(好ましくは胴体部48の先端側)にある状態で、操作ツマミ90の回転操作を行う。この場合、操作ツマミ90を90°(或いは、90°よりもやや大きい角度)回転操作することで、図6A及び図6Bに示すように、回転リング部材88を連れ回りさせ、穴部96を空洞部42の軸方向に対して略直交方向に臨ませる。 Then, the operation knob 90 is rotated in a state where the distal end portion of the insertion device 18 is on the proximal end side (preferably the distal end side of the body portion 48) with respect to the stopper portion 46. In this case, by rotating the operation knob 90 by 90 ° (or an angle slightly larger than 90 °), as shown in FIGS. 6A and 6B, the rotary ring member 88 is rotated and the hole 96 is hollow. It faces the direction substantially perpendicular to the axial direction of the portion 42.
 この回転リング部材88の回転により、穴部96を通っていたガイドワイヤ24はリング部92により捻られる。すなわち、リング部92の先端側に接触するガイドワイヤ24が一方面92a側に寄せられ、リング部92の基端側に接触するガイドワイヤ24が反対面92b側に寄せられる。これにより、ガイドワイヤ24は、リング部92に強い摩擦力をもって接触することになり、軸方向への移動が規制される(以下、規制状態という)。 The guide wire 24 that has passed through the hole 96 is twisted by the ring 92 by the rotation of the rotating ring member 88. That is, the guide wire 24 that contacts the distal end side of the ring portion 92 is brought closer to the one surface 92a side, and the guide wire 24 that comes into contact with the proximal end side of the ring portion 92 is brought closer to the opposite surface 92b side. Accordingly, the guide wire 24 comes into contact with the ring portion 92 with a strong frictional force, and movement in the axial direction is restricted (hereinafter referred to as a restricted state).
 挿入デバイス18は、規制状態で後退移動がなされることで、Y型コネクタ14から引き抜かれる。この際、ガイドワイヤ24がストッパ部46により動かなくなっていることで、挿入デバイス18の引き抜き時にガイドワイヤ24との間で引っ掛かりが生じても、ガイドワイヤ24の固定位置が維持されたままとなる。よって、挿入デバイス18の引き抜きを迅速に行うことができる。 The insertion device 18 is pulled out from the Y-type connector 14 by moving backward in a restricted state. At this time, since the guide wire 24 is not moved by the stopper portion 46, even if the guide device 24 is caught when the insertion device 18 is pulled out, the fixed position of the guide wire 24 is maintained. . Therefore, the insertion device 18 can be pulled out quickly.
 交換する次の挿入デバイス18には、固定されたままのガイドワイヤ24が先端側から挿入されて露出箇所75、85から露出され、この状態でY型コネクタ14の第1ポート62に挿入される。そして、胴体部48に進出した位置で、回転リング部材88を規制時と逆方向に回転させることで穴部96を空洞部42の軸方向に臨ませ、ガイドワイヤ24の規制状態を解除する。これにより、次の挿入デバイス18は、ガイドワイヤ24に沿って穴部96に簡単に挿入される。 In the next insertion device 18 to be replaced, the guide wire 24 that is fixed is inserted from the distal end side and exposed from the exposed portions 75 and 85, and in this state, is inserted into the first port 62 of the Y-type connector 14. . Then, when the rotary ring member 88 is rotated in the direction opposite to that at the time of restriction at the position where the body part 48 has been advanced, the hole 96 faces the axial direction of the cavity 42 and the restriction state of the guide wire 24 is released. Thereby, the next insertion device 18 is easily inserted into the hole 96 along the guide wire 24.
 以上のように、第1実施形態に係る交換補助デバイス10及びガイディングカテーテル組立体16によれば、ストッパ部46は、挿入デバイス18の交換において、挿入デバイス18の先端部が所定位置より基端側に移動した際に、挿入デバイス18から露出されるガイドワイヤ24の移動を規制する(ガイドワイヤ24を固定する)ことができる。そのため、ガイドワイヤ24を残して挿入デバイス18のみを引き抜くことが可能となる。これにより、固定されたガイドワイヤ24に次の挿入デバイス18を通すことで、挿入デバイス18を容易に交換することができ、この挿入デバイス18をスムーズに送達することができる。従って、交換補助デバイス10及びガイディングカテーテル組立体16を用いることで、血管内の診断や治療を迅速且つ良好に行うことが可能となる。 As described above, according to the replacement assisting device 10 and the guiding catheter assembly 16 according to the first embodiment, the stopper 46 is configured such that the distal end portion of the insertion device 18 is more proximal than the predetermined position when the insertion device 18 is replaced. When moved to the side, the movement of the guide wire 24 exposed from the insertion device 18 can be restricted (the guide wire 24 is fixed). Therefore, only the insertion device 18 can be pulled out while leaving the guide wire 24. Thereby, the insertion device 18 can be easily exchanged by passing the next insertion device 18 through the fixed guide wire 24, and the insertion device 18 can be delivered smoothly. Therefore, by using the replacement assisting device 10 and the guiding catheter assembly 16, intravascular diagnosis and treatment can be performed quickly and satisfactorily.
 また、第1実施形態に係るストッパ部46は、操作ツマミ90の操作により回転リング部材88のリング部92が回転することで、穴部96に通されていたガイドワイヤ24を捻ることができ、ガイドワイヤ24の移動を簡単に規制することができる。 The stopper portion 46 according to the first embodiment can twist the guide wire 24 that has been passed through the hole portion 96 by rotating the ring portion 92 of the rotating ring member 88 by the operation of the operation knob 90. The movement of the guide wire 24 can be easily regulated.
 なお、ガイドワイヤ24の移動を規制するストッパ部46は、上述した構成に限定されるものではなく、種々の構成を取り得る。以下に、ストッパ部46について幾つかの変形例を挙げて説明していく。なお、以下の説明において、第1実施形態に係る交換補助デバイス10と同一の構成、又は同一の機能を有する構成については同一の符号を付しその詳細な説明については省略する。 Note that the stopper portion 46 that restricts the movement of the guide wire 24 is not limited to the above-described configuration, and can have various configurations. Hereinafter, the stopper portion 46 will be described with some modifications. In the following description, the same components as those of the auxiliary replacement device 10 according to the first embodiment or the components having the same functions are denoted by the same reference numerals, and detailed description thereof is omitted.
〔第1変形例〕
 図7A~図7Dに示す第1変形例に係るストッパ部46Aは、断面形状が略半円状となった筒状に形成されており、空洞部100も平坦状の底壁102と、底壁102に連なる略半円状に設けられた天井壁104とによりトンネル状に構成されている。
[First Modification]
The stopper portion 46A according to the first modification shown in FIGS. 7A to 7D is formed in a cylindrical shape having a substantially semicircular cross section, and the hollow portion 100 also has a flat bottom wall 102 and a bottom wall. A tunnel wall is formed by a ceiling wall 104 provided in a substantially semicircular shape continuous to 102.
 そして、空洞部100の底壁102には、空洞部100の断面形状に略一致する平面形状を有する板部材106が配置されている。すなわち、板部材106は、先端側が直線状の縁部106aに、基端側が略半円状の縁部106bに形成されている。この板部材106先端側の両側部には、空洞部100の軸方向に対し直交方向に突出する軸部108a、108bが設けられている。一方の軸部108a(図7B中左側の軸部)は、筒状本体部40を貫通して外側に突出しており、筒状本体部40の外側にて操作レバー110(板部材操作部)が連結されている。 A plate member 106 having a planar shape that substantially matches the cross-sectional shape of the cavity 100 is disposed on the bottom wall 102 of the cavity 100. That is, the plate member 106 is formed with a straight edge 106a on the distal end side and a substantially semicircular edge 106b on the proximal end side. Shaft portions 108 a and 108 b projecting in a direction perpendicular to the axial direction of the cavity portion 100 are provided on both side portions on the front end side of the plate member 106. One shaft portion 108a (the shaft portion on the left side in FIG. 7B) protrudes outward through the cylindrical main body portion 40, and the operation lever 110 (plate member operation portion) is located outside the cylindrical main body portion 40. It is connected.
 操作レバー110は、板部材106の平面が底壁102に接触している状態で上方に延びており、その上部には術者が持ちやすいように操作ツマミ112が取り付けられている。操作レバー110は、軸部108a、108bを基点に回動自在となっており、上方を向いた状態から前方に傾けられることで、空洞部100内の板部材106の傾きを操作可能である。 The operation lever 110 extends upward in a state where the flat surface of the plate member 106 is in contact with the bottom wall 102, and an operation knob 112 is attached to the upper portion so that the operator can easily hold it. The operation lever 110 is rotatable about the shaft portions 108a and 108b, and can be operated to tilt the plate member 106 in the cavity portion 100 by being tilted forward from a state of facing upward.
 板部材106は、操作レバー110の前方への傾動にともない、先端側の縁部106aを支点として基端側の縁部106bが持ち上げられる。すなわち、板部材106は、空洞部100の断面を閉塞するように動作する。また、軸部108a、108bは、筒状本体部40に対し大きな摩擦力で軸支されており、操作レバー110から手が離されても、板部材106の基端側の持ち上がり状態がそのまま維持される。 As the plate member 106 tilts forward of the operation lever 110, the base end side edge 106b is lifted with the front end side edge 106a as a fulcrum. That is, the plate member 106 operates to close the cross section of the cavity 100. Further, the shaft portions 108 a and 108 b are pivotally supported with a large frictional force with respect to the cylindrical main body portion 40, and the lifted state of the base end side of the plate member 106 is maintained as it is even when the hand is released from the operation lever 110. Is done.
 ガイドワイヤ24のみが空洞部100に挿入されている状態では、板部材106が空洞部100を閉塞するように動作すると、天井壁104と基端側の縁部106bの間にガイドワイヤ24が挟まれることになる(図7C及び図7D参照)。すなわち、術者は、挿入デバイス18の先端部をストッパ部46よりも基端側に移動した後に、操作レバー110を前方に傾けることで、板部材106と天井壁104の間にガイドワイヤ24を挟み、ガイドワイヤ24の軸方向の移動を規制することができる。このように第1変形例に係るストッパ部46Aでも、第1実施形態に係るストッパ部46と同じ効果を得ることができる。 In a state where only the guide wire 24 is inserted into the cavity portion 100, when the plate member 106 operates so as to close the cavity portion 100, the guide wire 24 is sandwiched between the ceiling wall 104 and the base end side edge portion 106 b. (See FIGS. 7C and 7D). That is, the surgeon moves the distal end portion of the insertion device 18 to the proximal end side with respect to the stopper portion 46 and then tilts the operation lever 110 forward, whereby the guide wire 24 is placed between the plate member 106 and the ceiling wall 104. The movement of the guide wire 24 in the axial direction can be restricted. Thus, even with the stopper portion 46A according to the first modification, the same effect as the stopper portion 46 according to the first embodiment can be obtained.
〔第2変形例〕
 図8A~図8Dに示す第2変形例に係るストッパ部46Bは、筒状本体部120が円筒状に形成されるとともに、上側半部が切り欠かれた切り欠き部122を有することで、切り欠き部122を介して空洞部124が開放されている。そして、筒状本体部120の周囲には、この切り欠き部122を覆うように直方状の箱体126が取り付けられている。
[Second Modification]
The stopper portion 46B according to the second modification shown in FIGS. 8A to 8D has a cutout portion 122 in which the cylindrical main body portion 120 is formed in a cylindrical shape and the upper half portion is cut away. The cavity 124 is opened through the notch 122. A rectangular box 126 is attached around the cylindrical main body 120 so as to cover the notch 122.
 箱体126の内部には、筒状本体部120の上部に配置された押圧ボタン128(押圧部材)と、この押圧ボタン128を弾性的に支持する複数(第2変形例では4つ)のバネ部材130とが設けられている。押圧ボタン128は、4つのバネ部材130(弾性部材)により箱体126の上部に弾性的に押し付けられている。 Inside the box 126, a pressing button 128 (pressing member) disposed on the upper portion of the cylindrical main body 120 and a plurality of (four in the second modification) springs elastically supporting the pressing button 128 are provided. A member 130 is provided. The pressing button 128 is elastically pressed against the upper portion of the box body 126 by four spring members 130 (elastic members).
 押圧ボタン128は、上方に突出する操作部132と、操作部132の下側において左右方向に突出しバネ部材130に支持されるフランジ部134と、フランジ部134の下側に突出し断面円弧状に形成された閉塞部136とを有する。操作部132は、押圧ボタン128が上部に待機した状態で、押圧ボタン128を下方向に押し込み可能な長さ突出している。フランジ部134は、一方面がバネ部材130に支持され、他方面が箱体126の上部に接触している。閉塞部136は、対向する筒状本体部120の内壁124aと略一致する断面円弧状に形成されており、下方向への変位により空洞部124を閉塞可能である。 The push button 128 has an operation part 132 projecting upward, a flange part 134 projecting in the left-right direction below the operation part 132 and supported by the spring member 130, and projecting below the flange part 134 to have an arcuate cross section. The closed portion 136 is provided. The operation unit 132 protrudes to such a length that the push button 128 can be pushed downward in a state where the push button 128 is waiting at the top. One surface of the flange portion 134 is supported by the spring member 130, and the other surface is in contact with the upper portion of the box body 126. The closing portion 136 is formed in a circular arc shape that substantially matches the inner wall 124a of the opposed cylindrical main body portion 120, and can close the cavity portion 124 by being displaced downward.
 また、バネ部材130は、一端が箱体126内部の底面に固定され、他端がフランジ部134に接触し、押圧ボタン128に弾性力を付与する。このバネ部材130の内部には、押圧ボタン128の上下の変位を案内するガイド棒138が設けられている。 Further, one end of the spring member 130 is fixed to the bottom surface inside the box body 126, and the other end contacts the flange portion 134, and gives an elastic force to the pressing button 128. Inside the spring member 130, a guide bar 138 for guiding the vertical displacement of the push button 128 is provided.
 以上のように構成されたストッパ部46Bは、挿入デバイス18が後退しガイドワイヤ24のみが空洞部124に挿入された状態で、術者が押圧ボタン128を押圧することにより、閉塞部136が切り欠き部122を介して空洞部124に進出し、内壁124aと閉塞部136の間でガイドワイヤ24を挟み込むことができる。これによりガイドワイヤ24の軸方向の移動が規制される。なお、ストッパ部46Bには、押圧ボタン128が下方向に変位した際に、押圧ボタン128の変位状態を保持する機構(例えば、下方向に変位したフランジ部134を留める係止部)が設けられていてもよい。このように第2変形例に係るストッパ部46Bでも、第1実施形態に係るストッパ部46と同じ効果を得ることができる。 The stopper portion 46B configured as described above is configured such that the occlusion portion 136 is cut when the operator presses the push button 128 in a state where the insertion device 18 is retracted and only the guide wire 24 is inserted into the cavity portion 124. The guide wire 24 can be sandwiched between the inner wall 124a and the blocking portion 136 by advancing into the cavity portion 124 through the notch portion 122. Thereby, the movement of the guide wire 24 in the axial direction is restricted. The stopper portion 46B is provided with a mechanism that holds the displacement state of the push button 128 when the push button 128 is displaced downward (for example, a locking portion that holds the flange portion 134 displaced downward). It may be. As described above, the stopper portion 46B according to the second modification can obtain the same effect as the stopper portion 46 according to the first embodiment.
〔第3変形例〕
 図9に示す第3変形例に係るストッパ部46Cは、基本的には第2変形例に係るストッパ部46Bと同じ構成を有するが、筒状本体部120の切り欠き部122に弾性的に伸縮自在な膜材140が設けられている点で、第2変形例に係るストッパ部46Bとは異なる。膜材140は、押圧ボタン128の下方向への変位にともない閉塞部136に押圧されることで弾性変形して空洞部124を閉塞する。ストッパ部46Cは、膜材140を有することで、例えば、血液が箱体126や押圧ボタン128へ漏れるのを防ぐことができる。また、膜材140の閉塞により、血液がそれ以上基端側に移動することを防ぐこともできる。
[Third Modification]
The stopper portion 46C according to the third modified example shown in FIG. 9 basically has the same configuration as the stopper portion 46B according to the second modified example, but elastically expands and contracts with the cutout portion 122 of the cylindrical main body portion 120. It differs from the stopper part 46B which concerns on a 2nd modification by the point in which the flexible film | membrane material 140 is provided. The membrane material 140 is elastically deformed by being pressed by the closing portion 136 in accordance with the downward displacement of the pressing button 128 and closes the cavity portion 124. The stopper portion 46 </ b> C includes the membrane material 140, so that, for example, blood can be prevented from leaking to the box body 126 and the press button 128. Further, the blocking of the membrane material 140 can prevent blood from moving further to the proximal end side.
 また、ストッパ部46の他の構成例としては、ペンチのような一対の挟込部材を設け、ガイドワイヤ24を挟込操作により挟持して、その移動を規制するもの等が上げられる。さらに、ストッパ部46の構成は、機械的な機構に限定されるものではなく、電力供給により駆動する機構を採用し得る。要するに、ストッパ部46は、ガイドワイヤ24の移動を所定のタイミングで規制可能な種々の構成を適用することができる。 Further, as another configuration example of the stopper portion 46, a pair of sandwiching members such as pliers is provided, and the guide wire 24 is sandwiched by a sandwiching operation to restrict the movement thereof. Furthermore, the configuration of the stopper portion 46 is not limited to a mechanical mechanism, and a mechanism driven by power supply can be adopted. In short, the stopper portion 46 can employ various configurations that can restrict the movement of the guide wire 24 at a predetermined timing.
〔第2実施形態〕
 第2実施形態に係る交換補助デバイス10Aは、図10A及び図10Bに示すように、第1実施形態に係るY型コネクタ14と筒状本体部40が一体成形(連結)されて1つのデバイスとして構成されている点で、第1実施形態に係る交換補助デバイス10とは異なる。すなわち、交換補助デバイス10A(筒状本体部41)の胴体部48の基端側には、第1ポート62が連なっており、さらに第1ポート62に対し第2ポート64が斜めに連なっている。そして、第1ポート62の内腔は、交換補助デバイス10Aの空洞部43の一部を構成しており、この空洞部43は筒状本体部40の軸方向に沿って貫通形成されている。
[Second Embodiment]
As shown in FIGS. 10A and 10B, the replacement auxiliary device 10A according to the second embodiment is integrally formed (coupled) with the Y-type connector 14 and the cylindrical main body 40 according to the first embodiment as one device. It is different from the auxiliary replacement device 10 according to the first embodiment in that it is configured. That is, the first port 62 is connected to the base end side of the body portion 48 of the replacement auxiliary device 10 </ b> A (cylindrical main body portion 41), and the second port 64 is connected obliquely to the first port 62. . The lumen of the first port 62 constitutes a part of the cavity 43 of the exchange assisting device 10 </ b> A, and the cavity 43 is formed so as to penetrate along the axial direction of the cylindrical main body 40.
 なお、交換補助デバイス10Aは、ストッパ部46に連なる胴体部48先端から第1ポート62を含む距離が、ラピッドエクスチェンジタイプの挿入デバイス18におけるガイドワイヤ24の収容部分よりも長く設定されているが、胴体部48の先端から基端までの距離は、挿入デバイス18におけるガイドワイヤ24の収容部分よりも短く設定してもよい。 The replacement auxiliary device 10A is set such that the distance including the first port 62 from the front end of the body portion 48 connected to the stopper portion 46 is longer than the accommodating portion of the guide wire 24 in the rapid exchange type insertion device 18. The distance from the distal end to the proximal end of the body portion 48 may be set shorter than the accommodating portion of the guide wire 24 in the insertion device 18.
 このように、交換補助デバイス10Aは、Y型コネクタ14と筒状本体部40が一体成形されても、第1実施形態に係る交換補助デバイス10と同様の効果を得ることができる。また、交換補助デバイス10Aは、Y型コネクタ14の機能を有することで、部品点数を少なくすることができ、製造コストの低減、組立時の手間の軽減等を図ることができる。なお、ガイドワイヤ24の移動を規制するストッパ部46は、第1実施形態と同様に、第1~第3変形例のストッパ部46A~46Cの構成又は他の形態を取り得ることは勿論である。 Thus, even if the Y-type connector 14 and the cylindrical main body 40 are integrally molded, the replacement auxiliary device 10A can obtain the same effects as those of the replacement auxiliary device 10 according to the first embodiment. In addition, since the auxiliary replacement device 10A has the function of the Y-type connector 14, the number of parts can be reduced, and the manufacturing cost can be reduced and the labor required for assembly can be reduced. It should be noted that the stopper portion 46 that restricts the movement of the guide wire 24 can take the configuration of the stopper portions 46A to 46C of the first to third modified examples or other forms as in the first embodiment. .
〔第3実施形態〕
 第3実施形態では、図11に示すように、第1実施形態に係るガイディングカテーテル12と筒状本体部40(交換補助部11a)が一体成形されることにより、1つのガイディングカテーテル12Aとして構成されている点で第1及び第2実施形態とは異なる。換言すれば、このガイディングカテーテル12Aは、カテーテル手技において挿入デバイス18の交換を補助する機能を具備している。
[Third Embodiment]
In the third embodiment, as shown in FIG. 11, the guiding catheter 12 according to the first embodiment and the cylindrical main body 40 (exchange assisting portion 11a) are integrally formed, thereby forming one guiding catheter 12A. It differs from 1st and 2nd embodiment by the point comprised. In other words, the guiding catheter 12A has a function of assisting the exchange of the insertion device 18 in the catheter procedure.
 また、ガイディングカテーテル12Aは、第1実施形態に係るハブ28を省いて、管体26を交換補助部11aにより連結支持する構成となっている。すなわち、管体26の基端側にはストッパ部46が直接的に連なっている。そして、ストッパ部46の基端側に、上述した胴体部48、基端接続部50が設けられている。この場合、術者は、胴体部48をハブとして把持し、管体26を操作することが可能である。勿論、ガイディングカテーテル12Aは、ストッパ部46より先端側に管体26を操作するためのハブが設けられていてもよい。 Further, the guiding catheter 12A has a configuration in which the hub 28 according to the first embodiment is omitted and the tube body 26 is connected and supported by the replacement auxiliary portion 11a. That is, the stopper portion 46 is directly connected to the proximal end side of the tube body 26. The body portion 48 and the base end connection portion 50 described above are provided on the base end side of the stopper portion 46. In this case, the surgeon can hold the body portion 48 as a hub and operate the tube body 26. Of course, the guiding catheter 12 </ b> A may be provided with a hub for operating the tube body 26 on the distal end side from the stopper portion 46.
 また、基端接続部50には、Y型コネクタ14の先端接続部60が接続可能であり、これによりガイディングカテーテル12Aは、ガイディングカテーテル組立体16Aとして使用することができる。 Also, the distal end connection portion 60 of the Y-type connector 14 can be connected to the proximal end connection portion 50, whereby the guiding catheter 12A can be used as the guiding catheter assembly 16A.
 このようにガイディングカテーテル12Aが構成されていても、第1及び第2実施形態に係る交換補助デバイス10、10Aと同様の効果を得ることができる。また、ガイディングカテーテル12Aでも、部品点数を少なくすることができ、製造コストの低減、組立時の手間の軽減等を図ることができる。なお、ガイドワイヤ24の移動を規制するストッパ部46は、第1実施形態と同様に、第1~第3変形例のストッパ部46A~46Cの構成又は他の形態を取り得ることは勿論である。 Even if the guiding catheter 12A is configured in this manner, the same effects as those of the replacement assisting devices 10 and 10A according to the first and second embodiments can be obtained. In the guiding catheter 12A, the number of parts can be reduced, and the manufacturing cost can be reduced and the labor for assembling can be reduced. It should be noted that the stopper portion 46 that restricts the movement of the guide wire 24 can take the configuration of the stopper portions 46A to 46C of the first to third modified examples or other forms as in the first embodiment. .
〔第4実施形態〕
 第4実施形態では、図12に示すように、第1実施形態に係るガイディングカテーテル12、筒状本体部40(交換補助部11b)及びY型コネクタ14が一体成形され、1つのガイディングカテーテル12Bとして構成されている点で第1~第3実施形態とは異なる。すなわち、このガイディングカテーテル12Bは、第3実施形態に係るガイディングカテーテル12AにY型コネクタ14の機能を具備させたものである。
[Fourth Embodiment]
In the fourth embodiment, as shown in FIG. 12, the guiding catheter 12 according to the first embodiment, the cylindrical main body portion 40 (exchange assisting portion 11b), and the Y-type connector 14 are integrally formed, and one guiding catheter is formed. This is different from the first to third embodiments in that it is configured as 12B. That is, this guiding catheter 12B is obtained by providing the guiding catheter 12A according to the third embodiment with the function of the Y-type connector 14.
 なお、ガイディングカテーテル12Bは、ストッパ部46に連なる胴体部48先端から第1ポート62を含む距離が、ラピッドエクスチェンジタイプの挿入デバイス18におけるガイドワイヤ24の収容部分よりも長く設定されているが、胴体部48の先端から基端までの距離は、挿入デバイス18におけるガイドワイヤ24の収容部分よりも短く設定してもよい。 In the guiding catheter 12B, the distance including the first port 62 from the distal end of the body portion 48 connected to the stopper portion 46 is set to be longer than the accommodating portion of the guide wire 24 in the rapid exchange type insertion device 18. The distance from the distal end to the proximal end of the body portion 48 may be set shorter than the accommodating portion of the guide wire 24 in the insertion device 18.
 このようにガイディングカテーテル12Bが構成されていても、第1~第3実施形態に係る交換補助デバイス10、10A及びガイディングカテーテル12Aと同様の効果を得ることができる。この場合、部品点数をさらに少なくなるため、製造コストを大幅に低減できる他に、組立作業をなくすことができる。なお、ガイドワイヤ24の移動を規制するストッパ部46は、第1実施形態と同様に、第1~第3変形例のストッパ部46A~46Cの構成又は他の形態を取り得ることは勿論である。 Even if the guiding catheter 12B is configured in this way, the same effects as those of the exchange assisting devices 10 and 10A and the guiding catheter 12A according to the first to third embodiments can be obtained. In this case, since the number of parts is further reduced, the manufacturing cost can be greatly reduced, and the assembling work can be eliminated. It should be noted that the stopper portion 46 that restricts the movement of the guide wire 24 can take the configuration of the stopper portions 46A to 46C of the first to third modified examples or other forms as in the first embodiment. .
 上記において、本発明について好適な実施形態を挙げて説明したが、本発明は前記実施形態に限定されるものではなく、本発明の要旨を逸脱しない範囲において、種々の改変が可能なことは言うまでもない。 In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

Claims (7)

  1.  ワイヤ(24)に沿って案内される挿入デバイス(18)を挿通可能な筒状本体部(40、41、120)により構成され、一の挿入デバイスから他の挿入デバイスへの交換を補助するための交換補助デバイス(10、10A)であって、
     前記筒状本体部(40、41、120)は、その内部を軸方向に延在し前記挿入デバイス(18)及び前記ワイヤ(24)が移動自在な空洞部(42、43、100、124)と、
     前記空洞部(42、43、100、124)を内部に有し、前記挿入デバイス(18)の先端部が所定位置より基端側に移動した状態で、前記挿入デバイス(18)から露出されるワイヤ(24)の移動のみを規制するストッパ部(46、46A~46C)とを備える
     ことを特徴とする交換補助デバイス(10、10A)。
    It is constituted by a cylindrical main body (40, 41, 120) through which an insertion device (18) guided along the wire (24) can be inserted, and assists the exchange from one insertion device to another. Replacement auxiliary device (10, 10A),
    The cylindrical main body (40, 41, 120) extends in the axial direction inside thereof and is a cavity (42, 43, 100, 124) in which the insertion device (18) and the wire (24) are movable. When,
    It has the cavity (42, 43, 100, 124) inside, and is exposed from the insertion device (18) in a state where the distal end portion of the insertion device (18) has moved from the predetermined position to the proximal side. A replacement auxiliary device (10, 10A) comprising a stopper portion (46, 46A to 46C) for restricting only the movement of the wire (24).
  2.  請求項1記載の交換補助デバイス(10、10A)において、
     前記ストッパ部(46)は、
     前記挿入デバイス(18)及び前記ワイヤ(24)が挿通される穴部(96)を有し、前記筒状本体部(40)に対し回転することで前記穴部(96)を挿通する前記ワイヤ(24)を捻って係止する捻り部(88)と、
     前記筒状本体部(40、41)の外側に露出され前記捻り部(88)の回転を操作可能な捻り操作部(90)とを備える
     ことを特徴とする交換補助デバイス(10、10A)。
    Replacement auxiliary device (10, 10A) according to claim 1,
    The stopper portion (46)
    The wire having a hole (96) through which the insertion device (18) and the wire (24) are inserted, and being inserted through the hole (96) by rotating with respect to the cylindrical main body (40). A twisted portion (88) for twisting and locking (24);
    A replacement assisting device (10, 10A) comprising: a twisting operation portion (90) exposed to the outside of the cylindrical main body portion (40, 41) and capable of operating the rotation of the twisting portion (88).
  3.  請求項1記載の交換補助デバイス(10、10A)において、
     前記ストッパ部(46A)は、
     前記空洞部(100)の断面形状に略一致する面形状を有し、所定操作にともない前記空洞部(100)を閉塞するように動作することで前記ワイヤ(24)を係止する板部材(106)と、
     前記筒状本体部(40、41)の外側に露出され前記板部材(106)による前記空洞部(100)の閉塞を操作可能な板部材操作部(110)とを備える
     ことを特徴とする交換補助デバイス(10、10A)。
    The replacement auxiliary device (10, 10A) according to claim 1,
    The stopper portion (46A)
    A plate member (having a surface shape substantially coincident with the cross-sectional shape of the hollow portion (100)) and locking the wire (24) by operating so as to close the hollow portion (100) with a predetermined operation. 106)
    A plate member operation portion (110) exposed outside the cylindrical main body portion (40, 41) and operable to close the cavity portion (100) by the plate member (106). Auxiliary device (10, 10A).
  4.  請求項1記載の交換補助デバイス(10、10A)において、
     前記ストッパ部(46B、46C)は、
     押圧操作により前記空洞部(124)の略直交方向に変位し、前記空洞部(124)を構成する内壁(124a)との間で前記ワイヤ(24)を係止する押圧部材(128)と、
     前記押圧操作に抗するように前記押圧部材(128)を弾性的に押し出す弾性部材(130)とを備える
     ことを特徴とする交換補助デバイス(10、10A)。
    Replacement auxiliary device (10, 10A) according to claim 1,
    The stopper portion (46B, 46C)
    A pressing member (128) that is displaced in a substantially orthogonal direction of the cavity (124) by a pressing operation, and that locks the wire (24) with an inner wall (124a) that constitutes the cavity (124);
    An exchange auxiliary device (10, 10A) comprising: an elastic member (130) that elastically pushes out the pressing member (128) so as to resist the pressing operation.
  5.  請求項1~4のいずれか1項に記載の交換補助デバイス(10、10A)において、
     前記挿入デバイス(18)は、該挿入デバイス(18)の途中位置に設けられた露出箇所(75、85)から前記ワイヤ(24)を露出させるラピッドエクスチェンジタイプであり、
     前記筒状本体部(40、41、120)の前記ストッパ部(46、46A~46C)から基端部までの距離は、前記挿入デバイス(18)の先端部から前記露出箇所(75、85)までの距離よりも長い
     ことを特徴とする交換補助デバイス(10、10A)。
    The auxiliary exchange device (10, 10A) according to any one of claims 1 to 4,
    The insertion device (18) is a rapid exchange type that exposes the wire (24) from an exposed portion (75, 85) provided at an intermediate position of the insertion device (18).
    The distance from the stopper portion (46, 46A to 46C) to the base end portion of the cylindrical main body portion (40, 41, 120) is the exposure location (75, 85) from the distal end portion of the insertion device (18). Replacement auxiliary device (10, 10A) characterized in that it is longer than the distance up to.
  6.  ワイヤ(24)に沿って案内される挿入デバイス(18)を、内部を通して生体内の所望位置に送達可能なガイディングカテーテル(12)と、
     前記挿入デバイス(18)を挿通可能な筒状本体部(40、41、120)により構成され、一の挿入デバイスから他の挿入デバイスへの交換を補助するための交換補助デバイス(10、10A)とを、互いに接続することにより組み立てられるガイディングカテーテル組立体(16、16A)であって、
     前記筒状本体部(40、41、120)は、その内部を軸方向に延在し前記挿入デバイス(18)及び前記ワイヤ(24)が移動自在な空洞部(42、43、100、124)と、
     前記空洞部(42、43、100、124)を内部に有し、前記挿入デバイス(18)の先端部が所定位置より基端側に移動した状態で、前記挿入デバイス(18)から露出されるワイヤ(24)の移動のみを規制するストッパ部(46、46A~46C)とを備える
     ことを特徴とするガイディングカテーテル組立体(16、16A)。
    A guiding catheter (12) capable of delivering an insertion device (18) guided along the wire (24) through the interior to a desired location in vivo;
    Replacement auxiliary device (10, 10A) that is configured by a cylindrical main body (40, 41, 120) through which the insertion device (18) can be inserted and assists replacement from one insertion device to another insertion device. A guiding catheter assembly (16, 16A) assembled by connecting together,
    The cylindrical main body (40, 41, 120) extends in the axial direction inside thereof and is a cavity (42, 43, 100, 124) in which the insertion device (18) and the wire (24) are movable. When,
    It has the cavity (42, 43, 100, 124) inside, and is exposed from the insertion device (18) in a state where the distal end portion of the insertion device (18) has moved from the predetermined position to the proximal side. A guiding catheter assembly (16, 16A) comprising a stopper (46, 46A to 46C) for restricting only the movement of the wire (24).
  7.  ワイヤ(24)に沿って案内される挿入デバイス(18)を、内部を通して生体内の所望位置に送達可能なガイディングカテーテル(12A、12B)であって、
     当該ガイディングカテーテル(12A、12B)の基端側には、前記挿入デバイス(18)を挿通可能な筒状本体部により構成され、一の挿入デバイスから他の挿入デバイスへの交換を補助するための交換補助部(11a、11b)が設けられ、
     前記交換補助部(11a、11b)は、その内部を軸方向に延在し前記挿入デバイス(18)及び前記ワイヤ(24)が移動自在な空洞部(42、43、100、124)と、
     前記空洞部(42、43、100、124)を内部に有し、前記挿入デバイス(18)の先端部が所定位置より基端側に移動した状態で、前記挿入デバイス(18)から露出されるワイヤ(24)の移動のみを規制するストッパ部(46、46A~46C)とを備える
     ことを特徴とするガイディングカテーテル(12A、12B)。
    A guiding catheter (12A, 12B) capable of delivering an insertion device (18) guided along a wire (24) through the interior to a desired location in a living body,
    The proximal end side of the guiding catheter (12A, 12B) is constituted by a cylindrical main body portion through which the insertion device (18) can be inserted, and assists the exchange from one insertion device to another insertion device. Replacement auxiliary parts (11a, 11b) are provided,
    The exchange assisting portion (11a, 11b) has a hollow portion (42, 43, 100, 124) that extends in the axial direction inside thereof and in which the insertion device (18) and the wire (24) are movable,
    It has the cavity (42, 43, 100, 124) inside, and is exposed from the insertion device (18) in a state where the distal end portion of the insertion device (18) has moved from the predetermined position to the proximal side. A guiding catheter (12A, 12B) comprising a stopper portion (46, 46A to 46C) for restricting only the movement of the wire (24).
PCT/JP2013/051794 2013-01-28 2013-01-28 Replacement assist device, guiding catheter assembly, and guiding catheter WO2014115336A1 (en)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230091819A1 (en) * 2021-09-22 2023-03-23 Mark Wayne LENOX Catheter delivery guidewire clamp

Citations (4)

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US5299575A (en) * 1992-07-23 1994-04-05 Sandridge James B Short exchange guiding catheter apparatus and method
US5383853A (en) * 1992-11-12 1995-01-24 Medtronic, Inc. Rapid exchange catheter
JPH0889588A (en) * 1994-09-29 1996-04-09 Terumo Corp Catheter
JP2002034905A (en) * 2000-04-17 2002-02-05 Olympus Optical Co Ltd Endoscope, and its endoscope system

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Publication number Priority date Publication date Assignee Title
US5299575A (en) * 1992-07-23 1994-04-05 Sandridge James B Short exchange guiding catheter apparatus and method
US5383853A (en) * 1992-11-12 1995-01-24 Medtronic, Inc. Rapid exchange catheter
JPH0889588A (en) * 1994-09-29 1996-04-09 Terumo Corp Catheter
JP2002034905A (en) * 2000-04-17 2002-02-05 Olympus Optical Co Ltd Endoscope, and its endoscope system

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20230091819A1 (en) * 2021-09-22 2023-03-23 Mark Wayne LENOX Catheter delivery guidewire clamp
US11752309B2 (en) * 2021-09-22 2023-09-12 Mark Wayne LENOX Catheter delivery guidewire clamp

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