WO2023157444A1 - Dispositif médical et méthode de traitement - Google Patents

Dispositif médical et méthode de traitement Download PDF

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Publication number
WO2023157444A1
WO2023157444A1 PCT/JP2022/046137 JP2022046137W WO2023157444A1 WO 2023157444 A1 WO2023157444 A1 WO 2023157444A1 JP 2022046137 W JP2022046137 W JP 2022046137W WO 2023157444 A1 WO2023157444 A1 WO 2023157444A1
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WO
WIPO (PCT)
Prior art keywords
tube
distal
outer tube
catheter
shaft
Prior art date
Application number
PCT/JP2022/046137
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English (en)
Japanese (ja)
Inventor
大 冨田
春佳 杉村
嘉純 西村
透 住吉
健一 堀場
徹也 福岡
Original Assignee
テルモ株式会社
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Application filed by テルモ株式会社 filed Critical テルモ株式会社
Publication of WO2023157444A1 publication Critical patent/WO2023157444A1/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
    • 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
    • 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
    • A61M25/06—Body-piercing guide needles or the like

Definitions

  • the present invention relates to a medical device and treatment method for inserting into a blood vessel for treatment.
  • Guiding catheters are used to guide therapeutic devices such as balloon catheters and stent placement catheters that are inserted into blood vessels for treatment and diagnosis, etc., to the target site.
  • PTCA percutaneous transluminal coronary angioplasty
  • a guide wire for a guiding catheter is inserted through the skin of the wrist or thigh into the artery, and then to the entrance of the coronary artery. reach.
  • a guiding catheter is inserted along the guidewire into the artery, and the guidewire for the guiding catheter is subsequently withdrawn to engage the coronary ostia.
  • a thinner guidewire for the therapeutic device is inserted through the lumen of the guiding catheter and passed through the lesion in the coronary artery.
  • a balloon catheter is inserted along the guidewire for the treatment device, the tip of the balloon catheter is protruded from the opening of the tip of the guiding catheter, and advanced through the coronary artery to the periphery along the guidewire that has passed through the lesion. is placed on the lesion and the balloon is inflated for treatment.
  • Patent Document 1 a tubular portion connected to the distal end of a linear portion made of a metal wire is inserted into a guiding catheter and protruded from the distal end side to form a continuous tube of the guiding catheter and the tubular portion.
  • Devices are described for aspirating intravascular foreign bodies through a cavity. Foreign matter sucked from the tip opening of the cylindrical portion is discharged to the outside from the lumen of the cylindrical portion through the lumen of the guiding catheter.
  • the foreign matter When foreign matter is aspirated by the device described in Patent Document 1, the foreign matter may remain inside the guiding catheter. In this case, there is a possibility that the foreign matter remaining inside the guiding catheter will return to the blood vessel due to the operation after suction.
  • the present invention has been made to solve the above-described problems. It is an object of the present invention to provide a medical device and a treatment method capable of suppressing re-returning into a blood vessel after remaining in a blood vessel.
  • a medical device for achieving the above object is a medical device comprising a therapeutic device having an elongated shaft and an outer tube into which the shaft is inserted, wherein the outer tube holds the shaft.
  • Another tube that surrounds and forms a flow path with the outer peripheral surface of the shaft and has an outer diameter that is smaller than the proximal end or can be reduced to an outer diameter that is smaller than the proximal end. It is characterized by having a tip connection part at the tip that can be inserted into the body.
  • a treatment method according to the present invention for achieving the above object is a treatment method for percutaneously treating a blood vessel, comprising the steps of inserting a guiding catheter into the blood vessel, a tubular tip tube and a base from the tip tube.
  • a guide extension catheter having a linear shaft extending toward the end side is inserted into the inside of the guiding catheter from the proximal end side of the guiding catheter, and a portion of the distal tube extends distally of the guiding catheter.
  • a therapeutic device having an elongated shaft surrounding the shaft and forming a flow path with the outer peripheral surface of the shaft and having a smaller outer diameter than the proximal end;
  • the outer tube having a distal end connection portion that can be inserted into another tubular body can be reduced to a smaller outer diameter than the proximal side, and the guiding catheter is inserted from the proximal side of the guiding catheter. and causing the distal end of the therapeutic device to protrude distally beyond the distal tube through the interior of the distal tube, and inserting the distal connection portion into the proximal opening of the distal tube.
  • the distal end connector of the outer tube is inserted into the proximal opening of the distal end tube of the guide extension catheter having the tubular distal end tube fixed to the distal end of the elongated linear shaft. can be connected.
  • a treatment device that penetrates the tip tube and protrudes to the distal side beyond the tip tube performs treatment in the blood vessel, and an object separated from the blood vessel or the treatment device due to the treatment is transferred to the connected guide extension catheter. It can be discharged to the outside using the lumen of the tip tube and the outer tube. Therefore, the present medical device can effectively discharge an object separated from the blood vessel or the therapeutic device by treatment with the therapeutic device to the outside of the body, and prevents the object from remaining inside the guiding catheter and returning to the blood vessel. can be suppressed.
  • an object separated from the blood vessel or treatment device by treatment can be discharged to the outside using the connected tip tube of the guide extension catheter and the lumen of the outer tube. Therefore, the present treatment method can effectively expel an object separated from the blood vessel or the treatment device by treatment with the treatment device, and prevents the object from remaining inside the guiding catheter and returning to the blood vessel. can be suppressed.
  • the outer tube may be part of an outer catheter that is connected to the proximal end of the outer tube and has an outer hub that includes a suction connection that can be connected to a suction supply that supplies suction.
  • the outer hub has a main passage through which the shaft can pass, and a branch passage branching from the main passage and opening to the outside at the suction connection portion, and a branch portion of the main passage and the branch passage.
  • a valve element slidable with the shaft may be arranged on the proximal side of the shaft.
  • the therapeutic device may have an expandable/contractible balloon at the distal end of the shaft.
  • the medical device has a guide extension catheter having a tubular distal tube and a linear shaft extending proximally from the distal tube, the distal tube having a distal lumen through which the therapeutic device can pass.
  • a proximal opening that opens to the outside may be formed at the proximal end of the distal lumen, and the distal connecting portion of the outer catheter may be inserted in close contact with the proximal opening. This makes the medical device less likely to leak pressure between the tip tube and the outer tube. Therefore, the medical device can improve suction efficiency.
  • the outer tube may have grooves formed on the outer peripheral surface along the axial direction of the outer tube.
  • FIG. 3 is a cross-sectional view showing a state in which the medical device according to this embodiment is inserted into a guiding catheter; 3A is a cross-sectional view taken along line AA of FIG. 2, and FIG. 4B is a cross-sectional view taken along line BB of FIG.
  • FIG. 2 is a cross-sectional view for explaining the state of use of the medical device according to the present embodiment, where (A) is the state where the guide extension catheter is inserted into the guiding catheter, and (B) is the state where the medical device is inserted into the guiding catheter. indicates FIG. 4 is an enlarged plan view of the tip tube;
  • distal side the side of the device that is inserted into a blood vessel
  • proximal side the side of the device that is manipulated
  • a medical device 10 having an intermediate opening according to the present embodiment is inserted into a guiding catheter 100 to treat a lesion and discharge objects produced by the treatment, as shown in FIGS. 1 to 3. .
  • the medical device 10 includes a therapeutic device 20 having an elongate tubular shaft 21, an outer catheter 30 having an outer tube 31 surrounding the tubular shaft 21, and a guide extension catheter 40 having a tip tube 41 into which the tubular shaft 21 can be inserted. and
  • the guiding catheter 100 is a catheter with an elongated tubular body for guiding the therapeutic device 20 to a predetermined position within the blood vessel, and has a catheter tip opening 101 .
  • the guide extension catheter 40 is used to extend a tubular body for guiding the therapeutic device 20 to a predetermined position within the blood vessel from the guiding catheter 100.
  • the guide extension catheter 40 is inserted, for example, into a curved or bent coronary artery from the catheter tip opening 101 of the guiding catheter 100 placed in the blood vessel to the lesion, and the therapeutic device 20 smoothly reaches the lesion.
  • the guide extension catheter 40 includes a tubular distal end tube 41, a linear shaft 42 connected to the distal end tube 41 and extending from the distal end tube 41 toward the proximal side, and a grip portion to which the proximal end of the linear shaft 42 is fixed. 46.
  • the distal tube 41 is a tubular body having flexibility, and has a distal lumen 43 penetrating from the distal end to the proximal end.
  • a proximal opening 44 through which a distal lumen 43 opens is formed at the proximal end of the distal tube 41 .
  • a tip opening 45 through which the tip lumen 43 opens is formed at the tip of the tip tube 41 .
  • the proximal end portion of the distal tube 41 is formed to be inclined with respect to the axis X of the distal tube 41, and the proximal end opening 44 is also formed to be inclined. Therefore, the base end portion of the distal end tube 41 is formed in a half-pipe shape that opens sideways (in a direction perpendicular to the axis X).
  • the distal tube 41 can move through the lumen of the guiding catheter 100 and protrude distally from the catheter distal opening 101 of the guiding catheter 100 . That is, in the procedure, the tip tube 41 of the guide extension catheter 40 can be inserted closer to the lesion site than the guiding catheter 100 to give a stable backup to the therapeutic device 20 . Furthermore, the distal tube 41 can receive a suction force from the proximal side and suction an object from the distal opening 45 .
  • the tip tube 41 is made of a resin material. Although the constituent material of the tip tube 41 is not particularly limited, it is preferably, for example, a resin material or a resin material containing a metal reinforcing wire for reinforcement.
  • the linear shaft 42 is a flexible wire, is connected to the distal end tube 41, and extends from the distal end tube 41 to the proximal side.
  • the material of the linear shaft 42 is not particularly limited, it is preferably stainless steel, nickel-titanium alloy, or the like.
  • the proximal end of the linear shaft 42 is fixed to the grasping portion 46 .
  • the grasping part 46 is a part that is easily grasped and operated by the operator.
  • the therapeutic device 20 is a balloon catheter in this embodiment, and includes an elongated tubular shaft 21, a hub 22 fixed to the proximal end of the tubular shaft 21, and a balloon 23 fixed to the distal end of the tubular shaft 21. It has
  • the tubular shaft 21 includes an outer tubular shaft 24 which is a tubular body with open distal and proximal ends, and an inner tubular shaft 25 arranged inside the outer tubular shaft 24 .
  • the outer tubular shaft 24 has an expansion lumen 26 through which an expansion fluid for expanding the balloon 23 flows, and the inner tubular shaft 25 has a guide wire lumen 27 through which the guide wire 120 is inserted. formed.
  • the inner tubular shaft 25 has a distal end that passes through the inside of the balloon 23 and is open on the distal side of the balloon 23 , and a proximal end that passes through the side wall of the outer tubular shaft 24 to reach the outer tubular shaft 24 . It is liquid-tightly fixed by adhesive or heat-sealing.
  • the hub 22 includes an expansion opening 28 that communicates with the expansion lumen 26 of the outer tubular shaft 24 and functions as a port for the inflow and outflow of expansion fluid. Hub 22 is secured to the proximal end of outer tubular shaft 24 .
  • the balloon 23 has its distal end fixed to the inner tubular shaft 25 and its proximal end fixed to the outer tubular shaft 24 , and the inside of the balloon 23 communicates with the expansion lumen 26 .
  • the balloon 23 can be expanded radially outward by being supplied with fluid from the expansion lumen 26 and can be contracted radially inward by discharging fluid to the expansion lumen 26 .
  • a fat-soluble compound containing a fat-soluble drug is placed on the outer surface of the balloon 23, but the fat-soluble compound may not be placed, and the drug solution leaks from the inside of the balloon 23 through the pores provided in the balloon 23. It may be something to do.
  • the outer catheter 30 has an outer tube 31 surrounding the tubular shaft 21 of the therapeutic device 20, an outer hub 32 fixed to the proximal end of the outer tube 31, and a valve body 33 arranged within the outer hub 32. ing.
  • the outer tube 31 is a tubular body having flexibility.
  • the outer tube 31 includes an outer tube base end portion 34 fixed to the outer hub 32 , an outer tube center portion 35 disposed on the distal end side of the outer tube base end portion 34 , and a distal end portion of the outer tube 31 . and a distal connection portion 36 connectable to the distal tube 41 .
  • the proximal end portion 34 of the outer tube has a tubular shape and is fixed to the outer hub 32 .
  • the outer catheter 30 may be, for example, only the outer tube 31 , or may be a combination of the outer tube 31 with a Y connector attached to the proximal end thereof, or a detachable hub with a branch port attached to the proximal end of the outer tube 31 .
  • a groove 37 is formed along the axial center X direction of the outer tube 31 on the outer peripheral surface of the outer tube central portion 35 .
  • Groove 37 can accommodate at least a portion of linear shaft 42 of guide extension catheter 40 .
  • the tip connection portion 36 has an inner diameter and an outer diameter smaller than those of the outer tube central portion 35 .
  • the outer tube 31 preferably has a portion where the inner diameter and the outer diameter gradually decrease from the outer tube central portion 35 toward the distal connection portion 36 .
  • the outer diameter of the tip connection portion 36 is slightly smaller than the inner diameter of the tip tube 41 .
  • the distal connection part 36 has a length L or more in the direction of the axis X so that it can be inserted into the base end opening 44 having a length L (see FIG. 2) in the direction of the axis X without a gap. is preferred.
  • the portion inserted into the proximal end opening 44 is tapered, and the tapered portion smaller than the inner diameter of the distal end tube 41 of the guide extension catheter 40 is in close contact with the distal end lumen 43 or the proximal end opening 44 to connect the distal end more proximally.
  • the outer diameter of the portion 36 may be larger than the inner diameter of the distal end tube 41, or an inverted figure-eight shape may be used in which only the half-pipe opening side (partially opening side) has a larger outer diameter.
  • the distal end connecting portion 36 of the outer tube 31 has a smaller outer diameter than the outer tube central portion 35 and the outer tube proximal end portion 34 on the proximal side of the distal end connecting portion 36 of the outer tube 31.
  • it does not have an outer diameter smaller than that of the outer tube central portion 35 or the outer tube proximal end portion 34, and may have an outer diameter approximately equal to that of the outer tube central portion 35 or the outer tube proximal end portion 34, for example. good. In this case, it becomes easier to insert the therapeutic device 20 into the outer tube 31 .
  • the distal connection portion 36 of the outer tube 31 can be reduced in diameter, the therapeutic device 20 is inserted into the outer tube 31, and the balloon 23 arranged at the distal end of the therapeutic device 20 is opened at the distal end of the distal connection portion 36.
  • the diameter of the tip connecting portion 36 can be reduced after projecting from the portion to the tip side.
  • the outer tube 31 is formed of, for example, a heat-shrinkable tube, the distal end portion of the outer tube 31 is heated after the therapeutic device 20 is inserted into the outer tube 31 to reduce the diameter of the distal end connecting portion 36 of the outer tube 31.
  • the heat-shrinkable tube is, for example, a single-layer heat-shrinkable tube having a thickness of about 0.1 mm, and may be peelable so that the outer tube 31 can be easily removed after use.
  • the outer hub 32 has a main passage 38 that communicates with the lumen of the outer tube 31 and penetrates in the extending direction of the outer tube 31, and a branch passage 39 that branches from the main passage 38 and opens at a side suction connection portion 39A. have.
  • the valve element 33 is arranged closer to the proximal end than the branched portion of the main passage 38 and the branch passage 39 .
  • the suction connection portion 39A can be connected to a suction force supply portion (for example, a tube) that supplies suction force (negative pressure) from a suction source such as a pump.
  • the outer hub 32 may not have the branch passage 39 and the valve body 33 . In this case, the outer hub 32 may be connected to the opening of the main passage 38 with a Y connector having a branching passage and the valve body 33 .
  • the operator percutaneously inserts a guide wire for the guiding catheter 100 into the femoral artery, radial artery, or the like, and pushes the guiding catheter 100 along the guide wire to, for example, the coronary ostium of the ascending aorta.
  • the tip of the catheter 100 is engaged in a hooking manner.
  • the operator removes the guide wire for the guiding catheter 100, inserts a thinner guide wire 120 through the proximal opening of the guiding catheter 100, and inserts it through the catheter tip opening 101 of the guiding catheter 100. Insert into coronary artery.
  • the operator inserts the guide extension catheter 40 with the proximal end of the guide wire 120 inserted into the distal lumen 43 into the opening on the proximal side of the guiding catheter 100 and pushes it forward. It is protruded in the distal direction from the distal opening 101 and inserted into the coronary artery.
  • the operator advances the guide extension catheter 40 while leading the guide wire 120 so that the guide extension catheter 40 reaches the vicinity of the stenosed lesion.
  • the operator inserts the proximal end of the guidewire 120 into the guidewire lumen 27 of the therapeutic device 20 .
  • the therapeutic device 20 has been inserted into the outer catheter 30 .
  • the operator inserts the therapeutic device 20 and the outer catheter 30 into the proximal end opening 44 of the guiding catheter 100 and pushes them forward, and the guide extension arranged inside the guiding catheter 100 is pushed forward. It is inserted into proximal opening 44 of distal tube 41 of catheter 40 .
  • the therapeutic device 20 passes through the distal lumen 43 of the distal tube 41 and reaches the vicinity of the lesion of the coronary artery from the distal opening 45 of the distal tube 41 .
  • the operator places the balloon 23 inside the stenosed lesion.
  • the operator moves the outer catheter 30 in the distal direction while maintaining the position of the therapeutic device 20 , and inserts the distal end portion of the outer catheter 30 into the proximal opening 44 of the distal tube 41 .
  • the distal end portion of the outer catheter 30 is inserted into the proximal end opening 44 of the distal end tube 41 and brought into close contact therewith.
  • the proximal opening 29 of the guide wire lumen 27 of the therapeutic device 20 is preferably positioned closer to the proximal side than the proximal opening 44 of the distal tube 41 . This can prevent the guide wire 120 from leading out of the opening 29 on the proximal side of the therapeutic device 20 into a small gap between the distal lumen 43 and the outer peripheral surface of the therapeutic device 20 .
  • the operator connects the branch passage 39 of the outer hub 32 with a suction power supply unit such as a tube connected to a suction source such as a pump. Thereafter, the operator operates the suction source to start suction, and connects an inflator or the like to the expansion opening 28 of the treatment device 20 to supply the expansion fluid.
  • a suction power supply unit such as a tube connected to a suction source such as a pump.
  • the operator operates the suction source to start suction, and connects an inflator or the like to the expansion opening 28 of the treatment device 20 to supply the expansion fluid.
  • the inflation fluid moves into the balloon 23 through the inflation lumen 26 to expand the balloon 23 . Therefore, the lesion is spread out by the balloon 23 .
  • the thrombus, plaque, calcified lesion, or the like forming the lesion may detach from the blood vessel.
  • the balloon 23 is a drug-coated balloon (DCB)
  • DCB drug-coated balloon
  • excess lipid-soluble compounds including lipid-soluble drugs and lipid-soluble solids
  • the suction force from the suction source acts on the tip opening 45 via the lumen of the outer tube 31 and the tip tube 41 . Therefore, a lesion of the blood vessel or an object detached from the therapeutic device 20 (especially the balloon 23) is sucked from the distal end opening 45 of the distal tube 41 into the distal lumen 43, and the lumen of the outer tube 31, the main passage 38 and the branch are drawn. It passes through the passage 39 and is discharged to the outside from the suction connection portion 39A.
  • the valve element 33 arranged in the main passage 38 of the outer hub 32 is arranged on the proximal side of the branching portion of the main passage 38 with the branch passage 39, the suction force is applied to the proximal end of the outer hub 32. It is possible to suppress leakage to the side. Therefore, the suction force acting on the branch passage 39 can be efficiently transmitted to the tip opening 45 .
  • the operator deflates the balloon 23 after dilating the lesion with the balloon 23 .
  • the operator stops the suction by the suction source, but continues suction to remove plaque or calcified lesions remaining on the peripheral side of the balloon 23, fat-soluble compounds (including fat-soluble drugs and fat-soluble solids), etc. may be removed.
  • the operator withdraws the therapeutic device 20 and the outer catheter 30 from the body.
  • An object sucked from the tip opening 45 of the tip tube 41 at the time of suction is discharged from the tip lumen 43 to the outside through the lumen of the outer tube 31, so that the sucked object remains inside the guiding catheter 100. hard to do. Therefore, it is possible to prevent the aspirated object from returning into the blood vessel again during the subsequent procedure using the guiding catheter 100 .
  • the medical device 10 includes the therapeutic device 20 having the elongated tubular shaft 21 and the outer tube 31 into which the tubular shaft 21 is inserted,
  • the outer tube 31 surrounds the tubular shaft 21, forms a flow path with the outer peripheral surface of the tubular shaft 21, and has an outer diameter smaller than that of the proximal end. It has a tip connecting part 36 at its tip which can be reduced in diameter and can be inserted into another tubular body.
  • the medical device 10 connects the distal end of the outer tube 31 to the proximal end opening 44 of the distal end tube 41 of the guide extension catheter 40 having the tubular distal end tube 41 fixed to the distal end of the elongated linear shaft 42 .
  • a portion 36 can be inserted and connected.
  • treatment within the blood vessel is performed by the therapeutic device 20 that penetrates the distal end tube 41 and protrudes to the distal side beyond the distal end tube 41, and the blood vessel or an object detached from the therapeutic device 20 due to the treatment is connected.
  • the suction connecting portion 39A of the outer hub 32 can be discharged to the outside.
  • the medical device 10 can effectively discharge a blood vessel or an object separated from the treatment device 20 by treatment with the treatment device 20 to the outside of the body, and the object can remain inside the guiding catheter 100 and reenter the blood vessel. can be inhibited from returning to
  • the outer tube 31 is part of the outer catheter 30 that is connected to the proximal end of the outer tube 31 and that has an outer hub 32 with a suction connection 39A to which a suction supply that supplies suction can be connected.
  • the outer hub 32 has a main passage 38 through which the tubular shaft 21 can pass, and a branch passage 39 branching from the main passage 38 and opening to the outside at a suction connection portion 39A.
  • a valve element 33 slidable on the tubular shaft 21 is arranged on the proximal end side of the branched portion of the valve.
  • the therapeutic device 20 has an expandable/contractible balloon 23 at the distal end of the tubular shaft 21 .
  • an object separated from the blood vessel by treatment with the balloon 23 can be discharged to the outside from the suction connection portion 39A of the outer hub 32 using the distal end tube 41 of the guide extension catheter 40 and the lumen of the outer tube 31 .
  • the medical device 10 has a guide extension catheter 40 having a tubular distal tube 41 and a linear shaft 42 extending proximally from the distal tube 41, the distal tube 41 being a distal end through which the therapeutic device 20 can penetrate. It has a lumen 43 , and a proximal opening 44 that opens to the outside is formed at the proximal end of the distal lumen 43 . This makes it difficult for the medical device 10 to leak pressure between the distal tube 41 and the outer tube 31 . Therefore, the medical device 10 can improve suction efficiency.
  • a groove 37 is formed in the outer peripheral surface of the outer tube 31 along the axial center X direction of the outer tube 31 .
  • the medical device 10 can stably arrange the linear shaft 42 of the guide extension catheter 40 used together with the outer tube 31 in the groove 37 of the outer tube 31, thereby enabling stable suction.
  • the treatment method in this embodiment is a treatment method for percutaneously treating a blood vessel, and includes the steps of inserting the guiding catheter 100 into the blood vessel, and A guide extension catheter 40 having a linear shaft 42 extending to the side is inserted into the inside of the guiding catheter 100 from the proximal end side of the guiding catheter 100, and a portion of the distal tube 41 is positioned further than the guiding catheter 100.
  • a therapeutic device 20 having an elongated tubular shaft 21 surrounds the tubular shaft 21 to form a flow path with the outer peripheral surface of the tubular shaft 21 and has a smaller diameter than proximally.
  • the guiding catheter 100 together with the outer tube 31 having an outer diameter or an outer diameter that can be reduced to an outer diameter smaller than that on the proximal side and provided with a distal end connector 36 at the distal end that can be inserted into another tubular body. inserting the distal end of the therapeutic device 20 into the guiding catheter 100 from the proximal side of the device, protruding the distal end of the therapeutic device 20 from the distal end tube 41 to the distal side beyond the distal end tube 41, and connecting the distal end connection portion 36 At the same time or after the step of inserting into the proximal end opening 44 of the distal tube 41, the step of performing treatment with the treatment device 20, and the treatment with the treatment device 20, suction force is applied to the outer tube 31. and expelling an object that has been removed from the blood vessel or treatment device 20 by the treatment to the outside through the interior of the tip tube 41 and the outer tube 31 .
  • an object separated from the blood vessel or treatment device 20 by treatment can be discharged to the outside using the lumen of the distal tube 41 of the connected guide extension catheter 40 and the outer tube 31. . Therefore, in this treatment method, the blood vessel or an object separated from the treatment device 20 can be effectively expelled from the body by the treatment with the treatment device 20, and the object remains inside the guiding catheter 100 and reenters the blood vessel. You can restrain yourself from going back.
  • the therapeutic device 20 in this embodiment is a rapid exchange type in which the guidewire lumen 27 is arranged only at the distal end of the tubular shaft 21, but an over-the-air device in which the guidewire lumen is formed from the distal end to the proximal end of the shaft. It may be wire type.
  • the therapeutic device is not particularly limited as long as it is a device used for intravascular treatment.
  • therapeutic devices include a stent placement catheter having a stent placed on the outer peripheral surface of a balloon, a stent placement catheter for placing a self-expanding stent in a blood vessel, and a cutting device having blades placed on the outer peripheral surface of a balloon. It may be a balloon catheter, an atherectomy device for mechanically cutting a lesion, or the like.

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Abstract

L'invention concerne : un dispositif médical qui est capable d'évacuer, vers l'extérieur d'un corps, des substances séparées d'un vaisseau sanguin ou d'un dispositif de traitement en raison d'un traitement par le dispositif de traitement, et d'éviter que des substances ne restent à l'intérieur d'un cathéter de guidage et ne reviennent dans un vaisseau sanguin ; et une méthode de traitement.　Ce dispositif médical (10) comprend un dispositif de traitement (20) comportant un long corps tubulaire (21) et un tube externe (31) dans lequel le corps tubulaire (21) est inséré. Le tube externe (31) entoure le corps tubulaire (21), forme un passage d'écoulement entre la surface périphérique externe du corps tubulaire (21) et le tube externe, présente un diamètre externe plus petit que le côté d'extrémité proximale ou peut être contracté pour présenter un diamètre externe plus petit que le côté d'extrémité proximale, et comporte, sur son extrémité distale, une section de raccordement d'extrémité distale (36) qui peut être insérée dans un autre corps tubulaire.
PCT/JP2022/046137 2022-02-17 2022-12-15 Dispositif médical et méthode de traitement WO2023157444A1 (fr)

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