WO2014115336A1 - Dispositif d'assistance de remplacement, ensemble de cathéter de guidage, et cathéter de guidage - Google Patents

Dispositif d'assistance de remplacement, ensemble de cathéter de guidage, et cathéter de guidage 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
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English (en)
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/fr
Publication of WO2014115336A1 publication Critical patent/WO2014115336A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0169—Exchanging 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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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne un dispositif d'assistance de remplacement (10) constitué d'un corps cylindrique (40) au travers duquel un dispositif d'insertion (18) peut être inséré en étant guidé le long d'un fil-guide (24), et servant à assister le remplacement d'un dispositif d'insertion par un autre dispositif d'insertion. Le corps cylindrique (40) présente une partie cavité (42) s'étendant dans la direction axiale en passant par l'intérieur de cette dernière, à travers laquelle le dispositif d'insertion (18) et le fil-guide (24) peuvent être déplacés, et une partie d'arrêt (46) ayant la partie cavité (42) à l'intérieur, pour restreindre exclusivement le déplacement du fil-guide (24) exposé depuis le dispositif d'insertion (18), lorsque l'extrémité distale du dispositif d'insertion (18) a été déplacée en direction du côté de l'extrémité basale à partir d'une position prescrite.
PCT/JP2013/051794 2013-01-28 2013-01-28 Dispositif d'assistance de remplacement, ensemble de cathéter de guidage, et cathéter de guidage WO2014115336A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/JP2013/051794 WO2014115336A1 (fr) 2013-01-28 2013-01-28 Dispositif d'assistance de remplacement, ensemble de cathéter de guidage, et cathéter de guidage

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Application Number Priority Date Filing Date Title
PCT/JP2013/051794 WO2014115336A1 (fr) 2013-01-28 2013-01-28 Dispositif d'assistance de remplacement, ensemble de cathéter de guidage, et cathéter de guidage

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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)

* Cited by examiner, † Cited by third party
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 (ja) * 1994-09-29 1996-04-09 Terumo Corp カテーテル
JP2002034905A (ja) * 2000-04-17 2002-02-05 Olympus Optical Co Ltd 内視鏡とその内視鏡システム

Patent Citations (4)

* Cited by examiner, † Cited by third party
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 (ja) * 1994-09-29 1996-04-09 Terumo Corp カテーテル
JP2002034905A (ja) * 2000-04-17 2002-02-05 Olympus Optical Co Ltd 内視鏡とその内視鏡システム

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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